PHARMACEUTICAL EQUIVALENCE STUDY OF GENERIC AND SIMILAR METFORMIN HYDROCHLORIDE TABLETS

Authors

  • Thalita Prates da Silva Universidade Estadual de Maringá Laboratório Palafito Avenida Colombo, 5790 Maringá, PR, Brasil CEP 87020-900
  • Emilly Isabelli dos Santos Teodoro Universidade Estadual de Maringá Laboratório Palafito Avenida Colombo, 5790 Maringá, PR, Brasil CEP 87020-900
  • Mariana Nascimento de Paula Universidade Estadual de Maringá Laboratório Palafito Avenida Colombo, 5790 Maringá, PR, Brasil CEP 87020-900
  • João Carlos Palazzo de Mello Universidade Estadual de Maringá Laboratório de Biologia Farmacêutica - Palafito Avenida Colombo, 5790 Maringá, PR, Brasil CEP-87020-900
  • Daniela Cristina de Medeiros Araújo Centro Universitário Ingá - Uningá Endereço: Rod. PR 317, 6114 Parque Industrial 200 Maringá - PR, 87035-510

DOI:

https://doi.org/10.14450/2318-9312.v32.e2.a2020.pp160-167

Keywords:

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

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.

Author Biographies

Thalita Prates da Silva, Universidade Estadual de Maringá Laboratório Palafito Avenida Colombo, 5790 Maringá, PR, Brasil CEP 87020-900

Aluna do Programa de Pós-graduação em Ciências Farmacêuticas

Mariana Nascimento de Paula, Universidade Estadual de Maringá Laboratório Palafito Avenida Colombo, 5790 Maringá, PR, Brasil CEP 87020-900

Aluna do Programa de Pós-graduação em Ciências Farmacêuticas

João Carlos Palazzo de Mello, Universidade Estadual de Maringá Laboratório de Biologia Farmacêutica - Palafito Avenida Colombo, 5790 Maringá, PR, Brasil CEP-87020-900

Departamento de Farmácia

Daniela Cristina de Medeiros Araújo, Centro Universitário Ingá - Uningá Endereço: Rod. PR 317, 6114 Parque Industrial 200 Maringá - PR, 87035-510

Professora adjunta do curso de Farmácia

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Published

2020-07-07

How to Cite

Silva, T. P. da, Teodoro, E. I. dos S., Paula, M. N. de, Mello, J. C. P. de, & Medeiros Araújo, D. C. de. (2020). PHARMACEUTICAL EQUIVALENCE STUDY OF GENERIC AND SIMILAR METFORMIN HYDROCHLORIDE TABLETS. Infarma - Pharmaceutical Sciences, 32(2), 160–167. https://doi.org/10.14450/2318-9312.v32.e2.a2020.pp160-167

Issue

Vol. 32 No. 2 (2020)

Section

Original article

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