Zaklady Farmaceutyczne Polpharma S.a.

Przemyslaw Skoczen

Marcin Szulc

Aleksandra Drozd

Piotr Garczarek

Dominika Podwysocka

Marek Cichocki

Monika Oracz

Arkadiusz Majewski

Julia Hrakovsky

The present invention relates to a process for the preparation of an oral pharmaceutical preparation in the form of enteric coated granulate comprising dimethyl fumarate and pharmaceutically acceptable excipients. The invention relates also to an oral pharmaceutical preparation in the form of enteric coated granulate obtained by the process of the present invention and to use of the preparation in the treatment of multiple sclerosis.

Process for preparation of an enteric coated granulate comprising dimethyl fumarate

The invention particularly relates to crystalline (solid) forms of N-[2-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-1,3-dioxo-2,3-dihydro-1H-isoindol-4-yl]acetamide), i.e. Form N, Form M, Form O and Form P. It also refers to a pharmaceutical composition or dosage form comprising said crystalline forms. The invention also concerns said pharmaceutical composition or dosage form for use in a method of treating a disease or disorder defined in the claims. Finally, the invention pertains to the use of said novel crystalline forms for the preparation of a pharmaceutical composition or dosage form.

Crystalline forms of apremilast

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Straszyn, Poland

Przemyslaw Skoczen