WO2016046848A2

WO2016046848A2 - Novel formulation of concentrated natural actives in oil-water microemulsion for hair fall prevention and increase in hair density

Info

Publication number: WO2016046848A2
Application number: PCT/IN2015/050119
Authority: WO
Inventors: Jigar Hasmukhbhai Patel; Nilay Bharatendu PANDYA
Original assignee: Brillare Science Pvt Ltd.
Priority date: 2014-09-26
Filing date: 2015-09-23
Publication date: 2016-03-31
Also published as: WO2016046848A3

Abstract

The present invention relates to a novel oil in water based natural formulation for hair fall prevention and for hair growth with increase in hair density prepared from ingredients derived from natural sources either alone or in combination with other inert ingredients. Further the natural formulation is stable oil in water microemulsion form with higher percentage of oils and without any emulsifier.

Description

Title: Novel formulation of concentrated natural actives in oil/water microemulsion for hair fall prevention & increase in hair density

FIELD OF THE INVENTION

The present invention relates a novel oil in water based natural formulation for hair fall prevention prepared from plant actives in combination with other inert ingredients which also increase hair density. Further the natural formulation is stable oil in water microemulsion form with higher percentage of oils without adding any emulsifier.

BACKGROUND OF THE INVENTION

Hair loss or hair fall results in to the baldness or alopecia in both men and women. It's a universal problem and affects social life as well as has psychological impact in life.

The three stages of hair growth are the anagen, catagen, and telogen phases. Each strand of hair on the human body is at its own stage of development. Once the cycle is complete, it restarts and a new strand of hair begins to form. The rate or speed of hair growth is about 1.25 cm or 0.5 inches per month, or about 15 cm or 6 inches per year.

Anagen phase

The anagen phase is known as the growth phase. It begins in the papilla and can last from two to six years. The span at which the hair remains in this stage of growth is determined by genetics. The longer the hair stays in the anagen phase, the faster and longer it will grow. During this phase, the cells in the papilla divide to produce new hair fibers, and the follicle buries itself into the dermal layer of the skin to nourish the strand. About 85% of the hairs on one's head are in the anagen phase at any given time.

Catagen phase

Signals sent out by the body determine when the anagen phase ends and the catagen phase begins. The catagen phase, also known as the transitional phase, allows the follicle to, in a sense, renew itself. During this time, which lasts about two weeks, the hair follicle shrinks due to disintegration and the papilla detaches and "rests," cutting the hair strand off from its nourishing blood supply. Ultimately, the follicle is 1/6 its original length, causing the hair shaft to be pushed upward. While hair is not growing during this phase, the length of the terminal fibers increase when the follicle pushes them upward. Telogen phase

During the telogen, or resting, phase the follicle remains dormant anywhere from 1-4 months. Ten to fifteen percent of the hairs on one's head are in this phase of growth at any given time. In this phase the epidermal cells lining the follicle channel continue to grow as normal and may accumulate around the base of the hair, temporarily anchoring it in place and preserving the hair for its natural purpose without taxing the body's resources needed during the growth phase.

At some point, the follicle will begin to grow again, softening the anchor point of the shaft initially. The hair base will break free from the root and the hair will be shed. Within two weeks the new hair shaft will begin to emerge.

The anagen phase begins again once the telogen phase is complete. The process results in normal hair loss known as shedding. An overwhelming majority of the time the hair is on the scalp, it is growing. Only about 10% of the strands are in transition or resting at any one time. Hair grows about 6 inches a year for most people.

Most people lose anywhere from 50 to 100 strands of hair each day, according to the American Academy of Dermatology. For those who don't plan on counting their hair every day, there are ways to know when hair is thinning or being lost at a higher rate. When waking up in the morning, there may be an usually large amount on your pillow. When you comb your hair (especially without tugging, which can pull the hair out), more than normal will be left in the comb.

There are also other visual cues that women can look for over time. Although men's hair tends to recede from the forehead or the crown of the head, women tend to notice thinning on the top third to one half of the scalp

There are many formulations and surgical treatments are available in the market to prevent hair fall. US20060029557 discloses a natural hair care composition comprising extract of flowers of plant Butea frondosa and/or stem bark of plant Butea parviflora, and/or the exudates of stem and root of plant Butea superba, and a cosmetically acceptable carrier. Also disclosed are methods for obtaining the plant extract and use thereof in regulation of hair growth and prevention of hair loss in all kinds of hair disorders.

US6495174 discloses a composition comprising alcoholic extracts of herbs Rhizoma Zinziberis Recens, Rhizoma pinelliae, Flos carthami, Radix rehmanniae, Radix angelicae sinensis, Radix paenoiae rubra, Cacumen biotae, Semen sesami nigruin, Radix polydoni multiflori, Fructus mori combined with Tincture Capsicum, Tincture Cantharidinate and Oleum Ricini for direct application to scalp for the treatment of all kinds of alopecia in humans. US6447762 describes the preparation of a hair lotion for hair protecting action and prevention of hair loss comprising extracts of herbs Humulus lupulus, Rosmarinus officinalis and Swertia japonica and Silanodiol salicylate and other pharmaceutically acceptable carriers.

US6365199 discribes a hair growth formulation comprising of lemon peel extract including bioflavonoids membrane and castor oil.

US6451777 discloses a composition containing a compound from the group consisting of lupane triterpenes, derivatives of lupane, oleanane, ursane triterpenes and salts thereof for regulating hair growth and loss of hair.

US6358541 disclosed improved compositions comprising saw palmetto berry extract containing phytosterols and one or more low irritability constituents that enhance penetration of the extract into hair follicular pores, for the treatment of androgenetic alopecia. US6203782 discloses methods and compositions for promoting hair growth, preventing or minimizing hair loss, enhancing or restoring hair color or remelanization and treating other hair and skin conditions. The compositions include as an essential component a treatment agent in an amount effective for treating the condition, preferably selected from the class of herbs consisting of Foeniculum vulgares (fennel seed), Pimpinella anisum (anise), Carum carvi (caraway seeds) and mixtures thereof with each other and/or other herbs.

