NZ600568B - Topical formulations for the prevention of sexually transmitted disease and methods of producing the same - Google Patents

Abstract

600568 Disclosed is an oil-in-water formulation for the inhibition of the transmission of sexually transmitted diseases, characterized by enhanced skin protective properties consisting of in combination: (1) a skin protectant composition selected from the group consisting of allantoin, aluminum hydroxide gel, calamine, cocoa butter, cod liver oil, colloidal oatmeal, hard fat, kaolin, mineral oil, petrolatum, topical starch, white petrolatum, zinc acetate, zinc carbonate, zinc oxide, and mixtures thereof, provided in a skin protecting effective concentration; (2) a silicone-based skin protectant composition containing at least one silicone-containing excipient provided in a skin protecting effective concentration; (3) a humectant-excipient, selected from the group consisting of glycerine, anhydrous lanolin and combinations thereof, in the range of about 0.5 to 15.0 % wt/wt; (4) a non-ionic emulsifier selected from the group consisting of cetearyl alcohol, ceteareth-12, ceteareth-20 and mixtures thereof, in the range from about 0.5 to 15.0 % w/w; (5) a chelating compound in the range from about 0.1 to 0.01 % w/w; (6) a film-forming emollient in the range from about 1.0 to 10.0% w/w; and (7) water; wherein contact with the skin results in the in situ formation of a skin protective barrier layer effective in inhibiting the transmission of sexually transmitted diseases. ydroxide gel, calamine, cocoa butter, cod liver oil, colloidal oatmeal, hard fat, kaolin, mineral oil, petrolatum, topical starch, white petrolatum, zinc acetate, zinc carbonate, zinc oxide, and mixtures thereof, provided in a skin protecting effective concentration; (2) a silicone-based skin protectant composition containing at least one silicone-containing excipient provided in a skin protecting effective concentration; (3) a humectant-excipient, selected from the group consisting of glycerine, anhydrous lanolin and combinations thereof, in the range of about 0.5 to 15.0 % wt/wt; (4) a non-ionic emulsifier selected from the group consisting of cetearyl alcohol, ceteareth-12, ceteareth-20 and mixtures thereof, in the range from about 0.5 to 15.0 % w/w; (5) a chelating compound in the range from about 0.1 to 0.01 % w/w; (6) a film-forming emollient in the range from about 1.0 to 10.0% w/w; and (7) water; wherein contact with the skin results in the in situ formation of a skin protective barrier layer effective in inhibiting the transmission of sexually transmitted diseases.

Description

Patents Form # 5 PATENT OF ADDITION OUT OF PATENT APPLICATION # 588195 NEW ZEALAND Patents Act 1953 COMPLETE SPECIFICATION Title TOPICAL ATIONS FOR THEPREVENTION OFSEXUALLY TRANSMITTED DISEASEAND METHODS OFPRODUCING THE SAME We, CLJI CORPORATION Address: 550 Northlake Boulevard, North Palm Beach, Florida, United States of America, 33408 Nationality A body corporate organized and existing under the laws of : a do hereby declare the invention for which we pray that a patent may be granted to us and the method by which it is to be performed, to be particularly described in and by the following ent : _ 1 _ 401786NZB_PatofAdd~20120611_1152_EMM.doc FEE CODE — 1010 TOPICAL FORMULATIONS FOR THE PREVENTION OF SEXUALLY TRANSMITTED DISEASE AND S OF PRODUCING THE SAME CROSS REFERENCE TO RELATED APPLICATION This is a patent of addition to the invention claimed in the main patent, NZ patent 588195.

The modification or improvement, the subject of this application, relates to topical formulations r to those found in NZ 588195 except that the quaternary ammonium component has been eliminated.

The Inventors found surprisingly that formulations without the quaternary ammonium component maintained their efficacy without any deleterious effects, and with surate s in production costs.

