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Memorias del Instituto de Investigaciones en Ciencias de la Salud

On-line version ISSN 1812-9528

Abstract

AQUINO, Sonia Lorena Fretes-de et al. Quality vs. price evaluation of national and imported 850 mg metformin tablets marketed for the control of diabetes in Paraguay. Mem. Inst. Investig. Cienc. Salud [online]. 2019, vol.17, n.1, pp.93-98. ISSN 1812-9528.  http://dx.doi.org/10.18004/mem.iics/1812-9528/2019.017(01)93-098.

Metformin is the first-line drug, alone or combined, used in the initial treatment of type 2 diabetes patients, which had a prevalence of 8.0% in men and 8.3% in women at the national level with an annual cost of USD 283/person. The study was conducted with the objective of evaluating the physical and chemical quality and price of 850mg metformin tablets marketed in our country. National and imported products were analyzed, containing 850 mg of metformin HCl taking as reference the United States Pharmacopeia (USP 38). To evaluate the quality of the products, chemical physical tests were carried out, in addition to the dissolution profiles according to the test proposed by USP 38. The results obtained were found within the valuation specifications, between 96% and 101% of metformin and the dissolution profiles were between 70% and 90% of the amount declared in 20 minutes, with a dissolution efficiency (EF) between 58% and 93% with no statistically significant difference (p = 0.41). The variation of prices found was between USD 3.6 and USD 8.4. The products analyzed are interchangeable in terms of quality and in vitro dissolution profiles, being a tool to demonstrate the interchangeability of pharmaceutical products, looking for the best accessible price in the national market and facilitating the adequate treatment especially for the population of limited resources maintaining its quality and effectiveness.

Keywords : metformin; dissolution profiles; quality; type 2 diabetes mellitus.

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