Pharmaceutical composition containing dimethyl fumarate for administration at a low daily dose
AssigneeFWP IP ApS
InventorsChristin GALETZKA, Chris RUNDFELDT, Roland RUPP, Peder M. ANDERSEN
Life of this patent
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Abstract
The present invention relates to pharmaceutical compositions containing dimethyl fumarate (DMF). More specifically, the present invention relates to a pharmaceutical composition for oral use in treating psoriasis by administering a low daily dosage in the range of 375 mg±5% dimethyl fumarate, wherein the pharmaceutical formulation is in the form of an erosion matrix tablet.
Claims16
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.
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.
The pharmaceutical composition according to any one of the preceding claims, wherein the tablet core further comprises a binder.
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.
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.
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.
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.
The pharmaceutical composition according to any one of the preceding claims for administration once, twice or three times daily.
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.
Dependencies are inferred from the claim text.