AC 27/2/2013

Item no 4.87

UNIVERSITY OF MUMBAI

RevisedSyllabus Program:M.Pharm SemesterItoIV

(CreditBasedSemesterandGradingSystem witheffectfromtheacademicyear20132014)

M.Pharm.CreditBasedSystem SchemeExaminationSemestersItoIV & SyllabusSemestersItoIV ForALLBRANCHESOFM.PHARM.

M.Pharm. SemesterI(ForAllBranchesofStudy) No. Titleofthe subject Typeof Course Credits Contact hours/week ESE (hour) Weightage(%) CIA 1 ESE

C/E/S L I.L P T P ST IA Modern C 4 3 1 3 15 10 75 Pharm.&Med. Chem. 2 Modern C 4 3 1 3 15 10 75 Pharmaceutics 3 Modern C 4 3 1 3 15 10 75 Pharmacology 4 Modern C 4 3 1 3 15 10 75 Pharmaceutical Analysis 5 Studyof C 4 3 1 3 15 10 75 Natural Products 6 Seminar C 4 4 100 CIAContinuousInternalAssessment;ESEEndSemesterExamination;STSessionalTests;IAInternalAssessment,L Lectures,I.L.IntegratedLearninginvolvingTutorials,GroupDiscussions,Assignments,FieldWork;PPracticals,Lab. work,Project,CCore,EElective,SSelfStudy. TotalCredits:SemesterI24 InSemesterIlearnersofallBrancheswilltaketheabove5subjects,irrespectiveoftheirareaofspecializationin M.Pharm.TheEvaluationpatternforeverysubjectwillbe25marksforContinuousInternalAssessment(CIA)and 75marksfortheEndSemesterExamination.The25marksforCIAwillbedividedinto5marksforAttendanceand 5marksforsurprisequizzesandstudentteacherinteractionand15marksforaPeriodictestheldmidsemester. EverylearnerwilldeliveraSeminar.ThiswillevaluatedatthecollegelevelbyaCommitteeconsistingofthe Principal,andfacultyoftheDepartmentinwhichthestudentwillbedoinghisresearchwork.Aftertheconductof theSeminarthemarkswillbeforwardedbythecollege/institutiontotheUniversity.

SemesterII(Branchwise) No. Titleofthe subject Biostatistics andResearch Methodology CoreSubject1 CoreSubject2 Elective1 Elective2 Experimental Techniquesin Pharmaceutical Sciences Typeof Course C/E/S C Credits Contact hours/week L 3 I.L 1 P ESE (hour) T 3 P Weightage(%) CIE 1 4 ST 15 IA 10 ESE 75

2 3 4 5 6

C C E E C

4 4 4 4 4

3 3 3 3

1 1 1 1

3 3 3 3 6

15 15 15 15 15

10 10 10 10 10

75 75 75 75 75

CIAContinuousInternalAssessment;ESEEndSemesterExamination;STSessionalTests;IAInternalAssessment,L Lectures,I.L.IntegratedLearninginvolvingTutorials,GroupDiscussions,Assignments,FieldWork;PPracticals,Lab. work,Project,CCore,EElective,SSelfStudy. Inthesecondsemester,therewillbeonecommonpaperBiostatisticsandResearchMethodologyandapractical ExperimentalTechniquesinPharmaceuticalSciencesforallthebranchesofspecialization.Atpresentthesyllabus forExperimentalTechniquesinPharmaceuticalScienceshasbeenpreparedforthemainbranchesofspecialization namelyPharmaceuticalChemistry/MedicinalChemistry,Pharmaceutics,Pharmacognosy,Pharmaceutical Analysis/QualityAssuranceandPharmacology.StudentsofotherbranchesofspecializationlikeClinicalPharmacy, MedicinalNaturalProducts,BiopharmaceuticsandPharmacokineticsetc.canchoosetodotheexercises prescribedforanyoneoftheabovementionedbranches,preferablyselectingsomethingclosesttotheirbranchof specialization.EachBranchofSpecializationwillalsohavetwoCoresubjectsintheBranchofSpecializationand twoElectivesthatmaybeselectedfromtheListofElectivesspecifiedintheSyllabus. TheESEinthesubjectExperimentalTechniquesinPharmaceuticalScienceswillbeconductedbythe college/institutiononbehalfoftheuniversity.Aftertheconductoftheexamination,themarkswillbeforwarded bythecollege/institutiontotheUniversity TotalCredits:SemesterII24

SemestersIIIandIV ResearchworkrelatedtothetitleofthethesisthathasbeenregisteredwiththeUniversity. ThelearnershouldbeallottedaResearchGuideinSem.I.TheGuidingTeacher(ResearchSupervisor)alongwith thelearnermayplantheResearchareatobepursuedduringSems.IIIandIV.Thetitleofthethesisshouldbe communicatedtotheUniversitybeforethecommencementofSem.III.Thelearnerisexpectedtoworka minimumof40hrs/weekinResearchtobeentitledfor24CreditseachSemester.TheGuidingTeacher(Research Supervisor)willsignastatementtothiseffectattheconclusionofSemestersIIIandIV,whichmaybe communicatedtotheControllerofExaminationsattheconclusionofeachsemester.Beforecompletingthe course,thelearnerwillberequiredtogiveaColloquiumontheresearchworkcarriedoutbyhim/herduringSems. IIIandIV.TheColloquiumwillfollowanopenstructureandwillbeassessedbesidesothersbytheHeadofthe Department,theGuideandthePrincipaloftheCollege.AStatementthatthelearnerhasdeliveredaColloquium mustbesenttotheUniversityandwillbemandatedbeforetheconductofthevivavoceexaminationbythe University. Learnersshouldbeencouragedtoattendconferences,seminarswheretheymaypresenttheirresearchwork,and topublishthefindingsoftheirresearch. AttheendofSem.IVthelearnerwillsubmitathesistotheuniversity.Thiswilljointlybeevaluatedbytheguiding teacherandanexternalexaminerappointedbytheuniversityfromacademiaorfromthepharmaceuticalindustry. Theevaluationwillbeforatotalof100marks,ofwhich50markswillbegivenbytheguidingteacherand50 marksbytheexternalexaminer.Theparametersonwhichthemarkswillbegivenare:a.LiteratureSurvey(10 marks)b.Presentation(8marks)c.Methodology(7marks)d.ResultsandDiscussion(10marks)ande.Vivavoce (15marks).Thismakesatotalof50markstobegivenbytheguidingteacherandbytheexternalexaminer separately. TotalCreditsforM.Pharm.96

 SemesterI ALLBRANCHES ModernPharmaceuticalandMedicinalChemistry Unit 1 1.1 1.2 1.3 DrugDiscovery Historicalperspective LeadDiscovery LeadModificationidentificationofthepharmacophore,functionalgroupmodification, privilegedstructuresanddruglikemolecules,modificationstoincreasepotencyandthe therapeuticindex,modificationstoincreaseoralbioavailability Receptors Basicligandconceptsagonist,antagonist,partialagonist,inverseagonist,efficiencyand potency Interactions(Forces)involvedindrugreceptorcomplexes Receptortheoriesoccupancytheory,ratetheoryandactivationtheory Receptorclassificationthefoursuperfamilies ReceptorbindingassaysmeasurementofKd,Bmax andIC50 Topographicalandstereochemicalconsiderationsindrugreceptorinteractions ProdrugsandDrugDeliverySystems Enzymeactivationofdrugs,utilityofprodrugsaqueoussolubility,absorptionand distribution,sitespecificity,instability,toxicity,poorpatientacceptability,formulation problems. Carrierlinkedprodrugscarrierlinkagesforvariousfunctionalgroups,carrierlinked bipartiteprodrugs,macromoleculardrugcarriersystems,tripartiteprodrugs, mutualprodrugs,bioprecursorprodrugs(hydrolyticactivation,eliminationactivation, oxidativeactivation,reductiveactivation,nucleotideactivation,phosphorylation activation,sulfationactivationanddecarboxylationactivation). Selfstudyofspecificexamplesofdrugsthathavebeenconvertedtoprodrugsforsolving problemsrelatedtoADMEandtheirreleasemechanisms.Selfstudyofprodrugsinvolving specifictissuetargetingorspecificactivationatthetargettissue. DrugMetabolism Introductiontoxenobiotic/drugmetabolismanditsrelationtootherdefencesystems (Physicalbarriers,excretion,immunesystem). Typesofreactions(IandII),consequencesofdrugmetabolism(DM)[inactivation, bioactivation,prodrugs],organsofDM,localizationofdrugmetabolizingenzymes, CourseContent(Topics) 4hrs/week Hours 5 1 1 3

2 2.1

10 1

2.2 2.3 2.4 2.5 2.6 3 3.1

2 1 2 2 2 13 2

3.2

3.1 3.2 4 4.1

18 0.5

4.2

0.5

factorsaffectingdrugmetabolism. 4.3 CytochromeP450s:Introductiontothefamilyofenzymes,theirclassificationand nomenclature. CYP450catalyticcycle,differenttypesofreactionscatalyzedbyCYP450sandthe mechanismsofcatalysis. HumanCYP450sinvolvedinDM,theirdistributionandproperties,typicalsubstrates, specificprobesubstrates,specificinhibitors,inductionofCYPsandspecificinducers Discussionofglucuronosyltransferases,sulfotransferases,glutathioneStransferases,N acetyltransferases,andFMO[onlinessimilartothatspecifiedforCYPsaslistedabove]. Selfstudyofalcohol/aldehydedehydrogenases,xanthineandaldehydeoxidase,epoxide hydrolase,esterases,azoandnitroreductases(reactionscatalyzedbetheseenzymes, mechanismsofthereactions,typicalsubstrates/inhibitors/inducers) Enzymes Introductiontoenzymes,bindingsite,specificityofenzymecatalyzedreactionsandrate acceleration,MichaelisMentenkineticsandmethodsforplottingenzymekineticdata Mechanismsofenzymecatalysiscovalentcatalysis,acidbasecatalysis,electrostatic catalysis,someexamplesofthemechanismsofenzymecatalysis Coenzymecatalysispyridoxal5phosphate(racemases,decarboxylases, aminotransferases),nictoinamideandflavin(twoelectronmechanism,oneelectron mechanismandhydridetransfers),folicacidandthiamine(onecarbontransfer reactions). SelfstudyofHanesplot,CornishEisenthalBowdenplot, Selfstudyofrolesofcoenzymesbiotin,coenzymeA,cyanocobolamine,vitaminK 1

4.4

4.4

4.5

4.5

5 5.1

14 4

5.2

5.3

5.1 5.2 Books: 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12.

1 3 Total 60

TheOrganicChemistryofDrugDesignandDrugAction,SilvermanR.B.,AcademicPress. TextbookofDrugDesignandDiscovery,Eds.KrogsgaardLarsenP.,LiljeforsT.,MadsenU.,Taylor&Francis. DrugDiscoveryAHistory,SneaderW.,Wiley. MedicinalChemistry:AnIntroduction,ThomasG,Wiley. DrugDiscoveryAHistory,SneaderW,JohnWiley&Sons,Ltd. ComprehensiveMedicinalChemistry,SeriesEd.,HanschC.,PergamonPress. WilsonandGisvolds,TextbookofOrganicMedicinalandPharmaceuticalChemistry,LippincottRaven FoyesPrinciplesofMedicinalChemistry,LippincottWilliamsandWilkins. Drug Metabolizing EnzymesCytochrome P450 and Other Drug Metabolizing Enzymes in Drug Discovery and Development,LeeJS,ObachSRandFisherMB,MarcelDekker,FontisIndia,2003 Pharmaceutical Profiling in Drug Discovery for Lead Selection, Borchardt RT, Kerns EH, Lipinski CA, Thakker DR and WangB,AAPSPress,2004 DrugMetabolismCurrentConcepts,IonescuCandCairaMR,SpringerInternationalEdition HandbookofDrugMetabolism,WoolfTF,MarcelDekker,1999.

ModernPharmaceutics

4hrs/week

 Unit 1 1.1 1.2 1.3 DrugStability: Importanceandneedforstabilitytesting Revisionofdegradationpathways,kinetics,physicalstability SolutionandSolidstatestability,pHstabilityprofiles,vandugraphs,packageevaluation,ICH guidelines,statisticalaspectsinderivationofshelflife. SelfstudyCalculationsforshelflifebasedondegradationkinetics SolubilizationandDissolution: Importanceofaqueoussolubilityofdrugs,particularlyNCEs,surfactantsystemsandphasediagrams, polymericsurfactants,cosolvents,complexation,solidstatemanipulations,cyclodextrins,drug derivatization,saltscreening. Revisionofequationsofdissolutionandfactorsaffectingdissolution,intrinsicsolubilityanddissolution rate,validationoftesting,differentequipments(emphasisonUSPapparatus4),DissolutionofTDDS, particulates,gels&ointments,comparisonofprofilesbyf2analysis,developmentofdissolution method,relevanceofdissolutiontestinginANDAs,bioreleventmedia,BCSclassification,IVIVCstudy designandinterpretation SelfstudyCalculationsbasedonvarioussolubilityparametersandequationsofdissolution. Pharmacopoeialdissolutionapparatus,datatreatmentofdissolutionprofiles. Excipientsandintroductiontopolymers: Roleofexcipients,purity,safetyandtoxicitywithreferencetoroutesofexposureoral,inhalational, parenteral,others;regulatoryaspects,riskassessments,Harmonizationofexcipientstandardslike residualsolventsclass1,2,3. Differentclassesofexcipientssurfactants,speciallipids,superdisintegrants,gellingagents,colours andflavours,sweeteningagents,coprocessedexcipients. Definitionofpolymers,classification;conceptofpropertiesusedincharacterisation,methodsof polymerisation,biocompatibilityevaluation,applications Selfstudy:sourcesandbrandnamesofvariousexcipients OptimisationTechniques: Definition,Need,Advantages,descriptionoftermssuchasindependentvariable,responseparameters, responsesurface,contourplots,polynomialequations Simplexandfactorialdesignsinoptimisation ApplicationofoptimisationtechniquesinQbDinproductdevelopment Selfstudy:PlacketBurmandesign,centralcompositedesigns Preformulation: ScopeofPreformulationRole&importanceinNewDrugDiscovery&ApprovalprocessLead optimization,StepsinDesigningthepreformulationevaluationofanewdrug,criticalissuesand CourseContents(Topics) Hours 9 1 2 3

1.2 2 2.1

3 14 5

2.2

2.3

3 3.1

7 2

3.2

3.3

3.4 4 4.1

1 8 2

4.2 4.3 4.5 5 5.1

3 1 2 12 3

problems/constraints 5.2 KeyAreasinPreformulationresearchBulkCharacterization,SolubilityAnalysis,StabilityAnalysis, Compatibilitywithcommonexcipients PreformulationaspectsforTablets,Injectables,Liquidpreparations,Protein&peptidedrugs. Selfstudy:casestudyofdrugexhibitingvariouspolymorphicforms,drugexcipientcompatibility PowderTechnology(Micromeritics): Revisionoffollowingtopics: Importantdefinitions&Units Importanceofparticlesizeinpharmaceuticaldevelopment. Fundamental&derivedpropertiesofpowders Particlesizereductioncomminutionmechanisms&equipments Methodsofparticlesizedetermination(emphasisonbasicprinciples& interpretationofdata) 2 4

5.3 5.4 6 6.1

3 2 10 2

6.2

ComminutionTheoryofcomminution,millingrate(variousmathematicalrelationships),conceptof milling/grindingindex,energyforcomminution,distributionandlimitofcomminution Compactionofpowdersdefinitionsofcompression&consolidation,deformationmechanismsof matter,stepsincompactionoftablets(indetail),theoreticalaspectsForceVolume relationships/porositypressureequations(HeckelsLaw&equation),Granulationofpowderstheory, Effectofcompactionpressureonvarioustabletproperties,Energyforcompaction&effectof lubricationofgranules,instrumentationoftabletpresses(principles) Selfstudy:casestudiesoncompactionbehaviouroftwoexcipients

6.3

6.4

3 Total 60

Books: 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. DrugStabilityPrinciplesandPracticesbyCarstensenJ,MarcelDekker,3rdedn,Vol107,1990. PharmaceuticalStresstestingbyBaertschiSW,TaylorandFrancis,Vol153,2005. PharmaceuticalcharacterisationofPharmaceuticalSolidsbyBrittainHG,MarcelDekker,Vol70,1995 PreformulationinSolidDosageFormDevelopmentbyAdeyeyeMC,BrittainHG,InformaHealthcare,Vol178,2008. st Dissolution,BioavailabilityandBioequivalencebyAbdouHM,EdA.Gennaro,B.Migdalof,MackPrintingCompany,1 edn,1989. PharmaceuticalBioequivalencebyWellingPG,FrancisLST,DigheSV,MarcelDekker,Inc.,Vol.48,1991. PharmaceuticalDissolutionTestingbyBanakerU,MarcelDekker,Vol49,1992. ExcipienttoxicityandsafetybyWeinerML,KotkoskiLA,Vol103,MarcelDekker,1999. Martin'sPhysicalPharmacyandPharmaceutical Sciences,bySinkoPJ,EdLea&Feiger,LippincottWilliams&Wilkins, 6thedn,2010. ModernPharmaceuticsbyBankerGS,EdBankerGS&RhodesCT,MarcelDekker,4thedn,Vol121,2003. rd PharmaceuticalStatisticsbyBoltonS,MarcelDeckker,3 edn,Vol80,1997. The Theory and Practice of Industrial Pharmacy by Lachman L, Lieberman HA, Kanig JL, Varghese Publishing House, 3rdedn,1990. Pharmaceutical Dosage Forms: Tablets, Unit Operations and Mechanical Poperties EdAugsburger LL, Hoag SW, rd InformaHealthcareUSA,Inc.,3 edn,Vol1,2008. TechniquesofSolubilizationofDrugsbyYalkowskySH,MarcelDekker,Vol12,1985. PharmaceuticalDissolutionTestingbyDressmanJ.EdDressmanJ,KremmerJ,Tylor&Francis,2005. ControlledDrugDelivery:ClinicalApplications,byBrukSD,CRCPressInc.,Vol2,1983. nd HandbookofPharmaceuticalGranulationTechnologybyParikhDM,Informahealthcare,2 edition,Vol154,2007. PharmaceuticalPowderCompactionTechnologybyAlderbornG,NystromC,MarcelDekker,Vol71,1996.

 ModernPharmacology Unit 1 1.1 1.2 1.3 2 2.1 2.2 DrugAbsorption,distribution,metabolismandexcretion. Mechanismsoftransportofdrugacrossmembranes. Transportersinvolvedindrugabsorption,distributionandexcretionprocesses. SelfstudyDrugeffluxpathwaysandexperimentalmethodstostudydrugtransport. Pharmacokineticfactorsaffectingdrugaction Mechanismofdrugaction Classificationofreceptorsanddescriptionofeachclasswithexamples. CourseContents(Topics) Hours 11 5 3 3 11 1 4hrs/week

2.3

4 Signaltransductionmechanisms. Detailed description of signal mediation through cascades after adrenergic, muscarinic, GABAergic,insulinreceptorstimulation. Regulationofreceptors,theirinvolvementinvariousbiologicalprocessesincludingdiseases 1 resultingfromreceptormalfunctionandtheirroleinpharmacotherapeutics. Regulationofintracellularcalcium. Pharmacodynamicinteractionsinamulticellularcontexte.g.Vascularwall(interactionsof physiologicalligandsanddrugsinpathophysiologicalsetting). SelfstudyClassificationandcharacterizationofreceptorsIUPHAR(Eg.5HTreceptors) Functionsofsodiumandpotassiumchannelsandtherapeuticpotentialofchannel modulators. Factorsaffectingdrugresponsiveness. 2 1

2.4 2.5

2.6 3

2 3

5 5.1 5.2 6 6.1

Alterationinconcentrationofdrugthatreachesreceptors. Variationinconcentrationofanendogenousreceptorligand. Alterationinnumberandfunctionofreceptors. Clinicalselectivity:Beneficialvs.toxiceffectsofdrugs. a. Beneficialandtoxiceffectsmediatedbythesamereceptoreffectormechanism. b. Beneficial and toxic effects mediated by identical receptors but in different tissues orbydifferenteffectorpathways. c. Beneficialandtoxiceffectsmediatedbydifferenttypesofreceptors. Desensitization,tachyphylaxis. Drugtolerance. Cellularandmolecularmechanismsof 4 Drugdependence(Eg.Morphine). Microbialresistance. Advancesintherapyof CNS:Depression,Alzheimersdisease,Psychosis,Parkinsonsdisease,Epilepsy. 18 5

6.2 6.3 7 7.1 7.2 8 8.1

CVS:Hypertension,AnginaPectoris,Congestivecardiacfailure,Arrhythmia. ManagementofDiabetesMellitus. Apoptosis Molecularbiology,physiological,pharmacologicalimplicationsandtherapeuticprospects. SelfstudyInteractionbetweencell,growthfactorsandextracellularmatrix. Immunopharmacology Introductiontoimmunopharmacology,immunomodulators,Immunostimulantsand Immunosuppressants. SelfstudyAutoimmunity

5 2 4 2 2 6 4

8.2 Books: 1. 2. 3. 4. 5. 6.

2 Total 60

RangandDalespharmacologyElsevierChurchillLivingston. LangesBasicandclinicalpharmacology,KatzungB.G.MastersS.B.,TrevorA.G.TataMcGrawHill. Goodmann and Gilmans pharmacological basis of therapeutics, Edited by Laurence Brunton, Bruce Chabner and BjornKnollman,McGrawHill. Pharmacologicalreviews,AnnualreviewsInc. Advancesinpharmacology,AcademicPress. TrendsinPharmacologicalSciences,CellPressElsevierPublication. ModernPharmaceuticalAnalysis 4hrs/week Hours 6 4

Unit 1 1.1

Coursecontents(Topics) MulticomponentanalysisofdrugsusingUV Vis.spectroscopy: Simultaneousequationmethod,Absorbanceratiomethod,Differencespectroscopy, DerivativespectroscopyandIntroductiontoRatioderivativespectroscopy, SelfstudyPharmaceuticalapplicationsofabovetechniques(1.1) F.T.I.Rspectroscopy: Constructionandworking,Newersamplingtechniques. InterpretationofI.R.spectrainmidI.R.region(aliphaticandaromaticcompoundsforsimple compoundssuchasamines,alcohols,amides,nitriles,ketones,aldehydes,esters,acids,nitro andanhydrides). SelfstudyInterpretationofrecordedI.Rspectraofdrugsandorganiccompounds. NMRspectroscopy:
1

1.2 2 2.1 2.2

2 6 2 2

2.3 3 3.1

2 10 6

HNMR:

Basictheoreticalconcepts(Selfstudychemicalshift,splittingpatternandcouplingconstant2 hrs),Nonfirstorderspectra,methodstomakecomplexspectrasimple,FTNMR.

