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.
Claims19
An enteric coating tablet comprising:
- a core containing dimethyl fumarate or a pharmaceutically acceptable salt thereof as an active ingredient;
- an enteric coating layer;
- and
- a seal-coating layer comprising a cellulose-based polymer between the core and the enteric coating layer,
- wherein
- the active ingredient is included in an amount of 60 mg to 480 mg in 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
- the particle size distribution of dimethyl fumarate or a pharmaceutically acceptable salt thereof satisfies one or more 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.
(canceled)
-8. (canceled)
(canceled)
A method for preparing an enteric coating tablet comprising the following steps:
- a step of preparing a mixture by mixing dimethyl fumarate or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable additive;
- a step of preparing a core by directly tableting the mixture;
- a step of seal-coating the core;
- and
- a step of enteric coating the core,
- wherein, the enteric coating is performed with 6 to 9 weight parts of the enteric coating layer based on 100 weight parts of the core.
(canceled)
Dependencies are inferred from the claim text.