IP Library Granted Patent US 9,655,894
Granted Patent B2
US 9,655,894 · App. 14/665,715 · Granted May 23, 2017

Once-A day oxycodone formulations

Inventors: Benjamin Oshlack (Boca Raton, FL); Curtis Wright (Rockport, MA); Derek Prater (Cambridge, GB)
Assignee: Purdue Pharma L.P.
A61K31/485A61K9/2031A61K9/2054A61K9/2086
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Quick Facts
Patent No.
US 9,655,894
App. No.
14/665,715
Granted
May 23, 2017
Kind
B2
Abstract

The invention is directed to sustained release formulations containing oxycodone or a pharmaceutically acceptable salt thereof which provide a mean C 24 /C max oxycodone ratio of 0.6 to 1.0 or 0.7 to 1 after oral administration at steady state to patients and methods thereof.

Claims (12)

1. A method of treating pain for at least about 24 hours in a human comprising:

providing a C 24 /C max oxycodone ratio of from 0.6 to 1.0 and a T max of oxycodone at about 2 to about 8 hours in a human by orally administering to the human on a once-a-day basis a dosage form comprising a non-compressed plurality of units comprising:

oxycodone or a pharmaceutically acceptable salt thereof,

a sustained release material comprising ethylcellulose, a methacrylic acid copolymer, or mixtures thereof,

wherein the amount of the oxycodone or pharmaceutically acceptable salt thereof in the dosage form is from about 10 to about 320 mg,

the dosage form is a capsule and

is administered with food.

2. The method of claim 1 , comprising providing a T max of oxycodone at about 6 hours after said administration.

3. The method of claim 1 , comprising providing a T max of oxycodone at about 8 hours after said administration.

4. The method of claim 1 , wherein the dosage form provides an in-vitro release rate of oxycodone, when measured by the USP Basket Method at 100 rpm in 900 ml aqueous buffer at a pH of between 1.6 and 7.2 at 37° C., such that from 0% to about 40% of the oxycodone is released at 1 hour, from about 8% to about 70% of the oxycodone is released at 4 hours, from about 20% to about 80% of the oxycodone is released at 8 hours, from about 30% to about 95% of the oxycodone is released at 12hours, from about 35% to about 95% at of the oxycodone is released at 18 hours, and greater than about 50% of the oxycodone is released at 24 hours.

5. The method of claim 1 , wherein said administration is at steady state.

6. The method of claim 1 , wherein all of the oxycodone in the dosage form is in a sustained release form.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 23, 2017
From: EURO-CELTIQUE S.A.
To: PURDUE PHARMA L.P.
Reel/Frame 042479/0307 →
Continuity (5)
Continuation 14548435 · Nov 20, 2014
Continuation 12917148 · Nov 1, 2010
Continuation 10476409
Provisional Application 60288211 · May 2, 2001
Related Publication 20150231131A1 · Aug 20, 2015