FIELD OF THE INVENTION
[0001] The present invention relates to a hair care composition. Specifically, the present invention relates to a hair care composition to promote hair growth, strengthen roots, reverse hair damage and promotes overall health of hair and scalp. Also, the invention relates to a liposome-based topical composition comprising one or more active hair-growth promoting active ingredients entrapped in a lipid vesicle stabilized by a surfactant, and a method for 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] Hairs and scalp require uninterrupted right nutrition for steady and healthy growth, which may not be fulfilled from the diet. So, balanced nutrition must be therefore provided externally for their uninterrupted growth. The various hair care products present in the market contain several harmful chemical, preservatives and additives which may cause hair damage and scalp problems in long term use.
[0004] Resveratrol (3,4’,5-trihydroxystilbene) is a stilbenoid polyphenol compound and having antioxidant property commonly found in grapes, berries, nuts, red and white wines. It is also reported with anti-inflammatory, free radical scavenger, lowers blood glucose and anti-cancer therapeutic properties.
[0005] Resveratrol is known to increase the nitric oxide production which further leads to vasodilation. The release of potent vasodilator nitric oxide from the endothelium layer of smooth muscles leads to decrease the peripheral resistance which has a direct impact on arterial pressure and controls blood pressure. Resveratrol is also believed to boost mitochondrial function and, in turn, the energy production of the hair cells.
[0006] Dutasteride is inhibitor of the enzyme 5-alpha-reductase which inhibits the conversion of testosterone to dihydrotestosterone. Dutasteride inhibits both type I and type II (present in hair follicles) 5-alpha-reductase. Researches show that dutasteride is effective at treating hair loss.
[0007] Liposomes are microscopic vesicles composed of a single phospholipid bilayer or a plurality of concentric phospholipid bilayers which enclose aqueous phases. These vesicles can serve as drug carriers for hydrophobic as well as hydrophilic substances, including various drug molecules and peptides. Liposomes are prepared mainly from phospholipids of different headgroups and chain lengths, and cholesterol. Due to physicochemical similarities with cell membranes, liposomes are biocompatible, biodegradable and non-toxic vehicles for drug molecules.
[0008] The lipids of these liposomes or vesicles are organized in the form of lipid bilayers. The lipid bilayers encapsulate an aqueous volume which is either interspersed between multiple onion-like shells of lipid bilayers (forming multilamellar lipid vesicles or "MLV") or the aqueous volume is contained within an amorphous central cavity. Liposomes can be present as unilamellar vesicles (ULV) and multilamellar vesicles (MLV).
[0009] Liposomes are prime candidates for the systemic as well as topical delivery of drugs. Several studies showed that liposome encapsulation advantageously alters the pharmacokinetic fate of the drug after topical application.
[0010] Contemplated herein is an MLV-based topical formulation to deliver synergistic mix of hair-growth promoting active ingredients comprising resveratrol and dutasteride for improved hair growth.
[0011] The present invention satisfies the existing needs, as well as others, and generally overcomes the deficiencies found in the prior art.

OBJECTS OF THE INVENTION
[0012] An object of the present invention is to provide a hair care composition.
[0013] An object of the present invention is to provide a hair care composition, wherein the composition is a topical formulation.
[0014] An object of the present invention is to provide a topical hair care composition for pharmaceutical applications.
[0015] An object of the present invention is to provide a topical hair care composition for cosmetic applications.
[0016] An object of the present invention is to provide a topical hair care composition effective in promoting hair growth, strengthening roots, reversing hair damage and promoting overall health of hair.
[0017] An object of the present invention is to provide a topical hair care composition effective in promoting overall health of the scalp.
[0018] An object of the present invention is to provide a topical hair care composition comprising liposomes.
[0019] An object of the present invention is to provide a topical hair care composition comprising unilamellar vesicles (ULVs) and/or multilamellar vesicles (MLVs) as liposomes.
[0020] An object of the present invention is to provide an MLV-based topical hair care composition comprising one or more active hair-growth promoting active ingredients entrapped in a lipid vesicle stabilized by a surfactant.
[0021] An object of the present invention is to provide an MLV-based topical hair care composition comprising resveratrol and dutasteride synergistic mix entrapped in oleic acid liposomes stabilized by SPAN 80 surfactant.
[0022] An object of the present invention is to provide an MLV-based topical hair care composition comprising resveratrol and dutasteride synergistic mix entrapped in oleic acid MLVs stabilized by SPAN 80 surfactant.
[0023] Another object of the present invention is to provide an MLV-based topical hair care composition, which is suitable for all hair and skin types.
[0024] Another object of the present invention is to provide an MLV-based topical hair care composition that has a mild and gentle action on the hair and skin of the individual.
[0025] Another object of the present invention is to provide an MLV-based topical hair care composition for overall hair care as well as scalp hygiene.
[0026] Yet another object of the present invention is to provide a method for preparing an MLV-based topical hair care composition comprising one or more active hair-growth promoting active ingredients entrapped in a lipid vesicle stabilized by a surfactant.
[0027] Yet another object of the present invention is to provide a film hydration method for preparing an MLV-based topical hair care composition comprising one or more active hair-growth promoting active ingredients entrapped in a lipid vesicle stabilized by a surfactant.
