Evaluación comparativa de perfiles de disolución del  medicamento genérico lamivudina tableta 150 mg comercializado en Perú frente al innovador Epivir

Malena Castañeda-Alarcón; Encarna García-Montoya; Javier Rodríguez-Calzado; María Flores-Rodríguez; Miguel Grande-Ortíz; Luis Moreno-Exebio

doi:10.17843/rpmesp.2024.411.12821

Authors

Malena Castañeda-Alarcón Centro Nacional de Control de Calidad, Instituto Nacional de Salud, Lima, Perú https://orcid.org/0000-0001-7347-2189
Encarna García-Montoya Departamento de Farmacia y Tecnología Farmacéutica y Físico Química, Facultad de Farmacia y Ciencias de la Alimentación, Universidad de Barcelona, Barcelona, España https://orcid.org/0000-0003-1576-5586
Javier Rodríguez-Calzado Centro Nacional de Control de Calidad, Instituto Nacional de Salud, Lima, Perú. https://orcid.org/0000-0003-2401-600X
María Flores-Rodríguez Centro Nacional de Control de Calidad, Instituto Nacional de Salud, Lima, Perú https://orcid.org/0000-0001-5337-5306
Miguel Grande-Ortíz Centro Nacional de Control de Calidad, Instituto Nacional de Salud, Lima, Perú. https://orcid.org/0000-0002-5018-4616
Luis Moreno-Exebio Centro Nacional de Control de Calidad, Instituto Nacional de Salud, Lima, Perú. https://orcid.org/0000-0001-8920-1148

DOI:

https://doi.org/10.17843/rpmesp.2024.411.12821

Keywords:

Therapeutic Equivalence, Generic Drugs, Lamivudine, Bioequivalent Drugs, Dissolution, HIV

Abstract

Lamivudine is one of the most prescribed drugs in the world, and is used to treat human immunodeficiency and hepatitis B. This study aimed to evaluate the quality attributes and compare the dissolution profiles of two batches (A and B) of generic lamivudine 150 mg tablets with the innovator drug Epivir 150 mg tablets. We conducted an analytical, experimental, cross-sectional study, and used a spectrophotometric method at a wavelength of maximum absorption (λ) corresponding to 270 nm, to measure the percentage of dissolved drug. The study evaluated identification, content, dissolution and mass uniformity. Apparatus 2 USP (Paddle) 75 rpm, 900 mL of dissolution medium (37 ± 0.5 °C) was used in three dissolution media: pH 1.2; 4.5 and 6.8. Samples of 5 mL were obtained at 5, 10, 15, 20 and 30 min. Both batches of generic lamivudine (A and B) were found to have the same dissolution kinetic profile as the innovator drug. Both formulations met the criteria of very fast dissolving (85% dissolved in 15 min), and fast dissolving (85% dissolved in 30 min) drugs. Therefore, it was not necessary to calculate the similarity factor. We concluded that generic drugs A and B are in vitro equivalents to the innovator drug Epivir.

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