FORM 2
THE PATENTS ACT, 1970
(39 of 1970)
&
The Patents Rules, 2003 COMPLETE SPECIFICATION
(See section 10 and rule 13)
1. TITLE OF THE INVENTION :
"HAIR CARE COMPOSITION"

2. APPLICANT (S)
(a) NAME
(b) NATIONALITY
(c) ADDRESS

ZUVENTUS HEALTHCARE LTD.
India
Office No. 3101-3108, 3rd Floor, Building 3C, Oberai
Garden Estates, Chandivilli, Andheri (E), Mumbai 400 072
India

3. PREAMBLE TO THE DESCRIPTION
PROVISIONAL
The following specification describes the invention

COMPLETE
The following specification particularly describes the invention and the manner in which it is to be performed.

4. DESCRIPTION (Description shall start from next page)
5. CLAIMS (not applicable for provisional specification. Claims should start with the preamble - "l/we claim" on separate page)
6. DATE AND SIGNATURE (to be given at the end of last page of specification)
7. ABSTRACT OF THE INVENTION (to be given along with complete specification on separate page)
Note:-
*Repeat boxes in case of more than one entry.
To be signed by the applicants) or by authorized registered patent agent
"Name of the applicant should be given in full, family name in the beginning.
'Complete address of the applicant should be given stating the postal index no./code, state and
country
'Strike out the column which is/are not applicable.

