Forms of apremilast
The present disclosure is directed to novel forms of apremilast and pharmaceutical compositions comprising any of the novel forms of apremilast. Also provided are processes for the preparation of novel forms of apremilast.
1. Apremilast dimethylacetamide solvate Form I.
2. The apremilast dimethylacetamide solvate Form I according to claim 1 that has an X-ray powder diffraction pattern comprising peaks, in terms of 2-theta, at about 26.51 and about 17.93.
3. The apremilast dimethylacetamide solvate Form I according to claim 2 , further comprising peaks, in terms of 2-theta, at about 22.65, about 7.64, and about 24.96.
4. The apremilast dimethylacetamide solvate Form I according to claim 1 that is characterized by an endothermic event at about 129° C.
5. The apremilast dimethylacetamide solvate Form I according to claim 1 that is characterized by an endothermic event onset at about 126° C.
6. A composition comprising the apremilast dimethylacetamide solvate Form I according to claim 1 .
7. The composition according to claim 6 , wherein the composition is a pharmaceutical composition further comprising at least one pharmaceutically acceptable excipient.
8. A method of treating a disease selected from the group consisting of psoriatic arthritis, plaque psoriasis, and Behcet's disease comprising administering the pharmaceutical composition according to claim 7 to a subject in need thereof.
9. A method of making apremilast dimethylacetamide solvate Form I according to claim 1 , comprising exposing a starting material comprising apremilast to dimethylacetamide to yield apremilast dimethylacetamide solvate Form I.