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Generated: August 18, 2017

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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.
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Serving 500+ biopharmaceutical companies globally:

Federal Trade Commission
Express Scripts
Moodys
Boehringer Ingelheim
QuintilesIMS
McKinsey
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