Quick disintegrating tablet in buccal cavity and production process thereof

Abstract

The present invention relates to a quick disintegrating tablet in buccal cavity, comprising: a mixture, comprising a drug, a sugar (A), and an amorphous sugar (B), and after it is forming a tablet, it is humidified and dried. In particularly, the present invention relates to a quick disintegrating tablet in buccal cavity comprising: a mixture; comprising a drug, a sugar (A), and an amorphous sugar (B) which an amorphous-forming sugar in crystalline state is dissolved in a medicinally permitted solvent, the amorphous sugar is obtained from this solution by removing the solvent, and after it is forming a tablet, and it is humidified and dried. The tablet in the present invention is to provide stability against moisture at preserved, because the amorphous sugar changed to the crystalline state in a nonreversible reaction after it is humidified and dried in a manufacturing process. The tablet in the present invention is to further provide a design for the pharmaceutical preparation with respect to the stability of a drug, because the tablet is manufactured by one kind of a sugar and an amorphous sugar. Furthermore, the tablet in the present invention is to provide a production process by utilizing a common granulating machine and by utilizing a common tablet machine.

1 . A quick disintegrating tablet in buccal cavity, comprising: 
 a mixture, comprising:    a drug;    a sugar (A); and    an amorphous sugar (B);    and after forming a tablet, it being humidified and dried.    
     
     
         2 . The quick disintegrating tablet in buccal cavity according to  claim 1 , comprising: 
 a mixture, comprising:    a drug;    a sugar (A); and    an amorphous sugar (B) which can be obtained by dissolving a crystalline sugar capable of becoming amorphous in a medicinally permitted solvent and removing said solvent from said solution and drying; and    after forming a tablet, it being humidified and dried.    
     
     
         3 . The quick disintegrating tablet in buccal cavity according to  claim 1 , comprising: 
 a mixture, comprising:    a drug;    a sugar (A); and    an amorphous sugar (B) which can be obtained by dissolving a crystalline sugar capable of becoming amorphous in a medicinal permitted solvent and spray-drying said solution;    in which, after forming a tablet, said tablet being humidified and dried.    
     
     
         4 . The quick disintegrating tablet in buccal cavity according to  claim 1 , comprising: 
 a crystalline sugar capable of becoming amorphous is dissolved in a medicinally permitted solvent;    said solution is sprayed on a drug and/or a sugar (A) to coat and/or granulate, and after forming a tablet, it is humidified and dried.    
     
     
         5 . The quick disintegrating tablet in buccal cavity according to  claim 1  wherein said drug is present in an amount effective to cure a patient, wherein said amorphous sugar (B) is not less than 2 weight/weight % per preparation weight, and wherein said sugar (A) is in an amount of the total 100 w/w % of the preparation consisting essentially of the drug, the sugar (A) and the amorphous sugar (B).  
     
     
         6 . The quick disintegrating tablet in buccal cavity according to  claim 1  wherein the condition for humidification is performed at not less than an apparent critical relative humidity of a mixture consisting of a drug, a sugar (A), and an amorphous sugar (B).  
     
     
         7 . The quick disintegrating tablet in buccal cavity according to  claim 1  wherein the condition for humidity is 30 to 100 RH %, and wherein said condition is 15 to 50° C.  
     
     
         8 . The quick disintegrating tablet in buccal cavity according to  claim 1  wherein said amorphous sugar (B) is obtained by lyophilization and/or various granulating methods.  
     
     
         9 . A quick disintegrating tablet made by a dry blend granulation production process comprising the following steps: 
 (i) mixing a blend comprising at least one saccharide, wherein the saccharide is at least about 1-90% by volume of the dry blend;    (ii) compressing the mixed dry blend form step (i) into a tablet form;    (iii) humidifying the tablet by exposing the product of step (ii) to a humidified environment; and    (iv) drying the tablet humidified in step (iii), wherein the hardness of the dried tablet is greater than that of the compressed tablet of step (ii).