Nortic Holdings Inc.

Acasti Pharma U.s., Inc.

Grace Therapeutics Inc.

Grace Therapeutics U.s., Inc.

Vimal Kavuru

S George Kottayil

Amresh Kumar

Prasanna Sunthankar

Kamalkishore Pati

A method of providing an IV nimodipine infusion regimen using a solubilized nimodipine solution suitable for IV administration is disclosed. The IV nimodipine infusion regimen provides a constant infusion rate over the (entire) 24 hour period supplemented with higher infusions of nimodipine at set intervals to duplicate the 24 hour AUC and Cof an oral nimodipine dose.

Nimodipine parenteral administration

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 substantially free of organic solvent, 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.

Stable nimodipine parenteral formulation

A nasal spray formulation and a method of using a locally acting sodium channel blocker to treat pain is disclosed, wherein the nasal spray formulation comprises from about 5% to about 30% w/v of a locally active sodium channel blocker, from about 0.25% to about 5% w/v of a buffering agent, and from about 5 to about 99% w/v of a pharmaceutically acceptable carrier for nasal administration. The nasal spray formulation is preferably contained in a mechanical multi-dose pump which sprays a unit dose of the nasal spray formulation with a wide plume and small droplet size, such that the unit dose is administered by actuating the mechanical multi-dose spray pump device and spraying a volume of the nasal spray formulation into each nostril of a human subject. Preferably, the nasal spray formulation does not include a preservative.

Therapeutic composition of intranasal lidocaine

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 stable oral spray formulation comprising a glucocorticoid together with other excipients is disclosed. In preferred embodiments, the spray formulation is used to treat neurological disorders such as ataxia by being sprayed in an effective dose into the mouth of a patient.

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Holmdel, NJ, United States of America

Vimal Kavuru