DESC:FIELD OF THE INVENTION
The present invention relates to compositions for improving hair and scalp health and particularly to a serum based novel composition, comprising Pisum sativum (Pea) sprout extract, a composition comprising Piper nigrum berries extract and Inga alba bark extract and Grapeseed oil as natural active ingredients.
BACKGROUND OF THE INVENTION
Hair undergoes a regular cycle of growth. The normal rate of growth of hair is 1 cm per month. Each hair follicle goes through a cycle of a growth stage (anagen hair), and an involution or resting stage (telogen hair). The anagen stage lasts for about three years, while the telogen stage lasts for only about three months. Once the hair follicle reaches the telogen stage, the hair falls out. At any one time, and depending on the age and the sex of the person, up to 90% of hair follicles can be in anagen (growing phase) and only 10% in telogen (resting phase) when hairs are normally shed. An alteration in this ratio can lead to an increased rate of hair loss. Baldness or hair loss (also known as alopecia) involves the state of lacking hair especially on the head where it often grows. Hair loss is a common disorder that affects men and women of all ages. About 50% of men and women suffer from hair loss by the age of 40.
In general, excessive male hormone action, poor blood circulation, a scalp function decrease due to peroxides, bacteria, hereditary aging and stress are considered as the major causes for hair loss. The percentage of population affected by hair loss has increased due to nutritional imbalance, and increased levels of stress due to environmental pollution and modern lifestyle.
However, despite the wide spread prevalence of hair loss disorders, few effective treatments are available. Surgical treatments are available for the restoration of hair particularly to the scalp. But these techniques are painful and expensive. Further, there are various medicines or products available in the market for treating hair loss; medicines that are relatively expensive and have dangerous side effects. Such products provide only temporary relief. Hence, there exists a need for hair fall control compositions that are not only safe but also easy to use and affordable. Notably, there exist several herbal extracts which positively influence hair growth and vitality
Pea sprout is 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. The dermal papilla (specialized dermal cells) plays a major role in hair follicle development and growth, and controls the switch from telogen to anagen phase. It instructs the surrounding epithelial cells (hair matrix) to proliferate, move upward and differentiate into the multiple cell types (hair shaft, root sheaths).
A composition comprising Piper nigrum berries extract and Inga alba bark extract has anti-inflammatory, soothing, cleansing and purifying properties. This composition improves hair radiance and sensory properties and is suitable for all hair types.
Grapeseed (Vitis vinifera) oil, which is extracted from the seeds of grapes, typically wine grapes, contains high linoleic acid (Omega 6 fatty acid) content with nourishing properties and quick penetration into the skin. It is used in cosmetics and personal care products because of its natural antioxidant properties.
Although, there are numerous products claiming to prevent hair loss and promote healthy growth of hair, there is a continued need for better hair care formulations comprising the above plant extracts.
SUMMARY OF THE INVENTION
Accordingly, the inventors of the present invention have formulated a novel composition, comprising plant extracts, to be used in the form of serum for treatment of hair loss.
In accordance with an embodiment of the invention, there is provided a hair fall control serum, comprising: (a) Pisum sativum (Pea) sprout extract; (b) a composition comprising Piper nigrum berries extract and Inga alba bark extract; (c) Grapeseed oil; (d) at least one ingredient selected from the group consisting of Glycine, Vitamin B5, Vitamin B3, Vitamin H, Lemon oil and Rosemary oil; and (e) excipients.
Further, the excipients are selected from the group consisting of at least one vehicle, at least one denaturant, at least one co-solvent, at least one chelating agent, at least one pH modifier, at least one cooling agent, at least one fragrance, at least one solubilizer, at least one color protectant, at least one colorant and at least one preservative.
The above composition comprises: Pisum sativum (Pea) sprout extract in the range of 0.200 to 6.000%; a composition comprising Piper nigrum berries extract and Inga alba bark extract in the range of 0.05 to 5.00%; Grapeseed oil in the range of 0.0001 to 0.1%, Glycine in the range of 0.01 to 3.00%; Vitamin B5 in the range of 0.05 to 6.00%; Vitamin B3 in the range of 0.01 to 5.00%; Vitamin H in the range of 0.001 to 2.00%; Lemon oil in the range of 0.001 to 4.000%; Rosemary oil in the range of 0.001 to 2.000%; ethanol in the range of 2.5 to 30%, the denaturant in the range of 0.02 to 3%, the co-solvent in the range of 0.2 to 10%, the chelating agent in the range of 0.04 to 0.1%, the pH modifier in the range of 0 to 1.9%, the cooling agent in the range of 0 to 2%, the fragrance in the range of 0 to 2%, the solubilizer in the range of 0.13 to 20%, the colour protectant in the range of 0.04 to 0.4%, the colour in the range of 0 to 0.000300% and the preservative in the range of 0 to 1%.