3.2

13

CNMR:

TheoryandPrinciple. 3.3 4 4.1 4.2 4.3 Applicationsof2DNMR(onlyCOSYandHETCOR) MassSpectrometry: DifferentionisationtechniquesEI,CI,FD,FI,MALDI,API(APPI,APCI,ESI). DifferentanalysersQuadrupole,TOF,QTOF,Ioncyclotron,Iontrap. ConceptsforinterpretationofmassspectraMolecularionpeak,basepeak,Isotope abundance,fragmentationpathwaysfission,fission,MacLaffartyrearrangement,Retro DielsAlderrearrangement,Tandemmass(MSMS). Terminologiesofchromatography: SelfstudyTheoreticalplate,HETP,Platetheory,Ratetheory,VanDeemterequation,Isocratic elution,Gradientelution,capacityfactor,selectivityfactor,Resolution,tailingfactor, asymmetryfactor. 6 6.1 Advancesinchromatography: HPLCIonpairchromatography,Chiralchromatography(Chiralstationaryphases,useof mobilephaseadditives,precolumnderivatisation,chiraldetectors),UPLC,SelfstudyAdvances inHPLCdetectors(1hr). SupercriticalFluidchromatographyPrinciple,Instrumentationandpharmaceutical applications. SelfstudyHPTLCPrinciples,Instrumentationandapplicationsincludingfingerprintanalysis. GaschromatographyHeadspaceanalysis. GelelectrophoresisPrinciple,Instrumentationandapplications. Hyphenatedtechniques: Interfacesusedinandapplications GCMS,LCMS,LCMSMS 7.2 7 IntroductiontoLCNMRandMALDITLC. Thermoanalyticaltechniques: Principle,instrumentationandapplicationsincludinginterpretationofdatainpharmacyfor: 7.1 7.2 7.3 8 SelfstudyDSCandTGA TMA(Thermomechanicalanalysis). InterpretationofDSCandTGcurvesofsuitablecompounds/drugs(Selfstudy) Microscopy:Principle,Instrumentation,samplepreparationandpharmaceutical applicationsof ScanningElectronMicroscopy,TransmissionElectronMicroscopy,AtomicForceMicroscopy, 3 1 1 5 1 5 11 5 2 10 4 2 4

6.2

6.3 6.4 6.5 7 7.1

1 1 2 4 3

Confocalmicroscopy.

Books: 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15.

Total 60

ChromatographicmethodsbyA.Braithwaite&S.J.Smith,KluwerAcademicpublishers,Netherlands,London,USA. ThermalAnalysisofPharmaceuticalsbyCraig,Informa,CRCPress,IndianReprint. Practical Pharmaceutical Chemistry by A.H.Beckett and J.B.Stenlake, fourth edition, part two, CBS Publishers and Distributors. Spectrometric Identification of Organic compounds by R.M.Silverstein, F.X.Webster,D.J.Kiemle , Latest edition, John Wiley&Sons ApplicationsofabsorptionspectroscopyoforganiccompoundsbyJohnRobertDyer OrganicSpectroscopybyWilliamKemp,PALGRAVE. TextbookofPharmaceuticalAnalysisbyK.A.Connors,WileyIntersciencePublications. IntroductiontoSpectroscopybyD.L.Pavia,G.M.Lampman&G.S.Kriz. th Remington:TheScience&PracticeofPharmacy,20 edition,Vol.1,LippincotWilliams&Wilkins IntroductiontoModernLiquidChromatographybyL.R.Snyder,J.J.Kirkland3rdedition. ChiralseparationsbyLiquidChromatographyandRelatedTechnologiesChromatographicScienceSeriesbyHassanY., ImranAli,Vol.90. StaticheadspacegaschromatographyTheory&practicebyBrunoKolb&L.S.Ettre. rd EncyclopediaofChromatography,byJackCazes,3 edition,Vol.1,2&3. OnlineLCNMRandRelatedtechniquesbyKlasuAlbert,JohnWiley&Sons LCMSAPracticalUsersguide,byMarvinC.McMaster. StudyofNaturalProducts 4hrs/week

Unit 1 1.1

CourseContents(Topics) Introductiontostudyandresearchinherbaldrugs: Differentapproachestoplantselection,collectionandprocessingforherbaldrugresearch (Randomselection,Useofethnobotanicalinformation,Useofchemotaxonomical classificationetc). Recentadvancesinconceptofauthentication&standardizationsignificanceof chemotaxonomyandDNAfingerprintingwithrespecttogeneexpressionforsecondary metabolites. Extractionofphytochemicals Conceptsofextractionwithrespecttoactivityguidedfractionation&isolationof Markers/Biomarkers. Recenttrendsinextraction,optimizationofextraction,andanalysisofthephytochemicals ofdifferentclasses. Detaildiscussionoflargescaleextractionofthefollowing:(1)Opiumalkaloids(2)Piperine (3)Sennosides(4)Caffeine(5)Cinchonaalkaloids(6)Rutin(7)Lemongrassoil(8)Patchouli oil(9)Steroids(Diosgeninfromallsources)

Hours 4 2

1.2

2 2.1

18 2

2.2

2.3

2.4

Selfstudypreparationofflowchartanddiscussionofphysicochemicalprinciplesforall largescaleextractions Naturalproductsindrugdiscoveryanddrugdevelopment Roleofnaturalproductsasleadstothedesignofnewdrugswithcasehistorywith examplese.g.,artemisinin,taxane,camptothecinandafewothers. Naturalproductsderivedcombinatoriallibrariesandtheirsignificanceindrugsdiscovery programme(HITSandleads). SelfstudyDiscussionofleadmoleculesindrugdiscovery StudyoffollowingexcipientsofnaturalorigininNDDSwithrespecttosources, preparation,compositionandapplication Naturaldyes&colorants,sweeteners,flavoursandfragrantmaterials Kappacarrageenans,galactomannans,glucomannans,cellulosederivatives,lecithin,& alginates. SelfstudyRoleofexcipientsmentionedabove,informulations,withexamples Applicationofimmunoglobulinsfromplantsourcesindiagnosisandtherapy. Nutraceuticalsandtheirroleinhealthcare. Studyoffollowingclassesofherbswithtwoorthreesuitableexamplesofeach:(1) Antioxidants(2)Immunomodulators(3)Antihyperglycemics(4)Hepatoprotectives Statusofnaturalproductsinofficialbooks IntroductiontoHerbalPharmacopoeiasofdifferentcountries Monographsofnaturalproductsinotherofficialbooks. SelfstudyDiscussionofmonographoffewsubstancesofnaturalorigin

3 3.1

8 2

3.2

3.3 4

4 16

4.1 4.2

8 4

4.3 5 6 6.1

4 4 4 4

7 7.1 7.2 7.3 Books: 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16.

6 2 2 2 TOTALHOURS 60

PharmacognosyPhytochemistryMedicinalPlantsJeanBrunetton,LavoisierPublishing,Paris. TextbookofPharmacognosyTreaseandEvans14thedition.Elsevierscience TransgenicPlantsR.RanjanAgroBotanica,NewDelhi. Transgenic PlantsA Production system for Industrial and Pharmaceutical Proteins. by Meran Owen, Jan Pen John Wiley. MedicinalPlantTheirBioactivity,ScreeningandEvaluationCSIR. HomeopathicPharmacopoeiaofIndiaPublisherMinistryofHealth. TheAyurvedicFormularyofPartI&IIPublisherMinistryofHealth. ChineseMateriaMedicaYouPingZhuHarwoodAcademicPublishers. IndiaMateriaMedicaNadkarniA.K.BombayPopularPrakashan. PhytochemicalMethodsJ.B.HarboneChapmanandhall CultivationsandProcessingofMedicinalPlantsEd.byL.HornokJohnWiley. IntroductiontoFlavanoidsBohrnBruceA.HerwoodAcademicPublishers. CultivationandUtilizationofAromaticplantsEd.ByAtalC.K.andKapurB.M.CSIR. PlantTissueandCellCultureEd.H.E.StreetBlackwellScientificpublications. AflatoxinLeoA.GoldblattAcademicPressNewYork. MicrobialToxinsCiejler,KadisandAjlAcademicpress.

17. 18. 19. 20. 21. 22. 23. 24. 25. 26. 27.

AntimicrobialinFoodAlfredlarryBranen,P.MichaelDavidsonPublishinghouse ChemicalplantTaxonomyT.Swain,1963.AcademicPress,London. PlantTaxonomyandBiosystematics.C.AStace,1985.EdwardArnold,London. ModernmethodsofplantanalysisK.Paech,1956.,SpringerVerlag. IndianHerbalPharmacopoeia,Vol.1&2,RRL,IDMA,1998,2000. IndianPharmacopoeia,2010. StandardizationofBotanicals,V.Rajpal,2002.EasternPublishers,NewDelhi. NaturalCompoundsasDrugsVols.I&II,EditorFrankPetersen,RenAmstutz,DieDeutscheBibliothek,Germany. QualitycontrolofHerbalDrugs:AnApproachtoevaluationofBotanicals,PulokMukherjeeRiddhiInternational ChemicalsfromPlants:PerspectivesonPlantSecondaryProduct,Walton&Braun,ImperialCollegePress. st Towards Natural Medicine Research in the 21 Century H. Ageta, N. Aimi et al Excerpta Medica, International CongressSeries1157. SEMESTERII FORALLBRANCHES BiostatisticsandResearchMethodology 4hrs/week Hours 8 1 2 2 3

Unit 1 1.1 1.2 1.3 1.4 CollectionandOrganizationofdata

CourseContent(Topics) Biostatistics

Graphicalandpictorialpresentationofdata Measuresofcentraltendencyanddispersion Varianceandstandarddeviation,relativeerror,coefficientofvariation,precisionandaccuracy Samplingtechniques:simplerandomsampling;stratification;estimationofthemeanand proportion. Probability Definition.ConditionalprobabilityandBayestheorem.Probabilitydistributions:binomial, multinomialandPoissondistributions.Normalandlognormaldistributions.Useofnormal distributiontables. Regression Linearregressionandcorrelation,curvilinearregression,methodofleastsquares,curvefitting, Fiduciallimits,probitandlogitanalysis Parametrictests Testinghypothesis,Typesoferror.Levelofsignificance.Significancetestsandpvalue Testsofsignificancebasedonnormaldistribution,testofsignificanceforcorrelationcoefficients, confidenceintervalformeanandregressionproportion. Nonparametrictests Nonparametricprocedures:Chisquaregoodnessoffittest,signtest,MannWhitneytest;Wilcoxon signedranktest. Experimentaldesigns

2 2.1

6 6

3 3.1

6 6

4 4.1 4.2

8 4 4

5 5.1

4 4

6.1

Randomization,completelyrandomized,randomizedblockandLatinsquaredesigns,factorial design,crossoverandparalleldesigns StudentsshouldlearnuseofMinitab/RSoftwarefordatasummary,correlation,regression analysis,testofhypothesisandexperimentaldesign

6.2

7 7.1 8 8.1 9 ObjectivesandpurposeofResearch ResearchMethodology

TotalBiostatistics 40 2 2 2 2 6

TypesofresearchEducational,clinical,experimental,basic,appliedandpatentorientedresearch Literaturesurvey useoflibrary,booksandjournals,eJournals,retrievingpatentsandseekingreprints. Methodsandtoolsusedinresearch

10

Qualitiativeandquantitativestudies Simpledataorganization,descriptivedataanalysis Limitationsandsourcesoferrs Inquiriesinformofquestionnaire,opinionaireorbyinterview Statistical analysis of data including variance, standard deviation, standard error, mean, students t test and annova, correlation of data and its interpretation, computer data analysis 3 Scientificwritingandreporting Differenttypesofresearchpapers Titleandauthornames Abstractandkeywords Methodology ScientificPresentation Importance,typesanddifferentskills Content,formatofmodel,introductionandending Skillsfororalpresentationandtypesofvisualaids Questionnaire PatentsandTrademarks TheIndianpatentsystem Presentstatusofintellectualpropertyrights(IPR) Productpatentsandprocesspatent Requirementsandpreparationofpatentproposal Registrationofpatentinforeigncountries TotalResearchMethodology 20 Total(BiostatisticsandResearchMethodology) 60

11

12

Books: 1. 2. 3.

PharmaceuticalStatisticsPracticalandClinicalApplications,BoltonS.,MarcelDekker,Inc.N.,USA Biostatistics:AFoundationforAnalysisinHealthSciences,WayneWDaniel,JohnWiley&Sons,Inc. IntroductiontoStatisticalAnalysis,DixonW.J.andMasseyF.J.,McGrawHill,N.Y.,USA.

4. 5. 6. 7. 8. 9.

StatisticalMethods,SnedecorG.W.andCochranW.G.,IowaStateUniversityPress,Ames,Iowa. ResearchinEducation,JohnWBestandJamesVKhan,PrenticeHallofIndiaPvt.Ltd. EffectiveBusinessReportWriting,BrownLeland,PrenticeHallInc.India. PresentationSkills,MichaelHatton,IndianSocietyforTechnicalEducation,NewDelhi. ThesisandAssignmentwriting,AndersonJonathanandDurstonBerryH,WileyEasternLtd.,Bangalore. WritingaTechnicalPaper,DonaldHMenzel,McGrawHillBookCompany,Inc.,NewYork.

SemesterII BRANCH:PHARMACEUTICALCHEMISTRY Core1 AdvancedPharmaceuticalandMedicinalChemistry Unit 1 1.1 1.2 EnzymeInhibition Coverageofbasicaspectsofenzymekinetics,catalysis,transitionstatetheory. DrugResistancethroughalterationsofdruguptake,overproductionofenzyme,alterationsof theenzymeactivesite,overproductionofthesubstrateornewpathwaysforformationofthe product Drugsynergism,conceptsandmechanisms. Reversibleenzymeinhibitorscompetitiveinhibition,noncompetitiveinhibition, uncompetitiveinhibitionwithsuitableexamples.Detectionoftypeofinhibitionbysuitable plottingmethods.ConceptsofIC50andKi. Slowtightbindinginhibitors,covalentenzymeinhibitorsandmechanismbasedinhibitorswith suitableexamples.ConceptofKinactandKiforirreversibleinhibitors Selfstudyofspecificexamplesofdifferenttypesofinhibitorsandtheirdesign(someexamples likeCOXinhibitors,ACEinhibitors,RTinhibitors,HIVproteaseinhibitors,aromataseinhibitors, DHFRinhibitors,viralDNApolymeraseinhibitors,thymidylatesynthaseinhibitorsandothers) QSAR HistoricalAspects ElectronicEffectstheHammettequation,lipophiliceffects,experimentalmeasurementof lipophilicity,logPandlogD,effectofionizationonlogP,calculationoflogPandlogD,Steric effectstheTaftequation HanschAnalysis,FreeWilsonmethod,Toplissoperationalscheme Basicsofregressionanalysislinearandmultilinearregression,introductiontoPCA,PCR,PLS, 2 2 ANNandGFA.Correlationcoefficients(r andr pred),Ftest,standarderror,validation methodslikecrossvalidationbycalculationofq2,bootstrapanalysisandrandomization. ApplicationdomainforpredictionsusingaQSARmodel. Designoftrainingandtestsetsusingfactorialdesign SelfStudyDifferenttypesofdescriptorsreportedinliteraturethataccountforthesteric, electronicandlipophiliceffects. PeptidesandPeptidomimetics Coverageofpeptidestructure,biosynthesisofpeptidesandsolidphase/solutionsynthesisof peptides. Designofpeptidomimeticsbymanipulationoftheaminoacids,modificationofthepeptide backbone,incorporatingconformationalconstraintslocallyorglobally,helix,sheet,and CourseContent(Topics) Hours 16 2 1 4hrs/week

1.3 1.4

1 4

1.5

1.6

2 2.1 2.2

14 1 3

2.3 2.4

2 6

2.5 2.5

2 2

3 3.1

14 4

3.2

turnmimetics 3.3 SelfstudyofexamplesofpeptidomimeticsforsomeenzymesandreceptorslikeACE,CCK, bradykinin Antisensetherapeuticagents Historyandprinciples DesignofantisenseoligonucleotidesandsmallinterferingRNAs(siRNAs)withsomeexamples MolecularBiology,GeneticengineeringandBiotechnologyinproductionofbiologicalsas drugs. Selfstudyofbiotechnologybaseddrugs,vaccinesanddiagnosticagentswithrespecttotheir biologicalsource,theirdesignandthemechanismoftheiractions 2

4 4.1 4.2 5

6 2 4 6

5.1

Books 1. 2. 3. 4. TheOrganicChemistryofDrugDesignandDrugAction,SilvermanR.B.,AcademicPress.

Total 60

TextbookofDrugDesignandDiscovery,Eds.KrogsgaardLarsenP.,LiljeforsT.,MadsenU.,Taylor&Francis. MedicinalChemistry:AnIntroduction,ThomasG,Wiley. PeptideandProteinDesignforBiopharmaceuticalApplications,EdJensenK.J.,Ch.3AspectsofPeptidomimeticsby MaesV.,TourwD.,JohnWiley&Sons,Ltd,Chichester,UK. ComprehensiveMedicinalChemistry,SeriesEd.,HanschC.,PergamonPress. BurgersMedicinalChemistry,DrugDiscoveryandDevelopment,Wiley.

5. 6.

