POLYMERIC TOPICAL ANTISEPTIC COMPOUND AND METHOD OF USE

Abstract

Topical antiseptic rubs are disclosed that reduce microorganism loading on the skin surface preventing possible infections. The FDA currently recognizes ethanol, isopropanol and benzalkonium chloride as active ingredients but further defines the actives as chronic use drugs. The present invention describes formulations and applications of a liquid compound that forms a topical polymeric skin layer consisting of a given benzalkonium chloride concentration within the matrix, which quickly reduces all bacteria including the MERS, virus types, and kills spores including the Clostridium difficile. The second skin concept, is likened to the human skin cellular function of the stratum corneum, functions as a barrier to exogenous substances, which reduces any chronic flux of benzalkonium chloride into the epidermis and reducing symptoms of constant usage. The second skin polymeric application agglomerates, traps and kills bacteria. The second skin provides for cosmetic moisturizing, barrier effects and skin softness.

Claims

1. A composition for use on mammals as a topical antiseptic rub, said composition comprising: (a) a polymeric skin scaffold selected from the group consisting of: polymers of 1-Octadecanaminium N,N dimethyl [(3-trihdroxysilyl) propyl] chloride, silk protein, polyhexanide and mixtures thereof said skin scaffold further including a monomeric coupling agent selected from the group consisting of of alkyl dialkylammonium trimethoxysilylpropyl chloride; (b) an antimicrobial active selected from the group consisting of alkyldimethylbenzylammonium chloride of the formula ##STR00011## where n=8, 10, 12, 14, 16, 18; (c) a carrier for the polymers consisting of pharmaceutical grade water and surfactants selected from the group consisting of non-ionics, anionic, cationic, amphoteric and switterionic surfactants said surfactants also being suitable for emulsification of the composition; and (d) a clay stabilizer for the trimethoxysilyl functional group.

2. The composition of claim 1, further comprising a skin moisturizer selected from the group consisting of: Aloe Vera, Vitamin E acetate and mixtures thereof.

3. The composition of claim 1, further comprising an amino acid selected from the group consisting of: arginine, allantoin, L-alanine and mixtures thereof.

4. The composition of claim 1, further comprising an extracellular matrix comprising hyaluronic acid and sodium salts thereof.

5. The composition of claim 1, optionally containing additional components selected from the group consisting of a citric acid buffer, a fragrance, UVA and UVB absorbers, UV luminescent dyes for detection under a black light monitor, viscosity modifiers selected from the group consisting of hydroxyethyl cellulose, xanthan gum or modifiers to make a sol gel and mixtures thereof.

6. The composition of claim 1, wherein the polymeric skin scaffold forms a clear film of about 20-50 nm thickness which is plasticized with other components to form a flexible and lasting film.

7. The composition of claim 1, wherein said composition is applied in effective amounts to agglomerate and kill spores.

8. The composition of claim 1, wherein said composition dries in 30-120 seconds and displays activity against bacteria, virus, fungi, spores on human skin in about 15 seconds to about 10 minutes.

9. The composition of claim 1, wherein said composition improves skin softness and retains skin moisture on males and females having aged skin of about >50 years.

10. The composition of claim 1, wherein said composition reduces the skin flux of the benzalkonium chloride.

11. The composition of claim 1, wherein said composition extends the protection of the person treated with the topical antiseptic in hours as compared to minutes with alcohol.

12. The composition of claim 1, wherein said composition reduces patient to health care worker transfer of pathogens.

13. The composition of claim 1, wherein said composition reduces human bacterial generated odor and can be used as an odor masking agent.

14. The composition of claim 1, wherein said composition reduces skin irritation due to benzalkonium chloride and can be used in larger concentrations.

15. A composition for use on mammals as a topical antiseptic rub, said composition comprising: (a) a polymeric skin scaffold selected from the group consisting of: polymers of 1-Octadecanaminium N,N dimethyl [(3-trihdroxysilyl) propyl] chloride, silk protein, polyhexanide and mixtures thereof said skin scaffold further including a monomeric coupling agent selected from the group consisting of of alkyl dialkylammonium trimethoxysilyl propyl chloride; and (b) an extracellular matrix comprising hyaluronic acid and sodium salts thereof.

16. The composition of claim 15, further comprising an antimicrobial active selected from the group consisting of alkyldimethylbenzylammonium chloride of the formula ##STR00012## where n=8, 10, 12, 14, 16, 18 and mixtures thereof.

17. The composition of claim 15, further comprising a carrier for the polymers consisting of pharmaceutical grade water and surfactants selected from the group consisting of non-ionics, anionic, cationic, amphoteric and switterionic surfactants said surfactants also being suitable for emulsification of the composition.

18. The composition of claim 15, further comprising an amino acid selected from the group consisting of: arginine, allantoin, L-alanine and mixtures thereof.

19. The composition of claim 15, further comprising an extracellular matrix comprising hyaluronic acid and sodium salts thereof.

20. The composition of claim 15, optionally containing additional components selected from the group consisting of a citric acid buffer, a fragrance, UVA and UVB absorbers, UV luminescent dyes for detection under a black light monitor, viscosity modifiers selected from the group consisting of hydroxyethyl cellulose, xanthan gum or modifiers to make a sol gel and mixtures thereof.

Description

BRIEF DESCRIPTION OF THE FIGURES

[0035] FIG. 1 shows Bacillus spores evenly distributed in a slide.

[0036] FIG. 2 illustrates addition of the hand sanitizer with 1.6 wt % ODTMSPC active showing agglomerated spores and encapsulation.

[0037] FIG. 3 shows the Bacillus spores from FIG. 1 with hand sanitizer ODTMSPC at 1.6 wt % after 2 hours dried as water evaporated. The spores are encapsulated in ODTMSPC polymer film.

DETAILED DESCRIPTION OF THE INVENTION

Definitions

[0038] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art to which the invention belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, preferred methods and materials are described. For the purposes of the present invention, the following terms are defined below.

[0039] As used herein, the term alkyl refers to a straight chain or branched saturated hydrocarbon group having 1 to 22 carbon atoms. Where appropriate, the alkyl group may have a specified number of carbon atoms, for example, C.sub.1-6alkyl which includes alkyl groups having 1, 2, 3, 4, 5 or 6 carbon atoms in a linear or branched arrangement. Examples of suitable alkyl groups include, but are not limited to, methyl, ethyl, n-propyl, s-propyl, n-butyl, s-butyl, i-butyl, n-pentyl, 2-methylbutyl, 3-methylbutyl, 4-methylbutyl, n-hexyl, 2-methylpentyl, 3-methylpentyl, 4-methylpentyl, 5-methylpentyl, 2-ethylbutyl, 3-ethylbutyl, heptyl, octyl, nonyl, decyl, isodecyl, undecyl, dodecyl and the like.

[0040] As used herein, the term cycloalkyl refers to a saturated cyclic hydrocarbon. The cycloalkyl ring may include a specified number of carbon atoms. For example, a 3 to 8 membered cycloalkyl group includes 3, 4, 5, 6, 7 or 8 carbon atoms. Examples of suitable cycloalkyl groups include, but are not limited to, cyclopropyl, cyclobutyl, cyclopentyl, cyclohexyl, cycloheptyl and cyclooctyl.

[0041] As used herein, the term aryl is intended to mean any stable, monocyclic, bicyclic or tricyclic carbon ring system of up to 7 atoms in each ring, wherein at least one ring is aromatic. Examples of such aryl groups include, but are not limited to, phenyl, naphthyl, tetrahydronaphthyl, indanyl, fluorenyl, anthracenyl, phenanthrenyl, biphenyl and binaphthyl.

[0042] As used herein, the term alkylene refers to a divalent saturated hydrocarbon chain having 1 to 6 carbon atoms. Where appropriate, the alkylene group may have a specified number of carbon atoms, for example, C.sub.1-6 alkylene includes alkylene groups having 1, 2, 3, 4, 5 or 6 carbon atoms in a linear arrangement. Examples of suitable alkylene groups include, but are not limited to, CH.sub.2, CH.sub.2CH.sub.2, CH.sub.2CH.sub.2CH.sub.2, CH.sub.2CH.sub.2CH.sub.2CH.sub.2, CH.sub.2CH.sub.2CH.sub.2CH.sub.2CH.sub.2 and CH.sub.2CH.sub.2CH.sub.2CH.sub.2CH.sub.2CH.sub.2.

[0043] The term heterocyclic or heterocyclyl as used herein, refers to a cyclic hydrocarbon in which one to four carbon atoms have been replaced by heteroatoms independently selected from the group consisting of N, N(R), S, S(O), S(0).sub.2 and O. A heterocyclic ring may be saturated or unsaturated but not aromatic. A heterocyclic group may also be part of a spirocyclic group containing 1, 2 or 3 rings, two of which are in a spiro arrangement. Examples of suitable heterocyclyl groups include azetidine, tetrahydrofuranyl, tetrahydrothiophenyl, pyrrolidinyl, 2-oxopyrrolidinyl, pyrrolinyl, pyranyl, dioxolanyl, piperidinyl, 2-oxopiperidinyl, pyrazolinyl, imidazolinyl, thiazolinyl, dithiolyl, oxathiolyl, dioxanyl, dioxinyl, dioxazolyl, oxathiozolyl, oxazolonyl, piperazinyl, morpholino, thiomorpholinyl, 3-oxomorpholinyl, dithianyl, trithianyl and oxazinyl.

[0044] The term heteroaryl as used herein, represents a stable monocyclic, bicyclic or tricyclic ring of up to 7 atoms in each ring, wherein at least one ring is aromatic and at least one ring contains from 1 to 4 heteroatoms selected from the group consisting of O, N and S. Heteroaryl groups within the scope of this definition include, but are not limited to, acridinyl, carbazolyl, cinnolinyl, quinoxalinyl, quinazolinyl, pyrazolyl, indolyl, isoindolyl, 1H,3H-1-oxoisoindolyl, benzotriazolyl, furanyl, thienyl, thiophenyl, benzothienyl, benzofuranyl, benzodioxane, benzodioxin, quinolinyl, isoquinolinyl, oxazolyl, isoxazolyl, imidazolyl, pyrazinyl, pyridazinyl, pyridinyl, pyrimidinyl, pyrrolyl, tetrahydroquinolinyl, thiazolyl, isothiazolyl, 1,2,3-triazolyl, 1,2,4-triazolyl, 1,2,4-oxadiazolyl, 1,2,4-thiadiazolyl, 1,3,5-triazinyl, 1,2,4-triazinyl, 1,2,4,5-tetrazinyl and tetrazolyl. Particular heteroaryl groups have 5- or 6-membered rings, such as pyrazolyl, furanyl, thienyl, oxazolyl, indolyl, isoindolyl, 1H,3H-1-oxoisoindolyl, isoxazolyl, imidazolyl, pyrazinyl, pyridazinyl, pyridinyl, pyrimidinyl, pyrrolyl, thiazolyl, isothiazolyl, 1,2,3-triazolyl, 1,2,4-triazolyl and 1,2,4-oxadiazolyl and 1,2,4-thiadiazolyl.

[0045] Alkyl, cycloalkyl, heterocyclyl, heteroaryl and aryl groups of the invention may be optionally substituted with 1 to 5 groups selected from OH, O C.sub.1-6alkyl, CI, Br, F, I, NH.sub.2, NH(C.sub.1-6alkyl), N(C.sub.1-6alkyl).sub.2, SH, S C.sub.1-6alkyl, CO.sub.2H, C0.sub.2C.sub.1-6 alkyl, CONH.sub.2, CONH(C.sub.1-6 alkyl) or CON(C.sub.1-6alkyl).sub.2.

[0046] As used herein, the term divalent bridging group refers to a radical that has a valence of two and is able to bind with two other groups. Examples of suitable divalent bridging groups include but are not limited to (CH.sub.2).sub.t where t is an integer from 1 to 10, -0-, S, a divalent saturated or aromatic carbocyclic ring or a heterocyclic or heteroaromatic ring or a combination of such divalent and/or cyclic moieties. For example a saturated C.sub.6 cyclic group would include C.sub.6H.sub.11, a C.sub.6aromatic group would include C.sub.6H.sub.4, a C.sub.6 heterocyclic group would include

##STR00002##

and a C.sub.6 heteroaromatic would include

##STR00003##

[0047] Other divalent bridging groups include alkylene groups (CH.sub.2-).sub.t in which one or more carbon atoms have been replaced by NH, S, O,

##STR00004##

[0048] In a preferred embodiment the divalent bridging group is (CH.sub.2).sub.t where t is an integer from 1 to 10, especially 1 to 6, more especially 3 to 6.

[0049] The compounds of the invention may be in the form of pharmaceutically acceptable salts. It will be appreciated however that non-pharmaceutically acceptable salts also fall within the scope of the invention since these may be useful as intermediates in the preparation of pharmaceutically acceptable salts or may be useful during storage or transport. Suitable pharmaceutically acceptable salts include, but are not limited to, salts of pharmaceutically acceptable inorganic acids such as hydrochloric, sulphuric, phosphoric, nitric, carbonic, boric, sulfamic, and hydrobromic acids, or salts of pharmaceutically acceptable organic acids such as acetic, propionic, butyric, tartaric, maleic, hydroxymaleic, fumaric, maleic, citric, lactic, mucic, gluconic, benzoic, succinic, oxalic, phenylacetic, gallic methanesulphonic, toluenesulphonic, benezenesulphonic, salicylic sulphanilic, aspartic, glutamic, edetic, stearic, palmitic, oleic, lauric, pantothenic, tannic, ascorbic and valeric acids.

Polymeric Compositions

[0050] In a first aspect of the present invention, there is provided a carrier for the bactericidal active which comprises a water soluble liquid monomer and water soluble polymer compounds which when activated will through condensation polymerization at room temperature react to form a polymeric film skin or skin scaffold or biomimetic.

[0051] According to Zhong, engineering skin substitutes by tissue engineering approach has relied upon the creation of three-dimensional scaffolds as extracellular matrix (ECM) analog to guide cell adhesion, growth, and differentiation to form skin-functional and structural tissue. The three-dimensional scaffolds can not only cover wound and give a physical barrier against external infection as wound dressing, but also can provide support both for dermal fibroblasts and the overlying keratinocytes for skin tissue engineering. A successful tissue scaffold should exhibit appropriate physical and mechanical characteristics and provide an appropriate surface chemistry and nano and microstructures to facilitate cellular attachment, proliferation, and differentiation. Highlighted emerging fabrication technique is electrospinning that allows the design and fabrication of biomimetic scaffolds that offer tremendous potential applications in wound healing of skin.

[0052] The invention provides compositions containing: (i) an alkoxy silyl ammonium compound monomer; (ii) an alkoxy silyl ammonium compound polymer; (iii) a polymeric biguanide; (iv) a polymeric stabilizer such as a smectite, bentonite or filler such as hydroxyethyl cellulose; (v) a natural silk fibroin and (vi) multiple oxirane polymeric surfactants.

[0053] In some embodiments, the alkoxy silyl ammonium polymer and monomer combination film-forming agents is an alkoxy silyl quaternary ammonium film forming agent. Alkoxy silyl quaternary ammonium film forming agents are also known in the art as organosilicon quaternary ammonium film forming compounds.

