Authors
Jean-Christophe M Monbaliu, Torsten Stelzer, Eve Marie Revalor, Nopphon Weeranoppanant, Klavs F Jensen, Allan S Myerson
Publication date
2016
Journal
Organic Process Research & Development
Volume
20
Issue
7
Pages
1347–1353
Publisher
American Chemical Society
Description
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. On the basis of 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).
Total citations
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