Abstract
Objective: The main objective of the study was to assess the quality attribute of generic brands and newly formulated tablet of glimepiride and compare their drug release profile with innovator brand. Methods: Different brands were purchased from different markets of UAE. The validated high-performance liquid chromatography method was used to assess the quantitative analysis of glimepiride. The linearity of curve (r² = 0.9999) indicated the accuracy and precision of the analytical method. Comparative dissolution of newly formulated and generic tablets was carried out using USP dissolution apparatus II. Study was accomplished in phosphate buffer (pH = 7.8), the paddle speed was adjusted at 75 rpm. F1 and F2 factor among the brands and kinetic assessment were done to obtain the order of release. Results: Dissolution profiles of formulated tablets were almost same as that of innovator, 91.53 and 94.9, respectively, in 15 min. The statistical value between the different brands (F = 3.698) indicated that there were some differences among the few groups of tablets and p-value (0.002154) indicated that it supported H1 hypothesis. First-order and Weibull models described the drug release with r2 value of 0.9981–0.927210 and 0.9992– 0.9835, respectively. Stability of optimized formulated batch was also examined. Conclusion: It was concluded that the formulated tablets are stable and pharmaceutically as good as the innovators; however, all the selected brands could not be used interchangeably in the clinical practice. It was also concluded that the scrutiny and screening of the drug products, available in the markets, can help to build a better health-care setup.
Highlights
Glimepiride is useful in the treatment of non-insulin dependent diabetes mellitus [1,2]
Glimepiride falls in BCS Class II, it has low solubility and high permeability making it difficult to manufacture tablets with good dissolution rate that affects the systemic availability of drug in the body
The validated high-performance liquid chromatography (HPLC) method was used for the evaluation of glimepiride tablets
Summary
Glimepiride is useful in the treatment of non-insulin dependent diabetes mellitus [1,2]. It is 1-(p-(2-(3-ethyle-4-methyl-2-oxo-3- pyrroline-1carboxamido) ethyl) phenyl) sulfonyl)-3-(trans-4-methylcyclohexyl) urea which belongs to third generation of hypoglycemic sulfonylurea. In 2007, Adegbolagun et al [4] suggested a need to analyze and evaluate the generic brands available in the market. These drugs should be analyzed for their chemical and biopharmaceutical equivalence, strength, quality, purity, and releasing profile of active ingredient in comparison of innovator drug
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