The Future of Pharmaceutical Manufacturing Sciences.
The entire pharmaceutical sector is in an urgent need of both innovative technological solutions and fundamental scientific work, enabling the production of highly engineered drug products. Commercial-scale manufacturing of complex drug delivery systems (DDSs) using the existing technologies is challenging. This review covers important elements of manufacturing sciences, beginning with risk management strategies and design of experiments (DoE) techniques. Experimental techniques should, where possible, be supported by computational approaches. With that regard, state-of-art mechanistic process modeling techniques are described in detail. Implementation of materials science tools paves the way to molecular-based processing of future DDSs. A snapshot of some of the existing tools is presented. Additionally, general engineering principles are discussed covering process measurement and process control solutions. Last part of the review addresses future manufacturing solutions, covering continuous processing and, specifically, hot-melt processing and printing-based technologies. Finally, challenges related to implementing these technologies as a part of future health care systems are discussed.
Department of Pharmacy, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark. Electronic address: jukka.rantanen@sund.ku.dk.
Jukka
J
Rantanen
Institute of Process and Particle Engineering, Graz University of Technology, Graz, Austria; Research Center Pharmaceutical Engineering, Graz, Austria. Electronic address: khinast@tugraz.at.
Johannes
J
Khinast
D003198:Computer Simulation; D016503:Drug Delivery Systems / Q000295:instrumentation / Q000379:methods; D004345:Drug Industry / Q000295:instrumentation / Q000379:methods*; D008956:Models, Chemical; D011786:Quality Control; D013678:Technology, Pharmaceutical / Q000295:instrumentation / Q000379:methods*
in silico modeling; materials science; mathematical model; process analytical technology (PAT); quality by design (QBD)