Salts and pharmaceutical compositions thereof for the treatment of inflammatory disorders

1. A pharmaceutically acceptable salt of a compound according to Formula (I):

wherein the salt is a 1:1 free base/maleic acid salt in a crystalline form characterized at least by an X-ray powder diffraction peak at each of the following positions: 4.3, 8.3, 12.0, 15.0, 16.3, 18.1, 18.7, 19.3, 20.0, 20.4, 22.6, 23.5, 23.9, 24.0, 24.5, 25.4, 25.8, and 28.7±0.2° 2θ.

2. A method for preparing a pharmaceutically acceptable salt of claim 1 comprising:

combining the compound according to Formula I with maleic acid in an inert solvent; and

precipitating said salt from said solvent.

3. A method for preparing a pharmaceutically acceptable salt of claim 1 comprising:

combining the compound of Formula I and maleic acid in a suitable solvent in order to achieve full dissolution;

evaporating the solvent in order to achieve supersaturation; and

crystallizing the salt.

4. The method according to claim 2 , wherein the salt is obtained by mixing the compound of Formula I and the acid in a molar ratio of between 5:1 and 1:5 of Formula I:acid.

5. The method according to claim 2 , wherein the solvent is selected from acetonitrile, dioxane, THF, acetone, DCM, and MeOH.

6. A method for preparing a pharmaceutically acceptable salt according to claim 1 , comprising:

i) suspending 1 equivalent of the compound of Formula I in 20 volumes of 5% water in acetone at 25° C.,

ii) warming the suspension of step i) to 50° C.,

iii) adding 2.1 equivalent of maleic acid (1 M solution in THF) to the stirred suspension at 50° C. obtained in the previous step ii),

iv) cooling the mixture of step iii) to 25° C. at 1° C./min and stirring at 25° C. for 22 h,

v) separating by filtration the resulting solid obtained in the previous step iv), and

vi) drying under suction said resulting solid obtained in the previous step v).