Abstract

COMPARATIVE BIOEQUIVALENCE STUDY OF DIFFERENT BRANDS OF FLUCONAZOLE TABLETS MARKETED IN INDIA BY DISSOLUTION MODELLING AND QUALITY CONTROL TESTS

Vasavi Pachika*, N. Manya, P. Manisha, Rizwana Begum, T. Swarnamukhi and Syeda Khadija Fathima

ABSTRACT

Generic drugs are those whose patent protection has expired and are produced by companies other than the originator. Generic medications are often 20-90% less expensive than brand-name medications. The usage of generic or branded drugs has recently been a hot topic throughout the world. The marketing of multisource therapeutically comparable branded drug products with varying price poses a significant challenge to both the general patient and the prescribing physician in terms of quality, safety, bioavailability, and interchangeability. Branded pharmaceuticals take substantially longer to obtain authorised, but generic drugs require much less time. Our study's goal is to analyse the in-vitro bioequivalence of five commercially available Generic Brands of fluconazole 150mg offered in India. In the current study all of the assessed test parameters, such as weight variation, friability, disintegration, and dissolution, were performed for different brands of Fluconazole 150mg. To assess the bioequivalence and interchangeability of different brands, the multipoint in vitro dissolution profiles were compared using various FDA-recommended statistical methods such as model independent methods, such as the dissimilarity factor (f1) and the similarity factor (f2). ANOVA was used to evaluate the dissolution efficiency results of various brands to assess if all of the formulas tested were comparable or substantially different. According to IP standards, all of the tested brands except Brand D released more than 50% in 45 minutes. The experimental results revealed that ANOVA-based and model-independent techniques are more discriminative than f-factors, which may be interpreted by a single value to characterise the similarity of two dissolution profiles. As a result of the experimental findings, more post marketing surveillance is required to ensure that only safe, effective bioequivalent drug products with economic benefit reach the general public, and prescribing physicians should become more aware of the interchangeability of multisource branded generic drug products.

Keywords: ANOVA, Biowaiver, Bioequivalent. Branded, Generic, Dissolution Efficiency, Dissolution Profile, Therapeutically Equivalent.