Dissolution Test of Patent and Generic Drugs of Metformin Hydrochloride

Abstract

Type 2 diabetes is a chronic, multifactorial disease with a genetic predisposition caused by a deficit in the action or secretion of insulin, resulting in hyperglycemia, which is characterized by increased blood glucose levels. Metformin hydrochloride is the most frequently used medication. There is a wide variety of generic metformin products in the Mexican market, and these products can vary in quality depending on the manufacturing process and formulation. The purpose of this study was to assess the dissolution properties of 850-mg immediate-release metformin hydrochloride tablets from two batches of three different brands available in the Mexican market (in Mexico City): patent Dabex, interchangeable/generic Dinorax, and similar Setebaid. In vitro dissolution studies were performed in accordance with the Pharmacopoeia of the United Mexican States (FEUM). For the titration test, Dinorax exceeded the specifications (95–105%) as well as batch 2 of the Setebaid brand. For the dissolution tests, Dinorax and Setebaid passed but not Dabex. For weight variation, all brands were within the limits of acceptance criteria. The Dabex brand, which is considered a reference by FEUM, did not pass the dissolution test.