EFFECT OF STORAGE ON THE IN-VITRO AND IN-VIVO CHARACTERISTICS OF SOME MARKETED SUSTAINED-RELEASE CARDIOVASCULAR TABLETS

Khidr, Sayed H.; Niazy, Esmail M.; El-Sayed, Yousry M.

doi:10.21608/bfsa.1998.67982

EFFECT OF STORAGE ON THE IN-VITRO AND IN-VIVO CHARACTERISTICS OF SOME MARKETED SUSTAINED-RELEASE CARDIOVASCULAR TABLETS

Document Type : Original Article

Authors

¹ Department of Industrial Pharmacy, Faculty of Pharmacy, Assiut University, Assiut, Egypt

² Department of Pharmaceutics, College of Pharmacy, King Saud University, P.O. Box: 2457, Riyadh 11451, Saudi Arabia

10.21608/bfsa.1998.67982

Abstract

The in-vitro and in-vivo characteristics of the sustained-release cardiovascular drugs: nifedipine (N) nad procainamide (PA), commercially available as Adalat-Retard and Procainamide durules tablets were evaluated both before and after their storage at ambient condition and under different accelerated conditions of temperature and relative humidity (RH) for twelve months. The effect of storage on the physical properties, the release rate profiles, the chemical stability and the bioavailability of these tablets in beagle dogs was studied. The results showed no or small change in the physical properties or in the drug contents of both drugs under the storage conditions of the study, indicating good physical and chemical stability of these products. In spite of statistically significant difference found in the dissolution results between the prestorage and stored tablets, this difference was not considered to be of practical significant in case of these sustained release products. The in-vivo studies indicated a statistically significant difference in the area under the curve and in the average peak concentration between the prestored tablets and the tablets stored for twelve months under ambient and at 40°C/80% RH in case of PA durules. This is a sign for a possible change in the bioavailability of this product with storage regardless the conditions under which the product is stored.