US 9,808,453 B2
Pharmaceutical formulation containing opioid agonist, opioid antagonist and gelling agent
Benjamin Oshlack, Boca Raton, FL (US); Curtis Wright, Rockport, MA (US); and Christopher Breder, Greenwhich, CT (US)
Assigned to Purdue Pharma L.P., Stamford, CT (US); The P.F. Laboratories, Inc., Totowa, NJ (US); and Purdue Pharmaceuticals L.P., Wilson, NC (US)
Filed by Purdue Pharma L.P., Stamford, CT (US); THE P.F. LABORATORIES, INC., Totowa, NJ (US); and PURDUE PHARMACEUTICALS L.P., Wilson, NC (US)
Filed on Dec. 19, 2016, as Appl. No. 15/384,229.
Application 15/384,229 is a continuation of application No. 14/793,174, filed on Jul. 7, 2015, granted, now 9,561,225.
Application 14/793,174 is a continuation of application No. 13/956,467, filed on Aug. 1, 2013, granted, now 9,101,668, issued on Aug. 11, 2015.
Application 13/956,467 is a continuation of application No. 12/909,527, filed on Oct. 21, 2010, granted, now 8,524,275, issued on Sep. 3, 2013.
Application 12/909,527 is a continuation of application No. 10/214,413, filed on Aug. 6, 2002, granted, now 7,842,307, issued on Nov. 30, 2010.
Claims priority of provisional application 60/310,537, filed on Aug. 6, 2001.
Prior Publication US 2017/0157115 A1, Jun. 8, 2017
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/485 (2006.01); A61K 9/00 (2006.01); A61K 47/36 (2006.01); A61K 9/20 (2006.01); A61K 9/50 (2006.01); A61K 47/32 (2006.01)
CPC A61K 31/485 (2013.01) [A61K 9/0053 (2013.01); A61K 9/205 (2013.01); A61K 9/2027 (2013.01); A61K 9/2081 (2013.01); A61K 9/5078 (2013.01); A61K 47/32 (2013.01); A61K 47/36 (2013.01)] 20 Claims
1. A controlled release oral dosage form comprising:
a therapeutically effective amount of an opioid analgesic,
from about 10 ng to 275 mg of an opioid antagonist, and
particles consisting of a gelling agent, one or more pharmaceutically acceptable hydrophobic material(s) selected from the group consisting of cellulose polymers, acrylic polymers, polylactic acid, polyglycolic acid and a co-polymer of the polylactic acid and polyglycolic acid, and one or more additional pharmaceutically acceptable excipient(s),
wherein the gelling agent is releasable from said particles and a solubilized mixture having a viscosity unsuitable for injection is formed when the dosage form is crushed and dissolved in from about 1 to about 5 ml of water,
a weight ratio of the gelling agent to the opioid analgesic is from about 1:40 to about 40:1, and
the gelling agent is a gum.