DESC:
The following specification particularly describes the invention and the manner in which it is to be performed
HAIR CARE CONDITIONING SHAMPOO COMPOSITION

FIELD OF THE INVENTION
The present invention relates to an improved hair care shampoo composition which provides enhanced hair conditioning performance and anchorage. This composition is also sulphate and paraben free.
BACKGROUND OF THE INVENTION
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 incorporation of conditioning agents in the shampoo composition itself gives an added advantage of imparting moisture, smoothness and nourishment in a single application. It avoids usage of an extra application of conditioners after hair wash which aids in protecting and strengthening the hair. Conditioning shampoos leave hair soft and shiny.
US5217652 describes conditioning shampoo compositions comprising dimethicone and guar hydroxypropyltrimonium chloride. The exemplary conditioning shampoo compositions provide excellent washing and overall conditioning, including ease of wet combing for the hair, without excessive build-up of conditioner over a period of use.
US5490955 discloses shampoo composition comprising N-acyl a-amino acids like Sodium N-cocoyl glutamate e.g. available as Amisoft CS-11 from Ajinomoto Inc, Sodium pyrrolidone carboxylate, Dimethicone in various examples.
WO2007078485 discloses hair treatment composition which can contain hydrolyzed pea protein and Polyquaternium 10 as conditioning agents.
WO1997034570 discloses hair care compositions which provide improved conditioning and styling of hair. Preferred conditioning agents are dimethicone and guar hydroxypropyltrimonium chloride.
Hair- fall is a very common problem and affects most people at some time in their lives. Various topical treatments are available for this condition like minoxidil foam, minoxidil solution, procapil shampoo, ketoconazole shampoo, spironolactone lotion, copper peptide creams and lotion etc. Such treatments lead to further dryness of the hair and leave them entangled. Incorporation of an anti hair fall agent and good conditioners to a shampoo composition is a useful and economic solution of such problems. Agents like “Procapil” can be added which provide better anchorage to hair and prevent hair loss; conditioners present in the composition will help in making the hair manageable and shiny.
Procapil is a patented 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.
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.
US20060067905 discloses comopsitions of Procapil for treating hair loss. It also discloses shampoo composition of Procapil.
Most commonly used commercially available conditioning shampoos (e.g. ANAPHASETM marketed by Abbott, X-GAINTM by Cipla, MILDYTM by Intas) 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.
Hence, there is a need to develop a composition which should provide most of the advantages of hair care composition in a single unit without exhibiting side effects and should safely be used by both men and women.
The present invention features an improved hair care conditioning shampoo composition that provides good cleaning as well as enhanced conditioning and rinsability. The shampoo composition comprises a mixture of conditioning agents which were not incorporated in a single composition earlier. This shampoo composition imparts softness and shiny appearance with increased volume. The composition can further contain anti-hair fall agents which can address the problem of hair loss and provide strong anchorage to the scalp. Further the composition is sulphate and paraben free.
SUMMARY OF THE INVENTION
The present specification relates to a conditioning shampoo composition which is sulphate and paraben free and its process for preparation.

In one aspect, the present specification relates to a conditioning shampoo composition comprising:
(i) one or more amino acid based conditioning agents,
(ii) one or more foaming agents,
(iii) one or more pharmaceutically acceptable excipients; and
wherein the composition is sulphate and paraben free.

In another aspect, the present specification relates to a conditioning shampoo composition comprising:
(i) one or more conditioning agents,
(ii) one or more foaming agents,
(iii) one or more foam boosters,
(iv) one or more thickening agents; and
wherein the composition is sulphate and paraben free.
In another aspect, the present specification relates to a conditioning shampoo composition comprising:
(i) one or more conditioning agents,
(ii) one or more foaming agents,
(iii) one or more foam boosters,
(iv) one or more thickening agents,
(v) one or more pearlizing agents,
(vi) one or more humectants; and
wherein the composition is sulphate and paraben free.

