US 12,433,891 B2
Amorphous solid dispersions of dasatinib and uses thereof
Christian F. Wertz, Saint Louis Park, MN (US); and Tzehaw Chen, Corcoran, MN (US)
Assigned to Handa Therapeutics, LLC, San Jose, CA (US)
Filed by Handa Therapeutics, LLC, San Jose, CA (US)
Filed on May 5, 2022, as Appl. No. 17/737,409.
Application 17/737,409 is a continuation of application No. 17/545,370, filed on Dec. 8, 2021, granted, now 11,324,745.
Application 17/545,370 is a continuation of application No. 17/206,823, filed on Mar. 19, 2021, granted, now 11,202,778, issued on Dec. 21, 2021.
Application 17/206,823 is a continuation of application No. PCT/US2021/014742, filed on Jan. 22, 2021.
Claims priority of provisional application 63/018,182, filed on Apr. 30, 2020.
Claims priority of provisional application 62/965,650, filed on Jan. 24, 2020.
Prior Publication US 2022/0280512 A1, Sep. 8, 2022
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 31/341 (2006.01); A61K 31/4164 (2006.01); A61K 31/426 (2006.01); A61K 31/4439 (2006.01); A61K 47/14 (2017.01); A61K 47/32 (2006.01); A61K 47/38 (2006.01)
CPC A61K 31/506 (2013.01) [A61K 9/0053 (2013.01); A61K 9/10 (2013.01); A61K 31/341 (2013.01); A61K 31/4164 (2013.01); A61K 31/426 (2013.01); A61K 31/4439 (2013.01); A61K 47/14 (2013.01); A61K 47/32 (2013.01); A61K 47/38 (2013.01)] 20 Claims
 
1. A method of treating a patient with a leukemia, the method comprising:
administering to the patient a pharmaceutical composition comprising an amorphous solid dispersion;
wherein the amorphous solid dispersion comprises dasatinib and a methacrylic acid and ethyl acrylate copolymer that exhibits pH-dependent solubility;
wherein the dasatinib and the copolymer are present in the amorphous solid dispersion in a w/w ratio of 30:70 to 95:5 (dasatinib:copolymer); and
wherein the patient is co-administered a gastric acid-reducing agent selected from the group consisting of an H2 antagonist or a proton pump inhibitor.