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Braz. J. Pharm. Sci. (Online) ; 58: e20349, 2022. tab, graf
Article Dans Anglais | LILACS | ID: biblio-1420459

Résumé

Abstract Quality is paramount and needs to be maintained throughout the shelf life of pharmaceuticals. The current study aimed to evaluate the quality, potency, and drug-drug interaction in an in vivo animal model by using two drugs, namely, metoprolol and glimepiride. Tablets were selected for their physical characteristics, such as shape, size, and color. Quality control tests, such as weight variation, hardness, friability, and disintegration tests, and invitro drug release studies were performed as per USP. Drug-drug interaction and in vivo studies were carried out according to the standard protocol of the animal ethics committee. Quality control tests of both the tablets were within the specified range. The cumulative release percentages of the drugs were 81.12% and 85.36% for Metoprolol Tartrate and Glimepiride, respectively, in a physiological buffer solution within 1 h. The combination of metoprolol and Glimepiride also significantly decreased the blood glucose level in diabetic animals. However, the blood glucose level increased in the group receiving metoprolol only, but the difference was not significant. The result suggested that the formulations are safe. However, the chronic use of this combination requires frequent monitoring of blood glucose level to improve its efficacy and for the patient's safety.


Sujets)
Animaux , Mâle , Femelle , Souris , Contrôle de qualité , Comprimés/classification , Interactions médicamenteuses , Métoprolol/analyse , Techniques in vitro/méthodes , Préparations pharmaceutiques/analyse , Management par la qualité/statistiques et données numériques
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