[0028] Yet another object of the present invention is to provide a film hydration method for preparing an MLV-based topical hair care composition comprising the steps of:
a. briefly dissolving oleic acid, span 80 and one or more active hair-growth promoting active ingredients in an organic solvent, preferably methanol in a round bottom flask;
b. film formation by evaporating the organic solvent under vacuum using a rotary evaporator to remove even the traces of organic solvent;
c. overnight air-drying of the completely dried film from step b) to remove the traces of methanol and to prevent the formation of emulsion;
d. hydrating the dried film from step c) at ambient temperature for 1 h with phosphate-buffered saline (PBS) at a pH of 7.4; and
e. preparing the uniform size vesicular dispersion by sonication.
[0029] Yet another object of the present invention is to provide a topical hair care composition that is Non-irritant/Dermatologically safe and Dermatologically tested: safe for human scalp after long term use.

SUMMARY OF THE INVENTION
[0030] This summary is provided to introduce a selection of concepts in a simplified form that is further described below in the 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.
[0031] The present invention relates to a hair care composition. Specifically, the present invention relates to a topical hair care composition to promote hair growth, strengthen roots, reverse hair damage and promotes overall health of hair and scalp.
[0032] In an aspect, the present invention relates to a topical hair care composition for pharmaceutical applications.
[0033] In an aspect, the present invention relates to a topical hair care composition for cosmetic applications.
[0034] In an aspect, the present invention relates to a topical hair care composition effective in promoting hair growth, strengthening roots, reversing hair damage and promoting overall health of hair.
[0035] In an aspect, the present invention relates to a topical hair care composition effective in promoting overall health of the scalp.
[0036] In an aspect, the present invention relates to a topical hair care composition comprising liposomes.
[0037] In an aspect, the present invention relates to a topical hair care composition comprising unilamellar vesicles (ULVs) and/or multilamellar vesicles (MLVs) as liposomes.
[0038] In an aspect, the present invention relates to an MLV-based topical hair care composition comprising one or more active hair-growth promoting active ingredients entrapped in a lipid vesicle stabilized by a surfactant.
[0039] In an aspect, the present invention relates to an MLV-based topical hair care composition comprising resveratrol and dutasteride synergistic mix entrapped in oleic acid liposomes stabilized by SPAN 80 surfactant.
[0040] In an aspect, the present invention relates to an MLV-based topical hair care composition comprising resveratrol and dutasteride synergistic mix entrapped in oleic acid MLVs stabilized by SPAN 80 surfactant.
[0041] In another aspect, the present invention relates to an MLV-based topical hair care composition, which is suitable for all hair and skin types.
[0042] In another aspect, the present invention relates to an MLV-based topical hair care composition that has a mild and gentle action on the hair and skin of the individual.
[0043] In another aspect, the present invention relates to an MLV-based topical hair care composition for overall hair care as well as scalp hygiene.
[0044] In yet another aspect, the present invention relates to a method for an MLV-based topical hair care composition comprising one or more active hair-growth promoting active ingredients entrapped in a lipid vesicle stabilized by a surfactant.
[0045] In yet another aspect, the present invention relates to a film hydration method for preparing an MLV-based topical hair care composition comprising one or more active hair-growth promoting active ingredients entrapped in a lipid vesicle stabilized by a surfactant.
[0046] In yet another aspect, the present invention relates to a film hydration method for preparing an MLV-based topical hair care composition comprising the steps of:
a. briefly dissolving, oleic acid, span 80 and one or more active hair-growth promoting active ingredients in an organic solvent, preferably methanol in a round bottom flask;
b. film formation by evaporating the organic solvent under vacuum using a rotary evaporator to remove even the traces of organic solvent;
c. overnight air-drying of the completely dried film from step b) to remove the traces of methanol and to prevent the formation of emulsion;
d. hydrating the dried film from step c) at ambient temperature for 1 h with phosphate-buffered saline (PBS) at a pH of 7.4; and
e. preparing the uniform size vesicular dispersion by sonication.
[0047] In yet another aspect, the present invention relates to an MLV-based topical hair care composition that is Non-irritant/Dermatologically safe and Dermatologically tested: safe for human scalp after long term use.
[0048] Various objects, features, aspects and advantages of the inventive subject matter will become more apparent from the following detailed description of preferred embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS
[0049] FIG. 1 represents the particle size of formulation (DLS) 92.26 nm ideal for topical delivery.
[0050] FIG. 2 represents the Zeta potential of formulation -18.8 mV indicative of stability.
[0051] FIG. 3 represents the photomicrograph of oleic acid vesicle demonstrating complete and uniform formation of vesicles.
[0052] FIG. 4 represents the In-vitro drug release of formulation Sustained release was obtained nearly 64% of drug release in comparison to 90 % in plain drug.

DETAILED DESCRIPTION OF THE INVENTION
[0053] The following is a detailed description of embodiments of the disclosure. The embodiments are in such detail as to clearly communicate the disclosure. However, the amount of detail offered is not intended to limit the anticipated variations of embodiments; on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure.
[0054] All publications herein are incorporated by reference to the same extent as if each individual publication or patent application were specifically and individually indicated to be incorporated by reference. Where a definition or use of a term in an incorporated reference is inconsistent or contrary to the definition of that term provided herein, the definition of that term provided herein applies and the definition of that term in the reference does not apply.
[0055] Reference throughout this specification to “one embodiment” or “an embodiment” means that a particular feature, structure or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, the appearances of the phrases “in one embodiment” or “in an embodiment” in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.
[0056] In some embodiments, numbers have been used for quantifying weight percentages, ratios, and so forth, to describe and claim certain embodiments of the invention and 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 and attached claims 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. The numerical values presented in some embodiments of the invention may contain certain errors necessarily resulting from the standard deviation found in their respective testing measurements.
