Pharmaceutical Insights into Azithromycin: From API to Market-Ready Drug_ Swapnroop Drugs & Pharmaceutical_ APIMANUFACTURER_EXPORTER

Pharmaceutical Insights into Azithromycin: From API to Market-Ready Drug






1. What is Azithromycin API?

Azithromycin is a semi-synthetic macrolide antibiotic derived from erythromycin A. It belongs to the azalide subclass of macrolides and has bacteriostatic properties, meaning it inhibits bacterial growth rather than killing bacteria directly.

Key Characteristics of Azithromycin API:

  • Molecular Formula: C₃₈H₇₂N₂O₁₂

  • Molecular Weight: 748.98 g/mol

  • Structure: A 15-membered lactone ring with nitrogen substitution, improving its stability and efficacy.

  • Solubility: Slightly soluble in water but highly soluble in ethanol and methanol.

2. What is Azithromycin Used For?

Azithromycin is a broad-spectrum antibiotic effective against Gram-positive, Gram-negative, and atypical bacteria.

Common Indications:

✅ Respiratory tract infections (pneumonia, bronchitis, sinusitis, pharyngitis)
✅ Ear infections (otitis media)
✅ Skin and soft tissue infections
✅ Sexually transmitted infections (chlamydia, gonorrhea)
✅ Gastrointestinal infections (Helicobacter pylori, traveler's diarrhea)
✅ Community-acquired pneumonia (CAP)

Mechanism of Action:

Azithromycin binds to the 50S ribosomal subunit of bacteria, inhibiting protein synthesis and preventing bacterial growth.

3. Physicochemical Properties of Azithromycin

PropertyValue
Molecular FormulaC₃₈H₇₂N₂O₁₂
Molecular Weight748.98 g/mol
AppearanceWhite to off-white crystalline powder
Melting Point113-115°C
SolubilityFreely soluble in ethanol and methanol; slightly soluble in water
pH (1% solution)9.0 - 11.0

4. How is Azithromycin Synthesized?

Azithromycin is synthesized from Erythromycin A through a series of chemical modifications:

Steps in Azithromycin Synthesis:

  1. Lactone Ring Expansion – Erythromycin A undergoes modification to form a 15-membered lactone ring instead of a 14-membered ring.

  2. Introduction of an Azalide Group – The introduction of a nitrogen atom in the lactone ring enhances stability and improves tissue penetration.

  3. Purification and Crystallization – The final product is purified and crystallized to obtain pharmaceutical-grade Azithromycin.

Key reagents used:

  • Triethylamine

  • Acetic anhydride

  • Dimethylformamide (DMF)

  • Hydrochloric acid (HCl)

5. What are the Different Dosage Forms of Azithromycin?

Azithromycin is available in multiple dosage forms for different routes of administration:

Dosage FormStrengths Available
Tablets250 mg, 500 mg, 600 mg
Capsules250 mg, 500 mg
Oral Suspension100 mg/5 mL, 200 mg/5 mL
Intravenous (IV)500 mg per vial

6. How are Azithromycin Dosage Forms Prepared?

Tablet and Capsule Manufacturing:

  1. Blending: API is mixed with excipients (fillers, binders, disintegrants).

  2. Granulation: Wet or dry granulation ensures uniform drug distribution.

  3. Compression: Granules are compressed into tablets or filled into capsules.

  4. Coating (optional): Some tablets are film-coated for stability and better absorption.

Oral Suspension Preparation:

  • The powder form of Azithromycin is suspended in a flavored liquid.

  • Requires reconstitution with water before administration.

IV Formulation:

  • Azithromycin is formulated as a sterile lyophilized powder for reconstitution with normal saline or dextrose solution before IV administration.

7. What is the Appropriate Dosage of Azithromycin?

ConditionDosage Recommendation
Respiratory Infections500 mg on Day 1, followed by 250 mg daily for 4 days
Skin Infections500 mg per day for 3 days or 1 g per week
Chlamydia InfectionSingle dose of 1 g
Gonorrhea2 g single dose (often combined with ceftriaxone)

8. When Should Azithromycin Be Taken?

✅ Best taken on an empty stomach (1 hour before or 2 hours after meals).
✅ If it causes stomach upset, it can be taken with food.

9. Effects and Side Effects of Azithromycin

Positive Effects:

  • Rapid bacterial clearance

  • High tissue penetration (especially in lungs and skin)

  • Shorter treatment durations due to long half-life

Common Side Effects:

⚠️ Nausea, vomiting, diarrhea
⚠️ Abdominal pain
⚠️ Headache and dizziness

Rare but Serious Side Effects:

⚠️ QT Prolongation – Can cause heart rhythm abnormalities
⚠️ Liver Dysfunction – Jaundice, elevated liver enzymes

10. How is Azithromycin Tested?

TestPurpose
Identification Test (HPLC, IR Spectroscopy)Confirms chemical identity
Purity AnalysisEnsures minimal impurities
Dissolution & Disintegration TestsChecks drug release profile
Assay (Potency Test)Determines actual drug content

11. Challenges in Manufacturing Azithromycin

Challenges in API Manufacturing:

  • High sensitivity to moisture and light

  • Complex purification steps to remove impurities

  • Maintaining high yield during synthesis

Challenges in Dosage Form Manufacturing:

  • Uniform drug distribution in tablets and suspensions

  • Preventing degradation due to humidity

12. Storage Conditions for Azithromycin

FormulationStorage Condition
Tablets & CapsulesStore at 25°C (77°F), protect from moisture
Oral Suspension (Dry Powder)Store below 30°C; refrigerate after reconstitution
IV FormulationStore vials at 2-8°C

13. Packaging & Shelf Life of Azithromycin

  • Tablets & Capsules: Blister packs, plastic bottles

  • Oral Suspension: HDPE bottles with measuring spoons

  • IV Formulation: Sterile vials

Shelf Life:

  • Tablets & Capsules: 24-36 months


  • Oral Suspension: 5-10 days after reconstitution


    14. What Should the Label Claim Include?

    A proper label for Azithromycin should include the following essential details:

    ✅ Drug Name & Strength – Azithromycin 500 mg Tablets
    ✅ Dosage Instructions – Recommended dose and frequency of administration
    ✅ Storage Conditions – Store below 25°C, protect from moisture"
    ✅ Expiry Date – Clearly stated for safety
    ✅ Batch Number & Manufacturing Date – Ensures traceability
    ✅ Manufacturer Details – Swapnroop Drugs & Pharmaceuticals

    Plot No. D-187/16, Five Star Industrial Area, 

    Shendra MIDC, Aurangabad, Maharashtra, 431154, India

    E-mail:mktg.swapnroop@yahoo.com,mktg@swapnroop.com

    Mobile: +91 94202 94801

    Website:- www.swapnroopdrugs.com

    15. Where Can Azithromycin Be Procured?

    Azithromycin is available from pharmaceutical manufacturers, distributors, and wholesalers. It is a prescription-only medication in most countries and can be sourced from authorized suppliers who comply with regulatory standards.

    Leading Manufacturers of Azithromycin:

    1. Swapnroop Drugs & Pharmaceuticals
      ๐Ÿ“ Address: Plot No. D-187/16, Five Star Industrial Area, Shendra MIDC, Aurangabad, Maharashtra, 431154, India
      ๐Ÿ“ง Email: mktg.swapnroop@yahoo.com, mktg@swapnroop.com
      ๐Ÿ“ž Mobile: +91 94202 94801
      ๐ŸŒ Website: www.swapnroopdrugs.com

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