Examinando por Materia "Equivalence Trial"

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    PublicaciónAcceso abierto
    Equivalencia farmacéutica de medicamentos multifuentes de carbamazepina disponibles en Cercado de Lima marzo–abril 2018
    (Universidad Privada Norbert Wiener, 2020-12-03) Barrientos Ríos, Erasmo; Gutierrez De Los Santos, Isaac; Cárdenas Orihuela, Robert Armando
    The objective of this research was to determine the pharmaceutical equivalence of three multi-source carbamazepine 200 mg tablets versus the reference drug Tegretol 200 mg tablets (Novartis, Switzerland). Methodology: The multi-source and reference medications were acquired from pharmacies in Lima. Disintegration, friability, hardness, weight, and content assay tests were performed using High-Performance Liquid Chromatography (HPLC). The results were analyzed to establish statistically significant differences. Results: The comparative analysis of the products showed the following: the multi-source medications had an average weight of ($\mathbf{0.32 \pm 7.5 \%}$g). In the hardness test, they reported an acceptable value between ($\mathbf{2 – 2.5 \text{ kg/F}}$). Disintegration showed a time of less than 30 minutes. Friability was less than 1.5%. The active principle assay by HPLC ranged between 92.0% and 108.0%. It is noteworthy that all products comply with the official specifications for identification and assay of the active ingredient, hardness, and disintegration time. Conclusion: The multi-source carbamazepine 200 mg tablets evaluated and sold in Cercado de Lima are pharmaceutically equivalent when compared to the innovator drug (Tegretol).
  • Miniatura
    PublicaciónAcceso abierto
    Equivalencia farmacéutica de medicamentos multifuentes de sildenafilo de 50 mg que se dispensan en el distrito de San Juan de Miraflores – San Juan zona D en los meses de noviembre y diciembre 2017
    (Universidad Privada Norbert Wiener, 2018-09-06) Huatuco Amez, Olivia Patrich; Guillén Sulca, Walter Roberto; Cárdenas Orihuela, Robert Armando
    When performing the pharmaceutical equivalence of 50 mg sildenafil multi-source medicines dispensed in the district of San Juan de Miraflores during the months of November and December 2017, the objective was to evaluate in vitro the multi-source sildenafil medicines. This drug was chosen because, in recent years in Lima—particularly in the district of San Juan de Miraflores, according to pharmaceutical staff reports—it has been sold with great freedom, and since it is dispensed under different brands, it was necessary to determine whether equivalence existed in relation to the innovator. The methodology used included the corresponding parameters established by the United States Pharmacopeia for solid pharmaceutical forms, evaluating the external aspects and the physical parameters of the tablets, such as weight variation, hardness, disintegration, and friability. The results obtained in this study demonstrated that these pharmaceutical forms are similar with respect to these parameters, meeting the official specifications. The values obtained fall within the accepted averages for oral formulations of 50 mg sildenafil.