Physical Evaluation and In Vitro Bioequivalence Study of Marketed Aspirin Enteric Coated Tablets in KSA

摘要

Purpose: The main of this study is to evaluate the in-vitro bio equivalency of enteric coatedAspirin tablets in the Kingdom of Saudi Arabia (KSA). Methods: Two available brands of Aspirin enteric coatedtablets were randomly collected from various pharmacies, and were then coded as A (DISPRIN) and B (JUSPRIN).An innovator Aspirin enteric coated tablet was also procured fromalocal community pharmacy. Pure Aspirin drugwas procured from Sigma-Aldrich. General quality assessment such as weight variation, hardness, friability,disintegration test, and a dissolution study were performed as per USP guidelines. Results: All A and B brandspassed the weight variation test, as no more than two tablets failed, in all cases. The hardness test results for theinnovator, and brands A and B, were recorded as 4.91, 5.25 and 4.58 kg, respectively. The friability test was alsocarried out for the innovator and brands A and B, whereby all experienced weight loss of 0.086%, 0.030% and0.077%, respectively. Although the results of the disintegration test made it clear that the innovator, as well asbrands A and B, did not disintegrate in an acidic medium, all tablets disintegrated in a pH 6.8 buffer solution in19.36, 21.58 and 15.13 minutes, respectively. There were no significant variations in the dissolution profiles or inthe release profiles of the innovator, nor in brands A and B. There was a release of drug in a basic medium withinone hour (90.19%, 82.04% and 87.64%, respectively). Finally similarity factors (f2) were calculated for brands Aand B, which were 72.12% and 88.72%, respectively. Conclusion: On the basis of in-vitro tests, brands A and B areconsidered bioequivalent and interchangeable, while brand B is closer to the innovator in terms of hardness,disintegration and dissolution profile.[Muhammad Hadi Sultan, Md Sarfaraz Alam, Osama A. Madkhali, Md Sajid Ali., Muaid Ahmed Aqeel, RyanIbrahim Gaderi, Abdullah Muhammad Khardali. Physical Evaluation and In Vitro Bioequivalence Study ofMarketed Aspirin Enteric Coated Tablets in KSA. Life Sci J 2020;17(9):1-7]. ISSN: 1097-8135 (Print) / ISSN:2372-613X (Online). http://www.lifesciencesite.com. 1. doi:10.7537/marslsj170920.01.