BASFExcipientsSummary

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BASFProduct Binders GranulationInstantRelease

Form

Application

Synonyms

CompendialStatus

RetestPeriod Packaging

Kollidon25

powder

Mediummolecularpovidoneforusee.g.asabinderintablets, capsulesandgranules,asastabilizerfororalsuspensions,asa solubilizingagent,asadispersantforpigments,asanenzyme stabilizerandtoimprovebioavailability. Mediummolecularpovidoneforusee.g.asabinderintablets, capsulesandgranules,asastabilizerfororalsuspensions,asa solubilizingagent,asadispersantforpigments,asanenzyme stabilizerandtoimprovebioavailability. Mediummolecularpovidoneforusee.g.asabinderintablets, capsulesandgranules,asastabilizerfororalsuspensions,asa solubilizingagent,asadispersantforpigments,asanenzyme stabilizerandtoimprovebioavailability. Highmolecularpovidone.Ahighlyeffectivebinder,foruseasa stabilizerinoralandtopicalsuspensions,asathickener,andasa hydrophilizingagentorporeformingagentinmedicalplastics.

Polyvinylpyrrolidone,povidone

Ph.Eur.,USPNF,JP,FCC

36months

25kgbox

Kollidon30

powder

Polyvinylpyrrolidone,povidone

Ph.Eur.,USPNF,JP,FCC

36months

50kgPEdrum (Geismar)

Kollidon30LP

powder

Polyvinylpyrrolidone,povidone

Ph.Eur.,USPNF,JP,FCC

36months

25kgbox

Kollidon90F

powder

Polyvinylpyrrolidone,povidone

Ph.Eur.,USPNF,JP,FCC

24months

25kgbox

DirectCompressionInstantRelease Drybinderforgranulesandtabletsindirectcompressionandroller compaction,filmformerincoatings,protectivelayerandsubcoatfor tabletcores,filmformingagentinsprays,poreformerincontrolled releasematrixandmatrixformerformeltextr Rollercompaction,directcompressionfordrybinderinDC applications.Excellentforactiveswithlowcompressabilityand mediumtohighdosedactiveswhereasmallertabletisneeded. Vinylpyrrolidone/vinylacetate copolymer60/40,Copolyvidone, Copovidone Vinylpyrrolidone/vinylacetate copolymer(VP/VAc60/40), Copolyvidone,Copovidone Ph.Eur.,USPNF,JPE,FCCmonographin 36months process

KollidonVA64

powder

35kgdrum

KollidonVA64Fine

Finepowder

Ph.Eur.,USPNF,JPE,FCCmonographin 36months process

15kgbox

Ludipress

powder

Directcompression&fillerforhardgelatincapsules.

Lactose,povidone,crospovidone

ComponentsinPh.Eur.,USPNF,JPE

24months

20kgbox

LudipressLCE

powder

Directcompression,chewabletablets,effervescenttablets& lozenges.

Lactose,povidone

ComponentsinPh.Eur.,USPNF,JPE

24months

20kgbox

BASFExcipientsSummary
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BASFProduct

Form

Application

Synonyms

CompendialStatus

RetestPeriod Packaging

Binders(cont.) DirectCompressionInstantRelease Fastdisintegratingsolidoraldosageforms,especiallyoraldispersible tablets(ODT).Itissuitablefordirectcompressionmanufacturingby simplyblendingtheexcipientwiththeactiveandalubricant. 90%mannitol,5%crospovidone,5% Tablettingandpackagingcanbeaccomplishedonstandardmachines polyvinylacetate andwithstandardpackaginglikepushthroughblistersorPE containers.Inordertogetdesireddisintegrationtime,extraKollidon CLSFisrecommended.

Ludiflash

powder

ComponentsinPh.Eur.,USPNF

24months

20kgbox

DirectCompressionSustainedRelease KollidonSR powder pHindependentsustainedreleasematrixtabletsbydirect compression.Pelletsandgranulesbyrollercompactionormelt extrusion.Minitabletsbydirectcompression. 80%Polyvinylacetateand19% povidone,0.8%laurylsulfate&0.2% ComponentsinPh.Eur.,USPNF,JP/JPE silica
36months 20kgPEdrum

Disintegrants KollidonCL powder Superdisintegrantfortabletsandgranules.Solubilityand bioavailabilityenhancer.Canaswellbeusedintheinnerphaseof thewetgranulationprocesswithoutadverseeffectonswelling. Superdisintegrant,especiallyforsmalltabletstoavoidcontent uniformityproblems.Furthermore,itcanalsobeusedinwet granulationprocesses,whenlargeamountofgranulationliquidsare needed.Solubilityandbioavailabilityenhancer. Mainlyusedasstabilizerfororalandtopicalsuspensionsandto improvethedrugreleasecharacteristicsoftablets,capsulesand granules.AlsousedasaporeformerinSRformulationsand disintegrant. Crospovidone,croslinked polyvynilpyrrolidone Ph.Eur.,USPNF,JPE,FCC
36months 40kgPEdrum

KollidonCLF

powder

Crospovidone,croslinked polyvynilpyrrolidone

Ph.Eur.,USPNF,JPE,FCC

36months

30kgPEdrum

KollidonCLM

powder

Crospovidone,croslinked polyvynilpyrrolidone

Ph.Eur.,USPNF,JPE,FCC

36months

30kgPEdrum

KollidonCLSF

Superdisintegrantforfastdispersibletabletsaswellassmalltablets asitgeneratesapleasantfeelinginthemouthandavoidscontent uniformityproblems.Itcanalsobeusedinwetgranulation Finepowder processes,whenlargeamountofgranulationliquidsareneeded. Solubilityandbioavailabilityenhancer.

