BetaCaroteneTablets
(15mg)
1.Formulation
No.1No.2
Betacarotenedrypowder10%..................160.0g150.0g Ludipress[1].............................................240.0g–
Dicalciumphosphate[9],granulatedwith.............–175.0g 5%Kollidon30
AvicelpH101[5].................................................–100.0g KollidonCL[1]..............................................6.0g5.0g Aerosil200[4].....................................................–2.5g Talc[10]..............................................................–20.0g Calciumarachinate[2].........................................–2.5g Magnesiumstearate[2].................................2.0g–
2.Manufacturing(Directcompression)
Mixallcomponents,pass througha0.8mmsieveandpresswitha
mediumcompressionforce.
3.Tabletproperties
No.1No.2
Weight......................................................400mg502mg Diameter....................................................12mml2mm
Form........................................................biplanarbiplanar
Hardness......................................................59N57N
Disintegration.............................................12min1min
Friability........................................................0.1%0%
4.Chemicalandphysicalstability(20–25C)
FormulationNo.1:6Months12Months
Lossofbetacarotene3%4%
Hardness60N59N
Disintegration9min7min
Friability0.15%0.16%
FormulationNo.2:6Months12Months
Lossofbetacarotene<8%9%