Method of treating pain by administering 24 hour oral opioid formulations exhibiting rapid rate of initial rise of plasma drug level
AssigneeEuroceltique, S.A.
InventorsRichard Sackler, Paul Goldenheim, Robert Kaiko
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Abstract
Patients are treated with 24-hour oral sustained release opioid formulations which upon administration quickly release an effective portion of the opioid contained therein such that there is an initially more rapid opioid release so that the minimum effective analgesic concentration of the opioid can be more quickly achieved. In the method, the formulations are designed to provide a relatively large peak to trough concentration of the opioid, rather than a flattened serum concentration curve.
Claims10
A method for providing effective pain management in humans for a time period of about 24 hours, comprising
- preparing a solid, controlled-release oral dosage form by incorporating an analgesically effective amount of an opioid analgesic into a controlled release dosage form which provides a rapid rate of initial rise of the plasma concentration of said opioid such that the peak plasma level of said opioid analgesic obtained in-vivo occurs from about 2 to about 8 hours after administration of the dosage form, and which provides large peak to trough fluctuations in opioid levels even after repeated dosing, such that said dosage form provides effective pain relief for at least about 24 hours when administered to a human patient.
The method for providing effective pain management in humans, comprising
- preparing a solid, controlled release oral dosage form by incorporating an analgesically effective amount of an opioid analgesic into a controlled release dosage form which provides a dissolution profile in acidic pH such that at least about 10.2% of said opioid analgesic is released after 1 hour when measured according to the USP Paddle Method utilizing a USP Apparatus Type II in 700 ml of simulated gastric fluid, wherein said dosage form further provides an in vivo peak plasma level of said opioid analgesic at about 2 to about 8 hours after administration of said dosage form to a patient and said dosage form provides effective pain relief for at least about 24 hours.
Dependencies are inferred from the claim text.