Real-Time Prediction of Polymer-Coated Multiparticulate Dissolution using Process Analytical Technology

Many new and pipeline oral dose medicinal products are formulated to enable modified or extended release of the active ingredient to increase patient compliance and improve convenience by reducing the number of daily doses required by the patient. Multi-step Fluid Bed Coating processes are routinely used to produce modified release pellets or beads with dissolution performance being the key critical quality attribute for the process. While direct measurement of dissolution performance in-line may not be practical to implement, this study demonstrates the possibility of predicting dissolution drug release profiles on multiparticulates in a Wurster coating process, using an in-line measured coating thickness derived from the growth in the material’s particle size distribution.

 


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