US5000949 discloses a hair grooming composition, which promotes scalp and hair health and growth, comprising petroleum jelly, an oil extract of cactus, glycerin and oil of clover or other odorant and method of producing the composition.

T. Takahashi et. al., reported that Procynidin B-2 isolated from Apple juice acts as growth promoting factor on murine hair epithelial cells. Procyanidin B-2 therapy showed potential as promising cure for male pattern baldness (Phytother. Res. 15, 331 -36, 2001). US 20110076328 describes a composition for the treatment or prevention of a disorder resulting in hair loss comprises a cardiac glycoside as active principal. US20120157527 discloses The present invention relates to the cosmetic use of jasmonic acid derivatives of formula (I) in which: R.sub. l represents a radical COOR.sub.3, R.sub.3 denoting a hydrogen atom or a C.sub. l-C.sub.4 alkyl radical, optionally substituted with one or more hydroxyl groups; R.sub.2 represents a linear saturated or unsaturated hydrocarbon-based radical containing from 1 to 18 carbon atoms, or a branched or cyclic saturated or unsaturated hydrocarbon-based radical containing from 3 to 18 carbon atoms; and also an optical isomer thereof and/or a corresponding salt thereof, in a composition for caring for and/or making up keratin fibres, in particular human keratin fibres, for the purpose of inducing and/or stimulating the growth of the keratin fibres and/or of halting their loss and/or increasing their density.

US20120199152 discloses a composition for topical treatment of hair loss/alopecia including three natural, active ingredients, caffeine, saw palmetto berry extract, and epigallocatechin-3-gallate (EGCG). The invention also provides methods for using this composition to treat hair loss. US20130078301 describes method for stimulating hair growth includes providing a topical composition including a purified oil extract from Melaleuca alternifolia, also known as tea tree. The method may further include applying the topical composition to the skin surrounding the follicles of the human hair at least once a day. A method for preventing the loss of human hair includes providing a topical composition including a purified oil extract from Melaleuca alternifolia, also known as tea tree. The method may further include applying the topical composition to the skin surrounding the follicles of the human hair at least once a day.

WO2014027363 describes an invention relates to an intra-dermally, sub-dermally or topically administrable growth factor concentrate derived from approximately 500 x 106 to 1500 [chi] 106 human platelets per ml for treating hair loss. The concentrate comprises approximately 800 to 1200 pg/ml of Epidermal growth factor (EGF), 20 to 80 pg/ml of Vascular Endothelial growth factor (VEGF), 15 to 30 pg/ml of Basic fibroblast growth factor (b-FGF), 30000 to 40000 pg/ml of Transforming growth factor - [beta] (TGF- [beta]) and 100000 to 200000 pg/ml of Platelet Derived growth factor- AB (PDGF- AB). Common treatments for alopecia include hair transplantation, oral, and topical application of drugs and in some case natural solutions. Hair transplantation methods are usually painful, costly, and frequently result in an undesirable, unnatural appearance. The predominant oral as well as topical preparations are chemical products such as Rogaine^® and Regaine^®, Propecia^® and Proscar^®' Andolactone^®, Androcur^®, Eulexin^®. Additionally, oral contraceptives (containing estrogens and/or estradiol), tretinoin, and azelaic acid are drugs that have been the subject of scientific studies for their potential to enhance hair growth. There are also a variety of other products on the market today that claim to aid in the growth of hair. However most of these treatments may have undesirable side effects or may result in recurrence of the condition if application is discontinued.

Hence there is long felt need in the society for a stable and effective natural formulation prepared from ingredients derived from natural sources to prevent hair fall and for hair growth which also increase hair density.

The inventors of the present inventions have surprisingly found that effective and stable oil in water type emulsion with high percentage of oils can be prepared from the active agents derived from natural sources and one more inert ingredient without any synthetic emulsifier.

SUMMARY OF THE INVENTION

One aspect of the present invention is to provide a novel oil in water based natural formulation comprising concentrated plant actives for prevention of hair fall and hair growth with increase in hair density which does not contain any emulsifier.

One aspect of the present invention is to provide a novel oil in water based natural formulation comprising of plant actives such as scalp purifying agent, hair nourishing complex, hair growth promoter, scalp anti-aging extract, exfoliating agent, hair growth stimulating agent, hair densifier complex, anti-dandruff agent, embedded in oil globules with neutralizer, preservatives, and optionally one or more inert ingredients, wherein the formulation is devoid of emulsifier.

Yet another aspect of the present invention is to provide a novel oil in water based natural formulation comprising of emollient (Macadamia seed oil esters), scalp purifying agent (Mixture of caprylol glycine and xylitylglucoside), hair nourishing complex ((Mixture of Saccharum officinarum (Sugarcane) extract, citrus limon fruit (Lemon) extract, Betaine, Hexylene glycol, Pyrus malus (apple) fruit extract, Camellia sinensis leaf (Green tea leaf) extract and Hexapeptide -11) and/or (Mixture of Acetyl tetrapeptide-3 and trifolium pratense flower extract)), hair growth promoter (Pisum sativum sprout extract), scalp anti-aging extract (Pterocarpus marsupium bark extract), exfoliating agent (Glycolic acid), hair growth stimulating agent (Diaminopyrimidine oxide), hair densifier complex (Mixture of Ocimum basilicum hairy root culture ethanolic extract, Helianthus annuus seed oil and Cocos nucifera oil), anti-dandruff agent (Piper nigrum fruit extract), neutralizer, preservatives, scalp warming agent (Vanilly butyl ether) and optionally one or more inert ingredients, wherein the formulation is devoid of emulsifier. One more aspect of the present invention is to provide a novel oil in water based natural formulation comprising 15 to 25 % of Emollient (Macadamia seed oil esters), 2.5 to 10% of Scalp purifying agent (Mixture of Capryloyl glycine and Xylitylglucoside), 5 to 20% of Hair nourishing complex ((Mixture of Saccharum officinarum (Sugarcane) extract, Citrus limon fruit (Lemon) extract, Betaine, Hexylene glycol, Pyrus malus (apple) fruit extract, Camellia sinensis leaf (Green tea leaf) extract and Hexapeptide -11) and/or (Mixture of Acetyl tetrapeptide-3 and Trifolium pratense flower extract)), 2 to 5% of Hair growth promoters (Pisum sativum sprout extract), 1 to 5% of Scalp anti-aging extract (Pterocarpus marsupium bark extract), 1 to 20% of Exfoliating agent (Glycolic acid), 1.00 to 1.5% of Hair growth stimulating agent (Diaminopyrimidine oxide). 0.5 to 1.5% of Hair densifier complex (Mixture of Ocimum basilicum hairy root culture ethanolic extract, Helianthus annuus seed oil, Cocos nucifera oil), 0.2 to 1% of Anti-dandruff agent (Piper nigrum fruit extract), 0.01 to 1.00% of Scalp warning agent (Vanillyl butyl ether), 0.2 to 1.5% of Neutralizer, 0.45 to 2.00% of Preservatives and optionally one or more inert ingredients, wherein the formulation is devoid of emulsifier. Yet One more aspect of the present invention is to provide a novel oil in water based natural formulation comprising 15 to 25 % of Emollient (Macadamia seed oil esters), 2.5 to 10% of Scalp purifying agent (Mixture of Capryloyl glycine and Xylitylglucoside), 5 to 20% of Hair nourishing complex ((Mixture of Saccharum officinarum (Sugarcane) extract, Citrus limon fruit (Lemon) extract, Betaine, Hexylene glycol, Pyrus malus (apple) fruit extract, Camellia sinensis leaf (Green tea leaf) extract and Hexapeptide -11) and/or (Mixture of Acetyl tetrapeptide-3 and trifolium pratense flower extract)), 2 to 5% of Hair growth promoters (Pisum sativum sprout extract), 1 to 5% of Scalp anti-aging extract (Pterocarpus marsupium bark extract), 1 to 20% of Exfoliating agent (Glycolic acid), 1.00 to 1.5% of Hair growth stimulating agent (Diaminopyrimidine oxide). 0.5 to 1.5% of Hair densifier complex (Ocimum basilicum hairy root culture ethanolic extract, Helianthus annuus seed oil, Cocos nucifera oil), 0.2 to 1% of Anti-dandruff agent (Piper nigrum fruit extract), 0.01 to 1.00% of Scalp warning agent (Vanillyl butyl ether), 0.2 to 1.5% of Neutralizer, 0.45 to 2.00 of Preservatives and optionally one or more inert ingredients, wherein hair densifier complex comprises 0.1 to 10% Ocimum basilicum hairy root culture ethanolic extract, 50 to 80% of Helianthus annus seed oil and 20 to 40% of Cocos nucifera oil, while scalp purifying complex comprises of mixture of 10 to 15% of Capryloyl glycine and 25 to 50% of Xylityl glucoside, while hair nourishing complex comprises mixture of 14 to 16 % of Saccharum officinarum (Sugarcane) extract, 8.4 to 9.6% of Citrus limon fruit (Lemon) extract, 8 of 12% of Betaine, 8 to 12% of Hexylene glycol, 3.36 to 3.86% of Pyrus malus (apple) fruit extract, 2.26 to 2.57% of Camellia sinensis leaf (Green tea leaf) extract and 0.9 to 1.1% of Hexapeptide -11 and/or mixture of 0.8 to 1.2% of Acetyl tetrapeptide-3 and 5 to 8% of Trifolium pratense flower extract, wherein the formulation is devoid of emulsifier. One more aspect of the present invention is to provide a novel oil in water based natural formulation comprising about 20% of Emollient (Macadamia seed oil esters), 10% of Scalp purifying agent (Mixture of Capryloyl glycine and Xylitylglucoside), 5% of Hair nourishing complex ((Mixture of Saccharum officinarum (Sugarcane) extract, Citrus limon fruit (Lemon) extract, Betaine, Hexylene glycol, Pyrus malus (apple) fruit extract, Camellia sinensis leaf (Green tea leaf) extract and Hexapeptide -11) and/or (Mixture of Acetyl tetrapeptide-3 and Trifolium pratense flower extract)), 4% of Hair growth promoters (Pisum sativum sprout extract), 2 % of Scalp anti-aging extract (Pterocarpus marsupium bark extract), 1.5 % of alpha hydroxy acid (Glycolic acid), 1.5% of Hair growth stimulating agent (Diaminopyrimidine oxide). 1% of Hair densifier complex (Ocimum basilicum hairy root culture ethanolic extract, Helianthus annuus seed oil, Cocos nucifera oil), 1% of Anti-dandruff agent (Piper nigrum fruit extract), 0.3% of Scalp warning agent (Vanillyl butyl ether), 1% of neutralizer, 1.05% of preservatives (0.7% of Phenoxyethanol, 0.2% of Sodium benzoate, 0.15% of Potassium sorbate) and optionally one or more inert ingredients, wherein hair densifier complex comprises 0.1 to 10% Ocimum basilicum hairy root culture ethanolic extract, 50 to 80% of Helianthus annus seed oil and 20 to 40% of Cocos nucifera oil, while scalp purifying complex comprises of mixture of 10 to 15% of Capryloyl glycine and 35 to 50% of Xylityl glucoside, while hair nourishing complex comprises mixture of 14 to 16 % of Saccharum officinarum (Sugarcane) extract, 8.4 to 9.6% of Citrus limon fruit (Lemon) extract, 8 of 12% of Betaine, 8 to 12% of Hexylene glycol, 3.36 to 3.86% of Pyrus malus (apple) fruit extract, 2.26 to 2.57% of Camellia sinensis leaf (Green tea leaf) extract and 0.9 to 1.1% of Hexapeptide -11 and/or mixture of 0.8 to 1.2% of Acetyl tetrapeptide-3 and 5 to 8% of Trifolium pratense flower extract the formulation is devoid of emulsifier.

Yet another aspect of the present invention is to provide a process for preparing novel oil in water based natural formulation comprising the steps of

1. Dissolving hair growth stimulating agent (Diaminopyrimidine oxide) and hair growth promoter (Pisum sprout extract) in purified water by stirring.

2. Dissolving anti-dandruff agent (Piper nigrum fruit extract) and hair densifier complex (mixture of Ocimum basilicum hairy root cluture ethanolic extract, Helianthus annuus seed oil and Cocos nucifera oil) in to macadamia seed oil esters with stirring.

3. Adding the mixture of step 2) to step 1) with stirring for 30 minutes till proper emulsion will form.

4. Adding gradually Scalp anti-aging extract (Pterocarpus marsupium bark extract), preservatives (Sodium benzoate, Potassium sorbate, and Phenoxyethanol) into the mixure of step 3) with continuous stirring for 15 minutes.

5. Adding step by step, exfoliating agent (Glycolic acid), neutralizer (Triethanolamine) and Fragrance with stirring for 15 minutes.

6. Adding scalp purifying agent (Mixture of Capryloyl glycine and Xylityl glucoside) into the mixture of step 5) with stirring for 15 minutes. 7. Add step by step, hair nourishing complex (Mixture of Saccharum officinarum extract, citrus limon extract, Betaine, Hexylene glycol, pyrus malus fruit extract, Camellia sinensis leaf extract and Hexapeptide -11) in a mixture of step 6) with stirring for 15 minutes.

8. Optionally, Add step by step, hair nourishing complex (Mixture of Acetyl tetrapeptide-3 and trifolium pratense flower extract) with stirring for 15 minutes.

Yet one more aspect of the present invention is to provide a novel oil in water based natural formulation for the prevention of hair fall and for hair growth in human being with increase in hair density. Further aspects and embodiments of the present invention will be provided in the detailed description below with more detailed explanation and will apparent to persons skilled in the art after reading the specification or can be learned from the practicing the embodiment of the present invention. The features and advantages of the present invention may be apparent and obtained as presented in the claims. As will be realized, the composition of the present invention can be practiced with different modification and alterations, all without departing from the scope of present invention. The description is to be considered as illustrative only and not as a restrictive manner.

DETAILED DESCRIPTION OF THE INVENTION The instant invention of the present invention provides a novel oil in water based natural formulation comprising active ingredients derived from natural sources.

Further the present invention provides oil in water based natural formulation for the prevention of hair fall in human being and at the same time for growth of hair with increase in hair density.

The term "natural" or "herbal" as used herein refer to any phytochemical or mixture thereof that is obtained, isolated, and/or derived from one or more extracts of plant material(s) or essential oil(s) thereof. The term "plant material" refers to any plant material including, but not limited to, leaves, hark, stems, flowers, fruits, seeds, roots, and combinations thereof. The term "natural" and "herbal" can be used interchangeably.

The term "about" as described herein means that values slightly outside the cited values, i.e., plus or minus 5 to 10%. The term "%" as used herein means the % w/w or %w/v of the ingredient to be calculated with respect to weight and/or volume of total formulation. The term "hair growth" and "hair regrowth" can be used interchangeably.

The term "formulation" as used herein means oil in water based formulation and can be selected from emulsion, suspension, solution. Preferred is emulsion with more preferred is microemulsion.

Microemulsions are clear, thermodynamically stable, isotropic liquid mixtures of oil, water with the help of emulsifier. In contrast to ordinary emulsions, microemulsions form upon simple mixing of the components and do not require the high shear conditions generally used in the formation of ordinary emulsions. The three basic types of microemulsions are direct (oil dispersed in water, o/w), reversed (water dispersed in oil, w/o) and bicontinuous.

The present invention is oil in water based micro emulsion wherein the plant active which is in oil form is dispersed in aqueous phase and get embedded in oil globule form in aqueous phase. The inventors of the present invention have surprisingly found that the microemulsion of the plant active can be prepared by specific selection of inert ingredients without adding any emulsifier.

The formulation of present invention can be used for treatment of prevention of hair fall and growth of hair in human beings with increase in hair density. The novel oil in water based formulation as provided herein is effective combination of plant actives derived from natural sources which provide the end results without any undesirable side effects and further the provided formulation is stable.

Yet another advantage of the formulation of present invention is although there is higher % of oil present, the viscosity of the final formulation is lower which provides the ease in application and spreadability on scalp.

Further the present invention is in the form of oil in water formulation with higher amount of plant active which is in oil form but does not contain any emulsifier and yet stable and effective for prevention of hair fall and stimulates hair growth.

The novel formulation of the present invention comprises novel Emollient (Macadamia seed oil esters), Scalp purifying agent (Mixture of caprylol glycine and xylitylglucoside), Hair nourishing complex ((Mixture of Saccharum officinarum (Sugarcane) extract, citrus limon fruit (Lemon) extract, Betaine, Hexylene glycol, Pyrus malus (apple) fruit extract, Camellia sinensis leaf (Green tea leaf) extract and Hexapeptide -11) and/or (Mixture of Acetyl tetrapeptide-3 and trifolium pratense flower extract)) Hair growth promoter (Pisum sativum sprout extract), Scalp anti-aging extract (Pterocarpus marsupium bark extract), Exfoliating agent (Glycolic acid), Hair growth stimulating agent (Diaminopyrimidine oxide), Hair densifier complex (Mixture of Ocimum basilicum hairy root culture ethanolic extract, Helianthus annuus seed oil and Cocos nucifera oil), Anti-dandruff agent (Piper nigrum fruit extract), Neutralizer, Preservatives, Scalp warming agent (Vanilly butyl ether) and optionally one or more inert ingredients.

Inert ingredient as used herein means any ingredients which do not have any therapeutic or biological effect and can be mixed with any other therapeutic active ingredient without causing any undesirable biological effects or interacting in a deleterious manner with any of the other ingredients of the formulation in which it is contained.

Inert ingredient which can be used for the natural formulation of the present invention can be selected from the group consisting of neutralizer, preservatives, fragrances, coloring agent and carrier.

The active ingredients and other ingredients that are used in the preparation of formulation of present invention are described below;

Plant actives:

Plant actives as used herein means the active ingredient derived from plant. For the purpose of present invention the plant actives are emollient, hair nourishing complex, hair growth promoter, scalp anti- aging extract, hair densifier complex, and anti-dandruff agent. a) Macadamia seed oil esters

Water dispersible Macadamia oil esters (Macadamia ternifolia) is having with emollient, skin soothing, purifying and nourishing properties of macadamia oil. As per the present invention, Macadamia oil esters can be used in the range of 15 to 25%. b) Hair nourishing complex

Hair nourishing complexes are made up of one or more ingredients having a hair nourishing properties. There are two complexes, which can be used as hair nourishing complex.

1. Mixture of Saccharum officinarum (Sugarcane) extract, Citrus limon fuit (lemon) extract, Betaine,

Hexylene glycol, Pyrus malus (Apple) fruit extract, Camellia sinensis leaf (Green tea leaf extract) and Hexapeptide -11 It is a mixture of different plant derived extracts such as Saccharum officinarum extract, Citrus limon extract, Betaine, Hexylene glycol, Pyrus malus fruit extract, Camellia sinensis leaf extract as well as biofermented peptide. This complex mixture improves health of hair follicle, increase penetration of actives through follicle, and reduces hair loss.

Preferably it comprises of mixture of 14 to 16 % of Saccharum officinarum (Sugarcane) extract, 8.4 to 9.6% of Citrus limon fruit (Lemon) extract, 8 of 12% of Betaine, 8 to 12% of Hexylene glycol,

3.36 to 3.86% of Pyrus malus (apple) fruit extract, 2.26 to 2.57% of Camellia sinensis leaf (Green tea leaf) extract and 0.9 to 1.1% of Hexapeptide -11

Saccharum officinarum (Sugarcane) extract

Fruit extracts isolated from sugar cane offer natural exfoliating action through the action of a- hydroxy acids promoting cell renewal on the scalp. This helps clear the follicles of excessive buildup of dead cells, allowing more thicker hair growth.

Citrus limon fuit (lemon) extract

It is a fruit extract isolated from Citrus limon (lemon) fruits. The natural pH of the scalp is slightly acidic, so the acidic nature of this extract ensures that hair proteins are kept hard and more resistant to breakage.

Pyrus malus (apple) fruit extract

It is a natural fruit extract isolated from Apple fruits which containing natural a-hydroxy acids which provides exfoliating action on cells of scalp.

Betaine

Betaine is also known to be part of the important cascades for cellular production of ATP, the energy molecule of every living cell. Betaine has been shown in vitro to stimulate the production of collagen in human dermal fibroblasts. Improving the production of collagen in the skin helps to strengthen the extracellular matrix where the hair bulb principally resides.

Enhancing the energy cascades of the hair bulb improves the ability of the hair to function during the anagen or growth cycle of the hair fiber.

Hexapeptide- 11

Hexapeptide- 11 is a biofermented peptide which able to upregulate the Androgen Receptor gene (AR) indicating that the peptide appears capable of binding to the Androgen Receptor much the way testosterone will. This suggests that Hexapeptide- 11 may be able to influence the principal biochemical pathways responsible for converting young velus hair into mature terminal hair. Application

• Anti-hair loss, hair-regrowth formulations

• Anti-aging hair care products

• Tonics, serums, conditioners, masks, shampoos

As per the present invention, Mixture of Saccharum officinarum (Sugarcane) extract, Citrus limon fuit (lemon) extract, Betaine, Hexylene glycol, Pyrus malus (Apple) fruit extract, Camellia sinensis leaf (Green tea leaf extract) and Hexapeptide -11 complex can be used in the range of 5 to 20%. 2. Mixture of Acetyl tetrapeptide-3 and Trifolium pretense (clover) flower extract

It is mixture of biomimetic peptide (acetyl tetrapeptide-3) combined with a red clover extract. It targets the main causes of hair loss, providing fuller and thicker hair.

A biomimetic peptide (acetyl tetrapeptide-3) combined with a red clover extract rich in Biochanin A. its efficacy is based on the association and synergistic action of its two ingredients. Mixture shows direct action on 5a-reductase enzyme which is responsible for formation of

Dihydrotestosterone (DHT).

It also helps to produce good Extracellular matrix proteins such as collagen type III and anchoring fibers such as laminin and collagen VII which will favor a good hair anchoring in the hair bulb surrounding tissue.

Application

- Hair treatment

- Anti-aging hair care product

- Men hair care product - Treatment for seasonal hair loss

- Tonics

- Hair treatment for menopaused women

As per the present invention, Mixture of acetyl tetrapeptide-3 and Trifolium pranse (clover) flower extract can be used in the range of 0.5 to 5%. c) Hair growth promoter (Pisum sativum sprout extract)

An aqueous extract based on sprouts of organic pea (Pisum sativum), which reduces hair loss by inducing dermal papilla cells to reactivate hair growth especially in the anagen phase.

Application of Pisum sativum sprouts extract

· Anti-hair loss, hair-regrowth formulations

• Anti-aging hair care products

• Tonics, serums, conditioners, masks, shampoos As per the present invention, Pisum sativum sprout extract can be used in the range of 2 to 5%. d) Scalp anti aging extract (Pterocarpus marsupium extract)

It is an aqueous extract prepared principally from bark of Pterocarpus marsupium extract. It has a good anti-glycation (glycation being the major cause of aging of the scalp) activity, it reduces the seasonal hair loss. BY protecting & strengthening the bulb and restoring the normal hair growth cycle.

Application

-Hair tonics

-Hair care shampoo

As per the present invention, Scalp anti aging extract can be used in the range of 2 to 10%. e) Hair densifier complex (ocimum basilicum hairy root culture ethanolic extract, helianthus annuus seed oil and cocos nucifera oil)

Hair densifier complex is made up of one or more ingredients having hair densifying property. Preferred are ocimum basilicum hairy root culture ethanolic extract, helianthus annuus seed oil and cocos nucifera oil. Preferably the hair densifier complex comprises 0.1 to 10% of ocimum basilicum hairy root culture 20 ethanolic extract, 50 to 80% of helianthus annuus seed oil and 20 to 40% of cocos nucifera oil.

This complex mixture shows inhibitory effect on 5 a Reductase enzyme, which is mainly responsible for hair loss.

Ocimum basilicum hairy root culture ethanolic extract

An extract from a hairy root culture from basil, helps reduce hair loss by inhibiting 5 a reductase activity and by stimulating dermal papilla cells.

Application: Hair oil, hair serum, conditioner, hair pack, anti-aging hair care.

Helianthus annuus seed oil

Helianthus annuus oil is extracted from the seeds of the sunflower, Helianthus annuus and used as skin conditioning agent having emollient property. Cocos nucifera oil

Coconut oil is extracted from the kernels of the seeds of coconot palm, Cocos nucifera.

Application: Conditioning agent, Emollient, Masking Solvent Hair densifier complex can be used in the range of 0.5 to 1.5 %, preferably 1% of the total formulation f) Anti-dandruff agent (Piper Nigrum fruit (black paper) extract)

Extract of Piper Nigrum fruit (black paper) extract titrated in Piperine having anti dandruff, Anti- Inflammatory and Soothing Property.

Application:

- Anti-hair loss, hair-regrowth formulations

- Anti-aging hair care products

- Tonics, serums, conditioners, masks, shampoos

As per the present invention, piper nigrum fruit extract can be used in the range of 0.5 to 1.5%, preferably from 0.75 to 1.25% and most preferred is 1%.

Other actives

a) Scalp purifying agent (Mixture of Capryloyl glycine and Xylityl glucoside)

It is the biomimetic active which helps to control sebum production and control oil production. It also helpful for irritated and sensitive scalp. It also affective against fungus Malassezia furfur, which is responsible for causing dandruff. It comprises of 10-15% of Capryloyl glycine and 35 to

50% of Xylityl glucoside.

Application

- Hair care products for irritated and sensitive scalp

- Skin and scalp oiliness

- Dandruff

- Body and scalp deodorant

- Helps prevent microbial contamination in formulations As per the present invention, Scalp purifying agent can be used in the range of 2.5 to 10%. b) Exfoliating agent (Glycolic acid)

Glycolic Acid (hydroxyacetic acid) is the first member of the series of alpha-hydroxy carboxylic acids, which means it is one of the smallest organic molecules with both acid and alcohol functionality. Although Glycolic Acid occurs naturally as a trace component in sugarcane, beets, grapes and fruits. It is mainly used for chemical peeling. As per the present invention, Glycolic acid can be used in the range of 1 to 20%. Preferably 1 to 10% and most preferred is 1.5%. Other ingredients that can be used in place of glycolic acid are citric acid, stearic acid and palmitic acid. c) Neutralizer

Neutralizer can be selected from the group consisting of monoethanolamine, diethanolamine, triethanolamine, monopropanolamine, dipropanolamine, tripropanolamine, 2-amino-2-methyl-l ,3- propanediol, 2-amino-2-methyl-l -propanol, 2-amino-2-hydroxymethyl-l ,3- propanediol and mixtures thereof. Preferred one is triethanolamine. As per the present invention, Neutralizer can be used in the range of 0.2 to 1.5%, preferably 1%. d) Hair growth stimulating agent (Diaminopyrimidine oxide)

Hair growth stimulating agent as used herein means an agent that promotes the hair growth. The hair growth stimulating agent for the purpose of present invention is Diaminopyrimidine oxide. The hair growth stimulating agent promotes the proliferation of dermal papillae cells that control the hair cycle and also effectively retard hair loss and stimulate new hair growth. As per the present invention, hair growth stimulating agent can be used in the range of 0.2 to 1.5%. Preferably in the range of 1.0 to 1.5% and most prefer is 0.2%. e) Preservatives

Preservatives as used for the present invention is selected from the group consisting of sodium benzoate, potassium sorbate and Phenoxyethanol the other example are phenoxyethanol, methyl chloroisothiazolinone & methylisothiazolinone, gluconolactone, benzyl alcohol, DMDM Hydantoin, benzethonium chloride,sodium benzoate, dehydroacetic acid, chlorhexidine digluconate, methyl paraben, propyl paraben, butyl paraben, sodium methyl paraben, sodium propyl paraben, Diazodinyl urea. Preferred is combination of sodium benzoate, potassium benzoate and phenoxyethanol. More preferably about 0.20% of sodium benzoate, about 0.15% of potassium sorbate, about 0.70% of phenoxyethanol This combination of preservatives can be used in the range of 0.45 to 2%. f) Scalp warming agent (Vanillyl butyl ether)

The functional group of Vanillyl butyl ether is called the vanillyl group. It plays the main role in inducing the warming sensation via the nervous system, it enhances microcirculation and boosts delivery of nutrients and oxygen to the hair follicles. The scalp warming agent can be used in the range of 0.01 to 1%. g) Fragrance All types of individual & combination of following can be used fragrances. Citrus fragrances, berries fragrances, stone fruits fragrances, pip fruits fragrances, botanicals fragrances, cereals fragrances, tea fragrances, alcoholic fragrances, floral fragrances. h) Coloring agent

Water soluble and water insoluble grades of Colouring agent are Ponceau 4r, Brilliant blue, Indigo carmine, Carmine red colour, Sunset yellow, Quinoline yellow, Tartrazine, Erythrosine.

It is obvious for a person skilled in the art to add any other beneficial ingredient to the formulation of present invention for one or more beneficial effect and all are covered in the scope of the present invention.

EXAMPLES

Example: 1 For

Procedure:

1. Dissolving hair growth stimulating agent (Diaminopyrimidine oxide) and hair growth promoter (Pisum sprout extract) in purified water by stirring. 2. Dissolving anti-dandruff agent (Piper nigrum fruit extract) and hair densifier complex (mixture of Ocimum basilicum hairy root cluture ethanolic extract, Helianthus annuus seed oil and Cocos nucifera oil) in to macadamia seed oil esters with stirring.

3. Adding the mixture of step 2) to step 1) with stirring for 30 minutes till proper emulsion will formed. 4. Adding gradually Scalp anti-aging extract (Pterocarpus marsupium bark extract), Preservatives

(Sodium benzoate, Potassium sorbate, and Phenoxyethanol) into the mixure of step 3) with continuous stirring for 15 minutes.

6. Adding Scalp purifying agent (Mixture of Capryloyl glycine and Xylityl glucoside) into the mixture of step 5) with stirring for 15 minutes.

7. Add step by step, hair nourishing complex (Mixture of Saccharum officinarum extract, citrus limon extract, Betaine, Hexylene glycol, pyrus malus fruit extract, Camellia sinensis leaf extract and Hexapeptide -11) in a mixture of step 6) with stirring for 15 minutes.

Example-2 For 100ml

Example-3 For 100ml

Procedure: As per Example- 1

Example 4 For 100ml

Procedure: As per Example- 1 Example 5 For 100ml

Procedure: As per Example- 1

Example 6 For 100ml

Procedure:

1. Take purified water in a beaker.

2. Dissolving anti-dandruff agent (Piper nigrum fruit extract), Scalp warming agent (Vanillyl butyl ether) and hair densifier complex (mixture of Ocimum basilicum hairy root cluture ethanolic extract, Helianthus annuus seed oil and Cocos nucifera oil) in to macadamia seed oil esters with stirring.

5. Adding Scalp purifying agent (Capryloyl glycine and Xylityl glucoside) into the mixture of step 4) with stirring for 15 minutes.

6. Add step by step, hair nourishing complex (Saccharum officinarum extract, citrus limon extract, Betaine, Hexylene glycol, pyrus malus fruit extract, Camellia sinensis leaf extract and Hexapeptide -11) in a mixture of step 5) with stirring for 15 minutes.

7. Optionally, Add step by step, hair nourishing complex (Acetyl tetrapeptide-3 and trifolium pratense flower extract) with stirring for 15 minutes.

Example 7: For 100 ml

Procedure: As per Example-6

Stability study

Stability study has been performed for formulation as per example 5. The stability study results are provided below;

Packaging: PET Bottle

Condition: 30° C ± 2° C & 65% ± 5% RH Test & Limit Observations

Initial 3 months 6 months 9 months 12 months 36 months

Description *Clarity *Clarity *Clarity *Clarity *Clarity *Clarity pH (4.0 to 6.0) 5.1 4.9 4.9 4.7 4.7 4.5

Microbial contamination

Total viable aerobic

count 70 cfu/ml NA 75 cfu/ml NA 75 cfu/ml 85 cfu/ml

(NMT 1000 cfu/ml)

Fungi

(NMT 100 cfu/ml) Nil NA Nil NA Nil Nil

E. Coli

(Should be absent) Absent NA Absent NA Absent Absent

^:Clarity= Clear, Light to Dark yellow coloured, Transparent liquid with pleasant odor

NA: Not analysed

NMT: Not more than

Packaging: PET Bottle

Condition: 40° C ± 2° C & 75% ± 5% RH

*Clarity= Clear, Light to Dark yellow coloured, Transparent liquid with pleasant odor

NA: Not analysed

NMT: Not more than

Claims

We claim; 1. A novel oil in water based natural formulation comprising of plant actives selected from scalp purifying agent, hair nourishing complex, hair growth promoter, scalp anti-aging extract, exfoliating agent, hair growth stimulating agent, hair densifier complex, anti-dandruff agent embedded in oil globules with neutralizer, preservatives, and optionally one or more inert ingredients, wherein the formulation is devoid of emulsifier.

2. A novel oil in water based natural formulation comprising of Emollient (Macadamia seed oil esters), Scalp purifying agent (Mixture of caprylol glycine and xylitylglucoside), Hair nourishing complex ((Mixture of Saccharum officinarum (Sugarcane) extract, citrus limon fruit (Lemon) extract, Betaine, Hexylene glycol, Pyrus malus (apple) fruit extract, Camellia sinensis leaf (Green tea leaf) extract and Hexapeptide -11) and/or (mixture of Acetyl tetrapeptide-3 and Trifolium pratense flower extract)), Hair growth promoter (Pisum sativum sprout extract), Scalp anti-aging extract (Pterocarpus marsupium bark extract), Exfoliating agent (Glycolic acid), Hair growth stimulating agent (Diaminopyrimidine oxide), Hair densifier complex (Mixture of Ocimum basilicum hairy root culture ethanolic extract, Helianthus annuus seed oil and Cocos nucifera oil), Anti-dandruff agent (Piper nigrum fruit extract), Neutralizer, Preservatives, Scalp warming agent (Vanilly butyl ether) and optionally one or more inert ingredients, wherein the formulation is devoid of emulsifier.

3. A novel oil in water based natural formulation comprising 15 to 25 % of Emollient (Macadamia seed oil esters), 2.5 to 10% of Scalp purifying agent (Mixture of Capryloyl glycine and Xylitylglucoside), 5 to 20% of Hair nourishing complex ((Mixture of Saccharum officinarum (Sugarcane) extract, Citrus limon fruit (Lemon) extract, Betaine, Hexylene glycol, Pyrus malus (apple) fruit extract, Camellia sinensis leaf (Green tea leaf) extract and Hexapeptide -11) and/or (Mixture of Acetyl tetrapeptide-3 and trifolium pratense flower extract)), 2 to 5% of Hair growth promoters (Pisum sativum sprout extract), 1 to 5% of Scalp anti-aging extract (Pterocarpus marsupium bark extract), 1 to 20% of Exfoliating agent (Glycolic acid), 1.00 to 1.5% of Hair growth stimulating agent (Diaminopyrimidine oxide). 0.5 to 1.5% of Hair densifier complex (Mixture of Ocimum basilicum hairy root culture ethanolic extract, Helianthus annuus seed oil, Cocos nucifera oil), 0.2 to 1% of Anti-dandruff agent (Piper nigrum fruit extract), 0.01 to 1.00% of Scalp warning agent (Vanillyl butyl ether), 0.2 to 1.5% of Neutralizer, 0.45 to 2.00% of Preservatives and optionally one or more inert ingredients, wherein the formulation is devoid of emulsifier.

4. A novel oil in water based natural formulation comprising 15 to 25 % of Emollient (Macadamia seed oil esters), 2.5 to 10% of Scalp purifying agent (Mixture of Capryloyl glycine and Xylitylglucoside), 5 to 20% of Hair nourishing complex ((Mixture of Saccharum officinarum (Sugarcane) extract, Citrus limon fruit (Lemon) extract, Betaine, Hexylene glycol, Pyrus malus (apple) fruit extract, Camellia sinensis leaf (Green tea leaf) extract and Hexapeptide -11) and/or (Mixture of Acetyl tetrapeptide-3 and Trifolium pratense flower extract)), 2 to 5% of Hair growth promoters (Pisum sativum sprout extract), 1 to 5% of Scalp anti-aging extract (Pterocarpus marsupium bark extract), 1 to 20% of Exfoliating agent (Glycolic acid), 1.00 to 1.5% of Hair growth stimulating agent (Diaminopyrimidine oxide). 0.5 to 1.5% of Hair densifier complex (Ocimum basilicum hairy root culture ethanolic extract, Helianthus annuus seed oil, Cocos nucifera oil), 0.2 to 1% of Anti-dandruff agent (Piper nigrum fruit extract), 0.01 to 1.00% of scalp warning agent (Vanillyl butyl ether), 0.2 to 1.5% of neutralizer, 0.45 to 2.00 of preservatives and optionally one or more inert ingredients, wherein hair densifier complex comprises 0.1 to 10% Ocimum basilicum hairy root culture ethanolic extract, 50 to 80% of Helianthus annus seed oil and 20 to 40% of Cocos nucifera oil, while scalp purifying complex comprises of mixture of 10 to 15% of Capryloyl glycine and 25 to 50% of Xylityl glucoside, while hair nourishing complex comprises mixture of 14 to 16 % of Saccharum officinarum (Sugarcane) extract, 8.4 to 9.6% of Citrus limon fruit (Lemon) extract, 8 of 12% of Betaine, 8 to 12% of Hexylene glycol, 3.36 to 3.86% of Pyrus malus (apple) fruit extract, 2.26 to 2.57% of Camellia sinensis leaf (Green tea leaf) extract and 0.9 to 1.1% of Hexapeptide -11 and/or mixture of 0.8 to 1.2% of Acetyl tetrapeptide-3 and 5 to 8% of Trifolium pratense flower extract, wherein the formulation is devoid of emulsifier.

5. A novel oil in water based natural formulation comprising about 20% of Emollient (Macadamia seed oil esters), 10% of Scalp purifying agent (Mixture of Capryloyl glycine and Xylitylglucoside),

5% of Hair nourishing complex ((Mixture of Saccharum officinarum (Sugarcane) extract, Citrus limon fruit (Lemon) extract, Betaine, Hexylene glycol, Pyrus malus (apple) fruit extract, Camellia sinensis leaf (Green tea leaf) extract and Hexapeptide -11) and/or (Mixture of Acetyl tetrapeptide-3 and Trifolium pratense flower extract)), 4% of Hair growth promoters (Pisum sativum sprout extract), 2 % of Scalp anti-aging extract (Pterocarpus marsupium bark extract), 1.5 % of alpha hydroxy acid (Glycolic acid), 1.5% of Hair growth stimulating agent (Diaminopyrimidine oxide). 1% of Hair densifier complex (Ocimum basilicum hairy root culture ethanolic extract, Helianthus annuus seed oil, Cocos nucifera oil), 1% of Anti-dandruff agent (Piper nigrum fruit extract), 0.3% of Scalp warning agent (Vanillyl butyl ether), 1% of Neutralizer, 1.05% of Preservatives (0.7% of Phenoxyethanol, 0.2% of Sodium benzoate, 0.15% of Potassium sorbate) and optionally one or more inert ingredients, wherein hair densifier complex comprises 0.1 to 10% Ocimum basilicum hairy root culture ethanolic extract, 50 to 80% of Helianthus annus seed oil and 20 to 40% of Cocos nucifera oil, while scalp purifying complex comprises of mixture of 10 to 15% of Capryloyl glycine and 35 to 50% of Xylityl glucoside, while hair nourishing complex comprises mixture of 14 to 16 % of Saccharum officinarum (Sugarcane) extract, 8.4 to 9.6% of citrus limon fruit (Lemon) extract, 8 of 12% of Betaine, 8 to 12% of Hexylene glycol, 3.36 to 3.86% of Pyrus malus (apple) fruit extract, 2.26 to 2.57% of Camellia sinensis leaf (Green tea leaf) extract and 0.9 to 1.1% of Hexapeptide -11 and/or mixture of 0.8 to 1.2% of Acetyl tetrapeptide-3 and 5 to 8% of Trifolium pratense flower extract wherein the formulation is devoid of emulsifier.

6. A process for preparing novel oil in water based natural formulation comprising the steps of

a. Dissolving hair growth stimulating agent (Diaminopyrimidine oxide) and hair growth promoter (Pisum sprout extract) in purified water by stirring.

b. Dissolving anti-dandruff agent (Piper nigrum fruit extract) and hair densifier complex (mixture of Ocimum basilicum hairy root cluture ethanolic extract, Helianthus annuus seed oil and Cocos nucifera oil) in to macadamia seed oil esters with stirring.

c. Adding the mixture of step 2) to step 1) with stirring for 30 minutes till proper emulsion will formed.

d. Adding gradually Scalp anti-aging extract (Pterocarpus marsupium bark extract), Preservatives (Sodium benzoate, Potassium sorbate, and Phenoxyethanol) into the mixure of step 3) with continuous stirring for 15 minutes.

e. Adding step by step, exfoliating agent (Glycolic acid), Neutralizer (Triethanolamine) and Fragrance with stirring for 15 minutes.

f. Adding Scalp purifying agent (Mixture of Capryloyl glycine and Xylityl glucoside) into the mixture of step 5) with stirring for 15 minutes.

g. Add step by step, hair nourishing complex (Mixture of Saccharum officinarum extract, citrus limon extract, Betaine, Hexylene glycol, pyrus malus fruit extract, Camellia sinensis leaf extract and Hexapeptide -11) in a mixture of step 6) with stirring for 15 minutes.

h. Optionally, Add step by step, hair nourishing complex (Mixture of Acetyl tetrapeptide-3 and trifolium pratense flower extract) with stirring for 15 minutes.

7. The novel oil in water based natural formulation according to any preceding claims, which can be used for the prevention of hair fall and for hair growth in human being with increase in hair density.