US 12,440,456 B2
Method for treatment of depression with oral dosage forms of ketamine
Sascha Manthei, Pratteln (CH); Helene Rey, Pratteln (CH); Marc Fischer, Pratteln (CH); and Olaf Mundszinger, Pratteln (CH)
Assigned to KETABON GMBH, Munich (DE)
Filed by KETABON GmBH, Munich (DE)
Filed on Aug. 30, 2021, as Appl. No. 17/460,476.
Application 16/437,467 is a division of application No. 15/304,613, granted, now 10,335,379, issued on Jul. 2, 2019, previously published as PCT/EP2015/058318, filed on Apr. 16, 2015.
Application 17/460,476 is a continuation of application No. 16/437,467, filed on Jun. 11, 2019, granted, now 11,103,467, issued on Aug. 31, 2021.
Claims priority of application No. 14165057 (EP), filed on Apr. 17, 2014.
Prior Publication US 2021/0386691 A1, Dec. 16, 2021
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/135 (2006.01); A61K 9/00 (2006.01); A61K 9/20 (2006.01); A61K 9/50 (2006.01)
CPC A61K 31/135 (2013.01) [A61K 9/0053 (2013.01); A61K 9/2013 (2013.01); A61K 9/2077 (2013.01); A61K 9/2081 (2013.01); A61K 9/5078 (2013.01)] 38 Claims
 
1. A method for treatment of depression said method comprising orally administering an oral dosage form comprising ketamine or a pharmaceutically acceptable salt or solvate thereof to a patient suffering from depression,
wherein the oral dosage form provides an in vitro release of ketamine, when measured according to the USP Basket Method I in 0.1M HCl at 37° C. at 100 rpm of 0 to 40% after 2 hours, of 10 to 70% after 4 hours, of 30 to 85% after 6 hours and of 45 to 100% after 8 hours,
wherein the oral dosage form provides an in vitro release of ketamine, when measured according to the USP 1 Basket Method in 0.1M HCl at 100 rpm, after one hour at 37° C., in an aqueous solution containing 20% by volume of ethanol, in a ratio of less than 2:1 relative to the amount of ketamine released, so measured, after one hour at 37° C. in an ethanol-free aqueous solution, and
wherein the oral dosage form is a matrix controlled release dosage form, an osmotic controlled release dosage form, or a multi particulate controlled release dosage form.