HAIR CARE COMPOSITION
FIELD OF THE INVENTION
The present invention provides a novel cosmetic hair care composition. The composition of the invention is designed to maintain good growth of hair by keeping away dandruff as well as by giving it a conditioned effect. The invention also provides a process for preparing the composition.
BACKGROUND AND PRIOR ART
Personal cleansing articles have traditionally been marketed in a variety of forms such as bar soaps, creams, lotions, shampoos and gels. These cleansing formulations have attempted to satisfy a number of criteria to be acceptable to consumers. These criteria include cleansing effectiveness, skin feel, mildness to skin, hair, and ocular mucosae, and lather volume. Ideal personal cleansers should gently cleanse the skin or hair, cause little or no irritation, and not leave the skin or hair overly dry after frequent use.
Consumers often desire to have a hair shampoo that not only effectively cleanses the hair, but that also imparts other desirable properties, such as conditioning and lathering, to the hair. Thus, it is usually necessary to perform a post-shampoo conditioning to keep hair soft and shiny as referred in US patent 6451300.
Dandruff is a chronic condition that makes the scalp dry and scaly. The hair becomes unhealthy, thin and falls off resulting in decrease in the volume of hair. The presence of dandruff sometimes also gives rise to pimples on face. While dandruff is primarily a scaling condition, it is often also associated with some inflammation.
A cytotoxic agent or an antifungal agent is administered onto the scalp in a traditional treatment. However, no treatment so far provides long-term effect from the dandruff.
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Anti-dandruff shampoos are also well known in the art and are also commercially available. Anti-dandruff shampoos typically incorporate an anti-dandruff active and detersive surfactants. Among the preferred type of anti-dandruff agents are particulate, crystalline anti-dandruff agents, such as sulfur, selenium disulfide and heavy metal salts of pyridinethione. Soluble anti-dandruff agents, such as ketoconazole, are also known in the art as referred in US 6451300.
It was previously believed that excellent anti-dandruff efficacy could be achieved by
utilizing a coacervate to deposit anti-dandruff actives on the hair and scalp.
Unfortunately, the use of coacervates to deposit anti-dandruff actives on the hair or scalp
can negatively affect conditioning, specifically clean hair feel. In order to achieve good
conditioning, the level of anti-dandruff agent could be reduced, resulting in good
conditioning, but less than optimal anti-dandruff efficacy.
Ketoconazole as an antidandruff agent is used in the shampoo compositions in the prior
art such as in US 6,451,300. However, use of this single active ingredient has several
disadvantages as it brings about changes in hair texture, blisters on scalp, dry skin,
itching, oily or dry hair or scalp irritation, itching, or stinging in the place where the
medication is applied as referred in
http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a682816.html.
Hence, one solution may be to minimize higher quantities of a single active ingredient. However, it is found that any amount of an anti-dandruff agent has a tendency to spoil hair texture. Therefore, a conditioner is required. An user may have to apply the shampoo followed by the conditioner. The effects are however, not satisfactory.
Thus, if a composition is to provide anti-dandruff effect and conditioning, it must meet certain criteria with respect to a) efficacy, b) customer satisfaction, c) industrial feasibility and economy, d) customer satisfactory and appealability and f) aesthetically valuable ie. which has properties like consistency, smoothness pleasant odour, soothing colour etc.
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Such a superior combination of efficacy and conditioning can be difficult to achieve. Thus, there is a need to provide a hair care composition which provides anti-dandruff effect and also acts as a conditioner.
OBJECTS OF THE INVENTION:
The main object of the invention is to provide a hair care composition.
Another object is to provide a process for preparing the said hair care composition.
DETAILED DESCRIPTION OF THE INVENTION:
The present invention provides a novel hair care composition, which is a customer compatible and better efficacy composition, with a combination of two active ingredients and a conditioner.
An advantage of the composition of the invention is that it acts not only as an antidandruff composition which would be stable over a substantial period of time, but also would remain on the scalp for a longer period of time. The composition of the invention is provided in the form of gel or as a shampoo.
The composition of the present invention meets the criteria with respect to a) efficacy, b) customer satisfaction, c) industrial feasibility and economy, d) customer satisfactory and appealability and f) aesthetically valuable ie. which has properties like consistency, smoothness, pleasant odour, soothing colour etc.
Accordingly, the hair care composition of the invention comprises an effective amount of ketoconazole, zinc pyrithione and an agent selected from Amisoft ECS 22 SB and Sodium PCA optionally with anti-microbial agents and acceptable excipients. The said composition may exist in physical form such as gel and shampoo.
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The excipients employed in the composition may be selected from a moisturizer, humectant, viscosity modifier, film former, emollient solvent, provitamin, perfume, gelling agent, thickener, surfactant, preservative and solubilizer.
Thus, the primary ingredients of the composition are Ketoconazole and Zinc Pyrithione. The other ingredients may be varied depending upon whether a gel or a shampoo is to be prepared. For example, in gel preparation, sodium PCA may be used whereas for shampoo preparation Amisoft ECS 22 SB is used.
The other excipients that may be included in the composition, especially for preparation of a shampoo may be:
a) Surfactants
b) Antimicrobial Preservatives
c) Humectant Solvent
d) Pearlizing Agent
e) Thickening agent
f) Provitamins
g) Pearlizing agent
h) Perfume
i) Colour
j) Vehicle and etc.
The ingredients for preparation of gel are as under:
1) Gelling agents
2) Antimicrobial Preservatives
