Botanical Formulation Derived From Birch Bark

Abstract

A formulation and method of mitigation of symptoms of patients suffering from a neurocutaneous pain syndrome by topical application of the formulation. The formulation is obtained by steeping the bark of a tree from the genus Betula in an aqueous acidified solution and then subsequent filtering, packaging and sterilization.

1 . A topical formulation comprising an acidic aqueous extract of the bark of a tree from the genus  Betula.    
     
     
         2 . The topical formulation of  claim 1  wherein said tree is from the species  Betula alba.    
     
     
         3 . The topical formulation of  claim 2  wherein the pH of said formulation is between about 2.0 and about 5.0. 
     
     
         4 . The topical formulation of  claim 3  further comprising acetic acid. 
     
     
         5 . The topical formulation of  claim 4  wherein the formulation has been filtered one or more times. 
     
     
         6 . The topical formulation of  claim 5  wherein said filter has a pore size equal to or less than about 5.0 microns. 
     
     
         7 . The topical formulation of  claim 6  wherein said formulation is subjected to 30-50 kGY of gamma radiation after said formulation has been filtered. 
     
     
         8 . The topical formulation of  claim 7  wherein the formulation has been subjected to gamma radiation for a calculated period of time, dependent upon batch weight, to achieve a specific calculated dose of irradiation delivered of at least about 30 kGy, but no more than about 50 kGY, after the formulation has been filtered. 
     
     
         9 . The topical formulation of  claim 8  wherein said formulation is packaged in a pump spray container. 
     
     
         10 . The topical formulation of  claim 6  further comprising one or more medically acceptable or cosmetically/pharmaceutically/physiologically acceptable excipients selected from the group consisting of carriers, diluents, adjuvants, vehicles, preservatives, antibiotics and mixtures thereof. 
     
     
         11 . The topical formulation of  claim 10  wherein said formulation is in a form selected from the group consisting of emulsions, slurries, poultices, drenches, balms, salves, pomades, oils, jellies, foams, creams, solutions, shampoos, soaps, lotions, ointment, hydrogels, bath gels, shower gels, and gels. 
     
     
         12 - 23 . (canceled) 
     
     
         24 . A method of producing a topical formulation comprising the step of soaking bark from a tree of the genus  Betula  in an acid aqueous solution. 
     
     
         25 . The method of  claim 24  wherein the formulation has pH between about 2.0 and about 5.0. 
     
     
         26 . The method of  claim 25  wherein the formulation comprises acetic acid. 
     
     
         27 . The method of  claim 26  wherein the aqueous solution is boiled for at least 30 minutes. 
     
     
         28 . The method of  claim 27  wherein the tree is  Betula alba.    
     
     
         29 . The method of  claim 28  wherein the formulation has been filtered one or more times. 
     
     
         30 . The method of  claim 29  wherein the filter has a pore size equal to or less than about 5.0 microns. 
     
     
         31 . The method of  claim 30  wherein the formulation is subjected to 30-50 kGY of gamma radiation. 
     
     
         32 . The method of  claim 31  wherein the formulation has been subjected to gamma radiation for a calculated period of time, dependent upon batch weight, to achieve a specific calculated dose of irradiation delivered of at least about 30 kGy, but no more than about 50 kGY, after the formulation has been filtered. 
     
     
         33 . The method of  claim 32  wherein the formulation is packaged in a pump spray bottle. 
     
     
         34 . The method of  claim 30  wherein the formulation further comprises one or more medically acceptable or cosmetically/pharmaceutically/physiologically acceptable excipients selected from the group consisting of carriers, diluents, adjuvants, vehicles, preservatives, antibiotics and mixtures thereof. 
     
     
         35 . The method of  claim 34  wherein the formulation is in a form selected from the group consisting of emulsions, slurries, poultices, drenches, balms, salves, pomades, oils, jellies, foams, creams, solutions, shampoos, soaps, lotions, ointment, hydrogels, bath gels, shower gels, and gels. 
     
     
         36 - 47 . (canceled)