US 11,998,548 B2
Amorphous nilotinib microparticles and uses thereof
Christian F. Wertz, Saint Louis Park, MN (US); Tzehaw Chen, Cocoran, MN (US); and Joseph McTarsney, Shakopee, MN (US)
Assigned to NANOCOPOEIA, LLC, New Brighton, MN (US)
Filed by NANOCOPOEIA, LLC, New Brighton, MN (US)
Filed on Dec. 29, 2022, as Appl. No. 18/090,582.
Application 18/090,582 is a continuation of application No. 17/866,939, filed on Jul. 18, 2022.
Application 17/866,939 is a continuation of application No. 17/238,869, filed on Apr. 23, 2021, granted, now 11,389,450, issued on Jul. 19, 2022.
Application 17/238,869 is a continuation of application No. PCT/US2021/015864, filed on Jan. 29, 2021.
Claims priority of provisional application 62/968,749, filed on Jan. 31, 2020.
Prior Publication US 2023/0158026 A1, May 25, 2023
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/506 (2006.01); A61K 9/00 (2006.01); A61K 9/10 (2006.01); A61K 47/10 (2017.01); A61K 47/38 (2006.01)
CPC A61K 31/506 (2013.01) [A61K 9/0053 (2013.01); A61K 9/10 (2013.01); A61K 47/10 (2013.01); A61K 47/38 (2013.01)] 19 Claims
 
1. A method of delivering nilotinib to a patient suffering from a proliferative disorder, the method comprising administering to the patient a therapeutically effective amount of a pharmaceutical composition comprising an amorphous solid dispersion, the amorphous solid dispersion comprising nilotinib and one or more polymers;
wherein the one or more polymers comprises an anionic polymer comprising phthalate functionality;
wherein the nilotinib and the one or more polymers are present in the amorphous solid dispersion in a w/w ratio of 20:80 to 95:5 (nilotinib:polymer); and
wherein the administered amount of nilotinib is 50 to 80% less than a dose required for delivering a therapeutically effective amount of nilotinib in the fasted state using a conventional immediate-release crystalline nilotinib formulation.