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Methods of Reducing Alcohol-Induced Dose Dumping for Opioid Sustained Release Oral Dosage Forms

  • US 20090221621A1
  • Filed: 10/31/2006
  • Published: 09/03/2009
  • Est. Priority Date: 10/31/2005
  • Status: Abandoned Application
First Claim
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1. A method of use of a hydromorphone sustained release dosage form comprising providing the dosage form to a patient population which includes individuals that can be expected to at least occasionally co-ingest the dosage form with an alcoholic beverage, wherein the dosage form when tested in vivo on a population of test subjects has:

  • (a) a mean arithmetic ratio of;

    (i) a single dose maximum plasma hydromorphone concentration as a result of co-ingestion within about 30 minutes of the dosage form and about 240 milliliters of an aqueous solution having an alcohol concentration of about 20% volume/volumeto(ii) a single dose maximum plasma hydromorphone concentration as a result of co-ingestion within about 30 minutes of the dosage form and about 240 milliliters of the aqueous solution with water substituted for the alcoholthat is equal to or less than about 1.9;

    1; and

    /or(b) a ratio of;

    (i) an individual test subject'"'"'s single dose maximum plasma hydromorphone concentration as a result of co-ingestion within about 30 minutes of the dosage form and about 240 milliliters of an aqueous solution having an alcohol concentration of about 20% volume/volumeto(ii) the same test subject'"'"'s single dose maximum plasma hydromorphone concentration as a result of co-ingestion within about 30 minutes of the dosage form and about 240 milliliters of the aqueous solution with water substituted for the alcoholthat is equal to or less than about 5;

    1; and

    /or(c) a ratio of;

    (i) a median single dose, time to maximum plasma hydromorphone concentration as a result of co-ingestion within about 30 minutes of the dosage form and about 240 milliliters of an aqueous solution having an alcohol concentration of about 20% volume/volumeto(ii) a median single dose, time to maximum plasma hydromorphone concentration as a result of co-ingestion within about 30 minutes of the dosage form and about 240 milliliters of the aqueous solution with water substituted for the alcoholthat is in the range of from about 0.5 to about 1.0.

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