Comparative In-Vitro Physicochemical Evaluation and Dissolution Profiling of Glibenclamide 5mg tablet Marketed in Addis Ababa, Ethiopia

Abstract

AbstractThe safety of medicines is an essential part of patient safety. Global drug safety depends on strong national systems that monitor the development and quality of medicines. Poor quality medicines do not meet official standards for strength, quality, purity, packaging and labelling. Hence, this study determines in-vitro quality attributes of glibenclamide 5mg tablet marketed in Addis Ababa according to USP-38 drug monograph specifications. All tested brands meet the requirements for physical inspection & complied specification for friability and hardness. Besides, the tested brands met USP 38 specification for assay (99.96% to 108.85%) and for content uniformity (AV values ranges from 3.35 to 10.04). In-vitro release tests were carried out in phosphate buffer of 7.5 and 8.5 pH and showed drug release of ≥ 75%, met USP 38 requirements. However, significant difference with respect to dissolution profile among tested brands GL4 and GL6 were confirmed with comparator product through model independent approach. Moreover, DE values were studied and confirmed that GL4 and GL6 were not therapeutically interchangeable with innovator product.