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Introduction Properties of azithromycin dihydrate Uses Mechanism of action Requirement in Bangladesh Technology selection for Bangladesh Manufacturing process Safety aspects Process control Quality operations Environmental impact & solution
Introduction
Azithromycin, an azalide, a subclass of macrolide antibiotics, for oral administration. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749. Azithromycin was first discovered by G.Kobrehel and S.Djokic in 1980. S.Djokic have demonstrated the existence of the di-hydrate form of Azithjromycin in 1988. Azithromycin, as the dihydrate, is a white crystalline powder with a molecular formula of C38H72N2O122H2O and a molecular weight of 785 Azithromycin is supplied for oral administration as capsule containing azithromycin dihydrate equivalent to either 250 mg or 500 mg azithromycin along with some inactive ingredient known as expient.
Azithromycin, as the dihydrate, is a white crystalline powder. Its molecular formula is C38H72N2O122H2O Its molecular weight is 785. Melting point is 126C
Uses
Azithromycin is used to:
Pneumonia Typhoid Sinusitis Venereal diseases Chlamydia Gonorrhea Cervicitis Treat or prevent certain bacterial infections Middle ear infections Tonsillitis Throat infections Laryngitis Bronchitis
Mechanism of Action Azithromycin prevents bacteria from growing by interfering with their protein synthesis.
It binds to the 50S subunit of the bacterial ribosome, and thus inhibits translation of mRNA. Nucleic acid synthesis is not affected.
Requirement in Bangladesh According to Information Medical Statistics (IMS: up to 2nd quarter of 2010), the ranking of Azithromycin was in 1st position among all the generic present in Bangladesh.
Year 2011 2010 2009 Sale Value (Cr. Taka) 437 365 293 Share 5.73% 6.06% 5.73% Growth 19.75% 24.50% 15.05%
Manufacturing Process
The dosage form of Azithromycin contains Azithromycin Dihydrate USP as active ingredient.The manufacturing process of Azithromycin Dihydrate is as following: Raw materials: 1. Erythromycin Thiocyanide. 2. Methylene di-chloride (MDC) & methanol as solvent. 3. Acetic acid. 4. Acetone. 5. Sodium hydroxide
FLOW SHEET
Erythromycin Erythromycin Oxime Acid Erythromycin Oxime Base.
Azithromycin Intermediate
Azaazithromycin
Imono Ether.
Centrifuge.
QC & Packing.
Safety Aspects
Causes of industrial accident,
Unsafe Conditions
Defective tools Congestion of work place Poor house keeping Excessive noise Poor ventilation Radiation explore Inadequate support or guard In adequate warning system Fire & explosion hazard
UNSAFE ACTS
Improper speeds Improper working position
Failure to wear personal protective equipment Defective equipment
Follow the safety rules and procedures Alert to unsafe conditions and reactions
Use laboratory equipment only for its designed purpose Practical jokes strictly prohibited in Laboratory
Chemical Composition
Process Flows
Valve Control
Tank Level
Agitator Control
Product Weight
Quality Operations
The Quality Operations department consists of the following interfacing departmentsQuality Assurance
Microbiology Department
Quality Operations
Quality Control
Product Development
QA
Validation of three consecutive batches Good manufacturing Practice (GMP) Training and SOP Self inspection Stability testing Corrective Action (CA) & Preventive Action (PA) Certificate of Analysis (COA) Change Control Request Product quality review
Quality Control
Quality Control Receipt Verification Sampling Under Test Q. C. Testing
Q.C. Test
Preparation of Report And Checking Approved For Manufacturing Rejected Reprocess/Destruction
Sources
Enantiomeric impurities
Organic impurities
Inorganic impurities
Residual solvents
Heavy metals
Starting Materials.
By Products.
Degradation.
Pollutant
Sources
Packaging Material
Particulate
Grinding, Dryer
Effluent
Washing of equipment
Solution
Pollutant-Particulate material Pollution-Air Solution-Filtration systems
Dust-laden gases
Discharged Out
Porous medium
Chemical Structure: