A bioflavonoid composition, process of preparation and implementations thereof

Abstract

The present disclosure relates to a bioflavonoid composition comprising a bioflavonoid, at least one surfactant with a molecular weight between 300 and 1500 g / mol, and optionally a macromeric compound. The composition exhibits enhanced solubility and bioavailability and may be formulated into various delivery formats, including hard gelatin capsules and nutraceutical food products. The present disclosure also relates to a process for preparing the composition involves mixing the bioflavonoid with optional polysaccharides and suspending agents, followed by the addition of an aqueous surfactant and binder solution. The composition of the present disclosure is suitable for use in dietary supplements or medicaments and may be administered to manage various health conditions or disorders.

Description

A BIOFLAVONOID COMPOSITION, PROCESS OF PREPARATION AND IMPLEMENTATIONS THEREOFFIELD OF INVENTION

[0001] The present disclosure broadly relates to the field of bioflavonoids. The present disclosure particularly relates to bioflavonoid compositions, a process of preparing the composition, and a nutraceutical formulation comprising the composition.BACKGROUND OF THE INVENTION

[0002] Bioflavonoids are natural polyphenolic secondary metabolites, synthesized by plants. Bioflavonoids possess medicinal properties, such as antitumor, cardioprotective, anti-inflammatory, antimicrobial, antiviral, anti-psoriasis, anticancer, hepatoprotective, neuroprotective, nephroprotective, antibacterial, antiapoptotic, antiallergic and antioxidant activities. Unfortunately, these compounds are often insoluble in aqueous media and have low stability in gastric acid environment. The bioactivity of bioflavonoids as nutraceutical compounds is largely compromised due to their low solubility, resulting in poor absorption and reduced bioavailability of related oral dosage forms in digestive system following consumption. Attempts have been made to increase the aqueous solubility of the bioflavonoids by manipulating their hydrophilicity, and thereby boosting therapeutic potency using complex techniques.

[0003] Therefore, there is an unmet need to develop a simple composition to enhance the dissolution rate of the bioflavonoids, and thereby enhancing the bioavailability.SUMMARY OF INVENTION

[0004] In an aspect of the present disclosure, there is provided a bioflavonoid composition comprising: (a) a bioflavonoid; (b) at least one surfactant havingmolecular weight in a range of 300 to 1500 g / mol; and (c) optionally, at least one macromeric compound.

[0005] In another aspect of the present disclosure, there is provided a capsule comprising: (a) the bioflavonoid composition as disclosed herein; and (b) a polymeric shell.

[0006] In another aspect of the present disclosure, there is provided a process of preparing the composition as disclosed herein, the process comprising: (a) mixing stoichiometric amount of bioflavonoid, optionally at least one polysaccharide, and a suspending agent in a mixer to obtain a first mixture; and (b) adding to the first mixture an aqueous solution of at least one surfactant and optionally an aqueous solution of at least one water-soluble binder, to obtain the composition.

[0007] In an aspect of the present disclosure, there is provided a nutraceutical formulation comprising the composition as disclosed herein.

[0008] In an aspect of the present disclosure, there is provided a composition for use in the manufacture of a dietary supplement or a medicament.

[0009] In another aspect of the present disclosure, there is provided a method of managing a condition or a disorder, the method comprising administering the composition or the formulation as disclosed herein to a subject in need thereof.

[0010] These and other features, aspects, and advantages of the present subject matter will be better understood with reference to the following description. This summary is provided to introduce a selection of concepts in a simplified form. This summary is not intended to identify key features or essential features of the disclosed subject matter, nor is it intended to be used to limit the scope of the disclosed subject matter.BRIEF DESCRIPTION OF DRAWINGS

[0011] The following drawings form a part of the present specification and are included to further illustrate aspects of the present disclosure. The disclosure may be better understood by reference to the drawings in combination with the detailed description of the specific embodiments presented herein.

[0012] Figure 1 depicts results of pharmacokinetics study for WEI and unformulated hydroxyphenylchromone, in accordance with the embodiments herein.

[0013] Figure 2 shows results of monosodium iodo-acetate (MIA) induced osteoarthritis disease mode for efficacy studies in rabbits, wherein the graph represents changes in knee thickness in rabbits after 28days MIA challenge, in accordance with the embodiments herein.

[0014] Figure 3 shows results of rabbit knee X-Ray examination (normal control, disease control, treatment) on 28d post-MIA challenge, in accordance with the embodiments herein.

[0015] Figure 4 shows results of quantification of serum COX-2 level in LPS- challenged and WEI treated rabbits, in accordance with the embodiments herein.

[0016] Figure 5 shows results of quantification of serum TNF-a level in LPS- challenged and WEI treated rabbits, in accordance with the embodiments herein.DETAILED DESCRIPTION OF THE INVENTION

[0017] Those skilled in the art will be aware that the present disclosure is subject to variations and modifications other than those specifically described. It is to be understood that the present disclosure includes all such variations and modifications. The disclosure also includes all such steps, features, compositions, and compounds referred to or indicated in this specification, individually or collectively, and any and all combinations of any or more of such steps or features. Definitions

[0018] For convenience, before further description of the present disclosure, certain terms employed in the specification, and examples are delineated here. These definitions should be read in the light of the remainder of the disclosure and understood as by a person of skill in the art. The terms used herein have the meanings recognized and known to those of skill in the art, however, for convenience and completeness, particular terms and their meanings are set forth below.

[0019] The articles “a”, “an” and “the” are used to refer to one or to more than one (i.e., to at least one) of the grammatical object of the article.

[0020] The terms “comprise” and “comprising” are used in the inclusive, open sense, meaning that additional elements may be included. It is not intended to be construed as “consists of only”.

[0021] Throughout this specification, unless the context requires otherwise the word “comprise”, and variations such as “comprises” and “comprising”, will be understood to imply the inclusion of a stated element or step or group of elements or steps but not the exclusion of any other element or step or group of elements or steps.

[0022] The term “including” is used to mean “including but not limited to”. “Including” and “including but not limited to” are used interchangeably.

[0023] The term “bioflavonoids”, as used herein, refers to a large class of polyphenolic secondary metabolites synthesized by plants. Bioflavonoids have immunomodulatory, anti-inflammatory, antioxidant, antimicrobial, and anti cancer properties.

[0024] The term “surfactant”, as used herein, refers to a surface-active agent capable of lowering the surface tension (or interfacial tension) between different compounds and stabilize the interface in a composition.

[0025] The term “macromeric compound”, as used herein, refers to large monomers with relatively high molecular weight species having single functional polymerizable group, formed by preassembly of structural units designed to bestow particular properties on the final polymer.

[0026] The term “suspending agent”, as used herein, refers to a substance that is added to the composition to help the active ingredient to stay suspended or dispersed and reduce sedimentation or prevent caking at the bottom of the container.

[0027] The term “water-soluble binder”, as used herein, refers to polymers that dissolve, disperse, or form gel in water. Such polymers, when present in an aqueous system, facilitate in modifying the physical properties of the aqueous system. It is used to impart viscosity.

[0028] The term “stabilizer”, as used herein, refers to a substance added to prevent undesired change in the state of the ingredients of a composition or the composition itself.

[0029] The term “subject”, as used herein, refers to mammals, e.g., human, and non-human mammals. Examples of non-human animals include non-human primates, dogs, cats, cattle, horses, sheep, pigs, goats, rabbits, mice, rats, hamsters, guinea pigs, and etc. Unless otherwise noted, the terms “patient” or “subject” are used herein interchangeably. Preferably, the subject is human.

[0030] Ratios, concentrations, amounts, and other numerical data may be presented herein in a range format. It is to be understood that such range format is used merely for convenience and brevity and should be interpreted flexibly to include not only the numerical values explicitly recited as the limits of the range, but also to include all the individual numerical values or sub-ranges encompassed within that range as if each numerical value and sub-range is explicitly recited.

[0031] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the disclosure, the preferred methods, and materials are now described. All publications mentioned herein are incorporated herein by reference.

[0032] As discussed in the background, bioflavonoids have poor bioavailability due to insolubility in water. Studies show that unformulated bioflavonoids are expelled from the body within few minutes owing to poor solubility and extensive metabolism. Therefore, the present disclosure provides a bioflavonoid composition with surfactants, and macromeric compounds that is capable of improving the solubility of bioflavonoids, which further aids the prolonged and controlled release of the active. Embodiments herein provide bioflavonoid compositions. Accordingly, in an embodiment of the present disclosure, there is provided a bioflavonoid composition comprising: (a) a bioflavonoid; (b) at least one surfactant having molecular weight in a range of 300 to 1500 g / mol; and (c) optionally, at least one macromeric compound. The compositions, according to thepresent disclosure, exhibit increased efficacy. It has been observed by the present inventors that the composition, as disclosed herein, have improved efficacy, solubility, stability and bioavailability.Composition

[0033] In an embodiment of the present disclosure, there is provided a bioflavonoid composition comprising: (a) a bioflavonoid; (b) at least one surfactant having molecular weight in a range of 300 to 1500 g / mol; and (c) optionally, at least one macromeric compound. In another embodiment, the composition further comprises at least one suspending agent. In another embodiment, the composition comprises macromeric compound selected from at least one polysaccharide, water-soluble binder, or combination thereof. In another embodiment, the composition further comprises at least one stabilizer. In another embodiment, the composition further comprises at least one polar solvent. The composition, according to embodiments herein, is in a form selected from granules, pellets, powders, emulsions, nanoemulsions, gels, nanogels, tablet, beadlet, capsule, softlets, softgel, or lozenges.

[0034] In an embodiment of the present disclosure, there is provided a bioflavonoid composition comprising: (a) a bioflavonoid; (b) at least one surfactant having molecular weight in a range of 300 to 1500 g / mol; and (c), at least one macromeric compound.

[0035] In an embodiment of the present disclosure, there is provided a bioflavonoid composition comprising: (a) a bioflavonoid present in an amount ranging from 5 to 25% by weight; (b) at least one surfactant having molecular weight in a range of 300 to 1500 g / mol present in an amount ranging from 2 to 6% by weight; (c) at least one macromeric compound selected from a polysaccharide, a water-soluble binder, or combination thereof, wherein the polysaccharide present in an amount ranging from 8 to 12% by weight, wherein the water-soluble binder present in an amount ranging from 1 to 4% by weight; and (d) a suspending agent present in an amount ranging from 46 to 77% by weight, relative to the weight of the composition.Bioflavonoid

[0036] Embodiments of the composition, as disclosed herein, comprise a bioflavonoid. In an embodiment of the present disclosure, there is provided a composition comprising a bioflavonoid, wherein the bioflavonoid is a polyhydroxy flavonoid selected from di, tri, tetra, penta, hexa, hepta, octa, nona, or decahydroxy flavonoids. In another embodiment of the present disclosure, the bioflavonoid is a hexahydroxy flavonoid. In yet another embodiment of the present disclosure, the hexahydroxy flavonoid is 3, 5, 6, 7, 3', 4'- hexahydroxyflavone. Other hexahydroxy flavonoid such as 3,3',4',5,5',7-hexahydroxyflavone may further be included, in some embodiment of the composition as disclosed herein.

[0037] In an embodiment of the present disclosure, there is provided a bioflavonoid composition as disclosed herein, wherein the bioflavonoid is in an amount ranging from 2.0 to 90 % by weight, preferably 2.5 to 65% by weight and more preferably 2.5 to 60% by weight, relative to the weight of the composition. In another embodiment of the present disclosure, the bioflavonoid is in an amount ranging from 2 to 65 %, or 2.5 to 55 % by weight, or 3 to 50%, or 3.5 to 45%, or 4 to 40%, or 4.5 to 40%, or 5 to 38%, relative to the weight of the composition.Surfactant

[0038] Embodiments of the composition, as disclosed herein, comprise a surfactant. In an embodiment of the present disclosure, there is provided a composition as disclosed herein, wherein the surfactant has molecular weight in a range of 1000 to 1500 g / mol, preferably 1100 to 1400 g / mol.

[0039] In an embodiment of the present disclosure, there is provided a composition as disclosed herein, wherein the surfactant is selected from non-ionic surfactant or zwitterionic surfactant, preferably from esters of polyoxyethylene sorbitan fatty acids, esters of polyoxyethylene fatty acids, phospholipids or combinations thereof. In another embodiment of the present disclosure, the surfactant is an ester of polyoxyethylene sorbitan fatty acid, preferably polysorbates. Polysorbates are amphiphilic substances synthesized by reacting ethylene oxide with sorbitan fattyacid ester. The polysorbate may be selected from any one of polysorbate 20 (polyoxyethylene (20) sorbitan monolaurate), polysorbate 40 (polyoxyethylene (20) sorbitan monopalmitate), polysorbate 60 (polyoxyethylene (20) sorbitan monostearate), polysorbate 80 (polyoxyethylene (20) sorbitan monooleate), or combination thereof, preferably polysorbate 80 (Tween 80). In yet another embodiment of the present disclosure, the surfactant is an ester of polyoxyethylene fatty acid, preferably polyoxyethylene derivative of a castor oil, more preferably hydrogenated castor oil. In an embodiment, the phospholipid surfactant is soya lecithin. In another embodiment, the surfactant is poloxamer.

[0040] In an embodiment of the present disclosure, there is provided a composition as disclosed herein, wherein the surfactant is in an amount ranging from 0.1 to 90% by weight, preferably 0.1 to 80% by weight, more preferably 0.5 to 70% by weight, relative to the weight of the composition. In another embodiment of the present disclosure, the surfactant is in an amount ranging from 1 to 70%, 1 to 65%, 1 to 60%, 1 to 50%, 1 to 40%, 1 o 45%, 1 to 30%, 1 to 20%, 1 to 15%, 1 to 12%, 1 to 10%, 1 to 8%, 1 to 7%, 1 to 6%, 2 to 10%, 2 to 8%, 2 to 6%, or 1 to 5.5% by weight, relative to the weight of the composition.Macromeric compound

[0041] Embodiments of the composition, as disclosed herein, may further comprise a macromeric compound. In an embodiment of the present disclosure, there is provided a composition as disclosed herein, wherein the macromeric compound comprises at least one polysaccharide selected from carrageenan, hydroxypropylmethyl cellulose, guar gum, gum, agar agar, or combinations thereof. In another embodiment of the present disclosure, the macromeric compound comprises at least one polysaccharide selected from carrageenan, agar agar, hydroxypropylmethyl cellulose, or combinations thereof. In one another embodiment of the present disclosure, the macromeric compound is carrageenan. In yet another embodiment of the present disclosure, the macromeric compound is hydroxypropylmethyl cellulose. In yet another embodiment of the present disclosure, the macromeric compound is agar agar.

[0042] In an embodiment of the present disclosure, there is provided a composition as disclosed herein, wherein the polysaccharide is in an amount ranging from 1 to 80% by weight, preferably 1 to 60% by weight, more preferably 2 to 50% by weight, relative to the weight of the composition. In another embodiment of the present disclosure, the polysaccharide is in an amount ranging from 1 to 50%, 1 to 45%, 1 to 40%, 1 to 30%, 1 to 20%, 1 to 15%, 1 to 12%, 5 to 20%, 5 to 15%, 7 to 12% or 8 to 12% by weight, relative to the weight of the composition.

[0043] In an embodiment of the present disclosure, there is provided a composition as disclosed herein, wherein the polysaccharide and the surfactant are in a weight ratio range of 1 : 1 to 4: 1. In another embodiment of the present disclosure, the polysaccharide and the surfactant are in a weight ratio range of 1 : 1 to 3: 1, preferably 1 : 1.06 or 1.9: 1.

[0044] In an embodiment of the present disclosure, there is provided a bioflavonoid composition comprising: (a) a bioflavonoid present in an amount ranging from 2 to 90% by weight; (b) at least one surfactant having molecular weight in a range of 300 to 1500 g / mol present in an amount ranging from 0.1 to 90% by weight; and (c) at least one macromeric compound comprising at least one polysaccharide present in an amount ranging from 1 to 80% by weight, relative to the weight of the composition, wherein the polysaccharide and the surfactant are in a weight ratio range of 1 : 1 to 4: 1.

[0045] In an embodiment of the present disclosure, there is provided a composition as disclosed herein, wherein the macromeric compound comprises at least one water-soluble binder selected from vinyl polymers, acrylic polymers, ethylene oxide polymers, ethylene glycol polymers, natural polymers or combinations thereof, preferably from vinyl polymers or natural polymers. In another embodiment of the present disclosure, the vinyl polymer is polyvinyl pyrrolidone (PVP). In another embodiment of the present disclosure, the vinyl polymer is ethylene glycol polymers, such as polyethylene glycol (PEG). In yet another embodiment, the natural polymer is corn starch.

[0046] In an embodiment of the present disclosure, there is provided a composition as disclosed herein, wherein the water-soluble binder is in an amount ranging from0.01 to 90% by weight, preferably 0.5 to 80% by weight, relative to the weight of the composition. In another embodiment of the present disclosure, the water- soluble binder is in an amount ranging from 1 to 80%, 1 to 77%, 1 to 70%, 1 to 60%, 1 to 50%, 1 to 40%, 1 to 30%, 1 to 20%, 1 to 15%, 1 to 10%, 1 to 8%, or 1 to 6% by weight, relative to the weight of the composition.Suspending agent

[0047] Embodiments of the composition, as disclosed herein, may further comprise a suspending agent. In an embodiment of the present disclosure, there is provided a composition as disclosed herein, wherein the composition comprises at least one suspending agent selected from microcrystalline cellulose, dextrin, powdered cellulose, lactose, mannitol, sucrose, sorbitol, stearates, silica, silicates, or combinations thereof. In another embodiment of the present disclosure, the suspending agent is microcrystalline cellulose. In another embodiment of the present disclosure, the suspending agent is silica. In another embodiment of the present disclosure, the suspending agent is stearate, preferably magnesium stearate. In an embodiment, the suspending agent is dextrin selected from cyclodextrin, maltodextrin, hydroxyl propyl P cyclodextrin, or combinations thereof.

[0048] In an embodiment of the present disclosure, there is provided a composition as disclosed herein, wherein the suspending agent is in an amount ranging from 1 to 90% by weight, preferably 1 to 85% by weight, more preferably 1 to 76% by weight, relative to the weight of the composition. In another embodiment of the present disclosure, the suspending agent is in an amount ranging from 1 to 80%, 1 to 76%, 4 to 80%, 4 to 77%, 40 to 80%, 40 to 70%, 45 to 65%, 50 to 60%, or 50 to 65% by weight, relative to the weight of the composition.

[0049] In an embodiment of the present disclosure, there is provided a bioflavonoid composition comprising: (a) a bioflavonoid present in an amount ranging from 2 to 90% by weight; (b) at least one surfactant having molecular weight in a range of 300 to 1500 g / mol present in an amount ranging from 0.1 to90% by weight; (c) at least one macromeric compound selected from a polysaccharide, a water-soluble binder, or combination thereof, wherein the polysaccharide is present in an amount ranging from 1 to 80% by weight, the water-soluble binder is present in an amount ranging from 0.01 to 90% by weight; and (d) a suspending agent present in an amount ranging from 1 to 90% by weight, relative to the weight of the composition, wherein the polysaccharide and the surfactant are in a weight ratio range of 1 : 1 to 4: 1.Stabilizer

[0050] In an embodiment of the present disclosure, there is provided a composition as disclosed herein, wherein the composition further comprises a stabilizer selected from base, lipids, polyols, or combinations thereof. In another embodiment of the present disclosure, the stabilizer is a base selected from NaOH, KOH, hydroxides of alkali metals, or combinations thereof. In yet another embodiment of the present disclosure, the stabilizer is a lipid selected from phospholipids, preferably phosphatidyl choline. In another embodiment of the present disclosure, the stabilizer is a polyol, preferably propylene glycol. In an embodiment of the present disclosure, the stabilizer is in an amount ranging from 0.05 to 60% by weight, preferably 0.1 to 55% by weight, more preferably 0.1 to 50% by weight, relative to the weight of the composition. In an embodiment of the present disclosure, the stabilizer is in an amount ranging from 0.1 to 53%, or 0.1 to 48% by weight, relative to the weight of the composition.Polar solvent

[0051] In an embodiment of the present disclosure, there is provided a composition as disclosed herein, wherein the composition comprises a polar solvent.

[0052] In an embodiment of the present disclosure, the polar solvent is selected from water, ethanol, isopropyl alcohol, acetone or combinations thereof. In another embodiment of the present disclosure, the polar solvent is selected from water, isopropyl alcohol or combinations thereof. In yet another embodiment of the present disclosure, the polar solvent is water.

[0053] In an embodiment of the present disclosure, the polar solvent is present in quantity sufficient in the composition.

[0054] In an embodiment of the present disclosure, there is provided a composition as disclosed herein, wherein the composition is capable of providing controlled release of the bioflavonoid.

[0055] In an embodiment of the present disclosure, there is provided a composition as disclosed herein, wherein the composition is in the form of solid or liquid, preferably in the form of granules, pellets, beadlets, powder, emulsion, phytosome complex / compositions, dextrin complex, liposome, nanolipid particles, nanoemulsion, gels, nanogels, tablet, softlets, softgel, capsule, or lozenges.

[0056] In an embodiment of the present disclosure, there is provided a capsule comprising: (a) the bioflavonoid composition as disclosed herein; and (b) a polymeric shell.

[0057] In another embodiment of the present disclosure, there is provided a capsule comprising: (a) a bioflavonoid present in an amount ranging from 2 to 90% by weight; (b) at least one surfactant having molecular weight in a range of 300 to 1500 g / mol present in an amount ranging from 0.1 to 90% by weight; (c) at least one macromeric compound selected from a polysaccharide, a water-soluble binder, or combination thereof, wherein the polysaccharide present in an amount ranging from 1 to 80% by weight, wherein the water-soluble binder present in an amount ranging from 0.01 to 90% by weight; (d) a suspending agent present in an amount ranging from 1 to 90% by weight, relative to the weight of the composition; and (e) a polymeric shell.

[0058] In an embodiment of the present disclosure, there is provided a capsule as disclosed herein, wherein the polymeric shell is obtained from gelatin, collagen, cellulosic polymer, starch, or combinations thereof.

[0059] In an embodiment of the present disclosure, there is provided a capsule as disclosed herein, wherein the capsule comprises other additives selected from flavorants, colorants, dispersants, glidants, lubricants, or combinations thereof.

[0060] In an embodiment of the present disclosure, there is provided a process of preparing the composition as disclosed herein, the process comprising: (a) mixing stoichiometric amount of bioflavonoid, optionally at least one polysaccharide, and a suspending agent in a mixer to obtain a first mixture; and (b) adding to the first mixture an aqueous solution of at least one surfactant and optionally an aqueous solution of at least one water-soluble binder, to obtain the composition.

[0061] In an embodiment of the present disclosure, there is provided a process of preparing the composition as disclosed herein, wherein the process comprises extruding the composition through an extruder and shaping.

[0062] In an embodiment of the present disclosure, there is provided a nutraceutical formulation comprising the composition as disclosed herein.

[0063] In another embodiment of the present disclosure, there is provided a nutraceutical formulation comprising: (a) a bioflavonoid present in an amount ranging from 2 to 90% by weight; (b) at least one surfactant having molecular weight in a range of 300 to 1500 g / mol present in an amount ranging from 0.1 to 90% by weight; (c) at least one macromeric compound selected from a polysaccharide, a water-soluble binder, or combination thereof, wherein the polysaccharide is present in an amount ranging from 1 to 80% by weight, wherein the water-soluble binder is present in an amount ranging from 0.01 to 90% by weight; and (d) a suspending agent present in an amount ranging from 1 to 90% by weight, relative to the weight of the composition, wherein the polysaccharide and the surfactant are in a weight ratio range of 1 : 1 to 4: 1.

[0064] In another embodiment of the present disclosure, there is provided a nutraceutical formulation comprising: (a) a bioflavonoid present in an amount ranging from 2 to 90% by weight; (b) at least one surfactant having molecular weight in a range of 300 to 1500 g / mol present in an amount ranging from 0.1 to 90% by weight; (c) at least one macromeric compound selected from a polysaccharide, a water-soluble binder, or combination thereof, wherein the polysaccharide is present in an amount ranging from 1 to 80% by weight, wherein the water-soluble binder is present in an amount ranging from 0.01 to 90% byweight; (d) a stabilizer present in an amount ranging from 0.05 to 60% by weight, relative to the weight of the composition.Use

[0065] The composition, as disclosed herein may be formulated as nutraceutical formulation and / or food products. In an embodiment of the present disclosure, there is provided a nutraceutical formulation as disclosed herein, wherein the formulation is a food product selected from beverages, jelly, cake, pie, custard, non-frozen dessert, frozen dessert, ice cream, fruit pieces, confectionary, cereals, chocolates, or snack bars.

[0066] In an embodiment of the present disclosure, there is provided a composition as disclosed herein, wherein the composition is an anti-inflammatory and / or an immunomodulator composition.

[0067] In an embodiment of the present disclosure, there is provided a use of the composition as disclosed herein in the manufacture of a dietary supplement, nutraceutical, pharmaceutical, or a medicament.

[0068] In an embodiment of the present disclosure, there is provided a method of managing a condition or a disorder, the method comprising administering the composition or the formulation as disclosed herein to a subject in need thereof.

[0069] In an embodiment of the present disclosure, there is provided a method as disclosed herein, wherein the condition or disorder is selected from diabetes, metabolic disorders, hypertension, or arthritis. The composition, as disclosed herein, exhibits anti-inflammatory, antioxidant, anti-VEGF, anticancer, GLP-1 agonist, hepatoprotectant, neuroprotectant, and / or immunomodulator properties.

[0070] The composition, as disclosed herein, may be used in management of rheumatoid arthritis, metabolic disorders, osteoarthritis, bone and joint health, gut health, metabolic health, immune health, obesity, liver health, eye health, muscle heath, respiratory health, cardiovascular health, or diabetes.Methods

[0071] Embodiments herein provide a method for preparation of the bioflavonoid compositions as disclosed herein. In an embodiment, the method comprises (a) mixing stoichiometric amount of bioflavonoid, optionally at least one polysaccharide, in a mixer to obtain a first mixture; (b) adding to the first mixture an aqueous solution of at least one surfactant and optionally an aqueous solution of at least one water soluble, to obtain the composition. In an embodiment, the method comprises (a) mixing stoichiometric amount of bioflavonoid, optionally at least one polysaccharide, and a suspending agent in a mixer to obtain a first mixture; (b) adding to the first mixture an aqueous solution of at least one surfactant and optionally an aqueous solution of at least one water soluble, to obtain the composition.

[0072] In an embodiment, the method comprises extruding the composition through an extruder and shaping to obtain a plurality of beads and drying. In an embodiment, the beads are then dried to remove any water or solvent. In an embodiment, the method further comprises packing the bead in polymeric shells.Formulations

[0073] Embodiments herein may be formulated in the form of granule, pellet, powder, emulsion, nanoemulsion, gels, nanogels, tablet, phytosome, beadlet, capsule, softlets, softgel, or lozenges.

[0074] Embodiments herein provide a beadlet formulation.

[0075] In an embodiment of the present disclosure, there is provided a beadlet formulation, comprising a bioflavonoid; at least one surfactant having molecular weight in a range of 300 to 1500 g / mol; at least one macromeric compound; and at least one suspending agent.

[0076] In another embodiment of the present disclosure, there is provided a beadlet formulation, comprising a bioflavonoid, preferably a hexahydroxy flavonoid, more preferably 3, 5, 6, 7, 3', 4'- hexahydroxyflavone, in an amount ranging from 2 to 90% by weight; and at least one surfactant having molecular weight in a range of 300 to 1500 g / mol, preferably ester of polyoxyethylene sorbitan fatty acid, present in an amount ranging from 0.1 to 90% by weight; at least one macromericcompound selected from a polysaccharide, a water-soluble binder, or combination thereof, wherein the polysaccharide is present in an amount ranging from 1 to 80% by weight, wherein the water-soluble binder is present in an amount ranging from 0.01 to 80% by weight of the composition; and at least one suspending agent, preferably microcrystalline cellulose, present in an amount ranging from 1 to 90% by weight, relative to the weight of the composition.

[0077] Embodiments herein provide a tablet formulation.

[0078] In an embodiment of the present disclosure, there is provided a tablet formulation, comprising a bioflavonoid; at least one surfactant having molecular weight in a range of 300 to 1500 g / mol; at least one macromeric compound; and at least one suspending agent.

[0079] In another embodiment of the present disclosure, there is provided a tablet formulation, comprising a bioflavonoid, preferably a hexahydroxy flavonoid, more preferably 3, 5, 6, 7, 3', 4'- hexahydroxyflavone, in an amount ranging from 2 to 90% by weight; and at least one surfactant having molecular weight in a range of 300 to 1500 g / mol, preferably ester of polyoxyethylene sorbitan fatty acid, present in an amount ranging from 0.1 to 90% by weight; at least one macromeric compound selected from a polysaccharide, a water-soluble binder, or combination thereof, wherein the polysaccharide is present in an amount ranging from 1 to 90% by weight, wherein the water-soluble binder is present in an amount ranging from 0.01 to 80% by weight of the composition; and at least one suspending agent present in an amount ranging from 1 to 90% by weight, relative to the weight of the composition, wherein the suspending agent preferably comprises microcrystalline cellulose, magnesium stearate, and silica.

[0080] Embodiments herein provide a nanoemulsion formulation.

[0081] In an embodiment of the present disclosure, there is provided a nanoemulsion formulation, comprising a bioflavonoid; at least one surfactant having molecular weight in a range of 300 to 1500 g / mol; at least one macromeric compound; and at least one stabilizer.

[0082] In another embodiment of the present disclosure, there is provided a nanoemulsion formulation, comprising a bioflavonoid, preferably a hexahydroxyflavonoid, more preferably 3, 5, 6, 7, 3', 4'- hexahydroxyflavone, in an amount ranging from 2 to 90% by weight; and at least one surfactant having molecular weight in a range of 300 to 1500 g / mol, preferably ester of polyoxyethylene sorbitan fatty acid, present in an amount ranging from 0.1 to 90% by weight; at least one macromeric compound selected from a polysaccharide, a water-soluble binder, or combination thereof, wherein the polysaccharide is present in an amount ranging from 1 to 90% by weight, wherein the water-soluble binder is present in an amount ranging from 0.01 to 80% by weight of the composition; and at least one stabilizer, preferably a polyol and a base, present in an amount ranging from 1 to 90% by weight, relative to the weight of the composition.

[0083] Embodiments herein provide a phytosome formulation.

[0084] In an embodiment of the present disclosure, there is provided a phytosome formulation, comprising a bioflavonoid; at least one surfactant having molecular weight in a range of 300 to 1500 g / mol; at least one macromeric compound; at least one suspending agent, and a stabilizer.

[0085] In another embodiment of the present disclosure, there is provided a phytosome formulation, comprising a bioflavonoid, preferably a hexahydroxy flavonoid, more preferably 3, 5, 6, 7, 3', 4'- hexahydroxyflavone, in an amount ranging from 2 to 90% by weight; and at least one surfactant having molecular weight in a range of 300 to 1500 g / mol, preferably ester of polyoxyethylene sorbitan fatty acid, present in an amount ranging from 0.1 to 90% by weight; at least one macromeric compound selected from a polysaccharide, a water-soluble binder, or combination thereof, wherein the polysaccharide is present in an amount ranging from 1 to 80% by weight, wherein the water-soluble binder is present in an amount ranging from 0.01 to 90% by weight of the composition; at least one suspending agent present in an amount ranging from 1 to 90% by weight, relative to the weight of the composition, wherein suspending agent preferably comprises microcrystalline cellulose and silica; and at least one stabilizer, preferably a polyol, present in an amount ranging from 1 to 90% by weight, relative to the weight of the composition.

[0086] Embodiments herein provide a dextrin formulation.

[0087] In an embodiment of the present disclosure, there is provided a dextrin formulation, comprising a bioflavonoid; at least one surfactant having molecular weight in a range of 300 to 1500 g / mol; at least one macromeric compound; and at least one suspending agent.

[0088] In another embodiment of the present disclosure, there is provided a dextrin formulation, comprising a bioflavonoid, preferably a hexahydroxy flavonoid, more preferably 3, 5, 6, 7, 3', 4'- hexahydroxyflavone, in an amount ranging from 2 to 90% by weight; and at least one surfactant having molecular weight in a range of 300 to 1500 g / mol, preferably ester of polyoxyethylene sorbitan fatty acid, present in an amount ranging from 0.1 to 90% by weight; at least one macromeric compound selected from a polysaccharide, a water-soluble binder, or combination thereof, wherein the polysaccharide is present in an amount ranging from 1 to 80% by weight, wherein the water-soluble binder is present in an amount ranging from 0.01 to 90% by weight of the composition; at least one suspending agent present in an amount ranging from 1 to 90% by weight, relative to the weight of the composition, wherein suspending agent preferably comprises microcrystalline cellulose, dextrin and silica, wherein said dextrin is selected from cyclodextrin, maltodextrin, hydroxyl propyl P cyclodextrin, or combinations thereof; and at least one stabilizer, preferably a polyol, present in an amount ranging from Ito 90% by weight, relative to the weight of the composition.

[0089] Although the subject matter has been described with reference to specific embodiments, this description is not meant to be construed in a limiting sense. Various modifications of the disclosed embodiments, as well as alternate embodiments of the subject matter, will become apparent to persons skilled in the art upon reference to the description of the subject matter. It is therefore contemplated that such modifications can be made without departing from the spirit or scope of the present subject matter as defined.EXAMPLES

[0090] The disclosure will now be illustrated with following examples, which is intended to illustrate the working of disclosure and not intended to take restrictively to imply any limitations on the scope of the present disclosure. Unlessdefined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood to one of ordinary skill in the art to which this disclosure belongs. Although methods and materials similar or equivalent to those described herein can be used in the practice of the disclosed methods and compositions, the exemplary methods, devices and materials are described herein. It is to be understood that this disclosure is not limited to particular methods, and experimental conditions described, as such methods and conditions may vary.Example 1: Preparation of the bioflavonoid composition WEI

[0091] To prepare the bioflavonoid composition WEI, 2.3 kg of powdered 3,3’,4’,5,6,7-Hexahydroxyflavone (bioflavonoid), 1.0 kg of carrageenan powder (polysaccharide), and 5.97 kg of microcrystalline cellulose (suspending agent) were accurately weighed and passed through a 30# mesh sieve to ensure uniform particle size. The sieved powders were transferred into a Rapid Mixer Granulator (RMG) and dry-mixed for 10 minutes to achieve a homogeneous blend. Separately, 0.53 kg of Tween 80 (surfactant) was weighed into a stainless-steel container, to which 0.5 L of isopropyl alcohol (IP A) was added. This mixture (Tween 80-IPA) was stirred for 15 minutes until the Tween 80 was completely dissolved. In parallel, 0.2 kg of PVP K-30 was weighed and transferred into 10.0 kg of purified water in another stainless steel container and stirred continuously for 15 minutes to obtain a clear binder solution. The Tween 80-IPA solution was then slowly added to the PVP solution under continuous stirring to form a uniform binder phase. This binder solution was gradually added to the dry-mixed powder in the RMG over a period of 5 minutes while mixing, resulting in a cohesive wet mass. The wet mass was then unloaded and passed through an extruder fitted with a 1 mm mesh to form uniform extrudates. These extrudates were transferred to a spheronizer and processed at a speed of 1000 to 2000 RPM to obtain spherical beads (pellets). The pellets were subsequently dried in a fluidized bed dryer (FBD) until the moisture content was reduced to between 2% and 4% w / w to obtain the composition of Table 1. Finally, the dried pellets were sieved to remove any finepowder, packed in moisture-resistant polybags, and stored in sealed plastic drums to protect the composition from light and moisture.

[0092] Table 1: Bioflavonoid composition WEI.Example 2: Preparation of the working composition:

[0093] The working compositions WEI to WE5 were prepared using the process described in Example 1. For each formulation, batch quantities of powder of 3, 3’, 4’, 5, 6, 7- -Hexahydroxyflavone (micronized), carrageenan powder, and microcrystalline cellulose were sieved through a 30# mesh and dry-mixed in a Rapid Mixer Granulator (RMG) for 10 minutes. Separately, Tween 80 was dissolved in isopropyl alcohol, and PVP K-30 was dissolved in purified water under continuous stirring. The two solutions were combined to form a uniform binder phase, which was then added gradually to the dry mix in the RMG to form a cohesive wet mass. The wet mass was extruded through a 1 mm mesh and spheronized at 1000-2000 RPM to obtain uniform pellets. These were dried in afluidized bed dryer to achieve a final moisture content of 2%-4% w / w to obtain compositions of Table 2 where the amount of components is presented in weight percentage. The dried pellets were sieved to remove fine particles and packed in moisture-resistant polybags, then stored in sealed plastic drums to protect from light and humidity.Table 2: Exemplary working compositions WEI to WE5 (working examples).

[0094] WEI served as the reference composition. WE2 was prepared by reducing the active ingredient content in WEI by 50%. WE3 involved increasing the active ingredient concentration from 20% to 30% relative to WEI. In WE4, Tween 80 was replaced with hydrogenated castor oil as the surfactant. WE5 was formulated by omitting kappa carrageenan from the composition.

[0095] The compositions WE6 to WE11 were prepared using the same method described in Example 1, with formulation-specific variations in excipients asprovided in Table 3 where the amount of components is presented in weight percentage.

[0096] Table 3: Exemplary working compositions WE6 to WE11 (working examples).

[0097] WE6 was prepared by replacing Tween 80 in WEI with soya lecithin; WE7 used half the quantity of Tween 80 compared to WEI; WE8 included an increased amount of polyvinylpyrrolidone (PVP); WE9 was formulated using non- micronized Hexahydroxyflavone powder; WE 10 contained 20% less active ingredient than WEI; and in WEI 1 replaced PVP with com starch as the binder.The compositions WE12-WE15 and WE18-WE19 were prepared using the same method described in Example 1, with formulation-specific variations in excipients as provided in Table 4 where the amount of components is presented in weight percentage.

[0098] Table 4: Exemplary working compositions WE12-WE15 and WE18-WE19 (working examples)

[0099] WE12 was prepared by replacing Tween 80 with poloxamer; WE13 used sorbitan monooleate in place of Tween 80; WE14 included P-cyclodextrin as an additional excipient; WEI 5 incorporated maltodextrin; WEI 8 substituted kappa carrageenan with guar gum; and WE 19 used hydroxypropyl methylcellulose (HPMC) instead of kappa carrageenan.Example 3: Preparation of the non-working examples for the compositions

[0100] Non-working compositions NWE1 through NWE6 were prepared using the same general procedure described in Example 1, with modifications to component selection and quantities as outlined in Table 5, and the resulting compositions were evaluated.

[0101] Table 5: Exemplary non-working compositions NWE1-NWE6 (nonworking examples)NWE1 was prepared without Tween 80; NWE2 omitted polyvinylpyrrolidone (PVP); NWE3 replaced microcrystalline cellulose with maltodextrin; NWE4 replaced microcrystalline cellulose with P-cyclodextrin- microcrystalline cellulose tends to swell upon the addition of water, resulting in spherical beads during the process. When maltodextrin is used alone, the process isn't feasible because it is water soluble, and consequently, no beads are formed; NWE5 included 50% more Tween 80 than the reference formulation WEI; and NWE6 used modified starch in place of microcrystalline cellulose.Example 4: Solubility Evaluation of Compositions:

[0102] The solubility of the working as well as non-working compositions / formulations was evaluated using a standardized dissolution method. For each formulation, an amount equivalent to 100.0 mg of Hexahydroxyflavone was accurately weighed and transferred into 900 mL ofpurified water maintained as the dissolution medium. The dissolution was carried out using a paddle apparatus set at 50 RPM. Samples were collected at 30 minutes, 1 hour, 2 hours, and 4 hours, and subsequently analyzed for Hexahydroxyflavone content using a validated high-performance liquid chromatography (HPLC) method.

[0103] Table 6: Results of Solubility Evaluation of Compositions WE1- WE19 and NWE1-NWE6.

[0104] Table 7: Results of Solubility Evaluation of Compositions WE1- WE19 and NWE1-NWE6 (Continued).

[0105] As summarized in Tables 6 and 7, the formulations WEI, WE2, WE3, WE4, WE5, WE6, WE7, WE8, WE9, WE10, WE11, WE12, WE13, WE14, WE15, WE18, and WE19 demonstrated both good dissolution and controlled release over the four-hour period. These formulations also exhibited favorable physical stability throughout the study. In contrast, the unformulated raw material and certain non-working formulations (including select NWE series compositions)showed inferior solubility and / or instability. The results confirm that the optimized formulations significantly enhance the aqueous solubility of Hexahydroxyflavone.Example 5: In Vivo Efficacy and Bioavailability StudiesBioavailability Studies

[0106] The oral bioavailability of the test composition WEI was evaluated in male New Zealand White rabbits. Three animals, aged 6-8 weeks, were selected for the study. Prior to dosing, the rabbits were fasted for 10-12 hours to standardize absorption conditions. Working composition labelled as WEI was administered orally at a dose of 200 mg / kg body weight, calculated based on the active pharmaceutical ingredient (API) equivalence.

[0107] Blood samples were collected at multiple time points post-dosing: 30 minutes, 60 minutes, 1.5 hours, 2 hours, 3 hours, 4.5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, and 48 hours. Plasma was separated and analyzed using a validated liquid chromatography-mass spectrometry (LC-MS) method to quantify the concentration of hydroxyphenylchromone.

[0108] Table 8: Results of bioavailability study for WEI and unformulated hydroxyphenylchromone in rabbits.

[0109] As summarized in Table 8 and illustrated in Figure 1, the WEI -treated group exhibited significantly enhanced plasma concentrations of hydroxyphenylchromone compared to the unformulated compound. The maximum plasma concentration (Cmax) for WEI was 31.0 ng / mL, representing a1.3-fold increase over the unformulated hydroxyphenylchromone (22.6 ng / mL). Similarly, the area under the plasma concentration-time curve (AUCo-48h) for WEI was 546.6 hr- ng / mL, a 1.1 -fold increase compared to 500.9 hr- ng / mL for the unformulated compound. These results confirm that the WEI formulation significantly improves the oral bioavailability of hydroxyphenylchromone, likely due to enhanced solubility and optimized formulation characteristics.Monosodium Iodo-Acetate (MIA) Induced Osteoarthritis Disease Model — Efficacy Study in Rabbits

[0110] The therapeutic efficacy of the test formulation WEI was evaluated using a monosodium iodo-acetate (MIA)-induced osteoarthritis model in male New Zealand White rabbits. Animals aged 6-8 weeks were randomized into three groups (n = 3 per group): normal control, disease control, and WEI treatment group. The WEI formulation was administered orally at a dose of 100 mg / kg body weight once daily, starting from Day 1.

[0111] On Day 8, osteoarthritis was induced in the disease control and treatment groups by intra-articular injection of 4 mg of MIA into one knee joint. Knee swelling was monitored weekly using a vernier caliper to assess inflammation and joint degeneration. On Day 28, radiographic imaging was performed to evaluate structural changes in the affected joints.

[0112] Table 9: Results for rabbit knee x-ray examination (Disease Control & WEI Treatment)

[0113] As shown in Figure 2, the WEI -treated group exhibited significantly reduced knee swelling (0.76 mm) compared to the disease control group (1.97mm), representing a 2.6-fold reduction in joint inflammation. Radiological analysis (Figure 3) further confirmed the therapeutic benefit of WEI, with the treated group showing only mild joint space narrowing, minimal osteophyte formation, and slight changes in bone alignment, as summarized in Table 9. In contrast, the disease control group exhibited pronounced degenerative changes.

[0114] These findings indicate that WEI effectively mitigates the progression of osteoarthritis in the MIA-induced rabbit model, as evidenced by both clinical and radiological parameters. The reduction in inflammation and preservation of joint structure support the potential of WEI as a disease-modifying agent for osteoarthritis.Acute LPS-Challenged Anti-Inflammatory Efficacy Study in Rabbits

[0115] The anti-inflammatory efficacy of the test formulation WEI was evaluated using an acute lipopolysaccharide (LPS)-induced systemic inflammation model in male New Zealand White rabbits. Animals aged 6-8 weeks were randomized into three groups (n = 3 per group): normal control, disease control (LPS-challenged), and WEI treatment group. WEI was administered orally at a dose of 100 mg / kg body weight (API equivalence) once daily for seven consecutive days (Day 1 to Day 7).

[0116] On Day 7, systemic inflammation was induced in the disease control and WEI -treated groups via intravenous injection of purified Escherichia coli O128:B12 lipopolysaccharide (LPS) at a dose of 5 pg / kg body weight. Blood samples were collected at 30 minutes, 1 hour, and 2 hours post-LPS challenge to assess systemic inflammatory response by quantifying serum levels of cyclooxygenase-2 (COX-2) and tumor necrosis factor-alpha (TNF-a), two key pro-inflammatory biomarkers as shown in Figure 4.

[0117] As shown in Figures 4-5, the WEI -treated group exhibited a marked reduction in both COX-2 and TNF-a levels at all measured time points compared to the LPS-challenged disease control group. Specifically, COX-2 levels were reduced by a minimum of 37% and up to 60%, while TNF-a levels showed a reduction ranging from 26.6% to 48%. These reductions indicate a robust systemic anti-inflammatory response.

[0118] The results confirm that WEI significantly attenuates LPS-induced inflammation, as evidenced by the suppression of key inflammatory mediators. This supports the potential of WEI as an effective therapeutic agent for managing acute systemic inflammatory conditions.Example 6: Preparation of the Nutraceutical Formulations

[0119] The working compositions described in Examples WEI to WE 19 were further developed into nutraceutical formulations suitable for oral administration. These compositions were processed into free-flowing spherical pellets using a method as described previously.

[0120] The resulting pellets were dried to a moisture content of 2%-4% w / w and sieved to obtain uniform particle size. These pellets were then filled into size 0 or size 1 hard gelatin capsules using a semi-automatic capsule filling machine. Each capsule was designed to deliver a precise dose of the active ingredient, ensuring consistency and ease of administration.

[0121] In addition to capsule-based delivery, the compositions were also formulated into various food-grade nutraceutical products. The pelletized or powdered forms of the compositions were incorporated into a range of food matrices, including but not limited to beverages, jellies, cakes, pies, custards, non- frozen and frozen desserts, ice creams, fruit pieces, confectionery, cereals, chocolates, and snack bars. These food-based formats were developed to enhance consumer compliance and provide functional health benefits in convenient and palatable forms.

