Transcription of Solid Oral Dosage Forms Powder Blending - IKEV
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Solid Oral Dosage Forms Powder Blending - IKEV
Scott Bozzone, OperationsCork, IrelandSolid oral Dosage FormsPowder Blending KEV Meeting May 31, 2001 Mechanisms of Powder Blending Diffusion- redistribution of particles by random motion Vertical or axial motion Seen in rotational blenders Convection- transfer from one location to another Motion imparted by impeller as in Ribbon Blender Shear-formation of slip planes Motion imparted by high intensity mixersClassification of Mixing EquipmentMechanismEquipmentDiffusionV-Bl ender (Twin Shell)(Tumble)Double Cone BlenderBin BlenderHorizontal/Vertical DrumConvectionRibbon(Paddle or Plow)PlanetaryHorizontal High IntensityVertical High IntensityDiffusion (with I-Bar)PneumaticFluid Bed(Expansion with Gas)ReimeltReference: FDA Draft Guidance- SUPAC IR/MR-Scale-Up Post Approval Changes - Immediate and Modified Release - Equipment Addendum, April 1998; Selection vs. Material Type Non-cohesive blend(flows & mixes easily) Bin Blender Twin Shell Other precision, rotational blender Cohesive blend(lumpy, not free-flowing) High Shear ( Twin Shell w/ I-Bar, Colette, Lodige) Ordered Mix(drug << excipient) Tumbling mixers, cone mixer, high energy many types are allowable.
Scott Bozzone, Ph.D. Quality Operations Cork, Ireland Solid Oral Dosage Forms Powder Blending İKEV Meeting May 31, 2001
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