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 from 24 mg to 28 mg famotidine as an active pharmaceutical ingredient; and
a second compartment comprising from 750 mg to 850 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, and
wherein no more than about 1% of a sulfamide is present when the composition is stored at 40° 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° C. and 75% relative humidity for a period of one month.
2 . A pharmaceutical composition of claim 1 , wherein the first compartment and the second compartment are separated by a barrier layer.
3 . A pharmaceutical composition of claim 1 , wherein the composition is a tablet-in-tablet formulation wherein the second compartment completely surrounds the first compartment.
4 . 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,
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, and
wherein no more than about 1% of a sulfamide is present when the composition is stored at 40° 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° C. and 75% relative humidity for a period of one month.
5 . A pharmaceutical composition of claim 4 , wherein the first layer and the second layer are separated by a barrier layer.
6 . 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 .
7 . The method of claim 6 , wherein said human patient is at elevated risk of developing ibuprofen-induced ulcers.
8 . The method of claim 7 , wherein said human patient is also being administered low dose aspirin.
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 2 .
10 . The method of claim 9 , wherein said human patient is at elevated risk of developing ibuprofen-induced ulcers.
11 . The method of claim 10 , wherein said human patient is also being administered low dose aspirin.
12 . 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 .
13 . The method of claim 12 , wherein said human patient is at elevated risk of developing ibuprofen-induced ulcers.
14 . The method of claim 13 , wherein said human patient is also being administered low dose aspirin.
15 . 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 5 .
16 . The method of claim 15 , wherein said human patient is at elevated risk of developing ibuprofen-induced ulcers.
17 . The method of claim 16 , wherein said human patient is also being administered low dose aspirin.
18 . A pharmaceutical composition in the form of a capsule, wherein the capsule is filled with:
barrier-coated granules comprising from 24 mg to 28 mg famotidine as an active pharmaceutical ingredient and
from 750 mg to 850 mg ibuprofen as an active pharmaceutical ingredient.