PHARMACEUTICAL COMPOSITION CONTAINING DIMETHYL FUMARATE FOR ADMINISTRATION AT A LOW DAILY DOSE

1 . A pharmaceutical composition for oral use in treating psoriasis, wherein said composition is in the form of an erosion matrix tablet comprising a tablet core and one or more coating(s), wherein the tablet core comprises

i) 10 to 80% by weight dimethyl fumarate as an active substance, and

ii) 1 to 50% by weight of one or more rate-controlling agents,

wherein at least one of the one or more coating(s) is an enteric coating applied at a level of 1.5 to 3.5% by weight of the core, and

wherein the dose of dimethyl fumarate to be administered is 375 mg±5% per day.

2 . The pharmaceutical composition according to claim 1 , wherein the dose to be administered is 375 mg per day.

3 . The pharmaceutical composition according to claim 1 or 2 , wherein the tablet core comprises

i) 30 to 60% by weight of dimethyl fumarate; and

ii) 3 to 40% by weight of one or more rate-controlling agents.

4 . The pharmaceutical composition according to claim 3 , wherein the rate-controlling agent is a water-soluble polymer.

5 . The pharmaceutical composition according to any one of claims 1 - 4 , wherein the rate-controlling agent is a cellulose polymer or a cellulose derivative or a mixture thereof.

6 . The pharmaceutical composition according to any one of the previous claims, wherein the rate-controlling agent is selected from the group comprising hydroxypropyl cellulose, hydroxypropyl methyl cellulose (HPMC), methyl cellulose, carboxymethyl cellulose and mixtures thereof.

7 . The pharmaceutical composition according to claim 6 , wherein the rate-controlling agent is hydroxypropyl cellulose.

8 . The pharmaceutical composition according to any one of the preceding claims, wherein the tablet core further comprises a binder.

9 . The pharmaceutical composition according to claim 8 , wherein the binder is lactose.

10 . The pharmaceutical composition according to any one of the preceding claims, wherein the tablet core comprises:

i) 35-55% by weight of dimethyl fumarate;

ii) 3-12% by weight of hydroxypropyl cellulose; and

iii) 40-60% by weight of lactose.

11 . The pharmaceutical composition according to any one of the preceding claims, wherein the tablet core comprises:

i) 40-50% by weight of dimethyl fumarate;

ii) 3-12% by weight of hydroxypropyl cellulose; and

iii) 45-55% by weight of lactose.

12 . The pharmaceutical composition according to any one of the preceding claims, wherein the tablet core comprises:

i) 42-48% by weight of dimethyl fumarate;

ii) 3-10% by weight of hydroxypropyl cellulose; and

iii) 45-52% by weight of lactose.

13 . The pharmaceutical composition according to claim 11 or 12 , wherein the amount of hydroxypropyl cellulose is 3-6% by weight.

14 . The pharmaceutical composition according to any one of the preceding claims, wherein the tablet core further comprises 0.15-0.7% by weight of magnesium stearate and, optionally, 0.05 to 0.25% by weight of silicon dioxide.

15 . The pharmaceutical composition according to any one of the preceding claims for administration once, twice or three times daily.

16 . The pharmaceutical composition according to any one of the preceding claims for the treatment of mild to moderate, moderate to severe, or severe plaque psoriasis.