[0054] In some embodiments, the alkoxy silyl ammonium film-forming agent is a compound of formula:

##STR00005##

[0055] Other film forming agents include compounds corresponding to the following formula

R.sub.1,R.sub.2,R.sub.3SiCH.sub.2CH.sub.2CH.sub.2N.sup.+R.sub.YR.sub.XR.sub.ZW.sup.

wherein W.sup. is a Cl, Br; F or I, more in particular Cl.sup., R.sub.1, R.sub.2, R.sub.3 are CH.sub.3O or CH.sub.3CH.sub.2O groups. In particular embodiments, one or more of the following maybe suitable R.sub.1, R.sub.2, R.sub.3 which are selected from a hydrogen, hydroxy, alkoxy such as methoxy or ethoxy, alkyl such as methyl or ethyl; R.sub.Y is a C.sub.1-C.sub.5 alkyl group preferably a CH.sub.3 group; and R.sub.X is C.sub.1-C.sub.5 alkyl group preferably a CH.sub.3 group; and R.sub.Z is a C.sub.7-C.sub.18 alkyl or a mixture of various alkyl species but predominately C.sub.18 alkyl or C.sub.12 alkyl or both, more particularly C.sub.18 alkyl.

[0056] In particular embodiments, the alkoxy silyl ammonium film-forming compounds of formula are selected from 1-octadecanaminium-N,N-dimethyl-N-[(3-trimethoxysilyl)propyl]-chloride, 1-octadecanaminium-N,N-dimethyl-N-[(3-triethoxysilyl)propyl]chloride, and 1-octa-decanaminium-N,N-dimethyl-N-[(3-trihydroxysilyl)propyl]chloride, 3-trimethoxysilylpropyl-N,N-dimethyl-N-octadecyl ammonium chloride), 3-triethoxysilylpropyl-N,N-dimethyl-N-octadecyl ammonium chloride, 3-trimethoxysilyl propyl-N,N-dimethyl-N-octyl ammonium chloride, 3-triethoxysilylpropyl-N,N-dimethyl-N-octyl ammonium chloride, 3-triethoxysilylpropyl-N,N-dimethyl-N-isodecyl ammonium chloride, 3-trimethoxysilylpropyl-N,N-dimethyl-N-isodecyl ammonium chloride, 3-trimethyoxysilylpropyl-N,N-dimethyl-N-decyl ammonium chloride, 3-tri-ethyloxysilylpropyl-N,N-dimethyl-N-decyl ammonium chloride, 3-trimethyoxysilylpropyl-N,N-dimethyl-N-dodecyl ammonium chloride, 3-triethyloxysilylpropyl-N,N-dimethyl-N-dodecyl ammonium chloride, 3-trimethoxysilylpropyl-N,N-dimethyl-N-tetradecyl ammonium chloride, 3-triethoxysilylpropyl-N,N-dimethyl-N-tetradecyl ammonium chloride, 3-trimethoxysilylpropyl-N,N-dimethyl-N-hexadecyl ammonium chloride, 3-triethoxysilylpropyl-N,N-dimethyl-N-hexa-decylammonium chloride, 3-trimethoxysilylpropyl-N,N-dimethyl-N-octadecyl ammonium chloride, 3-triethoxysilylpropyl-N,N-dimethyl-N-octadecyl ammonium chloride, 3-trimethoxy-silylpropyl-N,N-dimethyl-N-docosyl ammonium chloride, 3-triethoxysilylpropyl-N,N-dimethyl-N-docosyl ammonium chloride, 3-trimethoxysilylpropyl-N,N-dimethyl-N-eicosyl ammonium chloride, 3-triethoxysilylpropyl-N,N-dimethyl-N-eicosyl ammonium chloride, 3-trimethoxy-silylpropyl-N,N-dimethyl-NC.sub.12-C.sub.16 ammonium chloride, where C.sub.12=65% and C.sub.16=33%, 3-triethoxysilylpropyl-N,N-dimethyl-NC.sub.12-C.sub.16 ammonium chloride, where C.sub.12=65% and C.sub.16=33%, 3-trimethoxysilylpropyl-N,N-dimethyl-NC.sub.16-C.sub.22 ammonium chloride, where C.sub.16=16% and C.sub.22=83%, 3-triethoxysilylpropyl-N,N-dimethyl-NC.sub.16-C.sub.22 ammonium chloride, where C.sub.16=16% and C.sub.22=83%, 3-trimethoxysilylpropyl-N,N-dimethyl-NC.sub.14-C.sub.18 ammonium chloride, where C.sub.14=4%, C.sub.16=31% and C.sub.18=64%, 3-triethoxysilylpropyl-N,N-dimethyl-NC.sub.14-C.sub.18 ammonium chloride, where C.sub.14=4%, C.sub.16=31% and C.sub.18=64%, 3-trimethoxysilylpropyl-N,N-dimethyl-NC.sub.12-C.sub.16 ammonium chloride, where C.sub.12=41%, C.sub.14=50% and C.sub.16=9%, 3-triethoxy-silylpropyl-N,N-dimethyl-NC.sub.12-C.sub.16 ammonium chloride, where C.sub.12=41%, C.sub.14=50% and C.sub.16=9%, 3-trimethoxysilylpropyl-N,N-dimethyl-NC.sub.12-C.sub.18 ammonium chloride, where C.sub.12=49%, C.sub.14=20%, C.sub.16=11% and C.sub.18=10%, 3-triethoxysilylpropyl-N,N-dimethyl-NC.sub.12-C.sub.18 ammonium chloride, where C.sub.12=49%, C.sub.14=20%, C.sub.16=11% and C.sub.18=10%.

[0057] The alkoxy silyl ammonium film-forming compound is present in the composition in an amount in the range of 0.1% to 5.0% w/w, particularly about 1.0% to 3.0% w/w, more particularly about 1.51 to 2.5% w/w of the active in the composition.

[0058] It is known that alkoxy silyl quaternary ammonium compounds hydrolyze in water forming the trihydroxy silicon functional group, therefore, for example, 3-trimethoxysilylpropyl-N,N-dimethyl N-octadecyl ammonium chloride is hydrolyzed to form 3-trihydroxy silylpropyl-N,N-dimethyl-N-octadecyl ammonium chloride. The alkyl silyl ammonium compound are made in ethanol or methanol as a solvent. There is 22% methanol in 1-octadecanaminium-N,N-dimethyl-N-[(3-trimethoxysilyl)propyl]chloride product and 22% ethanol is in 1-octadecanaminium-N,N-dimethyl-N-[(3-triethoxysilyl)propy]chloride.

[0059] The addition of the polymer 1-Octadecanaminimum N,N-Dimethyl N (3-trihydroxy-silyl)propyl chloride couples with the monomer forming high density sites upon drying (film forming) that are closer to the surface than the monomeric condensation polymeric reaction. The topography of the film formed becomes peaks and throughs.

[0060] The Polyhexanide salts for use in compositions according to the invention will typically be the protonated form of the following general formula;

##STR00006##

wherein n may have a value of up to about 500 or more, but typically has a value of 1-40, with termination of the polymer chain provided by an appropriate end group (see the Block reference described above). In preferred embodiments of the invention, n has an average value of 10-13; such a cosmetically acceptable Polyhexanide salt is the hydrochloride salt, which can be commercially obtained from Lonza under the trade name Vantocil P. Preferably, the Polyhexanide can be present in compositions according to the invention at a level of 0.01-0.5%, more preferably 0.2-0.1% by weight of the composition, though good results have been found with a level of 0.1-0.5% by weight of Polyhexanide salts in the composition.

