Abstract:
A composition and method of treating severe itching by topically administering a therapeutically effective amount of colloidal sulfur suspended in a pharmaceutically acceptable carrier including a diketone.

Description:
BACKGROUND OF THE INVENTION 
     Itching or Pruritis is a common dermatoloigical symptom. The causes of Pruritis are complex and not completely understood. Among the causes of itching are localized causes such as eczema of the scalp and fingers, general Pruritis such as low humidity or dry skin, skin diseases such as scabies, insect bites; systemic causes such as infectious causes. 
     Some kinds of itching are relieved by antihistamine but many others are not. Therefore, there is a need for improved treatments to relieve severe itching. The present invention provides a composition and method for treating Pruritis independent of systemic effects on the central nervous system. 
     SUMMARY OF THE INVENTION 
     The present invention provides an improved composition and method of treating severe itching comprising topically administering a therapeutically effective amount of colloidal sulfur suspended in a pharmaceutically acceptable carrier including a vicinal diketone and aliphatic poly-alcohol which may be esterified by a fatty acid. 
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     It has now been discovered that elemental sulfur, dispersed in a diketone with a poly-alcohol is effective for palliative treatment of Pruritis, regardless of the etiology of the itching. Or particularly, elemental sulfur, which may be in the form of flowers of sulfur or finely divided sulfur in relatively pure form from commercially available sources, may be dispersed in a vicinal diketone, to form a colloidal solution which may then be dispersed in an aqueous, fat or oil carrier fluid in which sulfur is otherwise insoluble, to form a stable dispersion of colloidal sulfur in a concentrate of 1 to 7 weight percent sulfur which advantageously may be used alone or in a combination with other antipruritic compounds to treat Pruritis. 
     More particularly, in accordance with the preferred embodiment of my invention, a dispersion of colloidal sulfur is formed by beating sulfur in a polyalcohol or ether or ester derivative thereof in a mixture with a diketone to produce a colloidal sulfur solution which may then be mixed in a carrier fluid, e.g. aqueous media, fats such as cream commonly employed in producing salves and ointments, or mineral or vegetable oils commonly used in producing dermatological formulations, and applied topically. Examples of useful products include creams, lotions, solutions, ointments and unguents containing colloidal sulfur solutions. 
     The concentration of diketone in the formulation is not critical and can vary over a wide range. Typically, however, the diketone will be present in an amount in a range of 5-40% by weight which is sufficient to permit about 7% by weight dispersion of sulfur in the formulation. 
     The formulation may contain additional ingredients on an optional basis, including both those which are biologically active and those which are biologically inactive. Examples of biologically active ingredients are amine-and- “caine”-type local anesthetics, antihistamines, corticosteroids, alcohol&#39;s, counterirritants and combinations of these agents. Specific examples within these groups include butaman, benzocaine, dibucaine, paramoxine, dimethisoquin, dyclonine, lidocaine, tetracaine, camphor, benzyl alcohol, menthyl, phenol, phenolated sodium, resorcinol, tar, camphorated metacresol, diphenhydramine, tripelennamine, hydrocortisone, histamine, methyl nicotinate, capsicum, methyl salicylate, turpentine oil, allyl isothiocyanate, ammonia, and salicylic acid. The concentrations of these active ingredients can range from 0.025% to 60%, the most appropriate amounts in each case depending on the agents. Appropriate concentration ranges from any particular agent will be apparent to those skilled in the Art. 
     The diketone should be one of several small molecular weight diketones so as to preserve its water solubility. Preferred are lower molecular weight ketones and diketones such as hydroxy diketone, diacetyl, or homologs thereof. 
     The invention will now be further described in connection with the following examples: 
     EXAMPLE I 
     Seventy five (75) g. of glycerol monostearate is heated to 130 degrees C. and 10 g. of diacetyl are added plus 8 g. of powdered elemental sulfur are added. The mix is stirred and the decanted liquid is poured into 100 ml. of water. The mixture is a milky colloidal solution suitable for topical application. 
     EXAMPLE II 
     Fifty (50) g. of propylene glycol is heated to 110 degrees C. with 10 g. of diacetyl. Then 5 g. of powdered elemental sulfur is added and kept at 110 degrees C. Then the solution is poured into 1% acacia solution to form a stable colloidal solution for topical application. 
     The preparation formed in Examples I and II were swabbed on itchy skin of volunteers who reported almost instant secession of itching. 
     While only preferred embodiments of the invention have been described, various changes may be made without departing from the spirit and scope of the invention.