Therapeutic antimicrobial compositions

Antimicrobial alcohol-containing compositions and methods of using the compositions to disinfect surfaces and provide therapeutic benefits are disclosed.

The present invention relates antimicrobial compositions which additionally
 provide therapeutic benefits to the skin.
 BACKGROUND OF THE INVENTION
 In addition to application of antimicrobial composition to hands, skin site
 preparation (surgical, catheter, wound, and patient) is a key component of
 integrated infection control program in all hospitals. Similarly in
 non-surgical situations, acne (acne vulgaris affecting the hair follicles
 and oil-secreting glands of the skin and manifesting as blackheads
 (comedones), whiteheads (pustules), and inflammation (papules), and acne
 conglobata- a more severe form, with deep cyst formation and subsequent
 scarring) is the most common of all skin problems and widely seen in
 younger population. Also, skin lesions (e.g., pseudofolliculitis barbae
 ("PFB")) before, during or after shaving are a major problem.
 Current skin prep products used in hospitals are prone to some
 disadvantages such as: 1) irritation; 2) potential for cellular oxidative
 reactions (Iodine and its derivatives); 3) poor antimicrobial activity
 against resistant microbes and emerging organisms; 4) lack of aesthetics;
 5) Lack of residual activity (iodine based formulations); and 6) lack of
 colorants for site identification (chlorhexidine gluconate "CHG"
 formulations). Similarly salicylic acid or benzoyl peroxide-based
 formulations cause either irritations or oxidative reactions. These
 reactions could potentially generate materials such as super oxides and
 other mutagens, and as a result there is a need to develop compositions
 that are much safer to skin with potential staining and anti-inflammatory
 properties while exhibiting antimicrobial activity against inflammation,
 odor or disease causing pathogens.
 The significance of proper prepping and usage of antimicrobials is on the
 rise, as nosocomial infections are becoming a major problem to health care
 organizations. Iodine and iodine-based products are being used due to
 their immediate activity against resident flora and also inherent staining
 properties as a site indicator for prepping or for needle insertion.
 Advancement in iodine based technology has occurred, and as a result
 number of new technologies emerged to overcome certain negative features
 of iodine. However, iodine or iodine-based technologies do not offer any
 residual activity, as a result the regrowth of resident flora is noted
 above the baseline over period of time. This feature limits the usage of
 iodine based products where persistent antimicrobial activity is an
 essential feature on moist and dry areas. It is well established that
 iodine based products exhibit activity by oxidizing microbial cellular
 components, while showing undesired irritations and sensitization's on
 human skin. At present combination of iodine and alcohol preparations are
 being developed to compete with CHG market. It is noteworthy that alcohol
 and iodine combination may increase irritation potential unless the blend
 is formulated in an emollient or gel based matrix, and yet, the
 combination may not exhibit residual activity comparable to CHG
 formulations. Though CHG based formulations are currently marketed as skin
 preps, the limiting factor again would be potential irritations as these
 products are being used as leave on or wipe-off and rinse-off products.
 The negative aspects of current products clearly demands for more potent
 yet gentle formulations or combinations that display antimicrobial
 efficacy, staining properties, anti-inflammatory features to reduce any
 inflammation around surgical site, needle site or non-surgical sites.
 Examples of non-surgical sites/inflammations include acne,
 pseudofolliculitis, infected areas by fungus, insects, viruses, sun burns,
 rash, dermatitis, Tinea pedis (Athlete's foot), scleroderma, psoriasis,
 atopic dermatitis, genital infections, dermatoses and itching, skin
 cancer, bacterial infections, alopecia and other infections.
 Plants and plant products have been used historically as chemopreventative
 products. In recent years, advancement in technology, miniaturization and
 high throughput screening has dramatically changed the bioactive compound
 discovery process. Number of active molecules were identified and with
 modifications in structures/functionalities several compounds have been
 commercialized to improve human health. The best recent examples are taxol
 from Taxus brevifolia, vincristine and vinblastin from Vinca rosea, and
 several other compounds. In recent years, naturals/botanicals/herbal
 products gained momentum in cosmetic and dietary product development.
 Natural products have several advantages over synthetic compounds in their
 slow and steady action with excellent safety profile. The research and
 development of novel compounds from natural source (Cosmeceuticals and
 Neutraceuticals) and evaluation of such compounds for their biological
 activity has seen all over the world. Most of the plant mixtures are
 ingested as dietary supplements but some are applied topically to treat
 various skin conditions. Ayurveda, the ancient Indian Materia Medica
 believes that such combinations produce a synergism where by the
 beneficial effects of the whole is greater than the sum of its parts.
 Among several plants or plant extracts, the following are known to exhibit
 favorable effects on skin conditions such as anti-irritant, wound healing
 and skin lesions:
 anti-irritant: Amalaki (Indian gooseberry)
 wound healing and skin lesions: Gotukola
 cancerous lesions-breast, skin, vulva: Curcum longa
 antiseptic/astringent: Guggui (a gum resin),
 Hydrastis canadensis (Golden seal)
 anti-inflammatory: Licorice
 skin ulcer, boils: Shallaki
 drug delivery system: Mango butter
 speeding cellular renewal: high mineral content of many muds
 There is overwhelming interest in natural ingredients for cleansing,
 coloration, and treatment of skin, wounds, scalp and hair. Since ancient
 times, humans have used preparations derived from plants to dye their
 hair, and skin and to heal their wounds.
 The tropical plant, Curcuma longa is widely consumed in Asia for variety or
 purposes. Turmeric (Curcuma longa) has been used to combat a variety of
 ailments such as cancer prevention. Volatile oil from the rhizomes
 displayed mosquitocidal activity. It is reported in the literature that
 ethyl acetate (EtOAC) extract yielded Curcumin 1, 2, and 3 which have
 shown inhibitory activity against topoisomerase -I and -II. Curcumin or
 turmeric yellow has a MW 368 and is the dyestuff from the root of curcuma
 longa and it is insoluble in water but soluble in alcohol. The striking
 feature of the extract is intense coloring characteristic with
 anti-inflammatory, anti-cancer, and wound healing properties. Similarly,
 extracts and pure compounds of Hydrastis canadensis (Golden seal), Croccus
 sativus (Saffron) and Alkanna tinctoria (Henna root) also known as
 cosmetic dyes due to their astringent properties. Though these features
 are known in the literature the coloring features of these extracts or
 pure compounds have not been used to develop preparations to prep
 surgical, catheter, wound and other non-surgical sites. In particular,
 these features have not been explored in combination with alcohol based
 gels such as gels containing naturally derived biomimmetic phospholipids
 along with preservatives to offer the following benefits:
 immediate and Persistent antimicrobial activity against skin flora
 (resident and transient )
 staining properties to locate the surgical site or catheter site.
 anti-inflammatory properties (anti-acne, pseudofolliculitis/skin lesions)
 reduction in skin prep time
 wound cleansers
 Accordingly, there is a continuing desire for antimicrobial compositions
 that are antimicrobially effective while also having therapeutic
 (anti-inflammatory) benefits and, when desired, staining properties to
 indicate a disinfected site.
 SUMMARY OF THE INVENTION
 One embodiment of the present invention provides an antimicrobial
 composition comprising:
 a) an antimicrobial selected from the group consisting of more than 30% by
 volume alcohol, an effective amount of triclosan and mixtures thereof;
 b) an effective amount of phenoxy ethanol, an effective amount of
 benzalkonium chloride or benzethonium chloride; and an effective amount of
 PHOSPOLIPID CDM; and
 c) an effective amount of a naturally occurring plant or extract thereof.
 In a second embodiment of the invention, the antimicrobials are further
 provided with an effective amount of triclosan, GERMALL PLUS and GERMABEN
 II. Additionally, the antimicrobial composition optionally also contains
 an effective amount of PHOSPOLIPID PTC.
 In yet another embodiment of the present invention, the antimicrobial
 compositions also demonstrated surprising therapeutic activity in treating
 bacterial inflammations of the skin such as acne, pseudofolliculitis (PFB)
 and skin lesions.
 Advantages of this invention include therapeutic benefits in addition to
 antimicrobial properties: enhanced anti-inflammatory properties with
 natural ingredients; reduced irritation potential with synergistic
 combination as compared to conventional skin preparations; multifunctional
 properties with staining features; other advantages of this invention
 (with-or without enhancing natural plants or extracts thereof) include an
 antimicrobial hand gel as an anti-acne product; as a therapeutic shaving
 gel to treat or heal skin lesions and prevent bacterial contamination; as
 a gel for treatment of Pseudofolliculitis barbae; as a gel for antiviral
 applications; as a no-rinse antimicrobial skin or dermal cleanser, urinary
 and fecal incontinent cleanser, deodorizer, antimicrobial wound cleanser,
 (burn patients, infection control during skin grafting procedure,
 skin/hand disinfection during plastic surgeries, to remove exudates around
 wound areas) and antimicrobial moisturizing lotion and/or gel.
 Another advantage of the present invention includes a method for
 controlling both intact and broken skin inflammations including local
 redness, local pain, local odor (i.e., foot and armpit odor), and
 increased exudate.
 DETAILED DESCRIPTION OF THE INVENTION
 The naturally occurring plants and plant extracts useful in this invention
 are any such compositions which impart therapeutic (healing) benefits
 and/or the coloring (staining) properties.
 As used herein, the expression "a naturally occurring plant or extract
 thereof" is intended to encompass both crude and/or purified forms of
 plants and extracts thereof as one skilled in the art will appreciate that
 plants and their extracts exist both in crude and purified form.
 Furthermore, "a naturally occurring plant or extract thereof" is intended
 to include those pure or crude plants and plant extracts derived by using
 organic solvents. Thus, oils derived from the plant or extract are
 excluded from the scope of the expression "a naturally occurring plant or
 plant extract".
 Examples of naturally occurring plants and plant extracts that possess both
 therapeutic and coloration benefits include: Curcuma longa; Hydrastis
 canadensis (Golden seal); and Croccus sativa (Saffron).
 Examples of naturally occurring plants and plant extracts that are
 colorless but possess therapeutic benefits include: Tea tree (Melaleuca
 alternifolia), Evening primrose (Oenothera biennis), Red clover (Trifolium
 pratense) and Aloe (Aloe vera).
 Examples of naturally occurring plants and plant extracts that possess
 coloring properties include Alkanna tinctoria (Henna root).
 As apparent t o one skilled in the art, the effective amount of naturally
 occurring plants or plant extracts used in this invention may vary
 according to several factors such as the desired degree of therapeutic
 benefit and/or coloration. However, good results have been achieved by
 using from about 1.0 to about 25.0, preferably from about 2.0 to about 15,
 most preferably from about 2.0 to about 5.0 percent by weight of the
 composition of the plant or plant extract.
 A surprising result concerning the alcohol-containing compositions even
 without the presence of naturally occurring plant or plants extracts is
 that such compositions provide therapeutic benefits, particularly
 anti-inflammatory benefits.
 The alcohol content of the present invention is greater than about 30
 percent by volume, typically from about 55 to about 90 percent by volume,
 preferably from 60 to about 85 and most preferably from 60 to about 70% by
 volume of the composition. The alcohols useful in the present invention
 include, ethyl alcohol, iso-propyl alcohol, n-propyl alcohol and
 combinations thereof. Ethyl alcohol may be used as the only alcohol in the
 invention or in another embodiment the alcohol content in the invention
 provides ethyl alcohol from about 40 to about 70% by volume, iso-propyl
 alcohol from about 5 to about 25% by volume and n-propyl alcohol from
 about 5 to about 25% by volume.
 Triclosan may be employed from about 0.1 to about 2.0, preferably from
 about 0.2 to about 1.0 by weight.
 The present invention contains a mixture of an effective amount of
 antimicrobials phenoxyethanol alcohol, PHOSPHOLIPID CDM, benzalkonium
 chloride, and preferably GERMALL PLUS and GERMABEN II. Phenoxy ethanol is
 used from about 0.25 to about 5.0 percent by weight, preferably from about
 0.3 to about 2.0, most preferably at about 0.3 to about 1.0 percent by
 weight. PHOSPHOLIPID CDM is used from about 0.01 to about 1.0, preferably
 from about 0.03 to about 0.7, most preferably 0.5 percent by weight.
 Benzethonium chloride or preferably benzalkonium chloride is used from
 about 0.02 to about 1.0, preferably from about 0.08 to about 0.5, most
 preferably about 0.1 to about 0.2 percent by weight.
 Other antimicrobial compositions have been found to particularly effective
 in improving the efficacy of the invention. These compositions include
 triclosan, PHOSPHOLIPID PTC, GERMALL PLUS and GERMABEN II.
 The amount of GERMALL PLUS and GERMABEN II, independently provided in the
 invention varies from about 0.05 to about 0.5 with 0.1 percent by weight
 preferred. In the present invention the use of GERMALL PLUS and GERMABEN
 II together has been found to be highly effective. The ratio of the two
 materials when employed together is from about 0.1:1 to 1:0.1 and most
 preferably 1:1 weight ratio.
 In addition to the antimicrobial compositions recited above, other
 antimicrobials may be employed with the present invention including nisin,
 bis-guanides, chlorhexidine gluconate, chlorhexidine digluconate,
 chlorhexidine diacetate, chlorhexidine dihydrochloride, triclosan, sodium
 hydroxy methyl glycinate, octanoyl collagenic acid, cetyl pyridinium
 chloride, phenol, iodine, parachlorometaxylenol (PCMX), polymeric
 quaternary ammonium compounds, their combinations and the like. The
 antimicrobial compositions are typically added at a level of from 0.1 to
 about 4.0 percent by weight.
 Other preferred ingredients employed in the invention include PHOSPHOLIPID
 PTC, which is employed from about 0.01 to about 1.0, preferably from about
 0.02 to about 0.08, and most preferably about 0.05 percent by weight.
 Australian tea tree oil and lemon grass oil are used in 1:1 ratio from
 about 0.5 to about 10.0, preferably from about 1.0 to about 7.0, and most
 preferably 5.0 weight percent.
 One highly preferred embodiment of the invention provides more than 40% by
 weight alcohol, an effective amount of phenoxy ethanol, an effective
 amount of benzalkonium chloride, an effective amount of GERMALL PLUS, an
 effective amount of GERMABEN-II, and an effective amount of PHOSPHOLIPID
 CDM. Additionally, the antimicrobial composition optionally also contains
 an effective amount of PHOSPHOLIPID PTC.
 In another preferred embodiment the antimicrobial mixture comprises greater
 than about 40% by weight alcohol, an effective amount of phenoxy ethanol,
 an effective amount of benzalkonium chloride, an effective amount of
 triclosan, an effective amount of GERMALL Plus, an effective amount of
 GERMABEN-II, and an effective amount of PHOSPHOLIPID CDM.
 In yet another preferred embodiment of the invention the antimicrobial
 mixture contains greater than about 40% by weight alcohol, an effective
 amount of phenoxy ethanol, an effective amount of benzalkonium chloride,
 an effective amount of benzethonium chloride, an effective amount of
 triclosan, an effective amount of GERMALL Plus, an effective amount of
 GERMABEN-II, and an effective amount of PHOSPHOLIPID CDM.
 In another highly preferred embodiment of the invention the antimicrobial
 mixture is greater than 40% by weight a mixture of alcohols such as ethyl
 alcohol, iso-propyl alcohol, and n-propyl alcohol, a mixture of two
 essential oils such as Australian tea tree oil, and lemon grass oil, an
 effective amount of phenoxy ethanol, an effective amount of benzalkonium
 chloride, an effective amount of triclosan, an effective amount of GERMALL
 plus, an effective amount of GERMABEN-II, and an effective amount of
 PHOSPHOLIPID CDM. Additionally, the antimicrobial composition optionally
 also contains an effective amount of Vitamin E linoleate.
 The antimicrobial compositions of the present invention are found to
 possess immediate and persistent activity over time. The compositions of
 the present invention also compare favorably with antimicrobial
 compositions which contain high levels of chlorhexidine gluconate or
 commercial products such as HIBISTAT and HIBICLENS, available from ZENECA
 Pharmaceuticals, which are commonly being used for disinfecting surgical
 scrubs, hand disinfectants and in preoperative preparation of patients.
 It is known in the art that chlorhexidine gluconate formulations exhibit a
 great build-up in activity between washes 1 and 7. This increase in
 activity is believed to be caused by its polar structure and its ability
 to attach to skin. After ten washes and neutralization with suitable
 inactivator, the activity of chlorhexidine gluconate falls significantly
 (approximately 30-50%) at wash 10, when testing is performed in accordance
 with a Health Care personnel hand wash protocol. Surprisingly, the
 compositions of the present invention provide more persistent
 antimicrobial activity than these other well-known antimicrobial agents.
 Another advantage of the present invention is the residual activity
 provided by the antimicrobial product. The present invention provides
 effective protection against a broad spectrum of organisms, including gram
 positive, gram negative, yeast and fungi both at the initial application
 time, but also after an extended period of time. We have found that unlike
 other antimicrobial compositions which are initially effective in killing
 microbes but which quickly lose their efficacy in about one hour.
 Surprisingly, the present invention is effective in preventing the
 appearance of microbes for an extended periods of time, such as greater
 than two hours, preferably for about three or four hours or more.
 It is preferable to include other ingredients in the formulation to enhance
 the efficacy of the antimicrobial composition. Included in this are
 essential oils to improve the rate at which the antimicrobial composition
 works as well as its residual activity. Suitable essential oils include
 Australian tea tree oil, lemongrass oil, thyme oil, lavender oil and clove
 oil and combinations thereof. Essential oils are used to increase the
 emolliency, moisturization, emollient and penetration properties of the
 present invention. Typically these oils are incorporated at the level of
 from about 1 to about 10 weight percent, and most preferably at about 5
 weight percent based upon the total composition.
 The present invention also employs thickening agents of acrylic acid which
 are crosslinked with an unsaturated polyfunctional agent such as polyallyl
 ether of sucrose. These acrylic acid functionalized polymers, commonly
 known as carbomers, are disclosed in U.S. Pat. Nos. 2,798,053 and
 3,133,865 herein incorporated by reference.
 The selection of the proper carbomer provides the antimicrobial formulation
 with the desired viscosity values. In order to have the desired feel the
 viscosity of the formulation must have a value of greater than about 5,000
 centipoise. More preferably the formulations will have a viscosity of from
 about 9,000 to about 22,000 and most preferably from about 11,000 to about
 20,000 centipoise as measured at 25.degree. C.
 A thickening agent, which is an addition agent comprised of an acrylic acid
 polymer crosslinked with an unsaturated polyallyl ether of sucrose is
 employed. The polymers are used in an amount sufficient to obtain a gelled
 composition of viscosity in the desired range.
 A number of these polymers, known in the art as carbomers are commercially
 marketed by B.F. Goodrich, (Cleveland, Ohio) such as CARBOPOL.RTM. 934,
 940 and 941; and by R.I.T.A. (Crystal Lake, Ill.)as ACRITAMER.RTM. 934,
 940 and 941, respectively. Typically the carbomer compounds are used from
 about 0.2 to about 2.0 percent by weight, and are preferably employed at a
 level of from about 0.4 to about 0.7 by weight of the total antimicrobial
 composition.
 A preferred carbomer polymer, among several preferred carbomers is R.I.T.A.
 ACRITAMER.RTM. 505E, a polyvinyl carboxy polymer crosslinked with ethers
 of pentaerythritol. ACRITAMER.RTM. 505E is preferred as a gelling agent or
 viscosity enhancer because it provides a transparent or translucent gel in
 the present invention.
 The most preferred carbomer is ULTREZ.RTM. 10 (available from BF Goodrich)
 a modified copolymer having a major portion of a mono olefinically
 unsaturated carboxylic acid monomer or its anhydride of 3 to 6 carbon
 atoms and a minor portion of a long chain acrylate or methacrylate ester
 monomer. The polymer is predominately acrylic acid and a smaller amount of
 a long chain acrylate monomer. The polymer is described in U.S. Pat. No.
 5,004,598, hereby incorporated by reference in its entirety.
 Another particularly preferred group of ingredients in the present
 invention are tack modifiers such as silicone waxes, stearoxy trimethyl
 silane, cyclomethicone, cetyl lactate, and alkyl lactates, (typically
 lengths C.sub.12 -C.sub.15). Moisturizers such as glycerin, water, lipids,
 waxes and the like are also helpful when employed in the present
 invention. Other solvents are also employed, such as propylene glycol, in
 order to provide for a more stable formulation.
 Other ingredients which may be added to the compositions include
 fragrances, emollients, pH adjusters, viscosity modifiers such as acrylic
 polymers, gums, xanthan gums and the like; transdermal enhancers,
 surfactants, dyes, colors and the like. These ingredients are well known
 in the art and are disclosed for example in U.S. Pat. No. 5,403,864 and
 5,403,587. The remainder of the present formulation is made up of water,
 preferably deionized water. Water typically makes up from 10 to about 40%
 by weight of the antimicrobial composition.
 The following formulation possesses highly effective antimicrobial
 properties.
 1. Ethyl alcohol (40-70%), Isopropyl alcohol (20-25%),n-Propyl alcohol
 (5-10%).
 2. Diisobutyl Phenoxy Ethoxy Ethyl Dimethyl Benzyl Ammonium chloride
 (0.05-0.5%), commonly known as benzethonium chloride.
 3. triclosan, commonly known as, 2, 4, 4'-trichloro-2-hydoxydiphenyl ether
 (0.2-0.5%)
 4. N, N-Bis (Hydroxymethyl) urea (0.08-0.5%), Methyl p-Hydroxybenzoate
 (0.009-0.5%), Propyl p-Hydroxy benzoate (0.0025-0.5%), 1, 2-Propane diol
 (0.050-0.056%),
 5. Coco Phosphotidyl PG-Dimonium chloride (0.05-0.5%)
 6. DL- and L-Ofloxacin (0.01-0.5%)
 7. Australian Tea Tree oil (1.0-5.0%)
 8. Lemongrass oil (1.0-5.0%)
 9. Thyme oil (1.0-5.0%)
 10. Lavender oil (1.0-5.0%)
 11. Clove oil (1.0-5.0%)
 The antimicrobial compositions of the present invention are effective in
 controlling microorganisms when an effective amount of the composition is
 topically applied to a substrate or location, such as the hands, acne
 sites, injection sites, or site for catheters, etc. The amount applied to
 be effective depends upon such environmental factors as the length of
 application, the amount of contact of the antimicrobial composition and
 the substrate, as well temperature and evaporation rates. Those with skill
 in the art will readily be able to determine the effective level necessary
 to control the microorganisms. Typically, from about 0.5 to about 10
 milliliters, preferably from about 1.0 to about 8, and most preferably
 from about 2.5 to about 5 milliliters of the antimicrobial composition is
 applied. This amount of the antimicrobial composition is found to be
 effective, to provide a logio reduction of 2 or more in the microbe
 population.