[0061] In some embodiments, the polymeric biguanide is a compound of formula:

##STR00007##

wherein Z is absent or an organic divalent bridging group and each Z may be the same or different throughout the polymer; n is at least 3, preferably 5 to 20 and X.sub.3 and X.sub.4 are independently selected from NH.sub.2, NHC(NH)NHCN, optionally substituted alkyl, optionally substituted cyclo alkyl, optionally substituted aryl, optionally substituted heterocyclyl and optionally substituted heteroaryl; or a pharmaceutically acceptable salt thereof. Preferably, the molecular weight of the polymeric compound is at least 1,000 amu, more preferably between 1,000 amu and 50,000 amu. In a single composition, n may vary providing a mixture of polymeric biguanides.

[0062] The above polymeric biguanide compounds and methods for their preparation are described in, for example, U.S. Pat. No. 3,428,576 to East et. al.

[0063] The preferred monomeric species is of the formula

##STR00008##

[0064] The polymeric biguanide is present in the composition in an amount in the range of 0.1% to 1.5% w/w, especially about 0.1% to about 1.0% w/w, more especially about 0.4% to about 0.6% w/w of the composition.

[0065] The polymeric biguanide is one of the most effective Pseudomonas aeruginosa biocides in water and active on biofilms of Pseudomonas. The Polyhexanide acts as a viable biocide and also as a water-soluble preservative for extended shelf life.

[0066] The silk protein (sericin and fibroin) are added to the polymer matrix for their ability to affect the film forming topographic properties of the silane monomer in providing a soft hand feel.

[0067] In some embodiments a stabilizer for the polymeric system is added to provide steric hindrance to the reactive trimethoxysilyl or trihydroxysilyl functional coupling groups. These stabilizer compounds are found to be smectite clays, montmorillonite, kaolin or bentonite clays, gums and sol gels. The water trapped within the clay matrix provides for a water bridge at the trihydroxysilyl stability and freeze point reduction.

[0068] In another aspect of the present invention, there is provided a suitable active antimicrobial or biocide that is compatible with a carrier to provide the bactericidal active. Benzalkonium chloride exists as a mixture of N,N-dimethyl alkyl amine homologs having the following structure. The benzalkonium antimicrobial agent can have the following structure:

##STR00009##

where n=8, 10, 12, 14, 16, 18.

[0069] Other quaternary ammonium salts that can be used correspond to the formula:

##STR00010##

wherein R.sub.1 is a benzyl group, R.sub.2 is a C.sub.2-C.sub.22 alkyl group and R.sub.3 and R.sub.4 are methyl groups. In one embodiment, the benzalkonium chloride is USP grade, having not less than 40% C.sub.12, not less than 20% C.sub.14, and not less than 70% C.sub.12 and C.sub.14 homologs combined. In another embodiment, the combination of C.sub.12 and C.sub.14 homologs is less than 90%, less than 85%, less than 80%, or less than 75% combined C.sub.12 and C.sub.14 homologs. In a further embodiment, the homolog distribution is approximately 67% C.sub.12, approximately 25% C.sub.14, approximately 7% C.sub.16 and approximately 1% C.sub.18.

[0070] The benzalkonium chloride compound is present in an amount in the range of about 0.1% to 2.0% w/w of the composition, especially about 0.1% to about 0.5% w/w, more especially about 0.1% to 0.2% w/w of the composition, and even more especially about 0.1% to 0.13% w/w of the composition in accordance with regulations according to the Federal Drug Administration 21 CFR Parts 333 and 369Tentative Final Monograph for Health-Care Antiseptic Drug.

[0071] In a noteworthy embodiment the monomeric/polymeric carrier and active possess a highly cationic charge or zeta potential that in water effects microorganisms that in turn have a negative or anionic charge. The concentrations of cationic actives allow for agglomeration of resident bacteria on the skin into packets of bacteria that are encapsulated and osmotically and electrochemical face cell lysis. This is extremely advantageous for Clostridium difficile spores contamination on skin.

[0072] The present invention provides a secondary carrier system of the active and film former polymer and monomer consisting of a surfactant system which emulsifies any oil to form an oil in water emulsion and wets and treats oil found on the skin during application. The surfactant package requires non-ionic or amphoteric or zwitterionic systems comprising an alcohol ethoxylate, an alkyl glucoside or alkyl polyglycoside and betaine

[0073] In particular embodiments, the alcohol ethoxylate is an alkyl alcohol ethoxylate, with HLB>9.0 for an oil in water emulsion; Biological activity in emulsions is found especially a C.sub.12-C.sub.18 alcohol ethoxylate and more especially a C.sub.12-15 alcohol ethoxylate group. In particular embodiments, the alcohol ethoxylate comprises 6 to 16 ethoxylate groups, especially about 10 to 14 ethoxylate groups. An example of a useful alcohol ethoxylate are Pareth-9, Laureth 4 or pentaerythritol ethoxylate also known as Polyol 4290.

[0074] The alcohol ethoxylate is present in the composition in an amount in the range of 0.1% to 2.0% w/w, especially 0.2 to 1.5% w/w, more especially about 0.5 to 1.0% w/w of the composition.

[0075] In particular embodiments, the alkylglucoside or alkylpolyglycoside is a C.sub.8-16 alkylglucoside or alkylpolyglycoside, or a mixture thereof. In some embodiments, the alkylglucoside or alkylpolyglycoside is selected from caprylyl glucoside, caprylyl/capryl glucoside, octyl glucoside, decyl glucoside, dodecyl glucoside, coco glucoside, lauryl glucoside, caprylyl polyglycoside, caprylyl/capryl polyglycoside, decyl polyglycoside, dodecyl polyglycoside, coco polyglycoside and lauryl polyglycoside.

[0076] The alkyl glucoside or alkylpolyglycoside is present in the composition in an amount in the range of 0.3% to 1.5% w/w, especially about 0.5 to 1.0% w/w of the composition.

[0077] In some embodiments the surfactant system allows for skin oils such as to be micellized and absorbed into the polymeric condensation matrix while providing adherence of the polymer to skin squama.

[0078] In some embodiments the surfactant system is chosen due to its properties not to flux into the skin. In some embodiments, particularly those applications to skin, such as cracking hands or feet, the composition may further comprise a moisturizing, soothing, healing and antibacterial extract of aloe vera, citronella, PCB, Hyaluronic acid sodium salt, lanolin and amino acids such as arginine or lysine.

[0079] In some embodiments, the composition may also include other optional components such as dodecylamine and dodecylamine citrate as cationic components to germinate spores. The use of dodecylamine in 0.001 to 1.0 wt % is incorporated into the polymeric matrix of the 1-octadecanaminium-N,N-dimethyl-N-[(3-triethoxysilyl)propyl]chloride polymer.

[0080] In some embodiments, the composition may also include other optional components such as rheological modifiers, pH adjusters, lubricants, humectants, UV absorbers, fragrances and dyes. Suitable rheological modifiers include smectite clays, hydroxyethyl cellulose, hydroxypropyl cellulose and Carbapol. Suitable pH adjusters include buffers, acids and bases. For example, a suitable acidic adjuster is citric acid and a suitable basic adjuster is sodium hydroxide. Other suitable acidic adjusters include sorbic acid and lactic acid.

[0081] Suitable lubricants or humectants include, for example, glycerin or DEA. Fragrances include essential oils and synthetic fragrances to provide the desirable odor. Dyes or other coloring agents may also be included to impart a suitable color to the composition.

