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(12) Patent Application Publication (10) Pub. No.: US 2011/0207768 A1 Bornstein (43) Pub US 2011 0207768A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2011/0207768 A1 Bornstein (43) Pub. Date: Aug. 25, 2011 (54) PHARMACEUTICAL COMBINATION OF Publication Classification ANTIBACTERAL AND ANTIFUNGAL CREAM (51) Int. Cl. A63L/35 (2006.01) (75) Inventor: Michael Bornstein, Richmond,Y 8 TX A63L/464A63L/46 (2006.01) A6IP3L/04 (2006.01) (73) Assignee: QUADRX A6IP3 L/10 (2006.01) PHARMACEUTICALS, (52) U.S. Cl. .......................... 514/304: 514/460, 514/399 Richmond, TX (US) (57) ABSTRACT (21) Appl. No.: 12/722,179 A method for the emperic treatment of an intertrigal skin 1-1. infection potentially caused by a gram-positive bacteria in a (22) Filed: Mar. 11, 2010 human patient that includes a topical administration to the O O patient of a pharmaceutical formulation comprising a bacte Related U.S. Application Data ricidal amount of a Gram-positive bactericide and an antimy (60) Provisional application No. 61/307,719, filed on Feb. cotic amount of an antifungal component Suspended in a 24, 2010. skin-barrier carrier. US 2011/0207768 A1 Aug. 25, 2011 PHARMACEUTICAL COMBINATION OF natural flora that reside on the surface and with deeper layers ANTIBACTERAL AND ANTIFUNGAL of the skin that is now compromised may allow bacterial CREAM infections to form, further aggravating the inflammation. The reverse is also true, when a treatment correctly treats a bac BACKGROUND OF INVENTION terial infection, the change in natural flora in and on the 0001 1. Field of the Invention compromised skin may allow fungal infections to form, fur 0002 Embodiments disclosed herein relate generally to ther aggravating the inflammation. methods and compositions for treating acute inflammatory 0008 Accordingly, there exists a continuing need for skin conditions. In particular, embodiments disclosed herein developments in the treatment of diaper rash and intertrigo. relate to the combination of a bactericidal agent and an anti fungal agent in the methods and compositions for treating SUMMARY OF INVENTION diaper dermatitis and/or intertrigo. 0003 2. Background Art 0009. In one aspect, embodiments disclosed herein relate 0004 “Diaper rash” or diaper dermatitis is one of the most to a method for the emperic treatment of an intertrigal skin prevalent inflammatory skin conditions that afflicts infants infection potentially caused by a gram-positive bacteria in a and young children. It is generally accepted that the diaper human patient that includes a topical administration to the rash is a contact irritant dermatitis that results from extended patient of a pharmaceutical formulation comprising a bacte contact of the skin with urine, feces, or both. Increased wet ricidal amount of a Gram-positive bactericide and an antimy ness in the diaper area makes the skin more Susceptible to cotic amount of an antifungal component Suspended in a damage by physical, chemical, and enzymatic mechanisms. skin-barrier carrier. Specifically, wet skin increases the penetration of irritant 0010. In another aspect, embodiments disclosed herein Substances. Enzymes in the outermost layer of the skin can relate to a pharmaceutical formulation for the empiric treat release ammonia converted from the urea present in urine, ment of an intertrigal skin infection potentially caused by a whereas enzymes in feces mixed with urine can cause an Gram-positive bacteria that includes a bactericidal amount of alkaline Surface pH, adding to the irritation. These conditions a Gram-positive bactericide and an antimycotic amount of an may also allow for the growth of fungi and/or bacteria. How antifungal component Suspended in a skin-barrier carrier. ever, most diaper dermatitis infections have historically been 0011. Other aspects and advantages of the invention will thought to arise from Candida albicans, a fungus found in the be apparent from the following description and the appended gastrointestinal tract. Other microbial agents have been iso claims. lated less frequently, perhaps more as a result of secondary infections. Changes in natural flora due, for example, to anti biotics prescribed for common ear and/or throat infections, DETAILED DESCRIPTION may contribute to further overgrowth in the diaper areas. 