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Claims for Patent: 8,309,613

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Claims for Patent: 8,309,613

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; Joerg (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:12/880,781
Patent Claims: 1. A method of treating an HIV infection comprising administering a solid pharmaceutical dosage form to a mammal in need of such treatment, wherein the dosage form comprises: ritonavir and lopinavir formulated in solid dispersion; a copolymer of N-vinyl pyrrolidone and vinyl acetate; and a sorbitan fatty acid ester having a HLB value of from 4 to 10.

2. The method of claim 1, wherein said ritonavir and lopinavir are present in an amount from 5% to 30% by weight of the dosage form, said copolymer of N-vinyl pyrrolidone and vinyl acetate is present from 50% to 85% by weight of the dosage form; and said sorbitan fatty acid ester is present from 2% to 20% by weight of the dosage form.

3. The method of claim 1, wherein said ritonavir and lopinavir are formulated in a solid dispersion which comprises said copolymer of N-vinyl pyrrolidone and vinyl acetate and said sorbitan fatty acid ester.

4. The method of claim 3, wherein said copolymer of N-vinyl pyrrolidone and vinyl acetate is copovidone, and said sorbitan fatty acid ester is sorbitan monolaurate.

5. The method of claim 1, wherein said ritonavir and lopinavir are formulated in a solid or glassy solution which comprises said copolymer of N-vinyl pyrrolidone and vinyl acetate and said sorbitan fatty acid ester.

6. The method of claim 5, wherein said copolymer of N-vinyl pyrrolidone and vinyl acetate is copovidone, and said sorbitan fatty acid ester is sorbitan monolaurate.

7. The method of claim 1, wherein said dosage form comprises at least one additive selected from flow regulators, disintegrants, bulking agents or lubricants.

8. A method of treating an HIV infection comprising administering a solid pharmaceutical dosage form to a patient in need of such treatment, wherein the dosage form comprises a solid dispersion which comprises: ritonavir, and lopinavir, a pharmaceutically acceptable surfactant having an HLB value of from 4 to 10, and a pharmaceutically acceptable water-soluble polymer having a Tg of at least 50.degree. C.

9. The method of claim 8, wherein said solid dispersion is a glassy or solid solution.

10. The method of claim 9, wherein said water-soluble polymer is a copolymer of N-vinyl pyrrolidone and vinyl acetate, and said surfactant is a sorbitan mono fatty acid ester.

11. The method of claim 9, wherein said water-soluble polymer is copovidone, and said surfactant is sorbitan monolaurate.

12. The method of claim 11, wherein said water-soluble polymer is present in an amount of from 50% to 85% by weight of the dosage form, and said surfactant is present in an amount of from 2% to 20% by weight of the dosage form.

13. The method of claim 12, wherein said ritonavir and lopinavir are present in an amount of from 5% or 30% by weight of the dosage form.

14. The method of claim 8, wherein said dosage form comprises at least one additive selected from flow regulators, disintegrants, bulking agents or lubricants.

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

16. The method of claim 8, 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, and a dose-adjusted AUC, in dogs under non-fasting conditions, of lopinavir plasma concentration of at least 20 .mu.g h/ml/100 mg.

17. A method of treating an HIV infection comprising administering a solid pharmaceutical dosage form to a patient in need of such treatment, wherein the dosage form comprises a solid dispersion which comprises: ritonavir and lopinavir; a pharmaceutically acceptable surfactant which has an HLB value of from 4 to 10, or a combination of pharmaceutically acceptable surfactants which has an HLB value of from 4 to 10; and 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.

18. The method of claim 17, wherein said solid dispersion is a solid solution or a glassy solution.
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