GemfibrozilTablets
(600mg)
1.Formulation
IGemfibrozil..............................................600g Cornstarch[3]........................................200g KollidonCL[1]..........................................20g Aerosil200[4]...........................................30g KollidonVA64[1].......................................40g IIEthanol96%...................................about72g IIIKollidonCL[1]..........................................20g Polyethyleneglycol6000,powder[6]..........10g Talc[10]....................................................40g Magnesiumstearate[2]...............................8g 2.Manufacturing(Wetgranulation)
GranulatemixtureIwithethanolII,dry,pass througha0.8mmsieveand
mixwiththecomponentsIII.Presswithhighcompressionforce(e.g.
28kN)to tablets
3.Tabletproperties
Weight.................................................950mg Diameter...............................................16mm
Form...................................................biplanar
Hardness................................................151N
Disintegration..........................................2min
Friability...................................................0.7%
Dissolution,USP(paddle),10min..............70%
20min.............84%
30min.............86%
关键字:gemfibrozil tablets