[0057] Various terms as used herein are shown below. To the extent a term used in a claim is not defined below, it should be given the broadest definition persons in the pertinent art have given that term as reflected in printed publications and issued patents at the time of filing.
[0058] As used in the description herein and throughout the claims that follow, 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.
[0059] Unless the context requires otherwise, throughout the specification which follow, the word “comprise” and variations thereof, such as, “comprises” and “comprising” are to be construed in an open, inclusive sense that is as “including, but not limited to.”
[0060] 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.
[0061] All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g. “such as”) provided with respect to certain embodiments herein is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention otherwise claimed. No language in the specification should be construed as indicating any non-claimed element essential to the practice of the invention.
[0062] Groupings of alternative elements or embodiments of the invention disclosed herein are not to be construed as limitations. Each group member can be referred to and claimed individually or in any combination with other members of the group or other elements found herein. One or more members of a group can be included in, or deleted from, a group for reasons of convenience and/or patentability. When any such inclusion or deletion occurs, the specification is herein deemed to contain the group as modified.
[0063] The description that follows, and the embodiments described therein, is provided by way of illustration of an example, or examples, of particular embodiments of the principles and aspects of the present disclosure. These examples are provided for the purposes of explanation, and not of limitation, of those principles and of the disclosure.
[0064] It should also be appreciated that the present disclosure can be implemented in numerous ways, including as a system, a method or a device. In this specification, these implementations, or any other form that the invention may take, may be referred to as processes. In general, the order of the steps of the disclosed processes may be altered within the scope of the invention.
[0065] The headings and abstract of the invention provided herein are for convenience only and do not interpret the scope or meaning of the embodiments.
[0066] 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.
[0067] While a particular form of the invention has been illustrated and described, it will be apparent that various modifications can be made without departing from the spirit and scope of the invention.
[0068] In an embodiment, the present invention present invention provide a hair care composition having an excellent effect including the promotion of hair growth, strengthening of hair roots, reversing hair damage and promoting overall health of hair as well as scalp without causing side effects or toxicity to the human body, which is based on natural substances.
[0069] In an embodiment of the present invention, the hair care composition relates to a hair care composition to promote hair growth, strengthen roots, reverse hair damage and promotes overall health of hair and scalp.
[0070] In an embodiment of the present invention, the hair care composition is a liposome-based hair care composition comprising various hair-growth promoting active ingredients.
[0071] In an embodiment of the present invention, the hair care composition is a liposome-based hair care composition comprising various lipids and / or fatty acids.
[0072] In an embodiment of the present invention, the hair care composition is a liposome-based hair care composition comprising biphasic liposomes.
[0073] In an embodiment of the present invention, the hair care composition is a liposome-based hair care composition, wherein the fatty acid is selected from but not limited to oleic acid, dicetayl phosphate, palmitic acid, cetyl sulphate, retinoic acid, phosphatidic acid, phosphatidyl serine, long chain amines, e.g., stearyl amines or oleyl amines, long chain pyridinium compounds, e.g., cetyl pyridinium chloride, quaternary ammonium compounds, or mixtures of these can be used. Most preferably oleic acid.
[0074] In an embodiment of the present invention, the hair care composition is a liposome-based hair care composition comprising oleic acid-based liposomes.
[0075] In an embodiment of the present invention, the hair care composition comprising resveratrol and dutasteride entrapped in oleic acid-based liposomes.
[0076] In an embodiment of the present invention, the hair care composition comprising oleic acid-based liposomes, wherein the liposomes are unilamellar (ULVs) or multilamellar vesicles (MLVs), preferably MLVs.
[0077] In an embodiment of the present invention, the hair care composition comprising resveratrol and dutasteride entrapped in oleic acid-based multilamellar vesicles (MLVs).
[0078] In an embodiment of the present invention, the hair care composition is an MLV loaded with one or more active hair-growth promoting active ingredients, wherein the MLV is stabilized by a surfactant.
[0079] In an embodiment of the present invention, the MLV-based topical hair care composition comprises oleic acid at a concentration of at least 10%, at least 20%, at least 30%, at least 40%, at least 45%, at least 50 wt %, at least 55 wt %, at least 60 wt %, at least 65 wt %, at least 70 wt %, at least 75 wt %, at least 80 wt %, at least 85 wt %, at least 90 wt %, at least 95 wt %, or at least 97 wt %, 35-40 wt %, 40-45 wt %, 45-50 wt %, 45-55 wt %, 45-65 wt %, 46-65 wt %, 47-65 wt %, 48-65 wt %, 49-65 wt %, 50-65 wt %, 51-65 wt %, 52-65 wt %, 53-65 wt %, 54-65 wt %, 55-65 wt %, 50-55 wt %, 55-60 wt %, 60-65 wt %, 65-70 wt %, or 70-75 wt %. Most preferably 10-40 wt%.
[0080] In an embodiment of the present invention, the MLV-based topical hair care composition comprises a synergistic mix of active hair-growth promoting active ingredients at a concentration of at least 1%, at least 2%, at least 3 wt %, at least 4 wt %, at least 5 wt %, at least 6 wt %, at least 7 wt %, at least 8 wt %, at least 9 wt %, at least 10 wt %, at least 15 wt %, at least 20 wt %, or at least 25 wt %, 35-40 wt %, 40-45 wt %, 45-50 wt %, 45-55 wt %, 45-65 wt %, 46-65 wt %, 47-65 wt %, 48-65 wt %, 49-65 wt %, 50-65 wt %, 51-65 wt %, 52-65 wt %, 53-65 wt %, 54-65 wt %, 55-65 wt %, 50-55 wt %, 55-60 wt %, 60-65 wt %, 65-70 wt %, or 70-75 wt %.
