Claims for Patent: 7,538,094

Summary for Patent: 7,538,094

Title:	Composition containing ribavirin and use thereof
Abstract:	Ribavirin formulations are disclosed for use in capsules or tablets as well as processes for their preparation and methods for their administration.
Inventor(s):	Kerrish; Donald J. (Wexford, PA), Bergeron; John R. (Middletown, MD), Augsburger; Larry L. (Severna Park, MD)
Assignee:	Three Rivers Pharmacueticals, LLC (Cranberry Township, PA)
Application Number:	10/882,358
Patent Claims:	1. A process of forming ribavirin particles, the process comprising: mixing ribavirin with at least one excipient to form a mixture; adding water to the mixture in an amount of from about 15 wt % to about 80 wt % based on the total weight of the mixture to form a wet granulated mixture; and drying the wet granulated mixture to form ribavirin containing particles. 2. The process according to claim 1, wherein the water is added at a rate of about 2 kg per minute to about 50 kg per minute. 3. The process according to claim 1, wherein said drying step comprises heating the wet granulated mixture to a temperature ranging from about 35.degree. C. to about 45.degree. C., until the particles contain a moisture content ranging from 0.5% to 5.0%. 4. The process according to claim 1 further comprising filling a plurality of capsules with the ribavirin containing particles wherein the plurality of capsules have a weight variability of within +/-8% and a ribavirin content with a standard deviation of less than about 4%. 5. The process of claim 1, further comprising spheronizing the wet granulated mixture prior to the drying step. 6. The process of claim 1, comprising mixing ribavirin with two or more excipients to form the mixture. 7. The process of claim 1, wherein the amount of water added to the ribavirin mixture is between about 50 wt % to about 80 wt % based upon the dry ingredients. 8. The process of claim 1, further comprising forming a dosage form from the ribavirin containing particles. 9. The process of claim 1, further comprising forming tablets from the ribavirin containing particles. 10. The process of claim 8, wherein the dosage form contains up to 1200 mg of ribavirin. 11. The process of claim 8, wherein the dosage form contains 400 mg to 600 mg of ribavirin. 12. The process of claim 1, further comprising filling a plurality of capsules with the ribavirin containing particles. 13. A process for preparing a ribavirin composition, the process comprising: mixing ribavirin with at least two excipients to form a mixture; adding water to the mixture in an amount of from about 15 wt % to about 80 wt % based on the total weight of the mixture to form a wet mixture; and forming a free flowing ribavirin composition from the wet mixture, wherein the composition has an angle of repose of no higher than about 35 degrees. 14. A process for preparing a free flowing granular ribavirin composition, the process comprising: wet granulating a ribivirin mixture by adding water in an amount of from about 50 wt % or more based on the weight of the mixture and drying the ribavirin mixture to form a free flowing ribavirin composition, wherein the ribavirin composition has an angle of repose no higher than about 35 degrees. 15. The process according to claim 13 wherein forming the free flowing ribavirin composition comprises spheronizing and drying the wet mixture. 16. The process according to claim 13 wherein forming the free flowing ribavirin composition comprises drying and milling the wet mixture. 17. The process according to claim 16 further comprising adding croscarmellose sodium and magnesium stearate to the dried, milled ribavirin composition. 18. The process according to claim 14 further comprising extruding and spheronizing the ribavirin mixture prior to drying the mixture. 19. The process according to claim 14 wherein the ribavirin composition has an angle of repose no higher than about 30 degrees. 20. The process of claim 1, wherein the mixture contains at least about 70% by weight of ribavirin. 21. The process according to claim 1 wherein ribavirin is mixed with at least one filler and at least one binder to form the mixture. 22. The process of claim 21, wherein the filler is selected from the group consisting of: lactose monohydrate and microcrystalline cellulose. 23. The process according to claim 1 wherein ribavirin is mixed with at least one filler, at least one disintegrant, and at least one binder to form the mixture. 24. The process of claim 1 wherein the mixing step comprises mixing at least about 70 wt % ribavirin with about 5-25 wt % microcrystalline cellulose, about 1-10 wt % croscarmellose, about 0.5-5 wt % povidone, about 1-15 wt % lactose, or the pharmaceutically acceptable salts or hydrates thereof to form the mixture. 25. The process according to claim 6 further comprising milling the dried ribavirin mixture to form the ribavirin containing particles. 26. The process according to claim 25 further comprising adding a disintegrant and a lubricant to the dried, milled ribavirin containing particles.

Details for Patent 7,538,094

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Hoffmann-la Roche Inc.	PEGASYS COPEGUS COMBINATION PACK	peginterferon alfa-2a and ribavirin		125083	June 04, 2004	7,538,094	2024-07-02
Schering Corporation A Subsidiary Of Merck & Co., Inc.	PEGINTRON/ REBETOL COMBO PACK	peginterferon alfa-2b and ribavirin		125196	June 13, 2008	7,538,094	2024-07-02