Sustained-release formulation of a cyclooxygenase-2 inhibitor
OwnerDavid B. Hedden, Sreekant Nadkarniinventors
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Abstract
There is provided an orally deliverable pharmaceutical composition comprising a selective cyclooxygenase-2 inhibitory drug of low water solubility such as celecoxib and a release-extending polymer. The composition is useful in treatment of cyclooxygenase-2 mediated conditions and disorders by once-a-day administration.
Claims37
An orally deliverable pharmaceutical composition comprising a therapeutically effective amount of a selective cyclooxygenase-2 inhibitory drug of low water solubility and one or more pharmaceutically acceptable polymers, wherein the composition provides an in vitro sustained-release dissolution profile following placement in a standard dissolution medium exhibiting
- (a) release of about 5% to about 35% of the drug 2 hours after said placement;
- (b) release of about 10% to about 85% of the drug 8 hours after said placement;
- and
- (c) release of about 30% to about 90% of the drug 18 hours after said placement.
The composition of claim 17 wherein the amount of celecoxib in each dose unit is about 100 mg to about 200 mg.
The composition of claim 26 wherein said articles are tablets or capsules.
An orally deliverable pharmaceutical composition comprising a therapeutically effective amount of a selective cyclooxygenase-2 inhibitory drug of low water solubility, a substantial portion or all of said compound being distributed in a matrix comprising hydroxypropylmethylcellulose having a nominal viscosity, 2% in water, of about 100 to about 8,000 cP.
An orally deliverable pharmaceutical composition comprising a therapeutically effective amount of a selective cyclooxygenase-2 inhibitory drug of low water solubility, a substantial portion or all of the drug being present in beads having a coating comprising a release-extending polymer or copolymer.
Dependencies are inferred from the claim text.