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US 9,750,736 B2Granted
Oxycodone formulations
AssigneePurdue Pharma L.P.
InventorsBenjamin Oshlack, Curtis Wright, Derek Prater
Life of this patent
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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.
Claims26
A sustained-release oral dosage form comprising:
- a plurality of units containing one or more active agents and one or more excipients, wherein
- one of the active agents is oxycodone or a pharmaceutically acceptable salt thereof,
- the excipients comprise a sustained release material comprising ethylcellulose, a methacrylic acid copolymer or a mixture thereof,
- the amount of the oxycodone or pharmaceutically acceptable salt thereof in the dosage form is from about 10 mg to about 320 mg,
- the dosage form provides a mean C24/Cmax oxycodone ratio of from 0.6 to 1.0 and a mean Tmax of oxycodone of about 6.5 to about 17 hours after steady state oral administration with food to humans,
- the dosage form is a capsule, and
- a diameter of each unit is from about 0.1 mm to about 5 mm.
4 more elements
A sustained-release oral dosage form comprising a plurality of units comprising:
- oxycodone or a pharmaceutically acceptable salt thereof,
- a sustained release material comprising ethylcellulose, a methacrylic acid copolymer, a hydroxyalkylcellulose, or mixtures thereof, and
- plasticizers,
- the dosage form providing a mean C24/Cmax oxycodone ratio of 0.6 to 1.0 and a mean Tmax of oxycodone of about 6.5 to about 17 hours after steady state oral administration to humans,
- wherein the amount of the oxycodone or pharmaceutically acceptable salt thereof in the dosage form is from about 10 mg to about 320 mg,
- the dosage form is a capsule, and
- a diameter of each unit is from about 0.1 mm to about 5 mm.
4 more elements
A sustained-release oral dosage form comprising:
- a plurality of units comprising oxycodone or a pharmaceutically acceptable salt thereof, a methacrylic acid copolymer and polyethylene glycol,
- wherein the amount of the oxycodone or pharmaceutically acceptable salt thereof in the dosage form is from about 10 mg to about 320 mg,
- the dosage form provides a mean C24/Cmax oxycodone ratio of 0.6 to 1.0 and a mean Tmax of oxycodone of about 6.5 to about 17 hours after steady state oral administration with food to humans,
- the dosage form is a capsule, and
- a diameter of each unit is from about 0.1 mm to about 5 mm.
2 more elements
Dependencies are inferred from the claim text.