Avaliação de equivalência farmacêutica de diferentes marcas de comprimidos de uso veterinário contendo prednisolona

Abstract

The veterinary market shows exponential growth every year, mainly veterinary drugs. Veterinary medicines must be adequate to the quality requirements, as well as medicines for human use. However, few studies evaluating the quality of these drugs are found. Prednisolone is a glucocorticoid drug with anti-inflammatory action, indicated for both human and veterinary use. The analysis of the quality of this drug is important, since it is widely used. Thus, this study aimed to evaluate the pharmaceutical equivalence of different brands of tablets for veterinary use containing the active ingredient prednisolone. The pharmaceutical equivalence assessment was carried out by determining the average weight, determination of hardness, determination of friability, disintegration time, determination of prednisolone content in the tablets, content uniformity and in vitro dissolution of 3 different brands of tablets identified as brand A, B and C. The tests were carried out in accordance with the Brazilian Pharmacopoeia 6th edition. In the mean weight analysis, samples A and B showed a coefficient of variation (0.48 and 1.42 respectively) within the range recommended by the Pharmacopoeia, however, sample C showed a value above the limit (11.05%). The average hardness obtained from sample A was 31 N, from sample B, 21.2 N and 40.55 N from sample C. In the friability test, the samples were approved, and A, B and C had a coefficient of variation of 1.12, 0 and 0.6%, in due order. In the disintegration time test, sample A tablets disintegrated in approximately 30 seconds, while samples B and C did not disintegrate within 2 hours of testing. Regarding the drug content, in sample A, the content was 98.18%, while B and C presented 63.11 and 82.01%, respectively. In content uniformity, the acceptance value obtained was 24.30, 58.85 and 48.90% of A, B and C, respectively. In the in vitro dissolution performed in distilled water for 30 minutes, the prednisolone dissolved in the tablets of A was 67.66%, while B and C did not present any release. In acid medium, the test was carried out in 2 hours, in 30 minutes A and B released, respectively, 73.29 and 48.4%. In two hours, the release was 72.13% (A) and 51.70% (B). Sample C had no release on the two media tested. The dissolution profiles obtained were compared using One-way ANOVA. The results obtained demonstrate that the evaluated products were not considered approved, under the experimental conditions employed.