 The present invention can also be prepared as an emulsion using techniques
 well known in the art, see for example U.S. Pat. No. 5,308,890. The active
 ingredients, excipients, etc., may be emulsified with an anionic,
 cationic, or nonionic surfactant or dispersing agent, or compatible
 mixtures thereof such as a mixture of an anionic or a nonionic surfactant,
 using, for example, from about 0.05% to about 5% by weight of a surfactant
 or dispersing agent based on the weight of the ingredients to be
 emulsified. Suitable cationic dispersion agents include lauryl pyridinium
 chloride, cetyldimethyl amine acetate, and alkyldimethylbenzylammonium
 chloride, in which the alkyl group has from 8 to 18 carbon atoms. Suitable
 anionic dispersing agents include, for example, alkali fatty alcohol
 sulfates, such as sodium lauryl sulfate, and the like; arylalkyl
 sulfonates, and the like; alkali alkyl sulfosuccinates, such as sodium
 octyl sulfosuccinate, and the like; and alkali arylalkylpolyethoxyethanol
 sulfates or sulfonates, such as sodium octylphenoxypolyethoxyethyl
 sulfate, having 1 to 5 oxyethylene units, and the like. Suitable non-ionic
 dispersing agents include, for example, alkyl phenoxypolyethoxy ethanols
 having alkyl groups from about 7 to 18 carbon atoms and from about 6 to
 about 60 oxyethylene units such as, for example, heptyl
 phenoxypolyethoxyethanols, ethylene oxide derivatives of long chained
 carboxylic acids such as lauric acid, myristic acid, palmitic acid, oleic
 acid, and the like, or mixtures of acids such as those found in tall oil
 containing from about 6 to 60 oxyethylene units; ethylene oxide
 condensates of long chained alcohols such as octyl, decyl, lauryl, or
 cetyl alcohols containing from 6 to 60 oxyethylene units; ethylene oxide
 condensates of long-chain or branched chain amines such as dodecyl amine,
 hexadecyl amine, and octadecyl amine, containing from about 6 to 60
 oxyethylene units; and block copolymers of ethylene oxide sections
 combined with one or more hydrophobic propylene oxide sections. High
 molecular weight polymers such as hydroxyethyl cellulose, methyl
 cellulose, polyacrylic acid, polyvinyl alcohol, and the like, may be used
 as emulsion stabilizers and protective colloids.

30 Minutes 1 Hour 2 Hours
 Formulation 1 4.6% 16.7% 19.9%
 Formulation 2 5.5% 18.8% 23.3%
 Untreated control 16.5% 35.3% 39.7%
 The results indicated that both Formulations 1 and 2 behaved similarly when
 compared with the and were superior to the untreated control. This
 indicates that the formulations were non-drying. Both formulations were
 surprising in that for formulations containing high levels of alcohol the
 products were not found to posses significant drying effects.
 EXAMPLE 7
 The following product formulation was prepared and tested in order to
 evaluate the antimicrobial properties using different microbiological
 strains: deionized water 27.8; ethyl alcohol 62.0 by volume; ULTREZ 10
 0.55; glycerin 0.5; cyclomethicone (245) 1.25; Dow Corning 580 wax 0.025;
 SILSOFT PEDM 0.2; CERAPHYL-28 0.5; CERAPHYL-41 1.0; phenoxyethanol 0.5;
 benzalkonium chloride (50% active) 0.2; PHOSPHOLIPID CDM 0.05; GERMALL
 PLUS. 0.1; GERMABEN II 0.1; 1906-AD Mod I 0.06 and pH adjuster.
 The antimicrobial properties of the formulation was evaluated a
 concentration of 99% (w/v), using exposure of fifteen seconds, thirty
 seconds, and one minute. The samples were prepared using a 0.1 ml aliquot
 of challenge suspension of approximately 1.0.times.10.sup.9 CFU/ml and
 were added to 9.9 ml of product and mixed thoroughly to achieve a 99%
 (w/v) concentration. The 15 second, 30 second and one minute exposures
 were timed with a calibrated minute/second timer.
 0.1 ml of each challenge suspension was placed into a sterile test tube
 containing 9.9 ml of Butterfield's Phosphate Buffer solution. This
 solution was used as a control. Appropriate ten-fold dilutions were made
 with Butterfield's Phosphate Buffer solution. After incubation,
 approximately 1-2 days at 35.degree. C., the colonies on the plates were
 counted using a hand-tally counter. The log.sub.10 values of the plates
 were compared to the initial population. It is understood that the numbers
 reported below as 10+7 is 10.sup.7. The results are as follows:
 The formulation demonstrates excellent antimicrobial activity, 99%
 reduction against all of the listed organisms. The above organisms include
 a broad spectrum of organisms, including gram negative, gram positive, and
 fungi microbes.