Crospovidone,croslinked polyvynilpyrrolidone

Ph.Eur.,USPNF,JPE,FCC

36months

30kgPEdrum

BASFExcipientsSummary
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BASFProduct Coatings InstantReleaseCoatings KollicoatIR

Form

Application

Synonyms

CompendialStatus

RetestPeriod Packaging

powder

Instantreleasecoating,lowperoxidebinder,poreformerin sustainedreleasecoatings,filmformerinspraysandtransdermal systems,suspension&emulsionstabilizerandprotectivecolloid.

75%polyvinylalcoholand25% polyethyleneglycolgraftcopolymer

Ph.Eur.,USPNF

24months

20kgPEdrum

KollicoatProtect KollicoatIRCoatingSystems KollicoatIRWhiteII KollicoatIRBlack

KollicoatIRBrilliantBlue

powder

Instantreleasecoating,moistureprotectionandsubcoating.Alsocan CoatingbasedonKollicoatIRandextra beusedasaperoxidefreewetgranulationbinderorasapore polyvinylalcohol formerinsustainedreleasecoatings.

PhysicalmixtureofKollicoatIRand monographedrawmaterials

36Months

20kgPEdrum

powder powder powder powder powder powder powder

aqueous dispersion (30%solids content)

KollicoatIRCarmine KollicoatIRRed
KollicoatIRSunsetYellow

KollicoatIRCoatingSystemscoloredcoatingmaterialsbasedon KollicoatIR.Fromsevenbasiccomponents,itispossibletoobtaina widevarietyofshadesofcoloredcoatingssimplybycombining differentnumbersandconcentrationsoftheseindividual components.

Polyvinylalcoholpolyethyleneglycol KollicoatIRPh.Eur.,USPNF.Pigments 36Months copolymerandcopovidone globallyapproved

25kgcarton box

KollicoatIRYellow EntericCoating KollicoatMAE30DP

Entericcoatingandsustainedreleasematrixforsoliddosageforms andsoftgelatincapsules.

Methylacrylicacidethylacrylate copolymer(1:1) Redispersibleandpartiallyneutralized methacrylicacidethylacrylate copolymer(1:1)

Ph.Eur.,USPNF(typeC),JPE

18Months

25kgPE drum,1000kg IBC

KollicoatMAE100P SustainedReleaseCoating KollicoatSR30D ProtectiveCoating KollicoatSmartseal30D

powder

Entericcoatingandsustainedreleasematrixforsoliddosageforms andsoftgelatincapsules.

Ph.Eur.,USPNF(typeD)

18Months

20kgdrum

aqueous dispersion

pHindependentsustainedreleasefilmcoatingandmatrix.

27%polyvinylacetate,2.5%povidone and0.3%sodiumlaurylsulfate

Ph.Eur.,USPNF

18Months

25kgPE drum,1000kg IBC

aqueous dispersion

Aqueouspolymerdispersionformoisturebarrierandtastemasking applications.

Methylmethacrylate diethylaminoethylmethacrylateco polymer(6:4)dispersion PhysicalmixtureofKollicoatIRand monographedrawmaterials

30Months

25kgPE Jerrican

KollicoatProtect

powder

Instantreleasecoating,moistureprotectionandsubcoating.Alsocan CoatingbasedonKollicoatIRandextra beusedasaperoxidefreewetgranulationbinderorasapore polyvinylalcohol formerinsustainedreleasecoatings.

36Months

20kgPEdrum

BASFExcipientsSummary
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BASFProduct Solubilizers Kollidon12PF

Form

Application

Synonyms

CompendialStatus

RetestPeriod Packaging

powder

Lowmolecularweightpovidones,pyrogenfreeusedasasolubilizing agent,crystallizationinhibitorandstabilizerininjectablesand ophthalmicproducts. Lowmolecularweightpovidones,pyrogenfreeusedasasolubilizing agent,crystallizationinhibitorandstabilizerininjectablesand ophthalmicproducts.

Polyvinylpyrrolidone,povidone

Ph.Eur.,USPNF,FCC

36months

50kgPEdrum

Kollidon17PF

powder

Polyvinylpyrrolidone,povidone

Ph.Eur.,USPNF,JP,FCC

36months

50kgPEdrum

CremophorEL

oilyliquid

Solubilizerandemulsifierforsemisolidandliquidformulationsof Polyoxyl35castoroil,macrogolglycerol waterinsolubleactivesandotherhydrophobiccompoundssuitable ricinoleate forparenteralformulations. Solubilizerinparenteraldosageforms,speciallyforsensitiveactive Polyoxyl35castoroil,macrogolglycerol ingredients,whereahigherpuritywasfoundtoimprovetheir ricinoleate stability. Solubilizerandemulsifierinoralandtopicalliquidandsemisolid dosageforms.

