title: Continuous manufacturing via hot-melt extrusion and scale up: regulatory matters.
abstract: 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.
authors.affiliation: Pharmaceutics Research Laboratory, Arundel Building, School of Life Sciences, University of Sussex, Brighton BN1 9QJ, UK. Electronic address: M.Maniruzzaman@sussex.ac.uk.
authors.forename: Mohammed
authors.initials: M
authors.lastname: Maniruzzaman
authors.affiliation: Pharmaceutics Research Laboratory, Arundel Building, School of Life Sciences, University of Sussex, Brighton BN1 9QJ, UK; Drug Applied Research Center and Faculty of Pharmacy, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: A.Nokhodchi@sussex.ac.uk.
authors.forename: Ali
authors.initials: A
authors.lastname: Nokhodchi
mesh_terms: D004345:Drug Industry / Q000331:legislation & jurisprudence; D006358:Hot Temperature; D007880:Legislation, Drug; D013678:Technology, Pharmaceutical / Q000331:legislation & jurisprudence