DESC:FIELD OF THE INVENTION
[0001] The present disclosure relates generally to the field of pharmaceutical composition. Particularly, the present disclosure provides a composition for skin care and mental well-being. The present composition can also find its application as a blend in other compositions/formulations.

BACKGROUND OF THE INVENTION
[0002] Background description includes information that may be useful in understanding the present invention. It is not an admission that any of the information provided herein is prior art or relevant to the presently claimed invention, or that any publication specifically or implicitly referenced is prior art.
[0003] The skin is the outer cover of the body. It is the largest organ in the human body and is considered to be pivotal because it is involved in a variety of physiological functions such as protection of several organs from environmental stimulations, offering a barrier for prevention of water and useful constituents in the body from release, regulation of body temperature and respiration.
[0004] As skin ages, its outer coverage becomes thinner and is more easily damaged. Intensifying this effect is the decreasing ability of the skin to heal itself as a person ages. There are many internal and external causes of skin aging. External causes include UV radiation and pollution, whereas internal causes include factors such as emotional stress that can trigger harmful effects impacting both skin health and beauty.
[0005] An increasing number of young people are today grappling with stress due to busy working & hectic work schedule or mismanaged lifestyle. Stress affects the physiology of an individual and can have a profound negative effect on their overall wellness. Current lifestyle of the young generation is a wake-up call for major health-related issues. Excessive busyness may impact one’s physical health by triggering or exacerbating muscle tension/pain, restlessness, insomnia, headaches, inflammation, compromised immune function, fatigue and the likes. These lifestyle disorders like stress, anxiety, insomnia etc. also affect the health of our skin.
[0006] Reports suggest that UV exposure and emotional stress increase the level of active cortisol in the skin by stimulating the expression of 11beta-hydroxysteroid dehydrogenase type 1 (11ß-HSD1), the enzyme that converts inactive cortisone to cortisol. This activation leads to delayed skin healing, a decrease in collagen production, and the activation of Nf-kB, provoking the release of pro-inflammatory cytokines, and thus, the production of reactive oxygen species (ROS). Together, it leads to the premature aging of skin and to the appearance of visible signs such as wrinkles, pigment spots, and dark circles under the eyes.
[0007] Numerous agents, compositions, and formulations are reported in the literature, capable of reducing the aging of the skin. However, these agents/formulations still suffer from certain limitations such as being expensive, ineffective and exhibiting certain side effects such as irritation, allergy, etc.
[0008] There is, therefore, a need in the art to develop a composition that reduces signs of aging, stress, and promotes mental well-being of a subject, and overcomes one or more problems associated with the conventional compositions/formulations thereof. The present invention satisfies the existing as well as other needs.

OBJECTS
[0009] Primary object of the present disclosure is to provide a composition that overcomes one or more limitations associated with the conventional compositions/formulations.
[00010] Another object of the present disclosure is to provide a composition that aids in reducing signs of aging and stress.
[00011] Another object of the present disclosure is to provide a composition that exhibits enhanced skin permeation and reduces mental stress (mood enhancer).
[00012] Another object of the present disclosure is to provide a composition that can be used as a blend in other skin care compositions/formulations and the likes.
[00013] Another object of the present disclosure is to provide a composition that exhibits superior storage stability and synergistic activity/functional reciprocity.
[00014] Another object of the present disclosure is to provide a composition that promotes the mental well-being of a subject.
[00015] Another object of the present disclosure is to provide a composition that is easy to prepare and economical.
[00016] Yet another object of the present disclosure is to provide a method of preparation of said composition.
[00017] Other objects of the present invention will be apparent from the description of the invention herein below.

SUMMARY
[00018] The present disclosure relates generally to the field of pharmaceutical composition. Particularly, the present disclosure provides a composition for skin care and mental well-being. The present composition can also find its application as a blend in other compositions/formulations.
[00019] An aspect of the present disclosure provides a composition comprising: 30 to 50 % w/w of a Tephrosia purpurea of the total weight of the composition; 30 to 50 % w/w of a Phaeodactylum tricornutum of the total weight of the composition; 5 to 15 % w/w of a Centella Asiatica of the total weight of the composition; and 5 to 15 % w/w of an Ocimum basilicum of the total weight of the composition.
[00020] Another aspect of the present disclosure provides a composition comprising: 35 to 45 % w/w of a Tephrosia purpurea of the total weight of the composition; 35 to 45 % w/w of a Phaeodactylum tricornutum of the total weight of the composition; 8 to 12 % w/w of a Centella Asiatica of the total weight of the composition; and 8 to 12 % w/w of an Ocimum basilicum of the total weight of the composition.
[00021] Yet another aspect of the present disclosure provides a formulation comprising: 30 to 50 % w/w of a Tephrosia purpurea of the total weight of the formulation; 30 to 50 % w/w of a Phaeodactylum tricornutum of the total weight of the formulation; 5 to 15 % w/w of a Centella Asiatica of the total weight of the formulation; 5 to 15 % w/w of an Ocimum basilicum of the total weight of the formulation; and rest being an excipient.
[00022] Other aspects, advantages, and salient features of the invention will become apparent to those skilled in the art from the following detailed description, which, taken in conjunction with the exemplary embodiments of the invention.