In yet another aspect, the present specification relates to a conditioning shampoo composition comprising:
(i) one or more amino-acid based conditioning agents,
(ii) one or more foaming agents,
(iii) one or more foam boosters,
(iv) one or more thickening agents,
(v) one or more Pearlizing agents,
(vi) one or more humectants; and
wherein the composition is sulphate and paraben free.

In another aspect, the present specification relates to a conditioning shampoo composition comprising:
(i) Procapil,
(ii) one or more conditioning agents,
(iii) one or more foaming agents,
(iv) one or more pearlizing agents,
(v) one or more foam boosters,
(vi) one or more thickening agents,
(vii) one or more humectants; and
wherein the composition is sulphate and paraben free.

In one aspect the present specification relates to a conditioning shampoo composition comprising:
(i) sodium pyrrolidone carboxylic acid,
(ii) disodium N-cocoyl glutamate,
(iii) hydrolyzed pea protein,
(iv) polyquaternium 10; and
(v) dimethicone and cocamidopropyl betaine and laureth 3 and guar hydroxypropyltrimonium chloride.

In another aspect the present specification relates to a conditioning shampoo composition comprising:
(i) 1% to 5% (w/v) sodium pyrrolidone carboxylic acid,
(ii) 1 % to 6.5% (w/v) disodium N-cocoyl glutamate,
(iii) 1% to 5% (w/v) hydrolyzed pea protein,
(iv) 0.05% to 2.0% (w/v) polyquaternium 10; and
(v) 1% to 5% (w/v) dimethicone and cocamidopropyl betaine and laureth 3 and guar hydroxypropyltrimonium chloride.
In yet another aspect, the present specification relates to a kit comprising:
A. a conditioning shampoo composition comprising:
(i) one or more amino acid based conditioning agents,
(ii) one or more foaming agents,
(iii) one or more pharmaceutically acceptable excipients; and
wherein the composition is sulfate and paraben free
B. minoxidil foam or solution.

In another aspect of the invention, the shampoo composition further comprises chelating agents, 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, preservative and fragrance to the prepared mixture.

DESCRIPTION OF THE INVENTION
In one aspect, the present specification relates to a conditioning shampoo composition comprising:
(i) one or more amino acid based conditioning agents,
(ii) one or more foaming agents,
(iii) one or more pharmaceutically acceptable excipients; and
wherein the composition is sulphate and paraben free.

In another aspect, the present specification relates to a conditioning shampoo composition comprising:
(i) one or more conditioning agents,
(ii) one or more foaming agents,
(iii) one or more foam boosters,
(iv) one or more thickening agents; and
wherein the composition is sulphate and paraben free.
In another aspect, the present specification relates to a conditioning shampoo composition comprising:
(i) one or more conditioning agents,
(ii) one or more foaming agents,
(iii) one or more foam boosters,
(iv) one or more thickening agents,
(v) one or more pearlizing agents,
(vi) one or more humectants; and
wherein the composition is sulphate and paraben free.
In yet another aspect, the present specification relates to a conditioning shampoo composition comprising:
(i) one or more amino-acid based conditioning agents,
(ii) one or more foaming agents,
(iii) one or more foam boosters,
(iv) one or more thickening agents,
(v) one or more Pearlizing agents,
(vi) one or more humectants; and
wherein the composition is sulphate and paraben free.

In another aspect, the present specification relates to a conditioning shampoo composition comprising:
(i) Procapil,
(ii) one or more conditioning agents,
(iii) one or more foaming agents,
(iv) one or more pearlizing agents,
(v) one or more foam boosters,
(vi) one or more thickening agents,
(vii) one or more humectants; and
wherein the composition is sulphate and paraben free.
In one aspect the present specification relates to a conditioning shampoo composition comprising:
(i) sodium pyrrolidone carboxylic acid,
(ii) disodium N-cocoyl glutamate,
(iii) hydrolyzed pea protein,
(iv) polyquaternium 10; and
(v) dimethicone and cocamidopropyl betaine and laureth 3 and guar hydroxypropyltrimonium chloride.