FIELD OF THE INVENTION This invention relates to l protective formulations for use in the prevention of the spread of sexually transmitted diseases (STDs); and particularly to unique l formulations including a plurality of film g excipients, which act in concert to provide a barrier to help inhibit the transmission of STDs.

BACKGROUND OF THE INVENTION Sexually transmitted diseases (STDs) are a universal concern, effecting millions of individuals and straining health care systems. More than 20 different sexually transmitted diseases have been identified by the l community and generally fall into two , including bacterial types (e.g., gonorrhea, chlamydia and syphilis) and viral types (human immunodeficiency' virus (HIV), human. papilloma virus (HPV) and hepatitis). The numerous diseases affect men, women and children of all backgrounds, races and economic classifications.

Despite years of research and educational programs, the transmission (If sexually transmitted diseases s ea global health threat. Although specific s of transmission may vary depending on the disease—causing organism, STDs are usually transmitted to the uninfected person through injured or exposed skin or mucous membranes during sexual contact.

Treatments may" be available for some types of STDs (e.g. antibiotic treatment for gonorrhea or chlamydia).

However, most people who suffer from these types of STDs are unaware that they have the disease and ore do not get the necessary treatment. Moreover, because of the sociological impact and generally negative stigma associated with these diseases, people are reluctant to seek such. treatments. The continued emphasis on educating the population as to the use of “mechanical barriers” such as condoms has helped to decrease the ity of most STDs but more tative methods need to be developed to prevent STD transmission.

Chemical actives such as microbicides, antimicrobials, and spermicides, most notably, nonylphenoxypoly(ethyleneoxy)— ethanol (also referred to as nonoxynol—9) have been used in topical ations to effectively reduce the rate of STD transmission, especially when used in conjunction with prophylactics. r, many of these chemical actives are harsh and have been shown to induce local irritation, inflammation, and ulcerations, which might actually favor the transmission of STDs. Thus, a need exists for topical formulations that do not cause irritation and will help inhibit the spread of STDs, especially when used in combination with condoms, and thereby e an additional degree of protection from contamination, should the condom become damaged.

PRIOR ART Although there are numerous patents and publications directed to ations containing chemical actives, such as, microbicides, antimicrobials, spermicides, and drug delivery carriers (liposomes, micelles), none of the known prior art teach formulations comprising non—irritating agents that provide a physical barrier to the tion of pathogens.

U.S. Patent ation 2003/0143189 A1 to Askill et al., is directed to a method of treating skin lesions by forming a polymeric film over the s to inhibit proliferation of infectious agents in the lesions. These compositions also include one or more al agents in combination therewith.

U.S. Patent 6,835,717 to Hildreth discloses a method of reducing the risk of a sexually transmitted en by ting a pathogen within the composition which consists of B—cyclodextrin° U.S. Patent No. 6,821,958 to Hershline discloses a method. of preventing 'viral transmission. using an alkylsulfate tive of sulfated dextrin as a topical formulation.

U.S. Patent 6,582,711 to Asmus et al., discloses an antimicrobial hydroalcoholic composition having a cationic polymeric thickener.

U.S. Patent No. 6,355,235 to Cone et al., ts of an antibody capable of trapping sperm and a pharmaceutical carrier.

U.S. Patent No. 6,328,991 to Myhling discloses a chemical composition to prevent the transmission of sexually transmitted diseases comprising nonylphenoxpoly—(ethyleneoxy)— ethanol, benzalkonium chloride and povidone iodine.

U.S. Patent 5,439,685 to Augros is a composition of an agent active against microorganisms responsible for sexually itted es together with a film—forming agent such as dimethylpolysiloxane, and benzalkonium chloride as a spermicidal.

U.S. Patent 4,952,411 to Fox, Jr. et al., is a composition of silver sulfadiazine, alone or in combination with chlorhexidine or sodium deoxycholate (antimicrobial and detergent).

