Claims for Patent: 8,318,202

Summary for Patent: 8,318,202

Title:	Stable compositions of famotidine and ibuprofen
Abstract:	Stable pharmaceutical compositions of famotidine and ibuprofen in a single unit dosage form are disclosed herein. The compositions comprise a famotidine core having a reduced or minimal surface area surrounded by a layer of ibuprofen. In some embodiments, the ibuprofen is in direct physical contact with the famotidine.
Inventor(s):	Xu; Jerry (Hunt Valley, MD), Tidmarsh; George F. (Portola Valley, CA)
Assignee:	Horizon Pharma USA, Inc. (Deerfield, IL)
Application Number:	13/403,930
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,318,202
Patent Claims:	1. A pharmaceutical composition comprising: a first layer comprising from 750 mg to 850 mg ibuprofen as an active pharmaceutical ingredient and at least one excipient, and a second layer comprising from 24 mg to 28 mg famotidine as an active pharmaceutical ingredient and at least one excipient, wherein the active pharmaceutical ingredients are in direct contact, wherein the pharmaceutical composition is in the form of a tablet, provided that if the pharmaceutical composition is a tablet-in-tablet formulation, the first layer completely surrounds the second layer, wherein the pharmaceutical composition is formulated for immediate release, and wherein none of the pharmaceutical composition, the first layer, the second layer, the famotidine, or the ibuprofen is enterically coated or formulated for sustained or delayed release, wherein the pharmaceutical composition is formulated so that release of the ibuprofen active pharmaceutical ingredient and the famotidine active pharmaceutical ingredient begins to occur at about the same time, wherein the famotidine is not present as barrier coated famotidine multiparticulates dispersed in an ibuprofen matrix, and wherein no more than about 1% of a sulfamide is present when the composition is stored at 40.degree. C. and 75% relative humidity for a period of one month. 2. The pharmaceutical composition of claim 1, wherein the composition comprises 800 mg ibuprofen and 26.6 mg famotidine. 3. The pharmaceutical composition of claim 1, wherein no more than about 1% of a sulfamide is present when the composition is stored at 40.degree. C. and 75% relative humidity for a period of three months. 4. The pharmaceutical composition of claim 1, wherein no more than about 1% of a sulfamide is present when the composition is stored at 40.degree. C. and 75% relative humidity for a period of six months. 5. The pharmaceutical composition of claim 1, wherein no more than about 0.6% of a sulfamide is present when the composition is stored at 40.degree. C. and 75% relative humidity for a period of one month. 6. The pharmaceutical composition of claim 1, wherein no more than about 0.6% of a sulfamide is present when the composition is stored at 40.degree. C. and 75% relative humidity for a period of three months. 7. The pharmaceutical composition of claim 1, wherein no more than about 0.6% of a sulfamide is present when the composition is stored at 40.degree. C. and 75% relative humidity for a period of six months. 8. The pharmaceutical composition of claim 1, wherein the composition is a tablet-in-tablet formulation wherein the first layer completely surrounds the second layer. 9. The pharmaceutical composition of claim 1, wherein the composition is a bilayer tablet. 10. A pharmaceutical composition comprising: a first layer comprising from 750 mg to 850 mg ibuprofen as an active pharmaceutical ingredient and at least one excipient, and a second layer comprising from 24 mg to 28 mg famotidine as an active pharmaceutical ingredient and at least one excipient, wherein the active pharmaceutical ingredients are in direct contact, wherein the pharmaceutical composition is in the form of a tablet, provided that if the pharmaceutical composition is a tablet-in-tablet formulation, the first layer completely surrounds the second layer, wherein the pharmaceutical composition is formulated for immediate release, and wherein none of the pharmaceutical composition, the first layer, the second layer, the famotidine, or the ibuprofen is enterically coated or formulated for sustained or delayed release, wherein the pharmaceutical composition is formulated so that release of the ibuprofen active pharmaceutical ingredient and the famotidine active pharmaceutical ingredient begins to occur at about the same time, wherein the famotidine is not present as barrier coated famotidine multiparticulates dispersed in an ibuprofen matrix, and wherein no more than about 1% of a sulfamide is present when the composition is stored at room temperature for a period of three months. 11. The pharmaceutical composition of claim 10, wherein the composition comprises 800 mg ibuprofen and 26.6 mg famotidine. 12. The pharmaceutical composition of claim 10, wherein no more than about 1% of a sulfamide is present when the composition is stored at room temperature for a period of six months. 13. The pharmaceutical composition of claim 10, wherein no more than about 1% of a sulfamide is present when the composition is stored at room temperature for a period of nine months. 14. The pharmaceutical composition of claim 10, wherein no more than about 1% of a sulfamide is present when the composition is stored at room temperature for a period of 12 months. 15. The pharmaceutical composition of claim 10, wherein no more than about 1% of a sulfamide is present when the composition is stored at room temperature for a period of 18 months. 16. The pharmaceutical composition of claim 10, wherein no more than about 1% of a sulfamide is present when the composition is stored at room temperature for a period of 24 months. 17. The pharmaceutical composition of claim 10, wherein no more than about 1% of a sulfamide is present when the composition is stored at room temperature for a period of 36 months. 