Continuous manufacturing of high quality pharmaceutical cocrystals integrated with process analytical tools for in-line process control

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

Research output: Contribution to journalArticle

22 Citations (Scopus)
97 Downloads (Pure)

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.
Original languageEnglish
Pages (from-to)3425-3434
Number of pages10
JournalCrystal Growth and Design
Volume16
Issue number6
Early online date28 Apr 2016
DOIs
Publication statusPublished - 1 Jun 2016

Keywords

  • continuous manufacturing
  • cocrystals
  • process analytical technologies (PAT)
  • in-line process control
  • near infrared reflectance
  • spatial filter velocimetry probes

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