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Sustained-releasePelletsofPropranololHCl
(drug-layeringprocess)
a)Formulation
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 a Glatt GPCG1 coater. The suspension was
sprayed continuously onto the fluidized, pre-heated pellets from the
botto m by the Wurster method. Weight gains of 5, 10, 15 and 20 % were
tested.
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
Coating weight .........................................20%
关键字:sustained release pellets
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