SUMMARY OF THE INVENTION The purpose of this invention is to provide non— irritating protective formulations to be used as an t in ting the spread of a broad range of sexually transmitted diseases.The products of the present invention can be formulated as a topical lotion, cream, on, emulsion, or the like, and will be hereinafter referred to as creams. ant's previous patent demonstrated that the use of antimicrobial/antiviral active agents in conjunction with film—forming excipients in the following formulations possessed unique skin protective barrier properties with enhanced persistence that inhibit “skin to skin” and “sore to sore” transmission. of pathogens (e.g., viruses, bacteria, fungi, parasites, ectoparasites and mycoplasmas) linked to icable diseases. ants have now discovered. that equivalent skin protective barrier properties, with enhanced persistence, which are also effective in providing the inhibition of “skin to skin” and. “sore to sore” transmission of pathogens (e.g., s, bacteria, fungi, parasites, ectoparasites and mycoplasmas) linked to communicable diseases, can be realized in the absence of an antimicrobial/antiviral agent.

Skin protectant products are regulated under CFR 21 Part 347 “Skin Protectant Drug Products for Over the Counter Human Use”. The official description of a skin tant is “a drug product that temporarily protects injured or d skin or nmcous membrane surfaces from harmful or annoying stimuli, and may help provide relief to such surfaces." These regulations cover applicable ingredients, as well as labeling requirements for over the counter skin protectants. Active ingredients ally classified as skin protectants compositions as well as certain combinations of these compositions are listed in the CFR 21 Sec. 347.10, reproduced in Table 1 below. In accordance with the instant invention, the phrase “a skin protectant composition provided in a skin protecting ive concentration” will be understood to mean any of the following ingredients within their ated range of concentrations: TABLE 1 These include any of the following within the concentration range ied: Ingredient Concentration Allantoin 0.5 to 2.0 % Aluminum hydroxide gel 0.15 to 5.0% Calamine 1.0 to 25.0 % Cocoa Butter 50.0 to 100.0% Cod liver oil 5.0 to 13.56 %(in accordance with Sec. 347.20(a)(l) or (a)(2), provided the t is labeled so that the quantity used in a 24-hr period does not exceed ,000 USP Units n A and 400 USP Units cholecalciferol.

Colloidal oatmeal 0.007 minimum; 0.003 minimum in combination with mineral oil in accordance with Sec. 347.20(a) (4) .

Dimethicone 1.0 to 30.0% Glycerin 20.0 to 45.0% Hard fat 50.0 to 100.0% Kaolin 4.0 to 20.0% I—Lanolin 12.5 to 50.0% Mineral Oil 50.0 to 100.0%; 30.0 to 35.0% in combination. with. colloidal oatmeal in accordance with Sec. 347.20(a)(4). atum 30.0 to 100.0% Topical starch 10.0 to 98.0% White petrolatum 30.0 to 100.0% Zinc acetate 0.1 to 2.0% Zinc carbonate 0.2 to 2.0% Zinc oxide 1.0 to 25.0% It has been discovered that incorporation of at least one of the aforementioned skin protectants compositions listed in Table 1 in combination with other film forming excipients, in particular, film—forming emollients (e.g., earyl alcohol, Cetyl alcohol), silicone—containing excipients/skin protectants (e.g , polydimethylsiloxane derivatives of varying viscosities, utilized either singly‘ or in combination, and. marketed. under names such as Dimethicone 20 and Dimethicone , fying agents (e.g. ed from Cetearyl alcohol (a mixture of fatty alcohols, predominantly l and cetyl alcohols, yethylene ethers of a mixture of high molecular mass saturated fatty acids (mainly cetyl alcohol and stearyl alcohol, having a number of ne oxide es in the polyoxyethylene chain, e.g. 20, 12 or the like, and referred to as Ceteareth—20, Ceteareth—12, or the like, and/or mixtures thereof), humectants (e.g. glycerin and anhydrous lanolin) and chelating compounds(e.g. disodium edetate) in a formulation for topical application results in a product that temporarily protects injured or exposed skin. or mucous membrane es from harmful or annoying stimuli, thereby preventing cross— contamination of pathogenic microorganisms responsible for sexually transmitted diseases (e.g., Herpes simplex virus type 1 and type 2 (HSV~1, HSV-Z), human immunodeficiency virus (HIV), or the like) through skin or mucous ne surfaces. The novel formulation. products of this invention. are persistent in that they form a film or barrier on healthy or even damaged skin.

