Pharmaceutical dosage form comprising a sulfite compound
OwnerPing Gao, Juliane M. Bauer +2inventors
InventorsPing Gao, Juliane M. Bauer, Gary D. Ewing, David C. Sperry
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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 sulfite 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.
Claims30
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) at least one pharmaceutically acceptable sulfite compound, wherein the capsule shells comprise gelatin, and wherein the at least one pharmaceutically acceptable sulfite compound is present in a total sulfite amount sufficient to inhibit gelatin cross-linking and/or pellicle formation in the capsule shells upon storage of the dosage form.
Dependencies are inferred from the claim text.