Multimodal Abuse Resistant and Extended Release Opioid Formulations

A dosage form for administration via the oral cavity, the dosage form comprising

• a) a drug combined with
• b) at least two ADER ingredients selected from the group consisting of
• (i) hydrogenated vegetable oils;
• (ii) polyoxyethylene stearates;
• (iii) glycerol monostearate;
• and
• (iv) poorly water soluble waxes having a melting point in the range from 45 to 100 degrees Celsius;
• wherein the ADER ingredients are selected and are present in amounts sufficient to reduce the amount of drug released from the dosage form in the USP Basket and Paddle Method at 100 revolutions per minute in 700 milliliters of simulated gastric fluid at 37 degrees Celsius, relative to the same dosage form lacking the ADER ingredients.

A method of treating a medical condition amenable to treatment with an opioid agonist, the method comprising administering to the oral cavity of a human patient afflicted with the condition an effective amount of a dosage form comprising

• a) an opioid agonist combined with
• b) at least two ADER ingredients selected from the group consisting of
• (i) hydrogenated vegetable oils;
• (ii) polyoxyethylene stearates;
• (iii) glycerol monostearate;
• and
• (iv) poorly water soluble waxes having a melting point in the range from 45 to 100 degrees Celsius;
• wherein the ADER ingredients are selected and are present in amounts sufficient to reduce the amount of the agonist released from the dosage form in the USP Basket and Paddle Method at 100 revolutions per minute in 700 milliliters of simulated gastric fluid at 37 degrees Celsius, relative to the same dosage form lacking the ADER ingredients.

A method of reducing the rate of release of an opioid agonist from an orally-administrable dosage form, the method comprising combining the agonist with at least two ADER ingredients selected from the group consisting of

• (i) hydrogenated vegetable oils;
• (ii) polyoxyethylene stearates;
• (iii) glycerol monostearate;
• and
• (iv) poorly water soluble waxes having a melting point in the range from 45 to 100 degrees Celsius.