Compressible and free-flow co-agglomerates of mannitol and granular starch

Abstract

Co-agglomerates of crystalline mannitol and granular starch, characterised in that they have a compressibility, as determined according to a test A, higher than 120 N, and preferably of 200 to 450 N, and a flow time, as determined according to a test B, of 3 to 15 seconds, and preferably of 4 to 8 seconds.

1 . A coagglomerate of crystalline mannitol and of granular starch, wherein:
 the tableting capacity, determined according to test A, is greater than 120 N, preferably between 200 and 450 N,   the flow grade, determined according to test B, is between 3 and 15 seconds, preferably between 4 and 8 seconds.   
     
     
         2 . The coagglomerate as claimed in  claim 1 , wherein the laser volume mean diameter D4,3 is between 60 and 500 μm, preferably of between 100 and 250 μm. 
     
     
         3 . The coagglomerate as claimed in  claim 1 , wherein the mannitol/starch ratio is between 99.5/0.5 and 50/50 and preferably between 95/5 and 70/30. 
     
     
         4 . The coagglomerate as claimed in  claim 1 , wherein:
 the aerated density is between 0.400 and 0.750 g/ml, preferably between 0.450 and 0.650 g/ml, and   the tapped density is between 0.500 and 0.850 g/ml, preferably between 0.550 and 0.750 g/ml.   
     
     
         5 . The coagglomerate as claimed in  claim 1 , wherein the starch is chosen from the group consisting of standard corn starch, extra white corn starch and potato starch, taken alone or in combination. 
     
     
         6 . The coagglomerate as claimed in  claim 1 , wherein the mannitol is provided both in the alpha and beta crystalline forms. 
     
     
         7 . A process for the preparation of a coagglomerate of crystalline mannitol and of starch as claimed in  claim 1 , wherein it comprises a step of spray-drying or of granulation of a mixture of a “solution” of mannitol and of starch, the starch being suspended in the mannitol solution. 
     
     
         8 . A process for the preparation of a coagglomerate of crystalline mannitol and of starch as claimed in  claim 1 , wherein it comprises a step of spray-drying or of granulation of a mixture of a mannitol solution and of dry starch, the starch being incorporated in the dry form in the spray-dryer or during the granulation step. 
     
     
         9 . The process as claimed in  claim 7 , wherein it comprises the following steps:
 a) preparing, at a temperature of between 45 and 65° C., a solution of mannitol and granular starch in which:
 the mannitol/starch ratio is between 99.5/0.5 and 50/50 and preferably between 95/5 and 70/30, 
 the solids content is between 25 and 45% as dry weight, 
   b) keeping said solution of mannitol and of starch at a temperature of between 45 and 65° C.,   c) spray-drying said solution in an MSD-type spray-dryer equipped with a high pressure spray-drying nozzle with recycling of the fine particles at the spray-dryer top,   d) recovering the coagglomerates of mannitol and of starch thus obtained.   
     
     
         10 . The process as claimed in  claim 8 , wherein it comprises the following steps:
 a) preparing, at a temperature of between 45 and 90° C., a mannitol solution in which the solids content is between 25 and 50% as dry weight,   b) keeping said mannitol solution at a temperature of between 45 and 90° C.,   c) spray-drying said solution in an MSD-type spray-dryer equipped with a high pressure spray-drying nozzle with recycling of the fine particles in the spray-dryer top, the dry starch being injected via a weight metering device into the system for recycling the fine particles in a mannitol/starch ratio of between 99.5/0.5 and 50/50 and preferably between 95/5 and 70/30,   d) recovering the coagglomerates of mannitol and of starch thus obtained.   
     
     
         11 . The process as claimed in  claim 7 , wherein it comprises the following steps:
 a) preparing, at a temperature of between 45 and 65° C., a solution of mannitol and of granular starch in which:
 the mannitol/starch ratio is between 99.5/0.5 and 50/50 and preferably between 95/5 and 70/30, 
 the solids content is between 25 and 45% as dry weight, 
   b) keeping said solution of mannitol and starch at a temperature of between 45 and 65° C.,   c) granulating said solution by spraying in a fluidized air bed granulator,   d) recovering the coagglomerates of mannitol and of starch thus obtained.   
     
     
         12 . A tablet comprising the coagglomerate of mannitol and of granular starch of in  claim 1 . 
     
     
         13 . A hard gelatin capsules intended for the food and pharmaceutical fields. 
     
     
         14 . A hard gelatin capsule, composed of the coagglomerates of mannitol and of granular starch of in  claim 1 . 
     
     
         15 . The hard gelatin capsule as claimed in  claim 14 , containing food or pharmaceutical ingredients. 
     
     
         16 . The tablet as claimed in  claim 12 , comprising food ingredients, pharmaceutical active ingredients, plant protection active ingredients and detergents.