BRIEF DESCRIPTION OF DRAWINGS
Figure 1. Effect of the hair fall control serum on the proliferation of dermal papilla cells (DPC).
Figure 2. Effect of the hair fall control serum on the proliferation of immortalized human keratinocyte (HaCaT) cell line.
Figure 3. Effect of the hair fall control serum on collagen synthesis in Human Foreskin Fibroblast, HFF-1 cell line.

DETAILED DESCRIPTION OF THE INVENTION
Discussed below are some representative embodiments of the present invention. The invention in its broader aspects is not limited to the specific details and representative methods. The illustrative examples are described in this section in connection with the embodiments and methods provided. The invention according to its various aspects is particularly pointed out and distinctly claimed in the attached claims read in view of this specification.
It is to be noted that, as used in the specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, a reference to a composition containing “a compound” includes a mixture of two or more compounds. It should also be noted that the term “or” is generally employed in its sense including “and/or” unless the content clearly dictates otherwise.
The expression of various quantities in terms of “%” or “% w/w” means the percentage by weight of the total solution or composition unless otherwise specified. Likewise the term “% v/v” means the percentage by volume of the total solution.
All cited references are incorporated herein by reference in their entireties. Citation of any reference is not an admission regarding any determination as to its availability as prior art to the claimed invention.
Hair loss is caused due to various factors such as hormonal disturbance, poor blood circulation, oxidative stress, microbial infections, and emotional and environmental stress. Currently, the problem has become acute due to the stresses of modern lifestyle and environmental pollution. However, treatments for addressing hair loss have not kept pace with the malady. Surgical methods of treating hair loss such as hair transplant are quite expensive whereas pharmaceutical supplements to combat this problem may have severe side-effects. Further, there is a dearth of affordable plant extract based treatment for preventing hair loss and maintaining its vitality.
Accordingly, the inventors of the present invention have formulated a novel hair fall control serum, comprising: Pisum sativum sprout extract; a composition comprising Piper nigrum berries extract and Inga alba bark extract; Grapeseed oil; at least one ingredient selected from the group consisting of Glycine, Vitamin B5, Vitamin B3, Vitamin H, Lemon oil, and Rosemary oil; and excipients.
Preferably, Pisum sativum (Pea) sprout extract is present in an amount in the range from 0.200 to 6.000%. Pisum sativum (Pea) sprout extract, which is based on organic pea sprouts (Pisum sativum) stimulates specific signal molecules in the dermal papilla required to reactivate hair growth. Due to its unique composition, Pisum Sativum (Pea) sprout extract offers a sustainable and novel approach to fight hair loss.
Another important constituent of the hair fall control serum is a composition comprising Piper nigrum berries extract and Inga alba bark extract. It is a natural complex made with extract of Piper nigrum berries (black pepper) titrated in piperine, extract of Inga alba barks, and sodium lauroyl lactylate. It has anti-inflammatory, soothing, cleansing and purifying properties, and helps in the treatment of skin damage. This product combination aids dandruff reduction, improves hair radiance and sensory properties, is suitable for all hair types, and is compatible with shampoo, conditioner and lotion formulas. Preferably, the hair fall serum comprises a composition comprising Piper nigrum berries extract and Inga alba bark extract in an amount in the range from 0.05 to 5.00%.
Yet another vital constituent of the hair fall control serum is Grapeseed oil. It is extracted from whole grape seeds (Vitis vinifera) and contains flavonoids, linoleic acid, Vitamin E and OPCs or oligomeric proanthocyanidins. The last two constituents are known to stop hair loss and promote hair regrowth. Preferably, Grepeseed oil is present in an amount in the range from 0.0001 to 0.1%.
Additionally, amino acids, vitamins and essential oils may be added to the hair fall control serum to improve nourishment of the hair and skin leading to healthier hair. Accordingly, the hair fall control serum may contain at least one ingredient selected from the group consisting of Glycine, Vitamin B5, Vitamin B3, Vitamin H, Lemon oil, and Rosemary oil. Preferably, the hair fall control serum contains glycine in an amount in the range from 0.01 to 3.00%, Vitamin B5 in an amount in the range from 0.05 to 6.00%, Vitamin B3 in an amount in the range from 0.01 to 5.00%; Vitamin H in an amount in the range from 0.001 to 2.00%; Lemon oil in an amount in the range from 0.001 to 4.000%; and Rosemary oil in an amount in the range from 0.001 to 2.00%.
The composition of the present invention further comprises excipients. The term “excipients” used herein refers to non active ingredients that are mixed with active components in the formulation of a composition. Further, the term “Active” used herein refers to an ingredient present in the formulation that is responsible for producing the desired physiological effect.
In the above hair fall control serum, the excipients are selected from the group consisting of at least one vehicle, at least one denaturant, at least one co-solvent, at least one chelating agent, at least one pH modifier, at least one cooling agent, at least one fragrance, at least one solubilizer, at least one colour protectant, at least one colourant and at least one preservative.
The term “vehicle” used herein refers to the medium through which the active ingredients are deposited onto the hair or skin. Examples of vehicles that can be used in the present invention include, but not limited to, water, ethanol and combinations thereof. Preferably, ethanol is present in an amount in the range from 2.5 to 30%.
The term “denaturant” as used herein refers to a chemical substance that has been added to ethanol to make it unfit for consumption. Examples of denaturants include, but not limited to, diethyl phthalate, isopropanol, methyl ethyl ketone, methyl isobutyl ketone, pyridine, benzene, naphtha and combinations thereof. Denaturants may be present in an amount in the range from 0.02 to 3.00%.
Preferably, the hair fall control serum contains a co-solvent such as propylene glycol in the range from 0.2 to 10%. It alters the permeability and the partition coefficient of the stratum corneum, thereby enabling a greater amount of the active ingredient to penetrate the skin.
A chelating agent is yet another crucial ingredient found in personal care compositions. They stabilize the composition by chelating trace metal ions, which in the free state catalyze undesired reactions leading to the decomposition of the active ingredients. Non-limiting examples of chelating agents used in the present composion include EDTA (Ethylenediaminetetraacetic acid) disodium salt, also called as Disodium EDTA IP, EDTA tetrasodium salt, trisodium citrate, sodium gluconate, ethylenediamine-N,N’-disuccinic acid, and so forth, each of which can be present either individually or in combination, in an amount in the range from 0.04 to 0.1%.
All personal care products have a preferential pH range in which performance is highest. The pH can be adjusted by the use of suitable substrates known as pH modifiers. Non-limiting examples of pH modifiers that can be used in the present invention include sodium hydroxide, lactic acid, citric acid, triethanolamine, and so forth, each of which can be used individually or in combination, in an amount in the range from 0 to 1.9%.
Preferably, the solubilizer is present in an amount in the range from 0.13 to 20%. A solubilizer is generally used to incorporate hydrophobic ingredients into a water based product. Examples of solubilizers include, but not limited to, Polyoxyethylene (20) sorbitan mono, PEG-40 Hydrogenated Castor oil, polysorbate 20, polysorbate 80, Caprol Micro Express, Cromollient SCE, caprylyl/capryl glucoside (octyl/decyl glucoside or C8-10 alkyl polyglucoside) and combinations thereof.
A preservative is generally added to a water based product, to prevent the proliferation of microorganisms such as fungi, bacteria and viruses. Preferably, the hair fall control serum contains the preservative in the range of 0 to 1%. Examples of the preservative include, but not limited to, sodium benzoate, methylparaben, propylparaben, butylparaben, benzyl alcohol, methylchloroisothiazolinone, methylisothiazolinone, phenoxyethanol, and combinations thereof.
Still further, the hair fall control serum of the present invention may include ingredients such as a cooling agent, for example menthol, in the range of 0 to 2%, a fragrance in the range of 0 to 2%, a colour proctectant in the range of 0.04 to 0.40%, and colour in the range of 0 to 0.000300%.
The present invention is more particularly described in the following non-limiting examples that are intended as illustrations only since numerous modifications and variations within the scope of the present invention will be apparent to a skilled artisan. Unless otherwise noted, all parts, percentages, and ratios reported in the following examples are on a weight basis, and all reagents used in the examples were obtained or made available from the chemical suppliers.
Examples 1 to 5.
Table 1. lists ingredients and their amounts present in the hair fall control serum of the present invention. The unit of each value is percent weight of the composition. Ingredients are combined and mixed by conventional means as known by one of ordinary skill in the art.

Table 1: Composition of Hair Fall Control Serum
No
Ingredients Function 1
2 3 4 5
1 Pisum sativum (Pea) sprout extract
Active 1.75
0.2 3 6 4
2 A composition comprising Piper nigrum berries extract and Inga alba bark extract
Active 0.1
5 3 1.7 0.05
3 Glycine Active 0.3
0.1 2.5 0.01 3
4 Vitamin B5
Active 0.5
0.05 1.5 6 2.8
5 Vitamin B3
Active 0.3
0.01 1 5 2.3
6 Vitamin H
Active 0.01
0.001 2 0.1 0.5
7 Lemon oil Active 0.01
3 0.1 0.001 0.008
8 Grapeseed oil Active 0.01
0.1 0.001 0.0003 0.007
9 Rosemary oil Active 0.01
0.1 2 0.001 0.005
10 Demineralized water Vehicle 74.58
69.09 38.58 77.69 46.1
11 Ethanol
17.8
7.6 20 2.5 30
12 Diethyl Phthalate Denaturant 0.18
0.05 0.2 0.02 0.5
13 Propylene Glycol Co-Solvent 2
0.5 5 0.2 8
14 EDTA disodium salt Chelating agent 0.1
0.05 0.08 0.1 0.1
15 Sodium hydroxide pH modifier 0.0145
0.00145 0.7 0.1 0.5
16 Lactic acid 0.1
0 1.58 0.1 0.17
17 Menthol Cooling Agent 0.1
0.12 2 0 0.01
18 Perfume Yellow Musk Fragrance 0.24
0.12 0 0 1
19 PEG-40 Hydrogenated Castor oil Solubilizer 1.2
10.51 13.29 0.1 0.52
20 Polyoxyethylene (20) sorbitan mono 0.3
3 3.32 0.03 0.13
21 Sodium Benzotriazolyl Butylphenol sulfonate & Buteth -3 & Tributyl Citrate Colour Protectant 0.2
0.2 0.1 0.1 0.2
22 Tris (Tetra methyl hydroxypiperidinol) Citrate water & ethanol 0.1
0.1 0.05 0.05 0.1
23 FD&C Yellow 5 CI 19140 Colour 0.000162
0 0.000177 0 0.000111
24 Blue 1 CI 42090
0.000094
0 0.000042 0 0.000047
25 Sodium Benzoate Preservative 0.1
0.1 0 0.2 0

Effect of the hair fall control serum (Example 1) on the proliferation of dermal papilla cells (DPC)
The dermal papilla cells consist of a cluster of specialized fibroblasts that play an important role in the morphogenesis and growth of hair follicles. The modulation of the balance of follicular proliferation and apoptosis in DPC may be a key strategy for the control of hair growth and regeneration. A big and healthy dermal papilla will produces more cells, and will lead to a production of thicker hair fiber by the hair follicle. Hence, the proliferative effect of the composition of the present invention was evaluated on human follicle dermal papilla cells (HFDPC). The HFDPC were incubated in a medium with composition of Example 1 at a concentration of 0.001 to 5%, and the increase in cell proliferation as compared to that of control was determined by MTT assay. The results are illustrated in figure 1. Cells incubated in a medium containing Minoxidil sulphate served as positive control whereas those incubated with 10% fetal bovine serum (FBS) served as control.
After 48 h of incubation, the proliferation of cells treated with both Minoxidil sulphate and the hair fall control serum of the present invention (Example 1) was compared to that of medium treated control ones and illustrated in figure 1. The cells treated with the composition of example 1 at concentrations ranging from 0.001 to 0.100% demonstrated a significant increase in proliferation by 30 to 88.70% as compared to control ones.
Effect of the hair fall control serum (Example 1) on the proliferation of immortalized human keratinocyte (HaCaT) cell line.
Epidermal cells act as a counterpart population to DPC to support and enhance scalp health and promote strengthening of hair. Hence, the proliferative effect of the composition of the present invention was evaluated on immortalized human keratinocyte (HaCaT) cell line. The HaCaT cells were incubated with a medium containing (Example 1) at concentrations of 0.001 to 10% and the increase in cell proliferation as compared to that for medium treated control cells was determined by MTT assay. The results are illustrated in figure 2. Cells incubated with 10% FBS (Fetal Bovine Serum) served as control, whereas those incubated in a medium containing EGF (Epidermal Growth Factor) served as positive control.
After 24 h of incubation, the proliferation of cells treated with both epidermal growth factor (EGF) and the hair fall control serum of the present invention (Example 1) was compared with that of medium treated control ones and illustrated in figure 2. The cells treated with the composition of example 1 at concentrations ranging from 0.001 to 0.100% (v/v) demonstrated a significant increase in proliferation by 29.9 to 41.30% as compared to control.
Effect of the hair fall control serum (Example 1) on collagen synthesis in Human Foreskin Fibroblast, HFF-1.
Renewal of extracellular matrix (ECM) proteins by stimulating skin remodelling increases size of hair follicles. The quality of ECM proteins in the dermal papilla is of prime importance for the cyclical growth of hair.
In order to evaluate the effect of the hair fall control serum on collagen synthesis, HFF-1 cells were incubated with the composition of Example 1. Cells incubated with 10% Fetal Bovine Serum (FBS) served as control, whereas those incubated with Ascorbic Acid served as positive control. After 72 h, collagen synthesis was assessed by Sirius red dye based colorimetric method. As shown in figure 3, cells treated with Example 1, at concentrations ranging from 0.0001 to 0.05% v/v, showed a significant increase in collagen synthesis of about 35 to 49% as compared to control ones.
The above findings suggest a hair growth promoting effect for the hair fall control serum of the present invention as reflected by an increase in proliferation of dermal papilla cells, epidermal keratinocytes and collagen synthesis.
While particular embodiments of the composition of the present invention have been illustrated and described, it would be obvious to those skilled in the art that various other changes and modifications can be made without departing from the spirit and scope of the invention. It is thereof intended to cover in the appended claims such changes and modifications that are within the scope of the invention.

CLAIMS:
We claim:
1. A hair fall control serum, comprising:
(a) Pisum sativum (Pea) sprout extract;
(b) a composition comprising Piper nigrum berries extract and Inga alba bark extract;
(c) grapeseed oil;
(d) at least one ingredient selected from the group consisting of Glycine, Vitamin B5, Vitamin B3, Vitamin H, Lemon oil, and Rosemary oil; and
(e) excipients.
2. The hair fall control serum, as claimed in claim 1, wherein:
(a) Pisum sativum (Pea) sprout extract is present in an amount in the range from 0.2 to 6.0%;
(b) a composition comprising Piper nigrum berries extract and Inga alba bark extract is present in an amount in the range from 0.05 to 5.00%; and
(c) Grapeseed oil is present in an amount in the range from 0.0001 to 0.1000%.
3. The hair fall serum, as claimed in claims 1 and 2, wherein:
(a) Glycine is present in an amount in the range from 0.01 to 3.00%;
(b) Vitamin B5 is present in an amount in the range from 0.05 to 6.00%;
(c) Vitamin B3 is present in an amount in the range from 0.01 to 5.00%;
(d) Vitamin H is present in an amount in the range from 0.001 to 2.00%;
(e) Lemon oil is present in an amount in the range from 0.001 to 4.000%; and
(f) Rosemary oil is present in an amount in the range from 0.001 to 2.000%.
4. The hair fall control serum, as claimed in claims 1 to 3, wherein the excipients are selected from the group consisting of at least one vehicle, at least one denaturant, at least one co-solvent, at least one chelating agent, at least one pH modifier, at least one cooling agent, at least one fragrance, at least one solubilizer, at least one colour protectant, at least one colourant and at least one preservative.
5. The hair fall control serum as claimed in claim 4, wherein the vehicle is selected from the group consisting of de-mineralized water, ethanol and combinations thereof.
6. The hair fall control serum as claimed in claim 4, wherein the denaturant is selected from the group consisting of diethyl phthalate, isopropanol, methyl ethyl ketone, methyl isobutyl ketone, pyridine, benzene, naphtha and combinations thereof and present in an amount in the range from 0.02 to 3.00%.
7. The hair fall control serum as claimed in claim 4, wherein the co-solvent is propylene glycol and present in an amount in the range from 0.2 to 10.0%.
8. The hair fall control serum as claimed in claim 4, wherein the chelating agent is selected from the group consisting of EDTA disodium salt, EDTA tetrasodium, trisodium citrate, sodium gluconate, ethylenediamine-N,N’-disuccinic acid and combinations thereof and present in an amount in the range from 0.04 to 0.1%.
9. The hair fall control serum as claimed in claim 4, wherein the pH modifier is selected from the group consisting of sodium hydroxide, lactic acid, citric acid, triethanolamine and combinations thereof and present in an amount in the range from 0 to 1.9%.
10. The hair fall control serum as claimed in claim 4, wherein the solubilizer is selected from the group consisting of Polyoxyethylene (20) sorbitan mono, PEG-40 Hydrogenated Castor oil, polysorbate 20, polysorbate 80, Caprol Micro Express, Cromollient SCE, caprylyl/capryl glucoside (octyl/decyl glucoside or C8-10 alkyl polyglucoside) and combinations thereof and present in an amount in the range from 0.13 to 20%.
11. The hair fall control serum as claimed in claim 4, wherein the preservative is selected from the group consisting of sodium benzoate, methylparaben, propylparaben, butylparaben, benzyl alcohol, methylchloroisothiazolinone, methylisothiazolinone, phenoxyethanol, and combinations thereof and present in an amount in the range from 0 to 1%.