Stable amorphous form of daclatasvir

A process for the preparation daclatasvir or a pharmaceutically acceptable salt thereof, wherein the process includes the synthetic step of reacting a compound of Formula (I) with a compound of Formula (II): Wherein LG is a leaving group and Z is a protecting group. The protecting group Z may be sel...

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Bibliographische Detailangaben
Hauptverfasser: Roman Gerber Aeschbacher, Armine Aramayisyan, Sven Haferkamp, Miriam Oberholzer, Arsen Sahakyan, Viktorya Rstakyan, David Hambardzumyan
Format: Patent
Sprache:eng
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Zusammenfassung:A process for the preparation daclatasvir or a pharmaceutically acceptable salt thereof, wherein the process includes the synthetic step of reacting a compound of Formula (I) with a compound of Formula (II): Wherein LG is a leaving group and Z is a protecting group. The protecting group Z may be selected from Boc, Cbz, Tosyl, Mesyl, Benzyl, Fmoc, substituted acetyl, Benzoyl and Tolyl. A process for the production of amorphous daclatasvir-2 HCl is also provided, comprising the steps of contacting daclatasvir-2 HCl with a pharmaceutically acceptable solvent; filtering off the solution or dispersion of the first step; and the immediate removal of the solvent from the filtered solution or dispersion of the second step, characterised in that the solvent removal is performed within a timescale of 10 seconds to 5 hours after the filtering step.