Pharmaceutical dosage form capable of maintaining stable dissolution profile upon storage
OwnerPing Gao, Juliane M. Bauer +1inventors
InventorsPing Gao, Juliane M. Bauer, Xiaorong He
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Abstract
The present invention provides a pharmaceutical dosage form comprising a fill material sealed in a gelatin capsule; the fill material comprises (a) a selective COX-2 inhibitory drug of low water solubility, and (b) a primary or secondary amine compound in an amount sufficient to inhibit cross-linking of gelatin in said gelatin capsule upon storage of the dosage form in a closed container maintained at 40° C. and 75% relative humidity for a period of 6 months.
Claims34
A pharmaceutical dosage form comprising a fill material sealed in capsule shells wherein the fill material comprises (a) a selective cyclooxygenase-2 inhibitory drug of low water solubility and (b) an amine agent comprising at least one pharmaceutically acceptable primary or secondary amine, wherein the capsule shells comprise gelatin, and wherein the amine agent is present in an amount sufficient to inhibit gelatin cross-linking and/or pellicle formation in the capsule shells upon storage of the dosage form.
26 The dosage form of claim 1 wherein the selective cyclooxygenase-2 inhibitory drug is selected from the group consisting of celecoxib, deracoxib, valdecoxib, rofecoxib, etoricoxib, 2-(3,5-difluorophenyl)-3-[4-(methylsulfonyl)phenyl]-2-cyclopenten-1-one, 2-(3,4-difluorophenyl)-4-(3-hydroxy-3-methyl-1-butoxy)-5-[4-(methylsulfonyl)phenyl]-3-(2H)-pyridazinone, and pharmaceutically acceptable salts and prodrugs thereof.
Dependencies are inferred from the claim text.