QUALITY PARAMETERS COMPARISON BETWEEN SIMILAR AND GENERIC ATENOLOL TABLETS AND THE REFERENCE PRODUCT

Authors

  • Emilly Isabelli dos Santos Teodoro Universidade Estadual de Maringá Av. Colombo, 5790 - Zona 7, Maringá/PR
  • Thalita Prates da Silva Universidade Estadual de Maringá Av. Colombo, 5790 - Zona 7, Maringá/PR
  • Mariana Nascimento de Paula Universidade Estadual de Maringá Av. Colombo, 5790 - Zona 7, Maringá/PR
  • João Carlos Palazzo de Mello Universidade Estadual de Maringá Av. Colombo, 5790 - Zona 7, Maringá/PR
  • Mariana Aparecida Lopes-Ortiz Centro Universitário Ingá- Uningá Rod. PR 317, 6114 Parque Industrial Maringá - PR
  • Daniela Cristina de Medeiros Araújo Centro Universitário Ingá- Uningá Rod. PR 317, 6114 Parque Industrial Maringá - PR

DOI:

https://doi.org/10.14450/2318-9312.v32.e4.a2020.pp366-373

Keywords:

comparative study, atenolol, generic drugs, similar drugs

Abstract

Pharmaceutical equivalence between two medicinal products corresponds to the proof that both contain the same drug, i.e., the same active ingredient or salt, the same concentration, pharmaceutical form and route of administration, containing or not identical excipients. Tests conducted on comparative quality analysis include physico-chemical tests and when applicable, microbiological, and biological tests. This study evaluated the quality parameters of two brands of generic (called D and E) and two brands of similar (B and C) were evaluated in relation to the reference drug (A) of atenolol 50 mg. Tests of weight variation, friability, disintegration and assay were performed. In addition, microbiological control of the samples was performed by counting the total number of mesophilic microorganisms. The result was that there was no growth of colonies. All samples tested met the requirements of the tests performed according to the parameters described in the Brazilian Pharmacopeia 6th edition.

Author Biographies

Emilly Isabelli dos Santos Teodoro, Universidade Estadual de Maringá Av. Colombo, 5790 - Zona 7, Maringá/PR

Aluna do Programa de Pós-Graduação em Ciências Farmacêuticas da Universidade Estadual de Maringá

Thalita Prates da Silva, Universidade Estadual de Maringá Av. Colombo, 5790 - Zona 7, Maringá/PR

Aluna do Programa de Pós-Graduação em Ciências Farmacêuticas da Universidade Estadual de Maringá

Mariana Nascimento de Paula, Universidade Estadual de Maringá Av. Colombo, 5790 - Zona 7, Maringá/PR

Aluna do Programa de Pós-Graduação em Ciências Farmacêuticas da Universidade Estadual de Maringá

João Carlos Palazzo de Mello, Universidade Estadual de Maringá Av. Colombo, 5790 - Zona 7, Maringá/PR

 Professor titular. Departamento de Farmácia

Mariana Aparecida Lopes-Ortiz, Centro Universitário Ingá- Uningá Rod. PR 317, 6114 Parque Industrial Maringá - PR

 Professora adjunta. Departamento de Farmácia

Daniela Cristina de Medeiros Araújo, Centro Universitário Ingá- Uningá Rod. PR 317, 6114 Parque Industrial Maringá - PR

 Professora adjunta. Departamento de Farmácia

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Published

2020-12-08

How to Cite

Teodoro, E. I. dos S., Silva, T. P. da, Paula, M. N. de, Mello, J. C. P. de, Lopes-Ortiz, M. A., & Medeiros Araújo, D. C. de. (2020). QUALITY PARAMETERS COMPARISON BETWEEN SIMILAR AND GENERIC ATENOLOL TABLETS AND THE REFERENCE PRODUCT. Infarma - Pharmaceutical Sciences, 32(4), 366–373. https://doi.org/10.14450/2318-9312.v32.e4.a2020.pp366-373

Issue

Vol. 32 No. 4 (2020)

Section

Original article

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