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EntericFilmCoatingofTablets
(OrganicSolution )
(AcetylsalicylicAcid100mg)
a)Formulationofthecores
ComponentCompanymg/Tablet
ASASynopharml00.0
LudipressBASF148.5
AvicelpH102FMC50.0
MagnesiumstearateBrlocher1.5
to tal300.0
b)Manufacturebydirectcompression:
Allthecomponentsweremixedfor10minutes,pass edthroughasieve
ofasizeof0.8mmandcompressedinto tabletsonarotarypresswitha
rateof40.000tablets/hatacompressionforceof15kN.Coreshape
wasconvexwithadiameterof9mmandtheengraving“BASF”.
Hardnessofthetabletswasabout60N.
c)Formulationsofthecoatingsuspension:
Theformulationisfor5kgofcores(diameter9mm;300mg)
ComponentPartsbyweight[g]
No.1No.2
KollicoatMAE100P344.52344.52
Triethylcitrate34.4534.45
Ethanol4214.60-
Isopropanol/Wasser(70/30)–4214.60
to tal4593.574593.57
Polymerapplied:10.0mg/cm2
Contento fpolymer:7.5%
c) Preparation of the spray suspension
Kollicoat MAE 100P and triethyl citrate were stirred into the solvent until
complete disSolution .
d) Process Parameters:
Coating pan:............................24” Accela Cota
Size of batch: ............................................5 kg
Inlet air temperature: ...............................50 C
Outlet air temperature:........................35-38 C
Product temperature: .........................30-35 C
Inlet air rate: ...........................................70 m_
Outlet air rate:.......................................140 m_
Spraying pressure: ................................2.0 bar
Nozzle diameter:...................................1.0 mm
Rate of spraying: ................................30 g/min
Time of spraying:......................................2.5 h
Pre heating ..............................................3 min
Final drying:.............................................5 min
关键字:enteric film coating
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