[0082] Non-limiting examples of preferred humectant type emollients include glycerol, polyglycerols (including: diglycerol, triglycerol, polyglycerin-3, tetraglycerol, hexaglycerol, decaglycerols) propylene glycol, dipropylene glycol, polypropylene glycol, polyethylene glycol (PEG-2 to PEG 45M, preferably a molecular weight between about 300 and 1,000), sorbitol, polyhydric alcohol ethoxylates (e.g. sorbeth 6, sorbeth-30, glycereth-1 to glycereth-31) methoxides of polyethylene glycol (Methoxy PEG-2 to Methoxy PEG-100) methoxides of polyhydric alcohol ethoxylates (e.g. glyc ereth-7 methoxide), pantothenol, gluconic acid salts and the like. Other humectant-type agents like that could also be employed include: 1,2,6-hexanetriol, acetamide MEA, aluminum hydroxide, arginine pea, butoxypropanol, butylene glycol, dimethyl imidazolidinone, dimethylsilanol hyaluronate, dipotassium glycyrrhizate, erythritol, ethoxy-diglycol, fructose, glucamine, gluconic acid, glucose, glucose glutamate, glucuronic acid, glutamic acid, glycogen, glycyrrhizic acid, heilmoor clay, hexacosyl glycol, hyaluronic acid, hydrogenated honey, hydrogenated starch, hydrolysate, hydrolyzed collagen, hydrolyzed elastin, hydrolyzed glycosaminoglycans, hydrolyzed keratin, hydrolyzed silk, hydrolyzed soy protein, hydrolyzed wheat protein, hydroxy ethyl sorbitol, inositol, inositol hexa-pea, lactamide MEA, lactic acid, lactitol, lactose, lysine pea, magnesium pea, maltitol, manganese pea, mannitol, mel (honey extract), menthyl pea, methyl gluceth-10, methyl gluceth-20, pea (pidolic acid), lactamide, polydextrose, polyglucuronic acid, polyglyceryl sorbitol, ppg-20 methyl glucose ether, PPG 38-buteth-37, saccharide isomerate, serica, silk amino acids, sodium carboxymethyl chitin, sodium lactate, sodium mannuronate methylsilanol, sodium PEA, sodium PEA methylsilanol, sodium polyglutamate, soluble collagen, sorbitol, sucrose, TEA-lactate, TEA-PEA, trehalose, trilactin, urea, xylitol, zea mays, zinc pea, and combinations thereof

[0083] In some embodiments, the compositions are aqueous compositions wherein the carrier comprises highly pure distilled water or demineralized water, especially where the carrier is water. Water with conductivity as low as possible to remove most minerals found in hard water. In some embodiments, the compositions of the invention can include alcohol such as ethanol or isopropanol as a component.

[0084] The compositions may conveniently be in the form of a liquid, gel, cream, foam or water soluble film. The water soluble film is the dried hydroxyethyl cellulose films dried at 180 F. The films can be wetted and applied to the skin. In some embodiments, the composition is impregnated in or coated on a textile to provide a wipe or sponge. In some embodiments, the composition is dispersed from a dispenser, such as a pump action dispenser, that dispenses a predetermined amount of composition. The compositions can be added to polyester non woven fabrics with high wet pick uptake to provide for a bath wipe, hand wipe, sponge wipe, or wound dressing.

[0085] The gel formulations have a viscosity in the temperature range of 5 C. to 50 C. in the range of from 5,000 to 60,000 mPa.Math.s, especially about 16,000 to 50,000 mPa.Math.s. The lower the ambient temperature, the greater the viscosity.

Uses of the Sanitizing Compositions of the Invention

[0086] The topical antiseptic compositions of the present invention have antimicrobial activity that is useful in applications such as hand sanitation in food process plants, restaurants, operating rooms, hospitals, military base and field hospital units, laboratories, nursing homes, adult care centers, schools, child care facilities, sports facilities, dairy farms and livestock farms, banks, public transport facilities, cruise ships, shopping malls and other places where there is a risk of the spread of microbial infection, particularly patients in immune compromised floors in hospitals, the elderly in care and the young in child care cancer wards or cystic fibrosis wards. The compositions of the present invention may readily be used as an individual's hand sanitizers to kill pathogens on their hands and also to avoid spreading of infection. The hand sanitizers may be applied to the hands after a soap and water wash or where water and soap are not available in any suitable manner, for example, from a bottle foamer, a tube or pump action container, a wipe or sponge or in a spray from an electrostatic precipitator device.

[0087] The FDA proposes that a consumer antiseptic rub active ingredient be considered bactericidal at the concentration and contact time that demonstrates a 3-log 10 (99.9 percent) or greater reduction in bacterial viability for all the tested strains. This is the same performance criterion used by the Clinical and Laboratory Standards Institute (NCCLS, Methods for Determining Bactericidal Activity of Antimicrobial Agents; Approved Guideline, NCCLS document M26-A, 1999).

Inspections be measured after a single bacterial challenge, rather than after repeated contamination

[0088] The sanitizing composition is effective against a wide range of pathogens which are either killed or inactivated following application of the composition. Pathogens which are killed or inactivated by the sanitizing compositions of the present invention include:

Bacteroides fragilis, Enterobacter species, Burkholderia cepacia (ATCC 25416 and ATCC 25608), Escherichia coli (ATCC 11775 and ATCC 25922), Klebsiella pneumoniae (ATCC 13883 and ATCC 27736), Pseudomonas aeruginosa (ATCC 15442 and ATCC 27853), Serratia marcescens (ATCC 8100 and ATCC 14756), Campylobacter jejuni (ATCC 33291 and ATCC 49943), Salmonella enterica Serovar Enteritidis (ATCC 13076) and Serovar Typhimurium (ATCC 14028), where Serovar refers to the subspecies classification of a group of microorganisms based on cell surface antigens, Shigella sonnei (ATCC 9290 and ATCC 25931), Gram-positive organisms such as Enterococcus faecalis (ATCC 19433 and ATCC 29212), Staphylococcus aureus (ATCC 6538 and ATCC 29213) and methicillin-resistant Staphylococcus aureus (ATCC 33591 and ATCC 33592), Streptococcus pyogenes (ATCC 14289 and ATCC 19615), Listeria monocytogenes (ATCC 7644 and ATCC 19115), and Streptococcus pneumoniae (ATCC 6303 and ATCC 49619).

Gram Positive Bacteria

[0089] Bacillus sp. (vegetative cell), Corynebacterium diptheriae, Clostridium difficile, Enterococcus faecalis, Enterococcus hirae, Listeria monocytogenes, Micrococcus luteus, Micrococcus sp., Mycobacterium tuberculosis, Mycobacterium smegmatis, Propionibacterium acnes, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus haemolyticus, Staphylococus hominis, Staphylococcus saprophyticus, Streptococcus faecalis, Streptococcus mutans, Streptococcus pneumonia and Streptococcus pyogenes.

Gram Negative Bacteria

[0090] Acinetobacter baumannii, Acinetobacter calcoaceticus, Aeromonas hydrophilia, Bacterioides fragilis, Burkholderia cepacia Citrobacter deversus, Citrobacter freundi, Enterobacter aerogenes, Enterobacter aglomerans, Enterobacter cloacae, Enterobacter gergoviae, Enterococcus, Escherichia coli, Escherichia coli 0157:H7, Eupenicillium levitum, Haemophilus influenza, Klebsiella oxytoca, Klebsiella pneumoniae, Klebsiella terriena, Legionella pneumophila, Morganella morganii, Penicillium luteum, Proteus mirabilis, Proteus vulgaris, Pseudomonas aeruginosa, Pseudomonas fluorscens, Salmonella cholera suis, Salmonella typhi, Salmonella typhimurium, Salmonella enterica, Serratia liquifaciens, Serratia marcescens and Xanthomonas campestris.

Viruses

[0091] Adenovirus Type II & IV, Bovine Adenovirus Type I & IV, Murine Norovirus 1, Feline pneumonitis, Herpes Simplex Type I, Herpes Simplex Type II, HIV-1 (AIDS), Middle Eastern Respiratory Syndrome Virus (MERS), Influenza A2 (Aichi), Influenza A2 (Asian), Influenza B, Influenza (H1N1), Mumps, Parinfluenza (Sendai), Rous Sarcoma, Reovirus Type I, Simian Virus 40, Vaccinia, MS2 (bacteriophage), PRD1 (bacteriophage), Rhinoviruses and Enterovirus 71.

