Formulations of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid

A continuous process for preparing a tablet comprising 3-(6-(1-(2,2-Difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid (‘Compound 1’) Form I, comprising the steps of:

• a) mixing Compound 1 Form I milled to a particle size between 1 and 5 microns, a filler, and a disintegrant in a blender to form a blend;
• b) preparing a granulation solution with water, a binder, and a surfactant;
• c) feeding the blend from step a) into a continuous twin screw granulator while adding the granulation solution from step b) to produce granules;
• d) drying the granules from step c) and milling them;
• e) blending the milled granules from step d) with a filler, disintegrant, and lubricant to form a blend;
• f) compressing the blend from step e) into a tablet, wherein the tablet comprises:
• i. 30-55 wt % of Compound 1 Form I by weight of the composition;
• ii. about 20 wt % to about 55 wt % of the filler by weight of the composition, wherein the filler is microcrystalline cellulose;
• iii. about 1.5 wt % to about 7.5 wt % of the disintegrant by weight of the composition, wherein the disintegrant is croscarmellose sodium;
• iv. about 0.2 wt % to about 5 wt % of the surfactant by weight of the composition, wherein the surfactant is sodium lauryl sulfate;
• v. about 1 wt % to about 10 wt % of the binder by weight of the composition, wherein the binder is polyvinylpyrrolidone;
• and
• vi. about 0.5 wt % to about 4.5 wt % of the lubricant by weight of the composition, wherein the lubricant is magnesium stearate;
• g) optionally coating the tablet from step f).