In vitro Pharmaceutical Bioequivalence of Amoxicillin 500 mg capsules

Authors

  • Keyla J. Medrano López National Autonomous University of Nicaragua, León
  • Fania V. Valladares Silva National Autonomous University of Nicaragua, León.
  • Cesar Antonio Peralta National Autonomous University of Nicaragua, León
  • Saura L. Mendoza Marín National Autonomous University of Nicaragua, León.
  • Yader B. Salgado Mercado National Autonomous University of Nicaragua, León
  • Tania M. Díaz Pérez National Autonomous University of Nicaragua, León.
  • Kimberly Morán Jarquín National Autonomous University of Nicaragua, León
  • Laura Celeste Escoto National Autonomous University of Nicaragua, León.
  • Meyling Arabely Palma Centeno National Autonomous University of Nicaragua, León

DOI:

https://doi.org/10.5377/universitas.v12i2.16408

Keywords:

Dissolution of drugs, amoxicillin capsules, dissolution profiles, Interchangeability, Quality of drugs.

Abstract

To establish the interchangeability of drugs, mainly generics, it is necessary to demonstrate their equivalence with respect to the reference drug (Talevi, Quiroga, & Ruiz, 2016). Among the main tests that are carried out are those of bioavailability, bioequivalence and the comparison of dissolution profiles. These tests make it possible to guarantee the safety of the exchange between drugs during clinical practice. Amoxicillin, a broad-spectrum antibiotic widely used in our country for the treatment of various infectious pathologies, is in Class I within the Biopharmaceutical Classification System (SCB) ( PAHO, 2011), therefore, its equivalence can be demonstrated through in vitro studies. In this study, the dissolution profiles of three Amoxicillin 500 mg capsules marketed in Nicaragua were compared, with the aim of demonstrating whether they are interchangeable. The methodology used in the study is that described in the FDA Guide for Comparison of Dissolution Profiles; Three dissolution media were used at pH 1.2, 4.5 and 6.8 and f2 was calculated to determine exchangeability. At pH 1.2, all the products reached a dissolved percentage greater than 85% in the first sampling time, in the pH 4.5 dissolution medium, both drug C and the reference did not reach it. On the other hand, at pH 6.8 , only drug B achieved more than 85% of the active principle dissolved in the first ten minutes of the test.

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Author Biographies

Keyla J. Medrano López, National Autonomous University of Nicaragua, León

Industrial Pharmacy Department, Faculty of Chemical Sciences.

Medicines Quality Control Laboratory

Fania V. Valladares Silva, National Autonomous University of Nicaragua, León.

Industrial Pharmacy Department, Faculty of Chemical Sciences.

Medicines Quality Control Laboratory.

Cesar Antonio Peralta, National Autonomous University of Nicaragua, León

Departamento Farmacia Industrial, Facultad de Ciencias Químicas.
Laboratorio de Control de Calidad de Medicamentos.

Saura L. Mendoza Marín, National Autonomous University of Nicaragua, León.

Industrial Pharmacy Department, Faculty of Chemical Sciences.

Drug Quality Control Laboratory.

Yader B. Salgado Mercado, National Autonomous University of Nicaragua, León

Industrial Pharmacy Department, Faculty of Chemical Sciences. Drug Quality Control Laboratory.  

Tania M. Díaz Pérez, National Autonomous University of Nicaragua, León.

Departamento Farmacia Industrial, Facultad de Ciencias Químicas.
Laboratorio de Control de Calidad de Medicamentos.

Kimberly Morán Jarquín, National Autonomous University of Nicaragua, León

Industrial Pharmacy Department, Faculty of Chemical Sciences.

Drug Quality Control Laboratory.

Laura Celeste Escoto, National Autonomous University of Nicaragua, León.

Industrial Pharmacy Department, Faculty of Chemical Sciences.

Drug Quality Control Laboratory.

Meyling Arabely Palma Centeno, National Autonomous University of Nicaragua, León

Industrial Pharmacy Department, Faculty of Chemical Sciences.

Drug Quality Control Laboratory.

References

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Talevi, A., Quiroga, P., Ruíz, M. (2014). Procesos Biofarmacéuticos: Su relación con el diseño de formas farmacéuticas y el éxito de la farmacoterapia. Editorial de la Universidad de la Plata.

Published

2021-12-30

How to Cite

Medrano López, K. J. ., Valladares Silva, F. V. ., Antonio Peralta, C. ., Mendoza Marín, S. L., Salgado Mercado, Y. B. ., Díaz Pérez, T. M. ., Morán Jarquín, K. ., Celeste Escoto, L. ., & Palma Centeno, M. A. . (2021). In vitro Pharmaceutical Bioequivalence of Amoxicillin 500 mg capsules. UNIVERSITAS (LEÓN): SCIENTIFIC JOURNAL OF THE UNAN-LEÓN, 12(2), 1–7. https://doi.org/10.5377/universitas.v12i2.16408

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Section

Articles