|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|
|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.