Therapeutic agent for intranasal administration and method of making and using same

Abstract

The present invention provides a composition suitable for intranasal administration comprising capsaicin, dihydrocapsaicin, and nordihydrocapsaicin in the form of capsicum used as a therapeutic agent.

1 . A composition comprising:
 an aqueous homeopathic dilution of  capsicum;      wherein the composition is suitable for intranasal administration to a human in need thereof;   wherein fast relief is defined as first relief from at least one rhinitis symptom occurring within about 30 minutes of administration.   
     
     
         2 . The composition of  claim 1 , wherein the homeopathic dilution of  capsicum  is at a concentration of about 0.00060% to about 0.010% w/w containing about 0.1 to about 2.0 ppm total capsaicinoids. 
     
     
         3 . The composition of  claim 1 , wherein the homeopathic dilution of  capsicum  is at a concentration of about 0.0020% to about 0.0080% w/w containing about 0.3 to about 1.5 ppm total capsaicinoids. 
     
     
         4 . The composition of  claim 1 , wherein the homeopathic dilution of  capsicum  is at a concentration of about 0.0030% to about 0.0080% w/w containing about 0.5 to about 1.5 ppm total capsaicinoids. 
     
     
         5 . The composition of  claim 1 , comprising rosemary extract at a concentration of about 0.02% to about 0.25% w/w. 
     
     
         6 . The composition of  claim 1 , comprising rosemary extract at a concentration of about 0.05% to about 0.08% w/w. 
     
     
         7 . The composition of  claim 1 , comprising rosemary extract at a concentration of about 0.06% to about 0.07% w/w. 
     
     
         8 . The composition of  claim 1 , wherein the first relief from symptoms occurs within about 15 minutes of administration. 
     
     
         9 . The composition of  claim 1 , wherein the first relief from symptoms occurs within about 5 minutes of administration. 
     
     
         10 . The composition of  claim 1 , wherein the first relief from symptoms occurs within about 3 minutes of administration. 
     
     
         11 . The composition of  claim 1 , wherein the first relief from symptoms occurs within about 1 minute of administration. 
     
     
         12 . The composition of  claim 1 , wherein the at least one rhinitis symptom relieved comprise nasal congestion, sinus pressure, headache, sinus pain or a combination thereof. 
     
     
         13 . The composition of  claim 9 , wherein the at least one rhinitis symptom relieved comprise one or more of nasal congestion, sinus pressure, headache or a combination thereof. 
     
     
         14 . The composition of  claim 1 , comprising eucalyptol at a concentration of about 0.07% to about 0.15% w/w. 
     
     
         15 . The composition of  claim 1 , comprising vegetable glycerin at a concentration of about 3.5% to about 5.0% w/w. 
     
     
         16 . The composition of  claim 1 , comprising vegetable glycerin at a concentration of about 3.9% to about 4.5% w/w. 
     
     
         17 . The composition of  claim 1 , comprising ascorbic acid at a concentration of about 0.10% to about 0.90% w/w. 
     
     
         18 . The composition of  claim 1 , comprising sea salt at a concentration of about 0.40% to about 1.2% w/w. 
     
     
         19 . A composition comprising:
 an aqueous solution of  capsicum  at a concentration of about 0.00060% to about 0.010% w/w containing about 0.1 to about 2.0 ppm total capsaicinoids;   wherein the composition is suitable for intranasal administration to a human in need thereof;   wherein the first relief from at least one rhinitis symptom occurs within about 30 minutes of administration.   
     
     
         20 . The composition of  claim 19 , wherein the aqueous solution of  capsicum  is at a concentration of about 0.0020% to about 0.0080% w/w containing about 0.3 to about 1.5 ppm total capsaicinoids. 
     
     
         21 . The composition of  claim 19 , wherein the aqueous solution of  capsicum  is at a concentration of about 0.0030% to about 0.0080% w/w containing about 0.5 to about 1.5 ppm total capsaicinoids. 
     
     
         22 . The composition of  claim 19 , comprising rosemary extract at a concentration of about 0.02% to about 0.25% w/w. 
     
     
         23 . The composition of  claim 19 , comprising rosemary extract at a concentration of about 0.05% to about 0.1% w/w. 
     
     
         24 . The composition of  claim 19 , comprising rosemary extract at a concentration of about 0.06% to about 0.07% w/w. 
     
     
         25 . The composition of  claim 19 , wherein the first relief from at least one symptom occurs within about 15 minutes of administration. 
     
     
         26 . The composition of  claim 19 , wherein the first relief from at least one symptoms occur within about 5 minutes of administration. 
     
     
         27 . The composition of  claim 19 , wherein the first relief from at least one symptom occurs within about 3 minutes of administration. 
     
     
         28 . The composition of  claim 19 , wherein the first relief from at least one symptom occurs within about 1 minute of administration. 
     
     
         29 . The composition of  claim 19 , wherein the at least one rhinitis symptom relieved comprises nasal congestion, sinus pressure, headache, sinus pain or a combination thereof. 
     
     
         30 . The composition of  claim 26 , wherein the at least one rhinitis symptom relieved comprises nasal congestion, sinus pressure, headache or a combination thereof. 
     
