DESC:FIELD OF THE INVENTION
[0001] The present disclosure relates generally to the field of pharmaceutical compositions. Particularly, the present disclosure provides a nutraceutical 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] 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. Reports suggest that emotional and physical stress increases the level of active cortisol in the skin by stimulating the expression of beta-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).
[0004] While the healthy food movement has been on the trend for the past few years, its significance has gained priority ever since the current pandemic set in. People have realized the importance of a healthier lifestyle, and this is where products like nutraceuticals have gained attention. Nutraceutical compositions (e.g. foods or naturally occurring food supplements intended for human ingestion, and thought to have a beneficial effect on human health) are commonly used for their preventative and medicinal qualities. Various nutraceuticals are recognized as providing relief from or preventing specific diseases and ailments.
[0005] Numerous compositions and formulations are reported in the literature, capable of improving the skin of an individual. However, these nutraceutical composition/formulations still suffer from certain limitations - target specific deficiencies like collagen, biotin, etc., apart from being expensive, ineffective, having low bioavailability, exhibiting certain side-effects such as irritation, allergy and broad health benefits. The skin is a reflection of the nutritional deficiencies and psychological problems. These factors such as poor gut health or anxiety issues lead to skin issues to flare up.
[0006] There is, therefore, a need in the art to develop a new and improved nutraceutical composition that improves the quality of the skin internally by targeting nutritional deficiencies as well as promoting the 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 OF THE INVENTION
[0007] Primary object of the present disclosure is to provide a composition that overcomes one or more limitations associated with the conventional compositions/formulations.
[0008] Another object of the present disclosure is to provide a composition that aids in reducing signs of aging, anxiety, insomnia and stress.
[0009] Another object of the present disclosure is to provide a nutraceutical composition that aids in reducing signs of aging, anxiety, insomnia and stress.
[00010] Another object of the present disclosure is to provide a composition that can be used as a blend in other nutraceutical compositions/formulations and the likes.
[00011] Another object of the present disclosure is to provide a composition that benefits the skin and enhances the mood of a subject.
[00012] Another object of the present disclosure is to provide a composition that reduces cortisol levels and increases serotonin production in a subject.
[00013] Another object of the present disclosure is to provide a composition that increases skin radiance, boost collagen production and reduces ageing signs on the skin.
[00014] Another object of the present disclosure is to provide a composition that increase the bio-availability of the ingredients used in the composition to have a deep routed effect when consumed.
[00015] Another object of the present disclosure is to provide a composition that exhibits superior storage stability and synergistic activity /functional reciprocity.
[00016] Another object of the present disclosure is to provide a composition that is easy to prepare and economical.
[00017] Another object of the present disclosure is to provide a method of preparation of said composition.
[00018] Other objects of the present disclosure will be apparent from the description of the invention herein below.

SUMMARY OF THE INVENTION
[00019] The present disclosure relates generally to the field of pharmaceutical compositions. Particularly, the present disclosure provides a nutraceutical composition for skin care and mental well-being. The present composition can also find its application as a blend in other compositions/formulations.
[00020] An aspect of the present disclosure provides a nutraceutical composition comprising: 30 to 50 % w/w of an Alpha-Casozepine of the total weight of the composition; 5 to 15 % w/w of a Crocus sativus of the total weight of the composition; 30 to 50 % w/w of a Bacopamonnieri of the total weight of the composition; and 5 to 15 % w/w of a Piper nigrum of the total weight of the composition.
[00021] Another aspect of the present disclosure provides a nutraceutical composition comprising: 35 to 45 % w/w of an Alpha-Casozepine of the total weight of the composition; 8 to 12 % w/w of a Crocus sativus of the total weight of the composition; 35 to 45 % w/w of a Bacopamonnieri of the total weight of the composition; and 8 to 12 % w/w of a Piper nigrum of the total weight of the composition.
[00022] Yet, another aspect of the present disclosure provides a nutraceutical formulation comprising: 30 to 50 % w/w of an Alpha-Casozepine of the total weight of the formulation; 5 to 15 % w/w of a Crocus sativus of the total weight of the formulation; 30 to 50 % w/w of a Bacopamonnieri of the total weight of the formulation; 5 to 15 % w/w of a Piper nigrum of the total weight of the formulation; and rest being an excipient.
[00023] 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 OF THE INVENTION
[00024] 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.
[00025] 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.
[00026] 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.
[00027] 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”.
[00028] As used herein, the terms “blend”, and “mixture” are all intended to be used interchangeably.
[00029] 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 and promotion of neural regeneration and mood enhancer and the like.
[00030] 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.
[00031] The headings and abstract of the invention provided herein are for convenience only and do not interpret the scope or meaning of the embodiments.
[00032] 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.
[00033] All publications herein are incorporated by reference to the same extent as if each individual publication or patent application were specifically and individually indicated to be incorporated by reference. Where a definition or use of a term in an incorporated reference is inconsistent or contrary to the definition of that term provided herein, the definition of that term provided herein applies and the definition of that term in the reference does not apply.
[00034] Groupings of alternative elements or embodiments of the invention disclosed herein are not to be construed as limitations. Each group member can be referred to and claimed individually or in any combination with other members of the group or other elements found herein. One or more members of a group can be included in, or deleted from, a group for reasons of convenience and/or patentability. When any such inclusion or deletion occurs, the specification is herein deemed to contain the group as modified thus fulfilling the written description that follows, and the embodiments described herein, is provided by way of illustration of an example, or examples, of particular embodiments of the principles and aspects of the present disclosure. These examples are provided for the purposes of explanation, and not of limitation, of those principles and of the disclosure.
[00035] Various terms as used herein are shown below. To the extent a term used in a claim is not defined below, it should be given the broadest definition persons in the pertinent art have given that term as reflected in printed publications and issued patents at the time of filing.
[00036] The present disclosure is on the premise of a surprising discovery that when Alpha-Casozepine, Crocus sativus, Bacopamonnieri and Piper nigrum are included as part of a nutraceutical 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.
[00037] The present disclosure relates generally to the field of pharmaceutical compositions. Particularly, the present disclosure provides a nutraceutical composition that boosts collagen production, delays skin ageing, promotes neural regeneration, reduces anxiety, insomnia, stress and promotes mental well-being of a subject through enhanced bioavailability of the ingredients used in the composition. The present composition can also find its application as a blend in other compositions/formulations.
[00038] An aspect of the present disclosure provides a provides a nutraceutical composition comprising: 30 to 50 % w/w of an Alpha-Casozepine of the total weight of the composition; 5 to 15 % w/w of a Crocus sativus of the total weight of the composition; 30 to 50 % w/w of a Bacopamonnieri of the total weight of the composition; and 5 to 15 % w/w of a Piper nigrum of the total weight of the composition.
[00039] In an embodiment, the composition comprising: whole of or a part of or an extract of Alpha-Casozepine, Crocus sativus, Bacopamonnieri, and Piper nigrum. The extract or the part may be obtained from root, leaves, shoot, fruits, rhizome, seed, stem, barks, flower, sap or bud of the plant and any combinations thereof.
[00040] 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 disintegrant, a chelating agent, a glidant, a colouring agent, a tonicity agent, a sweetening agent, a buffering agent, a preservative, 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.
[00041] 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.
[00042] 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.
[00043] 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.
[00044] 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.
[00045] In an embodiment, the binder(s) include but not limited to, cellulosic derivatives (such as methylcellulose, carboxymethyl cellulose, hydroxyethyl cellulose, hydroxyethylmethyl 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.
[00046] In an embodiment, the disintegrant(s) includes but not limited to, croscarmellose sodium, crospovidone, sodium starch glyconate, citric acid, calcium carbonate, pregelatinized starch,and combinations thereof. However, a person skilled in the art would appreciate that any other disintegrant(s) can be utilized to serve the intended purpose.
[00047] In an embodiment, the chelating agent(s) includes but not limited to, tetrasodiumglutamate 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.
[00048] In an embodiment, the glidant(s) includes but not limited to, colloidal silicon dioxide, precipitated silicon dioxide, fumed silica (CAB-O-SIL M-5P, trademark of Cabot Corporation), stearowet and sterotex, silicas (such as SILOID and SILOX silicas—trademarks of Grace Davison Products, Aerosil—trademark of Degussa Pharma), higher fatty acids, the metal salts thereof, hydrogenated vegetable oils, and combinations thereof. However, a person skilled in the art would appreciate that any other glidant(s) can be utilized to serve the intended purpose.
