Nasal cannabidiol compositions

Abstract

A nasally administered cannabinoid semi-solid or viscous liquid composition; nasal methods for administering the nasal pharmaceutical compositions; methods for manufacturing the nasal pharmaceutical compositions; and nasal methods of treating diseases treatable by the nasal pharmaceutical compositions formulated with a cannabinoid or mixtures thereof.

1 . A nasal pharmaceutical composition for topical application in the nasal cavity of a subject, the nasal pharmaceutical composition comprising:
 (a) a cannabinoid therapeutic active (cannabidiol);   (b) an oily vehicle; and   (c) a wetting agent or mixture of wetting agents and/or a pharmaceutically acceptable surfactant or mixture of surfactants,   wherein the nasal pharmaceutical composition is a semi-solid or viscous liquid nasal pharmaceutical composition, and   wherein, following administration to subject in need thereof, the nasal pharmaceutical composition achieves a serum cannabinoid concentration of at least about 0.1 ng/ml within 8 h in the subject after a single nasal administration.   
     
     
         2 . The nasal pharmaceutical composition of  claim 1 , wherein the subject has fasted prior to administration. 
     
     
         3 . The nasal pharmaceutical composition of  claim 1  capable of achieving a serum cannabidiol concentration of at least at least about 0.5 ng/ml within 8 h after nasal administration to a fasted subject. 
     
     
         4 . The nasal pharmaceutical composition of  claim 1  capable of achieving a serum cannabinoid concentration of at least about 1 ng/ml within 8 h after a single administration to a fasted subject. 
     
     
         5 . The nasal pharmaceutical composition of  claim 1  capable of achieving a serum cannabinoid concentration of at least about 40 ng/ml within 8 h after a single administration to a fasted subject. 
     
     
         6 . The nasal pharmaceutical composition of  claim 1 , wherein the nasal pharmaceutical composition is nasally administered to the subject's nasal vestibule of the subject's nostril. 
     
     
         7 . A nasal pharmaceutical composition formulated for delivery to the nasal cavity of a subject in need thereof, the nasal pharmaceutical composition comprising:
 (a) a therapeutically effective amount of a cannabinoid; and   (b) a pharmaceutically acceptable excipient;   wherein the nasal pharmaceutical composition is a semi-solid or viscous liquid nasal pharmaceutical composition having a viscosity within a viscosity range of between about 500 cps and about 100,000 cps;   wherein the cannabinoid comprises at least about 0.1 mg of CBD and/or at least about 0.1 mg of THC.   
     
     
         8 . The nasal pharmaceutical composition of  claim 7 , wherein the CBD is either CBD-rich or a pure CBD. 
     
     
         9 . The nasal pharmaceutical composition of  claim 7 , wherein the cannabinoid comprises CBD within a CBD range of at least about 5 mg and about 25 mg, at least about 0.1 mg and about 37.5 mg, at least about 1 mg and about 35 mg, or at least about 2 mg and about 30 mg, wherein the CBD range is inclusive. 
     
     
         10 . The nasal pharmaceutical composition of  claim 7 , wherein the semi-solid or viscous liquid nasal pharmaceutical composition is selected from the group consisting of a cream, a gel and a viscous liquid. 
     
     
         11 . The nasal pharmaceutical composition of  claim 10 , wherein the nasal pharmaceutical composition is formulated for topical application. 
     
     
         12 . The nasal pharmaceutical composition of  claim 7 , wherein the nasal pharmaceutical composition is formulated for treatment of schizophrenia in a subject in need thereof. 
     
     
         13 . The nasal pharmaceutical composition of  claim 7 , wherein the nasal pharmaceutical composition is formulated for treatment of a disorder in the subject in need thereof, wherein the disorder is schizophrenia and related to psychotic disorders. 
     
     
         14 . A method of treating a disorder in a subject, comprising nasally administering a nasal pharmaceutical composition into at least one nostril of the subject at least once per day in an amount effective to treat the subject's disorder and/or alleviate or reduce the subject's symptoms thereof, wherein, the nasal pharmaceutical composition comprises:
 (a) a therapeutically effective amount of a cannabidiol; and   (b) a pharmaceutically acceptable excipient;   wherein the nasal pharmaceutical composition is a semi-solid or viscous liquid nasal pharmaceutical composition having a viscosity within a viscosity range of between about 500 cps and about 100,000 cps;   wherein the cannabinoid comprises at least about 0.1 mg of CBD.   
     
     
         15 . The method of  claim 14 , wherein the cannabinoid comprises CBD within a CBD range of at least about 5 mg and about 25 mg, at least about 0.1 mg and about 37.5 mg, at least about 1 mg and about 35 mg, or at least about 2 mg and about 30 mg, wherein the CBD range is inclusive, or about 20 mg of CBD. 
     
     
         16 . The method of  claim 14 , wherein the cannabinoid is at least about 50% CBD, at least about 60% CBD, at least about 70% CBD, at least about 80% CBD, at least about 90% CBD, at least about 95% CBD, at least about 98% CBD, at least about 99% CBD, or about 100% CBD. 
     
     
         17 . The method of  claim 14 , wherein the cannabinoid contains between at least about 1 mg and about 35 mg of THC, inclusive, or between at least about 2 mg and about 30 mg of THC, inclusive. 
     
     
         18 . The method of  claim 14 , wherein nasal administration comprises nasally administering the nasal pharmaceutical composition into at least one nostril of the subject at least twice per day, at least three times per day, or at least four times per day. 
     
     
         19 . The method of  claim 14 , wherein the nasal pharmaceutical composition is administered to the subject at a dose within the dose range of about 50 μl to about 150 μl per nostril. 
     
     
         20 . The method of  claim 14 , wherein the nasal pharmaceutical composition is formulated for treatment of a disorder in the subject in need thereof, wherein the disorder is schizophrenia and related to psychotic disorders.