0005 Similar to diaper dermatitis, intertrigo is a skin 0012 Embodiments disclosed herein relate generally to inflammation of the body folds between adjacent areas of skin methods and compositions for treating acute inflammatory that usually develops from the chafing of warm, moist skin skin conditions. In particular, embodiments disclosed herein again skin, Such in the areas of the inner thighs and genitalia, relate to the combination of a bactericidal agent and an anti the armpits, under the breasts, the underside of the belly, fungal agent in the methods and compositions for treating behind the ears, and the web spaces between the toes and diaper dermatitis and/or intertrigo. fingers. Also like diaper dermatitis, intertrigo may also be 0013 The compositions of the present disclosure, in par caused by eithera bacterial or fungal infection that attacks the ticular the combination of a bactericidal agent and an anti skin upon breaking of the outer layer of the skin that serves as fungal agent may allow for the empiric treatment of diaper a waterproofbarrier. Such disruption of the outer layer of skin dermatitis and/or intertrigo. As known in the art, an empiric can be cause by when skin is exposed to prolonged heat, treatment refers to the initiation of treatment prior to deter moisture, maceration, friction, lack of air circulation, and/or mination of a firm diagnosis as an initiative againstan antici decreased skin pH. pated and likely cause of an infectious disease. The empiric 0006 Currently, compositions used to treat such skin treatment of the present disclosure may be broad-spectrum, in infections target either fungal or bacterial infections, with that it may treat a wide variety of possible microorganisms, most patients being prescribed an antifungal or bacteriostatic including both bacteria and fungus. Use of Such a broad medication. However, the choice of one treatment or another spectrum empiric treatment may allow for a more speedy may be incorrect because a laboratory may be required to recovery by a patient and avoid the need for laboratory tests. identify the source of the infection. Thus, the patient experi Additionally, the treatment may also prevent the growth of ences days of delay until the physician recognizes that the other microorganisms that did not originally contribute to the treatment does not work and Switches to the correct treatment. skin infection. Therefore, an accurate treatment necessitates the identifica 0014. Additionally, while diaper dermatitis has conven tion of an infection as either fungal or bacterial. tionally been though to result from fungal infections, the 0007 Although yeast and bacteria are both commonly inventor of the present application has observed an increased harbored in these areas of the body, the two normally live in incidence of bacterial infections in diaper dermatitis. Most of balance with each other and cause no symptoms. However, these bacterial infections are caused by bacteria belonging to when the natural balance of the flora is disrupted, for the Streptococcus genus or Staphylococcus genus, both of example, by an anti-fungal treatment or an anti-bacterial which are Gram-positive bacteria, including infections due to treatment, it can diminish the growth of one microorganism Methicillin-resistant Staphylococcus aureus (MRSA), which and allow overgrowth of the other. For example, even when a is a strain of a staph bacterium that has become resistant to treatment correctly treats a fungal infection, the change in many antibiotics, in diaper dermatitis. Accordingly, the treat US 2011/0207768 A1 Aug. 25, 2011 ment compositions and methods of the present disclosure which is also known by the name mupirocin. Pseudomonic may allow for the treatment of a bacterial infection, including acid B possesses an additional hydroxyl group at C8; MRSA infections. pseudomonic acid C possesses a double bond between C10 0015. In particular, the compositions of the present disclo and C11, instead of the epoxide; and pseudomonic acid D Sure may include at least three components: a bactericidal possesses a double bond at C4' and C5' in the 9-hydroxy agent, an antifungal agent, and a skin-barrier carrier. The nonanoic acid portion the compound. presence of each of these components may allow for an 0019. Alternatively, the Gram-positive bactericide may be empiric treatment for any fungal or bacterial infection while a pleuromutilin antibiotic Such as retapamulin. Pleuromuti also providing the necessary skin barrier properties to prevent lin, a naturally occurring antibiotic produced by Pleurotus the susceptible under skin layers from further attack. mutilus and P. passeckerianus has the general formula of 0016 Generally, anti-bacterial agents may be classified into two types, bactericides and bacteriostatics. Bactericidal antibiotics kill bacteria whereas bacteriostatic antibiotics CH only slow their growth or reproduction. The inventor of the / CH3 S present application has found that the use of bacteriostatics in a treatment does not provide a broad-spectrum empiric treat ment, particularly in view of the inventor's increased clinical observation of infections in diaper dermatitis and intertrigo resulting from MRSA. 0017. In a particular embodiment, the treatment composi tion of the present disclosure may include
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