LevothyroxineTablets (0.05mg) 1.Formulations No.1No.2 I.Levothyroxinesodium..................................0.05g0.05g Citricacid,anhydrous..........................................–10.00g Magnesiumstearate....................................1.00g1.00g
II.Ludipress[1].............................................99.00g89.00g 2.Manufacturing(Directcompression) PreparepremixI,addIIandpass themixturethorugha0.8mmsieve. Mixandpresswithlowcompressionforce. 3.Tabletproperties No.1No.2 Weight......................................................103mg101mg Diameter......................................................6mm6mm Form........................................................biplanarbiplanar Hardness......................................................52N45N Disintegration...........................................1–2min4min Friability........................................................0.1%<0.1% Contentuniformitynotcontrolled 4.Remarks IfthecontentuniformityofformulationNo.1doesnotmeettherequirements itwouldberecommendedto addasmallparto fLudipress (=partII)to thepremixI. ThefunctionofcitricacidinformulationNo.2isthestabilizationof theactiveingredient.Theeffectivenesswasnotcontrolledinthis formulation.
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