Core2

AdvancedOrganicChemistry

4hrs/week

Unit 1.0 1.1 AdvancedStereochemistry

CourseContent(Topics)

Hours 12 2

SelfStudyCoverageofthebasicconceptsinstereochemistryopticalactivity, specificrotation,racematesandresolutionofracemates,theCahnIngoldPrelog sequencerule,mesocompounds,pseudoasymmetriccentres,proR,proS,axesof symmetry,FischersDandLnotation,cistransisomerism,exoendo,synanti nomenclature.Stereoselectiveandstereospecificreactions.Conformational isomerisminacyclicsystems.Shapeofsixmemberedringsandeffectofsubstituents andreactivity. Chiralityinsystemslackingastereogeniccarbonatom Pointchiralitytertiaryaminesandphosphines Axialchiralityallenes,biphenylsandbinaphthyls

1.2 1.2.1 1.2.2

2 1 1

1.2.3 1.3

Helicalstructurespolynucleotides,polyaminoacids,biarylsandallenes Methodsforestimatingratiosofstereoisomersinamixture,separationand identificationoftheindividualcomponentsbyNMRspectroscopy,Xray crystallography. NucleophilicattackonacycliccarbonylcompoundsCramsrule,FelkinAhnrule. Lockingeffectsinnucleophilicreactionsatcarbonylgroups StereochemistryofimportantreactionsleadingtoformationofalkenesWittigand relatedreactions Catalysis&OrganometallicsinOrganicSynthesis Typesofcatalysis,heterogeneousandhomogenouscatalysis,advantagesand disadvantages,catalyticcycles Heterogeneouscatalysispreparation,characterization,kinetics,supportedcatalysts, catalystdeactivationandregeneration,someexamplesofheterogeneouscatalysis usedinsynthesisofdrugs. Homogenouscatalysis,hydrogenation,hydroformylation,hydrocyanation,Wilkinson catalysts,chiralligandsandchiralinduction,ZieglerNattacatalysts,someexamplesof homogenouscatalysisusedinsynthesisofdrugs Phasetransfercatalysistheoryandapplications Introduction,Classificationoforganometalliccompoundsbasedonhapticityand polarityoftheMCbond.Nomenclatureandgeneralcharacters.Synthesis,stability anddecompositionpathways. Transitionmetalcomplexeswithunsaturatedorganicmolecules,carbonmonoxide, alkenes,alkynes,allyl,dienes,cyclopentadienyl,arenecomplexes,preparation, properties,natureofbondingandstructuralfeatures,importantreactionsrelatingto nucleophilicattackonligandsandtoorganicsynthesis.Basicorganometallicreactions coveringoxidativereactions,migratoryreactions,insertions,extrusion,additions, eliminationstheirmechanismsandstereochemistry. SelfStudyBasicorganometallicreactionscoveringoxidativereactions,migratory reactions,insertions,extrusion,additions,eliminationstheirmechanismsand stereochemistry SynthonApproachandApplications Retrosynthesisanditsadvantages,rulesfordissectionofmolecules,meaningofthe term,disconnection,FGI,FGAandsynthons,guidelinesfortheorderofevents CXdisconnections;CCdisconnectionsalcoholsandcarbonylcompounds;1,2,1,3, 1,4,1,5,1,6difunctionalizedcompounds Strategiesforsynthesisofthree,four,fiveandsixmemberedrings Strategiesforsynthesisofaromaticandsaturatedheterocycles SelfStudyStrategiesforsynthesisofsaturatedheterocycles. AsymmetricSynthesis

1 1

1.4

1.5

2.0 2.1

12 1

2.2

1.5

2.3

1.5

2.4 2.5

1.5 1.5

2.6

2.7

3.0 3.1

13 1

3.2

3.3 3.4 3.5 4.0

3 3 2 6

4.1

Introductionandneed;chiralsynthesisusingchiralpool,chiralauxiliaries,chiral catalysts Enzymes,chiralsolventsandwholeorganisms Analyticalmethodsofdeterminingpurityofstereoisomers SelfStudyApplicationsinindustry CombinatorialChemistry Introduction,advantagesandplanningcombinatorialsynthesis Solidphaseandsolutionphasesynthesis Supports,linkers,andtags Deconvolutionanditeration Parallelsynthesis,multistepconvergentandsequentialsynthesis SelfStudyMulticomponentreactions GreenChemistry History,needandthegoalsofgreenchemistry Basicprinciplesofgreenchemistry,illustratedwithexamplestodiscussissuesof preventionofwasteorminimizebyproducts,atomeconomy,preventandminimize formationofhazardousortoxicproducts,designofsaferchemicalequivalents, selectionofappropriatesolvents,media,separationagents,improveeconomyand efficiencyofreactions,byuseofmicrowaves,ultrasoundetc.,anduseofrenewable startingmaterials. SelfStudyReactionscarriedoutusingMicrowaveandultrasound. Total

4.2 4.3 4.4 5.0 5.1 5.2 5.3 5.4 5.5 5.6 6.0 6.1 6.2

2 1 1 11 1 5 1 1 2 1 5 1 3

6.3 Books 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15.

2 60

Stereochemistryofcarboncompounds,ElielE,WilenSH,MandenLN,Wiley. StereochemistryofOrganicCompounds,NasipuriD,WileyEastern. AdvancedOrganicChemistry,CareyFAandSundbergRJ,PartAandB,Springer IntroductiontoGreenChemistry,RyanM.A.,TinnesandM.,AmericanChemicalSociety(Washington). CombinatorialChemistry;SynthesisandApplication,Eds.,WilsonS.R.CzarnikA.W.,Wiley:NewYork. OrganicChemistry,ClaydenJ,GreevesN,WarrenS,WothersP,OxfordUniversityPress. StereoselectiveSynthesis,AtkinsonRS,JohnWiley&Sons. TheOrganometallicChemistryoftheTransitionMetals,CrabtreeR.H.,JohnWiley TransitionMetalsinSynthesisofComplexOrganicMolecules,HegedusL.,UniversityScienceBooks. HomogenousTransitionMetalCatalysis,MastersC.,Chapman&Hall. PrinciplesandPracticeofHeterogenousCatalysis,ThomasJ.M.,ThomasM.J.,JohnWiley PrinciplesofAsymmetricSynthesis,GawleyR.E.,AubreyJ,Elsevier. GreenesProtectiveGroupsinOrganicSynthesis,Wuts,P.G.M.,GreenT.W.,Wiley OrganicSynthesisTheDisconnectionApproach,Stuart,W.,Wiley. Thelogicofchemicalsynthesis,CoreyEJandChengXM,JohnWileyandSons.

SemesterII BRANCH:PHARMACEUTICS Core1 AdvancedPharmaceuticsI Unit 1 1.1 1.2 1.3 SolidsoralSRsystem SelfstudyOverviewofSingleoralunitSRsystems. SelfstudyStructureandphysiologyofGIT. MechanismofRelease&Releasekineticequations. TypesDiffusioncontrolled,Dissolutioncontrolled,Reservoir,Matrix,Osmoticsystems,Ion exchangesystems Mucosaldrugdeliverysystemsbuccal,gingival,sublingual. 1.4 Multiparticulatesystemspelletization(emphasisonextrusionandspheronization). Orodispersiblesystems.PulsatileDrugdeliverysystems. ParenteralSRsystems Needandconcept,routesemployed Approachesaqueoussystems(complexation,useofpolymers),aqueoussuspensions (depotinjections,microspheres,magneticmicrospheres),Oilysolutions&suspensions, Emulsions(Microemulsions,multipleemulsions,),Implants(indetailconcept,properties desired,variousapproaches),prodrugs(chemicalmodifications),infusionpumps. SelfstudyBiopharmaceuticalaspects,Sterilization&stabilityissues Characterizationspecialemphasisonreleasestudies IssuesrelatedtoSafety,Toxicity&TissueInjury SpecializedEmulsions Microemulsions,Multipleemulsions,SelfEmulsifyingDrugDeliverysystems&SMEDDS; Formulationandphasebehaviour;Preparation&Characterization;BioavailabityAspects; Applications. SelfstudyTheoriesofEmulsification,Factorsinfluencingtypeofemulsionformed. GastroretentiveDrugDeliverySystems SelfstudyIntroduction;conceptofabsorptionwindow;needforGRDDS,gastricmotility; principlesofGastroretention;FactorscontrollingperformanceofGRDDS. DifferentApproachesHighdensitysystems,floatingsystems,mucoadhesivesystems, Expandablesystems,Magneticsystems,SuperporousHydrogels 5 CourseContents(Topics) Hours 13 3 1 4 4hrs/week

2 2.1 2.2

12 1 6

2.3 2.4 2.5 3 3.1

2 1 2 9 6

3.2 4 4.1

3 8 3

4.2

4.3 5 5.1 5.2 5.3

Evaluation. Oculardrugdeliverysystems. SelfstudyStructureandphysiologyofeye;Drugabsorptionanddispositionintheeye. Methodstoprolongoculardrugresidencewithemphasisonmucoadhesivesystems. Intraocularinserts;Nonerodibleinserts/Erodibleinserts. Novelophthalmicdrugdeliverysystems,Nanoparticles,liposomesandprodrugs.Ocular penetrationenhancers.

1 7 2 1 4

6 6.1 6.2

TransdermalDrugDeliverySystems SelfstudyStructureandphysiologyofskin. Principlesofskinpermeation. Kineticsofskinpermeation&penetrationenhancers. Types(Gels,Patches/films), Pressuresensitiveadhesives.

7 1 3

6.3 6.4 6.5 7

Development&evaluationinvitro,invivo. Iontophoresis. Recentadvancesuseofmicroneedlesintransdermaldrugdelivery. IntroductiontoPharmaceuticalProcessingDevelopment. (AsperICHguidelines)

1 1 1 4

7.1

ElementsinPharmaceuticaldevelopment Targetproductprofile CriticalQualityAttributes. LinkingMaterialAttributes&processparameterstoCQAsRisk Assessment Designspace ControlStrategy ProductLifecyclemanagement&continualimprovement.

7.2

SubmissionofPharmaceuticalDevelopmentandrelatedinformationinCTDformat. RelevantExamples.

Total 60 Books:
st 1.TargetedandControlledDrugDelivery:NovelCarrierSystemsbyVyasSP,KharRK,CBSPublishersandDistributors,1 edn, 2002.

2.ControlledandNovelDrugDeliverybyJainNK,CBSPublishersandDistributors,2008. 3.ControlledDrugDelivery:FundamentalsandApplicationsbyRobinsonJR,LeeVHL,Dekker,2ndedn,Vol29,1987.

4.NovelDrugDeliverySystembyChienYW,2ndedn,Vol50,InformaHealthcare,2003. 5.ProgressinControlledandNovelDrugDeliverySystemsbyJainNK,CBSPublishersandDistributors;2004. 6.OphthalmicDrugDeliverySystems,MitraAK,2ndedn.,DrugsandPharmaceuticalSciencesSeries,Vol.130,MarcelDekker, 2003. 7.Polymericdrugdeliverysystem,KwonGS,MarcelDekker,Vol148,2005. 8.NanoparticulateDrugDeliverySystembyThassuD,DeleersM,PathakY,MarcelDekker,Vol166,2007. 9.ControlledDrugDeliveryChallengesandStrategiesbyParkK,AmericanChemicalSociety,1997. 10.ColloidalDrugDeliverySystembyKreuterJ,MarcelDekkerVol66,1994. 12.www.ich.org 13.PharmaceuticalDosageForms:DisperseSystemsbyLiebermanHA,RiegerMM,BankerGS,MarcelDekker,Vol3,2ndedn, 2005. 14.PharmaceuticalEmulsionsandSuspensionsbyNielloudF,MartiMestresG,MarcelDekker,Vol105,2000. 14.ControlledReleaseSystemsFabricationTechnologybyDeanSTH,CRCPress,Vol1,1988. 15.BioadhesiveDrugDeliverySystemsbyMathiowitz.E,ChickeringDE,LehrCM,MarcelDekkerVol98,1999. 16.PharmaceuticalSkinPenetrationEnhancementbyWalters.KA,HadgraftJ,MarcelDekker,Vol59,1993. 17.PercutaneousAbsorptionbyBronaughRL,MaibachHI,TaylorandFrancis,3rdedn,Vol97,2005. 18.TransdermalControlledSystemicMedicationbyChienYW,MarcelDekker,Vol.31,1987. 19.OralMucosalDrugDeliverybyRathboneMJ,MarcelDekker,Vol74,1996. 20.ModifiedReleaseDrugDeliveryTechnologybyRathboneMJ,HadgraftJ,RobertsMS,LaneME,InformaHealthcare,2nd edn,Vol183(1),2008. 21.PharmaceuticalPelletizationTechnology,Ghebresellassie.I,,MarcelDekker,Vol.37 Core2 AdvancedPharmaceuticsII Unit 1 1.1 CourseContents(Topics) Targetedsystems:ActiveandPassiveapproaches: Tumourtargeting,Moleculartargetsforcellulartargeting,Ligandsasdeliveryandtargetingtools, Conceptofreceptormediatedendocytosis. SelfStudy:Conceptsandrationaleoftargeting:activeandpassivetargeting,Cellularbiochemistry andmoleculareventsindrugtargeting Pulmonaryandnasaldrugdeliverysystems: Nasaldrugdelivery: Nasaladministrationdosageforms,Strategiesforenhancementinnasalabsorption,Animal Hours 6 3 4hrs/week

1.2

2 2.1

14 4

modelsfornasalabsorptionstudies,Nasalpreparationsforsystemiceffect 2.2 Pulmonarydrugdelivery: Factorsaffectingparticledispositioninthelungs,Dosageformsforpulmonarydrugdelivery (Nebulizer,Metereddoseinhalers,Drypowderinhalers),Drugtargetingtotherespiratorytract, Pulmonaryreceptortargeting 2.3 SelfStudy:Anatomyandphysiologyoftherespiratorysystem,Airwayphysiologyanddisposition patterns Proteinandpeptidedrugdeliverysystems: Physicalandchemicalstabilityaspects,proteindegradationpathways,techniquesofstabilization ofproteinsandpeptides,barrierstotransportandapproachestocircumventmetabolicbarriers. Generalproteinformulationanddeliverysystemstrategies. Routesfordeliveryofproteinsandpeptideswithemphasisonoralandmucosaldelivery, pulmonarydelivery,nasaldeliveryandparenteraldelivery SelfStudy:Structureofproteinsandpeptides,analysisofproteinsandpeptides. Colloidaldrugdeliverysystems: NOTEthatforeverycolloidaldrugdeliverysystemthefollowingaspectstobeincluded: Introduction,comparisonwithothercolloidaldrugcarriers,Advantages/limitations,constituents andmechanismofformation,methodofpreparationanddrugloading,characterisationand evaluation,stability,longcirculating/modifiedformofcolloidaldrugcarrier,biodistributionand application. Thefollowingdrugdeliverysystemtobestudiedwithrespecttheseaspects 4.1 4.2 4.3 4.4 4.5 4.6 Liposomes Niosomes Nanoparticles Polymericmicelles SolidLipidnanoparticles. SelfStudy:AnoverviewcolloidalDrugDeliverywithrespecttoPhysicochemical& Biopharmaceuticalaspects Braintargeting: Introduction,TransportthroughBBB,FactorsaffectingdrugpermeationthroughBBB Braindrugdeliverystrategies: InvasiveIntracerebralimplants,Intraventricularinfusion,BBBdisruption, NoninvasivetechniquesChemicalmethod,Colloidaldrugcarrier,receptor/vectormediated approach. MiscellaneoustechniquesIntranasaletc SelfStudy:Bloodbrainbarrier,CSFbarrier,limitationsinbrainuptakeofdrug,desired 5 2 5 3 4 3 3 7.

3 3.1

11 4

3.2 3.3

1 3

3.4 4

3 22

5 5.1 5.2

7 1 3

5.3

physicochemicalcharacteristicsofdrugs. Books: 1.Targetedandcontrolleddrugdelivery:NovelcarriersystemsbyS.PVyasandR.KKhar,CBSpublishersanddistributors pvtLtd. 2.AdvancesincontrolledandnoveldrugdeliveryeditedbyN.K.Jain,CBSpublishersanddistributorspvtLtd. 3.RobinsonJ.RandLeecontrolledandnoveldrugdelivery. 4.Controlleddrugdelivery:Conceptsandadvances,S.P.Vyas,R.K.Khar,VallabhPrakashan. 5.ChienY.WNovelDrugDeliverySystem,Drugandpharmaceuticalscienceseries,Vol14,NewYorkInc,MarcellDekker. 6.ControlledandnoveldrugdeliveryeditedbyN.K.Jain,CBSpublishersanddistributorspvtLtd. 7.Advancesinpharmaceuticalsciencesvol1to5,byH.S.BeanandA.HBeckett. 8.GlenS.Kwon,PolymericdrugdeliverysystemMarcellDekkerSeries,Vol148,P.No.533560 9.ThassuDNanoparticulateDrugDeliverySystemVol166,MarcellDekkerSeries2007. 10.ParkK,ControlDrugDeliveryChallengesandStrategies,CRC,WashingtonDC1997 11.MacNallyEProteinFormulationandDelivery2ndedition,Vol75,2008 12.KreuterJ,ColloidalDrugDeliverySystem,Vol.66,MarcellDekker,IncNewYork,1994 SemesterII BRANCH:PHARMACEUTICALANALYSIS Core1 AnalyticalMethodDevelopmentandValidationTechniques Unit 1 CourseContents(Topics) Calibration&Validationofanalyticalinstruments: a. HPLC. b. UVVISspectrophotometer. c. FTIR. d. Dissolutiontestapparatus. HPLCassaymethoddevelopmentforAPIanddrugproducts: PreliminaryinvestigationsNatureofsample,itscompositionandproperties.(Itshouldalsoinclude significanceofpKa,partitioncoefficientandcurrentmethodstodeterminethesame),separationgoals, samplepretreatmentanddetection,developingseparation. Hours 4 4hrs/week Total 60

2 2.1

20 5

2.2

BasicsofseparationResolution,Resolutionasafunctionofsolventstrength,selectivityandcolumn platenumber;andsamplesizeeffect. SelfstudyDetectionComparisonofsensitivity,selectivity,advantages,disadvantagesandapplications withrespecttodetectorssuchasU.V,Fluorescence,PDA,RefractiveIndex,Evaporativelightscattering detectorandelectrochemicaldetectors. Samplepreparationandpretreatmentforsolid,liquid,semisolidsamples;columnswitchingandpre andpostcolumnderivatisation. SelfstudyColumnscharacteristicsofcolumnandcolumnpackingandcolumnspecifications. MethoddevelopmentforReversephase,Ionpairandionexchangechromatography,Gradientelution principleanddevelopmentofgradientseparation.Selfstudypharmaceuticalexamplesforthese methods(1hr). Quantitationanalysismeasurementofsignals,quantitationmethods,sourcesoferrors,procurement, storageanduseofreferencestandardsandworkingstandards. ICHguidelinesforanalyticalmethodvalidation(Q2withlatestrevision).Systemsuitabilitytestingasper USP,IP. SelfstudyOnedetailedHPLCanalysisofanyAPIbyUSPorIP(1hr) HPTLC: Methoddevelopmentandvalidationforfixeddosecombinationdrugsandherbalanalysis.

2.3

2.4

2.5 2.6

1 3

2.7

2.8

2.9 3

1 3

4 4.1

Impurityprofiling: SelfstudySourcesofimpuritiesandICHterminologiesOrganicimpurities,Inorganic impurities,Residualsolvents,Isolationandcharacterisationmethodsforimpurities (3hrs). 2. Analyticalmethoddevelopmentandquantitationofimpurities. ICHguidelinesQ3A,Q3B,Q3Cwithlatestrevisions. Bioanalyticalmethoddevelopmentandvalidation: Stepsfollowedsamplepreparation,liquidliquidextraction,precipitation,solidphaseextraction, sinteredcolumnsolidphaseextraction. Bionalyticalmethodvalidationincludingfull,partial,crossvalidation,selectivity,accuracy,calibration curve,stability(freezethawandmobilephase),recovery. CDERandICHguidelinesforbioanalyticalmethodvalidation. SelfstudyExamplesofbioanalyticalmethoddevelopmentandvalidationforaspecifieddrugestimated inurine/plasma/serumsamples. Stabilitytesting: Drugdevelopmentcycleandstabilitytesting. Stresstestingofdrugsubstances. Stabilityindicatingassays(specificandselective),Roleofkineticstudies. Stabilitytestingprotocols. 1.

9 5

4.2 5 5.1

4 13 3

5.2

5.3 5.4

4 2

6 6.1 6.2 6.3 6.4

11 2 1 3 1

6.5

Retestperiod/Shelflifedeterminationofdrugsubstances/phytopharmaceuticals/biotechnological productsandequipments. ICHguidelinesQ1AandQ1Bwithlatestrevisions.