Fungi, Algae, Mould, Yeast, Spores

[0092] Alterania alternata, Aphanizomenon sp., Aspergillus flavus, Aspergillus niger, Aspergillus sydowii, Aspergillus terreus, Aspergillus versicolor, Aspergillus verrucaria, Aureobasidium pullans, Candida albicans, Candida pseudotropocalis, Chaetomium globsum, Cladosporium cladosporioides, Chlorella vulgaris, Dreschslera australiensis, Epidermophyton sp., Epidermophyton floccosum, Gliomastix cerealis, Gloeophyllum trabeum, Microsporum sp., Microsporum audouinii, Monilia grisea, Oscillatoria, Penicillium chrysogenum, Pencillium commune, Penicillium funiculosum, Penicillium pinophilium, Penicillium variable, Phoma fimeti, Pithomyces chartarum, Poria placenta, Scenedesmus, Saccharonyces cerevisiae, Scolecobasidium humicola, Selenastrum sp., Trichoderma viride, Trichophyton interdigitale, Trichophyton maidson, Trichophyton mentogrophytes, Trichophyton rubrum and Trichophyton sp.

Protozoa Parasites

[0093] Cryptosporidium parvum (oocysts).

[0094] The following examples are intended to demonstrate the usefulness of preferred embodiments of the present invention and should not be considered to limit its scope or applicability in any way.

Example 1

[0095] My ShieldUnscented Antimicrobial Liquid Formulations with Aloe Vera

[0096] Several formulations were compounded as prepared with the following components as shown in Table 1 below:

TABLE-US-00001 TABLE 1 Formula Formula Formula Formula Formula No. 1 No. 2 No. 3 No. 4 No. 5 CHEMICAL Wt % Wt % Wt % Wt % Wt % DI Water 94.91 94.66 93.919 94.66 94.659 ODTMSPC.sup.1 2.2 2.2 2.2 ODTHSPCP.sup.2 0.01 0.01 0.01 0.01 0.01 ODTESPC.sup.3 2.2 2.2 PHMBG.sup.4 1.3 1.3 1.3 1.3 1.3 Silk Protein 0.01 0.01 0.01 0.01 Caprylyl Glucosicde 0.75 1.0 1.5 1.0 1.0 Laureth-4 0.50 0.50 0.75 0.5 0.5 C.sub.12/C.sub.15 Pareth12 Bzk Usp Nf 50% 0.26 0.26 0.26 0.26 0.26 Lauramine 0.001 Citric Acid Aloe Vera B Le.sup.5 0.05 0.05 0.05 0.05 0.05 Vit E Acetate Hyaluronic Acid 0.001 Phenoxyethanol 0.01 0.01 0.01 Methyl Paraben 0.01 0.01 Fragrance Blue No 1 .sup.11-Octadecanaminium, N,N, Dimethyl-N-[(3-trimethoxysilyl) propyl] chloride = ODTMSPC .sup.21-Octadecanaminium, N,N, Dimethyl-N-[(3-trihydroxysilyl) propyl] chloride polymer = ODTHSPCP .sup.31-Octadecanaminium, N,N, Dimethyl-N-[(3-triethoxysilyl) propyl] chloride = ODTESPC .sup.4Polymeric biguanide HCL .sup.5Aloe Barbadensis Leaf Extract

[0097] Several formulations were blended into DI water at 50 C with high shear mixing technology. As part A, the 1-Octadecanaminium, N, N, Dimethyl-N-[(3-trihydroxysilyl) propyl] chloride polymer (ODTHSPCP) was mixed into 85 C. DI water by itself under high shear mixing to dissolve the polymer prior to the Part B of other ingredients.

Part B: The addition of >2.2 wt % (>1.5 wt % active) 1-Octadecanaminium, N, N, Dimethyl-N-[(3-trimethoxysilyl) propyl] chloride (ODTMSPC) and 1-Octadecanaminium, N, N, Dimethyl-N-[(3-triethoxysilyl) propyl] chloride (ODTESPC) are added to 50 C. DI water with high shear mixing to dissolve and then requires additions of various surfactants for stable emulsions/dispersions. Compositions were subjected to hand feel and testing.

Example 2

[0098] My Shield-Unscented Antimicrobial Liquid or Foam Formulation with Aloe Vera

[0099] Several formulations were compounded as prepared with the following components:

[0100] Table 2 below show the formulations of Example 2.

TABLE-US-00002 TABLE 2 Formula Formula Formula Formula Formula No. 1 No. 2 No. 3 No. 4 No. 5 Chemical Wt % Wt % Wt % Wt % Wt % DI Water 94.938 94.688 94.677 94.673 93.868 ODTMSPC.sup.1 ODTHSPCP.sup.2 0.001 0.001 ODTESPC.sup.3 2.2 2.2 2.2 2.2 3.0 PHMBG.sup.4 1.3 1.3 1.3 1.3 1.3 Silk Protein 0.001 0.001 0.001 0.001 0.001 Caprylyl Glucosicde 1.0 1.0 1.0 1.0 1.0 Laureth-4 Polyol 4290 0.25 0.50 0.50 0.50 0.50 Bzk Usp Nf 50% 0.26 0.26 0.26 0.26 0.26 Lauramine 0.001 0.001 0.01 Citric Acid Aloe Vera B Le.sup.5 0.05 0.05 0.05 0.05 0.05 Vit E Acetate 0.001 Hyaluronic Acid 0.005 Phenoxyethanol 0.01 0.01 0.01 0.01 0.01 Methyl Paraben Clay 0.001 Blue No 1 .sup.11-Octadecanaminium, N,N, Dimethyl-N-[(3-trimethoxysilyl) propyl] chloride = ODTMSPC .sup.21-Octadecanaminium, N,N, Dimethyl-N-[(3-trihydroxysilyl) propyl] chloride polymer = ODTHSPCP .sup.31-Octadecanaminium, N,N, Dimethyl-N-[(3-triethoxysilyl) propyl] chloride = ODTESPC .sup.4Polymeric biguanide HCl = PHMBG .sup.5Aloe Barbadensis Leaf Extract

[0101] Several formulations were blended into DI water at 50 C. with high shear mixing technology. As part A, the 1-Octadecanaminium, N, N, Dimethyl-N-[(3-trihydroxysilyl) propyl] chloride polymer (ODTHSPCP) was mixed into 85 C. DI water by itself under high shear mixing to dissolve the polymer prior to the Part B of other ingredients.

Part B: The addition of >2.2 wt % (>1.5 wt % active) 1-Octadecanaminium, N, N, Dimethyl-N-[(3-trimethoxysilyl) propyl] chloride (ODTMSPC) and 1-Octadecanaminium, N, N, Dimethyl-N-[(3-triethoxysilyl) propyl] chloride (ODTESPC) are added to 50 C DI water with high shear mixing to dissolve and then requires additions of various surfactants for stable emulsions/dispersions. Compositions were subjected to hand feel and microbial laboratory testing.