[00049] 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.
[00050] 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.
[00051] In an embodiment, the sweetening agent(s) includes but not limited to, sucralose, acesulfame-K, aspartame, saccharine or saccharine sodium and calcium salts, sodium cyclamate, sucrose, fructose, glucose, sorbitol, and combinations thereof. However, a person skilled in the art would appreciate that any other sweetening agent(s) can be utilized to serve the intended purpose.
[00052] 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.
[00053] 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.
[00054] 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.
[00055] In an embodiment, the rheology modifying agent(s) include, but are not limited to acrylates crosspolymer, acrylates/C10-30 alkylacrylatecrosspolymer, 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 decadienecrosspolymer, 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.
[00056] 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.
[00057] 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, oenocarpusbatauafruit 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.
[00058] 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.
[00059] 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.
[00060] 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.
[00061] 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.
[00062] 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.
[00063] Another embodiment of the present disclosure provides a nutraceutical composition comprising: 35 to 45 % w/w of an Alpha-Casozepine of the total weight of the composition; 8 to 12 % w/w of a Crocus sativus of the total weight of the composition; 35 to 45 % w/w of a Bacopamonnieri of the total weight of the composition; and 8 to 12 % w/w of a Piper nigrum of the total weight of the composition.
[00064] In an embodiment, the nutraceutical composition comprising: 40 % w/w of an Alpha-Casozepine of the total weight of the composition; 10 % w/w of a Crocus sativus of the total weight of the composition; 40 % w/w of a Bacopamonnieri of the total weight of the composition; and 10 % w/w of a Piper nigrum of the total weight of the composition.
[00065] Further, aspect of the present disclosure is to provide a nutraceutical formulation comprising: 30 to 50 % w/w of an Alpha-Casozepine of the total weight of the formulation; 5 to 15 % w/w of a Crocus sativus of the total weight of the formulation; 30 to 50 % w/w of a Bacopamonnieri of the total weight of the formulation; 5 to 15 % w/w of a Piper nigrum of the total weight of the formulation; and rest being an excipient.
[00066] In an embodiment, the excipient is selected from a group consisting of a thickening agent, a bulking agent, a lubricant, a solubilizer, a binder, a disintegrant, a chelating agent, a glidant, a colouring agent, a tonicity agent, a sweetening agent, a buffering agent, a preservative, 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.
[00067] The composition/formulation detailed herein can be manufactured in one or several dosage forms. The formulation comprises one or more dosage form. In an embodiment, dosage form is selected from any or a combination of capsule, tablets or caplets; pills; powders such as a sterile packaged powder, a dispensable powder, and an effervescent powder; capsules including both soft or hard gelatin capsules such as HPMC capsules, lozenges, a sachet, a sprinkle, a reconstitutable powder or shake, a troche, granules, 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. 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.
[00068] In an embodiment, the nutraceutical composition/formulation of the present disclosure is administered orally.
[00069] With regards to the extract of any or a combination of Alpha-Casozepine, Crocus sativus, Bacopamonnieri, and Piper nigrum, commercially available extract 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.
[00070] In accordance with an embodiment, the ingredients of the composition of the present disclosure are commercially procured from the following traders:
S.No. INGREDIENTS TRADERS
1 Alpha-Casozepine Sundyota Numandis Probioceuticals Pvt Ltd
701-702, 7th floor, Indraprasth Corporate,
100 ft road, Prahladnagar, Ahmedabad- 380 015
2 Crocus sativus Maxcure Nutravedics Limited
3,Sector-6A, I.I.E.,SIDCUL Ranipur,
Haridwar Uttarakhand 249403
3 Bacopamonnieri
4 Piper nigrum

[00071] Alpha-Casozepine is a bioactive peptide originating from a S1 casein, a protein in cow’s milk, which has an affinity for gamma-aminobutyric acid (GABA) receptors in the brain. It is reported to have an anxiolytic effect.
