Enteric tablet containing dimethyl fumarate
AssigneeCuracle Co., Ltd.
InventorsMyung-Hwa Kim, Jung-In Pyo, Jong Hyon Mo, Cheol Woo Lee, Hyun-Ku Ji
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Abstract
The present invention relates to an enteric coating tablet comprising: a core containing, as an active ingredient, dimethyl fumarate or a pharmaceutically acceptable salt thereof; and an enteric coating layer, and provides a tablet, which exhibits an effect equal to that of a capsule dosage form currently on the market, can be prepared through a simple preparation process, and is a dosage form having excellent storage stability and administration convenience, and thus can be applied to various patient groups.
Claims16
An enteric coating tablet comprising:
- a core containing dimethyl fumarate as an active ingredient, and pharmaceutically acceptable additives;
- an enteric coating layer comprising methacrylic acid ethyl acrylate copolymer;
- and
- a seal-coating layer comprising hydroxypropyl methyl cellulose between the core and the enteric coating layer,
- wherein,
- the active ingredient is included in an amount of 60 mg to 250 mg in the core and in an amount of 40 to 45 weight % based on the core,
- the enteric coating layer is included in an amount of 6 to 9 weight parts based on 100 weight parts of the core,
- the seal-coating layer is included in an amount of 1 to 3 weight parts based on 100 weight parts of the core, and
- a particle size distribution of the dimethyl fumarate satisfies all of the following conditions:
- (a) the mean particle size of the lower 90% of the particles (D90) is 100 μm or less;
- (b) the mean particle size of the lower 50% of the particles (D50) is 50 μm or less;
- and
- (c) the mean particle size of the lower 10% of the particles (D10) is 20 μm or less,
- wherein the pharmaceutically acceptable additives comprise excipient, disintegrant and lubricant.
An enterically coated tablet, comprising:
- a core comprising 120 mg to 250 mg dimethyl fumarate at an amount of 40 to 45 weight % based on the core and pharmaceutically acceptable additives, wherein a mean particle size of the lower 90% of particles (D90) of the dimethyl fumarate is 100 μm or less, a mean particle size of the lower 50% of the particles (D50) is 50 μm or less, and a mean particle size of the lower 10% of the particles (D10) is 20 μm or less;
- a seal-coating layer in an amount of 1 to 3 weight parts based on 100 weight parts of the core, wherein the seal-coating layer comprises hydroxypropyl methyl cellulose;
- an enteric coating layer in an amount of 6 or 8 weight parts based on 100 weight parts of the core, wherein the enteric coating layer comprises methacrylic acid ethyl acrylate copolymer;
- and
- wherein the seal-coating layer is between the core and the enteric coating layer,
- wherein the pharmaceutically acceptable additives comprise excipient, disintegrant and lubricant.
Dependencies are inferred from the claim text.