In another aspect the present specification relates to a conditioning shampoo composition comprising:
(i) 1% to 5% (w/v) sodium pyrrolidone carboxylic acid,
(ii) 1 % to 6.5% (w/v) disodium N-cocoyl glutamate,
(iii) 1% to 5% (w/v) hydrolyzed pea protein,
(iv) 0.05% to 2.0% (w/v) polyquaternium 10; and
(v) 1% to 5% (w/v) dimethicone and cocamidopropyl betaine and laureth 3 and guar hydroxypropyltrimonium chloride.
In yet another aspect, the present specification relates to a kit comprising:
A. a conditioning shampoo composition comprising:
(i) one or more amino acid based conditioning agents,
(ii) one or more foaming agents,
(iii) one or more pharmaceutically acceptable excipients; and
wherein the composition is sulfate and paraben free
B. minoxidil foam or solution.

In another aspect of the invention, the shampoo composition further comprises chelating agents, 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, preservative and fragrance to the prepared mixture.
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 N-cocoyl 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 shampoo compositions generally comprise harsh surfactants which are difficult to replace completely due to cost constraint hence addition of amino acid derived ingredients at small dosages help to make mild & cost effective compositions. Amino acids provided externally are known to interact with the hair to give various benefits such as moisturizing, conditioning, strengthening, shine, and colour protection etc. Amino acids are components of skin natural moisturizing factor (NMF) & hence are essential for moisturizing of skin. Since the scalp is skin, amino acids are essential to keep it well-nourished & promote healthy hair growth. The amino acids suitable for present invention are sodium pyrrolidone carboxylic acid (AJIDEW® NL-50); disodium N-cocoyl 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.
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 0.05 to 2.0% w/v and 1 to 5% w/v respectively.
As used herein, the term “foaming agents” refers to a substance that facilitates formation of foam such as a surfactant. 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.

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.
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, coconut diethanolamide, lauric diethanolamide.
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.

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 adenosin phosphate, sodium lactate, pyrrolidone carbonate, glucosamine, cyclodextrin.
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), biotin, minoxidil, ginseng, trichozole, amla, brahmi and mixtures thereof.
The most useful anti- hair fall agent for present invention is Procapil; it enhances the hair anchorage to scalp and increases its microcirculation.

In one embodiment of the present invention, the conditioning shampoo composition may be used as a kit in combination with anti-hair fall medications like minoxidil (e.g. Rogaine®, Tugain, MINTOPTM), ketoconazole (e.g. Nizoral®), cyproperone acetate, medroxy progesterone acetate etc.
The use of these prescribed anti –hairfall medications leave your hair dry and unmanageable. Therefore prescription of a kit containing a conditioning shampoo along with such anti hair fall medication is a good alternate.

In yet another embodiment the present conditioning shampoo 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, 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, Polyquaternium 10 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 ease in combing hair. This is analysed by wet and dry combing by Diastron Tensile Tester (MTT175). This method is developed for hair care applications and for the evaluation of efficacy of shampoos and conditioners. The principle of the method is that a comb is driven through a tress of hair and the load required to achieve this is measured. Peak forces and work done can be calculated from the instrument output. Minimum the total work and force required combing hair; more is the conditioning effect of the composition.
The efficacy can also be assessed by Expert Grade Test which measures shine; smoothness, softness, manageability and texture feel by sensory evaluation of dry hair.
The specification will now be described in more detail by reference to the following non-limiting examples.
EXAMPLES
Example 1
Ingredients Amount (% w/w)
Sodium pyrrolidone carboxylic acid 1.0
Di-Sodium cocoyl glutamate 2.0
Pea protein 1.0
Disodium Laureth Sulfosuccinate 25.00
Sodium Lauoryl Sarcosinate 20.00
Cocoamido propyl betaine 10.00
Ethylene glycol monostearate 2.00
Cocomonoethanolamide 1.00
Polysorbate 60 2.00
PEG-150-Distearate 0.50
Polyquaternium 10 0.20
Dimethicone (and) Cocamidopropyl Betaine (and) Laureth 3 (and) Guar Hydroxypropyltrimonium Chloride 2.50
Methylchloroisothiazolinone and Methylisothiazolinone 0.10
Fragrance 0.10
Purified water Q.S.

