IN VITRO BIOEQUIVALENCE STUDY OF THREE GENERIC BRANDS OF ACYCLOVIR 400 MG TABLETS IN IRAN MARKET

Bioequivalence studies are established for evaluating the therapeutic equivalency of two different formulations (A generic formulation and a reference formulation) of the same drug. The aim of present study was to study in vitro bioequivalence of three brands of acyclovir 400 mg tablets in the Iran market.

Assay, weight variation, and dissolution studies were performed for three generic brands and one reference brand (Lovir). These three tests were compared with the United States Pharmacopeia (USP) drug standards. In order to compare the dissolution profile and determine the similarity of three generic brands with the reference brand, the difference (f1) and similarity (f2) factors were calculated.

The active pharmaceutical ingredients quantitative assay showed that all the brands of acyclovir tablets were between 90% and 110% of label claim. The results of weight variation tests indicated that all samples complied with USP specification limits. The results of the dissolution test showed that all brands released more than 80% of active pharmaceutical ingredient in a 45 minutes period, which corresponded to USP specifications. Regarding the dissolution profile and calculation of similarity (f1) and difference (f2) factors, none of the generic brands showed the same drug release characteristics as the reference brand.

This study showed that all brands of acyclovir tablets have acceptable quality characteristics in terms of assay, weight variation, and dissolution, but generic brands cannot be substituted for the reference brand.