[00072] Crocus sativus is commonly known as saffron crocus, or autumn crocus. It is a species of flowering plant of the Crocus genus in the iris family Iridaceae. It is best known for producing the spice saffron from the filaments that grow inside the flower. Saffron flower petals are rich in phenolic compounds showing antimicrobial and antioxidant activity.
[00073] Bacopamonnieri is a perennial, creeping herb native to the wetlands of southern and Eastern India, Australia, Europe, Africa, Asia, and North and South America. It is known by the common names water hyssop, water hyssop and brahmi. It is known to enhance and improve memory. It also exhibits antioxidant activity.
[00074] Piper nigrum (black pepper) is a flowering plant belonging to the Piperaceae family. It is cultivated as a fruit, dried, and used as a spice and seasoning. It grows in the southern parts of India and other tropical regions. The active constituent present in P. nigrum is piperine and has been used as a natural bioenhancer with other drugs to potentiate their therapeutic effects.
[00075] In an embodiment, the composition of the present disclosure can be manufactured by any conventional method such as homogenization method, know to or appreciated by a person skill in the art working in the related industry to serve the intended purpose. In an embodiment, any other method known to or appreciated by a person skilled in the art can be utilized to serve the intended purpose.
[00076] The ingredients of the composition/formulation of the present disclosure exhibit functional reciprocity there between, and accordingly aids in reducing signs of aging, anxiety, insomnia, stress and promoting mental well being of a subject. Compositions/formulations of the present disclosure also exhibit superior storage stability. Composition/formulation of the present disclosure upon ingestion interacts with some specific receptors, effectively reducing the cortisol production and increase in the production of serotonin in a subject, and hence, enhances the mood thereof (by providing relief from the stress). It also improves the overall quality of the skin (reduces the sign of aging, acne, dullness, stress etc.), upon frequent usage. It further facilitates neuronal regeneration and improves the synthesis of collagen (a major component of skin) that plays a vital role in strengthening as well as in maintaining elasticity and hydration of the skin. Composition/formulation of the present disclosure increases the bioavailability of each of ingredients, and enhances efficacy thereof.
[00077] In an embodiment, composition of the present disclosure can be used as a blend in other nutraceutical compositions/formulations. In an embodiment, composition of the present disclosure can be blended with any other compositions or formulations, including but not limited to nutraceutical compositions/formulations. Blending of the other compositions/formulations with the composition of the present disclosure further improves the benefit of the other compositions/formulations, particularly, with regards to aging, anxiety, insomnia, stress and mental well being of a subject.
[00078] Still another aspect of the present disclosure relates to a method for boosting collagen production, delaying skin ageing, promoting neural regeneration, reducing anxiety, insomnia, stress and promoting mental well-being of a subject, said method comprising administering to a subject in need thereof a nutraceutical composition comprising 30 to 50 % w/w of Alpha-Casozepine, 5 to 15 % w/w of Crocus sativus, 30 to 50 % w/w of Bacopamonnieri, and 5 to 15 % w/w of Piper nigrum. In an embodiment, the composition further comprises one or a plurality of excipient(s). In another embodiment, the nutraceutical composition comprises: 35 to 45 % w/w of Alpha-Casozepine, 8 to 12 % w/w of Crocus sativus, 35 to 45 % w/w of Bacopamonnieri, and 8 to 12 % w/w of Piper nigrum. In an embodiment, the composition further comprises one or a plurality of excipient(s). In another embodiment, the nutraceutical composition comprises: 40 % w/w of Alpha-Casozepine, 10 % w/w of Crocus sativus extract, 40 % w/w of Bacopamonnieri extract, and 10 % w/w of Piper nigrum extract. In an embodiment, the composition further comprises one or a plurality of excipient(s).