DETAILED DESCRIPTION
[00023] The embodiments herein and the various features and advantageous details thereof are explained more comprehensively with reference to the non-limiting embodiments that are detailed in the following description. Descriptions of well-known components and processing techniques are omitted so as to not unnecessarily obscure the embodiments herein. The examples used herein are intended merely to facilitate an understanding of the ways in which the embodiments herein may be practiced and to further enable those of skill in the art to practice the embodiments herein. Accordingly, the examples should not be construed as limiting the scope of the embodiments herein.
[00024] Unless otherwise specified, all terms used in disclosing the invention, including technical and scientific terms, have the meaning as commonly understood by one of ordinary skills in the art to which this invention belongs. By means of further guidance, term definitions may be included to better appreciate the teaching of the present invention.
[00025] As used in the description herein, the meaning of “a,” “an,” and “the” includes plural reference unless the context clearly dictates otherwise. Also, as used in the description herein, the meaning of “in” includes “in” and “on” unless the context clearly dictates otherwise.
[00026] As used herein, the terms “comprise”, “comprises”, “comprising”, “include”, “includes”, and “including” are meant to be non-limiting, i.e., other steps and other ingredients which do not affect the end of result can be added. The above terms encompass the terms “consisting of” and “consisting essentially of”.
[00027] As used herein, the terms “blend”, and “mixture” are all intended to be used interchangeably.
[00028] The term “mental well-being” is used synonymously and interchangeability throughout the specification. The term “mental well-being” as used herein refers to reduced anxiety, insomnia, stress, mood swings, etc. and promotion of neural regeneration and mood enhancer and the like.
[00029] The term “skin care” is used synonymously and interchangeability throughout the specification. The term “skin care” as used herein refers to skin aging, acne, dullness, sun damage and wrinkles and the like.
[00030] The terms “weight percent”, “vol-%”, “percent by weight”, “% by weight”, and variations thereof, as used herein, refer to the concentration of a substance as the weight of that substance divided by the total weight of the composition and multiplied by 100. It is understood that, as used here, “percent”, “%”, and the like are intended to be synonymous with “weight percent”, “vol-%”, etc.
[00031] In some embodiments, the numbers expressing quantities of ingredients, properties such as concentration, reaction conditions, and so forth, used to describe and claim certain embodiments of the invention are to be understood as being modified in some instances by the term “about”. Accordingly, in some embodiments, the numerical parameters set forth in the written description are approximations that can vary depending upon the desired properties sought to be obtained by a particular embodiment. In some embodiments, the numerical parameters should be construed in light of the number of reported significant digits and by applying ordinary rounding techniques. Notwithstanding that the numerical ranges and parameters setting forth the broad scope of some embodiments of the invention are approximations, the numerical values set forth in the specific examples are reported as precisely as practicable.
[00032] The recitation of ranges of values herein is merely intended to serve as a shorthand method of referring individually to each separate value falling within the range. Unless otherwise indicated herein, each individual value is incorporated into the specification as if it were individually recited herein.
[00033] The headings and abstract of the invention provided herein are for convenience only and do not interpret the scope or meaning of the embodiments.
[00034] The following discussion provides many example embodiments of the inventive subject matter. Although each embodiment represents a single combination of inventive elements, the inventive subject matter is considered to include all possible combinations of the disclosed elements. Thus if one embodiment comprises elements A, B, and C, and a second embodiment comprises elements B and D, then the inventive subject matter is also considered to include other remaining combinations of A, B, C, or D, even if not explicitly disclosed.
[00035] The present disclosure is on the premise of a surprising discovery that when Tephrosia purpurea, Phaeodactylum tricornutum, Centella Asiatica and Ocimum basilicum are included as part of a composition in the weight percentage as defined herein, it exhibits synergistic activity as compared to the individual ingredient. The observed synergistic effect is unexpected and surprising.
[00036] The present disclosure relates generally to the field of pharmaceutical compositions. Particularly, the present disclosure provides a composition that reduces signs of aging, enhances permeation, reduces mental stress (mood enhancer) and promotes mental well-being of a subject. The present composition can also find its application as a blend in other compositions/formulations.
[00037] An aspect of the present disclosure provides a composition comprising: 30 to 50 % w/w of a Tephrosia purpurea of the total weight of the composition; 30 to 50 % w/w of a Phaeodactylum tricornutum of the total weight of the composition; 5 to 15 % w/w of a Centella Asiatica of the total weight of the composition; and 5 to 15 % w/w of an Ocimum basilicum of the total weight of the composition.
[00038] In an embodiment, the composition comprising: whole of or a part of or an extract of or an oil of Phaeodactylum tricornutum, Tephrosia purpurea, Centella asiatica, and Ocimum basilicum. The extract or the part or the oil may be obtained from root, leaves, shoot, fruits, rhizome, seed, stem, barks, flower, sap or bud of the plant and any combinations thereof.
[00039] In an embodiment, the composition further comprises one or more excipients. The excipient is selected from a group consisting of a thickening agent, a bulking agent, a lubricant, a solubilizer, a binder, a chelating agent, a colouring agent, a tonicity agent, a buffering agent, a preservative, a moisturizing agent, a film former/waterproofing agent, a rheology modifying agent, a fragrance, an emollient, a humectants, an emulsifier, a diluents, a solvent and a combination thereof.
[00040] In an embodiment, the thickening agent(s) includes but not limited to, carbopol, carbomer, acrylate copolymer, beeswax, emulsifying cresmer wax, sodium acrylate/sodium acryloyl dimethyl tauratecopolymer (0.2-1.2% w/w), and combinations thereof. However, a person skilled in the art would appreciate that any other thickening agent(s) can be utilized to serve the intended purpose.
[00041] In an embodiment, the bulking agent(s) include but not limited to, lactose USP, starch 1500, mannitol, sorbitol, maltodextrin, maltitol or other non-reducing sugars; microcrystalline cellulose (e.g., Avicel), dibasic calcium phosphate (anhydrous or dihydrate), sucrose, and combinations thereof. However, a person skilled in the art would appreciate that any other bulking agent(s) can be utilized to serve the intended purpose.