3) Humectant Solvent
4) Viscosity modifiers
5) Emulsifying agent and Solubiliser
6) Moisturizer
7) Film former
8) Emollient Solvent
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9) Provitamins
10) Perfume ll)Vehicle and etc.
The said composition of the present invention is described in detail below:
The composition of present invention is a synergistic composition in that the ingredients ketoconazole, zinc pyrithione and the conditioning / moisturizing agent are not ordinarily combined since they are not expected in the art to work efficiently as a combination. In fact, it is on account of this thinking that the art only provides a shampoo and a different conditioner as well as a separate moisturizer. If these ingredients are combined, it is ordinarily observed that the resultant mixture separates out as precipitate, and no homogeneous composition is formed as is required and essential for gel or shampoo. Further, when the applicant combined these ingredients and weighed the same together, it was observed that the product obtained by such a combination is completely different and unacceptable at consumer level. After a lot of efforts and research, the applicant arrived at a method whereby the aforesaid ingredients may be effectively combined to form a synergistic composition whose cumulative effect is greater than the effect of individual ingredients and the combination is such that a homogeneous smooth mixture is formed instead of precipitated residues. Such a smooth and homogeneous mixture is desirable and required for a gel or shampoo.
COMPONENTS
A) Active Agents
The active agents in our composition include ketoconazole and zinc pyrithione.
Ketoconazole is effective in infections of the hair by dermatophytes and or yeasts, ringworm, tinea, versicolor, chronic mucocutaneous candidiasis, Candida vulvovaginities, and oral and esphageal candidiasis. The concentration of the ketoconazole is usually added in 0.5% to 5% and the more preferred being 1.5% to 3%.
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Zinc Pyrithione (also known as Zinc Omadine® or Zinc 2-pyridinethiol-l-oxide) is used to prevent microbial degradation. The chemical acts to prevent the growth of bacteria, fungi, mildew, and algae that can cause various types of deterioration such as
discoloration, staining, and odors. The concentration of the zinc pyrithione is usually added in 0.1% to 10% and the more preferred being 1 % to 5%. The largest use for zinc pyrithione is non-pesticidal (i.e., control of dandruff, seborrheic dermatitis, and psoriasis), and is regulated by the Food and Drug Administration.
Thus, the use of combination of the active agents makes the composition more effective, more compatible with the patient and with minimized side effects like hair texture, blisters on scalp, dry skin, itching, oily or dry hair or scalp irritation, itching, or stinging in the place where you applied the medication etc.
B) Conditioning Agent
The term "conditioning agent" includes any material, which is used to give a particular conditioning benefit to hair and/or skin. The anti-dandruff and conditioning shampoo compositions of the present invention comprise from about 1% to about 10%, by weight of the composition, preferably from about 1.5% to about 8%, more preferably from about 2% to about 5% of a conditioning agent suitable for application to the hair or skin. It is
believed that the conditioning agent provides improved conditioning benefits to the hair, particularly clean hair feel and wet rinse feel.
The conditioning agent comprises water insoluble, water dispersible, non-volatile; liquid that forms emulsified, liquid particles or is solubilized by the surfactant micelles, in the anionic detersive surfactant component (described above). Suitable conditioning agents for use in the shampoo composition are those conditioning agents characterized generally as silicones (e.g. silicone oils, cationic silicones, silicone gums, high refractive silicones, and silicone resins), organic conditioning oils (e.g. hydrocarbon oils, polyolefins, and fatty esters) or combinations thereof, or those conditioning agents which otherwise form liquid, dispersed, particles in the aqueous surfactant matrix herein. Such conditioning agents should be physically and chemically compatible with the essential components of
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the composition, and should not otherwise unduly impair product stability, aesthetics or performance.
The concentration of the conditioning agent in the shampoo composition should be sufficient to provide the desired conditioning benefits. Such concentration can vary with
the conditioning agent, the conditioning performance desired, the average size of the conditioning agent particles, the type and concentration of other components, and other like factors.
The usually used conditioner is glycerine. However, glycerine when used as a conditioner in the present shampoo composition is characterized by dry skin. The experiment was performed on the skin of volunteers, by spreading shampoo on their skin, which resulted in arid and parched skin. Thus, the use of glycerine as conditioner in the present shampoo composition, in similar way would also result in the dry scalp of the head and further
affect on the treatment of dandruff. It was surprisingly found that in the instant invention when Amisoft ECS 22SB is used as a conditioner along with a) ketoconazole and b) zinc pyrithione, it leaves hair soft and glossy. Further use of Amisoft ECS 22SB, when used as a conditioner with the present shampoo composition does not leave skin dry and hence the head scalp remains moist and healthy.
The conditioning agent used in the present invention is Amisoft ECS 22 SB. This conditioner is mixed along with the shampoo and hence need not be applied separately after the shampoo treatment. This leaves the hair soft and healthy and also its efficacy remains for a longer period of time.
C) Thickners
Thickeners are added to the compositions so as to provide consistency. The thickeners also make the composition pasty and hence avoid loss due to spillage during treatment. The thickeners included can be inorganic as well as organic. The inorganic thickeners are carbosil and silica thickeners. The organic thickeners include carrageenan, xanthum gum, sodium carboxy methyl cellulose, starch, polyvinlpyrrolidone, hydroxyethyl propyl cellulose, hydroxybutyl methyl cellulose, hydroxy propyl methyl cellulose and hydroxy
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ethyl cellulose etc. The inorganic or the organic thickeners may be incorporated in such a composition at a concentration of about 0.5 to about 6% by weight and preferably about 0.1 to about 3% by weight. Hydroxy propyl methyl cellulose is used as a thickening agent in our process.
D) Surfactants
Shampoo compositions of the invention comprise one or more cleansing surfactants,
which are cosmetically acceptable and suitable for topical application to the hair. It is
preferred that shampoo compositions of the invention comprise at least one further
surfactant to provide a cleansing benefit.
Suitable cleansing surfactants, which may be used singularly or in combination, are selected from anionic, amphoteric and zwitterionic surfactants, and mixtures thereof. The cleansing surfactant may be the same surfactant as the emulsifier, or may be different.
The anti-dandruff and conditioning shampoo compositions of the present invention comprise from about 5% to about 80%, by weight of the composition, more preferably from about 10% to about 60%, of an anionic detersive surfactant component suitable for application to the hair or skin. The anionic detersive surfactant is believed to provide cleaning and lather performance to the composition. Additionally, the anionic detersive surfactant forms a coacervate, upon aqueous dilution, with the cationic polymer component. This coacervate is believed to be important in providing the efficacy and conditioning benefits described herein. Examples of anionic surfactants are the alkyl sulphates, alkyl ether sulphates, alkaryl sulphonates, alkanoyl isethionates, alkyl succinates, alkyl sulphosuccinates, N-alkyl sarcosinates, alkyl phosphates, alkyl ether phosphates, alkyl ether carboxylates, ammonium lauryth sulphate, ammonium lauryl sulphate, and alpha-olefin sulphonates, especially their sodium, magnesium, ammonium and mono-, di- and triethanolamine salts. Typical anionic surfactants for use in shampoos of the invention include sodium oleyl succinate, ammonium lauryl sulphosuccinate, ammonium lauryth sulphate, ammonium lauryl sulphate, sodium dodecylbenzene sulphonate, triethanolamine dodecylbenzene sulphonate, sodium cocoyl isethionate,
sodium lauryl isethionate and sodium N-lauryl sarcosinate. The most preferred anionic
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surfactants are sodium lauryl sulphate, ammonium lauryl sulphate, sodioum lauryth sulphate and ammonium laureth sulphate.
Examples of amphoteric and zwitterionic surfactants include alkyl amine oxides, alkyl betaines, alkyl amidopropyl betaines, alkyl sulphobetaines (sultaines), alkyl glycinates, alkyl carboxyglycinates, alkyl amphopropionates, alkylamphoglycinates, cocamido propyl betaine, alkyl amidopropyl hydroxysultaines, acyl taurates and acyl glutamates, wherein the alkyl and acyl groups have from 8 to 19 carbon atoms. Typical amphoteric and zwitterionic surfactants for use in shampoos of the invention include lauryl amine oxide, cocodimethyl sulphopropyl betaine, cocamido propyl betaine.. The most preferred are lauryl betaine, cocamidopropyl betaine and sodium cocamphopropionate. The concentration of these surfactants can be about 1% to 10%. The more preferred concentration is 2% to 5%.
E) Preservatives
The compositions disclosed in the present embodiment have water content present in them, as they are aqueous compositions. These compositions once prepared need not be used immediately. Hence, there are chances of microbial growth in the composition due to water storage. This makes the composition useless and hence not appropriate for use. For this reason the antimicrobial preservatives are added. The antimicrobial preservatives used in the gel composition are methyl paraben and propyl paraben. Methyl paraben can be used in the concentration range of 0.1% to 1%. The most preferable concentration being 0.15% to 0.25%. Propyl paraben can be used in the concentration of 0.001% to 0.1 %. The more preferable concentration being 0.01% to 0.03%.
The shampoo composition contains larger concentrations of water the gel compositions. Hence the chances of microbial growth in the shampoo composition is higher than the one in the gel formation. Hence, along with methyl paraben and propyl paraben imidurea is also used as an antimicrobial agent to make the composition bacterial free and more
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effective. The concentration of imidurea can range from 0.25% to 5%. The more preferred concentration being 0.3% to 0.7%.
F) Gelling Agent
A gelling agent is used in a fomulation to give it a gel like properties. A good gel complies to properties like consistency, smoothness and crackless. The universal gelling agent used is from the class of acrylic acid co-polymer for example carbomer 940, a cationic acrylic homopolymer in powder form, such as polyquaternium-37 etc. The concentration of the gelling agent used is within the range of about 0.1% to 5%. The more preferred range is within 0.8% to 3%.
G Moisturizer
Moisturizers are substances that exert two basic actions: humectants, which are introduced into the stratum corneum to increase its water holding capacity; and occlusives, which provide a layer of oil on the surface of the skin to slow water loss and thus increase the moisture content of the stratum corneum. Some moisturizers contain both occlusives and humectants. Moisturizers are generally used in the composition to avoid dryness to the skin as well as composition after application of the gel. This keeps the skin and the hair moist and thus avoids them from becoming rough and dry. The moisturizers used in our invention are Dimethicone and Sodium PCA (Ajidew NL-50). This moisturizer has better efficacy and is more eminent than the other moisturizing agents like glycerine. Hence, after using a moisturizer the hair texture is maintained which becomes dry after using the active ingredients, the skin does not become dry and thus increases the water holding capacity. The concentration in which the moisturizer can be used is 0.001% to 0.1%. The more preferable being 0.01% to 0.03%.
H Solubilisers
The solubilisers are required especially in the gel composition so that the active ingredients remain soluble in the composition and do not precipitate out. In the absence
of the solubilisers the active ingredients like zinc pyrithione and ketoconazole precipitate
II*

