IP Library Granted Patent US 11,135,171
Granted Patent B2
US 11,135,171 · App. 16/666,810 · Granted Oct 5, 2021

Pharmaceutical formulation containing gelling agent

Inventors: Curtis Wright (Rockport, MA); Benjamin Oshlack (Boca Raton, FL); Christopher Breder (Bethesda, MD)
Assignee: PURDUE PHARMA L.P.
A61K9/2054A61J3/10A61K8/731A61K9/0002A61K9/006A61K9/0053A61K9/0095A61K9/06A61K9/08A61K9/1635A61K9/1641A61K9/1652A61K9/19A61K9/20A61K9/205A61K9/2009A61K9/2013A61K9/2018A61K9/2027A61K9/2031A61K9/2095A61K9/28A61K9/284A61K9/2806A61K9/2813A61K9/2846A61K9/2853A61K9/2866A61K9/2893A61K9/48A61K9/485A61K9/4808A61K9/4833A61K9/4858A61K9/4866A61K9/4875A61K9/4891A61K9/5047A61K9/5078A61K9/5089A61K9/70A61K31/137A61K31/167A61K31/192A61K31/439A61K31/4458A61K31/48A61K31/485A61K45/06A61K47/02A61K47/08A61K47/10A61K47/12A61K47/14A61K47/20A61K47/26A61K47/32A61K47/34A61K47/36A61K47/38
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Quick Facts
Patent No.
US 11,135,171
App. No.
16/666,810
Granted
Oct 5, 2021
Kind
B2
Abstract

Disclosed in certain embodiments is a controlled release oral dosage form comprising a therapeutically effective amount of a drug susceptible to abuse together with one or more pharmaceutically acceptable excipients; the dosage form further including a gelling agent in an effective amount to impart a viscosity unsuitable for administration selected from the group consisting of parenteral and nasal administration to a solubilized mixture formed when the dosage form is crushed and mixed with from about 0.5 to about 10 ml of an aqueous liquid; the dosage form providing a therapeutic effect for at least about 12 hours when orally administered to a human patient.

Claims (42)

1. A solvent system comprising:

(a) a solvent; and

(b) a solute comprising:

(i) oxycodone or pharmaceutically acceptable salt thereof;

(ii) an emulsifier;

(iii) a fatty acid ester;

(iv) a cellulosic polymer; and

(v) silicon dioxide;

the solvent system having a ratio of emulsifier to oxycodone or pharmaceutically acceptable salt thereof from about 40:1 to about 1:40 by weight.

2. The solvent system of claim 1 , having a ratio of emulsifier to oxycodone or pharmaceutically acceptable salt thereof from about 40:1 to about 1:1 by weight.

3. The solvent system of claim 1 , wherein the cellulosic polymer is hydroxyethyl cellulose.

4. The solvent system of claim 1 , further comprising cellulose acetate butyrate.

5. The solvent system of claim 1 , wherein the solvent system comprises triacetin.

6. The solvent system of claim 1 , further comprising a surfactant.

7. The solvent system of claim 1 , wherein the solvent system comprises triacetin and a surfactant.

8. A solvent system comprising:

(a) a solvent; and

(b) a solute comprising:

(i) an opioid analgesic in an effective amount to provide an analgesic effect upon oral administration,

(ii) a gelling agent comprising an emulsifier; and

(iii) a cellulosic polymer;

the solvent system having a ratio of emulsifier to opioid analgesic from about 40:1 to about 1:1 by weight, and

the solvent system having a viscosity unsuitable for parenteral administration.

9. The solvent system of claim 8 , having a ratio of emulsifier to opioid analgesic from about 15:1 to about 1:1 by weight.

10. The solvent system of claim 8 , having a ratio of emulsifier to opioid analgesic from about 8:1 to about 1:1 by weight.

11. The solvent system of claim 8 , having a ratio of emulsifier to opioid analgesic from about 8:1 to about 2:1 by weight.

12. The solvent system of claim 8 , having a ratio of emulsifier to opioid analgesic from about 8:1 to about 5:1 by weight.

13. The solvent system of claim 8 , wherein the cellulosic polymer is hydroxyethyl cellulose.

14. The solvent system of claim 8 , further comprising a fatty acid ester.

15. The solvent system of claim 8 , further comprising silicon dioxide.

16. The solvent system of claim 8 , further comprising cellulose acetate butyrate.

17. The solvent system of claim 8 , further comprising triacetin.

18. The solvent system of claim 8 , further comprising a surfactant.

19. The solvent system of claim 8 , further comprising triacetin, a surfactant, and cellulose acetate butyrate.

20. A solvent system comprising:

(a) a solvent; and

(b) a solute comprising:

(i) oxycodone or pharmaceutically acceptable salt thereof in an effective amount to provide an analgesic effect upon oral administration,

(ii) a gelling agent comprising an emulsifier; and

(iii) a cellulosic polymer;

the solvent system having a ratio of emulsifier to oxycodone or pharmaceutically acceptable salt thereof from about 40:1 to about 1:1 by weight, and

the solvent system having a viscosity unsuitable for parenteral administration.

Continuity (12)
Continuation 16121242 · Sep 4, 2018
Continuation 15702127 · Sep 12, 2016
Continuation 15284711 · Oct 4, 2016
Continuation 15015735 · Feb 4, 2016
Continuation 14638685 · Mar 4, 2015
Continuation 13946418 · Jul 19, 2013
Continuation 13890874 · May 9, 2013
Continuation 13765368 · Feb 12, 2013
Continuation 12262015 · Oct 30, 2008
Continuation 10214412 · Aug 6, 2002
Provisional Application 60310534 · Aug 6, 2001
Related Publication 20200138720A1 · May 7, 2020