Sustained-releaseCoating ofTramadolHClpellets
（drug-layeringprocess）
a）Polymercoating Theformulationisdesignedfor800gofpelletsmanufacturedbydrug layeringofnonpareilles.
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.................................................90m_/h
Nozzle diameter.....................................1.2mm
Spraying time.......................................225 min
Spraying rate.........................approx. 4.5 g/min
Ato mizing pressure.................................1.2bar
Drying...........................................40C/ 15min
Weight gain ..............................................20%
关键字：sustained release coating
