Article (Scientific journals)
Compact and Integrated Approach for Advanced End-to-end Production, Purification, and Aqueous Formulation of Lidocaine Hydrochloride
Monbaliu, Jean-Christophe; Stelzer, Torsten; Revalor, Eve et al.
2016In Organic Process Research and Development
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Keywords :
Active pharmaceutical ingredient; Pharmaceutical manufacturing platform; Integrated purification; Liquid formulation; Continuous-flow
Abstract :
[en] A compact, fully integrated, and automated system is developed for end-to-end production, purification, and formulation of the active pharmaceutical ingredient (API) lidocaine hydrochloride, a widely used local anesthetic. The purification strategy includes appropriate combination of extraction, reactive crystallization, and antisolvent cooling crystallization that enables the production of lidocaine hydrochloride formulated solution, for topical application meeting US Pharmacopeia (USP) standards. Based on the optimal yield observed in each step, the system sustains a daily production of 810 doses (dosage strength = 20 mg mL-1 i.e. 2% formulation in commercial denomination).
Disciplines :
Chemistry
Author, co-author :
Monbaliu, Jean-Christophe  ;  Université de Liège > Département de chimie (sciences) > Center for Integrated Technology and Organic Synthesis - CiTOS
Stelzer, Torsten;  University of Puerto Rico Medical Sciences Campus > Department of Pharmaceutical Sciences
Revalor, Eve;  University of Melbourne > Department of Chemical and Biomolecular Engineering
Weeranoppanant, Nopphon;  Massachusetts Institute of Technology - MIT > Department of Chemical Engineering
Jensen, Klavs;  Massachusetts Institute of Technology - MIT > Department of Chemical Engineering
Myerson, Allan;  Massachusetts Institute of Technology - MIT > Department of Chemical Engineering
Language :
English
Title :
Compact and Integrated Approach for Advanced End-to-end Production, Purification, and Aqueous Formulation of Lidocaine Hydrochloride
Publication date :
2016
Journal title :
Organic Process Research and Development
ISSN :
1083-6160
eISSN :
1520-586X
Publisher :
American Chemical Society, Washington, DC, United States
Peer reviewed :
Peer Reviewed verified by ORBi
Funders :
Defense Advanced Research Project Agency (DARPA) and Space and Naval Warfare Systems Center Pacific (SSC Pacific) under Contract No. N66001-11-C-4147.
Available on ORBi :
since 23 June 2016

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