Bulk and Micro-Scale Characterization of Continuous Powder Blending Integrated with an Multi-Point in-Line NIR As a PAT Tool

Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
AIChE Annual Meeting
October 31, 2012 - 4:20pm-4:40pm
Continuous manufacturing of solid pharmaceutical products has been an area of much research in the past few years. Most efforts have focused in characterizing the bulk properties and efficiency of continuous powder mixers as a function of operational and design parameters. The present study summarizes the bulk characterization of a new Glatt continuous powder (GCG-70) blender using experimental techniques previously reported [1,2]. While bulk characterization of a resulting blend is crucial to describe the mixing efficiency of a continuous mixer, it is not enough to determine the final quality of a blend, which can then be related to the performance in succeeding processes. A new approach to study final blends at the micro-scale using hyperspectral imaging to further understand phenomena such as API agglomeration and de-agglomeration in continuous mixing is reported here. Further along, comparison results from the integration of an in-line NIR as a PAT tool to monitor the concentration and variability of key components in final blends are described. Both approaches presented here were useful to further understand the continuous mixing process as a function of the design, operational and material properties parameters.

References:

[1] P.M. Portillo, M.G. Ierapetritou, F.J. Muzzio, Characterization of continuous convective powder mixing processes, Powder Technology 182 (2008) 368-378.

[2] A.U. Vanarase, F.J. Muzzio, Effect of operating conditions and design parameters in a continuous powder mixer, Powder Technology 208 (2011) 26-36

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