Process
1. Disodium Laureth Sulfosuccinate, Sodium Lauoryl Sarcosinate, Cocoamidopropyl Betaine, Polysorbate 60, Ethylene Glycol Monostearate, Cocomonoethanolamide, PEG-150-Distearate were heated to 70-75?C with stirring followed by cooling the mixture.
2. Polyquaternium 10 was added to purified water and heated to 55-66?C.
3. Aqueous phase was added to the surfactant phase under stirring followed by cooling.
4. Hydrolyzed pea protein, Disodium N-Cocoyl Glutamate, sodium PCA and Dimethicone & Cocamidopropyl Betaine C12-15 & Guar Hydroxypropyltrimonium Chloride were added to above mixture under stirring followed by cooling.
5. Fragrance & Methylchloroisothiazolinone and Methylisothiazolinone were added to above mixture and mixed.

Example 2
Ingredients Amount (% w/w)
Sodium pyrrolidone carboxylic acid 1.0
Di-Sodium cocoyl glutamate 2.0
Pea protein 1.0
Sodium Lauoryl Sarcosinate 20.00
Lauryl Glucoside 15.00
Cocodiethalamide 10.00
Cocoamido propyl betaine 4.5
Ethylene glycol monostearate 1.00
Cocomonoethanolamide 1.00
Polysorbate 60 2.00
PEG-150-Distearate 1.50
Polyquaternium 67 0.25
Glycerin 4.00
Silicone Quaternium-16 (and) Undeceth-11 (and) Butyloctanol (and) Undeceth-5 3.00
Dimethiconol (and) TEA Dodecylbenzenesulfonate (and) Laureth-23 2.00
Methylchloroisothiazolinone and Methylisothiazolinone 0.10
Fragrance 0.10
Citric Acid 0.73
Purified water Q.S.

Process
1. Sodium Lauoryl Sarcosinate, Cocoamidopropyl Betaine, Polysorbate 60, Ethylene Glycol Monostearate, Cocomonoethanolamide, PEG-150-Distearate, Lauryl Glucoside, Cocodiethalamide were heated to 70-75?C with stirring.
2. 70% of Glycerin,was added to Polyquaternium 67 and mixed well to make a uniform dispersion followed by addition of 60% water and heated to 60?C.
3. Mixture of step 2 was added to step 1 mixture.
4. 30% of purified water was added to rest amount of Glycerin and mixed with the above mixture with stirring.
5. After cooling, hydrolyzed pea protein, Disodium N-Cocoyl Glutamate, sodium PCA and Dimethicone, Silicone Quaternium-16 (and) Undeceth-11 (and) Butyloctanol (and) Undeceth-5, Dimethiconol (and) TEA Dodecylbenzenesulfonate (and) Laureth-23 were added to above mixture.
6. Fragrance & Methylchloroisothiazolinone and Methylisothiazolinone were added with stiring.

Example 3
Ingredients Amount (% w/w)
Procapil 1.0
Sodium pyrrolidone carboxylic acid 1.0
Di-Sodium cocoyl glutamate 2.0
Pea protein 1.0
Sodium Lauryl Ether Sulfate 70% 25.00
Cocoamido propyl betaine 10.00
Ethylene glycol monostearate 2.00
Propylene Glycol 5.00
Polysorbate 60 4.00
Colour 0.002
Methylchloroisothiazolinone and Methylisothiazolinone 0.10
Fragrance 0.10
Purified water Q.S.

