Comparative pharmaceutical and physicochemical equivalence of some brands of chlorphenamine maleate tablets

Abstract

Background: Generic drugs has been accompanied by a variety of problems of which the most critical is the increasingly widespread of distribution of counterfeit, fake and substandard drug product. Chlorphenamine maleate tablet is a widely used antihistamine which is available as a multi-sourced drug compound globally and also subject to varied challenges of multi-sourced products.

Objectives: This study reports the biopharmaceutical and chemical inequivalence of nine brands of chlorphenamine maleate tablets.

Methods: Biopharmaceutical and chemical equivalence of nine brands of chlorpheniramine maleate tablets were assessed using the official quality control procedure for; uniformity of weight, thin layer chromatography, friability test, hardness, disintegration test, dissolution rate and chemical content determination.

Results: All the brands complied with the official specification for uniformity of weight, and disintegration test, while one brand failed the friability test. The thin layer chromatogram confirmed the presence of chlorphenamine in all the brands. All the brands complied with dissolution profile specification of >70%w/w at C₄₅. Chlorphenamine maleate contents for eight brands ranged from 94.31±0.64 to 107.36±8.56%w/w which was within the official specification, while one brand was lower than the specification.

Conclusion: Of the nine chlorphenamine maleate tablet brands investigated, only seven brands could be regarded as biopharmaceutical and chemical equivalents and therefore can be used interchangeably.

Keywords: Chlorpheniramine maleate tablets, Chemical equivalence, Biopharmaceutical equivalence