Morphine formulations
AssigneeBecton Dickinson France
InventorsAlain CUINE, Didier Hoarau, Pauline Romain
Life of this patent
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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.
Claims49
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.
A pharmaceutical formulation comprising per mL:
- (a) from about 2 mg to about 10 mg of morphine sulfate pentahydrate;
- (b) from about 7 mg to about 9 mg of sodium chloride;
- (c) from about 2 mg to about 4 mg of sodium citrate dihydrate;
- (d) from about 0.7 to about 1.2 mg of citric acid monohydrate;
- (e) from about 0.1 to about 0.15 mg of disodium edetate dihydrate;
- (f) from about 0.04 to about 0.06 mg calcium chloride dihydrate;
- and
- (g) water for injection.
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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 isotonic agent is selected from sodium chloride, calcium chloride, potassium chloride, sodium bicarbonate, sodium lactate, Ringer's solution, dextrose, lactose, mannitol, glucose, glycerine, dextran, Normosol R, saline, Hartmann's solution, and mixtures and combinations thereof.
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A method of reducing pain in a subject, comprising:
- administering to the subject 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 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 5 to the formulation;
- d) disodium edetate dihydrate;
- (e) calcium chloride dihydrate;
- and
- (f) water for injection.
A method of reducing adverse effects of a injectable morphine pharmaceutical formulation comprising disodium edetate dihydrate, the method comprising the addition of calcium chloride dihydrate to the injectable morphine pharmaceutical formulation wherein the formulation comprises per mL:
- a) from about 2 mg to about 10 mg of morphine sulfate or a hydrate thereof;
- b) sodium chloride;
- c) 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 5 to the formulation;
- d) disodium edetate dihydrate;
- (e) calcium chloride dihydrate;
- and
- (f) water for injection.
Dependencies are inferred from the claim text.