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Blends of pre-gelatinized starch, microcrystalline cellulose, and impalpable lactose were granulated with increasing amount of water using a 25-liter top-drive (TD) high-shear granulator (Vector GMX-25) and a same sized bottom-drive (BD) high-shear granulators (Powrex FM-VG-25). Mixer blade speeds used were standard manufacturer settings.

Granulates were fluid-bed dried and milled with a FitzMill Comminutor. The particle size profile, bulk and tap density, flow index, and Carr index of milled granules were measured.

A quantity of 591g of milled granules from each batch were blended with 6g of dye and 3g (0.5%) of magnesium stearate (MgSt) in a PK Blend Master V-blender (0.946 liter; 1 quart).

Blended granules were pressed into tablets on a four station instrumented Stokes model 512 press operating at 40 rpm. Compaction profiles were determined at 5, 10, 15, 20, and 23 kN.

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