- 5:05 PM

Formulation and Process Development of AtriplaŽ Tablets

Mark Menning, Gilead Sciences, Inc., 333 Lakeside Dr., Foster City, CA 94404

ATRIPLAŽ (efavirenz, 600 mg, emtricitabine, 200 mg and tenofovir disoproxil fumarate, 300 mg) is a fixed-dose combination of SustivaŽ (efavirenz), EmtrivaŽ (emtricitabine), and VireadŽ (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.