Process for producing a pharmaceutical solid preparation containing a poorly soluble drug

Abstract

Among the conventional processes for producing solid dispersion, the solid dispersion obtained by a solvent method is excellent in terms of solubility and bioavailability of a poorly soluble drug. However, due to frequent uses of organic solvents in the solvent method, problems have arisen such as organic solvent residue in products, environmental pollution and operational safety as well as corporate problems such as capital investment and the like required to avoid such events. The present invention provides a process for preparing pharmaceutical solid preparations without use of organic solvents frequently used in conventional solvent methods. Specifically, the present invention provides a process for producing a pharmaceutical solid preparation, which is formulated by spraying a solution wherein a poorly soluble drug is dissolved in a plasticizer, and an aqueous solution and/or water dispersion of a water-soluble polymer from nozzle outlets simultaneously and separately in the process for producing the pharmaceutical solid preparation.

1 - 4 . (canceled)  
     
     
         5 . A pharmaceutical solid preparation produced by spraying from nozzle outlets simultaneously and separately 1) a solution of a poorly soluble drug dissolved in a plasticizer, and 2) an aqueous solution and/or water dispersion of a water-soluble polymer.  
     
     
         6 . The pharmaceutical solid preparation produced by the process according to  claim 5 , wherein said plasticizer is selected from a group consisting of citrate esters, glycerine esters, phthalate esters and polyvalent alcohols.  
     
     
         7 . The pharmaceutical solid preparation produced by the process according to  claim 5 , wherein said water-soluble polymer is selected from the group consisting of cellulose derivatives and poly(vinylpyrrolidone).  
     
     
         8 . The pharmaceutical solid preparation produced by the process according to  claim 6 , wherein said water-soluble polymer is selected from the group consisting of cellulose derivatives and poly(vinylpyrrolidone).  
     
     
         9 - 11 . (canceled)