Dissolution rate measurements as a predictory tool for assessing comparative bioavailability of generic ampicillin capsules

ABSTRACT

The dissolution rate of 12 batches of commercial ampicillin capsules manufactured by four leading pharmaceutical companies was determined by both closed and open dissolution systems. The most consistent results were those obtained by the USP method. The beaker as well as flow-through methods showed higher discriminating ability for differentiating the dissolution behavior of different batches of ampicillin capsules of the same brand. On the other hand, the flow- through method provided best discrimination of the dissolution characteristics of different brands. At the same time, the USP rotating basket method did not afford good discriminating ability for different lots belonging to the same brand or for different brands. The bioavailability of these products was assessed in human subjects according to a Latin square design: