Fumarate ester pharmaceutical compositions
AssigneeBanner Life Sciences LLC
InventorsTatyana Dyakonov, Sunil Agnihotri, Aqeel A. Fatmi
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Abstract
Described herein are pharmaceutical compositions comprising fumarate esters, methods for making the same, and methods for treating subjects in need thereof. In particular, oral pharmaceutical compositions comprising fumarate esters are described.
Claims30
An oral immediate release pharmaceutical composition comprising solid particles of one or more fumarate esters suspended in a single phase liquid matrix comprising a lipid liquid or lipophilic liquid vehicle at a weight ratio of fumarate ester to matrix from about 1:1 to about 1:9.
An oral immediate release pharmaceutical composition comprising:
- about 10% to about 50% of one or more fumarate esters comprising solid particles of dimethyl fumarate, monomethyl fumarate, or a combination thereof;
- and
- about 50% to about 90% of a single phase lipid liquid or lipophilic liquid vehicle.
A method for manufacturing an oral immediate release pharmaceutical composition comprising:
- (i) providing a single phase liquid matrix comprising a lipid liquid or lipophilic liquid vehicle and a suspension of one or more fumarate esters at a weight ratio of fumarate ester to matrix from about 1:1 to about 1:9;
- (ii) providing a soft capsule shell composition;
- (iii) casting the soft capsule shell composition into films using heat-controlled drums or surfaces;
- and
- (iv) forming a soft capsule comprising the matrix using rotary die encapsulation technology.
A pharmaceutical dosage form comprising a soft capsule encapsulating an immediate release composition comprising about 10% to about 50% of one or more fumarate esters comprising dimethyl fumarate, monomethyl fumarate, or a combination thereof and about 50% to about 90% of a single phase liquid vehicle comprising a lipid liquid or lipophilic liquid.
Dependencies are inferred from the claim text.