Example 3

[0102] My shieldUnscented Antimicrobial Gel Formulation with Aloe Vera

[0103] Several formulations as shown in Table 3 were compounded as prepared with the following components:

TABLE-US-00003 TABLE 3 Formula Formula Formula Formula Formula No. 1 No. 2 No. 3 No. 4 No. 5 CHEMICAL Wt % Wt % Wt % Wt % Wt % DI Water 95.179 94.679 94.179 94.129 94.129 Hydroxyethylcellulose 0.5 1.0 1.50 1.55 1.55 ODTMSPC.sup.1 2.2 2.2 2.2 2.2 ODTHSPCP.sup.2 ODTESPC.sup.3 2.2 PHMBG.sup.4 1.3 1.3 1.3 1.3 1.3 Silk Protein 0.001 0.001 0.001 0.001 0.001 Caprylyl Glucosicde 0.3 0.3 0.3 0.3 0.3 Laureth-4 0.2 0.2 0.2 0.2 0.2 C.sub.12/C.sub.15 Pareth12 Bzk Usp Nf 50% 0.26 0.26 0.26 0.26 0.26 Polyol 4290 Lauramine Citric Acid Aloe Barbadensis Le.sup.5 0.05 0.05 0.05 0.05 0.05 Vit E Acetate Hyaluronic Acid Phenoxyethanol 0.010 0.01 0.01 0.01 Methyl Paraben 0.01 Fragrance Blue No. 1 .sup.1Ex1-Octadecanaminium, N,N, Dimethyl-N-[(3-trimethoxysilyl) propyl] chloride = ODTMSPC .sup.21-Octadecanaminium, N,N, Dimethyl-N-[(3-trihydroxysilyl) propyl] chloride polymer = ODTHSPCP .sup.31-Octadecanaminium, N,N, Dimethyl-N-[(3-triethoxysilyl) propyl] chloride = ODTESPC .sup.4Polymeric biguanide HCL = PHMBG .sup.5Aloe Barbadensis Leaf Extract

[0104] Several formulations were blended into DI water at 50 C. with high shear mixing technology.

[0105] As part A, the Hydroxyethyl cellulose was mixed into 85 C. DI water by itself under high shear mixing to dissolve the gel prior to the Part B of other ingredients.

Part B: The addition of >2.2 wt % (>1.5 wt % active) 1-Octadecanaminium, N, N, Dimethyl-N-[(3-trimethoxysilyl) propyl] chloride (ODTMSPC) and 1-Octadecanaminium, N, N, Dimethyl-N-[(3-triethoxysilyl) propyl] chloride (ODTESPC) are added to 50 C. DI water with high shear mixing to dissolve and then requires additions of various surfactants for stable emulsions/dispersions. Part A was added to Part B with the components already mixed by a special reactor with side sweep agitation, circulation pump and high shear rotor stator agitator at 50 C. Compositions were subjected to hand feel and microbial laboratory testing.

Example 4

[0106] My Shield-Scented Antimicrobial Liquid or Foam Formulation with Aloe Vera

[0107] Several formulations were compounded as prepared with the following components as shown in Table 4 below:

TABLE-US-00004 TABLE 4 Formula Formula Formula Formula Formula No. 1 No. 2 No. 3 No. 4 No. 5 Chemical Wt % Wt % Wt % Wt % Wt % DI Water 95.117 95.117 94.668 95.118 93.869 ODTMSPC.sup.1 ODTHSPCP.sup.2 0.001 0.001 0.001 0.001 ODTESPC.sup.3 2.2 2.2 2.2 2.2 3.0 PHMBG.sup.4 1.3 1.3 1.3 1.3 1.3 Silk Protein 0.001 0.001 0.001 0.001 0.001 Caprylyl Glucosicde 0.5 0.5 1.0 0.05 1.0 Laureth-4 Polyol 4290.sup.6 1.0 1.0 0.5 1.0 0.5 Bzk Usp Nf 50% 0.26 0.26 0.26 0.26 0.26 Lauramine 0.001 Citric Acid Aloe Vera B Le.sup.3 0.05 0.05 0.05 0.05 0.05 Vit E Acetate 0.001 Hyaluronic Acid Phenoxyethanol 0.01 0.01 0.01 0.01 0.01 Tea Tree Oil 0.01 0.01 0.01 Lemon Eucalyptus 0.01 0.01 .sup.11-Octadecanaminium, N,N, Dimethyl-N-[(3-trimethoxysilyl) propyl] chloride = ODTMSPC .sup.21-Octadecanaminium, N,N, Dimethyl-N-[(3-trihydroxysilyl) propyl] chloride polymer = ODTHSPCP .sup.31-Octadecanaminium, N,N, Dimethyl-N-[(3-triethoxysilyl) propyl] chloride = ODTESPC .sup.4Polymeric biguanide HCL = PHMBG .sup.5Aloe Barbadensis Leaf Extract .sup.6POLYOL 4290 = Pentaerythritol Ethoxylate

[0108] Several formulations were blended into DI water at 50 C. with high shear mixing technology. As part A, the 1-Octadecanaminium, N, N, Dimethyl-N-[(3-trihydroxysilyl) propyl] chloride polymer (ODTHSPCP) was mixed into 85 C. DI water by itself under high shear mixing to dissolve the polymer prior to the Part B of other ingredients.

Part B: The addition of >2.2 wt % (>1.5 wt % active) 1-Octadecanaminium, N, N, Dimethyl-N-[(3-trimethoxysilyl) propyl] chloride (ODTMSPC) and 1-Octadecanaminium, N, N, Dimethyl-N-[(3-triethoxysilyl) propyl] chloride (ODTESPC) are added to 50 C. DI water with high shear mixing to dissolve and then requires additions of various surfactants for stable emulsions/dispersions. Compositions were subjected to hand feel and microbial laboratory testing.

Example 5

My Shield Sanitizing Bath Wipe, Hand Wipe, PreOp Wipe Formulation, Construction and Fabrication

[0109] In several test runs at American Flexpack, Green Bay Wis., using Sontara Style 8005 Non-woven Polyester Fabric 67 gms/m.sup.2 with wet pick up of 670%, wipes of two sizes were made to include 38.1 cm30 cm and 20 cm20 cm.

[0110] A test for various liquid wet pickup targets and hand feel is listed in Table 5.

TABLE-US-00005 TABLE 5 WIPE DIMENSIONS CM LIQUID AMOUNT GM HAND FEEL 38.1 30 100 GM PASS 38.1 30 50 GM PASS 38.1 30 20 GM PASS .sup.20 20 30 GM PASS .sup.20 20 20 GM PASS .sup.20 20 12 GM PASS

[0111] The wipes were packaged in Sterilized Polypropylene micro waivable film packet.

Example 6

My Shield Foam Formula No. 4 of Example 1 Table 1

[0112] Technical Standard for Disinfection (2002 Ministry of Health P.R. China)-2.1.1.7.4 Suspension Quantitative Germicidal Test by Guangdong Detection Center of Microbiology.

TABLE-US-00006 TABLE 6 CFU of CFU in Sample Test bacteria CFU Average test and time Tested organism number control in control sample Log kill Kill rate % My-shield E coli 1 3.0 10.sup.7 3.3 10.sup.7 <10 >5.00 >99.999 Formula ATCC 8099 Ex 1 E coli 2 3.3 10.sup.7 <10 >5.00 >99.999 At 10 min ATCC 8099 E coli 3 3.5 10.sup.7 <10 >5.00 >99.999 ATCC 8099 My shield Staphylococcus 1 4.2 10.sup.7 4.2 10.sup.7 <10 >5.00 >99.999 Formula aureus ATCC of Ex 1 6538 At 10 min Staphylococcus 2 3.9 10.sup.7 <10 >5.00 >99.999 aureus ATCC 6538 Staphylococcus 3 4.5 10.sup.7 <10 >5.00 >99.999 aureus ATCC 6538 Conclusion: All of the test results can meet the standards and the neutralizer being tested was qualified.

Example 7

My Shield Gel Formula Table 3 Formula No. 1

[0113] Technical Standard for Disinfection (2002 Ministry of Health P.R. China)-2.1.1.7.4 Suspension Quantitative Germicidal Test by Guangdong Detection Center of Microbiology.