Ph.Eur.,USPNF

24months

60kgmetal drum

CremophorELP

liquid

Ph.Eur.,USPNF

24months

60kgmetal drum

CremphorRH40

paste

PEG40hydrogenatedcastoroil

Ph.Eur.,USPNF

24months

60kgPEdrum

Soluplus

granule

Enablesnewlevelsofsolubilityandbioavailabilityforpoorlysoluble activeingredients.Developedspecificallyforsolidsolutions.

Polyvinylcaprolactampolyvinyl acetatepolyethyleneglycolgraft copolymer

DMFfiledintheUSAandJapan

36months

25kgbox

SolutolHS15

paste

Nonionicsolubilizerinpasteformforuseinhumanandveterinary Polyethyleneglycol15hydroxystearate parenteralwithlowtoxicity.

Ph.Eur.,USPNF

24months

50kgPEdrum

Solvents/Cosolvents 1,2Propylenglycol Pharma liquid Preservative,ascarrierforemulsifiersandasavehicleforflavours, asextractantforactiveprinciplesfromnaturalproducts,as plasticizerinaqueousfilmcoatingformulationsandasasolventor cosolventforawidevarietyofactive. Solvent fororal,topicalandparenteralapplications. Solvent fororal,topicalandparenteralapplications. Propyleneglycol,1,2propandiole Ph.Eur.,USPNF,JP,FCC
12months 220kgPE drum,1000 kgIBC 230kgPE drum 130kgPE drum 200kgmetal drum

LutrolE300 LutrolE400

liquid liquid

Polyethyleneglycol(PEG),Macrogol Polyethyleneglycol(PEG),Macrogol

Ph.Eur.,USPNF,JPE Ph.Eur.,USPNF,JP

24months

24months

SoluphorP

liquid

Solvent forinjectablesforanimalhealth.Whenitisusedintopical preparations,itacceleratestheabsorptionoftheactivesubstance.

2Pyrrolidone

Ph.Eur.

12months

BASFExcipientsSummary
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BASFProduct Solubilizers

Form

Application

Synonyms

CompendialStatus

RetestPeriod Packaging

LutrolL44

liquid

SolubilizerandcosolventforAPIs,dispersingandwettingagentfor liquiddispersionsandtoimprovesolubility,absorptionand bioavailabilityofpoorlysolubleAPIs,stabilizerandcoemulsifierin semisolidandcreamformulations. Emulsifierandsolubilizer,dispersingandwettingagentforsolid dispersionsandtoimprovesolubility,absorptionandbioavailability ofpoorlysolubleactivesinSODF,coemulsifierincreamsand emulsionsandsuspensionstabilizerandtabletlubricant. Thickeningagentandgelformer,asacoemulsifierandviscosity enhancerincreamsandliquidemulsions.Alsostabilizestopicallyand orallyadministeredsuspensionsandisusedintoothpastes,gargles andmouthwashes. Thickeningagentandgelformer,asacoemulsifierandviscosity enhancerincreamsandliquidemulsions.Alsostabilizestopicallyand orallyadministeredsuspensionsandisusedintoothpastes,gargles andmouthwashes. Thickeningagentandgelformer,asacoemulsifierandviscosity enhancerincreamsandliquidemulsions.Alsostabilizestopicallyand orallyadministeredsuspensionsandisusedintoothpastes,gargles andmouthwashes.Usedinsustainedreleaseformulations. Dissolutionenhancer,lubricant,dispersing/wettingagent,water solublelubricante.g.effervescenttablets.Avg.particlesizeof50 micron. Dissolutionenhancer,lubricant,dispersing/wettingagent,water solublelubricante.g.effervescenttablets.Avg.particlesizeof50 micron.

Poloxamer124,polyethylene polypropyleneglycol

Ph.Eur.,USPNF,JPE

24months

200kgmetal drum,18kg metaldrum

LutrolF68

prill

Poloxamer188,polyethylene polypropyleneglycol

Ph.Eur.,USPNF,JPE

24months

102kgfibre drum,25kg fibredrum

LutrolF87

prill

Poloxamer237,polyethylene polypropyleneglycol

Ph.Eur.,USPNF

24months

25kgfibre drum

LutrolF108

prill

Poloxamer338,polyethylene polypropyleneglycol

Ph.Eur.,USPNF

24months

80kgfibre drum,18kg fibredrum

LutrolF127

prill

Poloxamer407,polyethylene polypropyleneglycol

Ph.Eur.,USPNF,JPE,FCC

24months

90kgfibre drum,25kg fibredrum

Ltrolmicro68

microprill

Poloxamer188,polyethylene polypropyleneglycol

Ph.Eur.,USPNF,JPE

24months

25kgfibre drum

Ltrolmicro127

microprill

Poloxamer407,polyethylene polypropyleneglycol

Ph.Eur.,USPNF,JPE,FCC

24months

25kgfibre drum

BASFExcipientsSummary
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