Quality evaluation of solid pharmaceutical preparations for veterinary use containing cephalexin

Abstract

The analysis of pharmaceuticals is fundamental in both human and veterinary medicine. In this context, quality control must accompany the process from the acquisition of raw material to the transformation into a finished product, since its goal is to ensure safe and effective drugs for human or animal consumption. Considering the significant increase in veterinary prescriptions containing antimicrobial drugs, the present work carried out a search for information about the qualification of veterinary preparations available in the national market, highlighting, through legislation, the quality parameters applied to pharmaceutical products for veterinary use. The quality of solid pharmaceutical preparations containing cephalexin, acquired in the national veterinary pharmaceutical market, was also evaluated. The six different brands of cephalexin tablets and coated tablets analyzed in this study were approved with regard to identification, average weight, determination of mechanical strength in tablets, disintegration test, and content. The results of the determination of the content varied between 94.9% and 103%, being within the limits indicated for preparations for human use, as recommended by USP 44 and the Brazilian Pharmacopeia 6th edition. Even so, it is important to emphasize the need for improvement in the legislation that regulates the quality control of medicines for veterinary use, since the norms are not very specific, with an absence of parameters, specifications, and release procedures that ensure which tests should be performed. This study is a perspective that can bring subsidies for investigations of other therapeutic classes, considering the large number of formulations available in the Brazilian market of veterinary medicines.