6.6

2 Total 60

Books: PracticalHPLCMethodDevelopmentbyL.R.Snyder,2ndedition,JohnWiley&Sons, Analytical Method Validation and Instrument Performance Verification by Chung Chow Chan, Herman Lam, Y.C. Lee, XueMingZhang,WileyInterscience,JohnWiley&Sons,IncorpPublications. 3. UnitedStatesPharmacopoeiaandIndianPharmacopoeia. 4. Handbook of Isolation and Characterisation of Impurities in Pharmaceuticals by Satinder Ahuja &Karen Mills Alsante, Volume5,AcademicPress,USA. 5. HandbookofBioanalysis&DrugmetabolismbyGaryEvans,CRCPress(2004), 6. HPLCmethoddevelopmentbySatinderAhuja 7. Sethis Quantitative Analysis of Pharmaceutical Fomulations by P.D.Sethi, fourth edition, volume1, CBS Publishers andDistributors,NewDelhi. th th 8. RemingtonTheScience and Practice of Pharmacy, 20 edition RemingtonTheScience and Practice of Pharmacy, 20 edition. 9. ValidationandQualificationinAnalyticalLaboratories,2ndedition,LudwigHuber;InformaHealthcare. 10. Handbook of stability testing in pharmaceutical development Regulations, Methodologies and Best practices; Editor KimHuynhBa,Springer. 11. J.T.Carstensen,C.T.Rhodes,Drugstability:principles&Practices.LatestEdition.MarcelDekkerInc.,NewYork INTERNETREFERENCES: 1. 2. 1. 2. 3. USFDA(CDER)andICHguidelinesforBioanalyticalmethodvalidation. ICHguidelinesQ1A(R),Q3A(R),Q3B,Q3C,Q6A. ICHguidelinesforanalyticalmethodvalidation. CORE2 SpectroscopicStructuralElucidation Problemsofstructuralelucidationinvolvingthefollowingtechniques: UVspectroscopy. IRspectroscopy. 1 HNMRspectroscopy. 13 CNMRspectroscopy. MassSpectrometry. Theproblemsshouldcoverthefollowingaspects: Unit 1 CourseContents(Topics) Calculationofmaxfordienes,,unsaturatedketonesbyUVspectroscopy.Self studypracticeproblems(1hr)
1 PredictionofcharacteristicIRbands,NMRspectra( HNMR)chemicalshift,splitting 13 patternandratioofprotonintensity,( CNMR)numberofsignals,chemicalshiftand splittingpattern,massfragmentationpatterns.Selfstudypracticeproblems(2hrs) 1 13 DistinguishingcompoundsusingUV/IR/ HNMR/ CNMRand/orMass spectrometry.Selfstudypracticeproblems(2hrs)

4hrs/week

Hours 5

10

10

Interpretationofmassspectrawithexplanationoffragmentationpatterns.Selfstudy practiceproblems(2hrs)
1 13 ProblemsinvolvingstructureelucidationbyUV/IR/ HNMR/ CNMRand/or Massspectrometry,Selfstudypracticeproblems(8hrs)

26

Books:

Total

60

1 2 3 4

Introduction to Spectroscopy by D.L.Pavia, G.M.Lampman & G.S.Kriz, Latest edition, Thomson Brooks/Cole, United States. Spectrometric Identification of Organic compounds byRobert.M.Silverstein & Francis.X.Webster, D.J.Kiemle, Latest edition,JohnWiley&Sons. OrganicSpectroscopybyWilliamKemp. ApplicationsofabsorptionspectroscopyoforganiccompoundsbyJohnRobertDyer,PrenticeHall,London. SemesterII BRANCH:QUALITYASSURANCE QualityAssuranceSystems 4hrs/week CourseContents(Topics) Hours Regulatorybasisforvalidation:USFDAguidelines(cGMPguidelines,21CFR210211),EU 5 guidelines,WHOguidelines. Terminologyandvalidationoverview: 10 SelfStudy:Validationversusverification,testing,calibrationandqualification. 3 ConceptsofDQ,IQ,OQandPQ. 3 ConceptsofProspectivevalidation,retrospectivevalidation,Concurrentandrevalidation. 4 ValidationMasterPlan. ValidationofEquipment 10 DryPowderMixers 1 FluidBedandTraydryers 1 TabletCompressionMachine 2 Selfstudy:DryHeatSterilization/Tunnels 1 Autoclaves 2 Core1 Capsulefillingmachines. ValidationofIntegratedlinesbymediafilltest. UtilitiesValidation ValidationofPharmaceuticalWaterSystem&puresteam, ValidationofHAVCsystem ValidationofCompressedair CleaningValidation Selfstudy:CleaningofEquipment,CleaningofFacilities. AnalyticalMethodValidation:Generalprinciplesofanalyticalmethodvalidation, ValidationoffollowinganalyticalInstruments HPLC Dissolutiontestapparatus U.V./Visiblespectrophotometers 1 2 7 2 3 2 4 06 2 2 2

Unit 1 2 2.1 2.2 2.3 3 3.1 3.2 3.3 3.4 3.5 3.6 3.7 4 4.1 4.2 4.3 5 6 6.1 6.2 6.3

7 7.1 7.2 7.3 7.4 7.5 7.6 7.7 8 9 Books:

ProcessValidation Selfstudy:Prospective,concurrent,retrospective&revalidationSelfstudy Processvalidationoffollowingformulations Uncoated/Coatedtablets HardgelatinCapsules Ampoules&Vials Selfstudy:Ointment/Creams Selfstudy:LiquidOrals Transdermalpatches(Matrixsystems) SelfstudyComputersystemvalidationincontrollingthemanufacturingprocess. ProcessAnalyticalTechnologies(PAT)andQualitybyDesign(QbD)(USFDA)

13 1 2 2 2 2 2 2 2 3 Total 60

ValidationandQualificationinAnalyticalLaboratoriesbyLudwigHuber,Secondedition(2007),InformaHealthCare, NewYork,London. 2. PharmaceuticalProcessValidationbyR.NashandWachter,Volume129,Latestedition,MarcelDekkerInc,NewYork. 3. GMPforPharmaceuticalsbySidneyH.Willing,Fifthedition,MarcelDeckerSeries,NewYork. 4. UnitedStatesPharmacopoeia&IndianPharmacopoeia. 5. ValidationofPharmaceuticalprocess,F.J.CarletonandJ.Agalloco,MarcelDekkerInc. INTERNETREFERENCES: 1. 2. 3. 4. www.fda.gov(USFDAguidelinesforPATandQbD). www.ich.org WHOpublicationsonrelatedtopics. EMEAguidelines Core2 PharmaceuticalQualityManagement Unit 1 1.1 1.2 1.3 1.4 2 2.1 2.2 3 Conceptof TotalQualityManagement(TQM), Qualitycontrolandqualityassurance, Qualitycontrollaboratoryresponsibilities, Selfstudy:Goodlaboratorypractices GMP Organizationofpharmaceuticalmanufacturingunit,productionmanagement, Selfstudy:RevisedscheduleM. Personnel: CourseContents(Topics) Hours 8 2 2 2 2 8 4 4 12 4hrs/week

1.

Unit 3.1 3.2

CourseContents(Topics) Selfstudy:Introduction,Humanresourcedevelopment,QualificationExperienceandTraining, Responsibilities,PersonalHygieneandGowning. Location,Plantlayout,Lighting,Sewage,WaterhandlingSewage,RefugeandDisposal,Washing andtoiletfacility,Sanitation,ControlsofcontaminationandEnvironmentalcontrols. MaterialsManagement: APIs,rawmaterials&packagingmaterials,Purchasespecifications,Selectionofvendors, Intermediates&Finishedproducts,RejectedandRecoveredmaterials,Recalledproducts, Reagents&culturemedia,Referencestandards,Wastematerials. WarehousingGoodWarehousingPractices,distributionandrecords. ManufacturingOperationsandControl: Selfstudy:SanitationofManufacturingPremises,Lineclearance,MixupsandCross contamination,ProcessingandholdingofIntermediatesandBulkProducts Packaging,I.P.Q.C.,ReleaseandstorageofFinishedProduct,ProcessDeviationsandIncidents, Drugproductinspection,Yieldcalculations Expirydating,Manufacturingrecordreviewandapproval. DocumentationandRecords: InprocessandProductReleaseSpecifications,Masterproductionandcontrolrecord,Batch productionandcontrolrecord,StandardOperatingProcedures(SOP),ChangeControl,Site masterfile. PostOperationalActivities: Distribution,Complaintsandrecalls,evaluationofcomplaints,Recallprocedures,relatedrecords anddocuments. Outsourcing:Facilityaudit,Manufacturing,Packaging,Analytical,Clinicalandotherservices outsourcing. SiteandPlantsecurity: Securitypersonnel,Entryprocedurestosite&plant,Internalsecurity,Vehicleparking,Fuel storage,Canteen&cooking,Garden&horticulture. Audits: PrincipleofQualityaudit,Plantlevel,Departmentwisedocumentation.

Hours 6 6

4 4.1

8 6

4.2 5 5.1 5.2 5.3 6

2 8 3 3 2 6

7 7.1 7.2 8

5 2 3 2

9 Books 1. 2. 3.

3 Total 60

4. 5.

QualityAssuranceofPharmaceuticals,Vol.2,UpdatedEdition,WorldHealthOrganization,Geneva. S.H.Willing,GoodManufacturingPracticesforPharmaceuticals;AplanfortotalQualitycontrol,LatestEdition,Marcel Dekker. RegulatoryguidelinesrelatedtoGMPby a. 21CodeofFederalRegulation,Parts210,211&58(USFDAguidelines) b. EU,MHRA,UKGuidelinesonGMP c. ScheduleMofDrug&CosmeticsAct. QualityPlanning&AnalysisbyJ.M.JuranandF.M.Gryna,TataMcgrawHill,India. QualityAssuranceGuidebyOrganizationofPharmaceuticalProducersofIndia. SemesterII BRANCH:PHARMACOGNOSYANDPHYTOCHEMISTRY

Core1

AdvancesinPharmacognosyandPhytochemistry

4hrs/week

Unit 1 1.1

CourseContents(Topics) Factorsaffectingoccurrenceofcompoundsofnaturalorigin Discussionofdifferentfactorscontributingtothevariationinthecompositionand proportionofsecondarymetabolites. Conceptofvariationofphytochemicalswithrespecttoecotype,phenotypeand genotypicvariables.Studyofphytoalexins,allelochemicalsandaflatoxins,natural Pesticides(coverthetopicswithatleasttwoexamplesofeach). Recentadvancesandapplicationsofphytoalexins,allelochemicals&aflatoxins. Chemistry,sources&usesoffollowingclassesofphytochemicals (1)AlkaloidsOpioids&Purines(2)Iridoids(3)Coumarins(4)Xanthones

Hours 6 2

1.2

1.3 2

3 8

2.1

SelfstudyUpdateontraditionalusesandrecentapplicationsoffewexamplesofthe abovementionedclasses Chemistry,classification,sources,usesandstructureelucidationbyspectralmethods ofFlavanoids. SelfstudyComparativespectralanalysis&recentapplicationofdifferentclassesof flavanoids. Studyoffollowingtherapeuticclassesofagentsofplantandanimaloriginwith respecttosources,applicationsandchemistry(anytwoexamplesofeachclass). (1) Antibacterial (2) Hepatoprotective&Hypolipidemicagent (3) Antivirals Marinedrugsofdifferenttherapeuticclasses 1)Anticancer2)Cardiovasculardrugs3)Antivirals4)Anthelmintics5)Marinetoxins

3.1

Studyofphotosensitisesofnaturaloriginsuchasporphyrins,psoralenes,thiophenes, quininesandtheirsignificanceinPhotodynamictherapy(PDT)andphtotoxicity. SelfstudyRoleofPDTinhealthcarewithexamples. Introductiontoplanttissueculture(PTC)andplantbiotechnology. Geneticengineeringinplantsfordevelopmentofplantsresistanttopests,viruses, microbesanddiseases.Alterationinripeningoffruits.Advantagesanddisadvantageof BTcrops. Definition,Methodology,&applicationofbiotransformationofPhytochemicalswith suitableexamples.

6.1 7 7.1

3 5 3

7.2

Books

Total 60hrs

1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. 24. 25. 26. 27.

PharmacognosyPhytochemistryMedicinalPlantsJeanBrunetton,LavoisierPublishing,Paris. TextbookofPharmacognosyTreaseandEvans14thedition.Elsevierscience TransgenicPlantsR.RanjanAgroBotanica,NewDelhi. Transgenic PlantsA Production system for Industrial and Pharmaceutical Proteins. by Meran Owen, Jan Pen John Wiley. MedicinalPlantTheirBioactivity,ScreeningandEvaluationCSIR. HomeopathicPharmacopoeiaofIndiaPublisherMinistryofHealth. TheAyurvedicFormularyofPartI&IIPublisherMinistryofHealth. ChineseMateriaMedicaYouPingZhuHarwoodAcademicPublishers. IndiaMateriaMedicaNadkarniA.K.BombayPopularPrakashan. PhytochemicalMethodsJ.B.HarboneChapmanandhall CultivationsandProcessingofMedicinalPlantsEd.byL.HornokJohnWiley. IntroductiontoFlavanoidsBohrnBruceA.HerwoodAcademicPublishers. CultivationandUtilizationofAromaticplantsEd.ByAtalC.K.andKapurB.M.CSIR. PlantTissueandCellCultureEd.H.E.StreetBlackwellScientificpublications. AflatoxinLeoA.GoldBlattAcademicPressNewYork. MicrobialToxinsCiejler,KadisandAjlAcademicpress. AntimicrobialinFoodAlfredlarryBranen,P.MichaelDavidsonPublishinghouse ChemicalplantTaxonomyT.Swain,1963.AcademicPress,London. PlantTaxonomyandBiosystematics.C.AStace,1985.EdwardArnold,London. ModernmethodsofplantanalysisK.Paech,1956.,SpringerVerlag. IndianHerbalPharmacopoeia,Vol.1&2,RRL,IDMA,1998,2000. IndianPharmacopoeia,2010. StandardizationofBotanicals,V.Rajpal,2002.EasternPublishers,NewDelhi. NaturalCompoundsasDrugsVols.I&II,EditorFrankPetersen,RenAmstutz,DieDeutscheBibliothek,Germany. QualitycontrolofHerbalDrugs:AnApproachtoevaluationofBotanicals,PulokMukherjeeRiddhiInternational ChemicalsfromPlants:PerspectivesonPlantSecondaryProduct,Walton&Braun,ImperialCollegePress. Towards Natural Medicine Research in the 21st Century H. Ageta, N. Aimi et al Excerpta Medica, International CongressSeries1157. Core2 NaturalProductTechnology 4hrs/week

Unit 1 2 2.1

CourseContents(Topics) DetailedstudyofWHOguidelinesforqualitycontrolofcrudedrugs Studyofherbalformulations Classificationanddifferentstagesinpreparationofherbalformulationsfor therapeuticandcosmeticapplications Standardizationandevaluationofqualitycontrolandsafetyofherbalformulations IntroductiontodifferentAyurvedicdosageforms SelfstudyAnytwomarketedherbalformulationswithrespecttoconstituentsand uses. Quantitativeassaystodetermineextractionefficiency Generalmethodsofestimationofalkaloids,terpenoidsandflavonoids AnalysisofRutin,lycopene,curcuminoids,artemisinin,enzymesandlectinsby differentmethodsuchasUV,HPTLC,GC,gelelectrophoresisetc.,determinationof percentagepurity.

Hours 5 12 5

2.2 2.3 2.4

5 2 4

3 3.1 3.2

8 4 4

3.3

SelfstudyMerits&demeritsofdifferentmethodsofestimationofalkaloids, terpenoids&flavanoids. Introductiontoherbalproductbasedindustry Types,forms,scopeandapplicationofherbalindustries Typeofinfrastructureinvolvedinmakingstandardizedextractanddifferentdosages forms SelfstudyEquipmentandmachineryusedinlargescaleextraction Bioavailabilityandpharmacokineticaspectofherbaldrugswithexamplesofwell knowndocumentedherbaldrugs.Introductiontoconceptofphytoequivalenceand pharmaceuticalequivalence. IPRissuesrelatedtoherbalandnaturalproducts.EMEAandESCOPguidelinesfor herbalmedicinalproducts.PreparationofDMFforherbalmedicines. SelfstudyAnyonepatentrelatedtonaturalproducts. Total

4 4.1 4.2

6 4 2

4.3 5

3 6

6.1 Books 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. 24. 25. 26. 27.

3 60hrs

PharmacognosyPhytochemistryMedicinalPlantsJeanBrunetton,LavoisierPublishing,Paris. TextbookofPharmacognosyTreaseandEvans14thedition.Elsevierscience TransgenicPlantsR.RanjanAgroBotanica,NewDelhi. Transgenic PlantsA Production system for Industrial and Pharmaceutical Proteins. by Meran Owen, Jan Pen John Wiley. MedicinalPlantTheirBioactivity,ScreeningandEvaluationCSIR. HomeopathicPharmacopoeiaofIndiaPublisherMinistryofHealth. TheAyurvedicFormularyofPartI&IIPublisherMinistryofHealth. ChineseMateriaMedicaYouPingZhuHarwoodAcademicPublishers. IndiaMateriaMedicaNadkarniA.K.BombayPopularPrakashan. PhytochemicalMethodsJ.B.HarboneChapmanandhall CultivationsandProcessingofMedicinalPlantsEd.byL.HornokJohnWiley. IntroductiontoFlavanoidsBohrnBruceA.HerwoodAcademicPublishers. CultivationandUtilizationofAromaticplantsEd.ByAtalC.K.andKapurB.M.CSIR. PlantTissueandCellCultureEd.H.E.StreetBlackwellScientificpublications. AflatoxinLeoA.GoldBlattAcademicPressNewYork. MicrobialToxinsCiejler,KadisandAjlAcademicpress. AntimicrobialinFoodAlfredlarryBranen,P.MichaelDavidsonPublishinghouse ChemicalplantTaxonomyT.Swain,1963.AcademicPress,London. PlantTaxonomyandBiosystematics.C.AStace,1985.EdwardArnold,London. ModernmethodsofplantanalysisK.Paech,1956.,SpringerVerlag. IndianHerbalPharmacopoeia,Vol.1&2,RRL,IDMA,1998,2000. IndianPharmacopoeia,2010. StandardizationofBotanicals,V.Rajpal,2002.EasternPublishers,NewDelhi. NaturalCompoundsasDrugsVols.I&II,EditorFrankPetersen,RenAmstutz,DieDeutscheBibliothek,Germany. QualitycontrolofHerbalDrugs:AnApproachtoevaluationofBotanicals,PulokMukherjeeRiddhiInternational ChemicalsfromPlants:PerspectivesonPlantSecondaryProduct,Walton&Braun,ImperialCollegePress. st Towards Natural Medicine Research in the 21 Century H. Ageta, N. Aimi et al Excerpta Medica, International CongressSeries1157. SemesterII

BRANCH:PHARMACOLOGY Core1 AdvancedPharmacology Unit CourseContents(Topics) 1 Generalaspectsofdrugdiscoveryanddevelopment 2 HighThroughputScreening 2.1 TechniquesforHighthroughputscreening. a. Cellbasedassays b. Biochemicalassays. c. Radioligandbindingassays. 2.2 SelfstudyImportanceofpharmacokineticstudiesindrugdevelopment. 3 ToxicityStudies 3.1 Acute,subacuteandchronictoxicity Safetypharmacologyevaluation. Genetictoxicity,cytotoxicity,toxicogenomics Hours. 2 6 4 4hrs/week

2 8 5

3.2 SelfstudyScheduleY,OECD,ICHguidelinesfortoxicitystudiesbyvariousroutes. 4 IntroductiontoChronopharmacology 4.1 Circadianrhythm,BiologicalClock,Location,NeuroanatomyandNeurochemistry. Rhythmsandpharmacokinetics.

3 8 5 3 3 18 15

4.2 SelfstudyRhythmsandtherapeuticsofdiseasesofGITandasthma. 5 StemCellsandTherapeuticapplications 6 Noveldrugtargets 6.1 Physiologicalfunctions,pharmacologicalimplicationsandtherapeuticpotentialofthefollowing targetsites: Rhokinase(ROCK). Phosphoinositide3Kinase.(PI3K). Akt(ProteinkinaseB). Caspases. Proteases. Poly(ADPribose)Polymerase(PARP). Peroxisomeproliferatoractivatorreceptors(PPAR,). 6.2 SelfstudyBiologicalfunctionsofNitricoxide(NO)andtherapeuticpotentialofnitricoxide modulators. 7 Transporterproteins 7.1

Classification and biology of ATP binding cassette (ABC) transporter super family, Solute 5 carriertransporter(SLC). Multidrugresistanceproteins(MDR). Cysticfibrosistransmembraneregulator(CFTR).

7.2 ABCtransportesinvolvedindrugabsorptiondistributionandexcretion.

8 8 RoleofCytokines,Prostaglandins,TNF,Bradykinin,Leukotrienes,PAF,InterferonsandAdhesion moleculesinvariousimmunologicalandinflammatorydisorders Total 60 Books: 1. 2. 3. 4. 5. 6. RangandDalespharmacologyElsevierChurchillLivingston. LangesBasicandclinicalpharmacology,KatzungB.G.MastersS.B.,TrevorA.G.TataMcGrawHill. Goodmann and Gilmans pharmacological basis of therapeutics, Edited by Laurence Brunton, Bruce Chabner and BjornKnollman,McGrawHill. Pharmacologicalreviews,AnnualreviewsInc. Advancesinpharmacology,AcademicPress. TrendsinPharmacologicalSciences,CellPressElsevierPublication. Core2 ClinicalResearchMethodology Unit 1 Clinicaltrials 1.1 Introduction,drugdiscoveryanddrugdevelopment. 1.2 Variousphasesofclinicaltrials. 1.3 Studymethodology/designs,InclusionandExclusioncriteria,objectivesandendpoints(efficacyand safety),Methodsofallocation,blindingandrandomization. 1.4 Informedconsentprocess. 1.5 Studymonitoringanditsimportance. 1.6 Safetymonitoringinclinicaltrials. 1.7 SelfstudyBA/BEstudies,Postmarketingstudies. 2 Documentsinclinicalstudy EssentialdocumentsinclinicaltrialInvestigatorsBrochure(IB),Protocolandamendmentsin protocol,Casereportform(CRF),Informedconsentform(ICF),Contentofclinicalstudy report(CSR). 3 Ethicalguidelinesinclinicalresearch 3.1 History,ICHGCPanditsprinciples,IndianGCP(CDSCOGuidelines),ICMRguidelinesEthical guidelinesforBiomedicalResearchonhumansubjects2006,ScheduleY2005,USFDAguidelinesfor IND,NDA,ANDAapplications. 3.2 Selfstudy:EMEAorganizationanditsfunctions,EUregulatoryguidelines. 4 RolesandresponsibilityofvariousclinicaltrialpersonnelasperICHGCP Sponsor,Investigator,Monitor,Auditors 9 6 4 4 CourseContents(Topics) Hours. 14 10 4hrs/week

3 3

5 5.1 InstitutionalEthicsCommittee(IEC)/IndependentEthicsCommittee(IdEC)/InstitutionalReview Board(IRB) 5.2 SelfstudyEthicaltheories,IntegrityandMisconductinclinicalresearch. 6 RoleofQualityassuranceinclinicalresearch 7 ClinicalDataManagementandReportWriting 8 Pharmacoepidemiology Types,methods,andfactorsaffectingdrugutilization,applicationsofpharmacoepidemiologyin healthcareandrationaluseofdrugs 9 Pharmacovigilance 9.1 Definition,scopeandaimsofpharmacovigilance,AdversedrugreactionsClassification,mechanism, predisposingfactorsandcausalityassessment,Roleofclinicalpharmacistinreporting,evaluation, monitoring,preventionandmanagementofADRs. 9.2 Selfstudy:ReportingCIOMSforms,Periodicsafetyupdatereports(PSURs)asperIndianregulatory guidelines. 10 PharmacoeconomicsandOutcomesResearch TheoriesandmethodologiesofPharmacoeconomicsandOutcomesResearch.Applicationsof pharmacoeconomicstopharmacotherapyandmanagedhealthcare. Books 1. RickNG.DrugsFromDiscoverytoApproval,secondedition,JohnWiley&Sons,Inc2004.

5 2

3 2 3 5

10 5

Total 60

2. AllenCato,LyndaSutton,ClinicalDrugTrialsandTribulationsSecondEditionRevised,secondedition,MarcelDekker Inc;2ndRevisededitionMarch26,2002. 3. RonaldD.Mann,ElizabethB.Andrews.Pharmacovigilance,secondedition,JohnWiley&SonsLtd,2002. 4. ShayneC.Gad.DrugSafetyEvaluation.AJohnWiley&Sons,Inc.Publication,2000. 5. SandyWeinberg.GuidebookForDrugRegulatorySubmissions,firstedition,AJohnWiley&Sons,inc.2009. 6. DuolaoWangandAmeetBakhaiClinicalTrialsAPracticalGuidetoDesign,Analysis,andReporting,Remedica2006. 7. GiovannadiIgnazio,DiGiovannaandHaynes,PrincipalsofClinicalResearch,WrightsonBiomedicalPub.,2001 8. RKRondels,SAVarley,CFWebb,ClinicalDatamanagement,SecondEdition,JohnWiley&SonsInc,January1997. 9. StromBI,LimmelSE.TextbookofPharmacoepidemiology.Chichester,WestSussex,England:JohnWiley&SonsLtd; 2006. 10.Rascati,KarenL.EssentialsOfPharmacoeconomics.Philadelphia,Pa.:LippincottWilliams&Wilkins,2009. 11.M.F.Drummond,M.J.SculpherandG.W.Torrance,Methodsfortheeconomicevaluationofhealthcare programmes.OxfordUniversityPress,USA,2005.

12. Brenda Waning; Michael Montagne; William W McCloskey, Pharmacoepidemiology : principles and practice, New York:McGrawHill,2001 13. VariousGuidelineslike: ICH (International Conference on Harmonisation), GCP for registration of pharmaceuticals for human use. ICH HarmonisedTripartite GuidelineforGoodClinicalPractice,E6,1996. ICMRGuidelineEthicalGuidelinesforBiomedicalResearchonHumanSubjects. IndianGCPCentralDrugsStandardControlOrganization.GoodClinicalPractices GuidelinesforClinicalTrialsonPharmaceuticalProductsinIndia.NewDelhi:MinistryofHealth;2001. PharmacovigilanceProgrammeofIndia(PvPI) SEMESTERII BRANCH:BIOPHARMACEUTICSANDPHARMACOKINETICS Core1 Biopharmaceutics Unit 1 1.1 Mechanismsofdrugrelease Diffusioncontrolledrelease,chemicallycontrolledrelease,swellingcontrolledreleaseof drugsfromformulationsHiguchimodelandthePowerLawmodelfordrugreleaseand theircomparison,discussionofnewermechanisticmodelsdescribeddrugreleasefrom formulations Selfstudyofzero,first,andsecondorderreleasekineticsandtheirgraphicalprofiles DrugDissolution TheoriesofdrugdissolutionNoyesWhitneyDiffusionmodel;HixonCrowellModel; Interfacialbarriermodel(Continuousanddiscretereactionlimiteddissolution),concepts ofsolubilityversusdissolutionrate,physicochemicalfactorsaffectingdrugdissolution, pharmaceuticalfactorsaffectingdrugdissolution,physiologicalfactorsaffectingdrug dissolution,,methodsforestimationofsolubility,methodsfordeterminationof dissolutionrate Selfstudyofexpermimentalmethoddesignforsolubilityanddissolutionrate determination DrugAbsorption CourseContent(Topics) Hours 10 6 4hrs/week

1.2 2 2.1

4 18 14

2.2

3 3.1

16

Mechanismsofdrugabsorption,detaileddiscussionofthevarietyoftransportersandthe 12 roleoftransportersintheGItractandliverandtheirroleindrugabsorption, physicochemicalfactorsaffectingdrugabsorption,pharmaceuticalfactorsaffectingdrug absorption,physiologicalfactorsaffectingdrugabsoption,gutandhepaticmetabolism andtheirroleindeterminationofbioavailability,invtitroandinvivomethodsfor estimationofpermeability/transportacrossmembranes/absorption,computational methodsforpredictionofsolubility/permeability/absorption Selfstudyoftheexperimentaldesignofmethodsfordetermination/predictionofdrug transport RoutesofDrugAdministration 4

3.2

11

4.1

Discussionofthedifferentroutesofdrugadministrationfortheperspectiveofthenature oftheabsorptionbarrier/s,mechanismsofdrugrelease,drugpermeability/absorption fromthesiteofadministration,drug/pharmaceutical/physiologicalfactorsaffectingdrug dissolution/dissolutionrate/absorptionfromthedifferentroutesofdrugdelivery Selfstudyoftheadvantagesandlimitationofthedifferentroutesofadministrationand examplesofdrugadministeredbytheseroutes Discussionofthetraditionalandhighthroughputapproachestowardsestimationof solubility,dissolutionrateanddrugabsorptionanduseofthisinformationinadrug discoveryanddevelopmentsetting.

4.2

Books: 1.

Total 60

ClinicalPharmacokineticsandPharmacodynamicsConceptsandApplications,RowlandMandTozerTN,Walters KluwerLippincottWilliamsandWilkins. AppliedBiopharmaeuticsandPharmacokinetics,ShargelLandYuABC,AppletonandLange,InternationalEdition HandbookofBasicPharmacokineticsincludingclinicalapplications,RitschelWAandKearnsGL,APhA, BasicPharmacokinetics,JambhekarSSandBreenPJ,PharmaceuticalPress. BiopharmaceuticsandPharmacokinetics,VenkateshwarluV,PharmaBookSyndicate DrugBioavailabilityEstimtionofsolubility,permeability,absorptionandbioavailability,vanderWaterbeemdH, LennernasHandArturssonP,WileyVCH. ModellinginBiopharmaceutics,PharmacokineticsandPharmacodynamicsHomogenousandHeterogenous approaches,MacherasPandIliadisA,Springer Core2 Pharmacokinetics 4hrs/week

2. 3. 4. 5. 6.

7.

Unit 1

CourseContent(Topics) Introductiontopharmacokineticsanditsutilityindrugdesignanddosageregimendesign. Definitionsofabsorption,distribution,metabolism,excretion,elimination.Different approachesfordeterminationofpharmacokineticsofdrugsnoncompartmental, physiological,andcompartmentalmodeling.Assumptionsinvolvedintheevolutionofsingle andmulticompartmentmodels. Discussion(includingmathematicaldescriptionandequations)ofthepharmacokineticsof drugsshowingonecompartmentpharmacokineticsfollowingdifferentdosing methods/protocols[blood/plasma/urinesampling] Discussion(includingmathematicaldescriptionandequations)ofthepharmacokineticsof drugsshowingonecompartmentpharmacokineticsfollowingintravenousbolusdosing [blood/plasma/urinesampling] Discussion(includingmathematicaldescriptionandequations)ofthepharmacokineticsof drugsshowingonecompartmentpharmacokineticsfollowingintravenousmultiplebolusdosing

Hours 4

40

2.1

2.1

[blood/plasma] 2.2 Discussion(includingmathematicaldescriptionandequations)ofthepharmacokineticsof drugsshowingonecompartmentpharmacokineticsfollowingintravenousconstantinfusion dosing[blood/plasma]. Discussion(includingmathematicaldescriptionandequations)ofthepharmacokineticsof drugsshowingonecompartmentpharmacokineticsfollowingextravascularbolusdosing [blood/plasma].Discussionoftheconceptsofbioavailability(absoluteandrelative)and bioequivalence. Discussion(includingmathematicaldescriptionandequations)ofthepharmacokineticsof drugsshowingonecompartmentpharmacokineticsfollowingextravascularmultiplebolus dosing[blood/plasma]. Discussionofapproachestosolveproblemsrelatedtotheanalysisofpharmacokineticstudy dataobtainedafterdifferenttypesofdosing.Discussionofapproachestoproblemsolving involvingdatafrombioavailabilityandbioequivalencestudies.Discussionofapproachesto dosageregimendesign Selfstudyofproblemsandproblemsolvingrelatedtothetheoreticalconceptsoutlinedabove (bloodadurinedataanalysis) Discussionoftheprocessesofabsorption,distributionandeliminationwithrespecttohow theseprocessesimpactthevaluesofrateconstantsforabsorption/distribution/eliminationand thevaluesofbioavailability,volumeofdistributionandclearance. Introductiontodrugtransportersandtheirimpactonthepharmacokineticsofdrugsand pharmacokineticdrugdruginteractions. Briefintroductiontotheconceptofdoseandtimedependentpharmacokinetics[nonlinear pharmacokinetics]andtheirimpactondrugdevelopmentandclinicaluse. 5

2.3

2.4

2.5

2.6

10

10

Books: 1.

Total 60

ClinicalPharmacokineticsandPharmacodynamicsConceptsandApplications,RowlandMandTozerTN,Walters KluwerLippincottWilliamsandWilkins. AppliedBiopharmaeuticsandPharmacokinetics,ShargelLandYuABC,AppletonandLange,InternationalEdition HandbookofBasicPharmacokineticsincludingclinicalapplications,RitschelWAandKearnsGL,APhA, BasicPharmacokinetics,JambhekarSSandBreenPJ,PharmaceuticalPress. BiopharmaceuticsandPharmacokinetics,VenkateshwarluV,PharmaBookSyndicate

2. 3. 4. 5. 6.

DrugBioavailabilityEstimtionofsolubility,permeability,absorptionandbioavailability,vanderWaterbeemdH, LennernasHandArturssonP,WileyVCH. ModellinginBiopharmaceutics,PharmacokineticsandPharmacodynamicsHomogenousandHeterogenous approaches,MacherasPandIliadisA,Springer

7.

SEMESTERII BRANCH:CLINICALPHARMACY Core1 ClinicalPharmacy Unit 1 IntroductiontoClinicalPharmacy 1.1 Scope,ObjectivesandGoalsinHealthCare. 1.2 PracticeofClinicalPharmacyinHospitalsandCommunity. 2 Understandingthepatient 2.1 PharmacistPatientInterview,InterviewTechniques,communicationskills. 2.2 Patientorientedmedicalrecords(POMR):Medicationhistoryandrecords,habitsrelatedto useofOTCmedications,foods,allergiesandsensitivities. 2.3 Patientfollowupanddischargeinterviewforhospitalisedpatients. 2.4 PharmacologicalandBiochemicalexaminationsandtheirsignificance. 2.5 Ethicsrelatedtomedicalrecord 2.6 Dischargecard 2.7 SelfstudySupervisionoftherapeuticsuccess,sideeffectsandadverseeffects 3 Therapeuticuseofmedicine 3.1 Drugselectionandadministration.Problemsassociatedwithconcomitanttherapy. 3.2 Patientsensitivities,allergies.Precautionsduringuse,Dietcontrol. 3.3 Reasonsfornoncompliance,Strategiesforimprovingcompliance. 3.4 Useofdrugsandconcernsingeriatric,paediatricpatientsandinpregnancy 3.5 Drugdruginteractionsanddruginteractionswithfood,alcoholandtobacco. Therapeuticdrugmonitoring(TDM) 4.1 Introduction,individualizationofdrugdosageregimen(variabilitygenetic,age,weight, diseaseandinteractingdrugs). 4.2 IndicationsforTDM,protocolforTDM. 4.3 Pharmacokineticpharmacodynamiccorrelationindrugtherapy. 4.4 TDMofdrugsusedinfollowingdiseaseconditions:cardiovasculardiseases,CNSconditions etc. 5 Drugformulary,drugutilizationreview(DUR)includingrationaldrugtherapy 3 10 6 CourseContent(Topics) Hours 3 11 8 4hrs/week

6 DrugInformation 6.1 Introductiontoinformationresources 6.2 Druginformationcentre(DIC)andDruginformationservices. 6.3 Drugliteratureutilization,selection,evaluationandcommunication. 6.4 RoleofDICinensuringrationaluseofdrugs(RUD). 7 Standardtreatmentprotocolofselectednoncommunicablediseases/conditionslike diabetes,hypertension,stroke,obesity,arthritis,cardiopulmonarydysfunctionandfluidand electrolyteimbalance. 8 SelfstudyGeneralconceptsofpoisoningandtoxicology Criticalcaremanagement: CommonlifesupportsystemsAcuteandchronicrenalfailure,cardiacandepilepticattackand respiratoryfailure. Books: 1. 2. 3. 4. 5. 6. 7.

4 10

13

Total 60

J.T.Dipiro,R.L.Talbert,,G.C.Yee,G.R.Matzke,B.G.Wells,L.MichaelPosey(eds.), Pharmacotherapy:APathophysiologicApproach,6thed..,TheMcGrawHillCompanies,Inc.,2005. E.T.HerfindalandD.RGourley,TextBookofTherapeutics:DrugandDiseaseManagement,7thed.,LippincottWilliams &Wilkins,USA,2000. T.M. Speight and NHG Holford (ed.), Averys Drug Treatment: Principals and Practice of Clinical Pharmacology and Therapeutics,4thed.,ADISPress,Sydney,Australia,1997. Dennis L. Kasper, Eugene Braunwald, Anthony S. Fauci, Stephen L. Hauser, Dan L. Longo, J. Larry Jameson, and Kurt J. Isselbacher,(Eds.),Harrison'sPrinciplesofInternalMedicine,16thed.,TheMcGrawHillCompanies,Inc.,2004. PharmaceuticalPracticeA.JWinfield,R.M.E.Richards,Churchillivingstonepublication. DrugInteractionFacts,2003.DavidS.Tatro. Core2 ClinicalResearchMethodology 4hrs/week

Unit 1 Clinicaltrials

CourseContents(Topics)

Hours

10 Introduction,drugdiscoveryanddrugdevelopment,Variousphasesofclinicaltrials,study methodology/designs,InclusionandExclusioncriteria,objectivesandendpoints(efficacyandsafety), Methodsofallocation,blindingandrandomization,Informedconsentprocess,studymonitoringandits importance,Safetymonitoringinclinicaltrials,BA/BEstudies,Postmarketingstudies 2 Documentsinclinicalstudy EssentialdocumentsinclinicaltrialInvestigatorsBrochure(IB),Protocolandamendmentsinprotocol, Casereportform(CRF),Informedconsentform(ICF),Contentofclinicalstudyreport(CSR). 3 Ethicalguidelinesinclinicalresearch History,ICHGCPanditsprinciples,IndianGCP(CDSCOGuidelines),ICMRguidelinesEthicalguidelines 6 4

forBiomedicalResearchonhumansubjects2006,ScheduleY2005,USFDAguidelinesforIND,NDA, ANDAapplications RolesandresponsibilityofvariousclinicaltrialpersonnelasperICHGCP Sponsor,Investigator,Monitor,Auditors

InstitutionalEthicsCommittee(IEC)/IndependentEthicsCommittee(IdEC)/InstitutionalReviewBoard (IRB) RoleofQualityassuranceinclinicalresearch ClinicalDataManagementandReportWriting Pharmacoepidemiology Types,methods,andfactorsaffectingdrugutilization,applicationsofpharmacoepidemiologyinhealth careandrationaluseofdrugs

6 7 8

2 3 5

Pharmacovigilance Definition,scopeandaimsofpharmacovigilance,AdversedrugreactionsClassification,mechanism, predisposingfactorsandcausalityassessment,Roleofclinicalpharmacistinreporting,evaluation, monitoring,preventionandmanagementofADRs.

10

PharmacoeconomicsandOutcomesResearch TheoriesandmethodologiesofPharmacoeconomicsandOutcomesResearch.Applicationsof pharmacoeconomicstopharmacotherapyandmanagedhealthcare.

Books 1. 2. RickNG.DrugsFromDiscoverytoApproval,secondedition,JohnWiley&Sons,Inc2004.

Total 45

AllenCato,LyndaSutton,ClinicalDrugTrialsandTribulationsSecondEditionRevised,secondedition,MarcelDekker Inc;2ndRevisededitionMarch26,2002. RonaldD.Mann,ElizabethB.Andrews.Pharmacovigilance,secondedition,JohnWiley&SonsLtd,2002. ShayneC.Gad,DrugSafetyEvaluatio,AJohnWiley&Sons,Inc.Publication,2000. SandyWeinberg.GuidebookForDrugRegulatorySubmissions,firstedition,AJohnWiley&Sons,Inc.2009. DuolaoWangandAmeetBakhaiClinicalTrialsAPracticalGuidetoDesign,Analysis,andReporting,Remedica2006. GiovannadiIgnazio,DiGiovannaandHaynes,PrincipalsofClinicalResearch,WrightsonBiomedicalPub.,2001 RKRondels,SAVarley,CFWebb,ClinicalDatamanagement,SecondEdition,JohnWiley&SonsInc,January1997. StromBI,LimmelSE.TextbookofPharmacoepidemiology.Chichester,WestSussex,England:JohnWiley&SonsLtd; 2006. Rascati,KarenL.EssentialsOfPharmacoeconomics.Philadelphia,Pa.:LippincottWilliams&Wilkins,2009. M.F.Drummond,M.J.SculpherandG.W.Torrance,Methodsfortheeconomicevaluationofhealthcare programmes.OxfordUniversityPress,USA,2005.

3. 4. 5. 6. 7. 8. 9.

10. 11.

14.

Brenda Waning; Michael Montagne; William W McCloskey, Pharmacoepidemiology : principles and practice, New York:McGrawHill,2001 15. VariousGuidelineslike: ICH (International Conference on Harmonisation), GCP for registration of pharmaceuticals for human use. ICH HarmonisedTripartite GuidelineforGoodClinicalPractice,E6,1996. ICMRGuidelineEthicalGuidelinesforBiomedicalResearchonHumanSubjects. IndianGCPCentralDrugsStandardControlOrganization.GoodClinicalPractices GuidelinesforClinicalTrialsonPharmaceuticalProductsinIndia.NewDelhi:MinistryofHealth;2001. PharmacovigilanceProgrammeofIndia(PvPI) SEMESTERII BRANCH:MEDICINALCHEMISTRY Core1 AdvancedPharmaceuticalandMedicinalChemistry Unit 1 1.1 1.2 EnzymeInhibition Coverageofbasicaspectsofenzymekinetics,catalysis,transitionstatetheory. DrugResistancethroughalterationsofdruguptake,overproductionofenzyme,alterationsof theenzymeactivesite,overproductionofthesubstrateornewpathwaysforformationofthe product Drugsynergism,conceptsandmechanisms. Reversibleenzymeinhibitorscompetitiveinhibition,noncompetitiveinhibition, uncompetitiveinhibitionwithsuitableexamples.Detectionoftypeofinhibitionbysuitable plottingmethods.ConceptsofIC50andKi. Slowtightbindinginhibitors,covalentenzymeinhibitorsandmechanismbasedinhibitorswith suitableexamples.ConceptofKinactandKiforirreversibleinhibitors Selfstudyofspecificexamplesofdifferenttypesofinhibitorsandtheirdesign(someexamples likeCOXinhibitors,ACEinhibitors,RTinhibitors,HIVproteaseinhibitors,aromataseinhibitors, DHFRinhibitors,viralDNApolymeraseinhibitors,thymidylatesynthaseinhibitorsandothers) QSAR HistoricalAspects ElectronicEffectstheHammettequation,lipophiliceffects,experimentalmeasurementof lipophilicity,logPandlogD,effectofionizationonlogP,calculationoflogPandlogD,Steric effectstheTaftequation HanschAnalysis,FreeWilsonmethod,Toplissoperationalscheme Basicsofregressionanalysislinearandmultilinearregression,introductiontoPCA,PCR,PLS, 2 2 ANNandGFA.Correlationcoefficients(r andr pred),Ftest,standarderror,validationmethods 2 likecrossvalidationbycalculationofq ,bootstrapanalysisandrandomization.Application domainforpredictionsusingaQSARmodel. CourseContent(Topics) Hours 16 2 1 4hrs/week

1.3 1.4

1 4

1.5

1.6

2 2.1 2.2

14 1 3

2.3 2.4

2 6

2.5 3 3.1

Designoftrainingandtestsetsusingfactorialdesign PeptidesandPeptidomimetics Coverageofpeptidestructure,biosynthesisofpeptidesandsolidphase/solutionsynthesisof peptides. Designofpeptidomimeticsbymanipulationoftheaminoacids,modificationofthepeptide backbone,incorporatingconformationalconstraintslocallyorglobally,helix,sheet,and turnmimetics SelfstudyofexamplesofpeptidomimeticsforsomeenzymesandreceptorslikeACE,CCK, bradykinin Antisensetherapeuticagents Historyandprinciples DesignofantisenseoligonucleotidesandsmallinterferingRNAs(siRNAs)withsomeexamples MolecularBiology,GeneticengineeringandBiotechnologyinproductionofbiologicalsas drugs. Selfstudyofbiotechnologybaseddrugs,vaccinesanddiagnosticagentswithrespecttotheir biologicalsource,theirdesignandthemechanismoftheiractions

2 14 4

3.2

3.3

4 4.1 4.2 5

6 2 4 6

5.1

Books 1. 2. 3. 4. TheOrganicChemistryofDrugDesignandDrugAction,SilvermanR.B.,AcademicPress.

