Physico-chemical quality assessment of metformin hydrochloride tablets and capsules

Abstract

In the Brazilian market there are a variety of formulations of metformin hydrochloride, each presenting quality characteristics based on previous tests required by the National Health Surveillance Agency, however, this degree of requirements is not the same for all types of formulations. In addition, there are some technological and quality control limitations inherent to the custom production process, when compared to the processes performed by the pharmaceutical industries. The achievement of quality control is extremely important so that the safety, efficacy and credibility of the medicines are assured to the population that will consume them. The objective of this study was to evaluate the quality of metallidine hydrochloride 850mg commercialized in pharmacies in the city of Montes Claros - MG. In the methodological process these samples were submitted to the following tests: average weight, friability, hardness, disintegration and dosing. All the physical tests performed complied with the specifications described in the Brazilian Pharmacopoeia 5th edition. The dosing test for the tablets were within the specified range for the capsule sample was below specified. Therefore, more studies should be developed in quantitative analyzes, mainly in magazines to ensure the quality of this product.