[00042] In an embodiment, the lubricant(s) includes but not limited to, zinc stearate, magnesium stearate, stearic acid, calcium stearate, Vegetable stearin, and combinations thereof. However, a person skilled in the art would appreciate that any other lubricant(s) can be utilized to serve the intended purpose.
[00043] In an embodiment, the solubilizer(s) includes but not limited to, cyclodextrins, pH adjusters, salts and buffers, surfactants, fatty acids, phospholipids, metals of fatty acids, and combinations thereof. However, a person skilled in the art would appreciate that any other solubilizer(s) can be utilized to serve the intended purpose.
[00044] In an embodiment, the binder(s) include but not limited to, cellulosic derivatives (such as methylcellulose, carboxymethyl cellulose, hydroxyethyl cellulose, hydroxyethylmethyl cellulose, hydroxypropylmethyl cellulose etc), polyacrylates (such as Carbopol, polycarbophil, etc), Povidone (all grades), Polyox of any molecular weight or grade, irradiated or not, maize starch, povidone, copovidone, corn starch, starch, polyvinylpyrrolidone (PVP), microcrystalline cellulose (Avicel@ -Avicel 101), and combinations thereof. However, a person skilled in the art would appreciate that any other binder(s) can be utilized to serve the intended purpose.
[00045] In an embodiment, the chelating agent(s) includes but not limited to, tetrasodium glutamate diacetate (e.g., Dissolvine GL-47-S), EDTA salt, and combinations thereof. However, a person skilled in the art would appreciate that any other chelating agent(s) can be utilized to serve the intended purpose.
[00046] In an embodiment, the colouring agent(s) includes but not limited to, E102 Tartrazine, E104 Quinoline Yellow, E110 Sunset Yellow FCF, E120 - Cochineal, carminic acid, Carmines, E122 Azorubine (Carmoisine), E123 Amaranth, E124 Ponceau 4R (Cochineal Red A), E127 Erythrosine, E129 Allura Red, E131 Patent Blue, and combinations thereof. However, a person skilled in the art would appreciate that any other colouring agent(s) can be utilized to serve the intended purpose.
[00047] In an embodiment, the tonicity agent(s) includes but not limited to, dextrose, glycerin, mannitol, potassium chloride, sodium chloride, and combinations thereof. However, a person skilled in the art would appreciate that any other tonicity agent(s) can be utilized to serve the intended purpose.
[00048] In an embodiment, the buffering agent(s) includes but not limited to, sodium citrate, potassium citrate, sodium citrate di-hydrate, citric acid, citric acid monohydrate, sodium bicarbonate, potassium bicarbonate, sodium di-hydrogen phosphate and potassium di-hydrogen phosphate, and combinations thereof. However, a person skilled in the art would appreciate that any other buffering agent(s) can be utilized to serve the intended purpose.
[00049] In an embodiment, the preservative(s) includes but not limited to, sodium benzoate, potassium sorbate, phenoxyethanol, p-hydroxybenzoic acid esters, sorbic acid, benzoic acid, propionic acid or salts thereof; Alcohols such as benzyl alcohol, butanol or ethanol, isopropyl alcohol and quaternary ammonium compounds such as benzalkonium chloride, sodium benzoate, and combinations thereof. However, a person skilled in the art would appreciate that any other preservative(s) can be utilized to serve the intended purpose.
[00050] In an embodiment, the moisturizing agent(s) includes, but are not limited to lactic acid and other hydroxy acids and their salts, glycerin, propylene glycol, butylene glycol, sodium PCA, Carbowax 200, Carbowax 400, Carbowax 800, and combinations thereof. However, a person skilled in the art would appreciate that any other moisturizing agent(s) can be utilized to serve the intended purpose.
[00051] In an embodiment, the film former/waterproofing agent(s) includes, but are not limited to acrylates/C12-22 alkylmethacrylate copolymer, C30-38 olefin/isopropyl maleate/methylacrylate copolymer, polyethylene, waxes, vinylpyrrolidone/dimethiconylacrylate/ polycarbamylpolyglycol ester, butylated polyvinylpyrrolidone, polyvinylpyrrolidone/hexadecane copolymer, polyvinylpyrrolidone/eicosene copolymer, tricontanylpolyvinylpyrrolidone, Brassica campestris/Aleuritisfordi Oil copolymer, aminofunctional silicones, decamethylcyclopentasiloxane (and) trimethylsiloxysilicate, octadecene/ methylacrylate copolymer, and combinations thereof. However, a person skilled in the art would appreciate that any other film former/waterproofing agent(s) can be utilized to serve the intended purpose.
[00052] In an embodiment, the rheology modifying agent(s) include, but are not limited to acrylates crosspolymer, acrylates/C10-30 alkylacrylate crosspolymer, polyacrylic acid, sodium polyacrylate, polyacrylate, acrylates/vinyl ester copolymer, PVP/decene copolymer, styrene/MA copolymer, acetamide MEA, acrylamides copolymer, acrylates copolymer, acrylates/steareth-20 methacrylate copolymer, acrylates/beheneth-25 methacrylate copolymer, PEG-150/decyl alcohol/SMDI copolymer, PVP, PVM/MA decadiene crosspolymer, carbomer, PEG crosspolymer, acrylates/palmeth-25 acrylates copolymer, polysaccharide, polyether-1, sodium magnesium silicate, bentonite, trihydroxystearin, hydroxy stearate, aluminum-magnesium hydroxide stearate, acacia gum, xanthan gum, microcrystalline cellulose, cellulose gum, and combinations thereof. However, a person skilled in the art would appreciate that any other rheology modifying agent(s) can be utilized to serve the intended purpose.
[00053] In an embodiment, the fragrance(s) includes, but are not limited to alcohols, aldehydes, ketones, esters, ethers, acetates, nitriles, terpene hydrocarbons, nitrogenous or sulfurous heterocyclic compounds and essential oils. However, naturally occurring plant and animal oils and exudates comprising complex mixtures of various chemical components are also know for use as fragrance materials. The individual perfume raw materials which comprise a known natural oil can be found by reference to Journals commonly used by those skilled in the art such as Perfume and Flavourist; or Journal of Essential Oil Research, or those listed in reference texts such as the book by S. Arctander, Perfume and Flavor Chemicals, 1969, Montclair, New Jersey, USA and re-published by Allured Publishing Corporation Illinois (1994). Additionally, some perfume raw materials are supplied by the fragrance houses (Firmenich, International Flavors & Fragrances, Givaudan, Symrise) as mixtures in the form of proprietary 14 speciality accords. Non-limiting examples of the fragrance materials useful herein include pro- fragrances such as acetal pro-fragrances, ketal pro-fragrances, ester pro-fragrances, hydrolyzable inorganic-organic pro-fragrances, and combinations thereof. However, a person skilled in the art would appreciate that any other fragrance(s) can be utilized to serve the intended purpose.
[00054] In an embodiment, the emollient(s) includes but not limited to, caprylic/caprictriglyceride (e.g., Endimulse 33V), isononylisononanoate, squalane (e.g., neossancesqualane), patauaoil (e.g, oenocarpusbataua fruit oil), and combinations thereof. However, a person skilled in the art would appreciate that any other emollient(s) can be utilized to serve the intended purpose.
[00055] In an embodiment, the humectant(s) includes but not limited to, Glycerine, Propylene Glycol, Butylene glycol, aloe-vera gel, hexylene glycol, 25 glyceryl triacetate, Sodium hyaluronate, and combinations thereof. However, a person skilled in the art would appreciate that any other humectant(s) can be utilized to serve the intended purpose.
[00056] In an embodiment, the emulsifier(s) includes but not limited to, hydrogenated lecithin, C12-16 Alcohols, palmitic acid (e.g., Biophillic™ H) and cetylalcohol, glyceryl stearate, PEG-75 stearate, ceteth-20, steareth-2 (Emulium® Delta), and combinations thereof. However, a person skilled in the art would appreciate that any other emulsifier (s) can be utilized to serve the intended purpose.
[00057] In an embodiment, the diluent(s) includes but not limited to, microfine cellulose, lactose, starch, pregelatinized starch, calcium carbonate, calcium sulfate, sugar, dextrates, dextrin, dextrose, dibasic calcium phosphate dihydrate, tribasic calcium phosphate, kaolin, magnesium carbonate, magnesium oxide, maltodextrin, mannitol, potassium chloride, powdered cellulose, sodium chloride, sorbitol, talc, and combinations thereof. However, a person skilled in the art would appreciate that any other diluent(s) can be utilized to serve the intended purpose.
[00058] In an embodiment, solvent(s) includes but not limited to, methanol, ethanol, n-propanol, isopropanol, hexane, heptane, petroleum ether, cyclohexane, diethyl ether, diisopropyl ether, ethyl acetate, methyl acetate, ethyl formate, methyl formate, isobutyl acetate, n-butyl acetate, methylene chloride, ethylene chloride, chloroform, carbon tetrachloride, acetone, ethyl methyl ketone, diisobutyl ketone, methyl isobutyl ketone, 1,4- dioxane, toluene, ammonia solution, glacial acetic acid, ammonium hydroxide, sodium hydroxide, calcium hydroxide, calcium carbonate, potassium hydroxide, potassium carbonate, water, and combinations thereof. However, a person skilled in the art would appreciate that any other solvent(s) or a combination of solvent(s) can be utilized to serve the intended purpose.
[00059] While one or more embodiments of the present disclosure enumerates and describes a list of excipients that may be used in the composition to serve an intended purpose, it should be appreciated that one or more excipient(s) may also serve more than one function, obviating the need of inclusion of separate excipients for the specified purpose. Although several embodiments of the present disclosure names few of the commonly used excipients, any other excipient(s) known to or appreciated by a skilled person can also be used to realize the advantageous compositions of the present disclosure. Examples of useful excipients which can optionally be added to the composition are described in the Handbook of Pharmaceutical Excipients, 3rd edition, Edited by A. H. Kibbe, Published by: American Pharmaceutical Association, Washington DC, ISBN: 0- 917330-96-X, and in Handbook of Pharmaceutical Excipients (4th edition), Edited by Raymond C Rowe - Publisher: Science and Practice.
[00060] Another aspect of the present disclosure provides a composition comprising: 35 to 45 % w/w of a Tephrosia purpurea of the total weight of the composition; 35 to 45 % w/w of a Phaeodactylum tricornutum of the total weight of the composition; 8 to 12 % w/w of a Centella Asiatica of the total weight of the composition; and 8 to 12 % w/w of an Ocimum basilicum of the total weight of the composition.
[00061] In an embodiment, the composition further comprises 40 % w/w of a Tephrosia purpurea of the total weight of the composition; 40 % w/w of a Phaeodactylum tricornutum of the total weight of the composition; 10 % w/w of a Centella Asiatica of the total weight of the composition; and 10 % w/w of an Ocimum basilicum of the total weight of the composition.
[00062] Still another embodiment of the present disclosure provides formulation comprising: 30 to 50 % w/w of a Tephrosia purpurea of the total weight of the formulation; 30 to 50 % w/w of a Phaeodactylum tricornutum of the total weight of the formulation; 5 to 15 % w/w of a Centella Asiatica of the total weight of the formulation; 5 to 15 % w/w of an Ocimum basilicum of the total weight of the formulation; and rest being an excipient.
[00063] In an embodiment, the excipient is selected from a group consisting of thickening agent, a bulking agent, a lubricant, a solubilizer, a binder, a chelating agent, a colouring agent, a tonicity agent, a buffering agent, a preservative, a moisturizing agent, a film former/waterproofing agent, a rheology modifying agent, a fragrance, an emollient, a humectants, an emulsifier, a diluents, a solvent and a combination thereof.
[00064] In an embodiment, the formulation comprises one or more dosage form. In an embodiment, the dosage form is selected from a group consisting of nano-particles or microparticles, creams, lotion, gel, spray, ointment, granules, paste, powder, foam, film, emulsion or suspension.
[00065] The composition detailed herein can be manufactured in one or several dosage forms. In an embodiment, dosage form is selected from any or a combination of liquids such as suspensions, emulsions, semisolids, or gels. In an embodiment, the formulation may be in a solid, a liquid and a semi-solid form. In an embodiment, the solid may be nano-particles or microparticles. In an embodiment, the composition may be formulated into a cream, a lotion, a gel, a spray, an ointment, a granule, a paste, a powder, foam and a film. However, any or a combination of pharmaceutical dosage form(s), as known to or appreciated by a person skilled in the art, can be utilized to serve the intended purpose.
[00066] In an embodiment, the composition is administered topically. In an embodiment, the composition is administered topically. In an embodiment, the method involves application of the composition on the skin, optionally, only at the affected area till the skin is healed. In an embodiment, the composition is applied once or multiple times. In an embodiment, the composition is applied continuously for a long period of time, or intermittently.
[00067] In an embodiment, composition of the present disclosure can be used as a blend in other skin care compositions/formulations, and the other related compositions/formulations (formulated as including but not limited to serums, gels, lotion, oils, toners, cleansers, bath salts and the likes). Blending of the other compositions/formulations with the composition/formulation of the present disclosure further improves the benefit of the other compositions/formulations, particularly, with regards to skin permeability, reduction in cortisol level, improvement in skin tone, aging, mood and the likes.
[00068] With regards to the extract or the oil of any or a combination of Phaeodactylum tricornutum, Tephrosia purpurea, Centella asiatica, and Ocimum basilicum, commercially available extract or oil thereof can be used for realizing the composition of the present disclosure. Extracts may be available in concentrated liquid or dried powder form. However, extract prepared by any other method for isolation and extraction of active compounds, as known to or appreciated by a person skilled in the art, for example, maceration, soxhlet extraction, microwave-assisted extraction (MAE), ultrasound-assisted extraction (UAE), supercritical fluid extraction (SFE) and the likes can be used to serve its intended purpose, as laid down in the present disclosure.
[00069] In accordance with an embodiment, the ingredients of the composition of the present disclosure are commercially procured from the following trader:
S. No. INGREDIENTS TRADER
1 Tephrosia purpurea AKUMS Drugs & Pharmaceuticals Ltd.
Plot No.47, Sector 6A, I.I.E. SIDCUL, Ranipur, Haridwar, Uttarakhand 249403
2 Phaeodactylum tricornutum
3 Centella Asiatica
4 Ocimum basilicum

