WO1994021222A1

WO1994021222A1 - Sunblocking, emulsifying proteinaceous particulate lotion and manufacture

Info

Publication number: WO1994021222A1
Application number: PCT/US1994/002792
Authority: WO
Inventors: Richard Potter; Peter T. Pugliese
Original assignee: Nurture, Inc.
Priority date: 1993-03-15
Filing date: 1994-03-15
Publication date: 1994-09-29
Also published as: AU6408494A

Abstract

A method for preparing a natural proteinaceous sun protectant formulation from a lipophilic phase, an aqueous phase, and a substantially chemically intact proteinaceous particulate material that acts as a multi-purpose emulsifying agent, resulting in a sun protectant having the property of forming a dry film upon evaporation of the aqueous phase after application of the emulsion to a surface, wherein the proteinaceous particulate material also acts to screen the surface from the sun. Also provided is a sun protectant lotion including the above lipophilic phase, aqueous phase, and emulsifying agent.

Description

"SUNBLOCKING, EMULSIFYING PROTEINACEOUS PARTICULATE LOTION AND MANUFACTURE"

BACKGROUND OF THE INVENTION

Field of the Invention

5 The present invention is related to formulations including natural proteinaceous particulate materials that have sun protective and skin care effects.

Background of the Prior Art Conventional oil-in-water or water-in-oil emulsions, 0 particularly those used for topically applied cosmetics and agricultural sprays, are typically prepared with considerable heating and high-shear mixing, and generally require several ingredients to ensure suitable emulsification. Additionally, these formulations usually require additional ingredients in 5 order to achieve a useful balance of emulsification, viscosity, and stability.

Not atypically, sunscreen emulsions are formulated with at least one and often several emulsifiers which assist in the formation of the oil-in-water or water-in-oil emulsions. 0 Typical emulsifiers comprise a variety of synthetic chemicals, including laureth-4, steareth-10 and PEG-5 lauramide.

Certain animal proteins, usually in hydrolyzed form, are used in small concentrations as substantive coatings for skin and hair. These materials are solubilized, as opposed to 5 having colloidal properties, and problems with viscosity, tackiness, and odor, limit their useful concentration. Moreover, these materials are not recognized as having the ability to themselves form useful emulsions for topical application of active ingredients. Furthermore, hydrolyzed 0 animal proteins are not naturally occurring and carry some risk of skin irritation.

Oils and/or oily substances are common constituents in topical skin applications, including sunscreens. These oils tend to form a thin, fluid film which retards the drying of the skin after evaporation of other volatile ingredients found in the cream or lotion. However, it is also desirable to reduce the greasy or oily feel of these creams and lotions on the skin. In order to achieve a non-oily skin feel, the resulting film should be either very thin or contain very little oil.

Thus, presently known lotion and cream formulations generally comprise oil-in-water emulsions and/or are preferably applied to the skin in a very thin film. In either case, unless the film is greasy, it is not efficient as an occlusive film for preventing moisture loss from the skin and may still contain an undesirable amount of oil. Also, such films are easily rubbed off, thus allowing dehydration of the skin and a resultant uneven application of active ingredients contained therein.

Other attempts documented in the prior art to improve the film characteristics of topical skin applications include the addition of synthetic film-forming polymers to the skin lotion or cream. The concentration of the polymer in such formulations is usually quite low, on the order of only a few percent, in order to avoid the undesirable aesthetics of a polymeric coating on the skin. Additionally, higher polymer concentrations generally result in formulation viscosities which are too high for practical use.

However, the use of low concentrations of polymer also limits the amount of oil which can be bound into the film, thereby limiting the effectiveness of the film as a moisture entrapper over the skin and/or carrier of other ingredients. Moreover, the addition of synthetic polymers to a topical lotion is less desirable from a consumer stand point in terms of safety concerns.

Accordingly, a need remains in the art for sun protective skin care formulations which contain natural ingredients, and that form a thin, nongreasy feeling film on the skin, that contain sufficient oil to minimize moisture loss.

SUMMARY OF THE INVENTION The present invention overcomes many or all of the above identified problems in the art by utilizing natural proteinaceous materials that not only act to emulsify a lipophilic phase with an aqueous phase, but also to produce thin films. These films have non-oily, dry, flexible, occlusive, invisible and/or substantive properties. Such films can form on surfaces such as skin and hair. They can also form films on plant leaves and other vegetation. It has been found that virtually any lipophilic constituent, including oils or oily substances, can be readily emulsified with the proteinaceous particulate materials of the present invention. Indeed, while the present invention is related to a sun protective formulation, it will be appreciated that other ingredients (either oil or water soluble) can be carried in, or form a part of, the emulsion, such as emollients, oil- based vitamins, essential oils, fragrances, insect repellents, pharmaceuticals, and the like. These ingredients may be introduced in the lipophilic phase and/or aqueous phase, depending on their solubility, or carried as materials entrapped in the proteinaceous materials. Further details concerning the properties of the proteinaceous particulate materials of the present invention and their film forming abilities are disclosed in greater detail in the copending application, Serial No. 07/505,126. The emulsions of the present invention are typically off- white, smooth, and creamy, and they dry quickly when applied as a thin film to a surface. Also, since the proteinaceous materials of the invention serve several functions, for example-, as emulsifiers, co-emulsifiers, thickeners, stabilizers, emollients, agents, and film-formers, a minimal number of ingredients are required to build a useful formulation.

