(344c) Modeling of Residence Time Distribution of a Continuous Dry Granulation Tableting Line
AIChE Annual Meeting
2017
2017 Annual Meeting
Pharmaceutical Discovery, Development and Manufacturing Forum
Continuous Processing Technologies Applied in Drug Product Manufacturing
Tuesday, October 31, 2017 - 1:14pm to 1:36pm
In this work a dry granulation line, as one of the common ways of solid dosage form manufacturing, was investigated. The line consists of a feeding, blending, dry granulation, pneumatic transport and tableting step. For the determination of the residence time distribution in the considered unit operations as well as in the entire line a step change of API was performed at different total throughputs. As a system response the concentration of API was measured via in-line NIR spectroscopy at the outlet of blender, granulation and tablet press. Additionally, samples of powder, granules and tablets were drawn and analyzed off-line by means of UV/Vis as a reference.
Based on the experimental RTD data a transfer function was calculated and the transfer behavior of single unit operations modeled. The RTDs for single unit operations were interlinked and the entire process simulated with customized models in the process simulation software gSolids. The selected approach allows the prediction of out-of-spec material amount and the discharge time for different throughputs. This work shows promising results for both the inter- and extrapolation of RTDs for various throughputs and comparison with validation runs of the entire line.