Stable nimodipine parenteral formulation
AssigneeNortic Holdings Inc.
InventorsS. George Kottayil, Amresh Kumar, Prasanna Sunthankar, Vimal Kavuru, Kamalkishore Pati
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Abstract
A nimodipine injection concentrate and diluted formulation comprises nimodipine (base or salt), an effective amount of a hydrophilic surfactant, and a pharmaceutically acceptable carrier for injection which is an aqueous solution, an organic solvent, an oil, or a cyclodextrin, such that the nimodipine is substantially contained in a concentrated injection solution, suspension, emulsion or complex as a micelle or a colloidal particle or an inclusion complex and the formulation is stable and clear. In certain embodiments, the hydrophilic surfactant is polysorbate 80.
Claims20
A nimodipine injection concentrate formulation, consisting of nimodipine base or a pharmaceutically acceptable nimodipine salt in a concentration from about 0.01 mg/ml to about 5 mg/ml;
- an organic solvent;
- a pharmaceutically acceptable aqueous carrier;
- an optional preservative;
- and an effective amount of a single hydrophilic surfactant, such that nimodipine in the injection concentrate formulation is contained in micelles and the formulation is stable and clear and stored in a container, wherein the formulation has a dissolved oxygen content of about 2 ppm and a head space oxygen content of less than 5%.
Dependencies are inferred from the claim text.