Claims for Patent: 11,571,402

Summary for Patent: 11,571,402

Title:	Dispersible formulations of N-((R)-2,3-dihydroxypropoly)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide and uses thereof
Abstract:	The present disclosure relates to dispersible pharmaceutical compositions comprising N—((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide, and, optionally, a pharmaceutically acceptable carrier.
Inventor(s):	Kristin Patterson, Jiping Liu
Assignee:	SpringWorks Therapeutics Inc
Application Number:	US17/177,999
Patent Claims:	1. A dispersible pharmaceutical composition that disintegrates or dissolves within 10 minutes after being combined with a potable liquid, comprising: a. about 0.1 mg to about 20 mg of N—((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide of Formula (I) corresponding to about 0.1 wt/wt % to about 7 wt/wt % of N—((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide; b. about 50 wt/wt % to about 98 wt/wt % of one or more diluents; c. about 1 wt/wt % to about 10 wt/wt % of one or more disintegrants; d. one or more flavoring agents; e. one or more sweeteners; and f. about 0 wt/wt % to about 5 wt/wt % of one or more lubricants. 2. The pharmaceutical composition of claim 1, wherein the N—((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide is crystalline. 3. The pharmaceutical composition of claim 2, wherein the crystalline form of N—((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide is selected from the group consisting of: a) a crystalline form of N—((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide characterized by an XRPD pattern having peaks at 4.6±0.2, 7.3±0.2, and 14.6±0.2 degrees two theta; b) a crystalline form of N—((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide characterized by an XRPD pattern having peaks at one or more of 10.6±0.2, 13.7±0.2, 19.0±0.2, and 23.7±0.2 degrees two theta; and c) a crystalline form of N—((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide characterized by an XRPD pattern having peaks at one or more of 5.5±0.2 and 19.6±0.2 degrees two theta. 4. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition is orodispersible. 5. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition is a tablet, a powder, granules, minitablets, or pellets. 6. The pharmaceutical composition of claim 5, wherein the pharmaceutical composition is a powder that is a dispersible powder. 7. The pharmaceutical composition of claim 5, wherein the pharmaceutical composition is granules that are dispersible granules. 8. The pharmaceutical composition of claim 5, wherein the pharmaceutical composition is minitablets that are dispersible minitablets. 9. The pharmaceutical composition of claim 5, wherein the pharmaceutical composition is in the form of pellets that are dispersible pellets. 10. The pharmaceutical composition of claim 5, wherein the pharmaceutical composition is a dispersible tablet. 11. The pharmaceutical composition of claim 1, comprising: a. about 0.5 wt/wt % to about 1.2 wt/wt % of N—((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide; b. about 85 wt/wt % to about 95 wt/wt % of one or more diluents; c. about 3.5 wt/wt % to about 6 wt/wt % of one or more disintegrants; d. grape flavor; e. sucralose; and f. about 0.5 wt/wt % to about 2 wt/wt % of one or more lubricants.