out thus affecting the texture and consistency of the gel. Hence, solubilisers like propylene glycol and polysorbate 80 are used. In the shampoo compositions propylene glycol is used as an humectant solvent to avoid loss of water. Thus propylene glycol, holds the water content in the shampoo, even in hot weather conditions and thus maintains the consistency of the composition.
The concentration of propylene glycol can be about 2% to 25%. The more preferable concentration being about 3% to 10%.
I Other Ingredients
Many other ingredients, known to the person skilled in the art are used in these compositions. In gel composition Liquid paraffin is used as an emollient solvent, polyoxy 40 hydrogenated castor oil, (Cremophor RH 40 ) is used as an emulsifier for the mixing of the oil and water. For the proper spreading of the gel while application a film former is required. Povidone is used a film former in the gel composition. D Panthenol is used as a provitamin.
J Aesthetic Ingredients
Hair treatment compositions are frequently opacified or pearlised to enhance consumer appeal. Examples of opacifying agents include higher fatty acid alcohols, solid esters, high molecular weight fatty amides and alkanol amides and various fatty acid derivatives such as propylene glycol and polyethylene glycol esters. Preferred esters include polyethylene glycol distearates and ethylene glycol distearates. The level of opacifying or pearlescing agent employed is generally from 0.5% to 5%, preferably 0.5% to 2%.
The other ingredients used in the hair treatment compositions include colouring agents and fragrances etc.
In the present invention colour caramel is used as the colouring agent, Shikakai perfume, Perfumer AF and Perfume Legendry is used as a fragrance.
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In another aspect the invention provides a process for preparing a hair care composition comprising the steps of:
a) preparing the dispersion of viscosity modifier / thickener/gelling agent in water
b) addition of preservative
c) addition of excipients and active ingredient to above step
d) mixing and
e) pH adjustment.
The invention is described in detail herebelow with respect to the following examples which are provided merely for illustration and are not intended to restrict the scope of the invention in any manner. Any embodiments that may be apparent to a person skilled in the art are deemed to fall within the scope of the present invention.
Example A: PROCEDURE FOR GEL PREPARATION
Check the area and equipments for cleanliness. Filter through 100 mesh purified water IP to a capacity storage vessel. Prepare gel using suitable gelling agent and add to it the solution of methyl paraben and propyl paraben.
To the above step, add solution of Povidone IP (PVP K-30). Mix it well. Prepare the solution of Ketoconazole in propylene glycol IP and Tween 80 IP under heating. When a clear solution is formed, allow the temperature to reach 50°C± 10°C Add above mixture to gel. Heat the gel to 60 °C ± 10 °C. In a clean SS jacketed vessel . Take liquid paraffin IP ( Heavy ), Tween 80 IP, Cremophor RH 40 USPNF, Dimethicone IP, heat them together to 60 °C ± 10 °C. temperature. Mix it well. Add and mix to the above step. ( Temperature of both gel phase & oil phase should be 60 °C ± 10 °C. ). Continue mixing till room temperature is reached. In separate SS vessel mix in purified water. D-Panthenol add it to above step followed by Sodium PCA 50% aqueous solution. Make slurry of Zinc Pyrithione 50 % FPS. with Tween 80 in purified water triturate it well to form its free flowing liquid form. Mix the contents and stir it well. Rinse the SS vessel of above with water and add it to the bulk gel. Further, add appropriate perfume such as AF
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2375 (M/s AFF), Perfume Legendry (M/s IFF). At last, check the weight and pH of the preparation. Limit for pH 6.5 ± 0.5.
Note: The gelling agent :
Carbomer 940 ; the pH adjustment is done with help of by using NaOH (20 % solution).
EXAMPLE B: PROCEDURE FOR PREPARATION OF SHAMPOO
Check the areas and equipments for cleanliness, disperse under continuous stirring Hydroxy propoxy methyl cellulose K4M in purified water. Take care to avoid lump formation. In separate SS vessel dissolve Imidurea in purified water. In separate SS vessel dissolve ammonium chloride in purified water. Add this to the above step. Mix it well. In separate SS vessel dissolve Methyl paraben and propyl paraben in propylene glycol and add to the above mixture.
In separate SS vessel dissolve Ethylene glycol distearate in purified water and add to above mixture.
In other SS vessel dissolve Ketoconazole in propylene glycol and then transfer to the above step.
In another SS vessel Ammonium Lauryl sulphate, ammonium laureth sulphate, Cocamido Propyl Betaine and Amisoft ECS 22 SB. Mix it well.
To the contents of above step, add Zinc pyrithrone 50% FPS solution after dissolving it in 3 lit of purified water. Add D-panthenol, colour caramel and shikakai perfume.
Mix it well and pass through (# SS 20 sieve). At last check the volume and pH of the preparation.
Note : The pH adjustment is done with help of by using NaOH (20 % solution) and 0.1 N HC1.
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EXAMPLE 1: GEL
Composition -: Ketoconazole IP 2% w/w
Zinc Pyrithione 1 % w/w

SR.NO INGREDIENTS QTY IN %
1 Carbomer 940(Carbopol 940-M/sNoveon) 0.40
2 Xanthum Gum 0.20
3 Povidon K 30 0.1
4 Sodium PCA 0.02
5 Propylene Glycol 4.00
6 Methyl Paraben 0.20
7. Propyl Paraben 0.02
8 Ketoconazole 2.00
9 Zinc Pyrithione (50% Slurry) 2.00
10 Tween 80 1.0
11 Perfume AF 0.1
12 D-Panthenol 0.01
13 Liquid Paraffin 30
14 Cremophore 1.0
15 Dimethicone 0.5
16 Perfume Legendry 0.2
17 Purified Water Qs
The above composition was attempted for formation of a gel, by simply admixing the above ingredients However, it was found after preparation that the composition so prepared was not consistent / homogeneous. Such a composition cannot be used at a commercial level and passed on to consumers.
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EXAMPLE 2: GEL
Composition -: Ketoconazole IP 2% w/w
Zinc Pyrithione 1 % w/w

SR.NO INGREDIENTS QTY IN %
1 Carbomer 940(Carbopol 940-M/sNoveon) 0.40
2 Xanthum Gum 0.20
3 Povidon K 90 0.1
4 Sodium PCA 0.02
5 Propylene Glycol 4.00
6 Methyl Paraben 0.20
7. Propyl Paraben 0.02
8 Ketoconazole 2.00
9 Zinc Pyrithione 1.00
10 Tween 80 1.0
11 Perfume AF 0.3
12 Perfume Legendry 0.2
13 D-Panthenol 0.05
14 Liquid Paraffin 40
15 Cremophore 1.0
16 Dimethicone 0.5
17 Purified water Qs.

EXAMPLE 3: GEL
Composition -: Ketoconazole IP 2% w/w
Zinc Pyrithione l%w/w

SR.NO INGREDIENTS QTY IN %
1 Carbomer 940(Carbopol 940- M/sNoveon) 0.40
2 Dimethicone 2.0
3 Povidon K 90 0.1
4 Sodium PCA 0.2
5 Propylene Glycol 4.00
6 Methyl Paraben 0.20
7. Propyl Paraben 0.02
8 Ketoconazole 2.00
9 Zinc Pyrithione 1.00
10 Tween 80 1.0
11 Perfume AF 0.3
12 Cremophore 1.0
13 Liquid Paraffin 40
14 Purified water Qs
Product of Example 2 and 3 were found suitable for consumers.

EXAMPLE 4 : SHAMPOO
Composition -: Ketoconazole IP 2% w/v
Zinc Pyrithione 1% w/v

SR NO INGREDIENTS QTYIN %
l Ketoconazole 2
2 Propylene Glycol 5.0
3 Imidurea 0.5
4 Methyl Paraben 0.2
5 Propyl Paraben 0.02
6 Ammonium Lauryl Sulphate 15.0
7 Ammonium Laureth Sulphate 30
8 Cocamido Propyl Betaine 3.0
9 Ethylene Glycol Distearate 1.0
10 Zinc Pyrithrone 1.0
11 Ammonium Chloride 12
12 HPMC K4M 0.8
13 Shikakai Perfume 0.30
14 Colour Caramel 0.78
15 Purified Water Qs

EXAMPLE 5 : SHAMPOO
Composition -: Ketoconazole IP 2% w/v
Zinc Pyrithione 1 % w/v

SR NO INGREDIENTS QTYIN %
l Ketoconazole 2
2 Propylene Glycol 2.0
3 Imidurea 0.5
4 Methyl Paraben 0.2
5 Propyl Paraben 0.02
6 Sodium Lauryl Sulphate 10.0
7 Sodium Laureth Sulphate 35.0
8 Cocamido Propyl Betaine 3.0
9 Ethylene Glycol Distearate 1.0
10 Zinc Pyrithrone 1.0
11 Sodium Chloride 2.0
12 HPMC K4M 1.0
13 Purified Water Qs
The above composition was attempted for formation of a shampoo by simply admixing the above ingredients. However, it was found after preparation that the composition so prepared was not consistent / homogeneous and was consisting of precipitated residue. Such a composition cannot be used at a commercial level and passed on to consumers.
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EXAMPLE 6 : SHAMPOO
Composition -: Ketoconazole IP 2% w/v
Zinc Pyrithione 1 % w/v

