Examinando por Materia "Carbamazepine"

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    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).