Abstract

RODRIGUEZ-SAAVEDRA, Lennin Roswell et al. Comparative study of the biopharmaceutical quality of Alprazolam 0.5 mg commercialized in the Peruvian market. Mem. Inst. Investig. Cienc. Salud [online]. 2020, vol.18, n.3, pp.43-54. ISSN 1812-9528.  https://doi.org/10.18004/mem.iics/1812-9528/2020.018.03.43.

Alprazolam belongs to benzodiazepines. Its effects are attributed to the fact that it acts on specific membrane receptors, which facilitates the presynaptic and postsynaptic inhibitory action of γ-aminobutyric acid (GABA), especially in the ascending reticular formation. It is used to treat anxiety states, panic attacks, and intense stress. This study was carried out to analyze comparative parameters of in vitro quality control by evaluating the variation in weight, friability, hardness, disintegration time, profile and dissolution efficiency between the innovative drug (Xanax®) and multi-sources tablets that are marketed in the Peruvian market. To perform this, Alprazolam 0.5 mg multi-source tablets were selected from different laboratories comparing them with the innovative medicine and the physicochemical and biopharmaceutical characteristics were evaluated. Pharmacopoeial trials were evaluated as established in USP 42. The results of physicochemical tests indicated that analyzed samples did not have a significant difference and were within the established in the pharmacopoeia, as well as the profile and dissolution efficiency allowed to establish that their biopharmaceutical behavior was very similar for both types of molecules. It was established that Alprazolam 0.5 mg multi-source tablets from this research are bioequivalent with innovator, which makes it possible to propose to scientific community determination of biopharmaceutical equivalency as a support element in decision-making process for purchasing services pharmacist.

Keywords : Alprazolam; interchangeability; bioequivalence; quality control.

        · abstract in Spanish     · text in Spanish     · Spanish ( pdf )