Patent Document

CROSS REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation in part of Ser. No. 409,180, filed Aug. 18, 1982, now U.S. Pat. No. 4,483,851. 
    
    
     FIELD OF THE INVENTION 
     This invention relates to novel compositions and their use in epidermal burns, and more particulary to novel compositions useful for the treatment of epidermal muscous membranes and muscular burns and wounds or lesions in animals and humans by topical and infusion application of the composition. 
     BACKGROUND 
     There is disclosed in my parent application, Ser. No. 409,180, filed Aug. 18, 1982, now U.S. Pat. No. 4,483,851, the disclosure of which is hereby incorporated by reference, a composition for topically relating equine metritis comprising the following formulation in water in a concentration of about 40 to 60 weight percent: 
     
         ______________________________________Ingredient      Parts by Weight______________________________________Dextrose        2.0..0.-3.0..0.Buffering Mixture            4.0.-11.0.Carrier          8.0.-11.0.______________________________________ 
    
     These compositions are applied topically to the external genitalia of both male and female horses affected with contagious equine metritis. In several trials the composition was found to be 100% effective in curing the diseases if used on two successive days. By comparison, antibiotics used in the prior art had to be used at least five days to be effective, and then were not 100% effective. 
     It has now been discovered that this and related compositions are broadly effective in treatment of Pseudomonas aeruginosa infected burn patients and infected skin and muscle wounds. When the composition of the invention is applied to skin burns or wounds, it provides dramatic relief of pain, and dramatically accelerates the healing process. 
     SUMMARY OF THE INVENTION 
     It is accordingly one object of the present invention to provide a novel antibacterial composition. 
     A further object of the invention is to provide novel compositions and methods for the treatment of bacterial and fungal infections. 
     A still further object of the present invention is to provide a topical composition and methods for its use in the treatment of topical conditions such as burns, blisters and infections. 
     An even further object of this invention is to provide a method for treating Pseudomonas infected epidermal and muscular burns and wounds. 
     Other objects and advantages of the present invention will become apparent to those skilled in the art as the description thereof proceeds. 
     In satisfaction of the foregoing objects and advantages there is provided by this invention an antibacterial and antifungal composition for the treatment of epidermal and muscular burns and wounds, which composition comprises an aqueous solution of dextrose or dextrose metabolite, a buffering mixture of weak organic acids and alkali metal salts of weak organic acids, and a carrier, the composition being characterized as a viscous solution having a pH varying from 3.0 to 6.5 depending on lesion type. Also provided by the present invention is a method for application of this composition to epidermal burns and wounds, particularly those infected with Pseudomonas, which comprises topically applying the composition to the affected area. 
     DETAILED DESCRIPTION OF THE INVENTION 
     As pointed out above, the present invention is concerned with novel compositions and a method for the treatment of epidermal burns and wounds, particularly those infected with Pseudomonas. The composition inhibits growth of the pseudomonas on the injured area, and promotes healing in burns and wounds. The composition of the present invention in its broadest embodiment comprises an aqueous solution of dextrose or dextrose metabolite, a buffering mixture of weak organic acids and/or alkali metal salts of weak organic acids, and a carrier, the solution being characterized as a relatively viscous solution having a pH ranging from about 3.0 to 6.5. 
     The most preferred composition may be characterized as containing the following formulation per liter of solution: 
     
         ______________________________________Ingredient      Parts by Weight______________________________________Dextrose        5.0.-5.0..0.Buffering Mixture            5-2.0..0.Carrier         5.0.-15.0.______________________________________ 
    
