Orally dispersible tablet

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.

1 - 24 . (canceled) 
     
     
         25 . 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. 
 
     
     
         26 . The preparation according to  claim 25 , wherein the average Tmax value is not more than about 0.3 hours. 
     
     
         27 . The preparation according to  claim 26 , wherein the average Tmax value is not more than about 0.25 hours. 
     
     
         28 . The preparation according to any one of  claims 25 - 27 , wherein the Cmax is about 0.66 to about 2.05 ng/ml, and wherein the AUC (0-tlqc) is about 0.67 to about 1.62 ng·hr/ml. 
     
     
         29 . 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. 
 
     
     
         30 . The preparation according to  claim 29 , wherein the average Tmax value is not more than about 0.3 hours. 
     
     
         31 . The preparation according to  claim 30 , wherein the average Tmax value is not more than about 0.25 hours. 
     
     
         32 . The preparation according to any one of  claims 29 - 31 , the Cmax is about 2.54 to about 5.54 ng/ml, and wherein the AUC (0-tlqc) is about 1.98 to about 5.12 ng·hr/ml. 
     
     
         33 . 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. 
 
     
     
         34 . The preparation of  claim 33 , wherein the average Tmax value is not more than about 0.3 hours. 
     
     
         35 . The preparation of  claim 34 , wherein the average Tmax value is not more than about 0.25 hours. 
     
     
         36 . The preparation according to any one of  claims 33 - 35 , wherein the Cmax is about 4.85 to about 10.54 ng/ml, and wherein the AUC (0-tlqc) is about 3.60 to about 9.91 ng·hr/ml.