Morphine formulations
AssigneeFresenius Kabi Deutschland GmbH
InventorsAlain CUINE, Didier HOARAU, Pauline ROMAIN
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Abstract
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.
Claims20
A prefilled syringe comprising a pharmaceutical formulation comprising:
- (a) morphine, or a salt thereof, or a hydrate thereof;
- (b) an isotonic agent;
- (c) a buffering agent with anti-oxidative properties;
- (d) a chelating agent;
- (e) a complement to a chelating agent;
- and
- (f) water,
- wherein the formulation has a pH of from about 4.5 to about 6.5, and wherein following storage at 25° C./60% Relative Humidity for at least 12 months, the formulation comprises not more than about 0.2% pseudomorphine and not more than about 1.5% total impurities.
A method of reducing adverse effects of an injectable morphine pharmaceutical formulation comprising a chelating agent, the method comprising the addition of a complement to the chelating agent to the formulation.
Dependencies are inferred from the claim text.