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Continuous manufacturing via hot-melt extrusion and scale up: regulatory matters

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posted on 2023-06-09, 04:04 authored by Mohammed Maniruzzaman, Ali Nokhodchi
Currently, because globalization, the pharmaceutical industry is facing enormous challenges to comply with regulatory matters. Reduced patent life and overall decreased profitability of newly discovered drugs are also forcing the pharmaceutical industry to shorten the drug development time with maximum throughput. Therefore, continuous manufacturing (CM) processes via hot melt extrusion (HME) can be a promising alternative for achieving these goals. HME offers solvent-free green technology with a process that is easy to scale up. Moreover, CM provides better product quality assurance compared with batch processes, with fewer labor costs and shorter time to development. In this review, we primarily focus on various aspects of CM and the emerging application of HME to bridge the current manufacturing gap in pharmaceutical sphere.

History

Publication status

  • Published

File Version

  • Accepted version

Journal

Drug Discovery Today

ISSN

1359-6446

Publisher

Elsevier

Issue

2

Volume

22

Page range

340-351

Department affiliated with

  • Chemistry Publications

Full text available

  • Yes

Peer reviewed?

  • Yes

Legacy Posted Date

2016-11-17

First Open Access (FOA) Date

2017-11-17

First Compliant Deposit (FCD) Date

2016-11-17

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