Biogen Ma Inc.

Cheuk-Yui Leung

Peter Zawaneh

Shyam B Karki

Kalyan V Vasudevan

Yiqing Lin

Andrea Trementozzi

Jin Xu

Michael J Kaufman

William F Kiesman

Erwin Irdam

Ernest Quan

Pierre Boulas

Ivan Nestorov

Jinquan Dong

The present invention provides dimethyl fumarate (DMF) particles and methods of preparing the DMF particles. Also provided is DMF coated particles comprising DMF particles coated with an enteric coating. The invention also provides various dosage forms and methods of treating a disease or disorder (e.g., multiple sclerosis).

Dimethyl fumarate particles and pharmaceutical compositions thereof

The present invention provides novel pharmaceutical compositions of dimethyl fumarate. The pharmaceutical compositions of the present invention are in the form of a bead and comprise (i) an inert core; (ii) a first layer surrounding the inert core, wherein the first layer comprises dimethyl fumarate; and (iii) an enteric coating surrounding the first layer. Also provided are pharmaceutical compositions in the form of a bead comprising a core and an enteric coating surrounding the core, wherein the core comprises dimethyl fumarate. Methods of using the pharmaceutical compositions of the present invention for treating multiple sclerosis are also included.

Pharmaceutical bead formulations comprising dimethyl fumarate

The present invention provides novel pharmaceutical compositions of dimethyl fumarate. The pharmaceutical compositions of the present invention comprises a first pharmaceutical bead composition and a second pharmaceutical bead composition, wherein the first pharmaceutical bead composition is an enterically coated immediate-release composition and the second pharmaceutical bead composition is an enterically coated controlled-release composition, wherein the first pharmaceutical bead composition and the second pharmaceutical bead composition both comprise dimethyl fumarate Methods of using the pharmaceutical compositions of the present invention for treating multiple sclerosis are also included.

A controlled release dosage form containing monomethyl fumarate, a compound that can be metabolized into monomethyl fumarate in vivo, or a pharmaceutically acceptable salt thereof or combinations thereof, wherein the monomethyl fumarate, a compound that can be metabolized into monomethyl fumarate in vivo, or a pharmaceutically acceptable salt thereof or combinations thereof is delivered to the subject. Also provided is a method of treating a disease or disorder (e.g., multiple sclerosis) by orally administering a controlled release dosage form containing monomethyl fumarate, a compound that can be metabolized into monomethyl fumarate in vivo, or a pharmaceutically acceptable salt thereof or combinations thereof, wherein the monomethyl fumarate, a compound that can be metabolized into monomethyl fumarate in vivo, or a pharmaceutically acceptable salt thereof or combinations thereof.

Controlled release dosage form for once daily administration of dimethyl fumarate

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Acton, MA, United States of America

Cheuk-Yui Leung