Controlled release hydrocodone formulations
First Claim
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1. A process for preparation of a solid oral controlled-release dosage form of hydrocodone comprising incorporating hydrocodone or a salt thereof into a controlled-release matrix by forming granules and compressing granules into a tablet such that the tablet after administration to a human patient provides a C24/Cmax ratio of about 0.55 to about 1.0 and a therapeutic effect for at least about 24 hours.
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Abstract
A solid oral controlled-release dosage form of hydrocodone is disclosed, the dosage form comprising an analgesically effective amount of hydrocodone or a pharmaceutically acceptable salt thereof, and controlled release material.
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Citations
20 Claims
- 1. A process for preparation of a solid oral controlled-release dosage form of hydrocodone comprising incorporating hydrocodone or a salt thereof into a controlled-release matrix by forming granules and compressing granules into a tablet such that the tablet after administration to a human patient provides a C24/Cmax ratio of about 0.55 to about 1.0 and a therapeutic effect for at least about 24 hours.
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11. A process for preparation of a solid oral controlled-release dosage form of hydrocodone comprising incorporating hydrocodone or a salt thereof into a controlled-release matrix by forming granules and compressing granules into a tablet such that the tablet provides controlled release of the hydrocodone or the pharmaceutically acceptable salt thereof for a time period of from 8 to at least about 24 hours,
an in-vitro release rate of hydrocodone, when measured by the USP Basket Method at 100 rpm in 900 ml aqueous buffer at a pH of between 1.6 and 7.2 at 37° - C., of from 0% to about 35% at 1 hour, from about 10% to about 70% at 4 hours, from about 20% to about 75% at 8 hours, from about 30% to about 80% at 12 hours, from about 40% to about 90% at 18 hours, and greater than about 60% at 24 hours, and,
after administration to a human patient or a population of patients a C24/Cmax ratio of about 0.55 to about 1.0. - View Dependent Claims (12, 13, 14, 15, 16, 17, 18, 19)
- C., of from 0% to about 35% at 1 hour, from about 10% to about 70% at 4 hours, from about 20% to about 75% at 8 hours, from about 30% to about 80% at 12 hours, from about 40% to about 90% at 18 hours, and greater than about 60% at 24 hours, and,
Specification