Process
1. Sodium Lauryl Ether Sulfate, Cocoamidopropyl Betaine, Polysorbate 60, Ethylene Glycol Monostearate were heated to 70?C with stirring.
2. Propylene Glycol was added to the above phase-I with siring. And cooled to 40?C.
3. 50%of purified water was heated to 40?C and added to surfactant phase under stirring
4. Cooled the bulk to 30?C.
5. Hydrolyzed pea protein, Disodium N-Cocoyl Glutamate and sodium PCA and Dimethicone were added to above mixture under stirring.
6. Fragrance, colour solution, Procapil, Methylchloroisothiazolinone and Methylisothiazolinone were added and mixed for 10 minutes.

Example 4
Ingredients Amount (% w/w)
Procapil 0.50
Sodium Pyrrolidone carboxylic acid 1.00
Disodium N-Cocoyl Glutamate 2.00
Hydrolyzed Pea Protein 1.00
Disodium Laureth Sulfosuccinate 25.00
Sodium Lauoryl Sarcosinate 20.00
CAPB (Cocoamidopropyl Betaine) 10.00
Polysorbate 60 2.00
Ethylene Glycol Monostearate 2.00
Cocomonoethanolamide 1.00
PEG-150-Distearate 3.00
Dimethicone & Cocamidopropyl Betaine C12-15 & Guar Hydroxypropyltrimonium Chloride 4.50
Polyquaternium 10 0.40
Disodium EDTA 0.10
Methylisothiazolinone & Phenoxyethaol 0.50
Fragrance 0.05
Purified water Q.S.
Example 5
Ingredients Amount (% w/w)
Procapil 1.00
Sodium pyrrolidone carboxylic acid 1.00
Di-Sodium cocoyl glutamate 2.00
Pea protein 1.00
Disodium Laureth Sulfosuccinate 31.67
Sodium Lauoryl Sarcosinate 15.00
Cocoamido propyl betaine 8.33
Ethylene glycol monostearate 2.00
Polysorbate 60 2.00
Polyquaternium 10 0.40
Dimethicone (and) Cocamidopropyl Betaine (and) Laureth 3 (and) Guar Hydroxypropyltrimonium Chloride 4.50
Methylisothiazolinone & Phenoxyethanol 0.50
Cocomonoethanolamide 1.00
PEG-150-Distearate 3.00
Disodium EDTA 0.10
Fragrance 0.05
Purified Water Q.S.

Process
1. Disodium Laureth Sulfosuccinate , Sodium Lauoryl Sarcosinate, Cocoamidopropyl Betaine, Polysorbate 60,Ethylene Glycol Monostearate, Cocomonoethanolamide, PEG-150-Distearate were heated to 70-75?C with stirring.
2. 70 % Purified water was heated to 55-60?C and Disodium EDTA was added under stirring followed by addition of Polyquaternium 10.
3. The above solution was added to step 1 and cooled to 40- 45?C.
4. Hydrolyzed pea protein, Disodium N-Cocoyl Glutamate, sodium PCA and Dimethicone & Cocamidopropyl Betaine C12-15 & Guar Hydroxypropyltrimonium Chloride were added to to the mixture under stirring.
5. 30% of purified water was added and mixed for 20 minutes; the mixture was cooled to 30?C.
6. Procapil, Methylisothiazolinone & Phenoxyethanol & fragrance were added with stirring.