The hydrophobic portions of the instant formulations utilize a combination of film—forming excipients, including skin protectant(s) listed in Table l, silicones and silicone derivatives or like lents, and film—forming emollients.

The emulsifiers throughout the continuous aqueous phase disperse these ingredients. They liquefy and spread over the skin as a result of exposure to body heat. This forms a physical hydrophobic layer, which resides on the skin surface (including mucosal membranes) and provides a barrier, which would inhibit penetration of liquids, and pathogens that are ily hydrophilic in nature. When used in combination with consistent and careful use of condoms, the products of the present invention help inhibit the spread of STDs and protect the skin from contamination should the condom become damaged.

Accordingly, it is an ive of the instant invention to teach various l tive formulations to be used in preventing the spread of a broad range of sexually transmitted diseases.

Another objective of the present invention is to teach formulations which are condom compatible, meaning that they are latex friendly and provide ive lubricity.

It is yet another objective of the instant invention to teach skin protective formulations wherein contact with the skin results in the ion of a hydrophobic skin protective surface layer.

It is yet another objective of the instant invention to teach skin protective formulations wherein contact with the skin results in the formation of a ical barrier skin protective surface layer.

Yet another objective of the invention. is to teach products formulated as a lotion, cream, solution, emulsion, or other topically d product Other objects and advantages of this invention will become apparent from the following description, wherein are set forth, by way of illustration and example, n embodiments of this invention.

DETAILED PTION OF THE INVENTION Detailed embodiments of the instant invention are sed herein, however, it is to be understood that the disclosed embodiments are merely exemplary of the invention, which may be ed in various forms. Therefore, specific functional and structural details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representation basis for teaching one d in the art to variously employ the present invention in virtually any appropriately detailed structure, Zinc oxide is an inert, non—toxic chemical compound with the chemical formula of ZnO. Zinc Oxide can be used as a skin barrier. When applied. to skin, Zinc Oxide acts as a ical barrier that physically excludes isolates and prevents the skin from any contact with harmful stimuli. Zinc Oxide is often used in creams or lotions and provides a continuous barrier, which also helps prevent the loss of active ingredients due to on and rubbing. e of its inert, non—toxic characteristics and general non—solubility 311 water, it can be applied to skin as many times as may be needed. While zinc oxide is the preferred skin tant composition of the present invention, other suitable skin tant compositions and their amounts effective to provide skin protection as listed in Table 1 above could be used herein (e.g., Dimethicone).

Glycerin (INCI name: Glycerin) is a non—irritating humectant and film former. It is also water—soluble. Moreover, glycerin is compatible with latex products and provides extended lubricity, which makes it a common base for many products designed for genital use.

Lanolin is a humectant isolated from wool—bearing animals such as sheep. It is a product of the sebaceous gland and consists mostly of a mixture of cholesterol and the esters of l fatty acids. It has many commercial uses, including within the medical and cosmetic industries.

Benzalkonium Chloride is a member of the quaternary ammoniunl compounds. These nds are a group of ammonium salts in which organic radicals have been substituted for all four ens of the original ammonium cation. Benzalkonium Chloride has been reported to be an effective anti—viral wetting agent in the tion of ission of viral diseases such as HIV and herpes simplex virus. Benzalkonium Chloride is also listed in the FDA Topical Antimicrobial Drug Products Monograph as a First Aid Antiseptic.

