DESC:TECHNICAL FIELD OF THE INVENTION
The present invention relates to an improved hair care shampoo composition which provides enhanced hair conditioning performance, anchorage, stimulation of hair growth, control of hair fall. The composition of present invention comprises Procapil, redensyl, one or more amino acid based conditioning agents, (iii) one or more foaming agents which is useful in the treatment of hair loss and improves hair anchorage. The compositions of the present invention are free of sulphate and parabens. The present invention also discloses the methods of preparing such compositions.
BACKGROUND OF THE INVENTION
Hair loss/hair fall has become a ubiquitous affliction of human beings (both male and female gender) with the growing impact of global pollution and lifestyle changes. Most common reasons for radial or premature hair loss/hair fall are genetic predisposition, endocrine disorders, medication, radiation, chemotherapy, exposure to chemicals, nutritional factors, generalized or local skin diseases, stress, child birth, Alopecia areata and mechanical damage such as Trichotillomania, hair styling treatment, hair braids and weaves. Human hair also becomes soiled due to its contact with the surrounding atmosphere and, to a greater extent, from sebum secreted by the head. The build-up of the sebum causes the hair to have a dirty feel and an unattractive appearance. The soiling of the hair necessitates it being shampooed with frequent regularity.
Shampooing hair to remove dirt, excess oil and sebum is well known and has been used since long. When washing the hair with conventional shampoo compositions, the natural oils are removed together with the dirt and unwanted oils. When too much of the natural oil is removed, for example by frequent washing, the hair becomes less easy to comb or style and are left entangled or unmanageable which can further weaken and damage them. A variety of approaches have been introduced to alleviate the after-shampoo problems. It involves application of hair conditioners after shampooing. Such conditioners are applied in a separate step, after shampoo has been rinsed out; conditioners are allowed to remain on hair for a short time and rinsed. This process is time consuming and inconvenient. Further it has a disadvantage of disposition of the polymeric film onto the hair.
The effects of products which are sold as hair growth stimulating-agents or hair loss preventing-agents on hair include growth period inducing effects, hair growth period extending effects, 5a-reductase inhibitory effects, blood circulation promoting effects, antiseptic effects, anti-dandruff effects, moisturizing effects, antioxidant effects, etc., but the effects of preventing hair loss and stimulating hair growth of conventional agents are not sufficient. Currently, the most commonly used drugs for the treatment of hair loss include a topical formulation comprising 2,4-diamino-6-Piperidinopyrimidin-3-oxide (also known as “Minoxidil” formulation, see U.S. Pat. Nos. 4,139,619 and 4,596,812), which has been approved by the FDA, and an oral formulation comprising finasteride, which is a specific inhibitor of type II 5a-reductase. Hair restorers comprising minoxidil should be applied several times daily to maintain the hair growth effect, which is very cumbersome and easy to forget. Therefore, in many cases, the hair growth effect is not sufficiently obtained due to irregular application and arbitrary discontinuation of treatment.
Finasteride is a drug that inhibits the 5a-reductase which converts testosterone, one of the male hormones, into dihydrotestosterone (DHT) that causes hair loss. The administration of the drug inhibits the production of dihydrotestosterone, and thus the finasteride allows fine hair in bald areas to grow thick and long. As a result of clinical trials conducted on 1,879 men at the time of development, only 17% of the participants who were treated constantly for two years showed no hair loss, and 83% of the participants maintained or increased the number of hairs after the treatment. However, it takes several months to obtain the effect of preventing hair loss. Moreover, in case of females, there is a high risk of congenital deformity in fetus, and in the case of males, there are fears of side effects such as hypo sexuality, impotence, ejaculation disorder, etc. Further, the pressure to take up the drug during life so as to maintain the effect preventing hair loss causes significant restrictions in actual clinical use.
Procapil is a combination of three complimentary active substances namely, Apigenin, Oleanolic Acid and Biotinyl Tripeptide-1 and is marketed by Sederma. Apigenin is known to be an effective vasodilator. It dilates the blood vessels in the dermis which allows for a greater flow of blood to the hair follicles, promoting healthy hair growth. Oleanolic acid has a strong inhibitory action on the enzyme, 5 Alpha reductase, and thus constitutes an important component for the treatment of hair loss. It inhibits the transformation of testosterone into dihydrotestosterone. Biotinyl-GHK has protective and reparative effects on the constituents of the root sheath and dermal papilla; collagen IV and laminin 5. It has been found to enhance structuring by increasing concentrations of adhesion proteins responsible for anchorage of the hair in the dermis, to enhance maintenance of a viable root sheath, and to have anti-aging activity on hair follicle keratinocytes.
Redensyl® is composed of DHQG and EGCG2: two stabilized polyphenols targeting the ORS (Outer Root Sheath stem cells) bulge stem cells and the fibroblasts located in the dermal papilla (Human Follicular Dermal Papilla cells (also called HFDPc). Glycine and zinc are involved in hair metabolism. Glycine is a major constituent of specific hair proteins called keratin associated proteins. Zinc is essential for cystin incorporation into keratin. Redensyl® is composed of Dihydroquercetin-glucoside, Epigallocatechin gallate-glucoside, Glycine, Zinc chloride, Meta-bisulfite, Glycerin, Water
WO 00/58347 discloses production of tripeptide N-biotinyl-gly-his-lys or N- Biotinyl- GHK by grafting a biotin molecule on the N-terminal part of the tripeptide Gly-His-Lys, its use thereof in cosmetic or dermopharmaceutical compositions.
Most commonly used commercially available conditioning shampoos which are prescribed with anti-hair fall medications also contain harmful ingredients like sulphates and parabens which lead to further complications. Lauryl Sulphates (e.g. ammonium lauryl sulphate, sodium laury sulphate (SLS)) are most commonly used surfactant in marketed shampoo compositions. These surfactants have good detergency & foaming properties however they tend to make hair rough & scalp dry. The residual remains of these surfactants cause hair damages & scalp related problems. It strips hair off its moisture and other essential oils. It also damages hair follicles and results in hair loss. It is extremely dangerous to hair follicles that are exposed. Sulfates not only damage hair strands, but also damage the hair follicles themselves which can lead to hair loss and serious breakage. SLS is also harmful to color treated hair as it tends to fade the color with every wash. SLS exerts its damage by stripping skin of protective oils and moisture. Sulphate free compositions reduce irritation/ inflammation in the scalp, retains hair moisture, color and natural oil.
Parabens are cost-effective and provide protection against micro-organisms for an extended period of time. While there are multiple types of parabens; methyl, propyl and butylparaben are the most frequently used in beauty products. In recent years, concern has increased as to their role in producing potentially serious health side effects. For example, accelerate skin ageing process, interfere with male reproductive system and endocrine system, play a role in development of breast cancer etc.
Currently there is still unmet need for the hair fall control compositions with good hair conditioning and anchorage and which is sulphate and paraben free. Thus, the inventors of the present invention have developed the topical hair care shampoo composition of anti-hair fall agents which are having very minimal or no side effects and also provides good hair conditioning and strong anchorage to the scalp. Further the composition is sulphate and paraben free.
OBJECT OF THE INVENTION
The present invention relates to an anti-hair fall shampoo composition which is sulphate and paraben free and its process for preparation.
In one aspect, the present invention relates to a shampoo composition comprising:
(i) one or more anti-hair fall agents,
(ii) one or more amino acid based conditioning agents,
(iii) one or more foaming agents,
(iv) one or more pharmaceutically acceptable excipients; and
wherein the composition is sulphate and paraben free.
In another aspect, the present invention relates to a shampoo composition comprising:
(i) one or more anti-hair fall agents,
(ii) one or more amino acid based conditioning agents,
(iii) one or more foaming agents,
(iv) one or more foam boosters,
(v) one or more thickening agents; and
(vi) one or more pharmaceutically acceptable excipients
wherein the composition is sulphate and paraben free.
In another aspect, the present invention relates to a shampoo composition comprising:
(i) one or more anti-hair fall agents, selected from the group consisting of Procapil and Redensyl,
(ii) one or more amino acid based conditioning agents,
(iii) one or more foaming agents
(iv) one or more foam boosters,
(v) one or more thickening agents; and
(vi) one or more pharmaceutically acceptable excipients
wherein the composition is sulphate and paraben free.
In another aspect the present relates to a conditioning shampoo which further comprises chelating agents, paraben-free preservatives and fragrance.
In yet another aspect, the conditioning shampoo composition of the present invention may be prepared by;
(i) preparation of aqueous phase and surfactant phase,
(ii) addition of aqueous phase into the surfactant phase with continuous stirring; and
(iii) addition of conditioning agents, paraben-free preservative and fragrance to the prepared mixture.

In an another aspect the composition of the present invention is used as a hair fall control agent with good conditioning effect and increases anchorage of the hair to the scalp and promotes hair growth.
DESCRIPTION OF INVENTION
The present invention relates to an anti-hair fall shampoo composition which is sulphate and paraben free and its process for preparation.
In one aspect, the present invention relates to a shampoo composition comprising:
(i) one or more anti-hair fall agents,
(ii) one or more amino acid based conditioning agents,
(iii) one or more foaming agents,
(iv) one or more pharmaceutically acceptable excipients; and
wherein the composition is sulphate and paraben free.
In another aspect, the present invention relates to a shampoo composition comprising:
(i) one or more anti-hair fall agents,
(ii) one or more amino acid based conditioning agents,
(iii) one or more foaming agents
(iv) one or more foam boosters,
(v) one or more thickening agents; and
(vi) one or more pharmaceutically acceptable excipients
wherein the composition is sulphate and paraben free.
In another aspect, the present invention relates to a conditioning shampoo composition comprising:
(i) one or more anti-hair fall agents, selected from the group consisting of Procapil and Redensyl,
(ii) one or more amino acid based conditioning agents,
(iii) one or more foaming agents
(iv) one or more foam boosters,
(v) one or more thickening agents; and
(vi) one or more pharmaceutically acceptable excipients
wherein the composition is sulphate and paraben free.
In another aspect, the present invention relates to a shampoo composition comprising:
(i) one or more anti-hair fall agents, selected from the group consisting of Procapil Redensyl,
(ii) one or more conditioning agents,
(iii) one or more foaming agents
(iv) one or more foam boosters,
(v) one or more thickening agents; and
(vi) one or more pharmaceutically acceptable excipients
wherein the composition is sulphate and paraben free.
Wherein, the procapil and redensyl each individually are in the range of about 1% w/w to about 5% w/w of total composition

