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

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

Open Access

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

Author(s) -

Hiren G. Moradiya,

Muhammad T. Islam,

Nikolaos Scoutaris,

Sheelagh A. Halsey,

Babur Z. Chowdhry,

Dennis Douroumis

Publication year - 2016

Publication title -

crystal growth and design

Language(s) - English

Resource type - Journals

SCImago Journal Rank - 0.966

H-Index - 155

eISSN - 1528-7505

pISSN - 1528-7483

DOI - 10.1021/acs.cgd.6b00402

Subject(s) - pharmaceutical manufacturing , process engineering , process analytical technology , quality by design , process control , process (computing) , raw material , materials science , computer science , manufacturing engineering , work in process , engineering , chemistry , chemical engineering , bioinformatics , operations management , organic chemistry , particle size , biology , operating system

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

The content you want is available to Zendy users.

Already have an account? Click here to sign in.

Having issues? You can contact us here

Accelerating Research