Ketamine formulation
AssigneeFresenius Kabi USA, LLC
InventorsJessica Rozemberg, Jennifer Gehle-Novak
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Abstract
The invention provides a sterile, injectable pharmaceutical composition which includes a therapeutically effective amount of ketamine or a pharmaceutically acceptable salt thereof, a nitrite scavenger, a tonicity agent, and water, wherein the composition contains less than about 300 ppb of an N-nitrosoketamine impurity. The invention also provides a pharmaceutical product which includes a container and the composition of the invention aseptically sealed therein. The invention further provides a process for preparing the composition and product of the invention.
Claims18
A sterile, injectable pharmaceutical composition comprising a therapeutically effective amount of ketamine or a pharmaceutically acceptable salt thereof, ascorbic acid, a tonicity agent, and water,
- wherein the therapeutically effective amount of ketamine or the pharmaceutically acceptable salt thereof is present in an amount of about 0.1 mg/mL to about 10 mg/ml of ketamine free base,
- wherein ascorbic acid is present in an amount of about 0.005 mg/mL to about 1 mg/mL,
- wherein after 6 months of storage at room temperature, the composition (i) contains less than about 500 ppb of N-nitrosoketamine, (ii) retains at least about 95% of the initial amount of the ketamine free base, and (iii) has a pH of about 3.5 to about 5.5.
A sterile, injectable pharmaceutical composition comprising ketamine hydrochloride at a concentration equivalent to about 0.1 mg/mL to about 10 mg/mL of ketamine free base, from about 0.005 mg/mL to about 0.2 mg/mL of ascorbic acid, a tonicity agent, and water,
- wherein after 6 months of storage at room temperature, the composition (i) contains less than about 500 ppb of N-nitrosoketamine, (ii) retains at least about 99% of the initial amount of the ketamine free base, and (iii) has a pH of about 3.5 to about 5.5.
A pharmaceutical product comprising a container and a composition aseptically sealed in the container, wherein the composition comprises ketamine hydrochloride at a concentration equivalent to about 0.1 mg/mL to about 10 mg/ml of ketamine free base, from about 0.005 mg/mL to about 0.2 mg/mL of ascorbic acid, a tonicity agent, and water,
- wherein after 6 months of storage at room temperature, the composition (i) contains less than about 500 ppb of N-nitrosoketamine, (ii) retains at least about 95% of the initial amount of the ketamine free base, and (iii) has a pH of about 3.5 to about 5.5.
Dependencies are inferred from the claim text.