Esketamine formulations and methods for preparation and storage
AssigneeJanssen Pharmaceutica NV
InventorsCaroline Anne AERTS, Kris KAYENS, Koen Maria SCHRIJNEMAKERS, Mohamedilias JIMIDAR
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Abstract
The disclosure is directed to pharmaceutical compositions comprising esketamine or a pharmaceutically acceptable salt thereof and an oxidative degradant. In certain aspects, the oxidative degradant is 6-(2-chlorophenyl)-6-oxohexanoic acid or a pharmaceutically acceptable salt thereof. Methods for limiting the formation of oxidative degradants in a pharmaceutical composition comprising esketamine or a pharmaceutically acceptable salt thereof are also disclosed.
Claims16
A process for preparing a pharmaceutical composition comprising esketamine or a pharmaceutically acceptable salt thereof and not more than 0.2% (HPLC area) or not more than 0.2% w/w of 6-(2-chlorophenyl)-6-oxohexanoic acid or a pharmaceutically acceptable salt thereof, relative to the amount/weight of esketamine respectively, comprising mixing the esketamine or a pharmaceutically acceptable salt thereof with one or more pharmaceutically acceptable excipients;
- and exposing the esketamine to about 6 hours or less of light.
A process for preparing a pharmaceutical composition comprising esketamine or a pharmaceutically acceptable salt thereof and not more than about 120 ppm of 6-(2-chlorophenyl)-6-oxohexanoic acid or a pharmaceutically acceptable salt thereof, comprising mixing the esketamine or a pharmaceutically acceptable salt thereof with one or more pharmaceutically acceptable excipients;
- and exposing the esketamine to about 6 hours or less of light.
Dependencies are inferred from the claim text.