MORPHINE FORMULATIONS

摘要

Provided herein, generally, are pharmaceutical formulations, e.g., injectable pharmaceutical formulations with improved stability, comprising morphine sulfate or a hydrate thereof, and methods of producing and using the same. Also provided herein are kits comprising the formulations, e.g., injectable morphine formulations.

主权项

1. An injectable pharmaceutical formulation comprising per mL:
a) from about 2 mg to about 10 mg of morphine sulfate or a hydrate thereof; b) sodium chloride; c) a buffering system comprised of a buffering agent in an amount which provides a molar ratio of morphine sulfate to the buffering agent from about 0.4 to about 1.3 and is in an amount sufficient to provide a pH of about 5 to the formulation and a conjugate base to the buffering agent; d) disodium edetate or a hydrate thereof; (e) calcium chloride or a hydrate thereof; and (f) water for injection.