Abstract
Objective: This study was proposed to evaluate and compare the in vitro dissolution profiles of six Metformin Hydrochloride (MH) market products.
 Methods: Different dissolution apparatuses (USP apparatus II, IV and beaker method) were used to evaluate the dissolution profiles (in phosphate buffer, pH 6.8) of two immediate release (IR) generic products of Metformin Hydrochloride (MH): Cidophage® 1000 mg (G1, Egyptian market) and Metformin arrow® 1000 mg (G2, French market) with respect to the reference products named Glucophage® 850 mg (R1, Egyptian market and R2, French market). In addition to a generic controlled-release (CR) product; Cidophage Retard® 850 mg (G3) versus the reference product; Glucophage XR® 1000 mg (R3) (both from Egyptian market). Dissolution efficiency (D. E.) and the similarity factor (f2) were calculated. Weight uniformity, hardness, tablet dimensions and MH content were measured.
 Results: Results of the three apparatuses showed that MH IR products studied (reference and generics) did not meet the 75% USP 30 specifications for MH dissolved at 30 min. For MH CR products, Glucophage XR® did not fulfill the USP release criteria, while Cidophage Retard® did. USP apparatus IV revealed the highest sensitivity and discriminative capability.
 Conclusion: Generally, MH IR generics (G1 and G2) might be interchangeable with the innovator product (Glucophage®). However, Cidophage Retard® might not be interchangeable with Glucophage XR®.
Highlights
For many years, efforts have been made to minimize the number of in vivo studies required to approve a new molecule or a generic product
Our study revealed that the reported Metformin Hydrochloride (MH) pharmacopeial dissolution test was not discriminating enough, to show minor differences between dissolution patterns of different generics
Data with the flow-through cell apparatus approve that the dissolution method proposed has a greater discriminating ability compared to USP apparatus II and beaker method to assess differences in dissolution profiles of MH market products
Summary
Efforts have been made to minimize the number of in vivo studies required to approve a new molecule or a generic product. One of the approaches currently used is the in vitro (mainly dissolution) tests that act as a tool to predict drug product performance in vivo [1,2,3,4]. Dissolution testing is empirical in vitro laboratory performance test that judges how a drug is released from its dosage form efficiently. Dissolution profiles have been utilized to comprehend the influence of formulation composition on the in vitro release of an active pharmaceutical ingredient (API). It plays as well an important role in the context of science and risk-based process development, validation and evaluation of post-approval formulation changes to drug product quality [6]
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