FIELD: chemistry.
SUBSTANCE: coagglomerates of crystalline mannitol and granular starch in the ratio mannitol/starch from 99.5/0.5 to 50/50 have compressibility of 200 N to 450 N, flow time of 3 to 15 s and volume mean diameter D4.3 of particles based on laser granulometry of 60 to 500 mcm. The coagglomerates are intended for producing tablets or solid gelatin capsules for use in pharmaceutics. The method of producing said coagglomerates includes preparing, at 45-65°C, a solution of mannitol and granular starch or a mannitol solution only, where content of solid substance ranges from 25% to 45%, holding said solution at 45-65°C, spray-drying said solution in an MSD-type dryer equipped with a high pressure spray-drying nozzle with recycling of the fine particles at the spray-dryer top and, if necessary, adding dry starch, separating the obtained the coagglomerates of mannitol and of starch. The method can also include granulating the solution of mannitol and starch by spraying in a circular continuous fluidised-bed granulator with a discharge pipe or plug-flow rectangular continuous fluidised-bed granulator.
EFFECT: obtaining coagglomerates with good compressibility and good fluidity.
9 cl, 12 tbl, 8 ex
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Authors
Dates
2015-02-10—Published
2010-04-28—Filed