     This composition also contains about 600 to 1200 parts of water, and optionally about 5 to 100 parts of an alkali metal salt of acetic acid. Preferably, the composition contains citric acid and an alkali metal salt of citric acid as important buffering components. 
     The dextrose component of the composition is dextrose or a dextrose metabolite which is effective to provide antibacterial and antifungal properties to the composition when used in admixture with the other components. Thus the dextrose or equivalent material is an important component in the composition. 
     The buffering mixture is also an important ingredient of the composition. A sufficient amount of buffer should be present to provide a resulting solution having a pH of about 3.0 to 6.5, most preferably in the range of 3.2 for antipruritic properties and 6.5 for wounds and burns. Any buffer or mixture of buffers can be used for this purpose although mixtures of weak organic acids and alkali metal salts of organic acids are especially preferred. The amount of buffering agent present is also important since the total solution should contain about 7 to 15 weight percent of buffering agent for a suitable composition. 
     The preferred buffering agents are polycarboxylic acids, phosphates, and the like which will provide the required pH range. The most preferred buffers, however, comprise a mixture of hydroxy polycarboxylic acids having about 3 to 8 carbon atoms and their alkali metal salts, or mixtures thereof. Preferred organic acids include citric acid, malic acid, tartronic acid, tartaric acid, and mixtures thereof as well as the sodium and potassium salts of these acids. A highly preferred buffering system comprises a mixture of citric acid and sodium citrate. 
     The composition optionally contains an alkali metal salt of acetic acid in an amount of about 1 to 4 parts by weight. The preferred alkali metal salt is sodium acetate, although any alkali metal salt of acetic acid may be used. The salt functions to increase the antifungal activity of the compound. This has also been shown to impart a longer shelf life to the composition. When the composition contains the alkali metal salt of acetic acid, the antifungal activity is improved so that it will not support the growth of bacteria or fungi. 
     It is also preferred that the resulting solution be a viscous solution to inhibit drainage from the infected organs after topical application. Thus, a carrier vehicle is included in the composition to increase the viscosity of the solution. Suitable carriers include polyalkylene glycols, methyl cellulose and the like. The preferred carrier vehicle is a lower polyalkylene glycol such as glycerine. 
     The carrier also provides the proper consistency to the composition so that the composition has sufficient viscosity for topical application. It also provides the necessary consistency to the solution so it can be used as a lubricant in the treatment of animals such as horses. 
     A preferred formulation of the invention comprises the following components per liter of solution: 
     
         ______________________________________Ingredient         Parts by Weight______________________________________Dextrose           5.0.-5.0..0.Hydroxy carboxylic acid              2.5 to 1.0..0.Alkali metal salt of              2.5 to 1.0..0.hydroxy carboxylic acidCarrier            5.0.-15.0.______________________________________ 
    
     In a more preferred aspect of the invention, the composition would also contain an alkali metal salt of acetic acid in an amount of about 5 to 100 parts per liter of solution. Additionally, the remainder of the solution is preferably water. 
     The most preferred composition for use in the present invention comprises the following components: 
     
         ______________________________________Ingredient           Amount______________________________________Dextrose             5.0..0.                       gramsCitric acid          1.0..0.                       gramsSodium citrate       5.0.   gramsGlycerine            1.0..0.                       ccSodium acetate       2.5    gramsDistilled water      9.0..0.                       cc______________________________________ 
    