Total 60

TextbookofDrugDesignandDiscovery,Eds.KrogsgaardLarsenP.,LiljeforsT.,MadsenU.,Taylor&Francis. MedicinalChemistry:AnIntroduction,ThomasG,Wiley. PeptideandProteinDesignforBiopharmaceuticalApplications,EdJensenK.J.,Ch.3AspectsofPeptidomimeticsby MaesV.,TourwD.,JohnWiley&Sons,Ltd,Chichester,UK. ComprehensiveMedicinalChemistry,SeriesEd.,HanschC.,PergamonPress. BurgersMedicinalChemistry,DrugDiscoveryandDevelopment,Wiley. Core2 DrugMetabolism CourseContent(Topics) Introductiontoxenobiotic/drugmetabolism Introductiontoxenobiotic/drugmetabolismanditsrelationtootherdefencesystems (Physicalbarriers,excretion,immunesystem). Typesofreactions(IandII),consequencesofdrugmetabolism(DM)[inactivation, bioactivation,prodrugs],organsofDM,localizationofdrugmetabolizingenzymes, factorsaffectingdrugmetabolism. 4hrs/week Hours 6 2

5. 6.

Unit 1 1.1

1.2

CytochromeP450s:Introductiontothefamilyofenzymes,theirclassificationand nomenclature. Introductiontothefamilyofenzymes,theirclassificationandnomenclature. CYP450catalyticcycle,differenttypesofreactionscatalyzedbyCYP450sandthe mechanismsofcatalysis. HumanCYP450sinvolvedinDM,theirdistributionandproperties,typicalsubstrates, specificprobesubstrates,specificinhibitors,inductionofCYPsandspecificinducers GeneticpolymorphisminCYP450expression NONP450enzymes IntroductiontoNONP450enzymesinvolvedindrugmetabolism SelfstudyofNONP450sglucuronosyltransferases,sulfotransferases,glutathioneS transferases,Nacetyltransferases,xanthineoxidase,aldehydeoxidase,esterase, epoxidehydrolase,nitro/azoreducatasesandFMO[onlinessimilartothatspecifiedfor CYPsaslistedabove]. IntroductiontomethodsforstudyingDM.Discussionofinvitroandinvivotools,along withtheiradvantagesandlimitations{recombinantenzymes,subcellularfractions, hepatocytes,liverslices,perfusedliverandwholeanimalstudies}. DiscussionoftypesofDMstudiesmetabolicstability,crossspeciescomparisons, metaboliteprofilingandidentification,reactionphenotyping,CYPinhibitionandCYP inductionstudies. Introductiontoinsilicodrugmetabolitepredictionsandassociatedalgorithms.

20

2.1 2.2

2 8

2.3

2.4 3 3.1 3.2

3 20 05 15

6 Books: 1. 2. 3. 4. 5. 6. 7.

3 Total 60

ComprehensiveMedicinalChemistry,SeriesEd.,HanschC.,PergamonPress. WilsonandGisvolds,TextbookofOrganicMedicinalandPharmaceuticalChemistry,LippincottRaven FoyesPrinciplesofMedicinalChemistry,LippincottWilliamsandWilkins. Drug Metabolizing EnzymesCytochrome P450 and Other Drug Metabolizing Enzymes in Drug Discovery and Development,LeeJS,ObachSRandFisherMB,MarcelDekker,FontisIndia,2003 Pharmaceutical Profiling in Drug Discovery for Lead Selection, Borchardt RT, Kerns EH, Lipinski CA, Thakker DR and WangB,AAPSPress,2004 DrugMetabolismCurrentConcepts,IonescuCandCairaMR,SpringerInternationalEdition HandbookofDrugMetabolism,WoolfTF,MarcelDekker,1999. SEMESTERII BRANCH:PHARMACEUTICALBIOTECHNOLOGY Core1 PharmaceuticalBiotechnology 4hrs/week

Unit

CourseContent(Topics)

Hours

1 1.1 1.2

ProductionandControlofBiotechderivedproducts RecombinantDNAproductsinsulin,growthhormone,erythropoietin,cytokines Vaccinesattenuatedvirus,geneticalterationsoflivevirusasavectorofotherpathogens (recombinantvirusorrecombinantvacciniavirus) DiagnosticproteinsproteinA,proteinG,antibodies Qualitycontroltestingofbiotechproductsdeterminingimpurities,contaminationviral, bacterialendotoxin,rabbitpyrogentest,sterility,proteinidentification,fingerprintsby electrophoresis,isoelectricfocussing,immunogenicity,partialsequenceanalysis. Plantbiotechproducts Substancesproducedbyplantcellculture Transgenicplantsandtheirapplication Biotransformationswithplantcellculture Biotechproductsthroughfermentation Fermentationbatch,continuousfermentation Roleofbioengineeringinfermentationgeometryoffermentationtanks,designofimpellers, agitationsystemsandenvironmentalconditionsoffermentation Fermentativeproductionofimportantsecondarymetabolitespenicillins,aminoglycosides polyenemacrolides,macrolides,anthracyclines Principlesofdownstreamprocessingoffermentationproducts Unitoperationsandtechniquesemployedinndownstreamprocessingoffermentation products,microbialstrainselectionandpreservationmethods Genotypeandphenotypevariationofcharactersofmicrobes SelfStudyBiotransformation Biotransformationprinciplesandindustrialapplicationsintheproductionofchemicalsand drugs Immobilizationofenzymes,proteinsandtheirapplicationsbiosensors,enzymeelectrodes, immunosensors,opticalsensors

25 5 7

1.3 1.4

4 9

2 2.1 2.2 2.3 3 3.1 3.2

10 2 4 4 13 2 3

3.3

3.4 3.5

3 3

3.6 4 4.1

12

4.2

Books: 1. 2. 3. 4. 5. 6. 7.

Total 60

Biotechnology,H.J.Rechm,G.Reed.Vols112,A.Pulher,P.StadlerEds,Weinhelm,NewYork AtextbookofBiotechnology,H.D.KumarAffiliated,EastWestPressPvt.Ltd. GeneticEngineeringFundamentals,KarlKammer,MeyerVirginia,C.Clark. GenesV,BenjaminLewin,OxfordUniversityPress. MethodsinPlantMolecularBiologyandBiotechnology,BernardRGlick,JohnEThompson,CRCPress. GeneticandBiochemistryofAntiobioticsProduction,LeoCVining,Colin,StuttardButterworth,Heinemann. BiotechnologyApplicationsandResearch,PaulNChermisinoff,RobertPOuellett,TechnomicPublishingCo.Inc.

8.

Transgenic Plants: A production systems for industrial and pharmaceutical proteins, Meran R. L. Owen, Jan Pen, John WileyandSons. 9. Biotehnologyofantibiotics,WilliamRStrohl,MarcelDekker. 10. MolecularBiochemistryTherapeuticapplicationsandstrategies,SunilMaulikandSalilDPatel,JohnWileyandSons, Inc. Core2 BasicMolecularBiology 4hrs/week

Unit 1 2 2.1 2.2 2.3

CourseContent(Topics) Thebeginningsofmolecularbiology DNAStructureandRoleofDNA Organizationofthegenome,buildingfromnucleotidestochromatin Thegeneticcodeanditsrelationshiptoproteinstructure DNAreplication,Telomeremaintenance,mechanismsofDNArepair,DNA recombination TheversatilityofRNA Transcriptionandtranslationinprokaryotes;Transcriptionandtranslationin eukaryotes Epigeneticsandmonoallelicgeneexpression RNAprocessingandposttranscriptionalgeneregulation Mechanismsoftranslation Geneticallymodifiedorganisms:Useinbasicandappliedresearch RecombinantDNAtechnology,molecularcloning,&sometoolsforanalyzinggene expression Genomeanalysis:DNAtyping;Genomicsandbeyond;Medicalmolecularbiology: applicationsinCancerandGenetherapy;Genesandbehaviour Planttissuecultureandanimalcellculture

Hours 1 16 6 2 8

3 3.1

23 8

3.2 3.3 3.4 4 4.1

3 8 4 14 8

4.2

5 Books: 1. 2. 3. 4. 5. 6. 7.

6 Total 60

GenesIX,EdBenjaminLewin.OxfordUniversityPress. MolecularCellBiology,LodishH,BerkA,ZipurskySL,MatsudairaP.,BaltimoreD,DarnellJ,PublisherW.H.Freeman. MolecularBiologyoftheCell,AlbertsPublisherGarlandScience. Watson, J. D. Tania A. Baker, Stephen P. Bell, Alexander Gann, Michael Levine, Richard Losick, Molecular Biology of theGene,BenjaminCummings;6thEdition,2007. MolecularBiologyinMedicinalChemistry,DingemannTh,SteinhilberDandFolkersG,WileyVCH,Germany BasicPrinciplesofGeneManipulation,PrimroseSB,TwymanRMandOldRW,Blackwell. MolecularBiologyandbiotechnology,WalkerJMandRapleyR,RoyalSocietyofChemistry

SEMESTERII BRANCH:DRUGDELIVERYTECHNOLOGY Core1 AdvancedPharmaceuticsI Unit 1 1.1 1.2 1.3 SolidsoralSRsystem SelfstudyOverviewofSingleoralunitSRsystems. SelfstudyStructureandphysiologyofGIT. MechanismofRelease&Releasekineticequations. TypesDiffusioncontrolled,Dissolutioncontrolled,Reservoir,Matrix,Osmoticsystems,Ionexchange systems Mucosaldrugdeliverysystemsbuccal,gingival,sublingual. 1.4 Multiparticulatesystemspelletization(emphasisonextrusionandspheronization).Orodispersible systems.PulsatileDrugdeliverysystems. ParenteralSRsystems Needandconcept,routesemployed Approachesaqueoussystems(complexation,useofpolymers),aqueoussuspensions(depotinjections, microspheres,magneticmicrospheres),Oilysolutions&suspensions,Emulsions(Microemulsions, multipleemulsions,),Implants(indetailconcept,propertiesdesired,variousapproaches),prodrugs (chemicalmodifications),infusionpumps. SelfstudyBiopharmaceuticalaspects,Sterilization&stabilityissues Characterizationspecialemphasisonreleasestudies IssuesrelatedtoSafety,Toxicity&TissueInjury SpecializedEmulsions Microemulsions,Multipleemulsions,SelfEmulsifyingDrugDeliverysystems&SMEDDS;Formulation andphasebehaviour;Preparation&Characterization;BioavailabityAspects;Applications. SelfstudyTheoriesofEmulsification,Factorsinfluencingtypeofemulsionformed. GastroretentiveDrugDeliverySystems SelfstudyIntroduction;conceptofabsorptionwindow;needforGRDDS,gastricmotility;principlesof Gastroretention;FactorscontrollingperformanceofGRDDS. DifferentApproachesHighdensitysystems,floatingsystems,mucoadhesivesystems,Expandable systems,Magneticsystems,SuperporousHydrogels Evaluation. Oculardrugdeliverysystems. 5 CourseContents(Topics) Hours 13 3 1 4 4hrs/week

2 2.1 2.2

12 1 6

2.3 2.4 2.5 3 3.1

2 1 2 9 6

3.2 4 4.1

3 8 3

4.2

4.3 5

1 7

5.1 5.2 5.3

SelfstudyStructureandphysiologyofeye;Drugabsorptionanddispositionintheeye. Methodstoprolongoculardrugresidencewithemphasisonmucoadhesivesystems. Intraocularinserts;Nonerodibleinserts/Erodibleinserts. Novelophthalmicdrugdeliverysystems,Nanoparticles,liposomesandprodrugs.Ocularpenetration enhancers.

2 1 4

6 6.1 6.2

TransdermalDrugDeliverySystems SelfstudyStructureandphysiologyofskin. Principlesofskinpermeation. Kineticsofskinpermeation&penetrationenhancers. Types(Gels,Patches/films), Pressuresensitiveadhesives.

7 1 3

6.3 6.4 6.5 7

Development&evaluationinvitro,invivo. Iontophoresis. Recentadvancesuseofmicroneedlesintransdermaldrugdelivery. IntroductiontoPharmaceuticalProcessingDevelopment. (AsperICHguidelines)

1 1 1 4

7.1

ElementsinPharmaceuticaldevelopment Targetproductprofile CriticalQualityAttributes. LinkingMaterialAttributes&processparameterstoCQAsRiskAssessment Designspace ControlStrategy ProductLifecyclemanagement&continualimprovement. SubmissionofPharmaceuticalDevelopmentandrelatedinformationinCTDformat. RelevantExamples.

7.2

Total 60 Books: 1.TargetedandControlledDrugDelivery:NovelCarrierSystemsbyVyasSP,KharRK,CBSPublishersandDistributors,1stedn, 2002. 2.ControlledandNovelDrugDeliverybyJainNK,CBSPublishersandDistributors,2008. 3.ControlledDrugDelivery:FundamentalsandApplicationsbyRobinsonJR,LeeVHL,Dekker,2ndedn,Vol29,1987.

nd 4.NovelDrugDeliverySystembyChienYW,2 edn,Vol50,InformaHealthcare,2003.

5.ProgressinControlledandNovelDrugDeliverySystemsbyJainNK,CBSPublishersandDistributors;2004.

6.OphthalmicDrugDeliverySystems,MitraAK,2ndedn.,DrugsandPharmaceuticalSciencesSeries,Vol.130,MarcelDekker, 2003. 7.Polymericdrugdeliverysystem,KwonGS,MarcelDekker,Vol148,2005. 8.NanoparticulateDrugDeliverySystembyThassuD,DeleersM,PathakY,MarcelDekker,Vol166,2007. 9.ControlledDrugDeliveryChallengesandStrategiesbyParkK,AmericanChemicalSociety,1997. 10.ColloidalDrugDeliverySystembyKreuterJ,MarcelDekkerVol66,1994. 12.www.ich.org 13.PharmaceuticalDosageForms:DisperseSystemsbyLiebermanHA,RiegerMM,BankerGS,MarcelDekker,Vol3,2ndedn, 2005. 14.PharmaceuticalEmulsionsandSuspensionsbyNielloudF,MartiMestresG,MarcelDekker,Vol105,2000. 14.ControlledReleaseSystemsFabricationTechnologybyDeanSTH,CRCPress,Vol1,1988. 15.BioadhesiveDrugDeliverySystemsbyMathiowitz.E,ChickeringDE,LehrCM,MarcelDekkerVol98,1999. 16.PharmaceuticalSkinPenetrationEnhancementbyWalters.KA,HadgraftJ,MarcelDekker,Vol59,1993. 17.PercutaneousAbsorptionbyBronaughRL,MaibachHI,TaylorandFrancis,3rdedn,Vol97,2005. 18.TransdermalControlledSystemicMedicationbyChienYW,MarcelDekker,Vol.31,1987. 19.OralMucosalDrugDeliverybyRathboneMJ,MarcelDekker,Vol74,1996. 20.ModifiedReleaseDrugDeliveryTechnologybyRathboneMJ,HadgraftJ,RobertsMS,LaneME,InformaHealthcare,2ndedn, Vol183(1),2008. 21.PharmaceuticalPelletizationTechnology,Ghebresellassie.I,,MarcelDekker,Vol.37 Core2 Unit 1 ModelsforDDSEvaluation CourseContent(Topics) PharmacodynamicmodelsforevaluationofDDScontainingdrugsofvariouscategories e.g.cardiovascularagents,antidiabetic,antiinflammatory,antiepileptic,anticancer, hepatoprotectives,analgesics,antistress,antiasthmaticandantitussives. InvitrocellculturetechniquesforevaluationofdrugpermeationfromDDS,including isolation,maintenanceofcelllines,culturingmonolayers,evaluationofdrugtransport Invitro/exvivomodelsforevaluationofdrugabsorption InvitrocytotoxicityevaluationusingcellculturesandtechniquessuchasMTTassay,dye uptakeetc ToxicitytestinginvitroInvitrotoxicitytestinganditsapplicationtosafety evaluation,generalperspectives,invitrotrendsandissues,ocularandcutaneous irritation,validationofinvitrotoxicitytestsacute,subacuteandchronictoxicity testing,biochemicalbasisoftoxicity,designoftoxicologicalstudies,qualityassurancein toxicologicalstudies,toxicitybyroutesparenteral,oral,percutaneousandinhalation, targetorgantoxicityexemplifiedbyhepatotoxicityandcutaneous(dermal)toxicity. 4hrs/week Hours 20

3 4

5 5

10

 Books: 1. 2. 3. 4. ElectiveSubjects Elective1 RationalDrugDesign Unit 1.0 CourseContent(Topics)

Total 48

BioassayTechniquesfordrugdevelopment,AttaUrRahman,M.IqbalChoudhar,WilliamJThomsen. InvitroMethodsinPharmaceuticalResearch,Eds.J.V.Castell,M.J.Gomer,Lechon,AcademicPress InvitroToxicityTesting,JohnMFrazier. GeneralandAppliedToxicology,BryanBallantyne,TMarrsandP.Turner.

4hrs/week

Hours 5

MolecularMechanicsandtheforcefield.Generalformofagenericforcefield,force fieldparametrization. SelfStudyComparisonbetweenthedifferentforcefieldsinexistenceatpresenttime Energyminimization Steepestdescents,conjugategradients,NewtonRaphsonmethod,advantagesand limitationsofeachmethod Conformationalanalysis Systematicsearch,MonteCarlosimulations,Moleculardynamicssimulations,distance geometry,strengthsandlimitationsofeachmethod Docking Dockingbyenergyminimization,superimposition,moleculardynamics,Metropolis MonteCarlo,geneticalgorithms,buildupapproach.Differenttypesofscoringfunction, e.gsofsuccessfulapplicationofdocking. SelfStudySuccessfulapplicationsofdocking denovoliganddesign Classesofdenovoliganddesignactivesiteanalysismethods,wholemolecule methods,connectionmethods,randomconnectionanddisconnectionmethods,e.gsof successfulapplicationofdenovoliganddesign Fragmentbaseddrugdesign SelfStudySuccessfulapplicationsofdenovodrugdesign Pharmacophoremodelling Techniquesofdevelopingapharmacophoremapcoveringbothligandbasedand receptorbasedapproaches,incorporatingadditionalgeometricfeaturesintoa3D pharmacophore,useofapharmacophoremodelindrugdesign,.

1.1 2.0 2.1

1 6

3.0 3.1

10

4.0 4.1

10 8

4.2 5.0 5.1

2 10

5.2 5.3 6.0 6.1

2 2 9 7

6.2 7.0

SelfstudySuccessfule.g.ofpharmacophoremapsindrugdesign VirtualScreeningbasedonsimilarity,docking,pharmacophoremapsandfiltersfor druglikenessandADME 3DQSAR

th CoMFAandCoMSIA.Mentionofother3DQSARtechniquesandintroductiontothe4 , 5thand6thdimensioninQSAR.

2 3

8.0 8.1

6 4

8.2 Books 1. 2. 3. 4.

SelfStudy3DQSARmethodsotherthanCoMFAandCoMSIA Total

2 60

MolecularModellingPrinciplesandApplications,LeachA.R.,PrenticeHall. PracticalApplicationofComputerAidedDrugDesign,Ed.CharifsonP.,MarcelDekkerInc. 3DQSARinDrugDesign:Theory,MethodsandApplications,Ed.KubinyiH.,LedienESCOM. MolecularModelingandSimulationAnInterdisciplinaryGuide,SchlickT.,Springer. Elective2 SpectroscopicStructuralElucidation 4hrs/week

Problemsofstructuralelucidationinvolvingthefollowingtechniques: UVspectroscopy. IRspectroscopy. 1 HNMRspectroscopy. 13 CNMRspectroscopy. MassSpectrometry. Theproblemsshouldcoverthefollowingaspects: Unit 1 CourseContents(Topics) Calculationofmaxfordienes,,unsaturatedketonesbyUVspectroscopy.Selfstudy practiceproblems(1hr)
1 PredictionofcharacteristicIRbands,NMRspectra( HNMR)chemicalshift,splittingpattern 13 andratioofprotonintensity,( CNMR)numberofsignals,chemicalshiftandsplittingpattern, massfragmentationpatterns.Selfstudypracticeproblems(2hrs) 1 13 DistinguishingcompoundsusingUV/IR/ HNMR/ CNMRand/orMassspectrometry.Self studypracticeproblems(2hrs)

Hours 5

10

10

Interpretationofmassspectrawithexplanationoffragmentationpatterns.Selfstudypractice problems(2hrs)
1 13 ProblemsinvolvingstructureelucidationbyUV/IR/ HNMR/ CNMRand/orMass spectrometry,Selfstudypracticeproblems(8hrs)

26

Total 60

Books:

1 2 3 4

Introduction to Spectroscopy by D.L.Pavia, G.M.Lampman & G.S.Kriz, Latest edition, Thomson Brooks/Cole, United States. Spectrometric Identification of Organic compounds byRobert.M.Silverstein & Francis.X.Webster, D.J.Kiemle, Latest edition,JohnWiley&Sons. OrganicSpectroscopybyWilliamKemp. ApplicationsofabsorptionspectroscopyoforganiccompoundsbyJohnRobertDyer,PrenticeHall,London. Elective3 TitleoftheCourse:AdvancedBiochemistry 4hrs/week

Unit 1 Proteins

CourseContent(Topics)

Hours 15 5

1.1 Structureprimary,secondary,tertiary,quaternary;motifs,structuralandfunctionaldomains, proteinfamiliesandmacromolecularassemblies 1.2 Mechanismsforregulatingproteinfunction:Proteinproteininteractions,interactionwith 2+ ligands;Ca andGTPasmodulators,cyclicphosphorylationanddephosphorylation,proteolytic cleavage. 1.3 Purificationandcharacterisationofproteins:electrophoresis,ultracentrifugationandliquid chromatography,useofbiologicalassays,useofradioisotopes;MS,Xraycrystallography,NMR andhomologymodellingtodeterminestructures;aminoacidanalysis;cleavageofpeptides; proteinsequencing. 1.4 Proteinbiosynthesis:translationmachineryinprokaryoticandeukaryoticsystems;comparison ofsimilaritiesanddifferences,drugaffectingproteinbiosynthesisandproteinfunction 2 DNAandnucleicacids 2.1 DNA,RNAstructure,nomenclature,doublehelix,conformations,higherorderpackingand architectureofDNA,transcriptionandreplicationofDNAmechanismsinprokaryoticand eukaryoticsystems,DNArepairmechanisms,drugaffectingnucleotidebiosynthesis,RNAand DNAbiosynthesisandRNAandDNAfunction 3 Carbohydrates 3.1 Mono,diandpolysaccharidesandtheirnomenclature,stereochemistry,typesoflinkages; conjugatesofcarbohydrateswithothermoleculesglycoproteins,glycolipids,proteoglycans, lipopolysaccharidesandtheirbiologicalroles 4 Lipids 4.1 Classification,nomenclature,stereochemistry,storagelipids,membranelipids,lipidsas secondarymessengersandcofactors,biologicalroleoflipids,drugaffectinglipidmetabolism. 5 Selfstudyofproteinsuperfamilies,NandCterminalsequencing,DNAstructuresotherthanB DNA,DNAsequencing,DNApyrosequencing,cerebrosides,sphingolipids. Books:

15 15

8 8

7 7

15

Total 60

1. 2. 3. 4. 5. 6. 7. 8.

