US 9,808,432 B2
Methods for overcoming resistance to tramadol
John A. Zebala, Issaquah, WA (US)
Assigned to Syntrix Biosystems Inc., Auburn, WA (US)
Filed by Syntrix Biosystems, Inc., Auburn, WA (US)
Filed on Aug. 7, 2015, as Appl. No. 14/821,506.
Application 14/821,506 is a division of application No. 13/543,883, filed on Jul. 8, 2012.
Claims priority of provisional application 61/506,092, filed on Jul. 9, 2011.
Prior Publication US 2015/0342905 A1, Dec. 3, 2015
Int. Cl. A61K 31/135 (2006.01); A61K 45/06 (2006.01); A61K 9/20 (2006.01); A61K 9/28 (2006.01); A61K 9/00 (2006.01)
CPC A61K 31/135 (2013.01) [A61K 9/0053 (2013.01); A61K 9/2054 (2013.01); A61K 9/2059 (2013.01); A61K 9/28 (2013.01); A61K 9/2866 (2013.01); A61K 45/06 (2013.01)] 19 Claims
OG exemplary drawing
1. A method for treating a disorder modulated at least in part by opiate receptor activity or monoamine activity, comprising orally administering to a subject in need thereof a sustained release dosage form consisting of a therapeutically effective amount of O-desmethyltramadol, or a pharmaceutically acceptable salt thereof, 1-40 wt %, and pharmaceutical excipients, 10-90 wt %; wherein the O-desmethyltramadol is (1S, 2S)—O-desmethyltramadol or a combination of both (1R, 2R)—O-desmethyltramadol and (1S, 2S)—O-desmethyltramadol; wherein the excipients consist of one or more polymers selected from polysaccharide, acrylic resin, polyalkylene glycol, polyvinyl acetate, polyvinylpyrrolidone, protein-derived materials, and microcrystalline cellulose; a buffer; and, optionally, talc, colloidal silica, and/or magnesium stearate; and wherein the sustained release dosage form produces a plasma profile of O-desmethyltramadol that substantially replicates the plasma profile of O-desmethyltramadol following administration of tramadol.