Process for preparing drug substances in beadlet form

Details Process for preparing drug substances in beadlet form Process for preparing drug substances in beadlet form

A - Human Necessities

61

K

A61K 9/16 (2006.01) A61J 3/00 (2006.01) B01J 2/00 (2006.01) B01J 2/14 (2006.01) B01J 2/16 (2006.01)

Patent

CA 2112743

2112743 9300991 PCTABS00019 Drug substances in beadlet form are prepared with high bulk density spray-coating onto inert core particles, using coater-granulator apparatus, comprising: forming a fluidised bed of particles of inert core material within the processing chamber of a coater-granulator apparatus by passing a gaseous current between the rotating disc and the inner wall of the processing chamber; and forming beadlets by layering a drug onto the particles of the core material by spray-coating with a solution of the drug; characterised in that during beadlet formation, the spray-coated particles are (i) transferred to a drying zone surrounding the processing chamber, (ii) carried through the drying zone by a gaseous current, and (iii) returned to the processing chamber; the recirculation process being continued until beadlets having the desired drug load are formed.

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