Coated preparation
AssigneeTakeda Pharmaceutical Company Limited
InventorsHiroto Bando, Yoshihiro Omachi, Kenichiro Kiyoshima
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Abstract
The present invention provides a preparation containing pioglitazone or a salt thereof as an active ingredient, which shows high bioavailability of pioglitazone and less interindividual variation in blood drug concentration, as well as a preparation with suppressed color change during preservation. The preparation contains a core containing a pharmaceutically acceptable organic acid with water solubility at 20° C. of not less than 10 mg/mL and pKa1 (a negative common logarithm of the first acid dissociation constant Ka1) at 25° C. of not more than 5, and a coating layer containing pioglitazone or a salt thereof. The coating layer may further contain mannitol or trehalose.
Claims7
A preparation comprising
- a core comprising a pharmaceutically acceptable organic acid with water solubility at 20° C. of not less than 10 mg/mL and a negative common logarithm pKa1 of the first acid dissociation constant Ka1 at 25° C. of not more than 5, and
- a coating layer comprising pioglitazone hydrochloride, and further comprising (1) mannitol or trehalose, and (2) low-substituted hydroxypropylcellulose,
- wherein the pharmaceutically acceptable organic acid is selected from a group consisting of citric acid, tartaric acid, malic acid and ascorbic acid,
- wherein the weight ratio of pioglitazone to the pharmaceutically acceptable organic acid is 1:4 to 1:26, and wherein the content of the pharmaceutically acceptable organic acid contained in the core is 20-95 parts by weight, per 100 parts by weight of the preparation, and
- wherein the content of the low-substituted hydroxypropylcellulose in the coating layer is 0.5-70 parts by weight, per 100 parts by weight of the coating layer.
Dependencies are inferred from the claim text.