Development of in vitro in vivo correlation for Darunavir tablets

• Grant number: 12/18836-5
• Support Opportunities: Scholarships abroad - Research Internship - Doctorate
• Start date: March 01, 2013
• End date: June 30, 2013
• Field of knowledge: Health Sciences - Pharmacy
• Principal Investigator: Hérida Regina Nunes Salgado
• Grantee: Josilene Chaves Ruela Corrêa
• Supervisor: Hartmut Derendorf
• Host Institution: Faculdade de Ciências Farmacêuticas (FCFAR). Universidade Estadual Paulista (UNESP). Campus de Araraquara. Araraquara , SP, Brazil
• Institution abroad: University of Florida, Gainesville (UF), United States
• Associated to the scholarship: 11/05836-4 - Stability, polymorphism, dissolution and in vivo-in vitro correlation for darunavir tablets, BP.DR

Abstract

Darunavir is an antiretroviral drug, protease inhibitor of HIV-1 widely used. This drug has activity even in cases of viral resistance to other antiretroviral drugs. Darunavir is a new drug and little studied. There are no dissolution studies to darunavir raw material or finished product. Thus, we intend to develop discriminating dissolution method based on data from in vivo pharmacokinetic studies that will be used in evaluating the dissolution profile of darunavir product. The construction of a correlation in vivo-in vitro will also be studied in order to provide dissolution test predictive of in vivo behavior of darunavir and contribute to reducing the use of human volunteers in trials, especially when the production of generic drugs will be possible . This research is very innovative, has the partnership of researchers from different national and international institutions and will contribute to the field of pharmaceutical sciences in Brazil. (AU)