Sustained-ReleaseCoatingof
IbuprofenPellets
（Pelletsobtainedbydrug-layeringprocess）
Theformulationisdesignedfor800gofpelletsmanufacturedbydruglayering ofnonpareilles.
a）Subcoating Thepolymerspraysolutionforaweightgainof5%:
Spraysolution
Mowiol4-88（PVA）[9]............................48.0g Water....................................................432.0g b）Preparationofthespraysolution（subcoating）
DissolveMowiolinhotwaterandcoolwithstirring.
Processparameters
Machine.......................................GlattGPCG1
Method.........................Botto m-spray（Wurster）
Inletairtemperature.................................50C
Outletairtemperature...............................35C
Producttemperature................................40C
Airflow.................................................80m_/h
Nozzlediameter.....................................1.2mm
Sprayingtime........................................56min
Sprayingrate..........................approx.3.1g/min
Ato mizingpressure.................................1.2bar
Drying...........................................40C/15min
Subcoatingweight......................................5%
c） Polymer coating
The formulation is designed for 800g of subcoated pellets.
Polymer suspension
Kollicoat SR 30 D [1] ..........................533.0g
Triethyl citrate （TEC） [4] ............................16.0g
Water....................................................433.0g
Pigment suspension
Talc [3] ....................................................56.0g
Water ....................................................100.0g
d） Preparation of the spray suspension （polymer coating）:
Polymer suspension
Add TEC followed by Kollicoat SR 30 D to the given quantity of water
with stirring.
Pigment suspension
Add talc to the given quantity of water with vigorous stirring.
Spray suspension
Incorporate the pigment suspension into the polymer suspension with
stirring. The suspension must be stirred during the spraying process to
prevent settling.
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.......................................230 min
Spraying rate.........................approx. 4.5 g/min
Ato mizing pressure.................................1.2bar
Drying...........................................40C/ 15min
关键字：sustained release coating
