In-Vitro Quality Evaluation of Different Products of Amoxicillin- Clavulanate Potassium Tablets

Abstract

Amoxicillin- clavulanate potassium is a broad spectrum antibiotic used in the management of most bacterial infections. World-wide, it is manufactured and marketed by different companies. The innovator brand, Augmentin, is expensive, hence the need to substitute them with much cheaper generic brands.  Moreover, the quality of different products of the combination is not guaranteed. The object of this study was to evaluate the quality of five common products of amoxicillin-clavulanate potassium 625mg tablets marketed in Gondar town. Assessment of their quality were done by the evaluation of the physicochemical characteristics such as uniformity of weight, thickness, diameter, friability, hardness, disintegration time and assay of the products against pharmacopoeial standards and in comparison with the innovator brand. All branded tablets met the standards for acceptance. All brands have the weight uniformity, thickness and diameter within the specification. However, tablets from B2 & B3 have a significant difference in thickness with the innovator; and all brands have a significantly higher diameter than the innovator. All brand tablets have sufficient crushing strength and TS. However, B2 has higher TS, and B4 has lower TS than the innovator. All brand tablets have less than 1% friability. All tablets contain Amoxicillin and Clavulanate potassium within the stated standard range of 90-110%. However, B1 is with the highest, whereas B5 is with the lowest content. In conclusion, all the brands met the minimum requirements of the specifications in the standards. Moreover, there was no extended deviation between the innovator and other brands under investigation in many of the parameters.