Details for Patent: 8,871,271

Title:	Method and composition for pharmaceutical product
Abstract:	This invention is directed to a composition comprising dry granulated tenofovir DF and emtricitabine, and a method for making same. Dry granulation was unexpectedly found to be important in preparing a tenofovir DF containing composition suitable for inclusion in a combination dosage form containing emtricitabine, efavirenz and tenofovir DF.
Inventor(s):	Dahl; Terrence C. (Sunnyvale, CA), Menning; Mark M. (San Francisco, CA), Oliyai; Reza (Burlingame, CA), Yang; Taiyin (Monte Sereno, CA)
Assignee:	Gilead Sciences, Inc. (Foster City, CA)
Filing Date:	Jul 29, 2013
Application Number:	13/953,577
Claims:	1. A method comprising granulating a composition comprising emtricitabine and tenofovir DF without contacting the composition with a destabilizing amount of liquid water. 2. The method of claim 1 wherein liquid water is not combined with the composition prior to or during granulation. 3. The method of claim 1 wherein the composition further comprises at least one pharmaceutically acceptable excipient. 4. The method of claim 1 wherein granulation comprises aggregating the composition and comminuting it to desired dimensions. 5. The method of claim 4 wherein the aggregation is accomplished by slugging or roller compaction. 6. The method of claim 4 wherein the composition is sieved to recover granules of the desired dimensions. 7. The method of claim 6 wherein the granules are retained by a 1.25 mm mesh. 8. The method of claim 3 wherein the excipient is a lubricant. 9. The method of claim 8 wherein the lubricant is an alkali metal salt of a C8-C18 fatty acid.