Solid forms comprising (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione, compositions thereof, and uses thereof
Solid forms comprising (+)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione, compositions comprising the solid forms, methods of making the solid forms and methods of their use are disclosed. The methods include methods of treating and/or preventing disorders ameliorated by the reduction of levels of TNF-α or the inhibition of PDE4.
1. A method of treating a disease or disorder selected from the group consisting of psoriasis, psoriatic arthritis, rheumatoid arthritis, Behcet's Disease, rheumatoid spondylitis, an arthritic condition, atopic dermatitis, and ulcerative colitis, wherein the method comprises administering a therapeutically or prophylactically effective amount of a Form B crystal form of the compound of Formula (I):
which is enantiomerically pure, and which has an X-ray powder diffraction pattern comprising peaks at about 10.1, 13.5, 20.7, and 26.9 degrees 2θ.
2. The method of claim 1 , wherein the crystal form has an X-ray powder diffraction pattern further comprising peaks at about 12.4, 15.7, 18.1, and 24.7 degrees 2θ.
3. The method of claim 2 , wherein the crystal form has an X-ray powder diffraction pattern further comprising peaks at about 16.3, 22.5, 26.2, and 29.1 degrees 2θ.
4. The method of claim 1 , wherein the crystal form has an X-ray powder diffraction pattern matching the pattern depicted in FIG 5 .
5. The method of claim 1 , wherein the crystal form has a differential scanning calorimetry plot comprising an endothermic event with an onset temperature of about 154° C.
6. The method of claim 1 , wherein the crystal form has a differential scanning calorimetry plot matching the plot depicted in FIG 6 .
7. The method of claim 1 , wherein the crystal form has a thermal gravimetric analysis plot comprising a mass loss of less than about 1% when heated from about 25° C. to about 140° C.
8. The method of claim 7 , wherein the mass loss is about 0.25%.
9. The method of claim 1 , wherein the crystal form has a thermal gravimetric analysis plot matching the plot depicted in FIG 7 .
10. The method of claim 1 , wherein the crystal form exhibits a mass increase of less than about 1% when subjected to an increase in relative humidity from about 0% to about 95% relative humidity.
11. The method of claim 10 , wherein the mass increase is about 0.6%.
12. The method of claim 1 , wherein the crystal form has a moisture sorption isotherm plot matching the plot depicted in FIG 8 .
13. The method of claim 1 , wherein the crystal form is stable upon exposure to about 40° C. and about 75% relative humidity for about 4 weeks.
14. The method of claim 1 , wherein the disease or disorder is psoriasis.
15. The method of claim 1 , wherein the disease or disorder is psoriatic arthritis.
16. The method of claim 1 , wherein the disease or disorder is rheumatoid arthritis.
17. The method of claim 1 , wherein the disease or disorder is Behcet's Disease.
18. The method of claim 1 , wherein the disease or disorder is rheumatoid spondylitis.
19. The method of claim 1 , wherein the disease or disorder is an arthritic condition.
20. The method of claim 1 , wherein the disease or disorder is atopic dermatitis.
21. The method of claim 1 , wherein the disease or disorder is ulcerative colitis.