AcetylsalicylicAcid Paracetamol
(=Acetaminophen)Tablets
(250mg 250mg)
1.Formulation
Acetylsalicylicacid,crystalline(Merck)......250g Paracetamol,crystalline(BASF)................250g AvicelpH101[5].......................................60g Kollidon30(orKollidonVA64)[1]...............15g KollidonCL[1]..........................................25g 2.Manufacturing(Directcompression)
Passallcomponentsthrougha0.8mmsieve,mixandpresswith
mediumcompressionforce.
3.Tabletproperties
Weight.................................................605mg Diameter...............................................12mm
Form...................................................biplanar
Hardness..................................................90N
Disintegration.......................................<1min
Friability...................................................0.7%
4.ChemicalstabilityofformulationNo.2(20–25C,closed)
0Months6Months12Months
Acetylsalicylicacid100%100%100%
VitaminC100%100%96%
Freeaceticacid<0,01%<0.01%
Freesalicylicacid<0,01%<0.01%
关键字:氨基