Alpha-MethyldopaTablets
(500mg),DC
1.Formulations
No.1No.2
Alpha-Methyldopa.......................................500g500g (AlphaChemicals)
AvicelpH101[5]............................................54g200g KollidonVA64[1]...........................................20g30g KollidonCL[1]...............................................20g20g Talc[10].........................................................90g8g Aerosil200[4]..................................................7g1g Magnesiumstearate[2]....................................2g–
Calciumarachinate[2].........................................–1g 2.Manufacturing(Directcompression)
Passmagnesiumstearatetrougha0.2mmsieveandtheothercomponents
througha0.5mmsieve,mixandpresswithhighcompression
force(FormulationNo.1)andlowcompressionforce(FormulationNo.2).
3.Tabletproperties
No.1No.2
Weight..........................................693mg750mg Diameter...........................................12mml2mm
Form..........................................biplanarbiplanar
Hardness..............................................80N113N
Disintegration...........................................<1min1–2min
Friability.............................................0.4%0.8%
Dissolution,4min........................................86%–
16min......................................92%–
BASFPharmaIngredientsGenericDrugFormulations2004
2.8FormulationsofTabletsObtainedbyDirectCompression(LabScale)
4.Remark
InthecaseofformulationNo.1itwasnotpossibleto presstabletcores
ofabiconvexformbecausesomecappingeffectwasobserved.
关键字:甲基