Presentation Slide on Azithromycin Dihydrate
Transcript of Presentation Slide on Azithromycin Dihydrate
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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
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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 amolecular formula of C38H72N2O122H2O and a molecular weight of 785
Azithromycin is supplied for oral administration as capsulecontainingazithromycin dihydrate equivalent to either 250 mg or 500 mg
azithromycin along with some inactive ingredient known as expient.
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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
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Uses
Azithromycin is used to:
Pneumonia
Typhoid
Sinusitis
Venereal diseases
Chlamydia
Gonorrhea
Cervicitis
Treat or prevent certain
bacterial infections
Middle ear infectionsTonsillitis
Throat infections
Laryngitis
Bronchitis
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Mechanism of Action
Azithromycin prevents bacteria fromgrowing by interfering with their
protein synthesis.
It binds to the 50S subunit of the bacterialribosome, and thus inhibits translation of
mRNA.
Nucleic acid synthesis is not affected.
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Requirement in Bangladesh
According to Information Medical Statistics (IMS: upto 2nd quarter of 2010), the ranking of Azithromycin
was in 1st position among all the generic present in
Bangladesh.
Year Sale Value (Cr. Taka) Share Growth
2011 437 5.73% 19.75%
2010 365 6.06% 24.50%
2009 293 5.73% 15.05%
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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.
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Manufacturing Process
The dosage form of Azithromycin contains AzithromycinDihydrate 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
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FLOW SHEET
Erythromycin ErythromycinOxime Acid
ErythromycinOxime Base.
Imono Ether.Aza-
azithromycinAzithromycinIntermediate
Centrifuge.Drying &Milling.
QC &Packing.
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Safety Aspects
Causes of industr ial accident,
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
UnsafeConditions
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UNSAFE ACTS
Improper speeds
Improper working position
Failure to wear personalprotective equipment
Defective equipment
Alcoholic-beverage
Use of drugs
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General Safety Rules
Follow the safety rulesand procedures
Alert to unsafeconditions andreactions
Use laboratoryequipment only for itsdesigned purpose
Practical jokesstrictly prohibited inLaboratory
Label all chemicalscorrectly
Equipment must beinspected regularly
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Pharmaceutical Process Control
Process
TemperatureProcessPressure
PumpControl
ValveControl
ProcessFlows
ChemicalComposition
Tank LevelAgitatorControl
ProductWeight
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Quality Operations
The Quality Operations department consists of the following interfacing
departments-
QualityOperations
QualityAssurance
QualityControl
ProductDevelopment
MicrobiologyDepartment
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Quality Assurance (QA) Activities:
Validation of threeconsecutive 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
QA
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Quality Control
Quality Control
Receipt
Verification
Sampling
Under Test
Q. C. Testing
Rejected
Return toSupplier/Destruction
Approved
For Manufacturing
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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
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Sources of Impurities in Medicines
Sources
Activepharmaceutical
ingredients
Organicimpurities
StartingMaterials.
By Products. Degradation.
Inorganicimpurities
Residualsolvents
Enantiomericimpurities
Filter aids,charcoal
Reagents,ligands,
andcatalysts
Heavymetals
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Pollutant Sources
Non-bio degdrable plastic Packaging Material
Particulate Grinding, Dryer
Effluent Washing of equipment
Environmental impact and solution
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Solution
Pollutant-Particulate material
Pollution-Air
Solution-Filtration systems
Dust-ladengases
Porousmedium
Trapped &Collected
Gases devoidof the particle
DischargedOut
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Effluent Treatment Plant
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Thanks for your attentionThank you all
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Chemical Structure: