DESC:FIELD OF THE INVENTION
[0001] The present disclosure relates to cannabidiol (CBD). More specifically, the disclosure is directed to compositions or formulations comprising cannabidiol. The disclosure further relates to a method of preparing the same.

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] Cannabis plant, such as Cannabis sativa, Cannabis indica, Cannabis ruderalis, is known to comprise several constituents called cannabinoids with medical benefits. Tetrahydrocannabinol (THC), the most abundant component of the plant, is known to be psychoactive and is proven to be the ingredient responsible for the ‘high’ from marijuana. Cannabidiol or CBD is one of the many phyto-components of the cannabis plant and is considered the second most abundant component. This phyto-cannabinoid in cannabis plants accounts for up to 40% of the plant's extract. Unlike THC, it is considered to be devoid of psycho-activity. It has the molecular formula of C21H30O2 with the following structure (Formula I):

[0004] Significant efforts have been put towards finding new and improved compositions comprising cannabidiol, however, none of the current approaches/treatments seems to satisfy the existing needs, and are either proved ineffective or lead to serious long term side-effects. The inventors of the present disclosure provide safe and effective compositions comprising CBD.

OBJECTS OF THE INVENTION
[0005] An object of the present disclosure is to provide a pharmaceutical composition comprising cannabidiol or pharmaceutically acceptable salts thereof.
[0006] It is an object of the present disclosure is to provide a pharmaceutical formulation comprising cannabidiol or pharmaceutically acceptable salts thereof.
[0007] It is an object of the present disclosure is to provide a food supplement composition comprising cannabidiol or pharmaceutically acceptable salts thereof.
[0008] It is an object of the present disclosure is to provide a food supplement formulation comprising cannabidiol or pharmaceutically acceptable salts thereof.
[0009] It is an object of the disclosure to provide a composition that exhibits superior storage stability and synergistic activity /functional reciprocity.
[0010] It is an object of the disclosure to provide a composition that is easy to prepare and economical.
[0011] Other objects of the present invention will be apparent from the description of the invention herein below.

SUMMARY OF THE INVENTION
[0012] This summary is provided to introduce a selection of concepts in a simplified form that are further described below in Detailed Description section. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used as an aid in determining the scope of the claimed subject matter.
[0013] In an aspect, the present disclosure provides a pharmaceutical composition comprising as an active agent - cannabidiol or pharmaceutically acceptable salts thereof.
[0014] In an aspect, the present disclosure provides a pharmaceutical composition comprising a therapeutically effective amount of cannabidiol or pharmaceutically acceptable salts thereof.
[0015] In an embodiment, the present disclosure provides a food supplement composition comprising as an active agent - cannabidiol or pharmaceutically acceptable salts thereof.
[0016] In an embodiment, the present disclosure provides a food supplement formulation comprising as an active agent - cannabidiol or pharmaceutically acceptable salts thereof.
[0017] In an aspect, the present disclosure provides a pharmaceutical composition comprising cannabidiol or pharmaceutically acceptable salts thereof in an amount ranging between 0.02% and 2% by weight of the composition; optionally, one or more additional ingredients in an amount ranging between 0.02% and 2% by weight of the composition; and one or more pharmaceutically acceptable excipient in an amount ranging from 0.08% to 99.98% by weight of the composition.
[0018] In an aspect, the present disclosure provides a pharmaceutical composition comprising cannabidiol or pharmaceutically acceptable salts thereof in an amount ranging between 0.02% and 2% by weight of the composition; optionally, one or more additional ingredients in an amount ranging between 0.02% and 2% by weight of the composition; and one or more pharmaceutically acceptable excipient in an amount ranging from 0.08% to 99.98% by weight of the composition.
[0019] In an aspect, the present disclosure provides a food supplement composition comprising cannabidiol or pharmaceutically acceptable salts thereof in an amount ranging between 0.02% and 2% by weight of the composition; optionally, one or more additional ingredients in an amount ranging between 0.02% and 2% by weight of the composition; and one or more pharmaceutically acceptable excipient in an amount ranging from 0.08% to 99.98% by weight of the composition.
[0020] In an aspect, the present disclosure provides a food supplement composition comprising cannabidiol or pharmaceutically acceptable salts thereof in an amount ranging between 0.02% and 2% by weight of the composition; optionally, one or more additional ingredients in an amount ranging between 0.02% and 2% by weight of the composition; and one or more pharmaceutically acceptable excipient in an amount ranging from 0.08% to 99.98% by weight of the composition.
[0021] In an embodiment, the present disclosure provides a composition for enhancing anti-oxidant activity in a subject, said composition comprising a therapeutically effective amount of cannabidiol or pharmaceutically acceptable salts thereof.
[0022] In an embodiment, the present disclosure provides a composition for enhancing anti-inflammatory activity in a subject, said composition comprising a therapeutically effective amount of cannabidiol or pharmaceutically acceptable salts thereof.
[0023] In an embodiment, the present disclosure provides a composition for anti-aging in a subject, said composition comprising a therapeutically effective amount of cannabidiol or pharmaceutically acceptable salts thereof.
[0024] In an embodiment, the present disclosure provides a composition for enhancing skin viability in a subject, said composition comprising a therapeutically effective amount of cannabidiol or pharmaceutically acceptable salts thereof.
[0025] In an embodiment, the composition may further comprise any or a combination of eucalyptus oil, clove oil, ginseng, hempseed oil, menthol, ylang-ylang oil, rosemary oil, aloe vera, lavender oil, peppermint, borneol, grapeseed oil, brahmi oil, amla oil, extract of cranberry, chamomile oil, mint, fenugreek, and spearmint. In an embodiment, the composition comprises whole of ginseng, whole of aloe vera, whole of peppermint, whole of mint, whole of fenugreek, whole of spearmint, part of ginseng, part of aloe vera, part of peppermint, part of mint, part of fenugreek, part of spearmint, extract of ginseng, extract of aloe vera, extract of peppermint, extract of mint, extract of fenugreek, extract of spearmint, or combinations thereof. The part or extract may be obtained from root, leaves, shoot, fruits, rhizome, seed, stem, barks, flower, tubers, sap, bud and combinations thereof of the plant.
[0026] In an embodiment, the composition further comprises a pharmaceutically acceptable excipient. In an embodiment, the pharmaceutically acceptable excipient may be selected from any or a combination of a bulking agent, a diluent, a solubilizer, a binder, a disintegrant, a chelating agent, a glidant, a flavouring agent, a colouring agent, a tonicity agent, a sweetening agent, a buffering agent, a preservative, lubricant, and a co-solvent.
[0027] In an aspect, the present disclosure provides a pharmaceutical composition comprising as an active agent - cannabidiol or pharmaceutically acceptable salts thereof. In an aspect, the present disclosure provides a pharmaceutical composition comprising a therapeutically effective amount of cannabidiol or pharmaceutically acceptable salts thereof. In an embodiment, the present disclosure provides a pharmaceutical composition for enhancing anti-inflammatory activity comprising a therapeutically effective amount of cannabidiol or pharmaceutically acceptable salts thereof. In an embodiment, the present disclosure provides a pharmaceutical composition for reducing stress comprising a therapeutically effective amount of cannabidiol or pharmaceutically acceptable salts thereof. In an embodiment, the present disclosure provides a pharmaceutical composition for anti-aging comprising a therapeutically effective amount of cannabidiol or pharmaceutically acceptable salts thereof. In an embodiment, the present disclosure provides a pharmaceutical composition for enhancing skin viability in a subject comprising a therapeutically effective amount of cannabidiol or pharmaceutically acceptable salts thereof.
[0028] In an aspect, the present disclosure provides a food supplement composition comprising as an active agent - cannabidiol or pharmaceutically acceptable salts thereof. In an embodiment, the present disclosure provides a food supplement composition for enhancing anti-inflammatory activity comprising a therapeutically effective amount of cannabidiol or pharmaceutically acceptable salts thereof. In an embodiment, the present disclosure provides a food supplement composition for reducing stress comprising a therapeutically effective amount of cannabidiol or pharmaceutically acceptable salts thereof. In an embodiment, the present disclosure provides a food supplement composition for anti-aging comprising a therapeutically effective amount of cannabidiol or pharmaceutically acceptable salts thereof. In an embodiment, the present disclosure provides a food supplement composition for enhancing skin viability in a subject comprising a therapeutically effective amount of cannabidiol or pharmaceutically acceptable salts thereof.
[0029] In an aspect, the present disclosure provides a pharmaceutical formulation comprising as an active agent - cannabidiol or pharmaceutically acceptable salts thereof. In an aspect, the present disclosure provides a pharmaceutical formulation comprising a therapeutically effective amount of cannabidiol or pharmaceutically acceptable salts thereof. In an embodiment, the present disclosure provides a pharmaceutical formulation for enhancing anti-inflammatory activity comprising a therapeutically effective amount of cannabidiol or pharmaceutically acceptable salts thereof. In an embodiment, the present disclosure provides a pharmaceutical formulation for reducing stress comprising a therapeutically effective amount of cannabidiol or pharmaceutically acceptable salts thereof. In an embodiment, the present disclosure provides a pharmaceutical formulation for anti-aging comprising a therapeutically effective amount of cannabidiol or pharmaceutically acceptable salts thereof. In an embodiment, the present disclosure provides a pharmaceutical formulation for enhancing skin viability in a subject comprising a therapeutically effective amount of cannabidiol or pharmaceutically acceptable salts thereof.
[0030] In an aspect, the present disclosure provides a food supplement formulation comprising as an active agent - cannabidiol or pharmaceutically acceptable salts thereof. In an embodiment, the present disclosure provides a food supplement formulation for enhancing anti-inflammatory activity comprising a therapeutically effective amount of cannabidiol or pharmaceutically acceptable salts thereof. In an embodiment, the present disclosure provides a food supplement formulation for reducing stress comprising a therapeutically effective amount of cannabidiol or pharmaceutically acceptable salts thereof. In an embodiment, the present disclosure provides a food supplement formulation for anti-aging comprising a therapeutically effective amount of cannabidiol or pharmaceutically acceptable salts thereof. In an embodiment, the present disclosure provides a food supplement formulation for enhancing skin viability in a subject comprising a therapeutically effective amount of cannabidiol or pharmaceutically acceptable salts thereof.
[0031] In an aspect, the present disclosure provides a method of preparing a composition or formulation comprising a therapeutically effective amount of cannabidiol or pharmaceutically acceptable salts thereof.
[0032] In another aspect, the present disclosure relates to a method of enhancing anti-inflammatory activity in a subject by administering to the subject, a composition comprising cannabidiol or pharmaceutically acceptable salts thereof. In an embodiment, the present disclosure relates to a method of enhancing anti-oxidant activity in a subject by administering to the subject, a composition cannabidiol or pharmaceutically acceptable salts thereof. In another embodiment, the present disclosure relates to a method of decreasing aging in a subject by administering to the subject, a composition comprising cannabidiol or pharmaceutically acceptable salts thereof.
[0033] In yet another aspect, the present disclosure relates to a method of enhancing skin viability in a subject by administering to the subject, a composition comprising cannabidiol or pharmaceutically acceptable salts thereof.
[0034] In yet another aspect, the present disclosure relates to a method of enhancing wound healing in a subject by administering to the subject, a composition comprising cannabidiol or pharmaceutically acceptable salts thereof.
[0035] In yet another aspect, the present disclosure relates to a method for reducing stress in a subject by administering to the subject, a composition comprising cannabidiol or pharmaceutically acceptable salts thereof.
[0036] Other aspects of the invention will be set forth in the description which follows, and in part will be apparent from the description, or may be learnt by the practice of the invention.

BRIEF DESCRIPTION OF DRAWINGS
[0037] Characteristics and advantages of the subject matter as disclosed in the present disclosure will become clearer from the detailed description of an embodiment thereof, with reference to the attached drawing, given purely by way of an example, in which:
[0038] FIG. 1(a) - (c) represent the bar graph of the in vitro anti-inflammatory activity of CBD by inhibiting TNF-a, IL-8, and IL-6.
[0039] FIG. 2(a) and FIG. 2(b) represents the graph of anti-inflammatory activity of CBD in animal model.
[0040] FIG. 3(a) - (d) represent the graph of anti-aging effect of CBD by increase in anti-oxidant potential, fibroblast proliferation, collagen synthesis, and UV-B protection, respectively.
[0041] FIG. 4 represents the bar graph of the in vitro anti-acne activity of CBD by reducing sebum secretion.
[0042] FIG. 5(a) and FIG. 5(d) represent the graph of anti-stress activity of CBD by measuring various stress markers.

DETAILED DESCRIPTION OF THE INVENTION
[0043] 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 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.
[0044] 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 skill 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.
[0045] 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.
[0046] 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”.
[0047] As used herein, the terms “composition”, “blend”, or “mixture” are all intended to be used interchangeably.
[0048] 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.
[0049] The term ‘therapeutically effective amount’ used throughout the present disclosure denotes an amount sufficient to produce the desired effects without causing side-effects.
[0050] The term, "subject" used throughout the present disclosure denotes an animal, preferably a mammal, and most preferably a human. The term "mammal" used herein refers to warm-blooded vertebrate animals of the class 'mammalia', including humans, characterized by presence of male reproductive organ (penis). The term mammal includes animals such as dog, rabbit, bear, fox, wolf, monkey, deer, mouse, pig and human.
[0051] 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.
[0052] 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.
[0053] The headings and abstract of the invention provided herein are for convenience only and do not interpret the scope or meaning of the embodiments.
[0054] 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.
[0055] The present disclosure relates to cannabidiol (CBD). More specifically, the disclosure is directed to compositions or formulations comprising cannabidiol. The disclosure further relates to a method of preparing the same.
[0056] In an embodiment, the present disclosure provides a composition comprising as an active agent - cannabidiol or pharmaceutically acceptable salts thereof.
[0057] In an embodiment, the present disclosure provides a food supplement composition comprising as an active agent - cannabidiol or pharmaceutically acceptable salts thereof.
[0058] In an embodiment, the present disclosure provides a pharmaceutical composition comprising as an active agent - cannabidiol or pharmaceutically acceptable salts thereof. In an aspect, the present disclosure provides a pharmaceutical composition comprising a therapeutically effective amount of cannabidiol or pharmaceutically acceptable salts thereof. In an embodiment, the present disclosure provides a pharmaceutical composition for enhancing anti-inflammatory activity comprising a therapeutically effective amount of cannabidiol or pharmaceutically acceptable salts thereof. In an embodiment, the present disclosure provides a pharmaceutical composition for reducing stress comprising a therapeutically effective amount of cannabidiol or pharmaceutically acceptable salts thereof. In an embodiment, the present disclosure provides a pharmaceutical composition for anti-aging comprising a therapeutically effective amount of cannabidiol or pharmaceutically acceptable salts thereof. In an embodiment, the present disclosure provides a pharmaceutical composition for enhancing skin viability in a subject comprising a therapeutically effective amount of cannabidiol or pharmaceutically acceptable salts thereof.
[0059] In an embodiment, the present disclosure provides a food supplement composition comprising as an active agent - cannabidiol or pharmaceutically acceptable salts thereof. In an embodiment, the present disclosure provides a food supplement composition for enhancing anti-inflammatory activity comprising a therapeutically effective amount of cannabidiol or pharmaceutically acceptable salts thereof. In an embodiment, the present disclosure provides a food supplement composition for reducing stress comprising a therapeutically effective amount of cannabidiol or pharmaceutically acceptable salts thereof. In an embodiment, the present disclosure provides a food supplement composition for anti-aging comprising a therapeutically effective amount of cannabidiol or pharmaceutically acceptable salts thereof. In an embodiment, the present disclosure provides a food supplement composition for enhancing skin viability in a subject comprising a therapeutically effective amount of cannabidiol or pharmaceutically acceptable salts thereof.
[0060] In an embodiment, the present disclosure provides a pharmaceutical formulation comprising as an active agent - cannabidiol or pharmaceutically acceptable salts thereof. In an aspect, the present disclosure provides a pharmaceutical formulation comprising a therapeutically effective amount of cannabidiol or pharmaceutically acceptable salts thereof. In an embodiment, the present disclosure provides a pharmaceutical formulation for enhancing anti-inflammatory activity comprising a therapeutically effective amount of cannabidiol or pharmaceutically acceptable salts thereof. In an embodiment, the present disclosure provides a pharmaceutical formulation for reducing stress comprising a therapeutically effective amount of cannabidiol or pharmaceutically acceptable salts thereof. In an embodiment, the present disclosure provides a pharmaceutical formulation for anti-aging comprising a therapeutically effective amount of cannabidiol or pharmaceutically acceptable salts thereof. In an embodiment, the present disclosure provides a pharmaceutical formulation for enhancing skin viability in a subject comprising a therapeutically effective amount of cannabidiol or pharmaceutically acceptable salts thereof.
[0061] In an embodiment, the present disclosure provides a food supplement formulation comprising as an active agent - cannabidiol or pharmaceutically acceptable salts thereof. In an embodiment, the present disclosure provides a food supplement formulation for enhancing anti-inflammatory activity comprising a therapeutically effective amount of cannabidiol or pharmaceutically acceptable salts thereof. In an embodiment, the present disclosure provides a food supplement formulation for reducing stress comprising a therapeutically effective amount of cannabidiol or pharmaceutically acceptable salts thereof. In an embodiment, the present disclosure provides a food supplement formulation for anti-aging comprising a therapeutically effective amount of cannabidiol or pharmaceutically acceptable salts thereof. In an embodiment, the present disclosure provides a food supplement formulation for enhancing skin viability in a subject comprising a therapeutically effective amount of cannabidiol or pharmaceutically acceptable salts thereof.
[0062] In an embodiment, the composition may further comprise an additional ingredient selected from any or a combination of eucalyptus oil, clove oil, ginseng, hempseed oil, menthol, ylang-ylang oil, rosemary oil, aloe vera, lavender oil, peppermint, borneol, grapeseed oil, brahmi oil, amla oil, extract of cranberry, chamomile oil, mint, fenugreek, and spearmint. In an embodiment, the composition comprises whole of ginseng, whole of aloe vera, whole of peppermint, whole of mint, whole of fenugreek, whole of spearmint, part of ginseng, part of aloe vera, part of peppermint, part of mint, part of fenugreek, part of spearmint, extract of ginseng, extract of aloe vera, extract of peppermint, extract of mint, extract of fenugreek, extract of spearmint, or combinations thereof. The part or extract may be obtained from root, leaves, shoot, fruits, rhizome, seed, stem, barks, flower, tubers, sap, bud and combinations thereof.
[0063] In an embodiment, the weight percentage of cannabidiol may be about 0.001% to about 10%, preferably about 0.01% to about 5% of the composition. Specifically, the weight percentage of cannabidiol may be about 0.02%, 0.05%, 0.2%, 0.5%, 2%, or 5% of the composition.
[0064] In an embodiment, the weight percentage of additional ingredient may be about 0.001% to about 10%, preferably about 0.01% to about 5% of the composition. Specifically, the weight percentage of additional ingredient may be about 0.02%, 0.05%, 0.2%, 0.5%, 2%, or 5% of the composition.
[0065] In an embodiment, the weight percentage of pharmaceutically acceptable excipient may be about 0.08% to about 99.98% of the composition / formulation.
[0066] In a preferred embodiment, the present disclosure provides a pharmaceutical composition comprising cannabidiol or pharmaceutically acceptable salts thereof in an amount ranging between 0.02% and 2% by weight of the composition; optionally, one or more additional ingredients in an amount ranging between 0.02% and 2% by weight of the composition; and one or more pharmaceutically acceptable excipient in an amount ranging from 0.08% to 99.98% by weight of the composition.
[0067] In a preferred embodiment, the present disclosure provides a pharmaceutical composition comprising cannabidiol or pharmaceutically acceptable salts thereof in an amount ranging between 0.02% and 2% by weight of the composition; optionally, one or more additional ingredients in an amount ranging between 0.02% and 2% by weight of the composition; and one or more pharmaceutically acceptable excipient in an amount ranging from 0.08% to 99.98% by weight of the composition.
[0068] In a preferred embodiment, the present disclosure provides a food supplement composition comprising cannabidiol or pharmaceutically acceptable salts thereof in an amount ranging between 0.02% and 2% by weight of the composition; optionally, one or more additional ingredients in an amount ranging between 0.02% and 2% by weight of the composition; and one or more pharmaceutically acceptable excipient in an amount ranging from 0.08% to 99.98% by weight of the composition.
[0069] In a preferred embodiment, the present disclosure provides a food supplement composition comprising cannabidiol or pharmaceutically acceptable salts thereof in an amount ranging between 0.02% and 2% by weight of the composition; optionally, one or more additional ingredients in an amount ranging between 0.02% and 2% by weight of the composition; and one or more pharmaceutically acceptable excipient in an amount ranging from 0.08% to 99.98% by weight of the composition.
[0070] In an embodiment, the term ‘pharmaceutically acceptable salts’ includes the salts that behave similar to CBD in the physiological environment and do not possess cytotoxicity.
[0071] In an embodiment, the cannabidiol may be natural or synthesized. In an embodiment, the cannabidiol may be extracted from a Cannabis plant, preferably, from hemp. In another embodiment, it may be dried cannabis. In an embodiment, the composition is devoid of tetrahydrocannabinol (THC). In an embodiment, the composition is safe, non cytotoxic and does not show ocular irritation.
[0072] In an embodiment, the composition further comprises a pharmaceutically acceptable excipient. In an embodiment, the pharmaceutically acceptable excipient may be selected from any or a combination of a bulking agent, a diluent, a solubilizer, a binder, a disintegrant, a chelating agent, a glidant, a flavouring agent, a colouring agent, a tonicity agent, a sweetening agent, a buffering agent, a preservative, lubricant, and a co-solvent.
[0073] With regards to extract of any or a combination of ginseng, aloe vera, peppermint, mint, fenugreek, and spearmint, commercially available extracts can also 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.
[0074] In an embodiment, bulking agent(s) include but not limited to, lactose USP, Starch 1500, mannitol, sorbitol, maltodextrin, malitol or other non-reducing sugars; microcrystalline cellulose (e.g., Avicel), dibasic calcium phosphate (anhydrous or dihydrate), sucrose, etc. and mixtures thereof. However, a person skilled in the art would appreciate that any other bulking agent(s) can be utilized to serve the intended purpose.
[0075] In an embodiment, solubilizer(s) includes but not limited to, cyclodextrins, pH adjusters, salts and buffers, surfactants, fatty acids, phospholipids, metals of fatty acids and the likes. However, a person skilled in the art would appreciate that any other solubilizing agent(s) can be utilized to serve the intended purpose.
[0076] In an embodiment, 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 the like. However, a person skilled in the art would appreciate that any other binder(s) can be utilized to serve the intended purpose.
[0077] In an embodiment, 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 the like. However, a person skilled in the art would appreciate that any other glidant(s) can be utilized to serve the intended purpose.
[0078] In an embodiment, flavoring agent(s) includes but not limited to, fruit aromas such as orange, banana, strawberry, cherry, wild cherry, lemon; cardamom, anis, mint, menthol, vanillin, and ethyl vanillin, and other similar aromas such as coffee, or the mixtures thereof. However, a person skilled in the art would appreciate that any other flavoring agent(s) can be utilized to serve the intended purpose.
[0079] In an embodiment, 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, or the mixtures thereof. However, a person skilled in the art would appreciate that any other sweetening agent(s) can be utilized to serve the intended purpose.
[0080] In an embodiment, buffer system 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 the likes or combination thereof. However, a person skilled in the art would appreciate that any other buffer system can be utilized to serve the intended purpose.
[0081] In an embodiment, disintegrant(s) includes but not limited to, croscarmellose sodium, Crospovidone, sodium starch glyconate, citric acid, calcium carbonate, pregelatinized starch and mixture thereof. However, a person skilled in the art would appreciate that any other disintegrant(s) can be utilized to serve the intended purpose.
[0082] In an embodiment, lubricant(s) includes but not limited to, zinc stearate, magnesium stearate, stearic acid, calcium stearate, Vegetable stearin and mixture thereof. However, a person skilled in the art would appreciate that any other lubricant(s) can be utilized to serve the intended purpose.
[0083] In an embodiment, 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 mixture thereof. However, a person skilled in the art would appreciate that any other lubricant(s) can be utilized to serve the intended purpose.
[0084] In an embodiment, flavoring agent(s) includes but not limited to, fruit aromas such as orange, banana, strawberry, cherry, wild cherry, lemon; cardamom, anis, mint, menthol, vanillin, and ethyl vanillin, and other similar aromas, sodium benzoate or the mixtures thereof. However, a person skilled in the art would appreciate that any other flavoring agent(s) can be utilized to serve the intended purpose.
[0085] In an embodiment, preservative(s) includes but not limited to, 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 mixture thereof. However, a person skilled in the art would appreciate that any other preservative(s) can be utilized to serve the intended purpose.
[0086] In an embodiment, solvents 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 the likes. However, a person skilled in the art would appreciate that any other solvent or a combination of solvents can be utilized to serve the intended purpose.
[0087] In an embodiment, the present disclosure provides a formulation comprising a therapeutically effective amount of cannabidiol or pharmaceutically acceptable salts thereof.
[0088] In an embodiment, the present disclosure provides a formulation for enhancing anti-oxidant activity in a subject comprising a therapeutically effective amount of cannabidiol or pharmaceutically acceptable salts thereof.
[0089] In an embodiment, the present disclosure provides a formulation for enhancing anti-inflammatory activity comprising a therapeutically effective amount of cannabidiol or pharmaceutically acceptable salts thereof.
[0090] In an embodiment, the present disclosure provides a formulation for anti-aging comprising a therapeutically effective amount of cannabidiol or pharmaceutically acceptable salts thereof.
[0091] In an embodiment, the present disclosure provides a formulation for enhancing skin viability in a subject comprising a therapeutically effective amount of cannabidiol or pharmaceutically acceptable salts thereof.
[0092] In an embodiment, the composition further comprises a pharmaceutically acceptable excipient. In an embodiment, the pharmaceutically acceptable excipient may be selected from any or a combination of a bulking agent, a diluent, a solubilizer, a binder, a disintegrant, a chelating agent, a glidant, a flavouring agent, a colouring agent, a tonicity agent, a sweetening agent, a buffering agent, a preservative, lubricant, and a co-solvent.
[0093] In an embodiment, the composition may be formulated into solid, liquid, gas or aerosol forms.
[0094] In an embodiment, the composition may be formulated in the form of an oil, capsule, powder, tablet, sachet, film, granules, solution, dispersion, syrup, emulsion, smoke, vapor, suspension, serum, microparticles, nanoparticles, nanogel, cream, mask or aerosol spray. In a preferred embodiment, the composition may be formulated as a dissolving tablet/film, spray, capsule, tea bag, candy, syrup, solution, serum, cream, mask and the like.
[0095] In an embodiment, the composition may be administered orally, dermally, topically, transdermally, intravenously, subcutaneously, peritoneally, nasally, or combinations thereof. In a preferred embodiment, the composition may be administered topically or orally.
[0096] In an embodiment, the disclosure provides a medicament or food supplement comprising the composition.
[0097] In an embodiment, the present disclosure provides a method of preparing a composition or formulation comprising a therapeutically effective amount of cannabidiol or pharmaceutically acceptable salts thereof.
[0098] In another embodiment, the present disclosure relates to a method of enhancing anti-inflammatory activity in a subject by administering to the subject, a composition comprising cannabidiol or pharmaceutically acceptable salts thereof.
[0099] In an embodiment, the present disclosure relates to a method of enhancing anti-oxidant activity in a subject by administering to the subject, a composition cannabidiol or pharmaceutically acceptable salts thereof. Oxidation reactions can produce free radicals, which start chain reactions that damage cells. CBD terminates these chain reactions by removing free radical intermediates and inhibits other oxidation reactions by getting self-oxidized.
[00100] In another embodiment, the present disclosure relates to a method of decreasing aging in a subject by administering to the subject, a composition comprising cannabidiol or pharmaceutically acceptable salts thereof.
[00101] In another embodiment, the present disclosure relates to a method of enhancing skin viability in a subject by administering to the subject, a composition comprising cannabidiol or pharmaceutically acceptable salts thereof.
[00102] In yet another embodiment, the present disclosure relates to a method for reducing stress in a subject by administering to the subject, a composition comprising cannabidiol or pharmaceutically acceptable salts thereof.
[00103] In an embodiment, the method may be performed in addition to other treatments or therapies undertaken by the subject to improve the condition.
[00104] In yet another embodiment, the present disclosure relates to use of a composition comprising a therapeutically effective amount of cannabidiol or pharmaceutically acceptable salts thereof.
[00105] In an embodiment, the disclosure relates to use of a composition comprising a therapeutically effective amount of cannabidiol or pharmaceutically acceptable salts thereof for decreasing inflammation, aging, free radicals and improving skin viability.
[00106] CBD may be used in non-cytotoxic levels. Dosage may be dependent on the patient history, clinical factors and severity of the condition and may be determined by a medical practitioner.
[00107] In an embodiment, CBD may be administered once or in multiple administrations. It may be a sustained release administration for slow release of CBD in the subject.
[00108] In another embodiment, the present disclosure relates to cannabidiol for use in enhancing anti-inflammation, anti-oxidation, skin viability and anti-aging effects.
[00109] Cannabidiol for use in reduction of oxidative damage, increase in elastin level, free radical or reactive oxygen species scavenging is also covered.
[00110] 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 scope of the invention is determined by the claims that follow. 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:
[00111] 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: Antioxidant Activity:
[00112] The antioxidant activity was tested using DPPH (2, 2-diphenyl-1-picrylhydrazyl) assay. The scavenging reaction between (DPPH) and an antioxidant (H-A) may be written as:
(DPPH) + (H-A) (DPPH-H) + (A)
(Purple) (Yellow)
[00113] A freshly prepared DPPH solution exhibits a deep purple color with a maximum absorption at 517 nm. Antioxidants react with DPPH (purple) and get reduced to DPPH-H (yellow). This conversion decreases the absorbance and gives a measure of antioxidant potential. The degree of discoloration indicates the scavenging potential of the antioxidant compound or. The free radical scavenging activity of natural and synthetic CBD was evaluated spectrophotometrically by DPPH assay in vitro.
[00114] Natural and synthetic CBD were dissolved in 80% methanol to obtain stock concentration of 1 mg/ml. Stock solutions were diluted using 80% Methanol to achieve final concentrations range (10 µg/ml-100 µg/ml). Ascorbic acid was used as a positive control. Ascorbic acid was weighed and dissolved in 80% methanol to obtain the stock solution of 1 mg/ml, which was subsequently diluted at concentration from 1-100 µg/ml. 50 µL of the CBD (in 80% methanol) and L-ascorbic acid (reference item) at their respective concentrations were added in 96-well micro-titer plate followed by addition of 100 µl of freshly prepared 250 µM DPPH solution to each well. At the same time equal volume of DPPH with solvent (80% methanol) was used as blank. All the plates were covered with aluminum foil to protect the reaction from light and incubated for 30 minutes at 37 ºC. The absorbance of the wells was read at 517 nm using multi-well reader. The free radical scavenging activity of CBD was evaluated by following:
1. Calculating % reduction in absorbance using the following formula:
% reduction in absorbance = (Ac-As)/Ac*100,
where, Ac= absorbance of control sample, As = Absorbance of treated sample
2. Determining the IC50 values (concentration of the test solution required to demonstrate 50 % decrease in absorbance compared to that of blank).
Example 2: Anti-inflammatory activity
[00115] Anti-inflammatory potential of CBD was screened in Human Monocytic cell line (THP-1) by measuring the inflammatory cytokines/chemokines against LPS stimulation using ELISA.THP-1 is a human leukemia monocytic cell line, which has been extensively used to investigate the monocyte/macrophage functions, mechanisms, signaling pathways, nutrient and drug transport. Lipopolysaccharide (LPS) is the major component of Gram-negative bacteria cell walls and widely recognized as potent activator of inflammatory responses in monocytes.
[00116] Natural and synthetic CBD were dissolved in ethanol to prepare 250 mg/ml stock solution, which was further diluted in serum free medium for treatment of cells. Cells were treated with non-cytotoxic concentrations of CBD (0.0001 µg/ml to 0.1 µg/ml) and stimulated with inflammatory stimulus (LPS) for 24 h. LPS treated cells were included as Control. Untreated cells were included as Negative Control. Supernatants were collected and levels of cytokine (TNF-a, IL-8 & IL-6) were determined by ELISA.
Anti-inflammatory activity was determined by calculating the percent inhibition in cytokine levels and was calculated as follows:
% Inhibition = {[Conc. of marker in Control (LPS alone) – Conc. of marker in treated (Test item + LPS)]/Conc. of marker in Control (LPS alone)}*100
CBD demonstrated anti-inflammatory activity by the inhibition of inflammatory cytokines TNF-a, IL-8 and IL-6 (FIG. 1(a) – 1(c)).
Example 3: Anti-inflammatory activity in Animal models
[00117] Anti-inflammatory potential of various formulations of CBD was screened in rat paw edema model by measuring the inflammatory edema.
CDB formulation-2 showed 42% of anti-inflammatory activity in Rat Carrageenan induced paw edema model (FIG. 2(a) – 2(b)).
Example 4: Anti-aging effect of CBD
[00118] Two parameters were considered i.e. anti-ageing potential by protection against oxidative damage and anti-ageing potential by measuring the increase in elastin level in Human skin fibroblasts cell line (HFF-1). Natural and synthetic CBD were dissolved in ethanol to prepare 250mg/ml stock solution, which was further diluted in serum free medium for treatment of cells. Cells were plated and treated with CBD at various non cytotoxic concentrations (0.001 to 10%) for 24 h.
[00119] For measuring the protection against oxidative damage, Free radical scavenging potential of CBD (10 µg/ml – 1 mg/ml)was determined by DPPH assay.
[00120] For measuring the protection against UV-B induced damage, cells were exposed to UV-B (200mJ/cm2) and UV-B induced cytototoxicity of fibroblasts was determined by MTT assay.
[00121] Proliferation of fibroblasts was determined by MTT assay.
[00122] Collagen levels was determined by Sirius red dye.
[00123] FIG. 3(a)-(d) show that CBD exhibiting anti-oxidant potential, and protection against UVB induced damage
Example 5: Anti-acne effect by inhibition of sebum synthesis
[00124] Anti-acne effect of various concentration of CBD was screened by inhibition of sebum synthesis. Sebocytes were treated with CBD and linoliec acid (LA) and arachidonic (AA) as sebum stimulant for 48 h. Sebum levels were determined by Oil O red staining.
[00125] CDB showed anti-acne potential by inhibition of sebum synthesis (FIG. 4).
Example 6: Stress reduction potential of CBD
[00126] CDB showed stress reduction markers in animal model susing C57BL/6 mice (FIG. 5(a)-5(d)). After one week of acclimatization, the animals was randomized based on body weight divided into groups,. Mice in the chronic stress groups were subjected for following stress procedure. Mice was subjected to 4 cycles of 7 kinds of stress for four weeks.
[00127] Cold Stress: Transported in their home cages, with food, water and bedding, into a cold room maintained at 4°C for a period of 6 h. Day 2, Hypertonic Saline injection: Hypertonic saline i.e 9% was injected intraperitoneally at 10mL/kg. Day 3, Water swim stress: Animals will be forced to swim in warm water (40oC) for 30 min. Day 4, Light and Dark cycle was inversed. Day 5, Tilted cage Stress: Cages of animals was kept in a ~25O angle under uncomfortable tilted position for 6h. Day 6, Noise Stress: Loudspeaker was kept in the animal room and white noise (200db) was created for 6h. Day 7, Overcrowding stress: 10 Animals was kept in single cage for 4h. Mouse in the control group was left undisturbed in the housing facility during this time. Test item was dissolved in normal saline at final concentration of 25-50µM. Observations:
[00128] Post completion of CS & Treatment period, animals was subjected to following behavioral test during week 5.
[00129] Y maze test for memory function
[00130] Post completion of behavioral test, Mice was anaesthetized under isoflurane, blood will be collected through retro-orbital route, serum will be separated.
[00131] Corticosterone level in serum was estimated using ELISA method
[00132] Post completion of behavioral tests, all the animals were anesthetized to collect Cerebrospinal Fluid (CSF) using stereotaxic instrument as per in-house protocol.
Example 7: Dermal Safety
[00133] For assessing the dermal safety in fibroblasts, Human skin fibroblasts cell line (HFF-1) was used. Natural and synthetic CBD were dissolved in ethanol to prepare 250mg/ml stock solution, which was further diluted in serum free medium for treatment of cells. Cells were then plated and treated with CBD at various non-cytotoxic concentrations (0.001 % to 10 %) for 48 h. Cell viability was determined by MTT assay and % cytotoxicity and cell viability was calculated.
Example 8: Ocular Irritation
[00134] For evaluating Ocular Irritation, HET-CAM (Hen's Egg Test - Chorioallantoic Membrane) assay was performed in accordance with INVITTOX no. 96. Fertilized chicken eggs (Kuroiler breed) were incubated until embryonic day 10. On day 10, the eggshell was removed and the Chorioallantoic membranes (CAMs) of six eggs were treated with 0.3g of natural and synthetic CBD for 3 min. The CAMs were then rinsed with physiological saline and after 30 seconds were observed for any appearance of haemorrhage and lysis of blood vessels. Subjective evaluation of CAM reactions in test item treated group was then performed with respect to the reference item (i.e., CAMs reaction with Sodium dodecyl sulfate (SDS) corresponding to 0.1%, 0.5% and 1% for 5 min). The CAMs treated with physiological saline for 5 minutes corresponded to the negative control group.
[00135] Depending on the subjective evaluation with respect to reference item, each CAM reaction (N=6) in test item treated group was assigned a numerical score between 0 to 3, where “score 0” indicated no signs of haemorrhage and lysis of blood vessels (analogous to observations in CAMs treated with physiological saline for 5 min); “score 1” indicated occurrence of weak haemorrhage and lysis of blood vessels (analogous to observations in CAMs treated with SDS corresponding to 0.1% (w/v) of SDS for 5 min); “score 2” indicated occurrence of moderate haemorrhage and lysis of blood vessels (analogous to observations in CAMs treated with SDS corresponding to 0.5% (w/v) of SDS for 5 min) and “score 3” indicated occurrence of strong haemorrhage and lysis of blood vessels (analogous to observations in CAMs treated with SDS corresponding to 1% (w/v) of SDS for 5 min). The numerical scores pertaining to each CAM reaction in test item treated group were then summed up for evaluation of irritancy potential of test item.
Example 9: Pharmaceutical formulations comprising CBD and their Uses
Formulation 1: CBD NANOGEL
Table 1: CBD NANOGEL
S.No. Active/ Ingredients Qty/tube
(w/v) Ingredient’s use
1. CBD 2.0 Active
2. Propylene glycol 30.0 Humectant and preservative
3. Polyethylene glycol 400 30.0 Surfactant, ointment base
4. Carbopol ultrez 21 polymer 1.2 Gelling agent
5. Menthol 0.2 Skin to feel cool and then warm.
6. Glycerin 10.0 Humectant
7. Sodium Benzoate 0.2 Preservative
8. DM water 26.4 Solvent
Total 100.0

All the raw materials confirmed to the specified standards. To desired amount of DM Water, sodium benzoate was dissolved followed by Carbopol Ultrez 21 into the vessel to form gelling solution (Step 1). PEG 400 and PG were added in another beaker and CBD was dissolved completely with continuous heating. Then Glycerin and Menthol was added to this solution and mixed for 10 minutes with heating to form a clear solution. Step 1 gelling solution was added slowly to step 2 CBD solution with continuous heating to make a clear nanogel. The formulated clear nano gel was packed in pre sanitized containers.

Formulation 2: CBD ORAL SPRAY
Table 2: CBD ORAL SPRAY
S.No. Active/ Ingredients Qty/bottle
(w/v) Ingredient’s use
1. CBD 200 mg Active
2. Propylene glycol 4.0 Humectant and preservative
3. Sucralose 0.1 Sweeting agent
4. Sweet compound 0.5 Sweeting agent
5. DM Water 2.59 Solvent
6. Ethanol 1.0 Solvent
7. Vitamin C 0.1 Antioxidant
8. Ascorbic acid 0.01 Preservative
9. Peppermint PH101 flavor 0.5 Flavor
10. Methi G flavor 0.5 Flavor
11. Spearmint spl flavour 0.5 Flavor
Total 10.0

Firstly, CBD was dissolved in propylene glycol with mild heating. Then Ethanol, peppermint flavour, spearmint flavor, sweet compound and methi G were added to the above solution with continuous heating and mixing. Sucralose, vitamin C and ascorbic acid were dissolved in distilled water. This solution was added to above Step with continuous heating and mixing, followed by sonication for 20 minutes using a probe sonicator to get the final oral spray. The prepared oral spray was then filled in oral spray bottles
Formulation 3: CBD SYRUP 0.1%

Table 3: CBD SYRUP 0.1%
S.No. Active/ Ingredients Qty/Bottle
(gm/ml) Ingredient’s use
1. CBD 0.1 Active
2. Sorbitol 30.0 Solubilizer and sweetener
3. Propylene glycol 13.40 Humectant and preservative
4. Polyethylene Glycol 400 13.42 Solubilizer
5. Glycerin 30.0 Humectant and preservative
6. DM Water 10.0 Solvent
7. Vitamin C 1.0 Antioxidant
8. Ascorbic acid 0.025 Preservative
9. Sucralose 0.05 Sweeting agent
10. Mix berry emulsion qs. Flavor
11. Sweet compound 2.0 Sweeting agent
Total 100.0

CBD was dissolved in appropriate amount of propylene glycol. PEG400, sorbitol and glycerin were added to the above solution and mixed. To appropriate amount of water, sucralose, vitamin c, ascorbic acid and sweet compound were added and dissolved completely. Then this water solution was added in above solution and was mixed for 10 minutes. Mixed berry Emulsion was then added to the above solution. The Syrup was then sonicated using probe sonicator, followed by filling in pre-sanitized bottles.

[00136] 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.

WE CLAIMS:

1. A pharmaceutical composition, said composition comprising:
cannabidiol or pharmaceutically acceptable salts thereof in an amount ranging between 0.02% and 2% by weight of the composition;
optionally, one or more additional ingredients in an amount ranging between 0.02% and 2% by weight of the composition; and
one or more pharmaceutically acceptable excipient in an amount ranging from 0.08% to 99.98% by weight of the composition.
2. The pharmaceutical composition as claimed in claim 1, wherein the additional ingredient is selected from any or a combination of eucalyptus oil, clove oil, ginseng, hempseed oil, menthol, ylang-ylang oil, rosemary oil, aloe vera, lavender oil, peppermint, borneol, grapeseed oil, brahmi oil, amla oil, extract of cranberry, chamomile oil, mint, fenugreek, and spearmint.
3. The pharmaceutical composition as claimed in claim 1, wherein the pharmaceutical composition is formulated as oral dissolving tablet, oral spray, capsule, oral-dissolving film, tea bag, chocolate, gummy, syrup, or water.
4. The pharmaceutical composition as claimed in claim 1, wherein the pharmaceutically acceptable excipient is selected from any or a combination of a bulking agent, a diluent, a solubilizer, a binder, a disintegrant, a chelating agent, a glidant, a flavouring agent, a colouring agent, a tonicity agent, a sweetening agent, a buffering agent, a preservative, lubricant, and a co-solvent.
5. A food supplement composition, said composition comprising:
cannabidiol or pharmaceutically acceptable salts thereof in an amount ranging between 0.02% and 2% by weight of the composition; and
optionally, one or more additional ingredients in an amount ranging ranging between 0.02% and 2% by weight of the composition; and
one or more pharmaceutically acceptable excipient in an amount ranging from 0.08% to 99.98% by weight of the composition.
6. The food supplement composition as claimed in claim 5, wherein the additional ingredient is selected from any or a combination of eucalyptus oil, clove oil, ginseng, hempseed oil, menthol, ylang-ylang oil, rosemary oil, aloe vera, lavender oil, peppermint, borneol, grapeseed oil, brahmi oil, amla oil, extract of cranberry, chamomile oil, mint, fenugreek, and spearmint.
7. The pharmaceutical composition as claimed in claim 5, wherein the pharmaceutically acceptable excipient is selected from any or a combination of a bulking agent, a diluent, a solubilizer, a binder, a disintegrant, a chelating agent, a glidant, a flavouring agent, a colouring agent, a tonicity agent, a sweetening agent, a buffering agent, a preservative, lubricant, and a co-solvent.
8. The food supplement composition as claimed in claim 5, wherein the food supplement composition is formulated as oral dissolving tablet, oral spray, capsule, oral-dissolving film, tea bag, chocolate, gummy, syrup, or water.