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Claims for Patent: 8,449,910

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Claims for Patent: 8,449,910

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:13/620,150
Patent Claims: 1. A pharmaceutical composition 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 that is in direct contact with the first layer, 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, and 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, 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, and wherein the famotidine active pharmaceutical ingredient and the ibuprofen active pharmaceutical ingredient have a direct contact that does not exceed 130 mm.sup.2, provided that the pharmaceutical composition is not a tablet-in-tablet formulation having a famotidine shell completely surrounding an ibuprofen core.

2. 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.

3. 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.

4. 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.

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 six months.

6. 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.

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

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

9. The pharmaceutical composition of claim 1, wherein the first layer further comprises a binder selected from cellulose derivatives.

10. The pharmaceutical composition of claim 9, wherein the cellulose derivative is selected from the group consisting of powdered cellulose, microcrystalline cellulose, silicified microcrystalline cellulose, hydroxypropylcellulose, low substituted hydroxypropylcellulose, hydroxypropylmethylcellulose and mixtures thereof.

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

12. The pharmaceutical composition of claim 1, wherein the second layer component further comprises a binder selected from cellulose derivatives.

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

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

15. The pharmaceutical composition of claim 1, wherein the second layer further comprises colloidal silicon dioxide and microcrystalline cellulose.

16. A 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 ibuprofen active pharmaceutical ingredient is present in a first physical region and the famotidine active pharmaceutical ingredient is present in a second physical region that is in direct physical contact with the first physical region, wherein there is no barrier layer interposed between the first physical region and second physical region, 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 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, wherein the pharmaceutical composition is formulated for immediate release, 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, and wherein the famotidine active pharmaceutical ingredient and the ibuprofen active pharmaceutical ingredient have a direct contact that does not exceed 130 mm.sup.2, provided that if the pharmaceutical composition is a tablet-in-tablet formulation, the second physical region is completely surrounded by the first physical region.

17. The pharmaceutical composition of claim 16, 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.

18. The pharmaceutical composition of claim 16, 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.

19. The pharmaceutical composition of claim 16, 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.

20. The pharmaceutical composition of claim 16, 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.

21. The pharmaceutical composition of claim 16, 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.

22. A 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 first layer is in direct contact with the second layer, 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 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, wherein the pharmaceutical composition is formulated for immediate release, 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, and wherein the famotidine active pharmaceutical ingredient and the ibuprofen active pharmaceutical ingredient have a direct contact that does not exceed 130 mm.sup.2, provided that the pharmaceutical composition is not a tablet-in-tablet formulation having a famotidine shell completely surrounding an ibuprofen core.

23. The pharmaceutical composition of claim 22, wherein the pharmaceutical composition is in the form of a bilayer tablet.

24. A 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 ibuprofen active pharmaceutical ingredient and the famotidine active pharmaceutical ingredient are in distinct compartments, wherein the distinct compartments are in direct contact, wherein 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 or 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, 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, wherein the pharmaceutical composition is formulated for immediate release, 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, and wherein the famotidine active pharmaceutical ingredient and the ibuprofen active pharmaceutical ingredient have a direct contact that does not exceed 130 mm.sup.2, provided that the pharmaceutical composition is not a tablet-in-tablet formulation having a famotidine shell completely surrounding an ibuprofen core.

25. The pharmaceutical composition of claim 24, wherein at least 95% of the amount of ibuprofen initially present remains after the composition is stored at 40.degree. C. and 75% relative humidity for a period of one month.

26. The pharmaceutical composition of claim 24, wherein at least 95% 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.

27. The pharmaceutical composition of claim 1, wherein there is no barrier layer interposed between the first layer and second layer.
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