     
         31 . A composition comprising:
 an aqueous solution of  capsicum  at a concentration of about 0.00060% to about 0.010% w/w containing about 0.1 to about 2.0 ppm total capsaicinoids;   rosemary extract at a concentration of about 0.02% to about 0.25% w/w;   wherein the composition is suitable for intranasal administration to a human in need thereof;   wherein the first relief from at lease one rhinitis symptom occurs within about 30 minutes of administration.   
     
     
         32 . The composition of  claim 31 , wherein the aqueous solution of  capsicum  is at a concentration of about 0.0020% to about 0.0080% w/w containing about 0.3 to about 1.5 ppm total capsaicinoids. 
     
     
         33 . The composition of  claim 31 , wherein the aqueous solution of  capsicum  is at a concentration of about 0.0030% to about 0.0080% w/w containing about 0.5 to about 1.5 ppm total capsaicinoids. 
     
     
         34 . The composition of  claim 31 , comprising rosemary extract at a concentration of about 0.05% to about 0.1% w/w. 
     
     
         35 . The composition of  claim 31 , comprising rosemary extract at a concentration of about 0.06% to about 0.07% w/w. 
     
     
         36 . The composition of  claim 31 , wherein the first relief from symptoms occurs within about 15 minutes of administration. 
     
     
         37 . The composition of  claim 31 , wherein the first relief from symptoms occurs within about 5 minutes of administration. 
     
     
         38 . The composition of  claim 31 , wherein the first relief from symptoms occurs within about 3 minutes of administration. 
     
     
         39 . The composition of  claim 31 , wherein the first relief from symptoms occurs within about 1 minute of administration. 
     
     
         40 . The composition of  claim 31 , wherein the rhinitis symptoms relieved comprise at least one of nasal congestion, sinus pressure, headache, sinus pain or a combination thereof. 
     
     
         41 . The composition of  claim 37 , wherein the at least one rhinitis symptom relieved comprises nasal congestion, sinus pressure, headache or a combination thereof. 
     
     
         42 . A composition comprising:
 an aqueous solution of  capsicum  at a concentration of about 0.00060% to about 0.010% w/w containing about 0.1 to about 2.0 ppm total capsaicinoids;   rosemary extract at a concentration of about 0.02% to about 0.25% w/w;   wherein the composition is suitable for intranasal administration in a human in need thereof;   wherein the first relief from at least one symptom occurs within about 5 minutes of administration; and   wherein the symptoms comprise at least one of nasal congestion, sinus pressure, headache or a combination thereof.   
     
     
         43 . A composition comprising:
 an aqueous solution of  capsicum  at a concentration of about 0.00060% to about 0.010% w/w containing about 0.1 to about 2.0 ppm total capsaicinoids;   rosemary extract at a concentration of about 0.02% to about 0.25% w/w;   eucalyptol at a concentration of about 0.07% to about 0.15% w/w;   vegetable glycerin at a concentration of about 3.5% to about 5.0% w/w;   wherein the composition is suitable for intranasal administration in a human in need thereof;   wherein the first relief from at least one symptom occurs within about 5 minutes of administration; and   wherein symptoms consist of at least one of nasal congestion, sinus pressure, headache or a combination thereof.   
     
     
         44 . The composition of  claim 43 , comprising ascorbic acid at a concentration of about 0.10% to about 0.90% w/w and sea salt at a concentration of about 0.40% to about 1.2% w/w. 
     
     
         45 . The composition of  claim 43 , wherein the first relief from at least one symptom occurs within about 3 minutes of administration. 
     
     
         46 . The composition of  claim 43 , wherein the first relief from at least one symptom occurs within about 1 minute of administration. 
     
     
         47 . A composition comprising:
 an aqueous solution of  capsicum  at a concentration of about 0.00060% to about 0.010% w/w containing about 0.1 to about 2.0 ppm total capsaicinoids;   rosemary extract at a concentration of about 0.02% to about 0.25% w/w;   wherein the composition is suitable for intranasal administration to a human in need thereof;   wherein the composition does not require the administration of a second agent to enable tolerance of the composition;   wherein the first relief from at least one rhinitis symptom occurs within about 30 minutes of administration.   
     
     
         48 . A composition comprising:
 an aqueous solution of  capsicum  at a concentration of about 0.00060% to about 0.010% w/w containing about 0.1 to about 2.0 ppm total capsaicinoids;   rosemary extract at a concentration of about 0.02% to about 0.25% w/w;   wherein the composition is suitable for intranasal administration to a human in need thereof;   wherein the composition is self-administered;   wherein the first relief from at least one rhinitis symptom occurs within about 30 minutes of administration.   
     
     
         49 . A method for intranasal administration of an aqueous homeopathic dilution of  capsicum  to a human in need thereof comprising the steps of:
 administering intranasally a solution comprising about 0.00060% to about 0.010% w/w  capsicum  containing about 0.1 to about 2.0 ppm total capsaicinoids and rosemary extract at a concentration of about 0.02% to about 0.25% w/w;   effecting the first relief from at least one symptom nasal congestion, sinus pressure, sinus pain, headache or a combination thereof within about 30 minutes of administration.   
     
     
         50 . The method of  claim 47  wherein the  capsicum  is present in solution at a concentration of about 0.0020% to about 0.0080% w/w containing about 0.3 to about 1.5 ppm total capsaicinoids. 
     
     
         51 . The method of  claim 47 , wherein the first relief from at least one symptom occurs within about 5 minutes of administration.