[00079] Another aspect of the present disclosure relates to a nutraceutical composition for use in boosting collagen production, delaying skin ageing, promoting neural regeneration, reducing anxiety, insomnia, stress and promoting mental well-being of a subject, said nutraceutical composition including any or a combination of: 30 to 50 % w/w of Alpha-Casozepine, 5 to 15 % w/w of Crocus sativus, 30 to 50 % w/w of Bacopamonnieri, and 5 to 15 % w/w of Piper nigrum. In an embodiment, the composition further comprises one or a plurality of excipient(s). In an embodiment, the nutraceutical composition comprises: a 35 to 45 % w/w of Alpha-Casozepine, 8 to 12 % w/w of Crocus sativus, 35 to 45 % w/w of Bacopamonnieri, and 8 to 12 % w/w of Piper nigrum. In an embodiment, the composition further comprises one or a plurality of excipient(s). In an embodiment, the nutraceutical composition comprises: 40 % w/w of Alpha-Casozepine, 10 % w/w of Crocus sativus extract, 40 % w/w of Bacopamonnieri extract, and 10 % w/w of Piper nigrum extract. In an embodiment, the composition further comprises one or a plurality of excipient(s).
[00080] Still further aspect of the present disclosure relates to use of a nutraceutical composition for manufacture of a medicament for boosting collagen production, delaying skin ageing, promoting neural regeneration, reducing anxiety, insomnia, stress and promoting mental well-being of a subject, said composition including 30 to 50 % w/w of Alpha-Casozepine, 5 to 15 % w/w of Crocus sativus, 30 to 50 % w/w of Bacopamonnieri, and 5 to 15 % w/w of Piper nigrum. In an embodiment, the composition further comprises one or a plurality of excipient(s). In an embodiment, the nutraceutical composition comprises: 35 to 45 % w/w of Alpha-Casozepine, 8 to 12 % w/w of Crocus sativus, 35 to 45 % w/w of Bacopamonnieri, and 8 to 12 % w/w of Piper nigrum. In an embodiment, the composition further comprises one or a plurality of excipient(s). In an embodiment, the nutraceutical composition comprises: 40 % w/w of Alpha-Casozepine, 10 % w/w of Crocus sativusextract, 40 % w/w of Bacopamonnieri extract, and 10 % w/w of Piper nigrum extract. In an embodiment, the composition further comprises one or a plurality of excipient(s).
[00081] While the foregoing describes various embodiments of the disclosure, other and further embodiments of the disclosure may be devised without departing from the basic scope thereof. The invention is not limited to the described embodiments, versions or examples, which are included to enable a person having ordinary skill in the art to make and use the invention when combined with information and knowledge available to the person having ordinary skill in the art.
EXAMPLES
[00082] 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) NUTRACEUTICAL COMPOSITION

Table 1: A nutraceutical composition
Ingredient Amount (percentage)
Bacopamonnieri (Brahmi Extract) 40 %
Crocus sativus (Saffron Extract) 10 %
Piper nigrum (Piperine) 10 %
Alpha-Casozepine (Hydrolyzed milk protein) 40 %

[00083] The nutraceutical composition of the present invention was prepared by conventional homogenization method, weighing of 40% w/w of Bacopamonnieri (Brahmi Extract), 10 % w/w of Crocus sativus (Saffron Extract), 10 % w/w of Piper nigrum (Piperine) and 40 % w/w of Alpha-Casozepine (Hydrolyzed milk protein) as given in above Table 1 and were mixed together to obtain a nutraceutical composition.
(B) EFFICACY (SYNERGISTIC) STUDY: COLLAGENASE ASSAY
[00084] The present study demonstrated that the combination of Brahmi, saffron, piperine, and hydrolyzed milk protein extract exhibited significantly greater anti-collagenase activity compared to individual ingredients, suggesting their potential in anti-aging and skin care group.
[00085] 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 2: Concentration of brahmi extract, saffron extract, piperine, hydrolyzed milk protein and nutraceutical composition of the present invention.
S.No. Name of compound Concentration used
1 Brahmi extract 1 mg/ml
2 Saffron extract 1 mg/ml
3 Piperine 1 mg/ml
4 Hydrolyzed milk protein 1 mg/ml
5 Nutraceutical composition (Hydrolised Milk Protein (40%), Brahmi extract (40%), Piperine (10%) and Saffron extract (10%)) (Table 1) 1 mg/ml

Table 3: Percentage inhibition of brahmi extract, saffrom extract, piperine, hydrolyzed milk protein and nutraceutical composition of the present invention.
