Comparative Assessment of the Quality and Interchangeability of Some Brands of Dihydroartemisinin/Piperaquine Tablets Marketed in Niger Delta Region of Nigeria

Abstract

The research work was carried out to ascertain the quality and suitability for substitution in clinical practice of some brands of Dihydroartemisinin/Piperaquine phosphate (40 mg/320 mg) tablets marketed in Niger Delta Region of Nigeria. Ten different brands (A to J) of the drug were used. The tablets were subjected to various Official and non-Official test as specified by the Pharmacopoeias.  All the brands under review passed the test of physical assessment, the weight uniformity test and friability test. Brands A, B, C, F and G passed the hardness test while samples D, E, H, I and J failed the test. The disintegration time for all the brands were within the acceptable limit with the innovator brand (C) showing the shortest disintegration time of 0.75 minutes, while brand I, had the highest disintegration time of 7 minute. Samples B and D were pharmaceutically bioequivalent to the sample C (innovator brand) for Dihydroartemisinin. While samples B, H, and J were pharmaceutically bioequivalent to innovator product (sample C) for Piperaquine phosphate. Therefore, this study implies that only sample B is both pharmaceutically and therapeutically equivalent to the innovator brand, and thus they can be used interchangeably in clinical settings.