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Stability, polymorphism, dissolution and in vivo-in vitro correlation for Darunavir tablets

Grant number: 11/05836-4
Support type:Scholarships in Brazil - Doctorate
Effective date (Start): July 01, 2012
Effective date (End): March 12, 2014
Field of knowledge:Health Sciences - Pharmacy - Pharmaceutical Technology
Principal Investigator:Hérida Regina Nunes Salgado
Grantee:Josilene Chaves Ruela Corrêa
Home Institution: Faculdade de Ciências Farmacêuticas (FCFAR). Universidade Estadual Paulista (UNESP). Campus de Araraquara. Araraquara , SP, Brazil
Associated scholarship(s):12/18836-5 - Development of in vitro in vivo correlation for Darunavir tablets, BE.EP.DR

Abstract

Darunavir is a protease inhibitor antiretroviral drug to HIV-1 widely used, the drug has activity even in cases of viral resistance to other antiretrovirals. Darunavir is a new drug and little studied. It is known that the drug presents polymorphism and its different polymorphic forms can convert between them depending on the climatic conditions of the environment. The dissolution rate of the different polymorphs has not been studied and there are no studies involving the dissolution or stability darunavir raw material or product. The purpose of this project is to study the behavior of darunavir under environmental conditions of a tropical country with regard to their physical and chemical stability, involving the stability of its polymorphic form. The aim is to develop discriminative dissolution method based on in vivo data from pharmacokinetic studies. This method will be used in evaluating the dissolution profile of darunavir product during stability studies, and evaluate differences in the dissolution rate of the polymorphic forms. The construction of a correlation between in vivo-in vitro will also be studied in order to provide a dissolution test can predict the in vivo darunavir and contribute to reducing the use of human volunteers in clinical trials, especially when the production of generic drugs is possible. Analytical methods are developed and validated including chromatographic and spectrophotometric method with mass detection and indication of stability and that will be used in the characterization of possible degradation products. This research is innovative and will contribute to the area of pharmaceutical sciences.

Academic Publications
(References retrieved automatically from State of São Paulo Research Institutions)
CORRÊA, Josilene Chaves Ruela. Estabilidade, polimorfismo, dissolução e correlação in vivo-in vitro de Darunavir comprimidos. 2014. Doctoral Thesis - Universidade Estadual Paulista "Júlio de Mesquita Filho" Faculdade de Ciencias Farmaceuticas..

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