PHARMACEUTICAL COMPOSITIONS OF IBUPROFEN AND FAMOTIDINE
Stable pharmaceutical compositions of famotidine and ibuprofen in a single unit dosage form are disclosed herein. In some embodiments, the ibuprofen is in direct physical contact with the famotidine.
1 . A pharmaceutical composition, comprising:
a first compartment comprising 26.6 mg famotidine as an active pharmaceutical ingredient; and
a second compartment that is distinct from said first compartment wherein said second compartment comprises 800 mg ibuprofen as an active pharmaceutical ingredient,
wherein the pharmaceutical composition is formulated for immediate release, and wherein none of the composition, the first compartment, the second compartment, 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.
2 . A pharmaceutical composition of claim 1 , wherein the composition is a tablet-in-tablet formulation wherein the second compartment completely surrounds the first compartment.
3 . A pharmaceutical composition comprising:
800 mg ibuprofen as an active pharmaceutical ingredient and
26.6 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 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.
4 . A pharmaceutical composition of claim 3 , wherein the first layer and the second layer are separated by a barrier layer.
5 . 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 pharmaceutical composition of claim 1 .
6 . The method of claim 5 , wherein said human patient is at elevated risk of developing ibuprofen-induced ulcers.
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 pharmaceutical composition of claim 2 .
8 . The method of claim 7 , wherein said human patient is at elevated risk of developing ibuprofen-induced ulcers.
9 . 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 pharmaceutical composition of claim 3 .
10 . The method of claim 9 , wherein said human patient is at elevated risk of developing ibuprofen-induced ulcers.
11 . 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 pharmaceutical composition of claim 4 .
12 . The method of claim 11 , wherein said human patient is at elevated risk of developing ibuprofen-induced ulcers.