In an another aspect, the present invention relates to a shampoo composition comprising:
(i) about 1%w/w to about 5% w/w of Procapil
(ii) about 1%w/w to about 5% w/w of Redensyl
(ii) about 5% w/w to about 15% w/w of one or more agents,
(iii) about 35%w/w to about 60%w/w of one or more foaming agents
(iv) about 10%w/w to about 20%w/w of one or more foam boosters,
(v) about 1%w/w to about 10%w/w of one or more thickening agents; and
(vi) one or more pharmaceutically acceptable excipients
wherein the composition is sulphate and paraben free.
As used herein, the term “sulphate free” refers to a composition containing less than 5% sulphate, or less than 4% sulphate, or less than 3% sulphate, or less than 2% sulphate or less than 1% sulphate or completely free of sulphate.
In one aspect of the present invention, the composition is free of sulphate, preferably containing less than 5% of sulphate, more preferably containing less than 4% of sulphate, more preferably containing less than 2% of sulphate, more preferably containing less than 4% of sulphate, or more preferably containing less than 1% of sulphate or completely free of sulphate.
As used herein, the term “paraben free” refers to a composition containing less than 5% paraben, or less than 4% paraben, or less than 3% paraben, or less than 2% paraben or less than 1% paraben or completely free of paraben.
In one aspect of the present invention, the composition is free of paraben, preferably containing less than 5% of paraben, more preferably containing less than 4% of paraben, more preferably containing less than 2% of paraben, more preferably containing less than 4% of paraben, or more preferably containing less than 1% of paraben or completely free of paraben.
In another aspect the present invention relates to a conditioning shampoo which further comprises chelating agents, paraben-free preservatives and fragrance.
The term "about" includes all values having substantially the same effect, or providing substantially the same result, as the reference value. Thus, the range encompassed by the term "about" will vary depending on context in which the term is used, for instance the parameter that the reference value is associated with. Thus, depending on context, "about" can mean, for example, ±15%, ±10%, ±5%, ±4%, ±3%,
In yet another aspect, the shampoo composition of the present invention may be prepared by;
(i) preparation of aqueous phase and surfactant phase,
(ii) addition of aqueous phase into the surfactant phase with continuous stirring; and
(iii) addition of conditioning agents, paraben-free preservative and fragrance to the prepared mixture.

