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SustainedReleaseCoatingofVerapamil
Pellets
1.Formulation
IPolymerSuspension:
KollicoatEMM30D[1].........................325.0g AvicelpH105[5]...................................45.0g Pharmacoat603[Shin-Etsu]....................3.5g Water.................................................280.5g IIPigmentSuspension:
Kollidon30[1]........................................5.0g SicovitIronoxideRed30[1]....................5.0g Talc[10]...............................................39.0g Pharsil21046VP[Wacker]....................58.8g Water.................................................238.2g to tal:.....................................................1000g Solidcontent:.......................................214.1g IIIVerapamilHCIspheronizedpellets48%
(Seechapter5.4)...................................1000g IVAntitacksuspension:
Aerosil200[4]...........................................1g Water......................................................60g 2.Manufacturingofthesuspension
IDissolvePharmacoat603inwater,suspendAvicelpH105andadd
slowlyKollicoatEMM30D.
IIDissolveKollidon30inwater,suspendtheironoxidepigmentandtalc
andhomogenizeinacolloidmill.ThenaddPharsil21046VP.
AddthepigmentsuspensionIIto thewellstirredpolymersuspensionI.
Stirtheobtainedsuspensionduringtheentirecoatingprocess.
3. Coating procedure (Fluidized bed Aeromatic MP-1)
Loading of verapamil HCI pellets (III) .............................................1 kg
Quantity of solids applied.....................................141 g = 2.4 mg/cm2
Nozzle ...................................................................................0.8 mm
Spraying pressure ......................................................................1 bar
Inlet air .........................................................................100-120 m3/h
Inlet temperature..................................................................40-45 C
Pellet temperature................................................................28-31 C
Outlet temperature ...............................................................28-30 C
Spray rate .........................................................................7-11 g/min
Drying time after coating (45 C).................................................5 min
Antitack suspension after coating ................................................61 g
关键字:sustained release coating
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