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|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 (Portola Valley, CA)|
|Assignee:||Horizon Pharma USA, Inc. (Northbrook, IL)|
1. A pharmaceutical composition comprising a first portion that comprises 800 mg ibuprofen and a second portion that comprises 26.6 mg famotidine, wherein the surface area of
direct physical contact between ibuprofen and famotidine does not exceed 130 mm.sup.2, wherein no more than about 1% 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 and the famotidine occurs rapidly at about the same time, wherein none of the composition, the famotidine, and the ibuprofen is enterically coated or formulated for sustained or delayed
release, and wherein the composition is for use according to a TID (three times per day) administration schedule for reducing the risk of developing ibuprofen-induced ulcers in a human patient requiring ibuprofen for an ibuprofen-responsive condition.
2. The composition of claim 1 wherein the second portion is not in direct physical contact with the first portion.
3. The composition of claim 1 wherein the second portion comprises a layer of famotidine beads.
4. The composition of claim 3 wherein each of said famotidine beads is coated with a barrier layer.
5. The composition of claim 1 wherein the second portion comprises a famotidine core and the first portion comprises an ibuprofen shell that completely surrounds the second portion with a barrier layer interposed between the first and second compartments.
6. The composition of claim 5 wherein the core is substantially spherical in shape.
7. The composition of claim 5 wherein the core is substantially cylindrical in shape.
8. The composition of claim 1 wherein the second portion comprises a layer of famotidine and the first portion comprises a layer of ibuprofen and the two layers are separated by a barrier layer.
9. The composition of any one of claims 4, 5, and 8 wherein the barrier layer has a thickness ranging from 20 to 3,000 microns.
10. The composition of claim 9 wherein the barrier layer has a thickness ranging from about 25 to 250 microns.
11. The composition of claim 1 wherein the composition is formulated so that at least about 80% of the famotidine and at least about 80% of the ibuprofen are released from the composition into solution within 30 minutes at a pH of about 6.8 to about 7.4.
12. The composition of claim 1 wherein the release of famotidine from the composition begins within 5 minutes of the beginning of release of the ibuprofen from the composition.
13. The composition of claim 1 wherein at least 95% of the ibuprofen and the famotidine are each present when the composition is stored under room temperature storage conditions of 25.degree. C. and 60% relative humidity for a period of nine months.
14. The composition of claim 1 wherein at least 98% of the ibuprofen and the famotidine are each present when the composition is stored under room temperature storage conditions of 25.degree. C. and 60% relative humidity for a period of nine months.
15. The composition of claim 1 wherein the first portion completely surrounds the second portion.
16. The composition of claim 1 wherein the famotidine is not present as famotidine beads dispersed in an ibuprofen matrix.
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