[0081] In an embodiment of the present invention, the MLV-based topical hair care composition comprises resveratrol or salts thereof as active pharmaceutical ingredient at a concentration of at least 1%, at least 2%, at least 3 wt %, at least 4 wt %, at least 5 wt %, at least 6 wt %, at least 7 wt %, at least 8 wt %, at least 9 wt %, at least 10 wt %, at least 15 wt %, at least 20 wt %, or at least 25 wt %, 35-40 wt %, 40-45 wt %, 45-50 wt %, 45-55 wt %, 45-65 wt %, 46-65 wt %, 47-65 wt %, 48-65 wt %, 49-65 wt %, 50-65 wt %, 51-65 wt %, 52-65 wt %, 53-65 wt %, 54-65 wt %, 55-65 wt %, 50-55 wt %, 55-60 wt %, 60-65 wt %, 65-70 wt %, or 70-75 wt %.
[0082] In an embodiment of the present invention, the MLV-based topical hair care composition comprises dutasteride or salts thereof as active pharmaceutical ingredient at a concentration of at least 1%, at least 2%, at least 3 wt %, at least 4 wt %, at least 5 wt %, at least 6 wt %, at least 7 wt %, at least 8 wt %, at least 9 wt %, at least 10 wt %, at least 15 wt %, at least 20 wt %, or at least 25 wt %, 35-40 wt %, 40-45 wt %, 45-50 wt %, 45-55 wt %, 45-65 wt %, 46-65 wt %, 47-65 wt %, 48-65 wt %, 49-65 wt %, 50-65 wt %, 51-65 wt %, 52-65 wt %, 53-65 wt %, 54-65 wt %, 55-65 wt %, 50-55 wt %, 55-60 wt %, 60-65 wt %, 65-70 wt %, or 70-75 wt %.
[0083] In some embodiments of the present invention, the surfactant is in an amount selected from: at least 5 wt %, at least 10 wt %, at least 15 wt %, at least 20 wt %, at least 25 wt %, at least 30 wt %, at least 35 wt %, at least 40 wt %, at least 50 wt %, at least 55 wt %, at least 60 wt %, at least 65 wt %, at least 70 wt %, at least 75 wt %, at least 80 wt %, at least 85 wt %, at least 90 wt %, at least 95 wt %, at least 97 wt %, 0-2.5 wt %, 2.5-5 wt %, 5-10 wt %, 10-15 wt %, 15-20 wt %, 20-25 wt %, 25-30 wt %, 30-35 wt %, 35-40 wt %, 40-45 wt %, 45-50 wt %, 45-55 wt %, 45-65 wt %, 46-65 wt %, 47-65 wt %, 48-65 wt %, 49-65 wt %, 50-65 wt %, 51-65 wt %, 52-65 wt %, 53-65 wt %, 54-65 wt %, 55-65 wt %, 50-55 wt %, 55-60 wt %, 60-65 wt %, 65-70 wt %, 70-75 wt %, 75-80 wt %, 80-85 wt %, 85-90 wt %, 90-95 wt %, or 95-97 wt %.
[0084] In some embodiments of the present invention, the solubilizer is in an amount selected from: at least 5 wt %, at least 10 wt %, at least 15 wt %, at least 20 wt %, at least 25 wt %, at least 30 wt %, at least 35 wt %, at least 40 wt %, at least 50 wt %, at least 55 wt %, at least 60 wt %, at least 65 wt %, at least 70 wt %, at least 75 wt %, at least 80 wt %, at least 85 wt %, at least 90 wt %, at least 95 wt %, at least 97 wt %, 0-2.5 wt %, 2.5-5 wt %, 5-10 wt %, 10-15 wt %, 15-20 wt %, 20-25 wt %, 25-30 wt %, 30-35 wt %, 35-40 wt %, 40-45 wt %, 45-50 wt %, 45-55 wt %, 45-65 wt %, 46-65 wt %, 47-65 wt %, 48-65 wt %, 49-65 wt %, 50-65 wt %, 51-65 wt %, 52-65 wt %, 53-65 wt %, 54-65 wt %, 55-65 wt %, 50-55 wt %, 55-60 wt %, 60-65 wt %, 65-70 wt %, 70-75 wt %, 75-80 wt %, 80-85 wt %, 85-90 wt %, 90-95 wt %, or 95-97 wt % surfactant. Most preferably 10-20 wt %.
[0085] In an embodiment of the present invention, the hair care composition further comprises phosphate-buffered saline (PBS) at a concentration of at least 5 wt %, at least 10 wt %, at least 15 wt %, at least 20 wt %, at least 25 wt %, at least 30 wt %, at least 35 wt %, at least 40 wt %, at least 50 wt %, at least 55 wt %, at least 60 wt %, at least 65 wt %, at least 70 wt %, at least 75 wt %, at least 80 wt %, at least 85 wt %, at least 90 wt %, at least 95 wt %, at least 97 wt %, 0-2.5 wt %, 2.5-5 wt %, 5-10 wt %, 10-15 wt %, 15-20 wt %, 20-25 wt %, 25-30 wt %, 30-35 wt %, 35-40 wt %, 40-45 wt %, 45-50 wt %, 45-55 wt %, 45-65 wt %, 46-65 wt %, 47-65 wt %, 48-65 wt %, 49-65 wt %, 50-65 wt %, 51-65 wt %, 52-65 wt %, 53-65 wt %, 54-65 wt %, 55-65 wt %, 50-55 wt %, 55-60 wt %, 60-65 wt %, 65-70 wt %, 70-75 wt %, 75-80 wt %, 80-85 wt %, 85-90 wt %, 90-95 wt %, or 95-97 wt % surfactant.
