Once-a-day oxycodone formulations
First Claim
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1. A sustained-release oral dosage form for once-a-day administration comprising:
- a pharmaceutically acceptable matrix comprising an analgesically effective amount of oxycodone or a pharmaceutically acceptable salt thereof and a sustained release material, said dosage form providing an analgesic effect for at least about 24 hours after oral administration at steady state to human patients; and
said dosage form providing a mean C24/Cmax oxycodone ratio of 0.7 to 1.0 and a mean Tmax of about 6.5 to about 17 hours after steady state oral administration to said patients.
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Abstract
The invention is directed to sustained release formulations containing oxycodone or a pharmaceutically acceptable salt thereof which provide a mean C24/Cmax oxycodone ratio of 0.6 to 1.0 or 0.7 to 1 after oral administration at steady state to patients and methods thereof.
154 Citations
17 Claims
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1. A sustained-release oral dosage form for once-a-day administration comprising:
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a pharmaceutically acceptable matrix comprising an analgesically effective amount of oxycodone or a pharmaceutically acceptable salt thereof and a sustained release material, said dosage form providing an analgesic effect for at least about 24 hours after oral administration at steady state to human patients; and said dosage form providing a mean C24/Cmax oxycodone ratio of 0.7 to 1.0 and a mean Tmax of about 6.5 to about 17 hours after steady state oral administration to said patients. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 13, 14, 15)
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10. A sustained-release oral dosage form for once-a-day administration comprising:
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a pharmaceutically acceptable matrix comprising an analgesically effective amount of oxycodone or a pharmaceutically acceptable salt thereof and a sustained release material, said dosage form providing an analgesic effect for at least about 24 hours after oral administration at steady state to human patients; and said dosage form providing a mean C24/Cmax oxycodone ratio of 0.74 to 0.95 and a mean Tmax at about 6.5 to about 17 hours after oral administration at steady state to said patients. - View Dependent Claims (16)
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11. A sustained-release oral dosage form for once-a-day administration comprising:
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a pharmaceutically acceptable matrix comprising an analgesically effective amount of oxycodone or a pharmaceutically acceptable salt thereof and a sustained release material, said dosage form providing an analgesic effect for at least about 24 hours after oral administration at steady state to human patients; and said dosage form providing a mean C24/Cmax oxycodone ratio of 0.72 to 0.99 and a mean Tmax at about 6.5 to about 17 hours after oral administration at steady state to said patients. - View Dependent Claims (17)
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12. A method of preparing a sustained release dosage form comprising incorporating oxycodone or a pharmaceutically acceptable salt thereof and a sustained release material into a pharmaceutically acceptable matrix, and preparing the dosage form comprising the matrix, such that the dosage form provides an analgesic effect for at least about 24 hours, a mean C24/Cmax oxycodone ratio of 0.7 to 1.0 and a mean Tmax at about 6.5 to about 17 hours after administration at steady state to human patients.
Specification