 EXAMPLE 8
 Subjects were instructed not to use any anti-microbial and or antiseptic
 articles, with the exception of the test articles. Petri dishes were
 filled with approximately 11.5 ml of sterilized molten soybean casein
 digest agar. The agar was allowed to solidify and was placed in an
 incubator at 35.degree. C. overnight prior to inoculation. The test
 bacteria were grown in trypticase soy broth and diluted to obtain
 approximately 200-300 colony forming units (CFU) per 10 microliters. A 10
 microliter loop was used to deliver 10 microliter of the final dilution
 onto the covered surface of each agar plate and spread using the loop. The
 plates were allowed to dry inside the Petri dishes for 15-30 minutes
 before application to the subject arms. Prior to application to the
 subject's arms 70% iso-propyl alcohol was used for about 10 seconds to
 reduce the possibility of contamination. A technician applied about 2.5 ml
 of the test solution over the volar surface of the subject's arm. The
 subject then spread the solution from wrist to elbow until the test
 article disappeared.
 After applying and air drying, the subjects were challenged with the
 anti-microbial solution either immediately (within 5 minutes of
 treatment), 1 hour, 3 hours 5 or 8 hours post treatment. The antimicrobial
 solutions used were a commercially available 62% by volume ethyl
 alcohol(designated as A) and the formulation used in Example 7 above
 (designated as B).
 The results were as follows:

ANTIMICROBIAL HAND GEL
 COMPOSITION A
 Material Percent (W/V) Percent (W/W)
 Specially Denatured Alcohol 40B, 47.76 (60.6 (v/v) 57.39
 200 Proof (density = 0.7872
 g/mL @ 22.3.degree. C.)
 Purified Water (USP) (adjustable) 36.85 40.09
 Cyclomethicone 1.5 1.66
 (Dow Corning .RTM. 245 Fluid)
 Ceraphyl .RTM. 41 1.0 1.11
 Ceraphyl .RTM. 28 0.5 0.56
 Glycerin, 99% (USP) 0.5 0.56
 Phenoxyethanol 0.5 0.56
 (Dowanol .RTM. EPH Glycol Ether)
 Carbomer (Carbopol Ultrez 10) 0.45 0.50
 Silsoft .RTM. PEDM Organosilicone 0.2 0.22
 Fluid
 AMP-95 .RTM. (pH adjuster) 0.15 0.19
 Seafoam 143258 G Fragrance 0.12 0.13
 Propylene Glycol (USP) 0.1 0.11
 Germall .RTM. Plus 0.1 0.11
 Germaben .RTM. II 0.1 0.11
 Benzalkonium Chloride, 50% 0.2 0.22
 Solution (USP/NF)
 Phospholipid CDM 0.05 0.05
 Stearoxymethylsilane 0.025 0.03
 (Dow Corning .RTM. 580 Wax)
 Total 90.105% (W/V) 100.00 (W/W)
 The FDA issued a tentative final monograph (Federal Register, Vol.59, pp.
 31402 to 31452, Jun. 17, 1994) describing a procedure to demonstrate the
 antimicrobial efficacy of products intended for use as patient
 preoperative skin preparations. The procedure is a modification of ASTM
 E-1173-93. Activity of the pre-operative skin preparation is measured by
 comparing microbial counts obtained at various time intervals after
 application of the pre-operative treatment to skin sites located on the
 abdomen and in the groin to counts obtained from the same sites prior to
 treatment application.
 The FDA proposed performance criteria requires that skin prepped with a
 formulation show atleast 2-log reduction in the bacterial flora on
 abdominal skin sites and atleast 3-log reduction in the flora of groin
 sites 10 minutes after prepping. Additionally the proposed monograph
 indicates that six hours after product use the bacterial count from both
 sites must remain below baseline.
 This test method is conducted on subjects selected from a group of
 volunteers who, after refraining from using topical and oral
 antimicrobials for at least two weeks, exhibit high skin flora counts on
 the abdomen and groin.
 This study is within-subjects, paired comparison of two antimicrobial
 products. Bacterial reduction at 10 minutes and 6 hours was determined on
 abdominal and groin sites. In total 11 groin sites and 11 abdomen site
 with antimicrobial hand gel and 11 groin sites and 11 abdominal site with
 Betadine surgical scrub was evaluated using a 5-minute application
 procedure. Additionally, 4 groin sites and 4 abdominal sites were prepped
 with antimicrobial hand gel using a 30-second application procedure.

LOG.sub.10 REDUCTIONS
 TEST 10 MINUTE 6 HOUR
 PRO- EVALUATION EVALUATION
 DUCT TREATMENT ABDOMEN GROIN ABDOMEN GROIN
 A 5 MINUTES 2.29 3.12 1.94 2.64
 B 5 MINUTES 1.84 1.15 2.19 1.99
 A 30 SECONDS 2.77 2.04 1.47 2.03
 A: ANTIMICROBIAL HAND GEL
 B: BETADINE 7.5% POVIDONE-IODINE
 Interestingly Composition A met FDA 2 log (abdomen) and 3 log (Groin)
 reduction requirements after 10 minutes prepping, whereas, Composition B
 (Betadine) failed to meet these requirements. It is also quite surprising
 to note that comparing the results of Betadine at 5 minute treatment and
 antimicrobial hand gel at 30 seconds treatment, the gel has shown
 equivalent results to Betadine only after 30 seconds of treatment.
