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Claims for Patent: 8,598,185

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Claims for Patent: 8,598,185

Title:Unitary pharmaceutical dosage form
Abstract: In accordance with this invention a novel pharmaceutical product containing efavirenz, emtricitabine and tenofovir DF are provided as a multicomponent unitary oral dosage form, component 1 comprising tenofovir DF (and, optionally, emtricitabine) and component 2 comprising efavirenz, wherein components 1 and 2 are in a stabilizing configuration. In preferred embodiments component 1 is made by dry granulation.
Inventor(s): Dahl; Terrence C. (Sunnyvale, CA), Hussain; Munir A. (Belle Mead, NJ), Lipper; Robert A. (Pennington, NJ), Jerzewski; Robert L. (Belle Mead, NJ), Menning; Mark M. (San Francisco, CA), Oliyai; Reza (San Carlos, CA), Yang; Taiyin (Saratoga, CA)
Assignee: Bristol-Myers Squibb & Gilead Sciences, Inc. (Foster City, CA)
Application Number:11/453,122
Patent Claims: 1. A unitary dosage form comprising tenofovir DF in a first compartment and a surfactant and efavirenz in a second compartment, wherein the first and second compartments are physically discrete but associated with and in physical contact with one another, and further comprising emtricitabine.

2. The unitary dosage form of claim 1 wherein the compartments are layers.

3. The unitary dosage form of claim 2 which is suitable for oral administration.

4. The unitary dosage form of claim 2 which is a bilayer tablet weighing less than about 2.5 grams.

5. The unitary dosage form of claim 1 wherein the second compartment is produced by high shear wet granulation.

6. The unitary dosage form of claim 1 wherein the surfactant is sodium lauryl sulfate.

7. The unitary dosage form of claim 1 wherein the first compartment is produced by dry granulation.

8. The unitary dosage form of claim 1 wherein the total amount of efavirenz, emtricitabine and tenofovir DF is greater than about 60% by weight of the unitary dosage form.

9. The unitary dosage form of claim 1 which further comprises magnesium stearate, croscarmellose sodium, microcrystalline cellulose and hydroxypropyl cellulose.

10. The unitary dosage form of claim 9 wherein the approximate percentages by weight of efavirenz, tenofovir DF, emtricitabine, magnesium stearate, croscarmellose sodium, microcrystalline cellulose, sodium lauryl sulfate, and hydroxypropyl cellulose are, respectively, about 39, about 19, about 13, about 2, about 7, about 17, about 1 and about 2.

11. The unitary dosage form of claim 3 wherein efavirenz, emtricitabine and tenofovir DF are provided to a patient upon oral administration at substantially the same AUC and Cmax as the FDA approved products Truvada and Sustiva.

12. The unitary dosage form of claim 4 which weighs about from 1200 mg to 2300 mg (including any film coating that is optionally present).

13. The unitary dosage form of claim 4 wherein the layers are oriented horizontally along an axis of the tablet.

14. A container comprising the unitary dosage form of claim 1 and a desiccant.
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