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Continuous Manufacturing of High Quality Pharmaceutical Cocrystals Integrated with Process Analytical Tools for In-Line Process Control

By Moradiya, Hiren G.; Islam, Muhammad; Scoutaris, Nikolaos; Halsey, Sheelagh; Chowdhry, Babur Z.; Douroumis, Dennis

Published on CMKC

Abstract

A continuous manufacturing process for pharmaceutical indomethacin saccharine cocrystals was achieved by extrusion processing with high throughput. Down-stream milling and blending of the extrudates was followed by feeding the formulated cocrystals in a capsule-filling machine. By applying a quality by design approach, the process was optimized and scaled up to produce 3000 capsules/h of pharmaceutical cocrystals. Process analytical tools such as near infrared reflectance and spatial filter velocimetry probes were coupled at various process stages for in-line monitoring and quality control. Further physicochemical characterization of extruded batches confirmed the manufacturing of high quality cocrystals. A fully integrated continuous process starting from raw materials to produce a finished product was assembled with only six unit operations and a small footprint. The study is a paradigm of continuous manufacturing of pharmaceutical cocrystals.

Journal

Crystal Growth & Design. Volume 16, 2016, 3425-3434

DOI

10.1021/acs.cgd.6b00402

Type of publication

Peer-reviewed journal

Affiliations

  • University of Greenwich
  • Thermo Fisher Scientific

Article Classification

Research article

Classification Areas

  • PAT
  • API

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