AmbroxolHClSustained-ReleasePellets
（drug-layeringprocess）
Theformulationisdesignedfor800gofAmbroxolHCIloadedpellets
manufacturedbydruglayeringofnonpareilles.
a）Formulation
Polymersuspension
KollicoatSR30D[1]..........................533.0g Triethylcitrate（TEC）[4]............................16.0g Water....................................................433.0g Pigmentsuspension
Talc[3]....................................................56.0g Water....................................................100.0g b）Preparationofthespraysuspension
Polymersuspension
AddTECfollowedbyKollicoatSR30Dto thegivenquantityofwater
withstirring.
Pigmentsuspension
Addtalcto thegivenquantityofwaterwithvigorousstirring.
Spraysuspension
Incorporatethepigmentsuspensioninto thepolymersuspensionwith
stirring.Thesuspensionmustbestirredduringthesprayingprocessto
preventsettling.
c） Coating
The pellets were coated in an GPCG1 （Glatt）. The suspension was
sprayed continuously onto the fluidized, pre-heated pellets by the
Wurster method.
Process parameters
Machine .......................................Glatt GPCG1
Method .........................Botto m-spray （Wurster）
Inlet air temperature...........................50 – 55C
Outlet air temperature ........................29 – 32C
Product temperature..........................35 – 40C
Air flow ................................................90m3/h
Nozzle diameter.....................................1.2mm
Spraying time.......................................220 min
Spraying rate.........................approx. 4.5 g/min
Ato mizing pressure.................................1.2bar
Drying............................................40C/15min
Weight gain ..............................................20%
关键字：ambroxol hcl sustained