PrinciplesofBiochemistry,Lehninger,NelsonD.L.,C.B.SPublishers,NewDelhi. Biochemistry,StryerL,W.H.Freyment&Co.,NewYork. MolecularCellBiology,LodishH,DarneuJ,ScientificAmericanBooks,N.Y. BiochemistryThechemicalreactionsoflivingcells,Vol1&2,MetzlerDE,ElsevierAcademicPress. Biochemistry,BergJM,TymoczkoJLandStryerL,WHFreemanandCompanyandSumanasInc. BiomacromoleculesIntroductiontostructure,functionandinformatics,StanTsaiC,WileyLiss Protein:StructureandMolecularproperties,ThomasECreighton,W.H.Freeman. PhysicalBiochemistryPrinciplesandapplications,SheehanD,WileyBlackwell Elective4 Pharmacokinetics 4hrs/week

Unit

CourseContent(Topics) 1 Introductiontopharmacokineticsanditsutilityindrugdesignanddosageregimendesign. Definitionsofabsorption,distribution,metabolism,excretion,elimination.Different approachesfordeterminationofpharmacokineticsofdrugsnoncompartmental, physiological,andcompartmentalmodeling.Assumptionsinvolvedintheevolutionofsingle andmulticompartmentmodels. 2 Discussion(includingmathematicaldescriptionandequations)ofthepharmacokineticsof drugsshowingonecompartmentpharmacokineticsfollowingdifferentdosing methods/protocols[blood/plasma/urinesampling] 2.1 Discussion(includingmathematicaldescriptionandequations)ofthepharmacokineticsof drugsshowingonecompartmentpharmacokineticsfollowingintravenousbolusdosing [blood/plasma/urinesampling] 2.1 Discussion(includingmathematicaldescriptionandequations)ofthepharmacokineticsof drugsshowingonecompartmentpharmacokineticsfollowingintravenousmultiplebolusdosing [blood/plasma] 2.2 Discussion(includingmathematicaldescriptionandequations)ofthepharmacokineticsof drugsshowingonecompartmentpharmacokineticsfollowingintravenousconstantinfusion dosing[blood/plasma]. 2.3 Discussion(includingmathematicaldescriptionandequations)ofthepharmacokineticsof drugsshowingonecompartmentpharmacokineticsfollowingextravascularbolusdosing [blood/plasma].Discussionoftheconceptsofbioavailability(absoluteandrelative)and bioequivalence. 2.4 Discussion(includingmathematicaldescriptionandequations)ofthepharmacokineticsof drugsshowingonecompartmentpharmacokineticsfollowingextravascularmultiplebolus dosing[blood/plasma]. 2.5 Discussionofapproachestosolveproblemsrelatedtotheanalysisofpharmacokineticstudy dataobtainedafterdifferenttypesofdosing.Discussionofapproachestoproblemsolving involvingdatafrombioavailabilityandbioequivalencestudies.Discussionofapproachesto dosageregimendesign 2.6 Selfstudyofproblemsandproblemsolvingrelatedtothetheoreticalconceptsoutlinedabove (bloodadurinedataanalysis) 3 Discussionoftheprocessesofabsorption,distributionandeliminationwithrespecttohow theseprocessesimpactthevaluesofrateconstantsforabsorption/distribution/eliminationand thevaluesofbioavailability,volumeofdistributionandclearance.

Hours 4

40

10

10

4 Introductiontodrugtransportersandtheirimpactonthepharmacokineticsofdrugsand pharmacokineticdrugdruginteractions. 5 Briefintroductiontotheconceptofdoseandtimedependentpharmacokinetics[nonlinear pharmacokinetics]andtheirimpactondrugdevelopmentandclinicaluse. Books: 1.

Total 60

ClinicalPharmacokineticsandPharmacodynamicsConceptsandApplications,RowlandMandTozerTN,Walters KluwerLippincottWilliamsandWilkins. AppliedBiopharmaeuticsandPharmacokinetics,ShargelLandYuABC,AppletonandLange,InternationalEdition HandbookofBasicPharmacokineticsincludingclinicalapplications,RitschelWAandKearnsGL,APhA, BasicPharmacokinetics,JambhekarSSandBreenPJ,PharmaceuticalPress. BiopharmaceuticsandPharmacokinetics,VenkateshwarluV,PharmaBookSyndicate DrugBioavailabilityEstimtionofsolubility,permeability,absorptionandbioavailability,vanderWaterbeemdH, LennernasHandArturssonP,WileyVCH. ModellinginBiopharmaceutics,PharmacokineticsandPharmacodynamicsHomogenousandHeterogenous approaches,MacherasPandIliadisA,Springer

2. 3. 4. 5. 6.

7.

Elective5 MolecularBiology Unit CourseContent(Topics) 1 Introductiontobiologicalmacromolecules 2 DNAreplication,transcription,genesplicing,genecloning,geneexpression 3 Genotypeandphenotypevariationofcharactersandmicrobes 4 Geneticorganizationofprokaryoticandeukaryoticcells 5 Proteinbiosynthesisandregulationinduction,repressionofenzymes,catabolicexpression 6 Methodsofalterationofgeneticapparatusgenesmutation,transition,recombination, protoplastfusion 7 Proteomicsandgenomics Books: 1. Molecular Biotechnology, Principles and applications of recombinant DNA, Glick B. R. And Pasternak J. J. ASM Press, WashingtonDC Hours 8 10 8 8 8 8 4hrs/week

10 Total 60

2. 3. 4.

PrinciplesofGenomeAnalysisandGenomics,PrimroseS.B.AndTwymanR.M.,BlackwellPublishing,U.K. Gene Biotechnology and Techniques, Gen Engg, Mutagenesis, Separation Technology, Chirirjian J. G, Jones and BartlettPublishers Pharmaceutical Biotechnology An introduction for Pharmacists and Pharmaceutical Scientists, Crommelin D. A and SindelarR.D.,HarwoodAcademicPublishers. Elective6 GreenChemistry 4hrs/week

Unit 1

CourseContent(Topics) IntroductiontotheconceptsofGreenChemistryhistory,need,goals,limitations, obstaclesandopportunities IntroductiontotheprinciplesofGreenChemistrypreventionofwaste/byproducts, maximumincorporationofthematerialsusedintheprocessintothefinalproduct (atomeconomy),greenmetrics,prevention/minimizationofhazaradous/toxicproducts, designingsaferchemicalsbasicapproaches,selectionofappropriateauxiliary substances(solvents,separationagentsetc),energyrequirementsforreactions, selectionofstartingmaterials,renewablestartingmaterials,avoidanceofunnecessary derivatizationcarefuluseofblocking/protectinggroups Microwaveassistedorganicsynthesis;photochemicaltransformations;sonication;solid phasetransformations;aqueousphasetransformations;enzymatictransformations;etc SelfStudytransformationsusingionicliquids,PEG,polymersupportedreagents

Hours 5

1.1

15

1.2

1.2 2

13 Applicationofgreensyntheticreactions,greenstartingmaterials,greenreagents, greensolventsandreactionconditions,greencatalysisandexamplesofgreensynthesis, greenanalyticalmethods SelfStudyExamplesofGreensynthesis Futuretrendsingreenchemistryoxidationreductionreagentsandcatalysts; biomimeticsandmultifunctionalreagents;combinatorialgreenchemistry;solventless reactions;noncovalentderivatization;biomassconversion;emissioncontrol; biocatalysis 3 12

2.1 3

Books 1. 2. 3. 4. 5. 6.

Total 60

GreenChemistry:TheoryandPractice,AnastasPTandWarnerJC,OxfordUniversityPress. GreenChemistry:IntroductoryText,LancasterM,RCSLondon IntroductiontoGreenChemistry,RyanM.A.,TinnesandM.,AmericanChemicalSociety(Washington). HandbookofGreenChemistryandTechnology,ClarkeJandMacquarrieD,BlackwellPublishing. GreenChemistryGreeneralternativetosyntheticorganictransformations,AhluwaliaVK,NarosaPublications, New Delhi. OrganicSynthesisSpecialTechniques,AhluwaliaVKandAggarwalR,NarosaPublications. Elective7 DrugRegulatoryAffairs 4hrs/week

No. 1.0 2.0 2.1 2.2 2.2.1 2.2.2 2.2.3 2.2.4 2.3 NeedforRegulations IndianRegulations

CourseContents(Topics)

Hours 1 15 1 5

IntroductiontoIndianRegulations Drugs&CosmeticAct&RulesOverviewandrecentamendments ScheduleDIandDII(RegistrationandImport) ScheduleM ScheduleY CentralDrugLaboratories

ICMRguidelinesforethicalconsiderationsinbiomedicalresearchonhuman subjects BABEstudies Newdrugapplication Insurance,CompensationandIndemnificationoftrialsubjects ExpertReferral IBSC,RCGM ICMR NDAC CBBTDEC

2.4 2.5 2.6 2.7 2.7.1 2.7.2 2.7.3 2.7.4 2.8 2.9 2.10 3.0 3.1 3.2 3.3 3.4 3.5 3.6 3.7

2 1 1 1

WHOGMPCertification,FSCandCoPPprocedure ProceduresforobtainingTestlicense(Form29andForm11);ExportNOC Loanlicense/Contractmanufacturing USRegulations IntroductiontoUSRegulations HatchWaxmanActandamendments,FDAMedicareModernizationAct IntroductiontoOrangeGuideand21CFR Investigationalnewdrug(IND)filing USDrugMasterFile(DMF)filing,amendmentsandannualreports AbbreviatedNewDrugApplication(ANDA)filing NewDrugApplication(NDA)filing

1 1 1 6 1

1 1 1 1

3.8 4.0 4.1 4.2 4.3 4.4 4.4.1 4.4.3 4.4.4 4.4.5 4.5 4.6 5.0 5.1 5.2 5.3 5.4 5.5 5.6 5.7 5.8 5.9 5.10 5.11 6.0 6.1 6.2 6.3 6.4 6.5

Postapprovalchanges EuropeanRegulations IntroductiontoEuropeanRegulations ActiveSubstanceMasterFile(ASMF)filing CEPfiling MarketingAuthorizationandfilingprocedures NationalProcedure MutualRecognitionProcedure(MRP) DecentralizedProcedure(DCP) CentralizedProcedure(CP)

1 6 1 1

Handlingvariations ClinicalTrialRegulationsinEU OtherapplicableRegulationsandGuidelines OverviewofICHguidelines CTDformatofdossier eCTDfilingprocedure 21CFRPart11 AuditsandInspections,FDA483sLessonslearnt Overviewofregistrationprocessinothergeographies Biologicallicenseapplication(BLA) MedicalDeviceRegistrationprocess RegulationsgoverningStemCelltherapeutics IntroductiontoPharmacovigilanceandDrugSafety OrphanMedicinalProducts IntellectualPropertyRights(IPR) Overviewofpatentsfromregulatoryperspective PCTapplication&generalrules WTO/GATTsystem TRIPSAgreement Compulsorylicensing 1 1 1 1 1 1 1 1 4 2 10 1 1

6.6 6.7 6.8 Books 1. 2. 3. 4.

Patentsearch,draftingandfilingprocedure Patentinfringementanalysis Trademark/copyrightfilingprocedures Total 42

Good Drug Regulatory Practices: A Regulatory Affairs Quality Manual (Good DrugDevelopment Series, Vol 1, Helene I.Dumitriu http://www.amazon.com/GoodDrugRegulatoryPracticesDevelopment/dp/1574910515 GuidetoDrugRegulatoryAffairs/Buch,BrigitteFriese. DrugsandCosmeticsAct,1940andRules,1945.

Usefullinks: 5. 6. 7. 8. 9. 10. http://www.cdsco.nic.in/ http://clinicaltrials.gov/ http://dbtbiosafety.nic.in/ http://www.emea.europa.eu/ http://www.ich.org/ http://www.fda.gov/ Elective8 QualityAssuranceSystems 4hrs/week

Unit 1 2 2.1 2.2 2.3 3 3.1 3.2 3.3 3.4 3.5 3.6

CourseContents(Topics) Regulatorybasisforvalidation:USFDAguidelines(cGMPguidelines,21CFR210211),EUguidelines, WHOguidelines. Terminologyandvalidationoverview: SelfStudy:Validationversusverification,testing,calibrationandqualification. ConceptsofDQ,IQ,OQandPQ. ConceptsofProspectivevalidation,retrospectivevalidation,Concurrentandrevalidation.Validation MasterPlan. ValidationofEquipment DryPowderMixers FluidBedandTraydryers TabletCompressionMachine Selfstudy:DryHeatSterilization/Tunnels Autoclaves Capsulefillingmachines.

Hrs 5 10 3 3 4 10 1 1 2 1 2 1 2 7 2 3 2 4 6

3.7 ValidationofIntegratedlinesbymediafilltest. 4 UtilitiesValidation 4.1 ValidationofPharmaceuticalWaterSystem&puresteam, 4.2 ValidationofHAVCsystem 4.3 ValidationofCompressedair 5 CleaningValidation: Selfstudy:CleaningofEquipment,CleaningofFacilities. 6 AnalyticalMethodValidation:Generalprinciplesofanalyticalmethodvalidation,Validationof followinganalyticalInstruments

6.1 6.2 6.3 7 7.1

HPLC Dissolutiontestapparatus U.V./Visiblespectrophotometers ProcessValidation: Selfstudy:Prospective,concurrent,retrospective&revalidationSelfstudy

2 2 2 13 1 2 2 2 2 2 2 2 3 Total 60

Processvalidationoffollowingformulations 7.2 Uncoated/Coatedtablets 7.3 HardgelatinCapsules 7.4 7.5 7.6 7.7 8 9 BOOKS: 1. 2. 3. 4. 5. Ampoules&Vials Selfstudy:Ointment/Creams Selfstudy:LiquidOrals Transdermalpatches(Matrixsystems) SelfstudyComputersystemvalidationincontrollingthemanufacturingprocess. ProcessAnalyticalTechnologies(PAT)andQualitybyDesign(QbD)(USFDA)

ValidationandQualificationinAnalyticalLaboratoriesbyLudwigHuber,Secondedition(2007),InformaHealthCare, NewYork,London. PharmaceuticalProcessValidationbyR.NashandWachter,Volume129,Latestedition,MarcelDekkerInc,NewYork. GMPforPharmaceuticalsbySidneyH.Willing,Fifthedition,MarcelDeckerSeries,NewYork. UnitedStatesPharmacopoeia&IndianPharmacopoeia. ValidationofPharmaceuticalprocess,F.J.CarletonandJ.Agalloco,MarcelDekkerInc.

INTERNETREFERENCES: 1. 2. 3. 4. www.fda.gov(USFDAguidelinesforPATandQbD). www.ich.org WHOpublicationsonrelatedtopics. EMEAguidelines Elective9 Unit 1 Conceptof 1.1 TotalQualityManagement(TQM) 1.2 Qualitycontrolandqualityassurance 1.3 Qualitycontrollaboratoryresponsibilities 1.4 Selfstudy:Goodlaboratorypractices 2 GMP 2.1 Organizationofpharmaceuticalmanufacturingunit,productionmanagement, CourseContents(Topics) Hours 8 2 2 2 2 8 4 PharmaceuticalQualityManagement 4hrs/week

Unit 2.2 Selfstudy:RevisedscheduleM. 3 Personnel:

CourseContents(Topics)

Hours 4 12 6 6

3.1 Selfstudy:Introduction,Humanresourcedevelopment,QualificationExperienceandTraining, Responsibilities,PersonalHygieneandGowning. 3.2 Location,Plantlayout,Lighting,Sewage,WaterhandlingSewage,RefugeandDisposal,Washingand toiletfacility,Sanitation,ControlsofcontaminationandEnvironmentalcontrols. 4 MaterialsManagement: 4.1 APIs,rawmaterials&packagingmaterials,Purchasespecifications,Selectionofvendors, Intermediates&Finishedproducts,RejectedandRecoveredmaterials,Recalledproducts,Reagents &culturemedia,Referencestandards,Wastematerials. 4.2 WarehousingGoodWarehousingPractices,distributionandrecords. 5 ManufacturingOperationsandControl: 5.1 Selfstudy:SanitationofManufacturingPremises,Lineclearance,MixupsandCrosscontamination, ProcessingandholdingofIntermediatesandBulkProducts 5.2 Packaging,I.P.Q.C.,ReleaseandstorageofFinishedProduct,ProcessDeviationsandIncidents,Drug productinspection,Yieldcalculations 5.3 Expirydating,Manufacturingrecordreviewandapproval. 6 DocumentationandRecords: InprocessandProductReleaseSpecifications,Masterproductionandcontrolrecord,Batch productionandcontrolrecord,StandardOperatingProcedures(SOP),ChangeControl,Sitemaster file. 7 PostOperationalActivities:

8 6

2 8 3 3 2 6

7.1 Distribution,Complaintsandrecalls,evaluationofcomplaints,Recallprocedures,relatedrecordsand 2 documents. 7.2 Outsourcing:Facilityaudit,Manufacturing,Packaging,Analytical,Clinicalandotherservices outsourcing. 3

2 8 SiteandPlantsecurity: Securitypersonnel,Entryprocedurestosite&plant,Internalsecurity,Vehicleparking,Fuelstorage, Canteen&cooking,Garden&horticulture. 3 9 Audits: PrincipleofQualityaudit,Plantlevel,Departmentwisedocumentation. Total 60 Books 1. 2. 3. QualityAssuranceofPharmaceuticals,Vol.2,UpdatedEdition,WorldHealthOrganization,Geneva. S.H.Willing,GoodManufacturingPracticesforPharmaceuticals;AplanfortotalQualitycontrol,LatestEdition,Marcel Dekker. RegulatoryguidelinesrelatedtoGMPby a. 21CodeofFederalRegulation,Parts210,211&58(USFDAguidelines) b. EU,MHRA,UKGuidelinesonGMP c. ScheduleMofDrug&CosmeticsAct. QualityPlanning&AnalysisbyJ.M.JuranandF.M.Gryna,TataMcgrawHill,India. QualityAssuranceGuidebyOrganizationofPharmaceuticalProducersofIndia.

4. 5.

Elective10

Cosmeticology

4hrs/week

Unit

CourseContents(Topics)

Hours 8 4

1 GeneralAnatomyandPhysiologyofskin,hair,nailandtooth: 1.1 Selfstudy:Anatomyandphysiologyofskin,hair,nailandtoothemphasisonpointswithreferenceto cosmetics. 1.2 Problemsassociatedwithnormalfunctioningofskin,agedskin,dryskin,sensitiveskin,acne, pigmentationdisorders.Commonhairproblemshairloss,manageabilityproblems,splitends,shine andlusterdisorders;nailproblems;toothproblems. 2 Generalrawmaterialsincosmeticformulations: 2.1 OverviewofrawmaterialsWater,natural&syntheticoils,fats&waxes,inorganicsolids,emulsifiers, thickeners,hydrocolloids,polymers,surfactants,antioxidants,humectants,polysiloxanes, preservatives. 2.2 Colouringagentsusedincosmetics.Qualityevaluationofcolors,safety,toxicityandregulatoryaspects ofcolorsw.r.t.cosmeticproducts 2.3 Perfumesincosmetics:rawmaterialsinperfumery,developingaperfumecomposition,currenttrends includingemulsifiedandsolidperfumery,analyticalandseparationtechniquesofperfumes,sensory analysis,safetyandtoxicologicalevaluationofperfumes,manufacturingandpackagingofperfumes, legislationandregulationsforperfumesincosmetics. 2.4 Therapeuticingredientsinvariouscosmeticslikeskinproducts,dentifrices,haircareandnail preparations,andperformanceevaluationoftheseactivities. 2.3 Selfstudy:Detailsofgeneralrawmaterials(oils,fats,waxes,surfactants,preservatives,polysiloxanes), Historicalpurviewofperfumes,ApprovedcoloursasperIndian,EuropeanandUSspecifications 3 Applicationofnovelapproachesincosmeticformulations 3.1 Conceptsofmicroemulsions,liposomes,niosomes,nanoparticles,iontophoresis,toenhancefunctional attributes&deliveryofcosmeceuticals. 4 Herbalcosmetics 4.1 Currenttrendsinuseofherbalmaterialsincosmetics. Selfstudy:Discussiononaleovera,henna,teatreeoil,neeminvariouscosmeticproducts 5 Packagingandlabellingofcosmeticproducts 5.1 Packagingmaterials,specialitypackagesforcosmetics,labellingrequirementsforcosmetics 6 Qualitystandardsofcosmeticproducts: 6.1 BISguidelinesforqualityoffinishedproductsforcosmetics,qualitycontrol,texturalanalysis, performanceandpsychometricevaluationofvariouscosmeticproductssuchascreams,gels,powders, lipstick,naillacquer,shampoo,sunscreenproducts,dentifrices. 6.2 Microbiologicalqualityofcosmeticproducts. 6.3 Safetyandtoxicityevaluationofcosmeticproducts

19 2

4 4

6 2 4 5 5 18 8

2 4

6.4 Legalconsiderationsandregulatoryproceduresofcosmeticproducts 6.5 SelfstudyBIS,EuropeanandUSspecificationsaboutqualitystandardsofcosmeticproducts Books: 1. 2. 3. 4. 5. 6.