Example 6
In-Vitro Evaluation of conditioning efficacy of shampoo on Natural black Indian Hair tresses by wet combing
A 0.5% Procapil shampoo composition is prepared in accordance with Example 2. 0.3ml shampoo is applied on 10 wet hair tresses gently; tresses are then rinsed under tap water and combed gently to remove tangles. The tresses are then analyzed by Diastron Tensile Tester (MTT175) to find reduction in force to comb the hair tress after application of test product which denotes the conditioning effect.
The studied parameters are:
Total Work: Total force required to comb the hair tress- in gmf (joules)
Minimum the total work more the conditioning effect
Peak Load: Max force required to comb the hair tress- in gmf
Minimum the peak load more the conditioning effect
Result of the study:
Mean values of the studied parameters on hair tresses treated with the shampoo composition of the present invention at T0 (initial/before treatment) and T1 (after treatment) were calculated from readings of Diastron tensile tester (MTT175) and statistical analysis was done using Student test (normality of distributions checked) or with the Wilcoxon test (normality of the distributions rejected) after checking the normality of the distributions by the Shapiro- Wilk test at 1%. The significance threshold was fixed at 5%. On the basis of Diastron tensile tester (MTT175) by wet combing method analysis on hair tresses, significant improvement of hair conditioning effect was noted after 1st wash, for shampoo composition.
T0 (initial/before treatment) T1 (after treatment)
Total Work (joules) Mean
Standard Deviation 0.0647
0.01 0.0556
0.01
Significant at 5% (T0 vs Tn)
p=
Test Yes
<0.001
Wilcoxon
Peak Load (gmf) Mean
Standard Deviation 73.08
17.61 55.59
12.53
Significant at 5% (T0 vs Tn)
p=
Test Yes
<0.001
Wilcoxon

Example 7
In-Vitro Evaluation of conditioning efficacy of Regime containing MINTOP Forte Foam + Conditioning Shampoo by wet and dry combing method

A 0.5% Procapil shampoo composition is prepared in accordance with Example 2. 0.3 gm of Mintop Forte foam is applied to 10 hair tresses and gently lathers. Wait for 6 hours. Apply 0.3 ml of conditioning shampoo to each tress and gently lather. Tresses are then rinsed under tap water and combed gently to remove tangles. The tresses are then analyzed by Diastron Tensile Tester (MTT175) in wet and completely dry condition to find reduction in force to comb the hair tress after application of product which denotes the conditioning effect.
The studied parameters are:
Total Work: Total force required to comb the hair tress- in gmf (joules)
Minimum the total work more the conditioning effect
Peak Load: Max force required to comb the hair tress- in gmf
Minimum the peak load more the conditioning effect
Result of the study:
Mean values of the studied parameters on hair tresses treated with the Regime at T0 (initial/before treatment) and T1 (after treatment) were calculated from readings of Diastron tensile tester (MTT175) and statistical analysis was done using Student test (normality of distributions checked) or with the Wilcoxon test (normality of the distributions rejected) after checking the normality of the distributions by the Shapiro- Wilk test at 1%. The significance threshold was fixed at 5%.
Wet & dry combing analysis by Diastron tensile tester (MTT175) on hair tresses showed significant improvement of hair conditioning effect after Regime treatment.
Analysis of the Hair Conditioning by Wet Combing,
T0 (initial/before treatment) T1 (after treatment)
Total Work (joules) Mean
Standard Deviation 0.065
0.01 0.052
0.01
Significant at 5% (T0 vs Tn)
p=
Test Yes
6.63E-19
Student t-test
Peak Load (gmf) Mean
Standard Deviation 82.01
22.75 47.73
12.18
Significant at 5% (T0 vs Tn)
p=
Test Yes
2.37E-24
Student t-test

Analysis of the Hair Conditioning by Dry Combing
T0 (initial/before treatment) T1(after treatment)
Total Work (joules) Mean
Standard Deviation 0.019
0.01 0.014
0.00
Significant at 5% (T0 vs Tn)
p=
Test Yes
4.08E-12
Student t-test
Peak Load (gmf) Mean
Standard Deviation 190.71
69.79 115.32
39.09
Significant at 5% (T0 vs Tn)
p=
Test Yes
1.76E-14
Student t-test