[00070] Phaeodactylum tricornutum is a diatom. It is the only species in the genus Phaeodactylum. Unlike other diatoms, P. tricornutum can exist in different morphotypes and changes in cell shape can be stimulated by environmental conditions. It is known to have an anti-bacterial effect, provide relief from pain, improves brain function and mental health.
[00071] Tephrosia purpurea is a species of flowering plant in the family Fabaceae that has a pantropical distribution. It is a common wasteland weed. In many parts it is under cultivation as green manure crop. It is found throughout India and Sri Lanka in poor soils. Tephrosia purpurea is also used traditionally as folk medicine. It is used in the treatment of leprosy, ulcers, asthma, and tumors, as well as diseases of the liver, spleen, heart, and blood. It is also known to have anti-anxiety and anti-depressant effects.
[00072] Centella asiatica, commonly known as Gotu kola, kodavan, indian pennywort and asiatic pennywort, is a herbaceous, perennial plant in the flowering plant family Apiaceae, cultivated in native to Southeast Asian countries such as India, Sri Lanka, China, Indonesia, and Malaysia as well as South Africa and Madagascar. It is known to reduce inflammation and improving blood circulation.
[00073] Ocimum basilicum is a genus of aromatic annual and perennial herbs and shrubs in the family Lamiaceae, native to the tropical and warm temperate regions of all 6 inhabited continents, with the greatest number of species in Africa. Ocimum basilicum is commonly known as basil. It is known to have bactericidal and anti-fungal effect. It is generally used for the treatment of headaches, coughs, diarrhoea, constipation, warts, worms, and kidney malfunctions.
[00074] In an embodiment, the composition of the present disclosure can be manufactured by any conventional method such as emulsification method, know to or appreciated by a person skilled in the art working in the related industry to serve the intended purpose. However, any other method known to or appreciated by a person skilled in the art can be used to serve the intended purpose.
[00075] The composition of the present disclosure helps reduce the signs of aging, mental stress and promotes psychological well being of a subject. The ingredients of the composition of the present disclosure exhibit functional reciprocity there between, and accordingly aids in reducing signs of aging, enhancing permeation, reducing stress (mood enhancer) and promoting the overall mental well-being of the subject. Compositions/formulations of the present disclosure also exhibit superior storage stability.
[00076] Stress, anxiety, insomnia and the likes are some of the major contributors to most common problems like acne, skin aging, dullness, etc. The composition of the present disclosure acts by various mechanisms to enhance the skin permeation (allow deep penetration), relax the skin, improve the mood of the subject, and reduce cortisol levels.
[00077] Composition upon application, contacts the nerve endings in the dermis layer, interacts with the nervous system of the subject, effectively reduces cortisol production, and enhances the mood thereof. Further, there are neuropeptides present on the surface of the skin which act as neuromodulators for sending signals to the brain. The composition, upon application, comes in contact with these neuropeptides, penetrates deeply and carries the message of well-being (reduces stress) to the brain by enhancing the dopamine production and reducing cortisol levels. The composition strongly exhibits deep permeation and mood-enhancing benefits.
[00078] The composition upon application also increases the bio-permeation of the product than most of other commercially available topical compositions. The composition has the property to enhance penetration of the ingredients deep into the epidermis, and thereby effectively reduces cortisol levels, and increases B-endorphins and antioxidants production.
[00079] Still another aspect of the present disclosure relates to a method for reducing signs of aging, stress, enhancing penetration and promoting mental well-being of a subject, said method comprising administering to a subject in need thereof a composition comprising: 30 to 50 % w/w of a Tephrosia purpurea of the total weight of the composition; 30 to 50 % w/w of a Phaeodactylum tricornutum of the total weight of the composition; 5 to 15 % w/w of a Centella Asiatica of the total weight of the composition; and 5 to 15 % w/w of an Ocimum basilicum of the total weight of the composition. In another embodiment, composition comprises: 35 to 45 % w/w of a Tephrosia purpurea of the total weight of the composition; 35 to 45 % w/w of a Phaeodactylum tricornutum of the total weight of the composition; 8 to 12 % w/w of a Centella Asiatica of the total weight of the composition; and 8 to 12 % w/w of an Ocimum basilicum of the total weight of the composition.
[00080] Another aspect of the present disclosure relates to a pharmaceutical composition for use in reducing signs of aging, stress, enhancing penetration and promoting mental well being of a subject, said composition including: 30 to 50 % w/w of a Tephrosia purpurea of the total weight of the composition; 30 to 50 % w/w of a Phaeodactylum tricornutum of the total weight of the composition; 5 to 15 % w/w of a Centella Asiatica of the total weight of the composition; and 5 to 15 % w/w of an Ocimum basilicum of the total weight of the composition. In another embodiment, composition comprises: 35 to 45 % w/w of a Tephrosia purpurea of the total weight of the composition; 35 to 45 % w/w of a Phaeodactylum tricornutum of the total weight of the composition; 8 to 12 % w/w of a Centella Asiatica of the total weight of the composition; and 8 to 12 % w/w of an Ocimum basilicum of the total weight of the composition.
[00081] Still further aspect of the present disclosure relates to use of a pharmaceutical composition for manufacture of a medicament for reducing signs of aging, stress, enhancing penetration and promoting mental well being of a subject, said composition including: 30 to 50 % w/w of a Tephrosia purpurea of the total weight of the composition; 30 to 50 % w/w of a Phaeodactylum tricornutum of the total weight of the composition; 5 to 15 % w/w of a Centella Asiatica of the total weight of the composition; and 5 to 15 % w/w of an Ocimum basilicum of the total weight of the composition. In another embodiment, composition comprises: 35 to 45 % w/w of a Tephrosia purpurea of the total weight of the composition; 35 to 45 % w/w of a Phaeodactylum tricornutum of the total weight of the composition; 8 to 12 % w/w of a Centella Asiatica of the total weight of the composition; and 8 to 12 % w/w of an Ocimum basilicum of the total weight of the composition.
[00082] The foregoing description of the specific embodiments will so fully reveal the general nature of the embodiments herein that others can, by applying current knowledge, readily modify and/or adapt for various applications such specific embodiments without departing from the generic concept, and, therefore, such adaptations and modifications should and are intended to be comprehended within the meaning and range of equivalents of the disclosed embodiments. It is to be understood that the phraseology or terminology employed herein is for the purpose of description and not of limitation. Therefore, while the embodiments herein have been described in terms of preferred embodiments, those skilled in the art will recognize that the embodiments herein can be practiced with modification within the spirit and scope of the embodiments as described herein.
EXAMPLES
[00083] The present invention is further explained in the form of following examples. However, it is to be understood that the following examples are merely illustrative and are not to be taken as limitations upon the scope of the invention.
Example 1
(a) Composition
Table 1: A composition of the present invention.
Ingredient Amount (percentage)
Tephrosia purpurea 40 %
Phaeodactylum tricornutum 40 %
Centella Asiatica 10 %
Ocimum basilicum 10 %