2 2 Total 60

HarrysCosmeticologyEditedbyJ.B.WilkinsonandR.J.Moore,LongmanScientific&TechnicalPublishers Cosmetics Science and Technology, Edited by M.S. Balsam, E. Sagarin, S.D. Gerhon, S.J.Strianse and M.M.Rieger, Volumes1,2and3.WileyInterscience,WileyIndiaPvt.Ltd.,2008 PouchersPerfumes,cosmetics&Soaps,10thEd,EditorHildaButler,KlewerAcademicPublishers,Netherlands,2000 CosmeticTechnology,Ed.ByS.Nanda,A.NandaandR.Khar,BirlaPublicationsPvt.Ltd.,NewDelhi,2007 Handbook of Cosmetic Science and Technology, edited by M. Paye, A.O.Barel, H. I. Maibach, Informa Healthcare USA,Inc.2007. EncyclopediaofPharmaceuticalTechnology,Vol.6,Eds.JamesSwarbrick,JamesC.Boylan,MarcelDekkerInc.,1992 BISGuidelinesfordifferentcosmeticproducts Drugs&CosmeticsAct&Rules,1940(withlatestamendments).

7.

Elective11

PolymersinPharmacy

4hrs/week

Unit 1.0 2.0 2.1

CourseContents(Topics) HistoricalBackground,Basicdefinitions,Applications ClassificationofPolymers Classificationbasedonreactiontotemperatureandstructure/arrangement/architecturelinear, branched,crosslinked. PolymerizationmechanismsAddition&stepgrowthpolymerizationFreeradical,cationic,anionic andZieglerNattamechanisms Copolymerization Theoreticalaspectsofcopolymerization SelfstudyCasestudiesofanytwocopolymers Properties&Characterizationofpolymers FactorsaffectingandOverview Molecularweightanddeterminationofmolecularweight, Solidstatecharacterizationglasstransitiontemperature,Crystallinity, Solubilityofpolymers&Swellingpr,Mechanicalproperties SelfstudyCasestudyany3polymers characteristics&comparison MethodsofPreparationofPolymers

Hrs. 1 7 2

2.2

3.0 3.1 3.2 4.0 4.1 4.2 4.3 4.4 4.5 5.0

5 3 2 12 1 2 3 3 3 11

5.1 5.2 5.3 5.4 6.0 6.1 6.2 6.3 6.4 6.5 7.0 7.1 7.2 7.3 8.0 8.1

Bulkpolymerization,Solutionpolymerization, Suspensionpolymerization,Emulsionpolymerization. Additivesinpolymers,Fabricationofpolymericdevices/systems casting,extrusion,mouldingetc SelfstudyOneexamplepolymerforeachmethod BiocompatibilityofPolymers Safety&BiocompatibilityissuesOverview Reactionofpolymertotissues,effectofbody/hostsystemstopolymers Mechanismsoftissuereactions/injury, Evaluationofbiocompatibilityofpolymers SelfstudyPharmacopoeial&othertestsfortoxicityevaluationofpolymers BiocompatiblePolymers Generalfeaturesofbiocompatiblepolymers,enzymaticallydegradablebondsinpolymers Designofbiocompatiblepolymers&evaluation, SelfstudysomeexamplesPLGA,cellulosics,acrylates,hydrogels. Applicationsofpolymersinpharmacy. Overviewofapplicationsasthickeners,binders,coatingagents,adhesives,asreleasemodifying agents,includingsmartpolymers,elastomers Selfstudy:Oneexampleeachofadhesivepolymer,coatingagent,drugreleasemodifier,smart polymer

3 3 3 2 10 1 2 2 3 2 10 2 4 4 4 2

8.2

Total 60

Books:
nd 1. FundamentalPrinciplesofPolymericMaterialsbyRosenSL,WileyIntersciencePublication,2 edn,1993. 2. Martin's Physical Pharmacy and Pharmaceutical Sciences by Sinko PJ, Ed Lea & Feiger, Lippincott Williams & Wilkins, 6thedn,2010. nd 3. ControlledDrugDelivery:FundamentalsandApplications,RobinsonJR,LeeVHL,Dekker,2 edn,Vol29,1987. 4. BiodegradablePolymersasDrugDeliverySystems,ChasinM,LangerR,MarcelDekker,Vol45,1990. 5. ControlledandNovelDrugDeliverybyJainNK,CBSPublishersandDistributors,2008. 6. ControlledDrugDelivery:ClinicalApplications,byBrukSD,CRCPressInc.,Vol2,1983. 7. PolymericDrugDeliverySystembyKwonGS,MarcelDekker,Vol148,2005. 8. AqueouspolymericcoatingforpharmaceuticaldosageformsbyMcGinityJW,MarcelDekker,Vol79.

 Elective12 DrugEvaluationTechniques Unit 1 1.1 Basicprinciplesofdrugdiscoveryandbiologicalscreening Correlationbetweenvariousanimalmodelsandhumansituations. Correlationbetweeninvitroandinvivoscreens. Care,handling,breedingtechniquesoflabanimals. CPCSEA,OECD,ICHguidelinesinbrief. Highthroughputscreeningindrugdiscovery. Techniquesforhighthroughputscreening. Cellbasedassays Biochemicalassays. Radioligandbindingassays. Detectionmethods Fluorescencebasedassaytechniques Chemiluminescencebasedassaytechniques. SelfstudyUseofalternativemethodsofscreening: Zebrafishmodel Drosophila Typesofdrugsforwhichthesemodelscanbeused. 26 2 6 CourseContents(Topics) Hours 19 6 4hrs/week

1.2

1.3

1.4

2.1 2.2

Targetbaseddrugdiscoveryandinvitroscreeningtechniquesfor AntiplateletactivityTurbidimetric,GPIIB IIIAassaysusingplateletagregometer. CNS: Alzheimersdisease:invivowhichincludesaluminuminduced,scopolamine inducedmemoryloss.Invitroincludesacetylcholenesteraseactivity. Parkinsonsdisease:invivoincludesHaloperidol,reserpine,rotenone,MPTP inducedmodels. Antidepressantandanticonvulsants. Antidiabetic:Alloxan,STZ,geneticallydiabeticanimalsandvariousinvitromethods Antitubercular:BACTEC Anticancer:Fewinvitrocelllines,modelsformetastasis. AntiHIV:Varioustargetsinvolved Antimalarial. Immunomodulatory:invivoandinvitro methods. Antiinflammatory:Acute,subacuteandchronicmodels. SelfstudyAntioxidantactivity EstimationofdrugsfromcomplexmedialikebiologicalfluidsEg.blood,tissues, CSFetc.

2.3

3 6

2.4

2.5 2.6 2.7 3

2 2 5 5

SelfstudyUSFDAguidelinesforbioanalysismethodsincludingvalidation.

Invitroskinirritationandeyeirritationtests Invitrotestsforpyrogenicity SelfstudyAlternativemethodsfortoxicitytesting(invitro)

Books 1. 2. 3. 4. 5.

Total 60

H.G.Vogel,DrugdiscoveryandevaluationPharmacologicalAssaysSpringerVerlog. R.A.Turner,ScreeningmethodsinpharmacologyAcademicPress. D.R.LaurenceandA.L.BacharachEvaluationofdrugactivities:Pharmacometrics.AcademicPress. A.Schwartz,MethodsinPharmacologyPlenumPublishingCorporation. WebsiteAltox.org/ttrc/validationva

Elective13

AnalyticalMethodDevelopmentandValidationTechniques

4hrs/week

Unit 1

CourseContents(Topics) Calibration&Validationofanalyticalinstruments: a. a. b. c. HPLC. UVVISspectrophotometer. FTIR. Dissolutiontestapparatus. HPLCassaymethoddevelopmentforAPIanddrugproducts:

Hours 4

2 2.1

20 5

PreliminaryinvestigationsNatureofsample,itscompositionandproperties.(Itshouldalsoinclude significanceofpKa,partitioncoefficientandcurrentmethodstodeterminethesame),separationgoals, samplepretreatmentanddetection,developingseparation. BasicsofseparationResolution,Resolutionasafunctionofsolventstrength,selectivityandcolumn platenumber;andsamplesizeeffect.

2.2

2.3

SelfstudyDetectionComparisonofsensitivity,selectivity,advantages,disadvantagesandapplications withrespecttodetectorssuchasU.V,Fluorescence,PDA,RefractiveIndex,Evaporativelightscattering detectorandelectrochemicaldetectors. Samplepreparationandpretreatmentforsolid,liquid,semisolidsamples;columnswitchingandpre andpostcolumnderivatisation. SelfstudyColumnscharacteristicsofcolumnandcolumnpackingandcolumnspecifications. MethoddevelopmentforReversephase,Ionpairandionexchangechromatography,Gradientelution principleanddevelopmentofgradientseparation.Selfstudypharmaceuticalexamplesforthese methods(1hr). Quantitationanalysismeasurementofsignals,quantitationmethods,sourcesoferrors,procurement, storageanduseofreferencestandardsandworkingstandards. ICHguidelinesforanalyticalmethodvalidation(Q2withlatestrevision).Systemsuitabilitytestingasper USP,IP. SelfstudyOnedetailedHPLCanalysisofanyAPIbyUSPorIP(1hr) HPTLC: Methoddevelopmentandvalidationforfixeddosecombinationdrugsandherbalanalysis.

2.4

2.5 2.6

1 3

2.7

2.8

2.9 3

1 3

4 4.1 a.

Impurityprofiling: SelfstudySourcesofimpuritiesandICHterminologiesOrganicimpurities,Inorganic impurities,Residualsolvents,Isolationandcharacterisationmethodsforimpurities (3hrs). b. Analyticalmethoddevelopmentandquantitationofimpurities. ICHguidelinesQ3A,Q3B,Q3Cwithlatestrevisionsforall. Bioanalyticalmethoddevelopmentandvalidation: Stepsfollowedsamplepreparation,liquidliquidextraction,precipitation,solidphaseextraction, sinteredcolumnsolidphaseextraction. Bionalyticalmethodvalidationincludingfull,partial,crossvalidation,selectivity,accuracy,calibration curve,stability(freezethawandmobilephase),recovery. CDERandICHguidelinesforbioanalyticalmethodvalidation. SelfstudyExamplesofbioanalyticalmethoddevelopmentandvalidationforaspecifieddrugestimated inurine/plasma/serumsamples. Stabilitytesting: Drugdevelopmentcycleandstabilitytesting. Stresstestingofdrugsubstances. Stabilityindicatingassays(specificandselective),Roleofkineticstudies. Stabilitytestingprotocols. Retestperiod/Shelflifedeterminationofdrugsubstances/phytopharmaceuticals/biotechnological productsandequipments.

9 5

4.2 5 5.1

4 13 3

5.2

5.3 5.4

4 2

6 6.1 6.2 6.3 6.4 6.5

11 2 1 3 1 2

6.6

ICHguidelinesQ1AandQ1Bwithlatestrevisions.

2 Total 60

Books
nd PracticalHPLCMethodDevelopmentbyL.R.Snyder,2 edition,JohnWiley&Sons. Analytical Method Validation and Instrument Performance Verification by Chung Chow Chan, Herman Lam, Y.C. Lee, XueMingZhang,WileyInterscience,JohnWiley&Sons,IncorpPublications. 3. UnitedStatesPharmacopoeiaandIndianPharmacopoeia. 4. Handbook of Isolation and Characterisation of Impurities in Pharmaceuticals by Satinder Ahuja &Karen Mills Alsante, Volume5,AcademicPress,USA. 5. HandbookofBioanalysis&DrugmetabolismbyGaryEvans,CRCPress(2004), 6. HPLCmethoddevelopmentbySatinderAhuja 7. Sethis Quantitative Analysis of Pharmaceutical Fomulations by P.D.Sethi, fourth edition, volume1, CBS Publishers andDistributors,NewDelhi. th th 8. RemingtonTheScience and Practice of Pharmacy, 20 edition RemingtonTheScience and Practice of Pharmacy, 20 edition. 9. ValidationandQualificationinAnalyticalLaboratories,2ndedition,LudwigHuber;InformaHealthcare. 10. Handbook of stability testing in pharmaceutical development Regulations, Methodologies and Best practices; Editor KimHuynhBa,Springer. 11. J.T.Carstensen,C.T.Rhodes,Drugstability:principles&Practices.LatestEdition.MarcelDekkerInc.,NewYork INTERNETREFERENCES:

1. 2.

1. 2. 3.

USFDA(CDER)andICHguidelinesforBioanalyticalmethodvalidation. ICHguidelinesQ1A(R),Q3A(R),Q3B,Q3C,Q6A. ICHguidelinesforanalyticalmethodvalidation.

ExperimentalTechniquesinPharmaceuticalSciences

8hrs/week

SyllabusforthecourseExperimentalTechniquesinPharmaceuticalSciencesforthemainbranchesofpharmacynamely PharmaceuticalChemistry/MedicinalChemistry,Pharmaceutics,Pharmacology,PharmaceuticalAnalysis/QualityAssuranceand Pharmacognosyisgivenbelow.StudentsofotherbranchesofspecializationlikeClinicalPharmacy,MedicinalNaturalProducts, BiopharmaceuticsandPharmacokinetics,etc.canchoosetodotheexercisesprescribedforanyoneoftheabovementioned branches,preferablyselectingsomethingclosesttotheirbranchofspecialization. Anattemptshouldbemadetocoveraminimumof8exercisesinthesyllabusofaparticularbranch 1. PharmaceuticalChemistry(andMedicinalChemistry) Unit 1.0 2.0 Experiments MeasurementoflogPofapoorlywatersolubleandahighlywatersolubledrug DeterminationofthepKaofadrug(weakacidandweakbase)bypotentiometrictitrationand/orby UV/visiblespectroscopy MeasurementofVmaxandKmofanhydrolaseenzyme(canuseesterase,70hosphatise,orlipasetype enzymesStudentshouldlearnhowtoplotdatabyLinweaverBurkeandEadieHofsteemethods) Estimationoftwodrugsbysimultaneousequationmethodandbyabsorbanceratiomethod. (preferablyusecombinationsofdrugsthatareusedasfixeddrugcombination) Synthesisofsomedrugs(fore.g.thiazideandhydrothiazidederivatives)involvingmultistep(atleast threesteps)reactions.(StudentsshouldlearntomonitorthereactionbyTLC,separatethemain productfromimpuritiesbycolumnchromatographyandlearnuseofIRand1Hand13CNMRto checkthestructuresoftheintermediatesandthefinalcompoundsandestimateoverallyieldofthe reaction). Resolutionofracemicmixturesofacidicandbasiccompoundsbyformationofdiastereomers Synthesisofprodrugsofanyoneofthecommondrugsandstudyoftheirdecomposition(kinetics)in plasmaorserumtotheparentdrug(suggestuseofDCCbasedcouplingtoobtainesterprodrugs) EstablishaRPHPLCmethodfortheseparationofamixtureoftwoormorecompounds(e.gfixed dosecombinationdrugs,orprodrugssynthesizedaboveorapplytoreactionmonitoring) Workingwithphysicalmodelsballandstickorspacefillingmodels.Studentsshouldlearnto constructphysicalmodelsforglucose,vitaminC,propranolol,chloramphenicol.Thiswillenable studentstoidentifystereocentersandassigncorrectstereochemistrytothem. Demonstrationofsomemolecularmodellingexerciseslikeenergyminimization,moleculardynamics simulations,docking,2D/3DQSAR,structurebaseddrug,pharmacophoremappingetc.usingeither commerciallyavailableprogramsorfreeware.

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Pharmaceutics 1.StudyofdissolutionprofileofIRandERproducts.MathematicaltreatmentofdataforreleaseKineticsandf1andf2 analysis. 2.SimpleOptimizationdesign(formulationstudy/pHstabilitystudy) 3.DesignandevaluationofOrallyDisintegratingDrugDeliverySystem 4.Preparationandevaluationofmicrospheresforinhalationsystem 5.Preparationandevaluationoftransdermal/mucoadhesive/gastroretentivesystem 6.Constructingphasediagramforonesystemofoil,surfactantcosurf,water 7.Designofonevesicularsystemniosomes/liposomessystemscanbemade 8.Designoflipidparticulatesystem(nanosystemswithwaxcanbetried)

3.

Pharmacognosy 1)ExtractionandevaluationofMucilagefromsuitablesourcessuchasaloesorLeavesofAnnonasquamosaoranyother suitablesource. 2)ExtractionandanalysisofalkaloidssuchaspurinealkaloidsandTropaneorindolealkaloidsformsuitablenaturalsources. 3)PreparationandevaluationofextractofanthraquinoneglycosidesfromCassiaangustifolia/Cassiafistulaorrhubarbor othersuitablesource 4)ExtractionandanalysisofVolatileoilfromsuitablesourcessuchascloveoreucalyptusoranyother. 5)ExtractionanddetectionofinulinfromsuitablesourcessuchaschicoryorKuth. 6)Activityguidedfractionationofanyherbforitsantimicrobialand/orantioxidantactivity. 7)Preparationandevaluationofanyherbalchurna,dosageform(SitupaladiaorTriphala).

8)Extractionandanalysisofcarotenoidderivativesorflavonoidderivativesfromsuitablenaturalsourcesforeach. 4. PharmaceuticalAnalysisandQualityAssurance. 1. DeterminationofpKabyU.V.spectroscopy. 2. Sample preparation for I.R. spectroscopy (solid/liquids) and interpretation of IR bands for important functional groups. 3. AssaysfordrugsincombinationbyUVderivativespectroscopy. 4. Structuralelucidationworkshop:Interpretationof1HNMR,13CNMR,IRandMassspectrometryofsimplecompounds (maximum12carbonatoms). 5. StandardcalibrationcurvebyUVspectroscopyat a. max b. max+10nm c. max10nm 6. DeterminationofresponsefactorbyHPLC. 7. QualitativeandQuantitativeHPTLCanalysis(minimummixtureof3compounds). 8. AssaydeterminationbySimultaneousequation,AbsorbanceratioandDifferencespectroscopy. 9. DeterminationofResponsefactorbyHPLCanalysisofdrugs. 10. PreparativeTLCanalysis. 11. BioanalysisbyHPLC. 12. pHstabilityevaluationofAspirinbyTLC. 13. Failureinvestigation/InvestigationsofOutofSpecificationreportforproductsandanalyticalmethodology. 14. QualificationsofInstruments/Equipments. 15. Validationofanalyticalmethod/procedure/process. 16. Separationofcomponentsbycolumnchromatography. 17. CalibrationofUVspectrophotometer/HPLCcolumn 5. Pharmacology I) Experimentstobeperformedbystudents 1) Assayofantagonistusingasuitableisolatedtissuepreparation 2) DeterminationofpA2valuesofantagonistsusingasuitabletissuepreparation 3) Invitroantioxidantscreeningassays(anytwo)e.g.DPPH,NO,superoxide. Demonstrations a. Experimentsonintactanimalstoevaluate: 1) Anticatalepticactivity 2) Antianxietyactivity 3) Antiinflammatory/analgesicactivity 4) Musclerelaxantactivity b. Techniquesofdrugadministrationandbloodwithdrawal c. Noninvasivemethodsofmeasuringbloodpressure,pulse,ECGetc.

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Tutorials 1) Careandhandlingofanimals 2) CPCSEA,OECD,ICHguidelinesinbrief 3) Useofalternativemethodsofscreening(Typesofdrugsforwhichthesemodelscanbeused) Zebrafish Drosophilia 4) Techniquesforhighthroughputscreening Cellbasedassays Biochemicalassays Radioligandbindingassays References: Latesteditionsofthefollowingbooks/CDscanbereferred. 1. ExpharmProSimulatedanimalexperimentsinPharmacology,Elseviers 2. ExpharmStimulatedanimalexperiments,Ravindran 3. H.G.Vogel,DrugdiscoveryandevaluationPharmacologicalAssaysSpringerVerlog 4. M.N.Ghosh,FundamentalsofExperimentalPharmacology,ScientificBookAgency S.K.Kulkarni,PracticalPharmacologyandClinicalPharmacy,VallabhPublications. 5. 6. CPCSEA,OECD,ICHGuidelines.