[0086] In some embodiments of the present invention, the surfactant is selected from propylene glycol, polyethylene glycol (PEG), PEG 15 hydroxystearate (Solutol HS15), polyoxyl-10-Oleyl Ether (BRIJ® 97), polyethylene glycol 25 hydrogenated castor oil, polyethylene glycol (PEG) 40 hydrogenated castor oil (Kolliphor RH40, Cremophor RH40), polyethylene-polypropylene glycol (poloxamer 124), PEG 8 caprylic/capric glycerides (Labrasol), PEG 300 oleic glycerides (Labrafil M 1944), diethylene glycol monoethyl ether (Transcutol), lauroylmacrogol32 glycerides (GELUCIRE® 44/14), polyethylene glycol 400 (PEG 400), propylene glycol laurate (Lauroglycol FCC), D-a-Tocopherol polyethylene glycol 1000 succinate (TPGS), polyethylene-polypropylene glycol (poloxamer 188), polyethylene-polypropylene glycol (poloxamer 407), polyvinyl pyrrolidone (e.g., Mw 28-34 kDa, Mw 44-54 kDa (e.g., Kollidon 30), or 1-1.5M kDa (e.g., Kollidon 90), Iota Carrageenan, Xanthan gum, locust Bean gum, Kelcogel LT100, acacia gum, guar gum, gamma-Cyclodextrin, Tracacanth gum, hydroxypropyl methylcellulose (HPMC), carboxymethyl cellulose (CMC), microcrystalline cellulose (MCC), lecithin, polyethylene-polypropylene glycol (poloxamer 124), polyethylene glycol sorbitanmonolaurate (polysorbate 20, TWEEN 20), polyethylene glycol sorbitanmonopalmitate (polysorbate 40, TWEEN 40), polyethylene glycol sorbitanmonostearate (polysorbate 60, TWEEN 60), polyethylene glycol sorbitantristearate (polysorbate 65, TWEEN 65), polyethylene glycol sorbitanmonooleate (polysorbate 80, TWEEN 80), polyethylene glycol sorbitantrioleate (polysorbate 85, TWEEN 85), polyethylene glycol sorbitanhexaoleate, polyethylene glycol sorbitantetraoleate, sorbitanmonolaurate (SPAN 20), sorbitanmonopalmitate (SPAN 40), sorbitanmonostearate (SPAN 60), sorbitantristearate (SPAN 65), sorbitanemonooleate (SPAN 80), sorbitantrioleate (SPAN 85), sucrose laurate, sucrose palmitate, sucrose stearate, gamma-cyclodextrin, beta-cyclodextrin (e.g., CAPTISOL) pectin, whey protein, caseinates, quillaia/quillaj a saponins, quillaia extract, PEG 8 stearate, PEG 40 stearate, M1944CS, Cremophor RH 40 or a combination thereof. Most preferably the SPAN 80.
[0087] In some embodiments of the present invention, the liposomes or vesicles have average sizes ranging from at least about 1 nm, 10 nm, 50 nm, 100 nm, 200 nm, 300 nm, 400 nm, 500 nm, 600 nm, 700 nm, 800 nm, 900 nm, 1000 nm, 1100 nm, 1200 nm, 1300 nm, 1400 nm, 1500 nm, 1600 nm, 1700 nm, 1800 nm, 1900 nm, 2000 nm, 2500 nm, 3000 nm, 4000 nm, 5000 nm, 6000 nm, 7000 nm, 8000 nm, or at least 9000 nm. In some embodiments, the nanoparticles may have a diameter of less than 10,000 nm, 9000 nm, 8000 nm, 7000 nm, 6000 nm, 5000 nm, 4500 nm, 4000 nm, 3500 nm, 3000 nm, 2500 nm, 2000 nm, 1900 nm, 1800 nm, 1700 nm, 1600 nm, 1500 nm, 1400 nm, 1300 nm, 1200 nm, 1100 nm, 1000 nm, 900 nm, 800 nm, 700 nm, 600 nm, 500 nm, 250 nm, or less than 100 nm. The diameter of nanoparticles can range from any of the minimum values described above to any of the maximum values described above, for example from 1 nm to 10,000 nm, 50 nm to 5,000 nm, 10 nm to 250 nm, 20 nm to 200 nm, or 20 nm to 100 nm. Most preferably 20 nm to 100 nm.
[0088] In some embodiments of the present invention, the MLVs have average sizes ranging from at least about 1 nm, 10 nm, 50 nm, 100 nm, 200 nm, 300 nm, 400 nm, 500 nm, 600 nm, 700 nm, 800 nm, 900 nm, 1000 nm, 1100 nm, 1200 nm, 1300 nm, 1400 nm, 1500 nm, 1600 nm, 1700 nm, 1800 nm, 1900 nm, 2000 nm, 2500 nm, 3000 nm, 4000 nm, 5000 nm, 6000 nm, 7000 nm, 8000 nm, or at least 9000 nm. In some embodiments, the nanoparticles may have a diameter of less than 10,000 nm, 9000 nm, 8000 nm, 7000 nm, 6000 nm, 5000 nm, 4500 nm, 4000 nm, 3500 nm, 3000 nm, 2500 nm, 2000 nm, 1900 nm, 1800 nm, 1700 nm, 1600 nm, 1500 nm, 1400 nm, 1300 nm, 1200 nm, 1100 nm, 1000 nm, 900 nm, 800 nm, 700 nm, 600 nm, 500 nm, 250 nm, or less than 100 nm. The diameter of nanoparticles can range from any of the minimum values described above to any of the maximum values described above, for example from 1 nm to 10,000 nm, 50 nm to 5,000 nm, 10 nm to 250 nm, 20 nm to 200 nm, or 20 nm to 100 nm. Most preferably 20 nm to 100 nm.