Thus, in accordance with one aspect of the present invention, there is provided a method to make a sun protectant lotion that generally comprises the steps of providing an emulsifier consisting essentially of a substantially chemically intact proteinaceous particulate material, providing a lipophilic phase, providing an aqueous phase; combining in a mixture said proteinaceous particulate material, said lipophilic phase, and said aqueous phase; and agitating the mixture such that an emulsion forms, said emulsion having the property of forming a dry film upon evaporation of said aqueous phase after application of said emulsion to a surface and wherein said emulsion also acts to protect the surface from the sun.

The proteinaceous material is optimally derived from a natural vegetable source, such as seeds. Preferably, the seeds are selected from legumes and grains, such as canola, beans, barley, rape seed, and soya. In highly preferred embodiments, the seeds are oats.

The proteinaceous materials may be prepared by grinding a starting protein source and extracting the lipids from the resulting ground material with an organic solvent. Moreover, it is preferred that the resulting proteinaceous material have a protein concentration of from about 1% to 50%, more preferably of from about 5% to 25%. Also, it is preferred that the average particle size of the resulting proteinaceous material is from about l.Oμm to 300μm, more preferably from about 0.lμm to 20μm.

In one preferred embodiment, the proteinaceous material is derived from oats and has a protein concentration of from about 10% to 20% and an average particle size of from about lμm to lOμm. One sun protective composition is proposed where the lipophilic phase consists essentially of oat oil. Other oily materials, of course, can also be used.

The method may optionally further comprise the addition of an effective amount of a second sunscreen material. In preferred embodiments, the second sunscreen material is microtitanium dioxide, or any other similar metal oxide sunscreen or nonorganic sunscreen such as zinc oxide, an iron oxide, or the like. Also, the method may advantageously further comprise mixing an effective amount of such ingredients as an emollient, moisturizer, preservative, co- emulsifier, spreading agent, stabilizer, antioxidant, waterproofing agent, fragrance, insect repellent, or an active agent with one of the phases before the combining step. The active agent may advantageously be a pharmaceutical.

In accordance with another aspect of the present invention, there is provided a sun protectant formed from emulsifying a lipophilic phase, an aqueous phase, an emulsifying agent consisting essentially of a substantially chemically intact natural proteinaceous particulate material derived from seeds, and an agent selected from the group consisting of sunscreens, ultraviolet blockers, and ultraviolet screens. In a preferred embodiment, the agent is titanium dioxide.

Moreover, as mentioned above, the lotion may optionally contain a moiety selected from the group consisting of emollients, co-emulsifiers, spreading agents, moisturizers, stabilizers, preservatives, antioxidants, waterproofing agents, insect repellent, and fragrances. Also, it may advantageously contain an active ingredient, such as a pharmaceutical . DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

We have discovered that it is possible to prepare a natural sun protective formulation from an oat proteinaceous material, in particular, one from which lipids are removed, in combination with an aqueous phase and a lipophilic phase. The oat proteinaceous material acts as the emulsifying agent (the "proteinaceous emulsifying agents" or "proteinaceous particulate materials") , allowing the creation of an emulsion that can dry to form a thin film on the skin.

Another surprising aspect of this invention is that the emulsions can be formed spontaneously at room temperature and with minimal agitation. Also, the proteinaceous emulsifiers of the invention are totally natural and are extremely safe to use. I . The Emulsifying Agents of the Present Invention In the preferred embodiments of the present invention, the emulsifying agents are substantially chemically intact proteinaceous particulate materials derived from seeds. As will be understood, various processes can be used to prepare the proteinaceous emulsifying agents of the present invention from seed-type starting materials.

For example, Oughton, in U.S. Patent No. 4,154,728, describes a process for separating fractions of differing compositions from comminuted proteinaceous material from a variety of food sources, including wheat, rye, barley, triticale, peas, and buckwheat . The Oughton process comprises mixing the proteinaceous material with an aliphatic hydrocarbon or alcohol suitable to dissolve the lipids in the material. The wet slurry is distributed by means of centrifugation into fractions which differ primarily in protein composition, as well as starch composition. A similar process is applied to comminuted oats in U.S. Patent Nos. 4,211,695 and 4,211,801, also to Oughton.

To facilitate recovery of the protein, in particular, from the slurry produced in accordance with the foregoing processes, U.S. Patent Nos. 4,208,295 and 4,208,260 to Oughton disclose the application of an electric field to the mixture in collection of a comminuted oat fraction which clings to the anode. An improved method of recovery is disclosed in U.S. Patent No. 4,407,841 to Boocock, comprising the addition of aqueous ethanol to the slurry to agglomerate the proteinaceous material and to facilitate the separation thereof. It is preferred that the proteinaceous particulate materials of the present invention be prepared in a non- aqueous environment, and that the extraction be conducted with a nonpolar solvent, such as hexane. If water is used in the process, some changes to the protein structure may occur. These changes may be at least partially reversed by freeze drying (lyophilization) of the product. Heat is also deleterious, resulting in permanent changes in the properties of the proteinaceous emulsifying agents.

Accordingly, the proteinaceous particulate material is prepared by separating the protein and starch from lipids in the seed with organic solvents, such as propanol, ethanol, or hexanes, and most preferably, hexanes . This process removes the lipids and allows separation of other insoluble materials. The solvents are preferably nontoxic or removed prior to the use of the materials.

After the extraction of lipids and separation of the proteinaceous materials, the particles are separated to a desired particle size or range of sizes, depending upon the desired end use of the material. The resulting particles in preferred embodiments of the present invention have protein concentrations of from about 1% to 50%, or more preferably of from about 10% to 25%. Suitable average particle sizes of the protein compositions that form the proteinaceous emulsifying agents of the present invention may be in the range from 0. lμm to 300μm. Preferably, the average particle sizes are from 1- 10 μm. As a consequence, subsequent milling and/or separation steps are often necessary after extraction of the lipids and other undesired materials. Such milling and separation steps may be accomplished according to many processes that are conventional to, and well known in, the art. In proteinaceous emulsifying agents that are derived from natural seeds, such as grains and legumes, the particles are often irregular in shape due to crushing and fragmenting during the milling process. However, median particle size can be determined by milling parameters or by using a series of graduated sieves or through particle size analysis. Furthermore, in applications requiring more exacting control over the particle sizes, more advanced particle sizing apparatus and methods are available to those of skill in the art, such as gravimetric analyses or digital imagery sizing. The proteinaceous particulate materials are advantageously dried prior to use to remove solvent and other indigenous volatiles. In addition, depending upon the protein separation process, residual solvent could reside in the interstices of the particulate which could cause skin irritation. Drying can be accomplished by any number of known techniques, such as fluid bed drying or subjecting the powder to a vacuum with or without the addition of heat. Often, however, in the case of the proteinaceous emulsifying agents of the present invention, sufficient desolventization may be accomplished through air drying.

While the preferred proteinaceous emulsifying agents of the present invention are derived from oats, it will be appreciated that a variety of starting materials can be used to derive the emulsifying agents of the present invention. For example, virtually any seeds can be used as the starting material, such as those from legumes and grains, for example, canola, barley, beans, oats, rape seed, and soya. However, oats are highly preferred. II . Formulation of the Preferred Sun Protectant

As was mentioned above, because of the unique attributes of the proteinaceous emulsifying agents of the present invention, sun protective formulations of the present invention can have relatively few ingredients. The proteinaceous emulsifying agents of the present invention naturally possess sun protective qualities because of their composition and particulate structure. Thus, it is possible to prepare a sun protective formulation through simply mixing the emulsifying agents of the present invention in a lipophilic base and then introducing an aqueous phase, followed by agitation to form the final composition.

It is often desirable, however, to add certain other components in order to accentuate or supplement certain properties in the resulting products. For example, optimally a preservative is included in the formulations to inhibit the growth of bacteria and other microorganisms. Particularly useful preservatives include certain quarternium compounds, such as DOWICIL^® 200 (available from Dow Chemical Co. in Midland, MI) a 3,5, 7-triazo-azoniatricyclo- (3 , 3, 1, 1) -decane- 1, 3-chloro-2-propenyl, as well as parabens, such as, GERMABEN^® HE (straight or branched C_x - C₄ esters of parahydroxybenzoic acid) (available from Sutton Laboratories, Inc. in Chatham, NJ) .

Also, in certain applications, it is preferred to add additional moisturizing agents. For example, either natural or synthetic moisturizing agents may be suitably employed. Thus, jojoba oil (available from Tri-K Industries, Emerson, NJ) may be utilized as a natural moisturizer. Or, dimethicones or cyclomethicones, such as Silicone 200 or Silicone 345, respectively (available from Dow Corning, Midland, MI) , may be used as artificial moisturizing agents. In preferred embodiments, we believe that the lipophilic phase acts as an emollient. In particular, we prefer to use rice bran oil and/or hazelnut oil (each available from Tri-K Industries, Emerson, NJ) in the lipophilic phase, because of their emollient qualities. In a highly preferred embodiment, oat oil is used to prepare a very rich and creamy emulsion. Moreover, formulations prepared through the use of oat oil in the lipophilic phase have natural antioxidant effects that are highly desirable. In addition, certain other emollients may be used to supply increased adhesion, for example, or other desired effects. For instance, in a preferred embodiment of the present invention, we use Ceraphyl GA-D, a soybean oil maleate (available from Van Dyk & Co. in Bellville, NJ) . As will be appreciated, maleates, and other similar compounds, may be used as emollients to provide additional adhesive qualities.

Furthermore, in certain preferred embodiments, co- emulsifiers are used for maintaining stability. For example, in preferred embodiments, we use ARLACEL™ 165 (a glycerol and polyoxyethylene glycol stearate) and BRIJ™ 35 (a polyoxyethylene lauryl ether) (both available from ICI Americas, Inc., Wilmington, DE) as co-emulsifiers. Spreading agents are also useful supplements for the formulations of the present invention, such as FINSOLV™ TN (a C₁₂ to C₁₅ alcohol benzoate) (available from Finetex, Elmwood Park, NJ) .

A variety of stabilizers can also be suitably used in the present invention to maintain the viscosity of the formulation over time. For example, xanthan gums are suitable stabilizers, such as KELTROL™ (available from Kelco Co., San Diego, CA) .

As mentioned above, the particulate seed proteins used in the formulation possess certain abilities to block and/or absorb ultraviolet radiation. Thus, it is possible to prepare sun protectant formulations without any additional ultraviolet blockers. Without wishing to be bound to any particular theory, the proteinaceous particulate materials contain high percentages of amino acids with carboxyl, hydroxyl, amino, and aromatic groups. Such groups, as will be appreciated, are known to possess strong ultraviolet (UV) absorption across the range of the UV spectrum. Moreover, being particulates, the compositions additionally possess light blocking qualities.

For example, sun protective formulations prepared from the proteinaceous emulsifying agents, a lipophilic phase, and an aqueous phase, achieves a sun protection factor ("SPF") of about 8. An SPF value is defined as the UV energy required to produce a minimal erythemal dose ("MED") , or redness, of protected skin divided by the energy to produce an MED on unprotected skin. This SPF system essentially allows the calculation of the additional time that a person wearing a sunscreen product can remain in the sun without burning. As such, an SPF of 2 allows a user to stay in the sun twice as long, whereas an SPF of 15 increases the relative time to 15 times as long.

It will be appreciated, however, that the SPF system only measures protection from some UVB rays (290-320 nm) ; low UVB (280-290 nm) , UVA (320-400 nm) and UVC (less than 280 nm) are not well blocked by, or calculated in, the SPF system of sunscreen activity. Moreover, it will be understood that UVA rays are thought to be the radiation that is primarily responsible for long-term cumulative effects, such as basal skin cell carcinomas and the more lethal squamous cell carcinomas. Traditional screens, such as p-aminobenzoic acid (PABA) and homoethyl salicylate (2-hydroxybenzoic acid ethyl ester) do not effectively block UVA rays.

To enhance the protective qualities of the sun protective formulations, one may add any of the variety of sunscreen materials, ultraviolet blockers, or ultraviolet screens that are well known in the art. We prefer to use micro titanium dioxide (Ti0₂) (available from Creative Polymers, North Brunswick, NJ) , since it is relatively inert, non-toxic, and non-irritating to humans. Zinc oxide (ZnO) may also be used with similar beneficial effects. In a particularly preferred embodiment, Ti0₂ powder of

20-30 nanometers average particle size is used. In this embodiment, it is possible to achieve a skin protectant lotion with SPF values in the range of 7 to over 19. In addition, Ti0₂ is effective in blocking UVA rays. However, it will be appreciated that many other sunscreen agents, ultraviolet blockers, or screens can be suitably used in the present invention. For example, Avobenzone (1- (p-tert- butylphenyl) -3- (p-methoxyphenyl) - (3-propanedione) ,Lisadimate

(glycerol-1- (p-aminobenzoate) , Roxamidate (ethyl-4- [bis- (2- hydroxypropyl) amino] benzoate) , actinquinol (8-ethoxy-5- quinolinesulfonic acid) , p-aminobenzoic acid (PABA) , β- carotene, cinoxate (2-ethoxymethyl p-methoxy cinnamate) , 4-

(dimethylamino) benzoic acid, dioxybenzone (2, 2' -dihydroxy-4- methoxybenzophenone) , lawsone (2-hydroxy-l,4-naphthoquinone) , mexenone (2-hydroxy-4-methoxy-4 ' -methyl-benzophenone) , octabenzone (2-hydroxy-4- (octyloxy)benzophenone) , octyl methoxy cinnamate (2-ethyl p-methoxycinnamate) , oxybenzone (4- methoxy-2-hydroxybenzophenone) , sulisobenzone (5-benzoyl-4- hydroxy-2-methoxy-benzenesulfonic acid) , and homoethyl salicyate (2-hydroxybenzoic acid ethyl ester) are all well known sunscreen or sun blocking materials that can be used as sunscreen agents in the present invention. Other sunscreen agents, UV blockers, and/or screens can also be used.

In addition, it is also often desirable to include antioxidants, or active ingredients, such as insect repellents or pharmaceuticals in the sun protectant formulations of the present invention. For example, vitamin E may be used as an antioxidant.

Antioxidants are important in skin care products because a major root of photoaging is believed to be uncontrolled lipid peroxidation in the skin. The peroxidation is caused by the generation of free radicals when UV photons strike the skin. These radicals cause damage to vital skin components and also induce local inflammatory responses . Each of these processes appear to contain dangers : the damaged skin components lead to structural changes in the composition of the skin, potentially increasing the chances for further damage, including cancers; and the inflammatory responses lead to the release of histamine and prostaglandins which may occasionally lead to cancers.

Other suitable antioxidants include tocols, such as tocopherols or tocotrienols, that exhibit vitamin E activity, and certain esters of ferulic or caffeic acids (these later compounds are structurally similar to butylated hydroxyanisole (BHA) and butylated hydroxytoluene (BHT) , respectively) . In the alternative, if the sun protectant formulation is prepared with oat oil, it will possess natural antioxidant properties. It will be appreciated that antioxidants can have beneficial therapeutic effects in skin treatments. Generally, antioxidants serve to limit or inhibit lipid peroxidation, a mechanism that is believed to contribute to the aging of skin in sunlight. Moreover, some antioxidants also have anti- inflammatory and antimicrobial properties.

Vitamin E, in addition to its strong antioxidant properties, also plays a membrane stabilization role in which it protects against UV radiation and nitrosamine formation (a potent mutagen) . Moreover, it moisturizes dry skin, and appears to have anti-inflammatory properties. Vitamin E appears to act at the stratum corneum level in skin and, thus, appears to assist in the maintenance of connective tissues and to indirectly enhance the firmness, texture, and suppleness of the skin.

Other vitamins can be incorporated into the skin protectant compositions of the present invention, for their demonstrated roles in skin repair or growth processes . For example, vitamins A and D are major regulators of keratinization and assist in improving skin texture, smoothness, and firmness with repeated use. It has also been hypothesized that vitamin A esters may provide potent anti- aging properties through its esters' conversion to retinoic acid in the skin. Vitamin D is an important factor in epidermal cell turnover. Another potent antioxidant is vitamin C which is also a regulator of biosynthesis; it also, in some cases, has a skin lightening effect. Further, vitamin C has been shown to reverse damage to fibroblast cells, leading to the belief that it will possess anti-wrinkling effects.

As well, certain enzymes, such as superoxide dismutase (SOD) , inactivate highly reactive oxygen radicals

(superoxides) . Combinations of SOD and vitamin E have been shown, in addition to reducing damage to the skin from the sun, to have an accelerating effect on venous and arterial microcirculation. Derivatives and modified compounds are also contemplated in accordance with the present invention, such as vitamin E linoleate (penetrates the stratum corneum and epidermis, thus assisting in longer term moisturizing) and vitamin E nicotinate (possesses a pharmokinetic effect on microcirculation, and even appears to promote hair growth in certain cases) . Still further, bioactive complexes of essential fatty acids, including vitamin F, such as (UNIBIOVET™ (Induchem, France) have been shown to enhance skin elasticity, reduce wrinkles, and strengthen connective tissues. As well, melanin, either alone or in combination with other ingredients can be used. Optimally, the melanin is derivatized, as will be understood to one of skill in the art.

Also, a variety of fragrances can be used in the sun protectant formulations of the present invention. In particular, we prefer to use natural fragrances, such as certain aldehydes, terpenes, i.e., limonene, or tropical oils, i.e., coconut oil, or other fragrances, to add desirable aromas to the lotions.

Waterproofing agents are also desirable additives. Such agents enhance the abilities of the compositions on a surface to be submerged in water and continue to both bind to the surface and substantially retain the bulk of the film and its skin protective qualities. Examples of suitable waterproofing agents are acrylate t-octyl acrylamide copolymer (such as DERMACRYL 79™, National Starch & Chemical Co. , Bridgewater, NJ) ; polyvinylpyrrolidinone/eicosene copolymer (such as GANEX™, GAF Corp., New York, NY) ; and dimethicone, a mixture of fully methylated linear siloxane polymers end blocked with trimethylsiloxy units (such as Dow Corning 200 fluid, Midland, MI) .

Moreover, a wide variety of other ingredients may be encompassed within, or carried by, the compositions of the present invention. For example, many insect repellents may be suitably mixed with the compositions to form skin protective insect repellents. Also, a variety of active ingredients, such as pharmaceuticals, can be admixed into the compositions of the present invention. In one preferred embodiment, the photosensitive material beta-carotene is included in the formulation in an effective topical concentration.

Advantageously, the proteinaceous particulate materials of the present invention possess time release properties, wherein an agent that is incorporated within the proteinaceous particulate materials is released over time. The time release properties of certain of the proteinaceous particulate materials has been described in U.S. Patent No. 5,023,080, to Gupta, the disclosure of which. is incorporated by reference herein.

Accordingly, it is possible to include pharmaceuticals in the compositions of the present invention that will be slowly released to the skin of a person wearing the compositions. This is very useful in the treatment of inflammatory conditions of the skin or other irritating dermatological conditions .

Suitable quantities of each of the foregoing ingredients will be readily known to those of skill in the art, or can be easily determined without undue experimentation. For example, it is conventional in the art to include given quantities of sunscreen agents to attain standard sun blocking effects or UV absorptive effects (SPF) . Amounts of the other ingredients mentioned above are also readily determinable by one of skill in the art, and may be selected to attain desired tactile characteristics, feel, adhesion, water resistivity, and resilience, for example. Suitable guidance in selecting quantities of materials can also be found by reference to Examples II and III.

Thus, it will be appreciated that a wide variety of sun protective formulations can be prepared in accordance with the present invention. However, through the use of the proteinaceous emulsifying agents of the present invention, the sun protective formulations demonstrate reduced skin irritation and enhanced dermatologic therapeutic advantages. Also, because of the low energies and low heats required for emulsification, the sun protective formulations of the present invention are more efficiently prepared. Moreover, low heat processing allows for the inclusion of thermally sensitive ingredients in compositions formed with the proteinaceous emulsifying agents of the present invention. For example, it is possible to include fragrances, vitamins, germicides, and volatile oils.

It should be noted that, although several of the examples deal with lotions and emulsions, the sunscreens of the present invention are not restricted to compositions in these forms. Thus, sprays, topical creams and. liquids, microemulsions, two phase systems, suspensions, hyudro-alcoholic compositions, and anhydrous systems, as well as other formulations, are considered to be within the scope of the present invention. Thus, the examples should not be used to limit the scope of the invention. Further details, objects, and advantages of the present invention will be apparent through a review of the following Examples .

EXAMPLE I PREPARATION OF A PREFERRED EMULSIFYING AGENT A preferred Emulsifying Agent having a 10-20% protein content and an average particle size of 1-10 μm is derived as follows : Dried oats were ground using conventional techniques. Specifically, the ground materials were collected and placed in a vat containing hexane and stirred for between 0.25 to 5 hours. As will be understood, in the grinding process, a broad spectrum of particle sizes are formed, from "fines" to "roughs, " which are separated, one from the others, through conventional sieving apparatus. The fines had a particle size range from about 1 to about 300 μm with the majority being in the l-10μm range, and the roughs had a particle size range from about 300 to about 600 μm.

Generally, fines are suitable for refined emulsion preparation, and roughs may be appropriately used for other applications. The hexane solubilized the lipids from the particles. Thereafter, the solution was centrifuged at 4500 X gravity to layer out the insoluble proteinaceous materials. Next, the hexane was removed via centrifugation and the solid materials were air dried at room temperature and at reduced humidity (i.e., relative humidity not exceeding 50 percent) . Care was taken to ensure that the entire process remained relatively anhydrous.

EXAMPLE II PREPARATION OF A PREFERRED SUN PROTECTANT FORMULATION A stable sun protectant formula was prepared in the following manner:

The ingredients listed below in Table I, and referred to herein as Formulation I, were mixed in a vessel.

TABLE I

Ingredient Percent Function Supplier^*

Rice Bran Oil 5.0% Emollient Tri-K

Ceraphyl GA-D 1.0% Emollient Van Dyk

Arlacel 165 2.5% Co-emulsifier ICI

Brij 35 2.0% Co-emulsifier ICI

Finsolv TN 15.0% Spreading Agent Finetex

Silicone 225 2.0% Moisturizer Dow Corning

Proteinaceous 15.0% Protectant, Nurture, Particulate Emulsifier, Inc. Film Former

Ti0₂ 6.0% Sunscreen Creative Polymers

Water 50.3% Carrier/Solvent

Keltrol 0.2% Stabilizer Kelco

Germaben He 1.0% Preservative Sutton Labs

* The Suppliers abbreviated in the Table are: Creative Polymers, New Brunswick, NJ, Dow Corning, Midland, MI, Finetex, Elmwood Park, NJ, ICI Americas, Inc., Wilmington, DE, Kelco Co., San Diego, CA, Nurture, Inc., Missoula, MT, Sutton Laboratories, Inc., Chatham, NJ, Tri-K Industries, Emerson, NJ, Van Dyk & Co., Belleville, NJ.

The mixture was then agitated at 25oC to form a smooth, creamy textured, viscous fluid emulsion, that was very smooth to the touch, and that, when rubbed on skin, dried to form a thin film that was neither oily nor greasy to the touch.

Moreover, the film when dried was not easily rubbed off and could withstand immersion in water. The film was also not glossy and did not possess a sticky or tacky feel. On the skin, the composition had a soothing feeling and did not feel irritating. Moreover, the film appeared semi-occlusive, allowing the skin to breath through the film. Less complex formulations may also be prepared, as disclosed in the following Example.

EXAMPLE III PREPARATION OF A SIMPLE SUN PROTECTIVE FORMULATIONS Several less complex variations of the sun protective formulations have been prepared in the following manner:

The ingredients, as listed below in Table II, and referred to herein as Formulation II, were mixed and prepared into an emulsion as in Example II.

TABLE II

Ingredient Percentage

Rice Bran Oil 5.0%

Hazelnut Oil 5.0%

Silicone 200 2.0%

Silicone 345 3.0%

Vitamin E 2.0%

Proteinaceous 15% Particulate

Ti0₂ 5%

Water* to make 100%

* The water contained 0.2% of DERMACRYL waterproofing agent (National Starch & Chemical Corp., Bridgewater, NJ.

Formulation II is a thin lotion with reduced stability

(i.e., the emulsion is stable for only about 24 hours before separation) . However, the emulsion still exhibits film forming ability and the emulsion may be reconstituted through vigorous shaking. In a second simple lotion, referred to herein as

Formulation III, the ingredients, as listed below in Table III, were mixed and prepared into an emulsion as in Example II. TABLE III

Formulation III was very similar to Formulation II; it was thin and relatively unstable.

A third simple lotion, referred to herein as Formulation IV, was prepared through mixing the ingredients, as listed below in Table IV, to prepare an emulsion as in Example II.

TABLE IV

Ingredient Percentage

Rice Bran Oil 10.0%

Hazelnut Oil 5.0%

Jojoba 5.0%

Vitamin E 2.0%

Proteinaceous 20.0% Particulate

Ti0₂ 5.0%

Water* to make 100%

** The water contained 0.2% of DERMACRYL waterproofing agent (National Starch & Chemical Corp., Bridgewater, NJ.

Formulation IV resulted in a very thick yet wonderfully smooth emulsion. It characteristically spread onto surfaces with a slight roll-up or curl. Moreover, it was relatively stable, i.e., stayed stable without separation for greater than or equal to 48 hours. After separation, it could be reconstituted with vigorous shaking.

Sunscreen formulations according to the present invention may be prepared having a variety of SPF values . The SPF can be impacted by increasing or decreasing the percentage composition of the proteinaceous particulate and other UV blocking materials, such as Titanium dioxide. Several suitable formulations are set forth below:

VARIATION OF SPF IN SUNSCREEN FORMULATIONS

% bv Weight 1 £2 & £5

Rice Bran Oil 5.0 5.0 5.0 5.0 5.0

Isopropyl 15.0 15.0 20.0 15.0 15.0 Palmitate Arlacel 165 3.0 3.0 3.0 3.0 3.0

Solulan PB20 3.0 3.0 3.0 3.0 3.0

Brij 35 3.0 3.0 4.0 3.0 3.0

Peg 20 Stearate 0.5 0.5 1.0 0.5 1.0 Proteinaceous Particulate (oat) 15.0 7.5 - 15.0 7.5

Silicone 225 2.0 2.0 2.0 2.0 4.0

Ti0₂ 6.0 6.0 6.0

Water 46.0 53.5 49.5 52.5 55.0

Keltrol 0.15 0.15 0.15 0.15 0.15 Germaben 2e 1.0 1.0 1.0 1.0 1.0

Phenoxyethanol 0.5 0.5 0.5 0.5 0.5

Cetyl Alcohol - - 3.0 - 2.0

MEAN SPF 19+ 14.25 9.0 17.25 7.0

The foregoing description details specific methods and specific examples that can be employed to practice the present invention, and represents the best mode contemplated. However, it will be apparent to those of ordinary skill in the art that the disclosed embodiments may be modified without departing from the essence of the invention. Thus, however detailed the foregoing may appear in text, it should not be construed as limiting the overall scope hereof; rather, the ambit of the present invention is to be governed only by the lawful construction of the appended claims.

Claims

WHAT WE CLAIM IS :

1. A method for making a sun protectant lotion, comprising the steps of: providing an emulsifier consisting essentially of a substantially chemically intact proteinaceous particulate material; providing a lipophilic phase; providing an aqueous phase; combining in a mixture said proteinaceous particulate material, said lipophilic phase, and said aqueous phase; and agitating the mixture, such that an emulsion forms, said emulsion having the property of forming a dry film upon evaporation of said aqueous phase after application of said emulsion to a surface and wherein said emulsion also acts to protect the surface from the effects of the sun.

2. The method of Claim 1, wherein said proteinaceous material is derived from a natural source.

3. The method of Claim 2, wherein said natural source is seeds.

4. The method of Claim 3, wherein said seeds are selected from the group consisting of legumes and grains.

5. The method of Claim 3, wherein said seeds are selected from the group consisting of canola, beans, oats, rape seed, and soya.

6. The method of Claim 5, wherein said seeds are oats.

7. The method of Claim 1, wherein said proteinaceous material is derived from grinding a starting protein source and extracting lipids^' from the resulting ground material with an organic solvent.

8. The method of Claim 1, wherein said proteinaceous material has a protein concentration of from about 10% to 50%.

9. The method of Claim 8, wherein said protein concentration is from about 10% to 20%.

10. The method of Claim 1, wherein said proteinaceous material has a particle size range of from about l.Oμm to 300μm.

11. The method of Claim 10, wherein said particle size is from about lμm to lOμm.

12. The method of Claim 1, wherein said proteinaceous material is derived from oats and has a protein concentration of from about 10% to 20% and an average particle size of from about lμm to lOμm.

13. The method of Claim 1, further comprising adding an effective amount of a second sunscreen material in the combining step.

14. The method of Claim 13, wherein said second sunscreen material is titanium dioxide.

15. The method of Claim 1, further comprising adding an effective amount of an emollient in the combining step.

16. The method of Claim 1, further comprising adding an effective amount of a moisturizer in the combining step.

17. The method of Claim 1, further comprising adding an effective amount of a preservative in the combining step.

18. The method of Claim 1, further comprising adding an effective amount of a co-emulsifier in the combining step.

19. The method of Claim 1, further comprising adding an effective amount of a spreading agent in the combining step.

20. The method of Claim 1, further comprising adding an effective amount of a stabilizer in the combining step.

21. The method of Claim 1, further comprising adding an effective amount of an insect repellent in the combining step.

22. The method of Claim 1, further comprising adding an effective amount of a fragrance in the combining step.

23. The method of Claim 1, further comprising adding an effective amount of an antioxidant in the combining step.

24. The method of Claim 1, further comprising adding an effective amount of a waterproofing agent in the combining step.

25. The method of Claim 1, further comprising adding an effective amount of a pharmaceutical in the combining step.

26. The method of Claim 1, wherein said lipophilic phase consists essentially of oat oil.

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27. A sun protectant lotion formed from emulsifying a lipophilic phase, an aqueous phase, an emulsifying agent consisting essentially of a substantially chemically intact natural proteinaceous particulate material derived from seeds, and an agent selected from the group consisting of sunscreens, ultraviolet blockers, and ultraviolet screens.

28. The lotion of Claim 27, wherein said seeds are selected from the group consisting of legumes and grains.

29. The lotion of Claim 28, wherein said seeds are selected from the group consisting of canola, beans, oats, rape seed, and soya.

30. The lotion of Claim 28, wherein said seeds are oats.

31. The lotion of Claim 27, wherein said proteinaceous material is derived from grinding a starting protein source and extracting lipids from the resulting ground material with an organic solvent.

32. The lotion of Claim 27, wherein said proteinaceous material has a protein concentration of from about 10% to 50%.

33. The lotion of Claim 32, wherein said protein concentration is from about 10% to 20%.

34. The lotion of Claim 27, wherein said proteinaceous material has a particle size range of from about l.Oμm to 300μm.

35. The lotion of Claim 34, wherein said particle size is from about lμm to lOμm.

36. The lotion of Claim 27, wherein said proteinaceous material is derived from oats and has a protein concentration of from about 10% to 20% and an average particle size of from about lμm to lOμm.

37. The lotion of Claim 27, further comprising a moiety selected from the group consisting of emollients, co- emulsifiers, spreading agents, moisturizers, stabilizers, antiinflammatory agents, preservatives, antioxidants, fragrances, waterproofing agents, and insect repellents.

38. The lotion of Claim 37, further comprising an active ingredient .

39. The lotion of Claim 38, wherein said active ingredient is a pharmaceutical .

40. The lotion of Claim 27, wherein said agent is titanium dioxide.

41. The lotion of Claim 27, wherein said lipophilic phase consists essentially of oat oil.