[0122] The formulations maintained their physical stability and bioactive integrity during incorporation into food products, demonstrating compatibility with standard food processing conditions. The versatility of the compositions in both pharmaceutical and food-grade formats highlights their potential as multifunctional nutraceutical agents.ADVANTAGES OF THE PRESENT DISCLOSUREThe present disclosure provides a bioflavonoid composition, with the following advantages:Enhanced aqueous solubility. The compositions, particularly WEI through WEI 9, demonstrate significantly improved solubility in water compared to the unformulated raw material, enabling better dispersion and absorption.Improved bioavailability and systemic efficacy. In vivo pharmacokinetic studies confirm that the compositions, exhibit increased Cmax and AUC values, indicating enhanced oral bioavailability and sustained systemic exposure.Superior physical and chemical stability. The formulations maintain structural integrity and uniformity under standard storage and processing conditions. In contrast, non-working examples lacking key excipients showed physical instability or poor solubility.Demonstrated anti-inflammatory activity. In LPS-challenged rabbit models, the compositions significantly reduced pro-inflammatory biomarkers such as COX-2 and TNF-a, confirming their systemic anti-inflammatory potential.Efficacy in osteoarthritis management. In MIA-induced osteoarthritis models, the compositions reduced joint swelling and structural damage, as evidenced by radiological and clinical assessments, supporting their disease-modifying potential.Versatile formulation potential: The compositions can be conveniently formulated into hard gelatin capsules or incorporated into a wide range of food-grade nutraceutical products such as beverages, jellies, desserts, cereals, chocolates, and snack bars, enhancing consumer compliance and market adaptability.

Claims

I / We Claim:

1. A bioflavonoid composition comprising: a. a bioflavonoid; b. at least one surfactant having molecular weight in a range of 300 to 1500 g / mol; and c. optionally, at least one macromeric compound.

2. The composition as claimed in claim 1, wherein the surfactant has molecular weight in a range of 1000 to 1500 g / mol and preferably 1100 to 1400 g / mol.

3. The composition as claimed in claim 1, wherein the macromeric compound comprises at least one polysaccharide selected from carrageenan, hydroxypropylmethyl cellulose, guar gum, agar agar, gum, or combinations thereof.

4. The composition as claimed in claim 1, wherein the macromeric compound further comprises at least one water-soluble binder selected from vinyl polymers, acrylic polymers, ethylene oxide polymers, ethylene glycol polymers, natural polymers or combinations thereof, preferably selected from vinyl polymers or natural polymers.

5. The composition as claimed in claims 1 to 3, wherein the polysaccharide and the surfactant are in a weight ratio range of 1 : 1 to 4: 1.

6. The composition as claimed in claim 1, wherein the bioflavonoid is selected from polyhydroxy flavonoids.

7. The composition as claimed in claim 1, wherein the surfactant is selected from non-ionic surfactant or zwitterionic surfactant, preferably from esters of polyoxyethylene sorbitan fatty acids, esters of polyoxyethylene fatty acids, phospholipids or combinations thereof.

8. The composition as claimed in claim 1, wherein the composition comprises at least one suspending agent selected from microcrystalline cellulose, dextrin, powdered cellulose, lactose, mannitol, sucrose, sorbitol, stearates, silica, silicates, or combinations thereof.

9. The composition as claimed in claim 1, wherein the bioflavonoid is in an amount ranging from 2.0 to 90 % by weight, preferably 2.5 to 65% by weight and more preferably 2.5 to 60% by weight, relative to the weight of the composition.

10. The composition as claimed in claim 1, wherein the surfactant is in an amount ranging from 0.1 to 90% by weight, preferably 0.1 to 80% by weight and more preferably 0.5 to 45% by weight, relative to the weight of the composition.

11. The composition as claimed in claim 3, wherein the polysaccharide is in an amount ranging from 1 to 80% by weight, preferably 1 to 60% by weight and more preferably 2 to 50% by weight, relative to the weight of the composition.

12. The composition as claimed in claim 4, wherein the water-soluble binder is in an amount ranging from 0.01 to 90% by weight, preferably 0.5 to 80% by weight and more preferably 1 to 80% by weight, relative to the weight of the composition.

13. The composition as claimed in claim 8, wherein the suspending agent is in an amount ranging from 1 to 90% by weight, preferably 1 to 85% by weight and more preferably 1 to 76% by weight, relative to the weight of the composition.

14. The composition as claimed in claim 1, wherein the composition has moisture content in a range of 3 to 4% by weight of the composition.

15. The composition as claimed in claim 1, wherein the composition further comprises a stabilizer selected from base, lipids, polyol or combinations thereof.

16. The composition as claimed in claim 1, wherein the composition is capable of providing controlled release of the bioflavonoid.

17. The composition as claimed in claim 1, wherein the composition is in the form of solid or liquid, preferably in the form of granules, pellets, beadlets, powder, emulsion, phytosome complex / compositions, dextrin complex, liposome, nanolipid particles, nanoemulsion, gels, nanogels, tablet, softlets, softgel, capsule, or lozenges.

18. A capsule comprising: a. the bioflavonoid composition as claimed in claim 1; and b. a polymeric shell.

19. The capsule as claimed in claim 18, wherein the polymeric shell is obtained from gelatin, collagen, cellulosic polymer, starch, or combinations thereof.

20. The capsule as claimed in claim 18, wherein the capsule comprises other additives selected from flavorants, glidant, colorants, dispersants, lubricants, or combinations thereof.

21. A process of preparing the composition as claimed in any one the claims 1 to 17, the process comprising: a. mixing stoichiometric amount of bioflavonoid, optionally at least one polysaccharide, and a suspending agent in a mixer to obtain a first mixture; and b. adding to the first mixture an aqueous solution of at least one surfactant and optionally an aqueous solution of at least one water-soluble binder, to obtain the composition.

22. The process as claimed in claim 21, wherein the process comprises extruding the composition through an extruder and shaping.

23. A nutraceutical formulation comprising the composition as claimed in claim 1.

24. The nutraceutical as claimed in claim 23, wherein the formulation comprises a food product selected from beverages, jelly, cake, pie, custard, non -frozen dessert, frozen dessert, ice cream, fruit pieces, confectionary, cereals, chocolates, or snack bars.

25. The composition as claimed in claim 1, wherein the composition is an antiinflammatory and / or an immunomodulator composition.

26. Use of the composition as claimed in claim 1 in the manufacture of a dietary supplement or a medicament.

27. A method of managing a condition or a disorder, the method comprising administering the composition as claimed in claim 1 or the formulation as claimed in claim 24 to a subject in need thereof.

28. The method as claimed in claim 27, wherein the condition or disorder is selected from diabetes, metabolic disorders, hypertension, or arthritis.

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