NOVEL FORMS OF APREMILAST AND THE PROCESS OF MAKING THE SAME

摘要

The present invention provides novel crystalline forms of apremilast hemitoluene solvate, apremilast hydrate, and apremilast anhydrate and an amorphous form of apremilast, and processes for the preparation of these forms.

主权项

1. A process for preparing apremilast, said process comprising:
a) contacting (S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethanamine and 3-acetamidophthalic anhydride in toluene and acetic acid at elevated temperature to form a mixture; and b) isolating apremilast from the mixture of step a).