[0089] In an embodiment of the present invention, the MLV-based topical hair care composition may further comprise natural moisturizer selected from but not limited to lecithin, Coco-glucoside, beeswax, candelilla wax, shea butter, cocoa butter, and the like. Most preferred embodiments are beeswax, cocoa butter or the combinations thereof.
[0090] In an embodiment of the present invention, the MLV-based topical hair care composition may further comprise a thickener selected from but not limited to methyl cellulose, guar gum, Xanthan gum, Carbopol, Gum Arabic, Cornstarch, Gelatin, and the like.
[0091] In an embodiment of the present invention, the MLV-based topical hair care composition may further comprise effective amounts of one or a combination of several natural ingredients from a variety of herbs, including but not limited to those from Coconut, Olive, Almond, Sandalwood, Bhringraj, Amla, and the like.
[0092] In an embodiment of the present invention, the MLV-based topical hair care composition may further comprise Bees Wax, Cocoa Butter, Stearyl alcohol, Coconut oil, Olive oil, Almond oil, Sandalwood oil, Bhringraj oil, Amla oil, Propylene Glycol, Vitamin E, Triethylamine, Glycerol, and Water.
[0093] In an embodiment of the present invention, the MLV-based topical hair care composition is used for re-growth of hair; treating hair thinning, hair fall; and the like.
[0094] In an embodiment of the present invention, the MLV-based topical hair care composition may further be used for treating aging of hair related conditions including dry hair, split ends, oily / greasy hair, frizzy hair, dull hair, hair fall, hair greying, psoriasis, Seborrhoeic dermatitis, alopecia resulting from genetic conditions and treatments, androgenic alopecia, Alopecia areata, head lice, hair thinning, dandruff, infection-related hair loss (e.g.: Tinea capitis), itching and scaling of the scalp, and the like.
[0095] In an embodiment of the present invention, the MLV-based topical hair care composition can be applied once or twice daily, wherein the frequency of use depends on the needs of the user, the condition of the user's scalp, and other factors known in the hair care arts.
[0096] In an embodiment of the present invention, the MLV-based topical hair care composition may further comprise one or more other hair care ingredients, e.g., sunscreens, antioxidants, vitamins, oils and/or other herbals. The types and amounts of the above-discussed optional ingredients can be determined by one of ordinary skill in the art based upon general knowledge in the hair care formulation art.
[0097] In an embodiment of the present invention, the MLV-based topical hair care composition can be formulated as hair lotion, hair cream, hair gel, hair ointment, hair rinse or essence, or any other form suitable for topical application.
[0098] In an embodiment of the present invention, the MLV-based topical hair care composition has increased efficacy, improved percutaneous penetration, improved hair root penetration, excellent thermodynamic stability ensuring long shelf life, and low skin irritation.
[0099] In an embodiment of the present invention, the MLV-based topical hair care composition may further comprise oils selected from but not limited to sesame oil, perilla oil, castor oil, bean oil, grape seed oil, Cuscutae Semen oil, tea tree oil, tulsi oil, rosemary oil, lavender oil, rosewood oil, jojoba oil, bergamot oil, clove oil, mentha oil, sweet orange oil, lemongrass oil, sage oil, peppermint oil, clove oil, cinnamon oil, lavender oil, frankincense oil, geranium oil, juniper oil, thyme oil, eucalyptus oil, and the like.
[00100] In an embodiment of the present invention, the MLV-based topical hair care composition may further comprise herbal extract selected from but not limited to henna, indigo, cassia obovata, shikakai, neem, fenugreek, beet and powdered hibiscus extract.
[00101] In an embodiment of the present invention, the MLV-based topical hair care composition may further comprise additives generally used in cosmetics or drugs, for example, a plant extract, an oily component, a surfactant, alcohols, fatty acids, a preservative, an antioxidant, a pigment, a fragrance, UV absorbing agent, a viscosity adjusting agent, a chelating agent, a pH adjusting agent, vitamins, and the like, as long as these additives do not adversely affect the effects of the present invention.
[00102] In an embodiment of the present invention, the MLV-based topical hair care composition may further comprise angelica extract, ashwaganda extract, astragalus extract, bilberry extract, black cohosh extract, blue cohosh extract, blessed thistle extract, burdock extract, California poppy extract, cactus extract, celandine extract, chamomile extract, chaparral extract, chaste tree extract, chickweed extract, cleavers extract, coltsfoot extract, corn silk extract, cramp bark extract, damiana extract, dandelion extract, devil's claw extract, dong quai extract, echinacea extract, sib ginseng extract, eyebright extract, false unicorn root extract, fenugreek extract, ginkgo extract, ginseng root extract, goldenrod extract, goldenseal extract, gotu kola extract, horsetail extract, hyssop extract, kava extract, lady's mantle extract, licorice root extract, milk thistle extract, motherwort extract, nettle extract, oats extract, Oregon grape root extract, osha root extract, passionflower extract, pau d'arco extract, plantain extract, red clover extract, red root extract, reishi mushroom extract, sarsaparilla extract, saw palmetto extract, St. John's wort extract, schisandra berry extract, shepherds purse extract, skullcap extract, slippery elm extract, usnea lichen extract, uva ursi extract, valerian extract, wild cherry extract, wild yam extract, wormwood extract, yellow dock extract, yucca root extract or mixtures thereof.
[00103] In an embodiment of the present invention, the MLV-based topical hair care composition may further comprise natural, herbal, ayurvedic, siddha, unani or any other traditional treatment agents selected from the group consisting of antidandruff agents, antifungal agents, antimicrobial agents, antioxidants, toners, proteins, cleaners, and combinations thereof.
[00104] In an embodiment of the present invention, the MLV-based topical hair care composition may further comprise moisturizer selected from jojoba oil, cucumber extract, Coco-glucoside, Shea butter, Argan oil, Aloe Vera, Avocado oil, Butylene glycol, Vegetable glycerin, and the like.
[00105] In an embodiment of the present invention, the MLV-based topical hair care composition may further comprise preservative selected from sorbic acid, calendula oil, benzoic acid, citric acid, triclosan, triclocarban, phenoxyethanol, benzyl benzoate, benzyl alcohol, zinc pyrithione, benzalkonium chloride, and the like.
[00106] In an embodiment of the present invention, the MLV-based topical hair care composition may further comprise pH regulator selected from sodium hydroxide, citric acid, lactic acid, triethanolamine, Triethylamine, glacial acetic acid, sodium carbonate, acetic acid, and the like. Most preferred embodiment is Triethylamine.
[00107] In an embodiment of the present invention, the MLV-based topical hair care composition may further comprise an aromatic or fragrance generating agent, preferably a natural fragrance.
[00108] In an embodiment of the present invention, the natural fragrance can be selected from lemon, jasmine, lavender, mint ice, peach, red berry, apple, vanilla, rose, rosemary, mogra, sandalwood, orange, and the like.
[00109] In an embodiment of the present invention, the MLV-based topical hair care composition has pH in a range of between about 5 and about 9, preferably in a range of between about between about 5.0 and about 8.0, and more preferably a pH of 7.4.
[00110] In an embodiment of the present invention, the hair care composition has viscosity ranging from about 4200 to about 4400 cps.
[00111] In an embodiment of the present invention, the MLV-based hair care composition comprises resveratrol and dutasteride synergistic mix entrapped in oleic acid liposomes stabilized by SPAN 80 surfactant.
[00112] In an embodiment of the present invention, the MLV-based hair care composition comprises resveratrol and dutasteride synergistic mix entrapped in oleic acid liposomes stabilized by SPAN 80 surfactant, wherein the presence of resveratrol increases the cellular availability of dutasteride.
[00113] In an embodiment, the present invention relates to a method for preparing an MLV-based topical hair care composition comprising one or more active hair-growth promoting active ingredients entrapped in a lipid vesicle stabilized by a surfactant.
[00114] In an embodiment, the present invention relates to a film hydration method for preparing an MLV-based topical hair care composition comprising one or more active hair-growth promoting active ingredients entrapped in a lipid vesicle stabilized by a surfactant.
[00115] In an embodiment, the present invention relates to a method of preparing an MLV-based hair care composition comprising resveratrol and dutasteride synergistic mix entrapped in oleic acid liposomes stabilized by SPAN 80 surfactant.
[00116] In an embodiment, the present invention relates to a film hydration method of preparing an MLV-based hair care composition comprising resveratrol and dutasteride synergistic mix entrapped in oleic acid liposomes stabilized by SPAN 80 surfactant.
[00117] In yet another embodiment, the present invention relates to a method of preparing the hair care composition comprising the present invention relates to a method of preparing an MLV-based topical hair care composition comprising the steps of:
a. briefly dissolving, oleic acid, span 80 and one or more active hair-growth promoting active ingredients in an organic solvent, preferably methanol in a round bottom flask;
b. film formation by evaporating the organic solvent under vacuum using a rotary evaporator to remove even the traces of organic solvent;
c. overnight air-drying of the completely dried film from step b) to remove the traces of methanol and to prevent the formation of emulsion;
d. hydrating the dried film from step c) at ambient temperature for 1 h with phosphate-buffered saline (PBS) at a pH of 7.4;
e. preparing the uniform size vesicular dispersion by sonication.

EXAMPLES
[00118] The present disclosure is further explained in the form of following examples. However, it is to be understood that 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.
[00119] Example 1: A process of preparing the MLV-based topical hair care composition:
Briefly, oleic acid, soya lecithin span 80 and active ingredient mix (0.5 mg/ml duterasteride and 0.25 mg/ml) and were dissolved in methanol in a round bottom flask followed by evaporation of solvent under vacuum using a rotary evaporator (Perfit equipments, Ambala, India) to remove even the last traces of organic solvent. The completely dried film in rotary evaporator was left overnight for the removal of any possible traces of methanol and also to prevent the formation of emulsion due to the residual organic solvent. The dried film formed was then hydrated at ambient temperature for 1 h with PBS (pH 7.4). The prepared vesicular dispersion was sonicated to form the uniform size vesicular dispersion.
[00120] Example 2: Skin irritation testing of the MLV-based topical hair care composition:
Hair care composition as prepared in Example 1 is made into 100 ml pockets each and anonymously handed over to 5 male and 5 female subjects to test the adverse effects or skin irritancy of the composition. Each of the subjects were instructed to use 10 ml of formulated cream on an area of 2 square inches to the back of the subjects’ hands. The subjects were observed for lesions, redness and irritation. None of the subjects reported adverse effects or irritation while using or after using the composition.
