PHARMACEUTICAL EQUIVALENCE STUDY OF GENERIC AND SIMILAR METFORMIN HYDROCHLORIDE TABLETS

Thalita Prates da Silva, Emilly Isabelli dos Santos Teodoro, Mariana Nascimento de Paula, João Carlos Palazzo de Mello, Daniela Cristina de Medeiros Araújo

Abstract


Metformin is an oral hypoglycemic of the class of biguanides widely used in the treatment of type 2 diabetes mellitus. Pharmaceutical equivalence studies are aimed at evaluating some quality parameters of medicinal products by comparative analysis between the test drug (s) and the reference dosage form. Thus, the purpose of this study was to evaluate the pharmaceutical equivalence of two brands of generic drug and two brands of similar drug against the reference metformin hydrochloride tablets 850mg. The following tests were carried out: weight variation, friability, disintegration, assay and dissolution. The tested samples were approved in all the tests, meeting the criteria recommended by the Brazilian Pharmacopoeia 5ª edition. Thereby, it has been found that all drugs tested are pharmaceutically equivalent to the reference product.


Keywords


metformin; quality control; equivalence trial; drugs, generic; similar drugs



DOI: http://dx.doi.org/10.14450/2318-9312.v32.e2.a2020.pp160-167

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Copyright (c) 2020 Thalita Prates da Silva, Emilly Isabelli dos Santos Teodoro, Mariana Nascimento de Paula, João Carlos Palazzo de Mello, Daniela Cristina de Medeiros Araújo

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Infarma - Ciências Farmacêuticas

ISSN - 2318-9312 (Versão eletrônica)

ISSN - 0104-0219 (Versão impressa)

Conselho Federal de Farmácia - CFF

SHIS QI 15 Lote "L" - Lago Sul - Brasília - DF

CEP: 71635-615 - Fone: (61)3878-8751

e-mail:infarma@cff.org.br

Diretoria

Walter da Silva Jorge João, Presidente do Conselho Federal de Farmácia

Lenira da Silva Costa, Vice-Presidente do Conselho Federal de Farmácia

João Samuel de Morais Meira, Tesoureiro do Conselho Federal de Farmácia

Luiz Gustavo de Freitas Pires, Secretário-Geral do Conselho Federal de Farmácia