Stable nimodipine parenteral formulation
AssigneeNortic Holdings Inc.
InventorsS. George Kottayil, Amresh Kumar, Prasanna Sunthankar, Vimal Kavuru
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AssigneeNortic Holdings Inc.
InventorsS. George Kottayil, Amresh Kumar, Prasanna Sunthankar, Vimal Kavuru
Estimating the term…
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.
A nimodipine injection concentrate formulation, comprising nimodipine base or a pharmaceutically acceptable nimodipine salt in a concentration from about 0.01 to about 5 mg/ml;
A directly infusible nimodipine formulation suitable for parenteral administration in humans, comprising nimodipine in a concentration from about 0.01 mg/ml to about 1.0 mg/ml, a pharmaceutically acceptable organic solventconsisting of ethanol copmrising less than 2% w/v of the formulation, a pharmaceutically acceptable aqueous carrier, and an effective amount of a single hydrophilic surfactant which is polysorbate 80 and is from 0.01% to about 2.5% w/v of the formulation, such that the nimodipine is substantially contained in micelles, the formulation comprising a volume from about 50 ml to about 1000 ml and contained in a pharmaceutically acceptable container, the formulation being a stable clear micellar solution and displaying no precipitation of nimodipine, wherein the directly infusible nimodipine injection formulation does not contain poloxamer, a phospholipid, or an oil.
Dependencies are inferred from the claim text.