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Lecture 11: QbD and Scalable Manufacturing of Poorly Soluble Products

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Upon completion of this lecture of the eCourse, the participant should be able to:
  • Review scale up & QbD aspects in manufacturing of amorphous solid dispersions. Describe how the QbD principles may be applied to the development of enabled formulations of poorly soluble drugs.
  • Discuss scale up of HME and/or spray drying in brief. Discuss various CPPs, CQAs, and risk assessment in the manufacture of amorphous solid dispersions. 
  • Discuss identification of CQAs of enabled formulations of poorly soluble drugs and key aspects of control during scale-up of these products.
  • Discuss a systematic approach with the help of QbD principles to melt extrusion based on an understanding of the interplay between process and product enabling a rapid scale up.