Comparison of In Vitro Dissolution Profiles of Fluoxetine Capsules Marketed in Bahia, Brazil, Using UV-Spectrophotometric Method

作者:Viana Larissa C M G; Ferreira Matheus da S; Matos Rafael A; Sa Ramon R; da Silva Vagner C; Mota Milleno D; Guedes Alessandra da S; Magalhaes Hemerson I F; Santos Junior Anibal de F
来源:Latin American Journal of Pharmacy, 2016, 35(7): 1503-1508.

摘要

Fluoxetine is an antidepressant used worldwide that belongs to the class of selective serotonin reuptake inhibitors. The aim of this study was to compare the dissolution profiles of 20 mg capsules of fluoxetine available as the reference drug (product R), generic (product G), similar (Product S) and compounded (CA and CB) commercialized in Bahia, Brazil using a validated, simple, fast and low cost ultraviolet method. The dissolution test was used to obtain and compare dissolution profiles and establish similarities of pharmaceutical formulations, in compliance with the Brazilian Pharmacopoeia (2010). The disintegration occurred until 13 min. The products analyzed showed drug release in 15 min (R, G and S products) and 10 min (CA and CB products) after the dissolution test. Drug release was satisfactory for all products, since at least 70% of the fluoxetine was dissolved in the medium within 45 min of the test.

  • 出版日期2016