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Abstract

QUALITY ASSESSMENT AND IN VITRO BIOEQUIVALENCE STUDIES ON SOME GENERIC BRANDS OF FLUCONAZOLE CAPSULES COMMONLY DISPENSED IN NIGERIAN PHARMACIES

Ukwueze S. E.* and Rufus M.

ABSTRACT

Fluconazole is an antifungal agent commonly used for several fungal infections bedeviling many developing countries across Africa. Quality assurance of multi-source pharmaceutical products ensures that the manufacturing processes of the products comply with required specifications thereby assuring product efficacy when used interchangeably. This study was aimed at investigating the in-vitro dissolution profiles and other physicochemical parameters of different generics of fluconazole capsules that are available in some Nigerian markets to determine their biopharmaceutical equivalence and interchangeability. The quality and physicochemical equivalence of five different brands of fluconazole capsules (coded F1-F5) were subjected to official tests as specified in the USP (2009) and BP (2012), including physical examination, weight variation, disintegration, drug content and dissolution profiles. The content of active ingredient was determined using the UV-visible spectrophotometer at a maximum wavelength of 262 nm. Similarity factor was calculated to determine the bioequivalence of the brands against the innovator brand F1. All the brands passed the official standards for uniformity of weight (< 5.0 mg), disintegration (< 10 min), and dissolution (> 95% at 30 min) tests, while only F5 failed the test for content of active ingredient (< 90%). The Fit factor analysis showed that only brands F3 and F4 had a similarity factor greater than 50. In conclusion, some of the brands of fluconazole capsules analyzed were found not to be bio-pharmaceutically equivalent and interchangeable with the innovator brand, thereby underscoring the need for constant quality assurance of drug products in circulation.

Keywords: Fluconazole, interchangeability, similarity factor, disintegration time, innovator brand.


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