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SimethiconeInstantGranules
(60mgand120mg)
1.Formulation
I.Simethicone(Abil200,Goldschmidt).....10.0g CremophorRH40[1]...............................5.0g
II.KollidonVA64[1].....................................3.0g Ethanol..................................................40.0g III.Sorbito l,crystalline(Merck).....................50.0g Fructo se(Merck)....................................50.0g KollidonCL-M[1]....................................50.0g Orangeflavour(Dragoco)..........................0.5g 2.Manufacturing IntroducesolutionIIinto themixtureI.GranulatethepowdermixtureIII
withthewellstirredmixtureI/II,dryandpass througha1mmsieve.
Fill1or2ginsachets.
3.Propertiesofthegranules
–Freeflowingwhitegranules;
–98%coarserthan50μm;
–Easilydispersibleincoldwaterwithoutanyphysicalseparationduring 30min.
4.Administration
Takethecontento fonesachet(1g=60mgsimethiconeor2g=120mg simethicone)aspowderordispersetherecommendedamount(e.g.1to
2g)in100mlofdrinkingwater.
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