Oral dosage forms of methyl hydrogen fumarate and prodrugs thereof
View Patent ↗Improved oral dosage forms of methyl hydrogen fumarate and prodrugs thereof are disclosed. Methods of treating diseases such as multiple sclerosis and psoriasis using such dosage forms are also disclosed.
1. A method of making (N,N-Diethylcarbamoyl)methyl methyl (2E)but-2-ene-1,4-dioate-containing pharmaceutical pellets comprising:
mixing the (N,N-Diethylcarbamoyl)methyl methyl (2E)but-2-ene-1,4-dioate in an aqueous medium to form a wet mass;
adding acetic acid to the wet mass to form a mixture;
maintaining the mixture at a pH at or below 3.8; and
forming pellets.
2. The method of claim 1 , comprising maintaining the mixture at a pH at or below 3.5.
3. The method of claim 1 , wherein the step of mixing further comprising combining a binder to the aqueous medium and the (N,N-Diethylcarbamoyl)methyl methyl (2E)but-2-ene-1,4-dioate to form the wet massif; and
the step of forming pellets further comprising
extruding the mixture to form an extrudate;
spheronizing the extrudate to form pellets; and
drying the pellets.
4. The method of claim 1 , wherein the step of mixing further comprising combining a binder to the aqueous medium and the (N,N-Diethylcarbamoyl)methyl methyl (2E)but-2-ene-1,4-dioate to form the wet mass; and
the step of forming pellets further comprising
introducing the mass mixture onto a rotating friction plate to form pellets; and
drying the pellets.