Film-forming compostions for the film-coating of solid forms

Abstract

A film-forming composition including a fluidized hydroxypropyl starch and sorbitol, a film-coating method using the composition, and film-coated solid forms including a fluidized hydroxypropyl starch and sorbitol in the coating are described.

1 . A film-forming composition, in particular intended for the film-coating of solid forms, characterized in that it comprises a fluidized hydroxypropyl starch and sorbitol and in that the sorbitol is included in said film-forming composition at a content of between 5% and 80% by dry weight relative to the dry weight of fluidized hydroxypropyl starch, preferentially between 5% and 40%, more preferentially between 15% and 35%, the limit at 35% being preferentially excluded. 
     
     
         2 . The film-forming composition as claimed in  claim 1 , characterized in that the fluidized hydroxypropyl starch is a corn and/or legume starch, preferentially a pea starch, more preferentially a smooth pea starch. 
     
     
         3 . The film-forming composition as claimed in  claim 1 , characterized in that the fluidized hydroxypropyl starch and the sorbitol together represent between 15% and 100% by dry weight relative to the total weight of the solids of said film-forming composition, preferentially between 30% and 95%, more preferentially between 60% and 95%. 
     
     
         4 . The film-forming composition as claimed in  claim 1 , characterized in that it also comprises an antiaggregating agent, preferentially stearic acid. 
     
     
         5 . The film-forming composition as claimed in  claim 1 , characterized in that it also comprises an opacifying agent, preferentially titanium dioxide. 
     
     
         6 . The film-forming composition as claimed in  claim 1 , characterized in that the fluidized hydroxypropyl starch is made soluble. 
     
     
         7 . The film-forming composition as claimed in  claim 1 , characterized in that it is a ready-to-use product. 
     
     
         8 . The film-forming composition as claimed in  claim 1 , characterized in that it is an aqueous composition. 
     
     
         9 . The aqueous film-forming composition as claimed in  claim 8 , characterized in that it has a solids content of between 5% and 50% by weight, preferentially between 10% and 35%, more preferentially between 15% and 30%. 
     
     
         10 . The aqueous film-forming composition as claimed in  claim 8 , characterized in that it has a Brookfield viscosity, at 25° C., of less than or equal to 500 mPa·s, more preferentially of between 50 and 500 mPa·s, more preferentially between 80 and 300 mPa·s. 
     
     
         11 . A film-coating process, characterized in that it comprises:
 a step a′) of spraying an aqueous film-forming composition as defined in  claim 8  on to a moving bed of solid forms,   a step b) of drying the solid forms thus film-coated, preferentially concomitant with step a′).   
     
     
         12 . A film-coating process, characterized in that it comprises:
 a step a) of producing an aqueous film-forming composition comprising mixing a ready-to-use product as defined in  claim 7  with water,   a step a′) of spraying the aqueous film-forming composition obtained in step a) on to a moving bed of solid forms,   a step b) of drying the solid forms thus film-coated, preferentially concomitant with step a′).   
     
     
         13 . The film-coating process as claimed in  claim 11 , characterized in that the bed of solid forms is preheated to a temperature of between 30 and 60° C., preferentially between 30 and 40° C., in particular of about 35° C. 
     
     
         14 . A solid form comprising a core covered with at least one film-coating layer, characterized in that this film-coating layer comprises a fluidized hydroxypropyl starch and sorbitol, and in that the sorbitol is included in said film-coating layer at a content of between 5% and 80% by dry weight relative to the dry weight of fluidized hydroxypropyl starch, preferentially of between 5% and 40%, more preferentially between 15% and 35%, the limit at 35% being preferentially excluded. 
     
     
         15 . A film, in particular an orodispersible film, characterized in that it comprises a fluidized hydroxypropyl starch and sorbitol, and in that the sorbitol is included in said film at a content of between 5% and 80% by dry weight relative to the dry weight of fluidized hydroxypropyl starch, preferentially of between 5% and 40%, more preferentially between 15% and 35%, the limit at 35% being preferentially excluded. 
     
     
         16 . The film-coating process as claimed in  claim 12 , characterized in that the bed of solid forms is preheated to a temperature of between 30 and 60° C., preferentially between 30 and 40° C., in particular of about 35° C.