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Development and process scaling of repeat mini-blending as a complementary approach to deliver continuous direct compression

By Martin Prostredny1; Hikaru Graeme Jolliffe1; Richard Elkes2; Khalid Maqsood2; Yunfei Li Song2; Gavin Reynolds3; Bernhard Meir4; John Robertson1

1. CMAC, Technology and Innovation Centre 2. GSK Ware R&D 3. Oral Product Development, PT&D, Operations, AstraZeneca UK Limited 4. Gericke AG

Published on

Abstract

Process integration efforts in the pharmaceutical industry have led to an increased interest in Direct Compression, including Continuous Direct Compression. Accurate scale-up of powder blending and prediction of blend Critical Quality Attributes (CQAs) is key. The present work takes a modified approach for blend CQA characterisation in a high-shear semi-continuous blender (originally developed for low-shear batch blenders), and combines it with a blend content uniformity model (developed for high-shear continuous blenders) to characterise content uniformity responses of a high-shear semi-continuous blender (Gericke GBM-10-P Mini Blender).

Blend content uniformity assessed across process conditions and formulations shows that for a given formulation one set of model parameters can be regressed for all datapoints, allowing insight to be transferred between blender scales and types. This infers that lab-scale low-shear batch blenders can be used to predict the content uniformity response of the high-shear semi-continuous blender, minimising materials consumption and experimental burden.

Journal

Powder Technology

DOI

10.1016/j.powtec.2024.120224

Type of publication

Research Article

Affiliations

  • CMAC, Technology and Innovation Centre, 99 George Street, Glasgow G1 1RD, UK
  • GSK Ware R&D, Harris's Lane, Ware, Hertfordshire SG12 0GX, UK
  • Oral Product Development, PT&D, Operations, AstraZeneca UK Limited, Charter Way, Macclesfield SK10 2NA, UK
  • Gericke AG, Althardstrasse 120, CH-8105 Regensdorf, Switzerland

Article Classification

Peer-Reviewed Journal

Classification Areas

  • API
  • Oral Solid Dose
  • Process Analytical Technology
  • Regulatory

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