US 10,888,528 B2
Immediate release abuse-deterrent granulated dosage forms
Dinesh K. Haswani, Plymouth, MN (US); Derek V. Moe, Mound, MN (US); Victoria A. O'Neill, Wayzata, MN (US); Randal A. Seburg, Maple Grove, MN (US); and Manuel A. Vega Zepeda, Minnetonka, MN (US)
Assigned to Clexio Biosciences Ltd., Jerusalem (IL)
Filed by Clexio Biosciences Ltd., Jerusalem (IL)
Filed on Jan. 7, 2019, as Appl. No. 16/241,102.
Application 16/241,102 is a continuation of application No. 15/423,388, filed on Feb. 2, 2017, granted, now 10,201,505.
Application 15/423,388 is a continuation of application No. 15/210,760, filed on Jul. 14, 2016, granted, now 9,827,204, issued on Nov. 28, 2017.
Application 15/210,760 is a continuation of application No. PCT/US2015/064403, filed on Dec. 8, 2015.
Claims priority of provisional application 62/088,901, filed on Dec. 8, 2014.
Prior Publication US 2019/0133961 A1, May 9, 2019
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 9/50 (2006.01); A61K 9/28 (2006.01); A61K 45/06 (2006.01); A61K 31/4458 (2006.01); A61K 47/58 (2017.01); A61K 31/00 (2006.01); A61K 9/20 (2006.01); A61K 31/136 (2006.01); A61K 31/137 (2006.01); A61K 31/165 (2006.01); A61K 31/167 (2006.01); A61K 31/437 (2006.01); A61K 31/485 (2006.01); A61K 31/515 (2006.01); A61K 31/5513 (2006.01); A61K 31/554 (2006.01); A61K 47/61 (2017.01); A61K 47/54 (2017.01); A61K 47/59 (2017.01); A61K 9/00 (2006.01); A61K 31/135 (2006.01)
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)] 19 Claims
 
1. An immediate release abuse deterrent oral dosage form comprising:
core-shell particles that include
an active pharmaceutical ingredient that is ketamine, esketamine, or a pharmaceutically acceptable salt thereof;
a core comprising a gelling polymer and up to 10% by weight of the total amount of the active pharmaceutical ingredient in said core-shell particles;
an active pharmaceutical layer surrounding the core and comprising the active pharmaceutical ingredient; and,
at least one layer surrounding said active pharmaceutical layer, wherein the at least one layer comprises a pH-sensitive film comprising a pH-sensitive polymer that is insoluble in water at a pH greater than 5;
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, and,
wherein the dosage form resists attempted abuse of the active pharmaceutical ingredient by injection or nasal insufflation.