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

18 Citations (Scopus)

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.
LanguageEnglish
Pages3425-3434
Number of pages10
JournalCrystal Growth and Design
Volume16
Issue number6
Early online date28 Apr 2016
DOIs
Publication statusPublished - 1 Jun 2016

Fingerprint

Drug products
Process control
manufacturing
capsules
Capsules
Pharmaceutical Preparations
Rheology
footprints
quality control
Indomethacin
Quality Control
Velocity measurement
Quality control
Extrusion
Raw materials
Throughput
Infrared radiation
reflectance
filters
Monitoring

Keywords

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

Cite this

Moradiya, Hiren G. ; Islam, Muhammad T. ; Scoutaris, Nikolaos ; Halsey, Sheelagh A. ; Chowdhry, Babur Z. ; Douroumis, Dennis. / Continuous manufacturing of high quality pharmaceutical cocrystals integrated with process analytical tools for in-line process control. In: Crystal Growth and Design. 2016 ; Vol. 16, No. 6. pp. 3425-3434.
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Continuous manufacturing of high quality pharmaceutical cocrystals integrated with process analytical tools for in-line process control. / Moradiya, Hiren G.; Islam, Muhammad T.; Scoutaris, Nikolaos; Halsey, Sheelagh A.; Chowdhry, Babur Z.; Douroumis, Dennis.

In: Crystal Growth and Design, Vol. 16, No. 6, 01.06.2016, p. 3425-3434.

Research output: Contribution to journalArticle

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