Bioequivalence of Metformin as an Oral Antidiabetic: A Systematic Review

Abstract

Metformin is the first line in type 2 Diabetes Mellitus (DM). Metformin is available as an innovator drug and copy drug. The high price of innovator drugs makes it difficult for patients to obtain the required drugs. Therefore, many pharmaceutical industries have developed a copy of the innovator drug. To obtain .a distribution license, the pharmaceutical industry must conduct a bioequivalence test on metformin copy tablets to ensure that the copy drug has the same efficacy, safety, and quality as the innovator drug. However, several surveys show that most patients believe that the effectiveness of copy drugs is not equivalent to the innovator drug. This study aims to determine the bioavailability profile and bioequivalence profile of Metformin copy tablets to Glucophage® (Merck) innovator tablets so that it can provide an overview of the effectiveness of copy drugs with innovator drugs and the public no longer hesitate to use copy drugs. Metformin copy tablets are declared bioequivalent to the innovator drug if they provide a Confidence Interval (CI) value of 90% in the 80-125% range. All 500 mg, 850 mg, and 1000 mg doses of metformin copy tablets, both fasting and eating conditions, gave bioequivalent results to the innovator Glucophage® based on 90% CI.