The phrase “film—forming emollient” refers to any excipient suitable for ic and pharmaceutical applications, which forms 51 water—repelling film. According to 2a preferred, albeit non—limiting ment, the film—forming emollients are cetyl alcohol and cetostearyl alcohol. Cetyl alcohol (IUPAC name of decanol) is a member of the alcohol class of compounds. It is a solid. organic compound. and. belongs to a group of fatty alcohols. In addition to its use as an emollient, it is often used in the cosmetic industry as a surfactant in shampoos, fiers or thickening agents in the manufacture of skin creams and lotions. Cetostearyl alcohol is a blend of cetyl alcohol and stearyl alcohol, two fatty alcohols derived from vegetable sources.

The phrase “silicone—containing excipient” refers to any‘ silicone or silicone derivatives, including silicone—based skin protectants, suitable for cosmetic and pharmaceutical applications, which. acts as an ent and forms a water— repelling film, including silicone oils. In addition. to skin barriers, ne and silicone oils are highly substantive on the skin. As a result of this property, silicon and silicone oils are often used in l formulations, such as creams and lotions, to improve the substantivity of active ingredients on the skin.

After applying the topical formulations to the skin and removing volatile substances, the film formed as a result of using a silicone—containing excipient helps to maintain the active ingredient in close contact with the skin and prevents the loss of the active ient by abrasion. The ability to form hobic films, which can easily be applied, and spread over skin accounts for high ance to wash—off and rub—off.

Use of silicones in. topical formulations over petroleum—based products is more desirable because silicones do not exhibit the negative aesthetics of petroleum and, unlike petroleum, are known to be compatible with the materials used to manufacture condoms. According to one non—limiting embodiment, Dimethicone (preferably' Dimethicone 20 cSt and. Dimethicone 12500 cSt) is preferred. Dimethicone is a highly pure, latile silicone fluid, which is colorless and odorless. It can be used as a lubricant and emollient skin protectant. eth~12 is part of a family with the INCI name of Ceteareth—n and refers to polyoxyethylene ethers of a mixture of high molecular mass saturated fatty alcohols. The "n" indicates the average number of ethylene oxide residues in the yethylene chain. Ceteareth—12 is a non—toxic surfactant, which is frequently used as an fier in the cosmetic industry. The mixture of Cetearyl alcohol and Ceteareth—ZO (EMULGADE lOOONI, Cognis Corporation) is a non—ionic, self— emulsifying base commonly used in the production of oil/water creams and lotions.

Disodium Edetate, having the chemical name of disodium (ethylene—dinitrilo) tetra—acetate dihydrate, is also commonly known. as the disodiun1 salt of EDTA. The chemical acts as a chelating compound by preventing ients from binding to trace elements that may be present.

Excipients useful in forming the skin protective creams, according to the present invention are described in the following non—limiting example.

EXAMPLE 1 In formulating‘ a batch. of a skin protective cream according' to the invention, active ingredients and. excipients useful in the manufacture of this product, a particularly ive product resulted when ingredients were utilized within the following imate ranges: ACTIVE INGREDIENTS/EXCIPIENT TNT/WT}: RANGES Water phase (1) DEIONIZED WATER Q.S. (2) EDETATE DISODIUM 0.0l-O.l (3) ZINC OXIDE 1.0-8.0 (4) GLYCERIN (USP) 2.0-10 0 Oil Phase (5) DIMETHICONE 20 10.0—20.0 (6) DIMETHICONE 12500 3 O—l0.0 (7) CETEARYL ALCOHOL and/or CETEARETH~20 6 O—l0.0 (8) CETEARETH—lZ 0.5-3.0 (9) ANYHDROUS LANOLIN 0.5—3.0 (10) EARYL ALCHOHOL l 0—5.0 (ll) CETYL ALCOHOL l 0-5.0 A preferred, albeit non—limiting procedure for manufacture of the formulation ses the steps of: Procedure: 1. Heat to 75°C —Dimethicone 203 Dimethicone 12500, yl Alcohol and eth—2O (available as EMULGADE 1000 NI from Cognis), Ceteareth—12 (available as (EUMULGIN Bl from Cognis), Anhydrous Lanolinq Cetostearyl alcohol and Cetyl l. Allow the materials to melt. 2. Dissolve Disodium Edetate in the deionized water (USP). 3. Heat Step #2 to 75—78 °C. 4. Disperse the Zinc Oxide in the Glycerin to form a homogeneous dispersion.

