AZITHROMYCIN DIHYDRATE

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Contents
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.

Properties of Azithromycin Dihydrate:

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%

Technology Selection For Bangladesh

All Over the World in Pharmaceutical Arena, Azitromycin manufacturing in 3 dosage form, Tablet Capsule Injection But in Our Country and Patients Complaince we like capsule manufacturing process because, capsule manufacturing technology is,

Economically viable. Convenient to use. Good chemical stability.

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.

Drying & Milling.

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

Alcoholic-beverage Use of drugs

General Safety Rules

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

Label all chemicals correctly Equipment must be inspected regularly

Pharmaceutical Process Control

Process Temperature Process Pressure Pump Control

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

Quality Assurance (QA) Activities:

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

Approved For Manufacturing

Rejected Return to Supplier/Destruction

Completion of Batch of Finished Product

Completion of Batch of Finished Product Sampling by QA Under Test

Q.C. Test
Preparation of Report And Checking Approved For Manufacturing Rejected Reprocess/Destruction

Sources of Impurities in Medicines

Sources

Active pharmaceutical ingredients

Enantiomeric impurities

Organic impurities

Inorganic impurities

Residual solvents

Filter aids, charcoal

Reagents, ligands, and catalysts

Heavy metals

Starting Materials.

By Products.

Degradation.

Environmental impact and solution

Pollutant

Sources

Non-bio degdrable plastic

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

Gases devoid of the particle

Trapped & Collected

Effluent Treatment Plant

Thanks for your attention

Thank you all

Chemical Structure: