Pharmaceutical dosage form comprising a sulfite compound

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 sai...

Ausführliche Beschreibung

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Bibliographische Detailangaben
Hauptverfasser: GAO PING, BAUER JULIANE M, SPERRY DAVID C, EWING GARY D
Format: Patent
Sprache:eng
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Beschreibung
Zusammenfassung: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.