Abstract
Objective: Demonstrating therapeutic equivalency regarding the efficacy and safety among originator products and generics is a key step in permitting the marketing of generic products. The study aimed to evaluate the bioequivalence of five different generic brands of Glimepiride tablets under biowaiver conditions.
 Methods: The quality of the tablet products, including uniformity of weight, friability, and disintegration test, was assessed using the United State Pharmacopeia (USP) general monograph for the tablet dosage form. The content of glimepiride in the tablets was measured using UV spectrophotometer at the wavelength 229 nm. The release of Glimepiride from the tested and originator tablet products was evaluated using the dissolution profiles conducted in HCI buffer pH 1.2, and phosphate buffer pH 6.4 and 7.8 by USP dissolution apparatus II. The bioequivalence of test products was assessed using the similarity and difference factors. 
 Results:The tested products complied to USP requirements for quality standards; all the products show rapid disintegration, D1 show higher time (Three minutes) while D3 show lower time (28 seconds). The content of test products was (104.68, 93.75, 97.21, 97.03, and 102.10) for D1, D2, D3, D4, and D5 , respectively, compare to 103.70 for OB. Dissolution profiles revealed that the highest similarity to the originator was showed in pH 6.4; f2 ranged (74.5-68.4) for all the tested products and low similarity in pH 7.8; f2 ranged (45.2-64.7).
 Conclusion: The study showed that the generic products has noticeable similarity with the originator brand and it can be interchangeable.
Highlights
Demonstrating therapeutic equivalency regarding the efficacy and safety among innovator and generic products is a key step in permitting the marketing of generic products [1, 2]
The World Health Organization (WHO), International Council for Harmonization (ICH), and Food and Drug Administration (FDA) suggest wavier of in vivo bioequivalence studies using in vitro release dissolution data for immediate release oral solid dosage form based on Biopharmaceutical Classification System (BCS) [1, 611]
All the generic and originator products disintegrate in time less than 1 minute to 3 min, with highest disintegration time obtained by generic D1 (3:00 min); which will revealed in better release
Summary
Demonstrating therapeutic equivalency regarding the efficacy and safety among innovator and generic products is a key step in permitting the marketing of generic products [1, 2]. The World Health Organization (WHO), International Council for Harmonization (ICH), and Food and Drug Administration (FDA) suggest wavier of in vivo bioequivalence studies using in vitro release dissolution data for immediate release oral solid dosage form based on Biopharmaceutical Classification System (BCS) [1, 611]. BCS is based on waiving bioequivalence studies depending on the solubility and gastrointestinal permeability of drug substance and it use for generic products development by manufacturer as it save time and resources [1] For registration of generic products it is required that a bioequivalence study must be provided to indicate generic products are equivalence to originator one that must be with same active ingredient, same dosage forms, and strength, in order to submit for marketing authorization[12]. The solubility of drugs is slightly raised to (0.02) mg/ml in alkali media with pH>7 [26]
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