CPC A61K 9/5078 (2013.01) [A61K 9/0053 (2013.01); A61K 9/204 (2013.01); A61K 9/2009 (2013.01); A61K 9/2013 (2013.01); A61K 9/2018 (2013.01); A61K 9/2027 (2013.01); A61K 9/2054 (2013.01); A61K 9/2081 (2013.01); A61K 9/2886 (2013.01); A61K 9/5073 (2013.01); A61K 31/00 (2013.01); A61K 31/135 (2013.01); A61K 31/136 (2013.01); A61K 31/137 (2013.01); A61K 31/165 (2013.01); A61K 31/167 (2013.01); A61K 31/437 (2013.01); A61K 31/4458 (2013.01); A61K 31/485 (2013.01); A61K 31/515 (2013.01); A61K 31/554 (2013.01); A61K 31/5513 (2013.01); A61K 45/06 (2013.01); A61K 47/543 (2017.08); A61K 47/58 (2017.08); A61K 47/59 (2017.08); A61K 47/61 (2017.08)] | 20 Claims |
1. An immediate release abuse deterrent oral dosage form comprising:
an active pharmaceutical ingredient that is ketamine, esketamine, or a pharmaceutically acceptable salt thereof;
a core comprising up to 10% by weight of the total amount of the active pharmaceutical ingredient;
wherein the dosage form demonstrates an immediate release profile of the active pharmaceutical ingredient when administered to a human in therapeutic doses, and an extended release profile of the active pharmaceutical ingredient when administered to a human in supratherapeutic doses, wherein the immediate release profile is defined as not less than 75% of API released in 30 minutes, and the extended release profile is defined as not more than 95% released in 60 minutes, and wherein the release profiles are evaluated by dissolution in 300 mL of 0.1N HCl media using USP II apparatus at 50 RPM paddle speed and 37° C.
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