[00121] Example 3: Characterization of the MLV-based topical hair care composition:

Table 1: Various parameters of the MLV-based topical hair care composition
Particle size PDI Zeta potential In vitro drug release pH
92.26 nm 0.24 -18.8 mV Sustained release was obtained nearly 64% of drug release in comparison to 90 % in plain drug 7.4

[00122] Example 4: Viscosity of the MLV-based topical hair care composition:
Brookfield viscometer was used for the measurement of viscosity of the prepared cream (Example 1). The Brookfield viscometer was rotated at 100 rpm, spindle no.6. Each reading was taken after equilibrium was attained by the sample at the end of two minutes. The study was repeated three times and average value was found to be 4200 - 4400cps.
[00123] Example 5: Physical appearance of the MLV-based topical hair care composition after storage:
The formulated composition as prepared using Example 1 was evaluated in terms of physical character like phase separation and change in color and odour. No visible changes in colour and odour observed after storage for 2 months.
[00124] Example 5: Homogeneity of the MLV-based topical hair care composition:
Developed composition was tested for homogeneity by visual inspection after the composition was set in the container. It was tested for appearance and presence of any aggregates. No visible aggregates observed.
[00125] Example 6: Skin permeation testing of the MLV-based topical hair care composition:
The skin permeation study was conducted on optimized formulation prepared at 8:2 oleic acid: drug ratio (pH 7.4) (highest entrapment efficiency and more uniform sized vesicles). All formulations exhibited rapid release in an in vitro release study. Using a Franz diffusion cell, no dutasteride permeated through rat skin after 48h, such that it was not detected in the receptor chamber for all samples. The amount of dutasteride in the skin was significantly different (p<0.05) for oleic acid vesicles containing resveratrol (8.09±3.08µg/cm2) without resveratrol (1.89±0.40µg/cm2). Fatty acids facilitate a lipophilic environment, which favors resveratrol binding.
[00126] Example 7: Hair growth testing using the MLV-based topical hair care composition:
The hair growth–promoting activity for the selected nanoparticles revealed the highest hair length values in Albino rats after 28 days of the hair growth study compared, oleic acid vesicles’ physical mixture, dutasteride solution, and marketed minoxidil preparation groups as well as the control group. The images for both selected nanoparticles and marketed minoxidil groups showed a significant increase in the diameter of hair follicle and percent area fraction of cytokeratin 19 in the outer root sheath of hair follicle compared with other tested groups. Oleic acid-based vesicular formulation encapsulating Dutasteride and resveratrol found to be a good competitor to minoxidil for hair growth–promoting activity.

We Claims:

1. A topical hair care composition comprising liposomes loaded with one or more hair-growth promoting active ingredients, wherein the liposomes comprise:
a. multilamellar vesicles (MLVs) stabilized by a surfactant;
b. a synergistic hair-growth promoting active ingredient mix comprising a first active ingredient and a second active ingredient, wherein the first active ingredient is different from the second active ingredient;
characterized in that:
- the liposomes are biphasic liposomes;
- the MLVs are loaded with the synergistic hair-growth promoting active ingredient mix.
2. The composition as claimed in claim 1, wherein the synergistic hair-growth promoting active ingredient mix comprises resveratrol or salts thereof; and dutasteride or salts thereof.
3. The composition as claimed in claim 1, wherein the surfactant is SPAN 80.
4. The composition as claimed in claim 1, wherein the composition comprises hair-growth promoting, hair root strengthening, or hair damage reversing benefits.
5. The composition as claimed in claim 1, wherein the composition has a pH of about 7.4.
6. The composition as claimed in claim 1, wherein the composition has a viscosity ranging from about 4200 to about 4400 cps.
7. A topical hair care composition comprising liposomes loaded with hair-growth promoting active ingredients, wherein the liposomes comprise
a. multilamellar vesicles (MLVs) of oleic acid in an amount ranging from about 10% wt to about 40% wt., wherein MLVs are stabilized by SPAN 80 surfactant in an amount ranging from about 35% wt to about 65% wt.; and
b. a synergistic hair-growth promoting active ingredient mix comprising resveratrol or salts thereof and dutasteride or salts thereof, wherein
i. resveratrol or salts thereof is comprised in an amount ranging from about 2% wt to about 15% wt.
ii. dutasteride or salts thereof is comprised in an amount ranging from about 2% wt to about 15% wt.
characterized in that:
- the liposomes are biphasic liposomes;
- the MLVs are loaded with the synergistic hair-growth promoting active ingredient mix.
8. The composition as claimed in claim 1, wherein the oleic acid to synergistic active ingredient mix ratio is 8:2.
9. A process for preparing an MLV-based topical hair care composition loaded with one or more hair-growth promoting active ingredients comprises the steps of:
a. briefly dissolving, oleic acid, span 80 and one or more active pharmaceutical ingredients in methanol in a round bottom flask;
b. film formation by evaporating the organic solvent under vacuum using a rotary evaporator to remove even the traces of organic solvent;
c. overnight air-drying of the completely dried film from step b) to remove the traces of methanol and to prevent the formation of an emulsion;
d. hydrating the dried film from step c) at ambient temperature for 1 h with phosphate-buffered saline (PBS) at a pH of 7.4; and
e. preparing the uniform size vesicular dispersion by sonication.

10. The composition as claimed in claim 9, wherein the oleic acid to synergistic active ingredient mix ratio is 8:2.