18. The pharmaceutical composition of claim 10, wherein no more than about 0.6% of a sulfamide is present when the composition is stored at room temperature for a period of three months. 19. The pharmaceutical composition of claim 10, wherein no more than about 0.6% of a sulfamide is present when the composition is stored at room temperature for a period of six months. 20. The pharmaceutical composition of claim 10, wherein no more than about 0.6% of a sulfamide is present when the composition is stored at room temperature for a period of nine months. 21. The pharmaceutical composition of claim 10, wherein no more than about 0.6% of a sulfamide is present when the composition is stored at room temperature for a period of 12 months. 22. The pharmaceutical composition of claim 10, wherein no more than about 0.6% of a sulfamide is present when the composition is stored at room temperature for a period of 18 months. 23. The pharmaceutical composition of claim 10, wherein no more than about 0.6% of a sulfamide is present when the composition is stored at room temperature for a period of 24 months. 24. The pharmaceutical composition of claim 10, wherein no more than about 0.6% of a sulfamide is present when the composition is stored at room temperature for a period of 36 months. 25. The pharmaceutical composition of claim 10, wherein the composition is a tablet-in-tablet formulation wherein the first layer completely surrounds the second layer. 26. The pharmaceutical composition of claim 10, wherein the composition is a bilayer tablet. 27. A pharmaceutical composition comprising: a first layer comprising from 750 mg to 850 mg ibuprofen as an active pharmaceutical ingredient and at least one excipient, and a second layer comprising from 24 mg to 28 mg famotidine as an active pharmaceutical ingredient and at least one excipient, wherein the pharmaceutical composition is in the form of a tablet, provided that if the pharmaceutical composition is a tablet-in-tablet formulation, the first layer completely surrounds the second layer, wherein the pharmaceutical composition is formulated for immediate release, and wherein none of the pharmaceutical composition, the first layer, the second layer, the famotidine, or the ibuprofen is enterically coated or formulated for sustained or delayed release, wherein the pharmaceutical composition is formulated so that release of the ibuprofen active pharmaceutical ingredient and the famotidine active pharmaceutical ingredient begins to occur at about the same time, wherein the famotidine is not present as barrier coated famotidine multiparticulates dispersed in an ibuprofen matrix, wherein the famotidine active pharmaceutical ingredient and the ibuprofen active pharmaceutical ingredient have a surface area of direct physical contact that does not exceed 130 mm.sup.2, and wherein no more than about 1% of a sulfamide is present when the composition is stored at 40.degree. C. and 75% relative humidity for a period of one month. 28. The pharmaceutical composition of claim 27, wherein the composition comprises 800 mg ibuprofen and 26.6 mg famotidine. 29. The pharmaceutical composition of claim 27, wherein no more than about 1% of a sulfamide is present when the composition is stored at room temperature for a period of six months. 30. The pharmaceutical composition of claim 27, wherein no more than about 1% of a sulfamide is present when the composition is stored at room temperature for a period of nine months. 31. The pharmaceutical composition of claim 27, wherein no more than about 1% of a sulfamide is present when the composition is stored at room temperature for a period of 12 months. 32. The pharmaceutical composition of claim 27, wherein no more than about 1% of a sulfamide is present when the composition is stored at room temperature for a period of 18 months. 33. The pharmaceutical composition of claim 27, wherein no more than about 1% of a sulfamide is present when the composition is stored at room temperature for a period of 24 months. 34. The pharmaceutical composition of claim 27, wherein no more than about 1% of a sulfamide is present when the composition is stored at room temperature for a period of 36 months. 35. The pharmaceutical composition of claim 27, wherein no more than about 0.6% of a sulfamide is present when the composition is stored at room temperature for a period of three months. 36. The pharmaceutical composition of claim 27, wherein no more than about 0.6% of a sulfamide is present when the composition is stored at room temperature for a period of six months. 37. The pharmaceutical composition of claim 27, wherein no more than about 0.6% of a sulfamide is present when the composition is stored at room temperature for a period of nine months. 38. The pharmaceutical composition of claim 27, wherein no more than about 0.6% of a sulfamide is present when the composition is stored at room temperature for a period of 12 months. 39. The pharmaceutical composition of claim 27, wherein no more than about 0.6% of a sulfamide is present when the composition is stored at room temperature for a period of 18 months. 40. The pharmaceutical composition of claim 27, wherein no more than about 0.6% of a sulfamide is present when the composition is stored at room temperature for a period of 24 months. 41. The pharmaceutical composition of claim 27, wherein no more than about 0.6% of a sulfamide is present when the composition is stored at room temperature for a period of 36 months. 42. The pharmaceutical composition of claim 27, wherein the composition is a tablet-in-tablet formulation wherein the first layer completely surrounds the second layer. 43. The pharmaceutical composition of claim 27, wherein the composition is a bilayer tablet.