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 - 8 . (canceled) 
     
     
         9 . 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 as a medicament; wherein the preparation comprises at least one additional feature selected from the group consisting of (i) a higher ratio of the medicament in an unchanged form and a metabolite of the medicament after transfer into blood than that by oral administration, (ii) a masking agent, wherein the preparation comprises not less than about 10-fold improved bioavailability of (S)—N-[2-(1,6,7,8-tetrahydro-2H-indeno[5,4-b]furan-8-yl)ethyl]propionamide, as compared to that by oral administration and (iii) a sugar or sugar alcohol and a disintegrant, wherein the preparation comprises not less than about 10-fold improved bioavailability of (S)—N-[2-(1,6,7,8-tetrahydro-2H-indeno[5,4-b]furan-8-yl)ethyl]propionamide, as compared to that by oral administration. 
     
     
         10 . The preparation according to  claim 9 , wherein the preparation further comprises a disintegration time of not more than 30 sec. 
     
     
         11 . The preparation according to  claim 10 , wherein the preparation further comprises an absolute hardness of not less than 1.0 N/mm 2 . 
     
     
         12 .- 16 . (canceled) 
     
     
         17 . The preparation according to  claim 9 , which is a tablet. 
     
     
         18 . The preparation according to  claim 9 , which is in the form of a film, troche, solution, suspension, freeze-dried preparation, chewing gum or spray. 
     
     
         19 . A method for the prophylaxis and/or treatment of a bipolar disorder comprising administering (S)—N-[2-(1,6,7,8-tetrahydro-2H-indeno[5,4-b]furan-8-yl)ethyl]propionamide oral-mucosally to a human. 
     
     
         20 . The method according to  claim 19 , wherein the oral-mucosal administration is sublingual administration or buccal administration. 
     
     
         21 . The method according to  claim 19 , wherein (S)—N-[2-(1,6,7,8-tetrahydro-2H-indeno[5,4-b]furan-8-yl)ethyl]propionamide is administered in 0.05-1.0 mg per day. 
     
     
         22 . The method according to  claim 19 , wherein the bipolar disorder is bipolar disorder I. 
     
     
         23 . The method according to  claim 19 , wherein the prophylaxis and/or treatment of a bipolar disorder is a treatment of a depression symptom associated with the bipolar disorder or maintenance of a remission phase of the bipolar disorder. 
     
     
         24 . A drug for the prophylaxis and/or treatment of a bipolar disorder, which comprises, as an active ingredient, (S)—N-[2-(1,6,7,8-tetrahydro-2H-indeno[5,4-b]furan-8-yl)ethyl]propionamide to be oral-mucosally administered to a human. 
     
     
         25 . The drug according to  claim 24 , wherein the oral-mucosal administration is sublingual administration or buccal administration. 
     
     
         26 . The drug according to  claim 24 , wherein (S)—N-[2-(1,6,7,8-tetrahydro-2H-indeno[5,4-b]furan-8-yl)ethyl]propionamide is administered in 0.05-1.0 mg per day. 
     
     
         27 . The drug according to  claim 24 , wherein the bipolar disorder is bipolar disorder I. 
     
     
         28 . The drug according to  claim 24 , wherein the prophylaxis and/or treatment of a bipolar disorder is a treatment of a depression symptom associated with the bipolar disorder or maintenance of a remission phase of the bipolar disorder. 
     
     
         29 - 33 . (canceled)