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Claims for Patent: 8,501,228

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Claims for Patent: 8,501,228

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:13/620,141
Patent Claims: 1. A method for reducing the risk of developing ibuprofen-induced ulcers in a human patient requiring ibuprofen for an ibuprofen-responsive condition, said method comprising: administering to the human patient a first dose of famotidine, administering to the human patient a second dose of famotidine, and administering to the human patient a third dose of famotidine, and wherein for each administration, the famotidine is administered as a separate pharmaceutical composition in the form of a single tablet unit dosage form comprising: from 750 mg to 850 mg ibuprofen as an active pharmaceutical ingredient and from 24 mg to 28 mg famotidine as an active pharmaceutical ingredient, wherein the pharmaceutical composition is in the form of a bilayer tablet, wherein the ibuprofen active pharmaceutical ingredient is present in a first layer and the famotidine active pharmaceutical ingredient is present in a second layer, wherein the ibuprofen and famotidine are in direct physical contact, wherein at least one binder is present in the first layer and/or the second layer, wherein the pharmaceutical composition is formulated for immediate release, wherein none of the composition, the first layer, the second layer, the famotidine active pharmaceutical ingredient or the ibuprofen active pharmaceutical ingredient 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, 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 or at least 90% of the amount of ibuprofen initially present and at least 90% of the amount of famotidine initially present remains after the composition is stored at 40.degree. C. and 75% relative humidity for a period of one month, provided that the pharmaceutical composition is not a tablet-in-tablet formulation having a famotidine shell completely surrounding an ibuprofen core.

2. The method of claim 1, wherein said human patient is at elevated risk of developing ibuprofen-induced ulcers.

3. The method of claim 1, wherein the ibuprofen-responsive condition is chosen from rheumatoid arthritis and osteoarthritis.

4. The method 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.

5. The method 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 method 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. A method for reducing the risk of developing ibuprofen-induced ulcers in a human patient requiring ibuprofen for an ibuprofen-responsive condition, said method comprising: administering to the human patient a first dose of famotidine, administering to the human patient a second dose of famotidine, and administering to the human patient a third dose of famotidine, and wherein for each administration, the famotidine is administered as a separate pharmaceutical composition in the form of a single tablet unit dosage form comprising: from 750 mg to 850 mg ibuprofen as an active pharmaceutical ingredient, from 24 mg to 28 mg famotidine as an active pharmaceutical ingredient, and one or more pharmaceutically acceptable excipients, 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, 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 or at least 90% of the amount of ibuprofen initially present and at least 90% of the amount of famotidine initially present remains after the composition is stored at 40.degree. C. and 75% relative humidity for a period of one month, wherein the pharmaceutical composition is formulated for immediate release, wherein the composition is formulated so that release of both the ibuprofen active pharmaceutical ingredient and the famotidine active pharmaceutical ingredient occurs rapidly at about the same time, and wherein none of the composition, the famotidine active pharmaceutical ingredient, or the ibuprofen active pharmaceutical ingredient is enterically coated or formulated for sustained or delayed release, provided that the pharmaceutical composition is not a tablet-in-tablet formulation having a famotidine shell completely surrounding an ibuprofen core.

8. The method of claim 7, wherein the ibuprofen-responsive condition is chosen from rheumatoid arthritis and osteoarthritis.

9. The method of claim 7, 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.

10. The method of claim 1, wherein the first layer further comprises a disintegrant selected from the group consisting of starch derivatives, carboxymethylcellulose salts and crospovidone.

11. The method of claim 1, wherein the first layer further comprises a glidant selected from the group consisting of colloidal silicon dioxides, talc and corn starch.

12. The method of claim 1, wherein the first layer further comprises a binder selected from cellulose derivatives.

13. The method of claim 12, wherein the cellulose derivative is chosen from the group consisting of powdered cellulose, microcrystalline cellulose, silicified microcrystalline cellulose, hydroxypropylcellulose, low substituted hydroxypropylcellulose, hydroxypropylmethylcellulose and mixtures thereof.

14. The method of claim 1, wherein the second layer further comprises a glidant selected from the group consisting of colloidal silicon dioxides, talc and corn starch.

15. The method of claim 1, wherein the second layer further comprises a binder selected from cellulose derivatives.

16. The method of claim 15, wherein the cellulose derivative is chosen from the group consisting of powdered cellulose, microcrystalline cellulose, silicified microcrystalline cellulose, hydroxypropylcellulose, low substituted hydroxypropylcellulose, hydroxypropylmethylcellulose and mixtures thereof.

17. The method of claim 1, wherein the first layer further comprises a salt of carboxymethylcellulose, colloidal silicon dioxide, and microcrystalline cellulose.

18. The method of claim 1, wherein the second layer further comprises colloidal silicon dioxide and microcrystalline cellulose.

19. The method of claim 7, wherein said human patient is at elevated risk of developing ibuprofen-induced ulcers.

20. A method for reducing the risk of developing ibuprofen-induced ulcers in a human patient requiring ibuprofen for an ibuprofen-responsive condition, said method comprising: administering to the human patient a first dose of famotidine, administering to the human patient a second dose of famotidine, and administering to the human patient a third dose of famotidine, and wherein for each administration, the famotidine is administered as a separate pharmaceutical composition in the form of a single tablet unit dosage form comprising: a first layer comprising 800 mg ibuprofen as an active pharmaceutical ingredient, a carboxymethylcellulose salt, colloidal silicon dioxide, and microcrystalline cellulose, a second layer comprising 26.6 mg famotidine as an active pharmaceutical ingredient, colloidal silicon dioxide and microcrystalline cellulose, wherein the ibuprofen active pharmaceutical ingredient and the famotidine active pharmaceutical ingredient are in distinct compartments, wherein the ibuprofen and famotidine are in direct physical contact, 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 or at least 90% of the amount of ibuprofen initially present and at least 90% of the amount of famotidine initially present remains after the composition is stored at 40.degree. C. and 75% relative humidity for a period of one month, wherein the pharmaceutical composition is formulated for immediate release, wherein the composition is formulated so that release of both the ibuprofen active pharmaceutical ingredient and the famotidine active pharmaceutical ingredient occurs rapidly at about the same time, and wherein none of the composition, the famotidine active pharmaceutical ingredient, or the ibuprofen active pharmaceutical ingredient is enterically coated or formulated for sustained or delayed release, provided the pharmaceutical composition is not a tablet-in-tablet formulation having a famotidine shell completely surrounding an ibuprofen core.

21. The method of claim 20, wherein the pharmaceutical composition is in the form of a bilayer tablet.

22. The method of claim 1, wherein there is no barrier layer interposed between the first layer and second layer.
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