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Claims for Patent: 8,691,878

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Claims for Patent: 8,691,878

Title:Solid pharmaceutical dosage form
Abstract: A solid pharmaceutical dosage form providing improved oral bioavailability is disclosed for inhibitors of HIV protease. In particular, the dosage form comprises a solid dispersion of at least one HIV protease inhibitor and at least one pharmaceutically acceptable water-soluble polymer and at least one pharmaceutically acceptable surfactant, said pharmaceutically acceptable water-soluble polymer having a Tg of at least about 50.degree. C. Preferably, the pharmaceutically acceptable surfactant has an HLB value of from about 4 to about 10.
Inventor(s): Rosenberg; Jeorg (Ellerstadt, DE), Reinhold; Ulrich (Heidelberg, DE), Liepold; Bernd (Dossenheim, DE), Berndl; Gunther (Herxheim, DE), Breitenbach; Joerg (Mannheim, DE), Alani; Laman (Foster City, CA), Ghosh; Soumojeet (Lansdale, PA)
Assignee: AbbVie Inc. (North Chicago, IL)
Application Number:13/674,799
Patent Claims: 1. A method of treating HIV, comprising administering a solid pharmaceutical dosage form to a patient in need thereof, wherein the dosage form comprises ritonavir formulated in solid dispersion, and said solid dispersion comprises (1) a pharmaceutically acceptable surfactant having an HLB value of from 4 to 10, or a combination of pharmaceutically acceptable surfactants having an HLB value of from 4 to 10, and (2) a pharmaceutically acceptable water-soluble polymer having a Tg of at least 50.degree. C., or a combination of pharmaceutically acceptable water-soluble polymers having a Tg of at least 50.degree. C., and wherein the dosage form comprises from 50% to 85% by weight of the total dosage form of said water-soluble polymer or said combination of water-soluble polymers.

2. The method of claim 1, wherein said solid dispersion is glassy solution or solid solution.

3. The method of claim 2, wherein said solid dispersion comprises a copolymer of N-vinyl pyrrolidone and vinyl acetate.

4. The method of claim 3, wherein said solid dispersion comprises a sorbitan mono fatty acid ester.

5. The method of claim 2, wherein said solid dispersion comprises copovidone and sorbitan monolaurate.

6. The method of claim 2, wherein said surfactant or said combination of surfactants is present in an amount of from 2% to 20% by weight of the total dosage form.

7. The method of claim 2, wherein the dosage form comprises at least one additive selected from flow regulators, disintegrants, bulking agents or lubricants.

8. The method of claim 2, wherein the dosage from contains, upon storage for 6 weeks at 40.degree. C. and 75% humidity, at least 98% of the initial content of ritonavir.

9. The method of claim 2, wherein the dosage form has a dose-adjusted AUC, in dogs under non-fasting conditions, of ritonavir plasma concentration of at least 9 .mu.g h/ml/100 mg.

10. The method of claim 1, wherein the dosage form further comprises lopinavir formulated in solid dispersion.

11. The method of claim 2, wherein the dosage form further comprises lopinavir formulated in solid solution or glassy solution.

12. The method of claim 2, wherein the dosage form further comprises lopinavir formulated in solid solution or glassy solution which comprises (i) a pharmaceutically acceptable surfactant having an HLB value of from 4 to 10, or a combination of pharmaceutically acceptable surfactants having an HLB value of from 4 to 10, and (ii) a pharmaceutically acceptable water-soluble polymer having a Tg of at least 50.degree. C. or a combination of pharmaceutically acceptable water-soluble polymers having a Tg of at least 50.degree. C.

13. The method of claim 1, wherein said solid dispersion comprises said pharmaceutically acceptable surfactant and said pharmaceutically acceptable water-soluble polymer, and said pharmaceutically acceptable water-soluble polymer is present in an amount of from 50% to 85% by weight of the total dosage form.

14. The method of claim 2, wherein said solid dispersion comprises said pharmaceutically acceptable surfactant and said pharmaceutically acceptable water-soluble polymer, and said pharmaceutically acceptable water-soluble polymer is present in an amount of from 50% to 85% by weight of the total dosage form.

15. The method of claim 2, wherein the dosage form comprises a copolymer of N-vinyl pyrrolidone and vinyl acetate in an amount of from 50% to 85% by weight of the total dosage form.

16. The method of claim 15, wherein the dosage form comprises a sorbitan mono fatty acid ester in an amount of from 2% to 20% by weight of the total dosage form.

17. The method of claim 2, wherein the dosage form comprises copovidone in an amount of from 50% to 85% by weight of the total dosage form, and sorbitan monolaurate in an amount of from 2% to 20% by weight of the total dosage form.

18. The method of claim 17, wherein the dosage form further comprises lopinavir formulated in solid dispersion.

19. The method of claim 17, wherein the dosage form further comprises lopinavir formulated in solid solution or glassy solution.

20. The method of claim 17, wherein the dosage form further comprises lopinavir formulated in solid solution or glassy solution which comprises copovidone and sorbitan monolaurate.
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