US 12,109,193 B2
Spray-dried dispersions, formulations, and polymorphs of (s)-5-amino-3-(4-((5-fluoro-2-methoxybenzamido)methyl)phenyl)-1-(1,1,1-trifluoropropan-2-yl)-1H-pyrazole-4-carboxamide
Barbara J. Brandhuber, Boulder, CO (US); Lauren T. Brent, San Diego, CA (US); Charles Todd Eary, Longmont, CO (US); Andrew Kenna, San Diego, CA (US); Firas Khan, San Diego, CA (US); Vivian F. H. Renshaw, San Diego, CA (US); and Stacey Renee Spencer, Lyons, CO (US)
Assigned to Loxo Oncology Inc., Indianapolis, IN (US)
Appl. No. 17/260,745
Filed by Loxo Oncology, Inc., Indianapolis, IN (US)
PCT Filed Jul. 29, 2019, PCT No. PCT/US2019/043937
§ 371(c)(1), (2) Date Jan. 15, 2021,
PCT Pub. No. WO2020/028258, PCT Pub. Date Feb. 6, 2020.
Claims priority of provisional application 62/769,308, filed on Nov. 19, 2018.
Claims priority of provisional application 62/729,855, filed on Sep. 11, 2018.
Claims priority of provisional application 62/712,861, filed on Jul. 31, 2018.
Prior Publication US 2021/0330643 A1, Oct. 28, 2021
Int. Cl. A61K 31/415 (2006.01); A61K 9/00 (2006.01); A61K 9/20 (2006.01); A61K 31/635 (2006.01); A61P 35/04 (2006.01); C07K 16/28 (2006.01)
CPC A61K 31/415 (2013.01) [A61K 9/0053 (2013.01); A61K 9/2009 (2013.01); A61K 9/2018 (2013.01); A61K 9/2054 (2013.01); A61K 9/2059 (2013.01); A61K 31/635 (2013.01); A61P 35/04 (2018.01); C07K 16/2887 (2013.01); C07B 2200/13 (2013.01)] 6 Claims
 
1. A pharmaceutical composition comprising a spray-dried dispersion comprising a compound of Formula I:

OG Complex Work Unit Chemistry
or a pharmaceutically acceptable salt thereof and one or more polymers selected from the group consisting of an HPMCAS polymer, an HPMC polymer, a vinylpyrrolidone-vinyl acetate copolymer, and a polyvinylpyrrolidone (PVP) polymer and a pharmaceutically acceptable excipient.