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Claims for Patent: 7,767,225

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Claims for Patent: 7,767,225

Title:Capsule formulation of pirfenidone and pharmaceutically acceptable excipients
Abstract: A capsule formulation of pirfenidone is provided that includes pharmaceutically acceptable excipients. In one embodiment, this capsule formulation is capable of sustaining desirable pharmacokinetic responses in a patient. Further provided are methods of treating fibrotic conditions and other cytokine-mediated disorders by administering pirfenidone capsules of such formulation to a patient in need.
Inventor(s): Radhakrishnan; Ramachandran (Fremont, CA), Vladyka; Ronald (Somerset, NJ), Sultzbaugh; Kenneth (Bridge Water, NJ)
Assignee: Intermune, Inc. (Brisbane, CA)
Application Number:12/426,182
Patent Claims: 1. A capsule comprising a pharmaceutical formulation of 5-methyl-1-phenyl-2-(1H)-pyridone, wherein said pharmaceutical formulation comprises 5-30% by weight of pharmaceutically acceptable excipients and 70-95% by weight of 5-methyl-1-phenyl-2-(1H)-pyridone, wherein said excipients comprise an effective amount of binder to increase the AUC of pirfenidone upon oral administration, as compared to a capsule comprising no excipients.

2. The capsule of claim 1, wherein said excipients further comprise one or more selected from the group consisting of disintegrators, fillers, and lubricants.

3. The capsule of claim 1, wherein said binders comprise one or more selected from the group consisting of microcrystalline cellulose, povidone, and a combination of povidone and microcrystalline cellulose.

4. The capsule of claim 2, wherein said disintegrator is 2-10% by weight of the capsule, said binder is 2-30% by weight of the capsule, said filler is 2-30% by weight of the capsule, and said lubricant is 0.3-0.8% by weight of the capsule.

5. The capsule of claim 3, wherein said binder comprises povidone.

6. The capsule of claim 5, wherein said povidone comprises at least about 1% by weight of the formulation.

7. The capsule of claim 1, comprising 100-400 mg 5-methyl-1-phenyl-2-(1H)-pyridone.

8. The capsule of claim 3, wherein said binder comprises microcrystalline cellulose.

9. The capsule of claim 1, wherein said formulation comprises a wet-granulated mixture comprising the 5-methyl-1-phenyl-2-(1H)-pyridone, said effective amount of binder to increase the AUC of pirfenidone upon oral administration, a filler, and a disintegrator.

10. The capsule of claim 6, wherein the povidone comprises about 1-4% by weight of the formulation.

11. A method for treating a fibrotic condition or inhibiting actions of cytokines, comprising administering the capsule of claim 1 to a patient suffering from said fibrotic condition or suffering from a disorder mediated by said cytokines.

12. The capsule of claim 1, wherein said effective amount of binder increases the AUC of pirfenidone upon oral administration at least 30%, as compared to a capsule comprising no excipients.

13. The capsule of claim 12, wherein said effective amount of binder increases the AUC of pirfenidone upon oral administration at least 40%, as compared to a capsule comprising no excipients.

14. The capsule of claim 13, wherein said effective amount of binder increases the AUC of pirfenidone upon oral administration at least 60%, as compared to a capsule comprising no excipients.

15. The capsule of claim 6, wherein said povidone comprises at least about 1.85% by weight of the formulation.

16. The capsule of claim 15, wherein the binder further comprises microcrystalline cellulose.

17. The capsule of claim 8, wherein the binder further comprises povidone.

18. The capsule of claim 10, wherein the binder further comprises microcrystalline cellulose.

19. The capsule of claim 18, wherein the total amount of binder is 2-30% by weight of the formulation.

20. The capsule of claim 2, wherein: the pharmaceutically excipients comprise a lubricant, a filler, and a disintegrator, the binder comprises microcrystalline cellulose and povidone, the povidone is included in an amount of 1-4% by weight of the formulation, the total amount of binder is 2-30% by weight of the formulation, and the formulation comprises a wet-granulated mixture comprising the 5-methyl-1-phenyl-2-(1H)-pyridone, the binder, the filler, and the disintegrator.
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