[00084] The composition of the present invention was prepared by conventional emulsification method, weighing of 40% w/w of Tephrosia purpurea, 40 % w/w of Phaeodactylum tricornutum, 10 % w/w of Centella Asiatica and 10 % w/w of Ocimum basilicum as given in above Table 1 and were mixed together to obtain a composition.
(b) Efficacy (Synergistic) study: Collagenase assay
[00085] The present study demonstrated that the combination of Tephrosia purpurea, Phaeodactylum tricornutum, Centella Asiatica, Ocimum basilicum exhibited significantly greater anti-collagenase activity compared to individual ingredients, suggesting their potential in skin care group.

Table 2: Concentration of Tephrosia purpurea, Phaeodactylum tricornutum, Centella Asiatica, Ocimum basilicum and the composition of the present invention.
S.No. Name of compound Concentration used
1 Tephrosia purpurea 1 mg/ml
2 Phaeodactylum tricornutum 1 mg/ml
3 Centella Asiatica 1 mg/ml
4 Ocimum basilicum 1 mg/ml
5 Present composition (Tephrosia purpurea (40%), Phaeodactylum tricornutum (40%), Centella Asiatica (10%) and Ocimum basilicum (10%) (Table 1) 1 mg/ml

[00086] The collagenase assays were performed by first dissolving 10 mg of test sample in 10 ml of dimethyl sulfoxide (DMSO) (sample solution is 1 mg/ml) (Table 2). Subsequently, 2 µL of the test inhibitor/test sample and 10 µL of provided Collagenase (0.35 U/mL) were added to the Test Inhibitor well(s). In parallel, a well designated as the Enzyme Control (EC) was prepared by adding 10 µL of the provided Collagenase. The volumes of the Test Inhibitor and Enzyme Control wells were adjusted to 100 µL using Collagenase Assay Buffer. These preparations were then incubated at room temperature for a duration of 10 minutes. To initiate the assay reaction, a Reaction Mix was prepared for the all wells. For each reaction, 100 µL of Reaction Mix was prepared, comprising 40 µL of Collagenase Substrate (FALGPA) and 60 µL of Collagenase Assay Buffer. The Reaction Mix was thoroughly mixed, and 100 µL of it was added to each respective well, ensuring proper mixing. Absorbance measurements were recorded immediately using a microplate reader at 345 nm wavelength in kinetic mode. This was conducted at a temperature of 37?C for a duration of 15 minutes. In cases where samples exhibited low enzymatic activity, the absorbance measurements were extended to 1–3 hours. Calculated percent inhibition using the following equation:

Table 3: Percentage inhibition of Tephrosia purpurea, Phaeodactylum tricornutum, Centella Asiatica, Ocimum basilicum and composition of the present invention.
S.No. Name of Compound % Inhibition
1 Tephrosia purpurea 90.2
2 Phaeodactylum tricornutum 88.8
3 Centella Asiatica 72.6
4 Ocimum basilicum 28.2
5 Present composition (Tephrosia purpurea (40%), Phaeodactylum tricornutum (40%), Centella Asiatica (10%) and Ocimum basilicum (10%) (Table 1) 96.0

[00087] In this study, among the tested ingredients, the present composition (i.e., the Combination of Blend of 4 ingredients in the ratio- Tephrosia purpurea (40%), Phaeodactylum tricornutum (40%), Centella Asiatica (10%) and Ocimum basilicum (10%) demonstrated the highest inhibition percentage, with an impressive 96.0% inhibition of collagenase activity as compare to individual ingredients. Tephrosia purpurea and Phaeodactylum tricornutum showed lower anti-collagenase activity, with inhibition percentages of 90.2%, and 88.8%, respectively. Centella Asiatica displayed a 72.6% inhibition rate. Ocimum basilicum demonstrated a 28.2.% inhibition rate as shown in Table 3. Indeed, all ingredients possess good amount of anti-collagenase action, but when all ingredients are blended together in proper proportion the final composition showed synergistic action. It may be because action through multiple mechanisms. Firstly, the final Mixture can help to inhibit the activity of collagenase enzymes, preventing collagen degradation. Secondly, composition may possess strong antioxidant properties, which help to neutralize reactive oxygen species (ROS) that contribute to the activation of collagenase enzymes, suggesting their potential in skin care group.
(c) In vitro penetration enhancement study
[00088] Gel preparation was carried out by selecting HPMC K4M as gel base as it was found to be compatible with all components. UV Visible spectrophotometric calibration curve development for individual components in water were carried out to get the calibration curve equation which was used for calculation of arbitrary concentration. It was assumed that 1 ml of liquid component in 99 ml of solvent gives 100 PPM solution. Further calculations are based on same assumption. Calibration curve was plotted with average absorbance values in triplicate for increasing concentrations. Diffusion or release studies were carried out in Franz Diffusion cell for individual component gels (containing Tephrosia purpurea (40%), Phaeodactylum tricornutum (40%), Centella Asiatica (10%) and Ocimum basilicum (10%) individually) and mixture gel containing all components together in same proportion. Diffusion studies were carried out in triplicate (3 sets) for all the gel preparations. Concentration calculation was performed using calibration curve equations of individual pure components.
Preparation of gel
[00089] 4 % HPMC K4M gel - 2 gm HPMC K4M + 50 gm water (make upto 100 gm volume)
• Tephrosia purpurea - 6 gm gel + 4 gm solution
• Phaeodactylum tricornutum - 6 gm gel + 4 gm solution
• Centella Asiatica - 9 gm gel + 1 gm solution
• Ocimum basilicum - 9 gm gel + 1 gm solution

Table 4: Comparative studies for release pattern of component in Tephrosia purpurea gel and in composition gel.
Time interval Release of individual Tephrosia purpurea (267 nm) Release of composition
Average absorbance Average absorbance
30 min 0.0411 1.9427
1 hr 0.2183 2.6470

[00090] A comparative release of Tephrosia purpurea gel and in composition gel in 1 hrs is given in Table 4. The release of Tephrosia purpurea in the individual and composition was observed 0.2183 and 2.6470 respectively in 1 hrs. The results indicate that enhanced release was observed in the composition as compared to individual Tephrosia purpurea.
Table 5: Comparative studies for release pattern of component in Phaeodactylum tricornutum gel and in composition gel.
Time interval Release of individual Phaeodactylum tricornutum (222 nm) Release of composition
Average absorbance Average absorbance
30 min 1.0715 2.0533
1 hr 1.235 3.0555

[00091] A comparative release of Phaeodactylum tricornutum gel and in composition gel in 1 hrs is given in Table 5. The release of Phaeodactylum tricornutum in the individual and composition was observed 1.235 and 3.0555 respectively in 1 hrs. The results indicate that enhanced release was observed in the composition as compared to individual Phaeodactylum tricornutum.

Table 6: Comparative studies for release pattern of centella asiatica gel and in composition gel.
Time interval Release of individual centella asiatica (270 nm) Release of composition
Average absorbance Average absorbance
30 min 0.1186 2.0217
1 hr 0.1389 2.7876

[00092] A comparative release of centella asiatica gel and in composition gel in 1 hrs is given in Table 6. The release of centella asiatica in the individual and composition was observed 0.1389 and 2.7876 respectively in 1 hrs. The results indicate that enhanced release was observed in the composition as compared to individual centella asiatica.

Table 7: Comparative studies for release pattern of Ocimum basilicum gel and in composition gel.
Time interval Release of individual Ocimum basilicum (276 nm) Release of mixture
Average absorbance Average absorbance
30 min 1.4142 1.8127
1 hr 1.2193 2.3414

[00093] A comparative release of Ocimum basilicum gel and in composition gel in 1 hrs is given in Table 7. The release of Ocimum basilicum in the individual and composition was observed 1.2193 and 2.3414 respectively in 1 hrs. The results indicate that enhanced release was observed in the composition as compared to individual Ocimum basilicum.
[00094] Thus, it was observed from the Tables 4 to 7 that enhanced release of each ingredient was obtained in the present composition. One of the key reasons for the enhanced penetration of a mixture of herbal extracts is the synergistic effect that occurs when Tephrosia purpurea, Phaeodactylum tricornutum, Centella Asiatica and Ocimum basilicum are included as part of a composition in the desired weight percentage as defined herein.
[00095] The foregoing examples are merely illustrative and are not to be taken as limitations upon the scope of the invention. Various changes and modifications to the disclosed embodiments will be apparent to those skilled in the art. Such changes and modifications may be made without departing from the scope of the invention.

ADVNATEGES OF THE INVENTION
[00096] The composition of the present disclosure showed significant greater anti-collagenase activity as compared to individual ingredient. The composition of the present disclosure also showed enhanced penetration than the individual ingredient. These results showed synergistic effect is unexpected and surprising.
,CLAIMS:1. A composition comprising:
30 to 50 % w/w of a Tephrosia purpurea of the total weight of the composition;
30 to 50 % w/w of a Phaeodactylum tricornutum of the total weight of the composition;
5 to 15 % w/w of a Centella Asiatica of the total weight of the composition; and
5 to 15 % w/w of an Ocimum basilicum of the total weight of the composition.
2. The composition as claimed in claim 1, wherein the composition further comprises one or more excipients.
3. The composition as claimed in claim 1, wherein the excipient is selected from a group consisting of a thickening agent, a bulking agent, a lubricant, a solubilizer, a binder, a chelating agent, a colouring agent, a tonicity agent, a buffering agent, a preservative, a moisturizing agent, a film former/waterproofing agent, a rheology modifying agent, a fragrance, an emollient, a humectants, an emulsifier, a diluents, a solvent and a combination thereof.
4. A composition comprising:
35 to 45 % w/w of a Tephrosia purpurea of the total weight of the composition;
35 to 45 % w/w of a Phaeodactylum tricornutum of the total weight of the composition;
8 to 12 % w/w of a Centella Asiatica of the total weight of the composition; and
8 to 12 % w/w of an Ocimum basilicum of the total weight of the composition.
5. The composition as claimed in claim 1, wherein the composition further comprises:
40 % w/w of a Tephrosia purpurea of the total weight of the composition;
40 % w/w of a Phaeodactylum tricornutum of the total weight of the composition;
10 % w/w of a Centella Asiatica of the total weight of the composition; and
10 % w/w of an Ocimum basilicum of the total weight of the composition.
6. A formulation comprising:
30 to 50 % w/w of a Tephrosia purpurea of the total weight of the formulation;
30 to 50 % w/w of a Phaeodactylum tricornutum of the total weight of the formulation;
5 to 15 % w/w of a Centella Asiatica of the total weight of the formulation;
5 to 15 % w/w of an Ocimum basilicum of the total weight of the formulation; and
rest being an excipient.
7. The formulation as claimed in claim 6, wherein the excipient is selected from a group consisting of a thickening agent, a bulking agent, a lubricant, a solubilizer, a binder, a chelating agent, a colouring agent, a tonicity agent, a buffering agent, a preservative, a moisturizing agent, a film former/waterproofing agent, a rheology modifying agent, a fragrance, an emollient, a humectants, an emulsifier, a diluents, a solvent and a combination thereof.
8. The formulation as claimed in claim 6, wherein the formulation comprises one or more dosage form.
9. The formulation as claimed in claim 6, wherein the dosage form is selected from a group consisting of nano-particles or microparticles, creams, lotion, gel, spray, ointment, granules, paste, powder, foam, film, emulsion or suspension.
10. The formulation as claimed in claim 6, wherein the formulation is administered topically.