QA/QA0 = (1-β) + β*exp(-γ*L*FHeadspace*r)
where QA0 is initial quality attribute value, β is sensitivity of the QA to lubrication, γ is formulation-specific lubrication rate constant, L is characteristic mixing length scale, FHeadspaceis the blender headspace fraction, and r is the number of blending cycles.
2:1 blends of microcrystalline cellulose and spray-dried lactose or dibasic calcium phosphate were mixed with 1% magnesium stearate using Turbula bottle blenders and pilot/commercial scale blenders, varying blender volume, V, (30-1250 ml; 100-2000 Liters); Fheadspace(30, 70%); and r (24 to ~190,000 cycles). Tablets were manufactured using a Huxley-Bertram compaction simulator to evaluate the change in tablet tensile strength as a function of the extent of lubrication mixing. Other attributes of the blends/tablets were also evaluated including compressibility, bulk/tapped density, friability, and disintegration.
The validity of the proposed lubrication blending process scale-up model was shown for blenders from 30-ml to 2000-liter (an approximately five order of magnitude change in scale) for both placebo formulations. This validated scale-up model can be used to replace commercial-scale experiments with bench-scale, material-sparing experiments to support QbD lubrication blending process understanding and design space verification.
Would you like to access this content?
No problem. You just have to complete the following steps.
You have completed 0 of 2 steps.
You must be logged in to view this content. Log in now.
Purchase Technical Presentation
You must purchase this technical presentation using one of the options below.
If you already purchased this content recently, please click here to refresh the system's record of ownerships.
|Credits||0.5 Use credits|
|List Price||$25.00 Buy now|
|AIChE Members||$15.00 Buy now|
|AIChE Undergraduate Student Members||Free Free access|
|AIChE Graduate Student Members||Free Free access|