Paracetamol(=Acetaminophen) Doxylamine CaffeineEffervescent Granules(500mg 5mg 33mg/2.1g) 1.Formulation I.Paracetamol,powder...............................500g Doxylaminesuccinate..................................5g Caffeine(BASF).........................................33g Tartaricacid............................................391g Sodiumhydrogencarbonate....................417g
II.Kollidon30[1].............................................6g Isopropanol(orEthanol)..............................q.s. III.Sodiumcitrate...........................................30g Sugar.....................................................707g 2.Manufacturing GranulatemixtureIwithsolutionII,dryat60Cundervacuumconditions, sieveandmixwithIII. Fill2.1ginsachetsatmaximum30%ofrelativeatmospherichumidity. 3.Properties Freeflowinggranules. 4.Remark Ifthesolventinsopropanolisreplacedbywaterthegranulationshould bedoneinafluidizedbed.
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