(1–2RDAofVitamins) 1.Formulation I.Thiaminemononitrate(BASF)............................................2.2g Riboflavin(BASF)..............................................................2.2g CalciumD-panto thenate(BASF)......................................11.0g Pyridoxinehydrochloride(BASF)........................................2.2g Mannito l.......................................................................300.0g
II.Kollidon30[1]orKollidonVA64[1].................................20.0g Isopropanol.................................................................ca.80g III.VitaminAacetate VitaminD3drypowder 500000 50000i.u./g(BASF).......................................11.0g VitaminEacetatedrypowderSD50(BASF)....................31.0g Cyanocobalamingelatincoated0.1%(BASF).....................6.0g Ascorbicacid,crystalline(BASF).....................................80.0g Nicotinamide..................................................................20.0g AvicelpH101[5]............................................................65.0g Orangeflavour..................................................................7.0g Saccharinsodium.............................................................2.0g Magnesiumstearate[2].....................................................3.0g 2.Manufacturing(Wetgranulation) GranulatemixtureIwithsolutionII,dry,pass througha0.8mmsieve, mixwiththecomponentsIIIandpresswithmediumcompressionforce. 3.Tabletproperties Weight...............................................................................560mg Diameter.............................................................................12mm Form.................................................................................biplanar Hardness..............................................................................100N Disintegration(water).........................................................1–2min Friability..............................................................................<0.1%4. Chemical stability of vitamins A and C (20–25C, closed)0 Months 3 Months 6 MonthsVitamin A 15,500 i. u./g = 100% 15,500 i. u./g = 100% 14,300 i. u./g = 92%Vitamin C 85 mg = 106% 82 mg = 102% 77 mg = 96%
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