. With high speed mixing, slowly add the materials from Step #3 (Water phase) to the materials from Step #1 (Oil phase). Initiate cooling. 6. When at 60 °C; add the dispersion from Step#4 to the materials from Step #5 ion). 7. When at 50 °C, reduce mixing speed. 9. When at 40 °C, further reduce the mixing speed.

. When at 25°C stop mixing.

While not wishing to be bound to any particular theory, it is believed that these film forming excipients and active ingredient form a neutral and hydrophobic layer barrier which is also believed to interact with the skin thereby having a stabilizing effect upon the hydrophobic layer, which results in the enhanced persistence of the product. The use of a silicone—containing skin protectant, e.g. Dimethicone 20 and Dimethicone 12500, or‘ a like equivalent, acts in coordination with at least one of the skin protectants itions as defined in CFR 21 Sec. 347.10, e.g. Zinc Oxide, or others from Table l, excipients and the film—forming emollients, and melts when contacted with the heat of the body. This in turn forms a physical hobic layer that provides a barrier, which s to inhibit penetration of liquids, and sexually transmitted ens , bacterial) which are primarily hydrophilic in ‘nature. This property’ helps protect the user front contamination due to sexual contact with infected individuals.

In order to ascertain any differences between the use of the formulation as described herein, and a formulation additionally containing an ral, e.g. benzalkonium chloride, the following experiment was carried out.

S K I N B A R R I E R F O R M U L A T I O N % (w/w) ‘Dimethicone 20 (Dow coming Q7—9l20 Silicone Fluid 15.030060120 icone 12500 (Dow Corning Q7—9120 Silicone Fluid 12500 I CSt). 20040 Zinc Oxide, USP .004008016 Cetearyl Alcohol & eth—ZO (Emulgade 8.016032064 Glycerin, USP 5.010020040 Ceteareth~l2 gin Bl, Cognis) 1.002004008 Edetate Disodium, USP 0.050100200 Anhydrous Lanolin, USP 1.002004008 earyl Alcohol, NF 3.006012024 Cetyl Alcohol, NF l 2.004008016 lPurified Water USP 57.865731460 \ 100.00 TABLE 1 In accordance with the teachings of the present invention, the skin barrier formulation illustrated in Table l was prepared. Additionally, a second formulation was prepared, to which the antiviral ingredient Benzalkonium Chloride (Benzalkonium Chloride 50% Solution,NF) was added in an amount of 0.20% w/wq A test ol was followed in order to evaluate the barrier function of the cream product against fluid and virus transmission alone and with the addition of Benzalkonium Chloride. The challenge virus selected was Herpes Simplex Virus Type 2, ATCC VR—734.

Three pieces of filter‘ paper‘ were weighed and. placed onto a sterile glass Petri dish. Following, a piece of porous membrane (pore size 10 pm) was placed on top of the filter paper layer [except for Filter Paper Only (No Membrane) Control]. The carrier was pre—incubated at 37i1°C (Actual, 37°C) for 10:1 minutes (Actual, 10 s) with the lid off prior to r manipulation.

To determine efficacy as a viral barrier, 1.00 g of test agent was spread evenly across the upper side of the membrane area. Thereafter, 0.2 mL of the challenge virus was applied evenly to the treated membrane. The carrier was covered, sealed in parafilm, and incubated at 37i1°C (Actual, 37°C) for 3011 minutes (Actual, 30 minutes).