 Also, it is interesting and surprising to note that Composition A exceeded
 the proposed FDA criteria for performance on both abdominal and groins
 sites when the 5-minute treatment procedure was employed. Using a
 30-second treatment procedure, Composition A met the proposed efficacy
 criteria when applied to abdominal sites but didn't provide the required
 3-log reduction after 10 minute prepping on groin sites. However,
 Composition B identified as Betadine surgical scrub, which was evaluated
 by the 5 minute treatment procedure only, failed to meet the proposed
 performance criteria for both the abdominal and groin sites.
 The bacterial counts remained below the baseline for 6 hours and thus both
 products met the FDA requirements to qualify as a pre-operative product.
 This data shows the strong antimicrobial activity and depositing features
 of the compositions of this invention.
 EXAMPLE 10
 Therapeutic Skin Shave
 Composition A was used as a shaving gel, and found quite effective for the
 treatment of PFB. Eight subjects were part of this screening study. Each
 subject used the product for six weeks. After six weeks of the
 application, there was a significant decrease in the number of PFB lesions
 on both the left side and right side of the face as assessed clinically by
 the grader. A visual comparison of digital photographs between visit 1 and
 visit 3 showed clear improvement in three subjects. These test results
 clearly suggests the anti-inflammatory properties of the Composition A
 gel. At the end of the study subjects perceived an improvement in the
 appearance of their PFB/razor bumps. Thus, surprisingly Composition A has
 shown potential for the treatment of bacterial driven PFB.
 EXAMPLE 11
 Therapeutic Acne Application
 A twelve-week study was conducted to assess the efficacy of an
 antimicrobial gel for the treatment of acne vulgaris. Volunteer subjects
 were selected from a pool of healthy men and women ages 12-30. Subjects
 qualified for participation by having at least 15 inflammatory acne
 lesions (predominantly papules) on their face, no more than 5 pustules,
 and a Cook Acne Grading score of 2 to 4 (Cook, C H, Centner, R L,
 Michaels, S E. An acne grading method using photographic standards Arch.
 Dermatol. 1979. 115:571) Fourteen subjects completed this study.
 At baseline, after three days of product use, and after one, four and
 twelve weeks of product use, subjects' faces were examined and graded for
 lesion erythema and lesion elevation (by palpation) on the forehead,
 cheeks and chin. Subjects also had inflammatory acne lesions (papules,
 pustules and nodules), non-inflammatory acne (open and closed comedones)
 and macules counted on the forehead, cheeks and chin. Subjects completed
 self-assessment questionnaires at each visit after baseline, and completed
 a post-usage questionnaire at the last visit (twelve weeks).
 After just three days of treatment a significant reduction in papules was
 observed for the chin region. After 1 week, 4 weeks and 12 weeks, a
 significant reduction in papules was observed over the whole face when
 compared to baseline. Moreover, by 12 weeks, a significant reduction in
 closed comedones was also observed, which indicates that the test product
 not only significantly reduces inflammatory acne, but also significantly
 reduces closed comedones which are believed to be the pre-cursor lesion to
 inflammatory papules (Burke, B M, Cunliffe, W J. The assessment of acne
 vulgaris: the Leeds technique Br. J. Dermatol. 1984. 111:83). Moreover,
 the average percent improvement from baseline in inflammatory papules was
 16% at Day 3, 35% at 1 week, 39% at 4 weeks and 53% at 12 weeks. The
 degree of improvement observed during this study compares very favorably
 with the comparative effects of 10% benzoyl peroxide, and 10% benzoyl
 peroxide in combination with 3% topical erythromycin. Sklar et al. (Sklar,
 J L, Jacobson, C, Rizer, R L, Gans, E H. Evaluation of Triaz 10% Gel and
 Benzamycin in acne vulgaris J. Dermatological Treatment. 1996. 7:147)
 observed that 10% benzoyl peroxide reduced papules and pustules by 16% at
 1 week, 43% at 4 weeks, and 56% at 12 weeks of treatment compared to
 baseline. In addition they showed that the combination of 10% benzoyl
 peroxide and 3% topical erythromycin reduced papules and pustules an
 average of 24% at 1 week, 43% at 4 weeks and 54% at 12 weeks. Their data
 compares very favorably with the results obtained with the present study
 with treatment effectiveness essentially comparable. Thus, antimicrobial
 Composition A proved to be effective in treatment of acne.