INTRANASAL DELIVERY SYSTEM FOR DANTROLENE
The present invention provides a method for rapidly and reliably delivering dantrolene, or derivatives thereof, alone or in combination with other compounds, to the systemic circulation by administration via the nasal route to produce rapid onset of beneficial effects in the treatment or prevention of malignant hyperthermia (MH), spasticity, and Ecstasy intoxication. The present invention further provides intranasal pharmaceutical compositions comprising dantrolene sodium or any pharmaceutically acceptable salts thereof in a variety of pharmaceutical dosage forms, with and without other compounds.
1 . A method for preventing or treating MH and/or spasticity, said method comprising
intranasally administering to a patient in need of such prevention or treatment an effective amount of a pharmaceutical composition comprising dantrolene, or a pharmaceutically acceptable salt thereof;
wherein said pharmaceutical composition is intranasally administered; and
wherein said pharmaceutical composition is in the form of a powder.
2 . (canceled)
3 . An intranasal pharmaceutical composition suitable for the prevention or treatment of MH and/or spasticity, comprising an effective amount of dantrolene, or a pharmaceutically acceptable salt thereof along with a pharmaceutically acceptable nasal carrier; wherein said composition is in the form of a powder.
4 . The composition according to claim 3 , wherein the carrier is powder.
5 . (canceled)
6 . (canceled)
7 . The method of claim 1 , wherein the dantrolene is in the form of dantrolene free acid, dantrolene sodium, or any acceptable salt.
8 . The method of claim 1 , wherein the dantrolene may be administered practiced by nasal administration of dantrolene by itself or in a combination with other active ingredients in a pharmaceutical composition such as baclofen, benzodiazepines, cyproheptadine, tetrahydrocannabinol, and/or gabapentin.
9 . A method of providing fast relief from the symptoms of MH or spasticity comprising nasal administration of dantrolene sodium or pharmaceutically acceptable salt to a subject in need thereof.
10 . A method for rapidly and reliably delivering via nasal administration a therapeutically effective concentration of dantrolene to the systemic circulation of a patient for the treatment of MH and/or spasticity.