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Claims for Patent: 8,067,451

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Claims for Patent: 8,067,451

Title:Methods and medicaments for administration of ibuprofen
Abstract: A method for administration of ibuprofen to a subject in need of ibuprofen treatment is provided, in which an oral dosage form comprising a therapeutically effective amount of ibuprofen and a therapeutically effective amount of famotidine is administered three times per day.
Inventor(s): Tidmarsh; George (Portola Valley, CA), Golombik; Barry L. (Incline Village, NV), Sharma; Puneet (Gaithersburg, MD)
Assignee: Horizon Pharma USA, Inc. (Northbrook, IL)
Application Number:11/779,204
Patent Claims: 1. An oral dosage in tablet form comprising a first portion that comprises 800 mg ibuprofen and a second portion that comprises 26.6 mg famotidine, wherein a barrier layer comprising hydroxyl propyl methyl cellulose 2910, polyoxyethylene glycol 400, polysorbate 80, and titanium dioxide surrounds the second portion completely separating it from the first portion, wherein upon storage of the oral dosage in tablet form at 40.degree. C. and 75% humidity for one month, no more than about 0.5% total famotidine impurities is present in the oral dosage in tablet form; wherein the oral dosage in tablet form is formulated so that release of both the ibuprofen and the famotidine occurs rapidly at about the same time, wherein none of the oral dosage in tablet form, the famotidine, and the ibuprofen is enterically coated or formulated for sustained or delayed release, wherein the oral dosage in tablet form 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 selected from the group consisting of rheumatoid arthritis, osteoarthritis, and pain from a condition other than rheumatoid arthritis and osteoarthritis wherein the human patient does not suffer at the times of administering from a condition characterized by hypersecretion of gastric acid and/or from active severe oesophagitis and/or Barrett's ulceration, and/or from gastroesophageal reflux disease.

2. The oral dosage in tablet form of claim 1, wherein the oral dosage in tablet form is packaged with instructions to administer the oral dosage in tablet form 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 selected from the group consisting of rheumatoid arthritis, osteoarthritis, and pain from a condition other than rheumatoid arthritis and osteoarthritis.

3. The oral dosage in tablet form of claim 1, wherein the oral dosage in tablet form releases at least 60% of the ibuprofen and at least 60% of the famotidine within 20 minutes at a pH of 6.8 to 7.4 under in vitro assay conditions.

4. The oral dosage in tablet form of claim 3, wherein the oral dosage in tablet form releases at least 75% of the ibuprofen and at least 75% of the famotidine within 20 minutes at a pH of 6.8 to 7.4 under in vitro assay conditions.

5. The oral dosage in tablet form of claim 1, wherein the second portion further comprises microcrystalline cellulose.

6. The oral dosage in tablet form of claim 1, wherein the oral dosage in tablet form is prepared by a process comprising: blending 800 mg ibuprofen with at least one pharmaceutically acceptable excipient to yield the first portion; blending 26.6 mg famotidine with at least one pharmaceutically acceptable excipient to yield the second portion; coating said second portion with a barrier layer comprising hydroxyl propyl methyl cellulose 2910, polyoxyethylene glycol 400, polysorbate 80, and titanium dioxide to form a barrier layer-encased second portion; combining said first portion and said barrier layer-encased coated second portion to yield a combined first and second portion wherein the first and second portions are separated by the barrier layer; and compressing said combined first and second portion to yield the oral dosage in tablet form.

7. The oral dosage in tablet form of claim 6, wherein the second portion further comprises microcrystalline cellulose.

8. A method for reducing the risk of developing ibuprofen-induced ulcers in a human patient requiring ibuprofen for an ibuprofen-responsive condition selected from the group consisting of rheumatoid arthritis, osteoarthritis, and pain from a condition other than rheumatoid arthritis and osteoarthritis, said human patient being at risk of developing ibuprofen-induced ulcers, said method consisting essentially of: administering to the human patient a first dose of an oral dosage in tablet form of claim 1, administering to the human patient a second dose of the oral dosage in tablet form; and administering to the human patient a third dose of the oral dosage in tablet form, wherein the first, second, and third doses are administered according to a TID (three times per day administration) schedule in a total daily dose of famotidine of about 80 mg, effective for reducing the risk of said human patient developing ibuprofen-induced ulcers, and also for reducing a symptom for which ibuprofen was required, and further wherein the human patient does not suffer at the times of administering from a condition characterized by hypersecretion of gastric acid and/or from active severe oesophagitis and/or Barrett's ulceration, and/or from gastroesophageal reflux disease.

9. The oral dosage in tablet form of claim 1, wherein the only active ingredient for decreasing gastric acid secretion or neutralizing gastric acid in said oral dosage in tablet form is famotidine.

10. An oral dosage in tablet form consisting essentially of: a first portion that comprises 800 mg ibuprofen and a second portion that comprises 26.6 mg famotidine, wherein a barrier layer comprising hydroxyl propyl methyl cellulose 2910, polyoxyethylene glycol 400, polysorbate 80, and titanium dioxide surrounds the second portion completely separating it from the first portion, wherein upon storage of the oral dosage in tablet form at 40.degree. C. and 75% humidity for one month, no more than about 0.5% total famotidine impurities is present in the oral dosage in tablet form; wherein the oral dosage in tablet form is formulated so that release of both the ibuprofen and the famotidine occurs rapidly at about the same time, wherein none of the oral dosage in tablet form, the famotidine, and the ibuprofen is enterically coated or formulated for sustained or delayed release, and wherein the oral dosage in tablet form 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 selected from the group consisting of rheumatoid arthritis, osteoarthritis, and pain from a condition other than rheumatoid arthritis and osteoarthritis wherein the human patient does not suffer at the times of administering from a condition characterized by hypersecretion of gastric acid and/or from active severe oesophagitis and/or Barrett's ulceration, and/or from gastroesophageal reflux disease.
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