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United States Patent 19 11 Patent Number: 5,686,089 Mitra Et Al

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United States Patent 19 11 Patent Number: 5,686,089 Mitra Et Al US005686089A United States Patent 19 11 Patent Number: 5,686,089 Mitra et al. 45 Date of Patent: Nov. 11, 1997 4,600,620 7/1986 Lloyd et al. ............................ 428/195 (54) TISSUE MOISTURIZING AND ANTMICROBIAL COMPOSITIONS 4,615,697 10/1986 Robinson .... 604/890 4,636,202 1/1987 Lowin et al. 604/236 4,675.226 6/1987 Ott .............. ... 428/102 (75 Inventors: Sekhar Mitra; George Endel Deckner, 4,983,392 1/1991 Robinson ............ ... 424/427 both of Cincinnati, Ohio 5,043,463 8/1991 Carraher, Jr. et al. 556/88 5,147,646 9/1992 Graham ............... ... 424/424 73 Assignee: The Procter & Gamble Company, 5225,196 7/1993 Robinson ........ ... 424/427 Cincinnati, Ohio 5,238,843 8/1993 Carpenter et al. .. ... 435/264 5,344,655 9/1994 Salsai et al. ............................ 424/443 21 Appl. No. 544,113 FOREIGN PATENT DOCUMENTS 22 Filed: Oct. 16, 1995 97036 12/1983 European Pat. Off.. 3-275619 12/1991 Japan. Related U.S. Application Data 1288641 9/1972 United Kingdom. 2119709 11/1983 United Kingdom. 63 Continuation of Ser. No. 172,451, Dec. 23, 1993, aban doned. OTHER PUBLICATIONS 51 Int. Cl. ... A01N 25/10; A61K9/10 "Candida Tropicalis Vulvovaginits”, Horowitz et al., Obstet 52 U.S. Cl. .................. 424/405; 424/78.07; 424/78.35: rics & Gynecology, vol. 66, No. 2, Aug. 1985. 424/487 "Butoconzaole-Pharmacologic Considerations, Chemistry 58) Field of Search .................................... 424/443,446, and Microbiology", Matthews, Journal of Reproductive 424/405, 78.07, 78.35,487 Medicine, 1986; 31 (supp): pp. 655-657. "Antifungal. Therapy in the Management of Chronic Can 56) References Cited didiasis", Horowitz, Am J ObstetGynecol, 1988; 158:996. “Mycotic Vulvovaginits: A Broad Overview”, Horowitz, U.S. PATENT DOCUMENTS Am J ObstetGynecol, 1991; 165:1188-92. 3,047,445 7/1962 Gresham ................................ 15446 "A New Vaginal Antifungal Agent-Butoconazole Nitrate', 3,050,217 8/1962 Mackey et al. ... 222/211 Jacobson et al., Acta Obstet Gynecol Scand, 1985; 3,616,133 10/1971 Thomas ................................... 161/57 64:317-321. 3,654,064 4/1972 Laumann et al. ... 161/156 "Terzolo (Terconazole): A Technical Background". 3,666,608 5/1972 Mattes .............. 161/62 PDR-Cotrisone, Lotrimin p. 1997 44th ed. 1990. 3,674,617 7/1972 Mattes ...................................... 161/62 3,709,764 1/1973 Thomas ............ ... 156/177 USPDI 1989 Clotrimazole pp. 2451, 851, 854. 3,717,655 2/1973 Godefroi et al. ... 260/309 Primary Examiner-Neil S. Levy 3.726,750 4/1973 Stillings ......................... 161/57 Attorney, Agent, or Firm-Mary Catherine Poland; Douglas 3,881210 5/1975 Drach et al. ... 15/104.93 C. Mohl; David K. Dabbiere 3,965,518 6/1976 Muoio ...... ... 15/104.93 3,965,519 6/1976 Hermann ... ... 15/04.93 57 ABSTRACT 4,075,033 2/1978 Knox et al. ........................... 134/6 4,078,071 3/1978 Walker ......... ... 424,273 The present invention relates to improved topical pharma 4,112,167 9/1978 Dake et al. ... 428/154 ceutical compositions having improved aesthetics which are 4,154,883 5/1979 Elias ................. ... 428/171 useful for imparting antimicrobial actives. In particular, it 4200,097 4/1980 Hobbs, Jr. et al. ... 128/251 relates to topical moisturizing compositions containing one 4,276,338 6/1981 Ludwa et al. ..... ... 428/137 4287.251 9/1981 King et al. ... 428/198 or more antimicrobial active compounds. These composi 4.298,649 11/1981 Meitner ............................... 428/198 tions are also useful for providing relief from symptoms 4,358,449 11/1982 Heeres et al.. 424/248.58 associated with, for example, vaginal yeast infections. 4,408,437 10/1983 Crouch et al. ... ... 53/431 4,436,780 3/1984 Hotchkiss et al. ...................... 428/198 15 Claims, No Drawings 5,686,089 1. 2 TSSUE MOSTURZNG AND percent of a water-insoluble monoolefinic monomer or mix ANTIMICROBIAL COMPOSTIONS ture. The polymer is said to swell in ethanol and in water with a swelling ratio of 2:1 to 22:1. This is a continuation of application Ser. No. 08/172,451, Candida also causes vulvovaginitis, meningitis, pulmo filed on Dec. 23, 1993, abandoned. nary candidiasis, thrush, and endocarditis. It is most often associated, however, with the organism that is responsible TECHNICAL FIELD for vaginal yeast infections in women. This condition occurs The present invention relates to improved topical phar most frequently, and with greater severity, in areas where the maceutical compositions having improved aesthetics which climate is warm and moist. It often follows antibiotic are useful for imparting antimicrobial actives. In particular, O therapy and is difficult to eradicate. it relates to topical moisturizing compositions containing Conventional commercially-available treatments for one or more antimicrobial active compounds. These com vaginal yeast infections are creams which cause leakage and positions are also useful for providing relief from symptoms suffer serious negatives in terms of skinfeel (i.e. they often associated with, for example, vaginal yeast infections. feel very tacky and greasy on the skin). They also have poor 15 absorption and residue characteristics. BACKGROUND OF THE INVENTION The present invention provides topical moisturizing com positions in the form of an aqueous gel which treat microbial Several environmental and pathologic conditions produce infections which provide improvements in residue and skin drying or desiccation of membranous tissue of the mamma feel characteristics. lian body. These conditions produce dry mouth 20 (xerostonia), dry eye (sicca conditions) and dry vaginal, dry It is therefore an object of the present invention to provide nasal or dry rectal mucosa, and/or dry skin that are aestheti improved compositions which are excellent carders for cally unpleasing and/or irritating to the individuals having certain antimicrobial actives and which provide reduced tack Such conditions. and provide the user with an improved skinfeel. One method for moisturization of dry tissue uses an oily 25 SUMMARY OF THE INVENTION substance as the principal ingredient in the form of creams, The present invention relates to pharmaceutical compo lotions, or salves that are applied to the affected tissue in an sitions for moisturizing membranous tissue and treating attempt to preventfurther dehydration of the tissue. They act infections comprising: by placing a water-impermeable hydrophobic barrier over (a) a safe and effective amount of an antimicrobial; the treated tissue. Petrolatum, mineral oil, lanolin and iso 30 propyl myristate are examples of hydrophobic materials so (b) a moisturizing component; and used. These preparations alone provide only symptomatic (c) an pharmaceutically acceptable aqueous gel carrier relief. In addition, they impart a greasy, sticky feel to the wherein said composition has a viscosity of from about skin and stain clothing. 40,000 cps to about 100,000 cps. 35 The present invention also relates to a method for treat Another method for moisturization uses hydrophilic mol ment of dry membranous tissue and treating infections ecules which can attract water. Hydrophilic Small molecules comprising administering a safe and effective amount of such as glycerin and glycerin/water mixtures, urea, and these topical compositions and to methods for the prophy propylene glycol are known humectants said to be useful in actic treatment of infection by application of these compo moisturizing skin. sitions to healthy membranous tissue. Several synthetic hydrophilic materials, which in the AI levels and ratios are by weight of the total presence of water adhere to the skin and/or mucous composition, unless otherwise indicated. membranes, have been used by themselves or in conjunction with one or more active or treating agents in various DETALED DESCRIPTION OF THE INVENTION pathological conditions, but they have not been used in 45 moisturizing compositions having a specific viscosity range, The compositions of the present invention contain the for dryness of epithelial cells such as those of the skin or essential components as well as various optional compo mucosa. These hydrophilic materials are often referred to in ments as indicated below. the art as hydrogels. Humectants/Moisturizers. The compositions of the instant Disorders in these mucosal areas can often lead to 50 invention comprise one or more water-soluble humectants/ infections, such as a yeast infection. Yeast infections are moisturizers. A variety of humectants/moisturizers can be among the most common to mankind. Microbes of the genus employed and can be present at a level of from about 1% to Candida are normal inhabitants of the bowel. These about 10%, more preferably from about 2% to about 8% and microbes are also found on the skin and in sputum of healthy mostpreferably from about 3% to about 5%. These materials individuals. Candida albicans is by far the most pathogenic 55 include the C-C diols and triols; urea; guanidine; glycolic member of the Candida family. Suitable treatments for such acid and glycolate salts (e.g. ammonium and quaternary infections are well known. For example, U.S. Patent No. alkyl ammonium); lactic acid and lactate salts (e.g. ammo 4.226,848 discloses a composition for adhering a pharma nium and quaternary alkyl ammonium); polyhydroxy alco ceutical preparation to the mucosa of the oral or nasal hols such as sorbitol, glycerin, hexanetriol, propylene cavities. An exemplary acrylic acid polymer disclosed glycol, hexylene glycol and the like; polyethylene glycol; therein is the lightly cross-linked acrylic acid-allyl sucrose sugars and starches; sugar and starch derivatives (e.g. copolymer available under the trademark CARBOPOLCS alkoxylated glucose); D-panthenol; hyaluronic acid; lacta 934 from B. F. Goodrich Chemical Co., which is said to form mide monoethanolamine; acetamide monoethanolamine; a high viscosity gel-like dispersion in water. and mixtures thereof. U.S. Pat. No. 4,548,990 discloses a controlled-release 65 Preferred humectants/moisturizers for use in the compo drug delivery composition whose cross-linked polymeric sitions of the present invention are the C-C diols and triols.
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