In an another aspect the composition of the present invention is used as a hair fall control agent with good conditioning effect and increases anchorage of the hair to the scalp and promotes hair growth.
The terms comprise, consist of, or consist essentially of the essential elements and limitations of the invention described herein, as well any of the additional or optional ingredients, components, or limitations described herein. The term "comprising" (and its grammatical variations) is “open ended” and used in the inclusive sense of "having" or "including" and not in the exclusive sense of "consisting only of “. The terms "a" and "the" as used herein are understood to encompass the plural as well as the singular.
All percentages, parts and ratios are based upon the total weight of the composition of the present invention, unless otherwise specified. All such weights as they pertain to the listed ingredients are based on the active level and, therefore, do not include carriers or byproducts that may be included in commercially available materials, unless otherwise specified.
The topical compositions useful in this invention contain formulations suitable for topical application to skin and scalp. The term "topical" as employed herein relates to the use of a composition along with a suitable pharmaceutical carrier, and applied according to the method of the present invention at the site of hair loss, reduced hair growth or baldness for exertion of local action. Accordingly, such topical compositions useful in the methods of the present invention include those pharmaceutical forms in which the compound is applied externally by direct contact with the skin surface to be treated.
As used herein, the term anti-hair fall agents or anti fall control agents can be used interchangeably. As used herein, the term “anti-hair fall agent” refers to a compound which prevents hair loss and provides better anchorage to the scalp. One or more anti- hair fall agent can be incorporated in the shampoo composition of the present invention selected from but not limited to, Procapil (mixture of apigenin, oleanolic acid and biotinyl-GHK), natural extracts (like bamboo extract, avocado extract), Redensyl, biotin, minoxidil, ginseng, trichozole, amla, brahmi and mixtures thereof. These agents are presnt in the amount of from about 0.1% w/w to about 5% w/w.
The anti-hair fall agents as used herein refers to redesnyl, procapil or combination thereof. Redensyl™ is made of molecules targeting the ORS (Outer Root Sheath stem cells) bulge stem cells located in the bulge along the hair, are less productive, and less adapted to improve the quality of the matrix (made of keratinocytes) supporting the hair follicle growth and fibroblasts located in the dermal papilla (also called HFDPc) are less efficient in communicating with the stem cells, meaning that the matrix will not be renewed as it used to. Initiating the anagen phase becomes more sluggish, and hair loss becomes a part of daily life.
Procapil which is combination of a vitaminated matrikine with apigenin and oleanolic acid from olive tree promotes hair anchorage by hammering on below three causes of hair loss:
(i) The androgenic cause via the inhibition of 5a-reductase, the enzyme responsible for conversion of testosterone into DHT.
(ii) The circulatory system cause, promoting micro-circulation at the scalp level which is essential for optimal hair regrowth.
(iii) The mechanical cause, reinforcing the anchoring of hair in the sheath of skin.
In an embodiment procapil is present in amount of about 5% w/w, preferably about 4% w/w, about 3% w/w, about 2% w/w, about 1% w/w. More preferably in an amount of about 2%w/w, about 1% w/w.
In an embodiment Redensyl is present in amount of about 5% w/w, preferably about 4% w/w, about 3% w/w, about 2% w/w, about 1% w/w. More preferably in an amount of about 2%w/w, about 1% w/w.
As used herein, the term “conditioning agent” refers to an agent that improves the feel, texture and appearance of hair. At the time of shampooing nutrients from scalp and hair are also removed along with dirt and grime. Conditioning agents provide nourishment to the hair. It is therefore, imperative that the lost nourishment is replenished immediately. Conditioning agents also moisturizes hair and make them soft and silky. They prevent hair from drying off after shampoo application. Conditioning agents further makes hair smooth and strong, so whenever a comb passes through it, it comes out and gives the look we desire without breaking a single hair. Conditioning hair means protecting it against breakage and also the climatic and environmental factors like excessive sunlight, wind, etc.
The present invention may contain one or more conditioning agents selected from, but are not limited to glycolic acid and glycolate salts (e.g. ammonium and quaternary alkyl ammonium); salicylic acid; lactic acid and lactate salts (e.g., ammonium and quaternary alkyl ammonium); aloe vera (e.g., aloe vera gel or in any of its variety of forms); starches; sugar and starch derivatives (e.g., alkoxylated glucose, fructose, glucosamine); amino acids (e.g sodium pyrrolidone carboxylic acid (AJIDEW® NL-50); disodium Ncocoyl glutamate (AMISOFT), hydrolyzed pea protein (Promois WJ), aspartame glycerol monolaurate, sodium dimyristaminocystine, sodium cocoyl glycinate, potassium cocoyl glycinate, TEA-cocoyl alaninate, sodium stearoyl glutamate, sodium palmoyl glutamate, arginine cocoate, cocoyl glutamic acid); silicones (e.g. dimethicone, Cetyl Dimethicone, Cetearyl Methicone) & cocamidopropyl betaine C12-15 & guar hydroxypropyltrimonium chloride; polyquaternium 10; panthenol; lanolin (e.g. ethoxylated lanolin), egg yolk, polypeptides, mineral oil, vinylpyrolidone, polyethyleneimine, polyaminoamide, PEG silicone.
The conditioning agents which may be used in present invention include but not limited to sodium pyrrolidone carboxylic acid, disodium N-cocoyl glutamate, hydrolyzed pea protein, polyquaternium 10 and dimethicone & cocamidopropyl betaine C12-15 & guar hydroxypropyltrimonium chloride. Sodium pyrrolidone carboxylic acid is a natural humectant derived from L-Glutamic acid which helps keep skin and hair fresh-looking. It may be used in a concentration of 1 to 5% w/v. Disodium N-cocoyl glutamate is an amino acid based surfactant which has excellent conditioning effect and may be used in a concentration of 1 to 6.5% w/v; hydrolyzed pea protein restores hair moisture and revitalizes hair strength that was lost by damages. It may also be used in a concentration range of 1 to 5% w/v. Polyquaternium 10 and dimethicone & cocamidopropyl betaine C12-15 & guar hydroxypropyltrimonium chloride may be used in a concentration of from about 0.05 to about 2.0% w/v and about 1 to 5% w/v respectively.
In an embodiment the total amount of one or more conditioning agents are used in amount of about 5% w/w to about 15% w/w, more preferably in an amount of about 9%w/w, about 11%w/w, about 12%w/w, about 13%w/w, about 14%w/w and about 15%w/w. The conditioning agents can be used as a mixture.
Various other materials may also be present in the compositions useful in the subject invention. These include any manner of humectants, proteins and polypeptides, an alkaline agent and mixtures thereof. The compositions of the present invention may also comprise one or more of various additives and excipients including plant extracts, oily ingredients, surfactants, alcohols, fatty acids, preservatives, antioxidants, colorants, fragrances, UV absorbers, viscosity modifiers, chelating agents (e.g., EDTA), pH-adjusting agents, and vitamins. In addition, the topical compositions useful herein can contain conventional cosmetic adjuvants, such as dyes, sunscreen (e.g., titanium dioxide), pigments, and fragrances.
As used herein, the term “foaming agents” refers to a substance that facilitates formation of foam. The foaming agents may be selected from disodium laureth sulfosuccinate, sodium lauoryl sarcosinate, sodium alpha olefin sarcosinate, alkyl benzene polyoxyethyl sulphonates, fatty acid alkanolamides, fatty amine oxides, alkylpolyglucoside, cocoamphocarboxyglycinate, cocoamphoacetate, cocoamphocarboxy-glycinate, disodium oleamido MEA sulfosuccinate and mixtures thereof. The total amount of foaming agents is present in an amount of about 35%w/w to about 60%w/w. More preferably the total amount of foaming agents may be used in the range of about 40%w/w to about 55%w/w of the total formulation.
As used herein, the term “thickening agents” refers to a substance that increases the viscosity of the composition. Suitable thickeners include Carboxylic Acid Polymers like carbomers (e.g Carbopol.RTM. 954), natural gums (e.g. guar, xanthum), cellulose derivatives (e.g. carboxy methylcellulose, methyl cellulose), PEG 6,000, PEG 120, cocomonoethanolamide, PEG-150-Distearate, sodium chloride, ammonium chloride, polyvinyl alcohol and mixtures thereof. The total amount of thickening agents are present in an amount of about 1%w/w to about 10%w/w of the total formulation.
As used herein, the term “foam boosters” refers to a substance that increases the amount of foam and the size of the bubbles. Various useful foam boosters include but are not limited to Polysorbate 60, Cocoamidopropyl Betaine 37%, coconut diethanolamide, lauric diethanolamide. The foam boosters are present in an amount of about 10%w/w to about 20%w/w of the total formulation.
As used herein, the term “pearlizing agents” refers to a substance that imparts rich pearlescent appearance to the composition. Suitable pearlizing agents include but not limited to behenic acid, ethylene glycol monostearate, ethylene glycol distearate, calcium stearate, 1,2-propylene glycol distearate, 1,2-1,3- and 1,4-butylene glycol distearate. The pearlizing agents are present in an amount of about 2%w/w to about 10%w/w of the total formulation.
As used herein, the term “humectant” refers to an agent which retains moisture in the product. Various humectants that can be used are but not limited to glycerine, propylene glycol, polyethylene glycol, sorbitol solution, 1,2,6 Hexanetriol, butylene glycol, urea, alphahydroxy acids (AHA’s), erythritol, trehalose, diglycerin, xylitol, maltitol, maltose, glucose, fructose, sodium chondroitin sultate, sodium hyaluronate, sodium adenosine phosphate, sodium lactate, pyrrolidone carbonate, glucosamine, cyclodextrin. The humectants are present in an amount of about 1%w/w to about 15%w/w of the total formulation.
In yet another embodiment the shampoo composition of the present invention is prescribed or used as a kit with minoxidil foam or solution (e.g. Rogaine®, TUGAINTM, MINTOPTM).
The present invention may contain one or more anti-dandruff agents which provide added advantage to the conditioning shampoo composition. The anti-dandruff agents can be selected from but are not limited to zinc pyrithione (ZnPTO), ketoconazole, salicylic acid, climbazole, terbinafine, octopirox, piroctone olamine, selenium sulfide and mixtures thereof.
The shampoo composition of the present specification may further comprise one or more additional ingredients, which provide added benefits to the object of the composition. Such additional ingredients may include one or more substances such as, without limitations, cleaning agents, skin conditioning agents, hair styling agents, hair growth promoters, sunscreen and/or sunblock compounds for hair and/or skin, moisturizers/humectants, film formers, emulsifiers, emollients, fragrance, paraben-free preservatives like methylisothiazolinone & phenoxyethanol, formaldehyde, sorbic acid, imidazolidinyl urea etc, chelating agents like disodium EDTA, sodium polyphosphonates etc. and dermatologically acceptable carriers.
The shampoo composition of the present invention can be prepared by various formulation and mixing techniques or methods known in the art for preparing conditioning shampoo compositions. For example; mixture of foaming agents, foam boosters, thickeners and pearlizing agents is heated to 70-75?C to form the surfactant phase. Aqueous phase is prepared by mixing humectant, chelating agent, conditioning agent and purified water. Aqueous phase is added to the surfactant phase with continuous stirring followed by addition of conditioning agents, preservative and fragrance.
The efficacy of the composition of the present invention is measured in terms of sensorial attributes (detangling, combability, static, shine, softness, smoothness and bounce) and Tensile strength using Tesile tester. All the parameters were evaluated at 2 time points - Baseline and post 10 wash cycles. This method is developed for hair care applications and for the evaluation of efficacy of shampoos and conditioners. After 10 washes there was a significant improvement in sensorial parameters like detangling, combability, static (reduction), shine, softness, smoothness and bounce when compared to baseline or initial damaged state and also a significant improvement in Tensile strength and Percentage Elongation when compared to baseline or initial damaged state was observed.
The following examples will further describe certain specific aspects and embodiments of the invention in greater details and are not intended to limit the scope of invention.
EXAMPLES
Example 1:
Ingredients Ex 1a
%w/w Ex 1b
%w/w Ex 1c
%w/w
Disodium Laureth Sulfosuccinate 20 25 30
Sodium Lauoryl Sarcosinate 10 20 15
Cocoamidopropyl Betaine 20 10 17
Dimethicone, 5 4.5 2.5
Polyethylene Glycol 3.5 3 2
Disodium Cocoyl Glutamate 3 2 2
Ethylene Glycol Monostearate 1 2 3
Procapil 2 1 1.5
Redensyl 1 1 2
Sodium Pyrrolidone carboxylic
Acid 0.8 1 0.1
Pea Protein 1.5 1 0.1
Cocomonoethanolamide 1.25 1 1.5
Phenoxyethanol-
Ethylhexylglycerin 0.3 1 0.9
Polyquaternium 10 1 0.4 0.2
EDTA 0.05 0.1 0.1
Fragnance 0.1 0.1 0.1
Purified water QS QS QS

