Pharmaceutical combinations of oxycodone and naloxone

A pharmaceutical composition comprising about 20 mg oxycodone hydrochloride and 0.80 to 0.90 mg naloxone hydrochloride in a dosage form that provides sustained release of at least the oxycodone hydrochloride.

A pharmaceutical composition comprising about 40 mg oxycodone hydrochloride and 0.80 to 0.90 mg naloxone hydrochloride in a dosage form that provides sustained release of at least the oxycodone hydrochloride.

A pharmaceutical composition comprising about 10 mg to about 40 mg oxycodone or a pharmaceutically acceptable salt thereof and 0.65 to 0.90 mg naloxone or a pharmaceutically acceptable salt thereof in a dosage form, wherein said composition when tested in-vitro by the USP Apparatus I (Basket) method of U.S. Pharmacopela XXIV (2000) at 100 rpm in 900 ml simulated gastric fluid (SGF) at 37° C. provides a dissolution rate of said naloxone or pharmaceutically acceptable salt thereof which is within ±20% relative to the dissolution rate of said oxycodone or pharmaceutically acceptable salt thereof at 1 hour, 4 hours and 12 hours.

A pharmaceutical composition comprising about 10 mg to about 40 mg oxycodone or a pharmaceutically acceptable salt thereof in sustained release form and an amount of naloxone or a pharmaceutically acceptable salt thereof to provide a mean Cmax of plasma naloxone of less than 5 pg/ml upon single dose administration to a population of human subjects.

A pharmaceutical composition comprising oxycodone or a pharmaceutically acceptable salt thereof in an amount that is the oxycodone base equivalent of about 10-40 mg oxycodone hydrochloride and naloxone or a pharmaceutically acceptable salt thereof in an amount that is the equivalent of 0.65 to 0.75 mg naloxone base in a dosage form that provides sustained release of at least the oxycodone or pharmaceutically acceptable salt thereof.

A method of treating pain in a human patient comprising orally administering a pharmaceutical composition comprising about 10 mg to about 40 mg oxycodone or a pharmaceutically acceptable salt thereof and 0.65 to 0.90 mg naloxone or a pharmaceutically acceptable salt thereof to a patient in pain, said composition providing a sustained release of at least the oxycodone or pharmaceutically acceptable salt thereof.

A method of preparing a sustained release dosage form comprising incorporating 0.65 to 0.90 mg naloxone or a pharmaceutically acceptable salt thereof into a pharmaceutical composition comprising about 10 to about 40 mg oxycodone or pharmaceutically acceptable salt thereof, said composition providing a sustained release of at least the oxycodone or pharmaceutically acceptable salt thereof.

A method of reducing the parenteral abuse of an oxycodone sustained release product comprising incorporating 0.65 to 0.90 mg naloxone or a pharmaceutically acceptable salt thereof into an oxycodone sustained release product comprising about 10 to about 40 mg oxycodone or pharmaceutically acceptable salt thereof.

The use of naloxone or a pharmaceutically acceptable salt thereof in the preparation of a medicament to reduce the parenteral abuse of an oxycodone sustained release product, said medicament comprising 0.65 to 0.90 mg naloxone or a pharmaceutically acceptable salt thereof.

A method of treating pain comprising administering a pharmaceutical composition comprising about 10 mg oxycodone hydrochloride and 0.65 to 0.90 mg naloxone or pharmaceutically acceptable salt thereof in a dosage form that provides sustained release of at least the oxycodone hydrochloride and thereafter increasing the dosage by administering a pharmaceutical composition comprising about 20 mg oxycodone hydrochloride and 0.65 to 0.90 mg naloxone or pharmaceutically acceptable salt thereof in a dosage form that provides sustained release of at least the oxycodone hydrochloride.

A method of treating pain comprising administering a pharmaceutical composition comprising about 20 mg oxycodone hydrochloride and 0.65 to 0.90 mg naloxone or pharmaceutically acceptable salt thereof in a dosage form that provides sustained release of at least the oxycodone hydrochloride and thereafter increasing the dosage by administering a pharmaceutical composition comprising about 40 mg oxycodone hydrochloride and 0.65 to 0.90 mg naloxone or pharmaceutically acceptable salt thereof in a dosage form that provides sustained release of at least the oxycodone hydrochloride.

A method of treating pain comprising administering a pharmaceutical composition comprising about 10 mg oxycodone hydrochloride and 0.65 to 0.90 mg naloxone or pharmaceutically acceptable salt thereof in a dosage form that provides sustained release of at least the oxycodone hydrochloride and thereafter increasing the dosage by administering a pharmaceutical composition comprising about 20 mg oxycodone hydrochloride and 0.65 to 0.90 mg naloxone or pharmaceutically acceptable salt thereof in a dosage form that provides sustained release of at least the oxycodone hydrochloride and thereafter increasing the dosage by administering a pharmaceutical composition comprising about 40 mg oxycodone hydrochloride and 0.65 to 0.90 mg naloxone or pharmaceutically acceptable salt thereof in a dosage form that provides sustained release of at least the oxycodone hydrochloride.

A kit for the treatment of pain comprising:

• a container comprising at least one formulation comprising about 10 to about 40 mg oxycodone or a pharmaceutically acceptable salt thereof and naloxone or a pharmaceutically acceptable salt thereof;
• said kit further comprising indicia indicating the use of said formulation.