Stabilized dialkyl fumarate compositions
AssigneeEnspire Group LLC
InventorsAbdul Rashid, Zhang Julia Zhang, Minh Tran, Dahai Guo, Yi Zeng, Charchil Vejani, Hengsheng Adam Feng
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Abstract
Stabilized liquid, suspension or gel compositions containing a dialkyl fumarate and comprising a vehicle which serves as a protective base, a pharmaceutically acceptable surfactant, and a pharmaceutically acceptable acidulant, and methods of preparing such compositions are disclosed. Capsules and other dosage forms containing the stabilized liquid, suspension or gel compositions are also disclosed.
Claims34
A liquid, suspension or gel composition comprising:
- a) about 10-50% by weight of a dialkyl fumarate;
- bi) about 30-75% by weight of a vehicle comprising one or more compounds selected from the group consisting of pharmaceutically acceptable waxes, solid aliphatic alcohols, vegetable oils, hydrogenated vegetable oils, and mixtures of two or more thereof;
- or
- bii) about 30-85% by weight of a vehicle comprising one or more compounds selected from the group consisting of of poly(ethylene glycols);
- c) about 1-30% by weight of at least one pharmaceutically acceptable surfactant;
- and
- d) about 1-10% by weight of a pharmaceutically acceptable acidulant;
- based on the total weight of the composition.
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The suspension composition of claim 31, wherein dimethyl fumarate is present in about 34.53%, lactic acid is present in about 4.32%, the vehicle is present in about 35.97%, polyoxyl-40 hydrogenated castor oil is present in about 10.07%;
- and sorbitan monooleate is present in about 15.11% by weight.
A suspension composition comprising:
- a) about 10-50% by weight of dimethyl fumarate;
- b) about 30-85% of a pharmaceutically acceptable vehicle;
- ci) about 1-15% by weight of polyoxyl-40 hydrogenated castor oil;
- cii) about 1-20% by weight of sorbitan monooleate;
- and
- d) about 1-10% by weight of lactic acid;
- based on the total weight of the composition.
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A liquid, suspension or gel composition which releases dialkyl fumarate by a mechanism in which the formulation, upon interaction with an aqueous environment in vivo, forms an oil-in-water emulsion, releasing the dialkyl fumarate and making it bioavailable.
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Dependencies are inferred from the claim text.