(178f) Formulation and Process Development of Atripla® Tablets

ATRIPLA® (efavirenz, 600 mg, emtricitabine, 200 mg and tenofovir disoproxil fumarate, 300 mg) is a fixed-dose combination of Sustiva® (efavirenz), Emtriva® (emtricitabine), and Viread® (tenofovir disoproxil fumarate). ATRIPLA is the first single tablet, dosed once daily for the treatment of HIV-1 infection in adults. This presentation will provide a perspective on the challenges associated with the formulation and process development of ATRIPLA tablets under an aggressive timeline. The main points of discussion will be: importance of active ingredient physicochemical properties, selection of formulation composition, manufacturing process and dosage form, and process optimization and scale-up.