COMPARATIVE STUDY ON THE PHYSICO-CHEMICAL STABILITY OF ACETYLSALICYLIC ACID TABLETS PREPARED BY MICROENCAPSULATION AND OTHER PREPARATIVE TECHNIQUES

Document Type : Original Article

Authors

Department of Pharmaceutics, Faculty of Pharmacy, Mansoura University, Mansoura, Egypt

Abstract

Acetylsalicylic acid (ASA) tablets were prepared using microencapsulation, wet-granulation with hydroalcohlic gelatin dispersion and direct compression using emdex and avicel. Commercially available microencapsulated ASA tablets were used for the comparative study. Batches of tablets that showed good physical and mechanical properties and dissolution characteristics were selected for the stability study. Stability testing was carried out at ambient conditions, 52% R.H. at 20°C and finally at 95% R.H. at the same temperatures. The results were recorded at the start of the accelerated stability investigation and after subsequent one month intervals for six months storage time period. The rate of decomposition under these stress conditions was determined. There was a significant increase in tablets weight, thickness, friability percent and disintegration time. However, a marked decrease in tablet hardness and dissolution rate was observed. Maximum stability was obtained for ASA tablets directly compressed with avicel and by wet-granulation. Emdex could be considered as the most suitable vehicle at low humidity for stability of ASA tablets. The hydrolytic decomposition of the prepared tablets followed the first order pathway. Both prepared and commercial microencapsulated ASA tablets were not suitable for storage at high humidity level.