TABLE-US-00007 TABLE 7 CFU of CFU in Sample Test bacteria CFU Average test and time Tested organism number control in control sample Log kill Kill rate % My-shield E coli 1 3.0 10.sup.7 3.4 10.sup.7 <10 >5.00 >99.999 Formula ATCC 8099 Ex 1 E coli 2 3.3 10.sup.7 <10 >5.00 >99.999 At 10 min ATCC 8099 E coli 3 3.6 10.sup.7 <10 >5.00 >99.999 ATCC 8099 My shield Staphylococcus 1 4.2 10.sup.7 4.3 10.sup.7 <10 >5.00 >99.999 Formula aureus ATCC of Ex 1 6538 At 10 min Staphylococcus 2 4.0 10.sup.7 <10 >5.00 >99.999 aureus ATCC 6538 Staphylococcus 3 4.5 10.sup.7 <10 >5.00 >99.999 aureus ATCC 6538 Conclusion: All of the test results can meet the standards and the neutralizer being tested was qualified.

Example 8

My Shield Gel Formula of Table 3 Formula No. 1

[0114] Assessment of Antimicrobial Activity Using a Time Kill Procedure ASTM E2315-16 Against Burkholderia cepacia ATCC 25416

TABLE-US-00008 TABLE 8 Exposure Test CFU/mL Log % Lab No Sample ID Lot # time samples CFU/ml average Reduction Reduction Control 0 min 1 1.10 10.sup.8 1.06 10.sup.8 2 1.02 10.sup.8 129332 My Shield 38L17 2 min 1 6.2 10.sup.6 6.4 10.sup.6 1.22 93.96 Hand Ex Jan 2 6.6 10.sup.6 Sanitizer 09/19 5 min 1 2.8 10.sup.6 3.4 10.sup.6 1.49 96.79 2 4.0 10.sup.6 10 min 1 4.4 10.sup.4 4.8 10.sup.4 3.34 99.95 2 5.2 10.sup.4 Conclusion: Hand Sanitizer Lot 38L17 showed 93.96% anti-microbial activity against B cepacia at 2 min, 96.79% at 5 min. and 99.95% at 10 min, contact time against Burkholderia cepacia ATCC 25416.

Example 9

My Shield Topical Antiseptic Formula of Table 3 Formula No 1

[0115] Assessment of Antimicrobial Activity Using a Time Kill Procedure ASTM E2315-16 Against Burkholderia cepacia ATCC 25416

TABLE-US-00009 TABLE 9 Sample Exposure CFU/ml % Lab No ID Lot # time Reps CFU/ml average Log Kill Reduction control 0 hours 1 4.4 10.sup.8 4.8 10.sup.8 2 5.2 10.sup.8 128906 Myshield 09K17 15 sec 1 8.8 10.sup.6 8.5 10.sup.6 1.75 98.23 Topical 2 8.2 10.sup.6 Anti 30 sec 1 6.0 10.sup.6 5.9 10.sup.6 1.91 98.77 Septic 2 5.8 10.sup.6 60 sec 1 3.5 10.sup.6 4.0 10.sup.6 2.08 99.16 2 4.5 10.sup.6 Conclusion: My Shield Topical Antiseptic Lot 09K17 showed 98.23% anti-microbial activity against B cepacia at 15 seconds of contact time, 98.77% at 30 seconds and 99.16% at 60 seconds.

Example 10

My Shield Topical Antiseptic Formula Table 3 Formula No. 1 ASTM E2197-11

[0116] Evaluation for Clostridium difficile spores ATCC 43598

TABLE-US-00010 TABLE 10 Mean Log.sub.10 Density of Control Carrier 7.2M CFU/membrane Log.sub.10 Mean Log.sub.10 Mean Log.sub.10 Carrier no Post Exposure CFU/Carrier Density MT Reduction 1 >200 >2.3010 >2.3010 <4.9237 2 >200 >2.3010 3 >200 >2.3010 4 >200 >2.3010 5 >200 >2.3010

Test Substance Preparation: Ready to use

[0117] Test Organism: Clostridium difficilespore form (ATCC 43598)
Exposure temperature: Room temperature (21 C.)
Exposure time: 10 minutes
# of carriers tested: 5 test carriers and 3 control carriers
Soil Load: No soil load required
Test Carrier plating: Entire contents of 10.sup.0 (vial) only.

Neutralizer: PBS 4+0.14% Lecithin+1.0% Tweet 80

Carrier Quantitation Control:

[0118] 2.4510.sup.6 (6.39 Log.sub.10) CFU/carrier (PASS)

Test Results:

[0119] Average survivors: >2.0010.sup.2 (>2.30 Log.sub.10) CFU/carrier

=<99.998% (<4.9237 Log.SUB.10.) Reduction

Example 11

Film Thickness of ODTMSPC

[0120] Test on thickness of skin scaffold of monomer 1-Octadecanaminium N, N Dimethyl [(3-trimethoxysilyl)propyl]chloride with Dual Polarization Interferometry

TABLE-US-00011 TABLE 11 TIME POST THICKNESS REFRACTIVE MASS INJECTION nm INDEX ngmm.sup.2 40 seconds 41.31 1.3496 3.83 10 minutes 33.51 1.3534 3.76

Example 12

Film Thickness of ODTMSPCP

[0121] Film thickness of skin scaffold of polymer 1-Octadecanaminium NN Dimethyl (3 Trihydroxysilyl)propyl chloride polymer with Dual Polarization interferometry.

TABLE-US-00012 TABLE 12 TIME POST THICKNESS REFRACTIVE MASS INJECTION nm INDEX ngmm.sup.2 40 seconds 1.85 1.4612 1.341 10 minutes 0.84 1.4891 0.683

Example 13

Bacillus Spore Effects of Hand Sanitizer Addition in Plate

[0122] In this experiment live Bacillus spores in a plate too many to count (TMTC) were photographed by a Zeiss microscope as shown in FIG. 1. The plate in FIG. 2 had the addition of my Shield Hand Sanitizer Foam Table 1 Formula No. 2 added to the plate 20 ml. The cationic formulation agglomerated the spores into groupings. In FIG. 3 the Hand Sanitizer dried and film formed over the spores encapsulating the spores.

Example 14

[0123] Efficacy of Rub on Middle Eastern Respiratory Syndrome (MERS) Surrogate Virus on Human Skin. Hand Sanitizer Table 1 Formula No 2

[0124] Arizona State University Test on humans (skin) with hand rub against MERS 3 ml of hand sanitizer rubbed on hands, dried and tested after 5 minutes residence time.

[0125] Results: my-shield Hand Sanitizer was able to achieve a >99.9% (>3.19 log 10) reduction. All replicates in the presence my-shield Hand Sanitizer Foam were below the limit of detection for the assay suggesting that greater reductions are achievable. Results are shown in Table 13.

TABLE-US-00013 TABLE 13 My-shield Hand Sanitizer Test Using Four Human Subjects Against Feline Infectious Peritonitis Virus (FIPV) PRE POST EXPOSURE EXPOSURE LOG 10 PERCENT SAMPLE VIRAL TITER VIRAL TITER REDUC- REDUC- ID LOG 10/ML LOG 10 PER mL TION TION Human 6.0 <2.50 >3.50 99.97% Subject 1 Human 5.75 <2.50 >3.25 99.94% Subject 2 Human 5 <2.50 >2.50 99.7% Subject 3 Human 5 <2.50 >3.50 99.97% Subject 4 Average 6 <2.50 >3.19 99.9% Conclusions: Detection Limit = 2.50 log10 per ml my-shield Hand Sanitizer Foam is effective at reducing feline infectious peritonitis

[0126] The contents of all references cited in the instant specifications and all cited references in each of those references are incorporated in their entirety by reference herein as if those references were denoted in the text.

[0127] While the many embodiments of the invention have been disclosed above and include presently preferred embodiments, many other embodiments and variations are possible within the scope of the present disclosure and in the appended claims that follow. Accordingly, the details of the preferred embodiments and examples provided are not to be construed as limiting. It is to be understood that the terms used herein are merely descriptive rather than limiting and that various changes, numerous equivalents may be made without departing from the spirit or scope of the claimed invention.