Orally dispersible tablet
AssigneeTakeda Pharmaceutical Company Limited
InventorsYutaka Tanoue, Tetsuya Matsuura, Yutaka Yamagata, Naoki Nagahara
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Abstract
The present invention provides a preparation with improved disintegration property, a preparation showing improved bioavailability of a medicament, production methods thereof and the like. A rapidly disintegrating preparation comprising granules comprising a medicament coated with a coating layer containing sugar or sugar alcohol; and a disintegrant. A production method of a rapidly disintegrating preparation including a step of producing granules comprising a medicament, a step of forming a coating layer containing sugar or sugar alcohol on the obtained granules and a step of mixing the coated granules with a disintegrant and molding the mixture.
Claims13
1-24. (canceled)
A preparation for oral-mucosal absorption, comprising (S)—N-[2-(1,6,7,8-tetrahydro-2H-indeno[5,4-b]furan-8-yl)ethyl]propionamide in an amount of 0.1 mg,
- wherein the fasting state Cmax of (S)—N-[2-(1,6,7,8-tetrahydro-2H-indeno[5,4-b]furan-8-yl)ethyl]propionamide after administration to a human subject is about 0.43 to about 3.13 ng/ml,
- wherein the AUC (0-tlqc) of (S)—N-[2-(1,6,7,8-tetrahydro-2H-indeno[5,4-b]furan-8-yl)ethyl]propionamide after administration to a human subject is about 0.48 to about 2.26 ng·hr/ml, and
- wherein the average Tmax value of the plasma level of (S)—N-[2-(1,6,7,8-tetrahydro-2H-indeno[5,4-b]furan-8-yl)ethyl]propionamide after administration to a human subject is not more than about 0.4 hours.
A preparation for oral-mucosal absorption, comprising (S)—N-[2-(1,6,7,8-tetrahydro-2H-indeno[5,4-b]furan-8-yl)ethyl]propionamide in an amount of 0.4 mg,
- wherein the fasting state Cmax of (S)—N-[2-(1,6,7,8-tetrahydro-2H-indeno [5,4-b]furan-8-yl)ethyl]propionamide after administration to a human subject is about 2.04 to about 6.89 ng/ml,
- wherein the AUC (0-tlqc) of (S)—N-[2-(1,6,7,8-tetrahydro-2H-indeno[5,4-b]furan-8-yl)ethyl]propionamide is about 1.52 to about 6.68 ng·hr/ml, and
- wherein the average Tmax value of the plasma level of (S)—N-[2-(1,6,7,8-tetrahydro-2H-indeno[5,4-b]furan-8-yl)ethyl]propionamide after administration to a human is not more than about 0.4 hours.
A preparation for oral-mucosal absorption, comprising (S)—N-[2-(1,6,7,8-tetrahydro-2H-indeno[5,4-b]furan-8-yl)ethyl]propionamide in an amount of 0.8 mg,
- wherein the fasting state Cmax of (S)—N-[2-(1,6,7,8-tetrahydro-2H-indeno[5,4-b]furan-8-yl)ethyl]propionamide after administration to a human subject is about 3.63 to about 14.06 ng/ml,
- wherein the AUC (0-tlqc) of (S)—N-[2-(1,6,7,8-tetrahydro-2H-indeno[5,4-b]furan-8-yl)ethyl]propionamide after administration to a human subject is about 2.48 to about 14.43 ng·hr/ml, and
- wherein the average Tmax value of the plasma level of (S)—N-[2-(1,6,7,8-tetrahydro-2H-indeno[5,4-b]furan-8-yl)ethyl]propionamide after administration to a human subject is not more than about 0.4 hours.
Dependencies are inferred from the claim text.