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US Patent 5656295 - Controlled release oxycodone compositions

US Patent Issued on August 12, 1997
Estimated Patent Expiration Date: Icon_subject March 19, 2016Estimated Expiration Date is calculated based on simple USPTO term provisions. It does not account for terminal disclaimers, term adjustments, failure to pay maintenance fees, or other factors which might affect the term of a patent.
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Abstract

A method for substantially reducing the range in daily dosages required to control pain in approximately 90% of patients is disclosed whereby an oral solid controlled release dosage formulation having from about 10 to about 40 mg of oxycodone or a salt thereof is administered to a patient. The formulation provides a mean maximum plasma concentration of oxycodone from about 6 to about 60 ng/ml from a mean of about 2 to about 4.5 hours after administration, and a mean minimum plasma concentration from about 3 to about 30 ng/ml from about 10 to about 14 hours after repeated "q12h" (i.e., every 12 hour) administration through steady-state conditions. Another embodiment is directed to a method for substantially reducing the range in daily dosages required to control pain in substantially all patients by administering an oral solid controlled release dosage formulation comprising up to about 160 mg of oxycodone or a salt thereof, such that a mean maximum plasma concentration of oxycodone up to about 240 ng/ml from a mean of up to about 2 to about 4.5 hours after administration, and a mean minimum plasma concentration up to about 120 ng/ml from about 10 to about 14 hours after repeated "q12h" (i.e., every 12 hour) administration through steady-state conditions are achieved. Controlled release oxycodone formulations for achieving the above are also disclosed.

Inventors

Assignee

Application

No. 618344 filed on 03/19/1996

US Classes:

424/468, Sustained or differential release type424/469, Discrete particles in supporting matrix424/470, Where particles are granulated424/486, Synthetic polymer424/487, Acrylic acid and derivatives424/488, Polysaccharides (e.g., cellulose, etc.)424/494, Cellulose derivatives424/495, Ethyl cellulose424/496, Containing natural gums/resins424/497, Containing solid synthetic polymers424/498, Containing waxes, higher fatty acids, higher fatty alcohols, or derivatives thereof424/501, Contains solid synthetic resin424/502Contains waxes, higher fatty acids, higher fatty alcohols

Field of Search

424/468, Sustained or differential release type424/469, Discrete particles in supporting matrix424/470, Where particles are granulated424/487, Acrylic acid and derivatives424/488, Polysaccharides (e.g., cellulose, etc.)424/494, Cellulose derivatives424/496, Containing natural gums/resins424/497, Containing solid synthetic polymers424/498, Containing waxes, higher fatty acids, higher fatty alcohols, or derivatives thereof424/464, Tablets, lozenges, or pills424/465, With claimed perfecting feature in contents (e.g., excipient, lubricant, etc.)424/466, Effervescent424/467Printed, embossed, grooved, or perforated

Examiners

Primary: Webman, Edward J.

Attorney, Agent or Firm

US Patent References

4862598, Quick connect/disconnect repeatable sensor mounting apparatus
Issued on: 09/05/1989
Inventor: Barlow ,   et al.
4990341, Controlled release hydromorphone composition
Issued on: 02/05/1991
Inventor: Goldie, et al.
5266331Controlled release oxycodone compositions
Issued on: 11/30/1993
Inventor: Oshlack, et al.

International Classes

A61K 009/22
A61K 009/26

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