Evaluation of the alprazolam tablets 0.5 mg: a comparative study over references medicines, generic and similars medicines

Authors

  • Aristides Avilo do Nascimento Instituto Superior de Teologia Aplicada - INTA. Rua Coronel Antonio Rodrigues Magalhães, 359, Sobral, Ceará.
  • Nayara Araújo Cardoso Instituto Superior de Teologia Aplicada - INTA. Rua Coronel Antonio Rodrigues Magalhães, 359, Sobral, Ceará.
  • Glenda Azevedo Rodrigues Instituto Superior de Teologia Aplicada - INTA. Rua Coronel Antonio Rodrigues Magalhães, 359, Sobral, Ceará.
  • Thalles Yuri Loiola Vasconcelos Instituto Superior de Teologia Aplicada - INTA. Rua Coronel Antonio Rodrigues Magalhães, 359, Sobral, Ceará.
  • Francisca Valéria Bezerra Sampaio Marques Instituto Superior de Teologia Aplicada - INTA. Rua Coronel Antonio Rodrigues Magalhães, 359, Sobral, Ceará.
  • Eloi e Vasconcelos de Lima Instituto Superior de Teologia Aplicada - INTA. Rua Coronel Antonio Rodrigues Magalhães, 359, Sobral, Ceará.
  • Josiane Lima Mendes Instituto Superior de Teologia Aplicada - INTA. Rua Coronel Antonio Rodrigues Magalhães, 359, Sobral, Ceará.

DOI:

https://doi.org/10.14450/2318-9312.v28.e2.a2016.pp98-104

Keywords:

alprazolam, tablets, quality control

Abstract

About 20 % of the Brazilian population is affected by anxiety disorders are more prevalent among women aged between 34 and 59 years and alprazolam is the second most widely used anxiolytic to treat this pathology. As to the characteristics of tablets, these must have physical and chemical stabilities, disintegrate at the expected time, be little crumbly, also smooth and shiny surface.The aim of this work was to evaluate the quality of alprazolam 0.5 mg tablets, making the comparison between reference, generic and similar medicines commercially available, as regards the visual aspect and the average weight tests, hardness and friability. For the assay, 270 uncoated tablets of 0.5 mg alprazolam were used, from three different laboratories. Among them, 90 were from Reference category medicines (Group A), 90 were Generic medicines (group B) and 90, Similar medicines (group C). Each group was composed of three subgroups corresponding to different batches, and each subgroup contained 30 tablets of the same lot. The assay was done in triplicate. Thus, the group A was composed of lots A1, A2, and A3; Group B consisted of the lots B1, B2 and
B3 and the group C consisted of lots C1, C2, and C3. All lots were approved in the assays average weight and friability. However, considering package, the group C presented the number of the lot and expiration date illegible; and in the hardness test, two tablets of C1 lot showed hardness below of the specifications described by the Brazilian Pharmacopeia 5th Edition.

Author Biographies

Aristides Avilo do Nascimento, Instituto Superior de Teologia Aplicada - INTA. Rua Coronel Antonio Rodrigues Magalhães, 359, Sobral, Ceará.

Docente Responsável Técnico da Farmácia Escola das Faculdades INTA

Nayara Araújo Cardoso, Instituto Superior de Teologia Aplicada - INTA. Rua Coronel Antonio Rodrigues Magalhães, 359, Sobral, Ceará.

Farmacêutica Pesquisadora

Mestrando em Biotecnologia - Universidade Federal do Ceará - campus Sobral

Glenda Azevedo Rodrigues, Instituto Superior de Teologia Aplicada - INTA. Rua Coronel Antonio Rodrigues Magalhães, 359, Sobral, Ceará.

Farmacêutica pesquisadora

Thalles Yuri Loiola Vasconcelos, Instituto Superior de Teologia Aplicada - INTA. Rua Coronel Antonio Rodrigues Magalhães, 359, Sobral, Ceará.

Farmacêutico pesquisador

Francisca Valéria Bezerra Sampaio Marques, Instituto Superior de Teologia Aplicada - INTA. Rua Coronel Antonio Rodrigues Magalhães, 359, Sobral, Ceará.

Técnica de Laboratório da Farmácia Escola das Faculdades INTA

Eloi e Vasconcelos de Lima, Instituto Superior de Teologia Aplicada - INTA. Rua Coronel Antonio Rodrigues Magalhães, 359, Sobral, Ceará.

Farmacêutico Pesquisador

Mestrando em Biotecnologia - Universidade Federal do Ceará - campus Sobral

Josiane Lima Mendes, Instituto Superior de Teologia Aplicada - INTA. Rua Coronel Antonio Rodrigues Magalhães, 359, Sobral, Ceará.

Farmacêutica Pesquisadora do Núcleo de Atendimentos e Práticas Integradas (NAPI) das Faculdades INTA.

 

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Published

2016-07-05

How to Cite

do Nascimento, A. A., Araújo Cardoso, N., Azevedo Rodrigues, G., Loiola Vasconcelos, T. Y., Bezerra Sampaio Marques, F. V., e Vasconcelos de Lima, E., & Mendes, J. L. (2016). Evaluation of the alprazolam tablets 0.5 mg: a comparative study over references medicines, generic and similars medicines. Infarma - Pharmaceutical Sciences, 28(2), 98–104. https://doi.org/10.14450/2318-9312.v28.e2.a2016.pp98-104

Issue

Vol. 28 No. 2 (2016)

Section

Original article

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