To determine efficacy as a moisture barrier, during the carrier ation/pre—incubation step, 1.00 g of test agent was spread evenly across the upper side of the membrane area. ing, the carrier was incubated at 37i1°C (Actual, 37°C) for 10:1 minutes (Actual, 10 minutes). Thereafter, 0.2 mL of cell culture medium was applied evenly to the treated membrane. The carrier was covered, sealed in lm, and incubated at 37i1°C (Actual, 37°C) for 30:1 minutes (Actual, 30 minutes). It was d for moisture adsorption only.

To determine moisture penetration of the filter paper, after the contact time, the membrane — if applicable, was carefully lifted and removed. The filter paper layer was weighed to measure moisture adsorption.

To determine viral penetration, the filter paper layer was placed in a 50—mL e tube with l5—mL of ry medium.

The filter paper layer was squeezed with a cell scraper.

Following, the tube was vortexed on a vortex—type mixer for 1—2 minutes and held at room ature for about 5 minutes. The tube was then vortexed using a vortex—type mixer for an additional 1—2 s; it was then centrifuged at 5000 rpm for 5 minutes. The supernatant was collected and passed through a 0.45 pm syringe filter prior to use in diluting and plating.

Media and reagents: RPMI 1640 + 5% Newborn Calf Serum + 0.5% Polysorbate 80 RPMI 1640 + 5% Newborn Calf Serum Filter paper, ashless circles, 47 mm diameter, WhatmanTM No. lO—Mm membrane filters, circles, 47 mm diameter, type TCTP The results are summarized in Table 2, wherein it is seen that the efficacy of the comparative formulations with and without Benzalkonium Chloride were equivalent in their ability to block the ation of both viral and moisture challenges.

Sample ID Cream I I Input Virus Virus Volume Normalized Dosage Virus* Recovered* ion* of virus/ Moisture (Logm (Logv (Log—to media* gaina TCIDM) TClOm) Taro”) (mL) (g Skin Barrier Formula of Table Number l—Virus ** _ 1.00g 4.33 i 0.36 $3.01 Test Sample Skin Barrier Formula 1 plus Benzalkonium O ' 2 mL Chloride ** — — 1.00g 4.71 i 0.38 $3.01 21.70 0,02 (virus) Virus Test Sample TABLE 2 It is to be understood that while a certain form of the invention is illustrated, it is not to be limited to the specific form or arrangement herein. described. and. shown. It * Results represent the averaged data from three ates.

**A complete blockade of virus was observed in all three replicates. a Normalized based on the moisture gain from a Cream—only (no virus or media) sample will be apparent to those skilled in the art that various s may" be made without departing from the scope of the invention and the invention is not to be considered limited to what is shown and described in the specification and drawings/figures.

All patents and publications mentioned in this specification are tive of the levels of those d in the art to which the invention pertains. All patents and publications are herein incorporated by reference to the same extent as if each individual publication was specifically and individually indicated to be incorporated by reference. It is to be understood that while a certain. forwl of the invention is illustrated, it is not to be limited to the specific form or arrangement herein described and shown. It will be apparent to those skilled in the art that various changes may be made without departing from the scope of the invention and the invention is not to be considered limited to what is shown and described. in the specification. One d in the art will y appreciate that the present invention is well adapted to carry out the objectives and obtain the ends and advantages mentioned, as well as those inherent therein. The excipients and related compounds bed herein are presently representative of the preferred embodiments, are intended to be exemplary and are not intended as limitations on the scope. Changes therein and other uses will occur to those skilled in the art which are encompassed within the spirit of the invention and are defined by the scope of the appended claims. Although the ion has been described in connection with specific preferred embodiments, it should be understood that the invention as claimed should not be unduly limited to such specific embodiments. Indeed, various modifications of the bed modes for carrying out the invention, which are obvious to those skilled in the art, are intended to be within the scope of the following claims.

Claims (1)

1. WHAT IS CLAIMED IS: