Formulation Design of Herbal Gel-based sunscreen containing Silymarin from Milk Thistle and other ingredients to enhance UV Protection and other applications

Abstract

The skin is the first layer of defense and a mechanical barrier to our body against external exposures. This barrier is disturbed when the skin is exposed to the harmful UV (Ultra Violet) rays. The primary mechanism behind UV skin damage is the generation of reactive oxygen species. ROS causes oxidation and activates enzymes. These enzymes further damage the elastic and collagen fibers of the connective tissue of the skin and cause premature skin aging. As a result of UV exposure, skin is prone to acute skin cancer, allergies, erythema, and tanning. Secondary metabolites, which are organic compounds produced by plants and other microorganisms, play a crucial role in pharmaceutical, agricultural, and biotechnological applications. These metabolites include alkaloids, flavonoids, terpenoids, and phenolics, which possess properties such as antimicrobial, anticancer, anti-inflammatory, and antioxidant activities. Invention relates to the development of herbal skincare gel-based formulations, specifically focusing on the creation of effective products for enhancing skin health and appearance. This includes the formulation of active ingredients for improved skincare outcomes.

Specification

Description:FIELD OF INVENTION
[001] This invention, in general, relates to cosmetic compositions. More specifically, this invention relates to natural sunscreen compositions and processes for producing the same.
BACKGROUND AND PRIOR ART
[002] Human skin is sensitive to solar rays and overexposure to sun can cause not only simple sunburn or an erythema, but also burns of varying severity. The other negative effects of over-exposure to solar rays are, tanning, immune suppression, photosensitivity or drug related photosensitivity and photo allergies. Sun can also cause the skin to lose its elasticity and form wrinkles, leading to premature ageing. Dermatosis may also be caused due to over-exposure to solar rays. In extreme cases, some people can develop skin cancer.
[003] Outdoor activities including typical field-related jobs and sporting activities expose the skin to sun. It has been estimated that nearly 75 percent of the sun-inflicted skin damage on the average person's skin over a lifetime is the result of being just outdoors. Hence we require a protection so that we can expose ourselves to the sunlight without getting harmed. These concerns have been heightened by evidence that the earth's ozone layer has suffered severe depletion in recent years. Ozone is recognized as the stratospheric component shielding against the harmful forms of ultraviolet radiation. But still 5% of the sunrays coming to the earth are composed of the ultraviolet rays. These ultraviolet rays are composed of the shorter-wavelength (290-320 nm) UVB rays that cause indirect sun tanning and the longer-wavelength (320-400 nm) UVA rays that are responsible for direct sun tanning. Sunscreen compositions offer a scientific solution to the above-identified harmful effects of over-exposure to the ultraviolet rays.
[004] Topical application sunscreen formulations are known. Sunscreen active are generally classified as organic sun screenersor inorganic sun screeners. Organic sun screeners absorb strongly at specific wavelengths and are transparent to visible light. However, some organic sun screeners such as Oxybenzone are known to cause photo allergic reactions. Inorganic sun screeners such as Titanium dioxide at higher levels leave visible residue referred as whitening of the skin.

[005] To overcome these allergic side effects of organic sun screeners and non-aesthetics of inorganic sun screeners, there exist the need for devising newer formulations, that can protect the skin from the harmful effects of the ultraviolet radiations of sun without any undesirable side effects. It is against this background the present invention has been brought out.
[006] Silibinin is a flavonolignan compound that is abundantly found in the extract of the milk thistle plant (Silybum marianum. Silymarin, a flavonolignan complex that contains silibinin, was isolated from milk thistle in the 17th century and has been clinically used to treat various liver ailments for more than 3 decades. silibinin possesses strong cancer chemopreventive properties in various animal models of carcinogenesis, including skin cancer.
[007] Experimental findings in mouse skin carcinogenesis models suggest that antioxidant activity of silibinin is important in protecting against skin injuries induced by chemicals or radiation as well as carcinogenesis.
[008] The protective effect of silibinin against UVB-induced skin injuries in the mouse model is clinically relevant, because sun exposure, particularly UV radiation, is one of the major causes of skin aging and cancer. It is anticipated that the skin-protecting effects of silibinin could be used for humans through cosmeceutical preparation. Silymarin/silibinin is found in some high-end moisturizers to prevent cutaneous oxidative damage and photoaging.
[009] Sunscreen compositions comprising herbal extracts that can act as antioxidants are known in prior art. Sunscreen compositions containing herbal extracts such as green tea, aloe vera, chamomile rosemary are also known in the art. Further, it is known in the art to devise sunscreen compositions having silymarin, wherein the silymarin act as sunscreen actives. The present invention is distinct from the above prior art compositions as described hereunder.
[010] Conventional sunscreens are widely used to protect the skin from the damaging effects of ultraviolet (UV) radiation, including sunburn, premature aging, and an increased risk of skin cancer. These sunscreens typically utilize chemical and physical UV filters, such as oxybenzone, avobenzone, zinc oxide, and titanium dioxide, to block or absorb harmful UV rays. While these filters are effective in providing a barrier against UV radiation, they often come with certain drawbacks. For instance, some chemical filters have been associated with skin irritation, allergic reactions, and potential hormonal disruption in sensitive individuals.
SUMMARY OF THE INVENTION
[011] The skin serves as a critical defense barrier against external factors, but UV radiation can compromise this barrier, leading to oxidative damage and premature aging. Reactive oxygen species (ROS) generated by UV exposure damage collagen and elastin fibers, contributing to various skin issues, including cancer, allergies, erythema, and tanning. Plant secondary metabolites, such as alkaloids, flavonoids, terpenoids, and phenolics, offer potential protective properties due to their antioxidant activities. This study focuses on Milk thistle (Silybum marianum), a medicinal plant known for its flavonolignans, particularly silymarin, which may have UV protective effects. The research involves extracting and analyzing these metabolites using Soxhlet extraction, HPLC, and LC-MS techniques. The goal is to develop a safer, SPF enriched cosmetic product by addressing the issues associated with current organic cosmetic claims.
DETAILED DESCRIPTION OF THE INVENTION
[012] In one preferred embodiment, there is provided a safe and effective natural sunscreen composition comprising extract of plant Milk Thistle.
[013] In another preferred embodiment, there is provided a safe and effective natural sunscreen composition comprising extract of plant Milk Thistle.
[014] In yet another preferred embodiment, there is provided a safe and effective natural sunscreen composition comprising Silymarin, individually or mixtures thereof, isolated and characterized from the extract of plant Milk Thistle.
[015] In one another preferred embodiment, the present invention provides for a safe and effective natural sunscreen composition, 0.1%- 2% Silymarin, 1% of Carbopol, 30% of aloe vera gel, 0.4% of Vitamin E, 5% of Zinc Oxide, 0.4% of Coconut Oil, 0.5% of methyl paraben, 0.1% of Potassium Hydroxide, 2% Carrot seed oil, 0.80% of Tri ethanol amine, Fragrance and Distilled Water.
[016] In still another aspect, the present invention provides for a method for producing a natural sunscreen composition, the method comprising extracting plant extracts from Milk Thistle by soxhlation, filtering the plant extract, concentrating the plant extract to dryness on a rotatory evaporator under vacuum at optimum temperature and producing a natural sunscreen composition employing the said dried mass.
[017] In still another aspect, the invention provides for a method for producing a natural sunscreen composition, the method comprising extracting plant extracts from Milk Thistle by soxhlation, filtering the plant extract, concentrating the plant extract to dryness on a rotatory evaporator under vacuum at optimum temperature and producing a natural sunscreen composition employing the said dried mass.
[018] In yet another aspect, the invention provides for a method for producing a natural sunscreen composition, the method comprising extracting plant extracts from Milk Thistle by solvent extraction using an organic solvent selected from the group comprising petroleum ether, hexane, cyclohexane, benzene, dichloromethane, chloroform, ethyl acetate, acetone, methanol and ethanol, either alone or in combination thereof, purifying the resultant extract; separating the pure compound; characterizing the compound as flavonolignans and producing the natural sunscreen composition using the flavonolignans thus produced.
[019] In yet another preferred embodiment, the present invention provides for a delivery system containing a natural sunscreen composition comprising extract of plant Milk Thistle.
[020] In still another preferred embodiment, the present invention provides for a delivery system containing a natural sunscreen composition comprising extract of plant Milk Thistle wherein the delivery system includes gels. , C , Claims:[021] 1. A natural sunscreen composition comprising extract of plant Milk Thistle.
[022] 2. The natural sunscreen composition according to claim 1, wherein the composition comprises 0.1% to 2% by weight of the extract of plant Milk Thistle.
[023] 3. The natural sunscreen composition according to claim 1, wherein the cosmetically acceptable carrier comprises by weight; 1% of Carbopol, 30% of aloe vera gel, 0.4% of Vitamin E, 5% of Zinc Oxide, 0.4% of Coconut Oil, 0.5% of methyl paraben, 0.1% of Potassium Hydroxide, 2% Carrot seed oil, 0.80% of Triethanol amine, Fragrance and Distilled Water.
[024] 4. A delivery system for topical application, comprising the natural sunscreen composition according to claim 1, wherein the delivery system comprises gel as a vehicle for topical application of said sunscreen composition.
[025] 5. A natural sunscreen composition comprising flavonolignans (Silymarin) isolated and characterized from the extract of plant Milk Thistle.
[026] 6. The natural sunscreen composition according to claim 5, wherein the composition comprises flavonolignans individually or as mixtures thereof.
[027] 7. The natural sunscreen composition according to claim 5, wherein the composition comprises 0.1% to 2% by weight of Silymarin.
[028] 8. The natural sunscreen composition according to claim 5, wherein the cosmetically acceptable carrier comprises by weight; 1% of Carbopol, 30% of aloe vera gel, 0.4% of Vitamin E, 5% of Zinc Oxide, 0.4% of Coconut Oil, 0.5% of methyl paraben, 0.5% of Potassium Hydroxide, 2% Carrot seed oil, 0.80% of Tri ethanol amine, Fragrance and Distilled Water.
[029] 9. A delivery system for topical application, comprising the natural sunscreen composition according to claim 5, wherein the delivery system comprises gels as a vehicle for topical application of said sunscreen composition.
[030] 10. A method of producing a natural sunscreen composition, the method comprising: extracting plant extracts from Milk Thistle by soxhlet extraction; filtering the plant extract, concentrating the plant extract to dryness on a rotatory evaporator under vacuum at optimum temperature and employing the dried mass.
[031] 11. A delivery system for topical application, comprising the natural sunscreen composition produced according to the method of claim 5, the delivery system comprising gel as base.
[032] 12. A method of producing a natural sunscreen composition, the method comprising extracting plant extracts from milk thistle by soxhlation, filtering the plant extract, purifying the extract by crystallization to obtain pure Silymarin and employing cosmetically acceptable carrier to produce a natural sunscreen composition.

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