Presentation Slide on Azithromycin Dihydrate

7/28/2019 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:

Presentation Slide on Azithromycin Dihydrate

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