S. No. Name of Compound % Inhibition
1 Brahmi extract 66.2
2 Saffron extract 63.4
3 Piperine 59.0
4 Hydrolyzed milk protein 75.7
5 Nutraceutical composition (Hydrolised Milk Protein (40%), Brahmi extract (40%), Piperine (10%) and Saffron extract (10%)) as shown in Table 1 77.8

[00086] In this study, among the tested ingredients, the nutraceutical composition (i.e., the Combination of Blend of 4 ingredients in the ratio- Hydrolysed Milk Protein (40%), Bacopa (40%), Piperine (10%) and Saffron (10%)) demonstrated the highest inhibition percentage, with an impressive 77.8% inhibition of collagenase activity as compare to individual ingredients. Black Pepper Extract, and Saffron Extract, showed lower anti-collagenase activity, with inhibition percentages of 59.0%, and 63.4%, respectively. Brahmi Extract displayed a 66.2% inhibition rate. Milk protein hydrolysate (HMP) demonstrated a 75.7% inhibition rate as shown in Table 3.
[00087] It has been observed from the above study that when all the ingredients are blended together in proper proportion the final composition showed synergistic action. It may be because action through multiple mechanisms. Firstly, the final composition 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. This synergistic interaction can lead to enhanced biological activity and improved therapeutic outcomes. Furthermore, combining herbal extracts may also help to address the limitations or potential side effects associated with individual extracts. By combining different extracts, it is possible to achieve a balanced and well-rounded formulation that minimizes any potential adverse effects and maximizes the therapeutic benefits. Overall, in the primary proof of concept study, the evidence from in vitro studies suggests that the combination or blend of herbal ingredients holds promise as a more effective approach to utilizing the therapeutic potential of herbal ingredients.
[00088] 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
[00089] The nutraceutical composition of the present disclosure helps to inhibit the activity of collagenase enzymes, preventing collagen degradation. The composition may possess strong antioxidant properties, which help to neutralize reactive oxygen species (ROS) that contribute to the activation of collagenase enzymes. In vitro studies have demonstrated that the combination or blend of herbal extracts generally exhibits superior action compared to individual herbal extracts. Thus, the combination of Brahmi, saffron, piperine, and hydrolyzed milk protein extract exhibited significantly greater anti-collagenase activity compared to individual ingredients, suggesting their potential in anti-aging and skin care group.
,CLAIMS:1. A nutraceutical composition comprising:
30 to 50 % w/w of an Alpha-Casozepine of the total weight of the composition;
5 to 15 % w/w of a Crocus sativus of the total weight of the composition;
30 to 50 % w/w of a Bacopamonnieri of the total weight of the composition; and
5 to 15 % w/w of a Piper nigrum 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 2, wherein the excipient(s) is selected from a group consisting of a thickening agent, a bulking agent, a lubricant, a solubilizer, a binder, a disintegrant, a chelating agent, a glidant, a colouring agent, a tonicity agent, a sweetening agent, a buffering agent, a preservative, 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 nutraceutical composition comprising:
35 to 45 % w/w of an Alpha-Casozepine of the total weight of the composition;
8 to 12 % w/w of a Crocus sativus of the total weight of the composition;
35 to 45 % w/w of a Bacopamonnieri of the total weight of the composition; and
8 to 12 % w/w of a Piper nigrum of the total weight of the composition.
5. The composition as claimed in claim 1, wherein the nutraceutical composition comprising:
40 % w/w of an Alpha-Casozepine of the total weight of the composition;
10 % w/w of a Crocus sativus of the total weight of the composition;
40 % w/w of a Bacopamonnieri of the total weight of the composition; and
10 % w/w of a Piper nigrum of the total weight of the composition.
6. A nutraceutical formulation comprising:
30 to 50 % w/w of an Alpha-Casozepine of the total weight of the formulation;
5 to 15 % w/w of a Crocus sativus of the total weight of the formulation;
30 to 50 % w/w of a Bacopamonnieri of the total weight of the formulation;
5 to 15 % w/w of a Piper nigrum 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 disintegrant, a chelating agent, a glidant, a colouring agent, a tonicity agent, a sweetening agent, a buffering agent, a preservative, 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 tablet, capsule, lozenges, sachet, sprinkle, reconstitutable powder or shake, a troche, granules, powder, solution, syrup, emulsion, suspension, semisolids or gel.
10. The formulation as claimed in claim 6, wherein the formulation is administered orally.