US 12,350,379 B2
Extended release pharmaceutical formulation and methods of treatment
Paul William Glue, Dunedin (NZ); Natalie June Medlicott, Dunedin (NZ); and Peter William Surman, Auckland (NZ)
Assigned to DOUGLAS PHARMACETICALS LTD, Auckland (NZ)
Filed by DOUGLAS PHARMACEUTICALS LTD., Auckland (NZ)
Filed on Jun. 28, 2022, as Appl. No. 17/851,590.
Application 17/851,590 is a continuation of application No. 16/890,222, filed on Jun. 2, 2020, granted, now 11,471,416, issued on Oct. 18, 2022.
Application 16/890,222 is a continuation of application No. 16/754,389, granted, now 11,471,415, issued on Oct. 18, 2022, previously published as PCT/IB2018/057851, filed on Oct. 10, 2018.
Application 16/754,389 is a continuation in part of application No. 15/728,695, filed on Oct. 10, 2017, granted, now 10,441,544, issued on Oct. 15, 2019.
Claims priority of provisional application 62/695,966, filed on Jul. 10, 2018.
Prior Publication US 2022/0347104 A1, Nov. 3, 2022
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 9/28 (2006.01); A61K 9/00 (2006.01); A61K 9/20 (2006.01); A61K 31/135 (2006.01); A61K 45/06 (2006.01); A61P 25/22 (2006.01)
CPC A61K 9/2866 (2013.01) [A61K 9/2031 (2013.01); A61K 9/2813 (2013.01); A61K 9/2853 (2013.01); A61K 31/135 (2013.01); A61P 25/22 (2018.01); A61K 9/0053 (2013.01); A61K 45/06 (2013.01)] 23 Claims
 
1. A method of treating a patient for treatment-resistant depression; treatment-resistant anxiety, including but not limited to DSM-V Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder, Post-Traumatic Stress Disorder, and/or Obsessive-Compulsive Disorder; or DSM-5 Specific Phobia comprising:
selecting a patient in need of such treatment; and
orally administering to the patient a tablet comprising:
a core comprising:
i) a therapeutically effective amount of an active agent selected from the group consisting of ketamine, norketamine, pharmaceutically acceptable salts thereof, and combinations thereof;
ii) at least one high molecular weight polyethylene oxide (PEO) that is cured, wherein said high molecular weight PEO has an approximate molecular weight of from about 2 million to about 7 million, based upon rheological measurements, and is present in an amount of at least about 30% (by weight) of the core,
wherein said tablet is crush resistant and has a breaking strength of at least about 200 N; and wherein said tablet comprises active agent at a concentration of at least about 12% by weight,
wherein the tablet treats the symptoms of said treatment-resistant depression; treatment-resistant anxiety, including but not limited to DSM-V Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder, Post-Traumatic Stress Disorder, and/or Obsessive-Compulsive Disorder; or DSM-5 Specific Phobia.