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TheophyllineSustainedReleaseTablets
(400mg),Wg 1.Formulations
No.1No.2
ITheophylline,powder(BASF)........................400g400g Granulac140[8]...........................................337g356g IIKollicoatSR30D[1]......................................198g–
KollicoatEMM30D[1]..........................................–132g IIIAerosil200[4]..................................................4g4g Magnesiumstearate[2]....................................4g4g 2.Manufacturing(Wetgranulation)
GranulatethemixtureIwithKollicoatSR30DorKollicoatEMM30D(II)in
afluidizedbed(inlettemperature45-55C,outlettemperature21-25C,
nozzle0.8mm,spraypressure1.5-2.0bar,sprayrate10g/min),mix
withthecomponentsofIIIandpressto tabletswithmediumcompression
force.
3.Tabletproperties
Percento fKollicoat(solidpolymer)............7.4%5.0%
Weight.................................................797mg811mg Diameter........................................19x8.5mml9x8.5mm
Form.....................................................oblongoblong Hardness................................................276N228N
Friability...................................................0.1%<0.1%
关键字:theophylline sustained release
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