Comparative evaluation of dissolution profiles of the generic drug lamivudine 150 mg tablet marketed in Peru vs. the innovative Epivir

Authors

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.

Downloads

Download data is not yet available.

References

ONUSIDA. Hoja informativa-Últimas estadísticas sobre el estado de la epidemia de sida. (acceso 4 de agosto de 2022). Disponible en https://www.unaids.org/es/resources/fact-sheet.

Ministerio de Salud. Situación epidemiológica del VIH/SIDA en el Perú. Lima: MINSA; 2021. Disponible en: https://www.dge.gob.pe/portal/docs/vigilancia/vih/Boletin_2021/setiembre.pdf

Canto YE, Gervasi GMD, Alvirio LAM. Impact of the TARGA Program on the reduction of AIDS cases in the Peruvian health system, 1983-2018. Rev Panam Salud Publica/Pan Am J Public Heal 2020;44. doi. 10.26633/RPSP.2020.27.

World Health Organization. A Fifty-first report of the WHO Expert Committee on specifications for pharmaceutical preparations.. Geneva: WHO; 2017. Disponible en: https://www.who.int/publications/i/item/9789241210034.

Sweet CM. The Politics and Policies of Regulating Generics in Latin America: A Survey of Seventeen States. J Health Polit Policy Law 2017;42 (3):485–512. doi: 10.1215/03616878-3802953.

Pérez-Chauca M; Gomez H. Intercambiabilidad de medicamentos en el Perú: Panorama actual y perspectivas futuras. Rev Peru Med Exp Salud Publica 2021;38(2):337-44. doi: 10.17843/rpmesp.2021.382.7322.

Dirección General de Medicamentos Insumos y Drogas - DIGEMID. Decreto Supremo 024-2018 SA: Reglamento que regula la intercambiabilidad de Medicamentos. El Peruano 2018:11. Disponible en: https://www.digemid.minsa.gob.pe/webDigemid/normas-legales/2018/decretosupremo-n-024-2018-sa/.

Sapsirisavat V, Vongsutilers V, Thammajaruk N, Pussadee K, Riyaten P, Kerr S, et al. Pharmaceutical Equivalence of Distributed Generic Antiretroviral (ARV) in Asian Settings: The Cross-Sectional Surveillance Study – PEDA Study. PLoS One 2016;11(6) doi: 10.1371/JOURNAL.

PONE.0157039.

Ruiz de Paz K. Estudio de Bioequivalencia “in vitro” de tres productos genéricos (tabletas) de liberación inmediata que contienen Metformina Clorhidrato 850 mg con el medicamento innovador comercializados en Perú. [Tesis] Lima. Universidad Peruana Cayetano Heredia, 2017. Disponible en https://repositorio.upch.edu.pe/handle/20.500.12866/1023.

Chumpitaz-Cerrate V, Moreno-Exebio L, Ruiz-Ramirez E, Franco-Quino C, Flores-Rodríguez M, Chávez-Rimache L. Therapeutic Equivalence Evaluated Through In Vitro Studies of Multi-Source Drugs: A Moxifloxacin Case Study in Lima, Peru. Dissolution Technol 2022. doi: 10.14227/DT290122PGC1.

Grande-Ortiz M, Taipe-Cadenillas S, Villodas-Saldaña C, Rodríguez-Calzado J, Moreno-Exebio L. Therapeutic equivalence evaluated by in vitro studies of multisource pharmaceutical products: Case studies of amoxicillin, doxycycline and fluconazole in Lima, Peru. Rev Peru Med Exp Salud Publica 2019;36(1):74–80. doi: 10.17843/RPMESP.2019.361.3912.

US Pharmacopeia (USP). USP 42/NF 37. The United States Pharmacopeial Convention. United Book Press Inc. 2018.

European Medicines Agency. ICH M9 guideline on biopharmaceutics classification system-based biowaivers. vol. 31. 2020. Disponible en: https://www.ema.europa.eu/en/ich-m9-biopharmaceutics-classification-system-based-biowaivers-scientific-guideline.

Notario Dongil C, Gómez Lluch T, de La Torre A, Proy Vega B. Adherencia al tratamiento antirretroviral en pacientes VIH. Revista Multidisciplinar Del Sida. 2022;10(26):7–13. Disponible en: https://www.revistamultidisciplinardelsida.com/adherencia-al-tratamiento-antirretroviral-en-pacientes-vih/

Fernandes C, Moreira de Campos LM, Pianetti GA. Validação de metodologia para doseamento e estudo de equivalência farmacêutica de comprimidos de lamivudina 150 mg. Rev Bras Ciências Farm 2003;39(4);381-9. doi: 10.1590/S1516-93322003000400005.

Wang T, Hoag SW, Eng ML, Polli J, Pandit NS. Quality of antiretroviral and opportunistic infection medications dispensed from developing countries and Internet pharmacies. J Clin Pharm Ther 2015; 40(1):68-75. doi: 10.1111/JCPT.12226.

Ozturk N, Kaynak MS, Sahin S. Comparison of dissolution profiles of commercially available Lamivudine tablets. Dissolution Technol

;22:38–43. doi: 10.14227/DT220415P38.

Bisso Y. Comparación de perfiles de disolución de un medicamento Genérico vs la referencia comercial de Lamivudina-Abacavir[Tesis]. Buenos Aires: Universidad de Belgrano, 2010. Disponible en: https://repositorio.ub.edu.ar/bitstream/handle/123456789/5093/444_Bisso.pdf?sequence=1&isAllowed=y.

Dezani AB, Pereira TM, Caffaro AM, Reis JM, Serra CH dos R. Equilibrium solubility versus intrinsic dissolution: Characterization of lamivudine, stavudine and zidovudine for BCS classification. Brazilian J Pharm Sci 2013; 49(4):853-63. doi: 10.1590/S1984-82502013000400026.

Patel JR, Barve KH. Intestinal Permeability of Lamivudine Using Single Pass Intestinal Perfusion. Indian J Pharm Sci 2012;74(5): 478-81. doi: 10.4103/0250-474X.108441.

Published

2024-03-25

Issue

Section

Brief Report

How to Cite

1.
Castañeda-Alarcón M, García-Montoya E, Rodríguez-Calzado J, Flores-Rodríguez M, Grande-Ortíz M, Moreno-Exebio L. Comparative evaluation of dissolution profiles of the generic drug lamivudine 150 mg tablet marketed in Peru vs. the innovative Epivir. Rev Peru Med Exp Salud Publica [Internet]. 2024 Mar. 25 [cited 2024 Apr. 24];41(1):69-75. Available from: https://rpmesp.ins.gob.pe/index.php/rpmesp/article/view/12821

Most read articles by the same author(s)