     The addition of sodium acetate in the most preferred embodiment increases the anti--fungal activity of the compound. The sodium acetate containing compound was shown to have longer shelf life than the same compound without sodium acetate, since it will not support the growth of bacteria or fungi. 
     The resulting composition is an aqueous solution with sufficient consistency to drain slowly. In use for treatment of contagious equine metritis, the composition is applied topically directly to the external genitalia of stallions and mares and preferably is used one time each day for at least two successive days. An effective amount is simply a thorough application of the viscous solution to the external genitalia manually. It has been found that this method will provide 100% effectiveness in curing horses of the contagious equine metritis organism-caused disease. 
     Although the composition was originally developed for treatment of contagious equine metritis, it has been found that the composition is also effective against Pseudomonas infections where the infection occurred on the external genitalia of the affected horses. This discovery led to the discovery of use of the composition of the invention for burn patients and patients with skin and muscle wounds infected with Pseudomonas bacterias, particularly Pseudomonas aeruginosa. When the composition was applied to accidental skin burns, it not only gave dramatic relief of pain, but also prevented the blistering of the epidermis as well as dramatically accelerating wound healing. The same results were obtained in several cases with skin burns from sun, steam, heat, friction and grease. 
     The compound was also shown to accelerate the healing of contact (allergenic) dermatitis. When the compound was applied at the time of exposure to poison ivy, the skin lesions of poison ivy did not develop. When applied to early cases, the compound was shown to be antipruritic within a few minutes of application, and greatly accelerated the healing of the skin lesions. Similar relief and reduction of swelling was observed in cases of insect-induced skin reactions. The composition is also useful in healing burns caused by friction, chemical and heat. 
     In experiments involving skin and wound lesions of dogs, cats, cattle and horses, the composition of the invention was shown to greatly accelerate the healing of superficial and deep skin and muscle wounds. It not only prevented bacterial and fungal infections of the wound, but it dramatically hastened the healing of the wound and the new growth of skin thereover. In numerous cases of animal wounds involving cats, dogs, cattle and horses, the composition dramatically promoted complete wound healing after other &#34;state of the art&#34; medical treatments failed to produce satisfactory results. 
     Although the exact mechanism by which the composition works is not known, it was originally developed to enhance the normal bacteria flora of the skin to produce an anti-bacterial-like metabolite to inhibit the growth of the contagious equine metritis (CEM) organism. In addition to the production of the antibacterial metabolite, it appears that the rapid healing of wounds caused by the composition of the invention provides an environment that discourages the growth of pathogenic bacteria and fungi. 
     Further, the composition has other beneficial properties and functions, including anti-pruritic properties, reduction of tissue fluids in epidermal vesicles and wound lesions, increased circulation to wound lesions and inhibition of bacterial and fungal growth in wounds. 
     In preliminary tests on numerous cases of burns and naturally induced viral, bacterial, fungal, allergic and traumatic diseases of the eye, external ear, nose, oral mucosa, periodontal tissues, external genitalia, vagina, uterus, perianal and dermal tissue, and muscles affected with deep wound lesions, the composition was shown to dramatically accelerate the healing of lesions in the mucous membranes, epidermis, dermis and muscles. With the exception of neoplasia, the compound was effective on any type of lesion. 
     The following examples are to illustrate the invention, but the invention is not to be considered as limited thereto. In the examples and throughout the specification, parts are by weight unless otherwise indicated. 
    
    
     EXAMPLE 1 
     The following composition was prepared: 
     
         ______________________________________Ingredient          Parts by Weight______________________________________Dextrose            25.0.   gramsCitric acid         5.0.    gramsSodium citrate      25      gramsGlycerine           1.0..0. ccs.Water               4.0..0. ccs.______________________________________ 
    
     The resulting composition was a viscous solution having a pH of 3.20. 
     To show the effectiveness of the compound on CEM, twenty horses were selected for testing. Each of the twenty horses was treated with a single treatment of the solution by manually applying topically directly to the external genitalia of the horses. From this test, 17 of the horses were found to be cured by the single treatment. The three horses which were not cured with the single treatment were then treated again with two successive treatments which were found to successfully cure the disease. Accordingly, in the field it is recommended that the disease be treated one time per day with application of the composition on at least two successive days. 
     EXAMPLE 2 
     The following composition is prepared: 
     
         ______________________________________Ingredient          Parts by Weight______________________________________Distilled water     9.0..0. cc.Glycerine           1.0..0. cc.Dextrose            5.0..0. gramsCitric acid         1.0..0. gramsSodium citrate      5.0.    gramsSodium acetate      2.5     grams______________________________________ 
    
     The resulting composition is a viscous solution having a pH of 3.0. The compound of the invention is topically applied to ten patients having second degree epidermal heat burns. In all ten cases, the patients experience dramatic relief of pain, and no blistering of the burn area occurs. Further, the healing time of the burn is dramatically accelerated. In addition, none of the patients develop Pseudomonas aeruginosa infections in the area of the burn. Similar results are obtained in cases where the skin burns are caused from sun, steam, friction and grease. 
     The invention has been described herein with reference to certain preferred embodiments. However, as obvious variations thereon will become apparent to those skilled in the art, the invention is not to be considered as limited thereto.

Technology Category: 1