Example 8
Sensory Evaluation of hair manageability, softness, smoothness and shine effect by expert panel test on dry hair, using conditioning shampoo and Regime (MINTOP Forte Foam + Conditioning Shampoo)
Conditioning Shampoo- Product A
MINTOP Forte Foam + Conditioning Shampoo– Regime
30 identical tresses of hair are used for the study. The tresses of hair used for this study are made of Indian -natural- black hair. The hair tresses are divided in 2 groups as follows:
1. 15 tresses are treated with the (Conditioning Shampoo) product A
2. 15 tresses are treated with the (Mintop Forte Foam + Conditioning Shampoo)- Regime

Treatment with Conditioning Shampoo
A 0.5% Procapil shampoo composition is prepared in accordance with Example 2. 0.3ml shampoo is applied on wet hair tresses gently; tresses are then rinsed under tap water and combed gently to remove tangles. The hair tresses are kept for overnight drying, comb 5 times individual tress after complete drying to remove major tangles.
Regime (Mintop Forte Foam + Conditioning Shampoo) Application
0.3 gm of Mintop Forte foam is applied to hair tresses and gently rub them 10 times from top of the tress to tip. Wait for 6 hours. Wet each hair tress in tap water. Apply 0.3 ml of conditioning shampoo to each tress and gently lather. Tresses are then rinsed under tap water and combed gently to remove tangles. The hair tresses are kept for overnight drying, comb 5 times individual tress after complete drying to remove major tangles.
The analysis shows good results with respect to manageability, softness, smoothness & shine after application of test product & regime.
,CLAIMS:WE CLAIM:
1. A conditioning shampoo composition comprising:
(i) one or more amino acid based conditioning agents,
(ii) one or more foaming agents,
(iii) one or more pharmaceutically acceptable excipients; and
wherein the composition is sulfate and paraben free.
2. The conditioning shampoo composition of 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.

3. The conditioning shampoo composition of 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 3 and guar hydroxypropyltrimonium chloride and mixtures thereof.

4. The conditioning shampoo composition of 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.

5. The conditioning shampoo composition of claim 1, wherein the pharmaceutically acceptable excipients are selected from one or more of foam boosters, one or more of thickening agents, one or more of pearlizing agents, one or more of humectants and mixtures thereof.

6. The conditioning shampoo composition of claim 1, wherein the composition further comprises anti-hair fall agents selected from bamboo extract, combination of apigenin, oleanolic acid and biotinyl-GHK, avocado extract, biotin, minoxidil, ginseng, trichozole, amla, brahmi and mixtures thereof.

7. The conditioning shampoo composition of claim 6, wherein the anti-hair fall agent is a combination of apigenin, oleanolic acid and biotinyl-GHK.

8. The conditioning shampoo composition of claim 3, comprising:
(i) sodium pyrrolidone carboxylic acid,
(ii) disodium N-cocoyl glutamate,
(iii) hydrolyzed pea protein,
(iv) polyquaternium 10; and
(v) dimethicone and cocamidopropyl betaine and laureth 3 and guar hydroxypropyltrimonium chloride.

9. The conditioning shampoo composition of claim 8, comprising:
(i) 1% to 5% (w/v) sodium pyrrolidone carboxylic acid,
(ii) 1 % to 6.5% (w/v) disodium N-cocoyl glutamate,
(iii) 1% to 5% (w/v) hydrolyzed pea protein,
(iv) 0.05% to 2.0% (w/v) polyquaternium 10; and
(v) 1% to 5% (w/v) dimethicone and cocamidopropyl betaine and laureth 3 and guar hydroxypropyltrimonium chloride.

10. A kit comprising:
A. a conditioning shampoo composition comprising:
(i) one or more amino acid based conditioning agents,
(ii) one or more foaming agents,
(iii) one or more pharmaceutically acceptable excipients; and
wherein the composition is sulfate and paraben free
B. minoxidil foam or solution.