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Comparative bioavailability of two formulations of azithromycin
R Gulati1, C D Tripathi, D Chandra
1Department of Pharmacology, Maulana Azad Medical College, Bahadurshah Zafar Marg, New Delhi-110 002.
The Journal of the Association of Physicians of India
|March 29, 2001
Summary
This study found two brands of azithromycin capsules to be bioequivalent. Pharmacokinetic parameters and in vitro dissolution tests confirmed similar absorption profiles for both azithromycin preparations.
Area of Science:
- Pharmacology
- Clinical Pharmacy
Background:
- Azithromycin is a widely used macrolide antibiotic.
- Bioequivalence studies are crucial for generic drug approval.
Purpose of the Study:
- To assess the bioequivalence of two azithromycin capsule brands.
- To meet regulatory requirements for drug product equivalence.
Main Methods:
- A double-blind, randomized crossover study in 12 healthy male volunteers.
- Single oral dose of 500 mg azithromycin (test or reference brand).
- Serum azithromycin levels analyzed via microbiological assay; pharmacokinetic parameters (Cmax, Tmax, AUC, etc.) determined.
Main Results:
- Similar mean peak serum azithromycin concentrations (Cmax) and time to reach peak concentration (Tmax) between test and reference brands.
- No statistically significant differences in other pharmacokinetic parameters.
- In vitro dissolution results correlated with in vivo absorption.
Conclusions:
- The test and reference brands of azithromycin capsules are bioequivalent.
- The findings support the interchangeability of the two azithromycin formulations.