Process:
1. Surfactant Phase: Disodium Laureth Sulfosuccinate, Sodium Lauoryl Sarcosinate, Cocoamidopropyl Betaine, Ethylene Glycol Monstearate, Cocomonoethanolamide were mixed together with stirring and heating to form solution 1
2. Aqueous phase: Purified water, Disodium edeate and polyquaternium were mixed together and heated with heating to form a solution 2
3. Pea protein, Disodium N-Cocoyl Glutamate, sodium PCA, Dimethicone, and hydroxypropyltrimonium chloride were mixed to form solution 3
4. Solution 2 was added to Solution 1 with stirring and Solution 3 was added to mixture of solution 1 and 2 with continuous stirring and cooling
5. Finally, Procapil and Redensyl were added to the step 4 to form final formulation.

Example 2:
In-Vitro Evaluation of in-vitro Hair Sensory attributes and Tensile Strength on Damaged Hair Tresses after 10 washes:
The composition of the present invention was evaluated for in-vitro Hair Sensory attributes and Tensile Strength on Damaged Hair Tresses after 10 washes. The sensory parameters which were evaluated are detangling, combability, static, shine, softness, smoothness and bounce and these parameters were evaluated by six experts by. Table 1 to 6 represents the summary of results for the tested parameters.

Table 1: Sensory Analysis of Detangling
Time Points Mean Score of Detangling (Mean± SD)
Baseline 0.67+0.516
Post 10 wash cycles 3.33+0.516
Note: Increase in the scores indicates improvement in hair detangling
Conclusion: After 10 wash cycles with the compositions of the present invention, mean score for detangling showed a significant increase from baseline, indicating significant improvement in detangling.

Table 2: Sensory Analysis of Combability
Time Points Mean Score of Combability (Mean± SD)
Baseline 0.67+0.516
Post 10 wash cycles 4.00+0.516
Note: Increase in the scores indicates improvement in combability
Conclusion: After 10 wash cycles with the compositions of the present invention, mean score for combability showed a significant increase from baseline, indicating significant improvement in combability.

Table 3: Sensory Analysis of Static (Frizz)
Time Points Mean Score of Static (Frizz) (Mean± SD)
Baseline 1.50+0.548
Post 10 wash cycles 3.67+0.516
Note: (Increase in the scores indicates reduction in static – Frizz
Conclusion: After 10 wash cycles with the compositions of the present invention, the mean score of static (frizz) showed a significant increase from baseline indicating significant reduction in static (frizz).

Table 4: Sensory Analysis of Shine
Points Mean Score of Shine
(Mean± SD)
Baseline 1.33+0.516
Post 10 wash cycles 3.00+0.000
Note: Increase in the scores indicates improvement in combability
Conclusion: After 10 wash cycles with the compositions of the present invention, the mean score of shine showed a significant increase from baseline indicating significant increase in shine.

Table 5: Sensory Analysis of Softness
Time Points Mean Score of Softness
(Mean± SD)
Baseline 1.33+0.516
Post 10 wash cycles 3.00+0.632
Note: Increase in the scores indicates improvement in combability
Conclusion: After 10 wash cycles with the compositions of the present invention, the mean score of softness showed a significant increase from baseline indicating significant improvement in softness.

Table 6: Sensory Analysis of Smoothness
Time Points Mean Score of Smoothness (Mean± SD)
Baseline 1.50+0.548
Post 10 wash cycles 3.33+0.516
Note: Increase in the scores indicates improvement in combability
Conclusion: After 10 wash cycles with the compositions of the present invention, the mean score of smoothness showed a significant increase when compared to baseline indicating significant improvement in smoothness.

Table 7: Sensory Analysis of Bounce
Time Points Mean Score of Bounce
(Mean± SD)
Baseline 1.67+0.516
Post 10 wash cycles 3.33+0.516
Note: Increase in the scores indicates improvement in combability
Conclusion: After 10 wash cycles with the compositions of the present invention, the mean score of bounce showed a significant increase from baseline indicating significant improvement in hair bounce.

Table 8: Changes in Maximum Tensile Strength (GF) after treatment
Time Points Mean Score of Max GF
(Mean± SD)
Baseline 70.32+21.077
After Treatment 99.17+0.516
Note: Increase in the scores indicates improvement in Tensile Strength
Conclusion: After 10 wash cycles with the compositions of the present invention, there was a significant increase in the mean score of maximum GF after treatment as compared to baseline indicating improvement in Tensile strength from initial state.
,CLAIMS:We Claim:
1. A shampoo composition comprising:
(i) one or more anti-hair fall agents,
(ii) one or more amino acid based conditioning agents,
(iii) one or more foaming agents,
(iv) one or more pharmaceutically acceptable excipients; and
wherein the composition is sulphate and paraben free.

2. The Shampoo composition of claim 1, comprising:
(i) one or more anti-hair fall agents, selected from the group consisting of Procapil and
Redensyl or combination thereof,
(ii) one or more conditioning agents,
(iii) one or more foaming agents,
(iv) one or more foam boosters,
(v) one or more thickening agents; and
(vi) one or more pharmaceutically acceptable excipients
wherein the composition is sulphate and paraben free.

3. The shampoo composition as claimed in claim 1, wherein the amount of procapil is in the range of about 1% w/w to 5% w/w of total composition.
4. The shampoo composition as claimed in claim 1, wherein the amount of Redensyl is in the range of about 1% w/w to 5% w/w of total composition.
5. A method of preparing the shampoo composition as claimed in claim 1, wherein the method comprises:
(i) preparation of aqueous phase and surfactant phase,
(ii) addition of aqueous phase into the surfactant phase with continuous stirring; and
(iii) addition of conditioning agents, paraben-free preservative and fragrance to the prepared
mixture.

6. The use of composition as claimed in claim 1, as a hair fall control agent with good conditioning effect and increases anchorage of the hair to the scalp and promotes hair growth.
7. The shampoo composition as claimed in claim 1, wherein the amino acid based conditioning agents are selected from one or more of sodium pyrrolidone carboxylic acid, disodium N-cocoyl glutamate, hydrolyzed pea protein, aspartame glycerol monolaurate, sodium dimyristaminocystine, sodium cocoyl glycinate, potassium cocoyl glycinate, triethanolamine cocoyl alaninate, sodium stearoyl glutamate, sodium palmoyl glutamate, arginine cocoate, cocoyl glutamic acid and mixtures thereof.
8. The shampoo composition, as claimed in claim 1, further comprising one or more of conditioning agents selected from panthenol, dimethicone, cetyl dimethicone, lanolin, polyethyleneimine, polyquaternium 10, dimethicone and cocamidopropyl betaine and laureth and guar hydroxypropyltrimonium chloride and mixtures thereof and are present in an amount of about 5% w/w to about 15% w/w of the total composition.
9. The shampoo composition, as claimed in claim 1, wherein the foaming agents are selected from one or more of disodium laureth sulfosuccinate, sodium lauoryl sarcosinate, sodium alpha olefin sarcosinate, alkyl benzene polyoxyethyl sulphonates, fatty acid alkanolamides, fatty amine oxides, alkylpolyglucoside, cocoamphocarboxyglycinate, cocoamphoacetate, cocoamphocarboxy-glycinate, disodium oleamido monoethanolamine sulfosuccinate and mixtures thereof and are present in an amount of about 35%w/w to about 60%w/w of the total composition.
10. The shampoo composition, as claimed in claim 1, wherein the composition further comprises anti-hair fall agents selected from bamboo extract, avocado extract, biotin, minoxidil, ginseng, trichozole, amla, brahmi and mixtures thereof.
11. The Shampoo composition as claimed in claim 1, comprising:
(i) about 1%w/w to about 5% w/w of Procapil
(ii) about 1%w/w to about 5% w/w of Redensyl
(ii) about 5% w/w to about 15% w/w of one or more conditioning agents,
(iii) about 35%w/w to about 60%w/w of one or more foaming agents
(iv) about 10%w/w to about 20%w/w of one or more foam boosters,
(v) about 1%w/w to about 10%w/w of one or more thickening agents; and
(vi) one or more pharmaceutically acceptable excipients
wherein the composition is sulphate and paraben free.