SR NO INGREDIENTS QTYIN %
1 Ketoconazole 2
2 Propylene Glycol 5
3 Imidurea 0.5
4 Methyl Paraben 0.2
5 Propyl Paraben 0.02
6 Ammonium Lauryl Sulphate 15.0
7 Ammonium Laureth Sulphate 40.0
8 Cocamido Propyl Betaine 3.0
9 Ethylene Glycol Distearate 1.0
10 Zinc Pyrithrone 1.0
11 Ammonium Chloride 0.2
12 Xanthum Gum 2.0
13 Purified Water Qs

EXAMPLE 7 : SHAMPOO
Composition -: Ketoconazole IP 2% w/v
Zinc Pyrithione 1 % w/v

SR NO INGREDIENTS QTYIN %
1 Ketoconazole 2
2 Propylene Glycol 2
3 Imidurea 0.5
4 Methyl Paraben 0.2
5 Propyl Paraben 0.02
6 Ammonium Lauryl Sulphate 10.0
7 Ammonium Laureth Sulphate 35.0
8 Cocamido Propyl Betaine 3.0
9 Ethylene Glycol Distearate 1.0
10 Zinc Pyrithrone 1.0
11 Hydroxy Propyl Cellulose 1.0
12 Disodium EDTA 0.1
13 Purified Water Qs

EXAMPLE 8 : SHAMPOO
Composition -: Ketoconazole IP 2% w/v
Zinc Pyrithione 1 % w/v

SR NO INGREDIENTS QTYIN %
l Ketoconazole 2
2 Propylene Glycol 5
3 Imidurea 0.5
4 Methyl Paraben 0.2
5 Propyl Paraben 0.02
6 Ammonium Lauryl Sulphate 15.0
7 Ammonium Laureth Sulphate 30.0
8 Cocamido Propyl Betaine 3.0
9 Ethylene Glycol Distearate 1.0
10 Zinc Pyrithrone 2.0
11 Ammonium Chloride 1.2
12 Hydroxy Propyl Methyl Cellulose 1.2
13 Colour Caramel 0.78
14 Amisoft ECS 22 SB 3.0
15 D-Panthenol 0.2
16 Shikakai Perfume AFF 0.3
17 Purified Water Qs to 1.5 Lt

EXAMPLE 9 : SHAMPOO
Composition -: Ketoconazole IP 2% w/v
Zinc Pyrithione 1% w/v

SR NO INGREDIENTS QTYIN %
l Ketoconazole 2
2 Propylene Glycol 5
3 Imidurea 0.5
4 Methyl Paraben 0.2
5 Propyl Paraben 0.02
6 Ammonium Lauryl Sulphate 15.0
7 Ammonium Laureth Sulphate 30.0
8 Cocamido Propyl Betaine 3.0
9 Ethylene Glycol Distearate 1.0
10 Zinc Pyrithrone 2.0
11 Ammonium Chloride 1.2
12 Hydroxy Propyl Methyl Cellulose 1.2
13 Colour Caramel 0.78
14 Amisoft ECS 22 SB 3.0
15 D-Panthenol 0.2
16 Shikakai Perfume AFF 0.3
17 Purified Water Qs to 1.5 Lt

EXAMPLE 10 : SHAMPOO
Composition -: Ketoconazole IP 2% w/v
Zinc Pyrithione 1 % w/v

SR NO INGREDIENTS QTYIN %
1 Ketoconazole 2
2 Propylene Glycol 5
3 Imidurea 0.5
4 Methyl Paraben 0.2
5 Propyl Paraben 0.02
6 Ammonium Lauryl Sulphate 15.0
7 Ammonium Laureth Sulphate 30.0
8 Cocamido Propyl Betaine 3.0
9 Ethylene Glycol Distearate 1.0
10 Zinc Pyrithrone 2.0
11 Ammonium Chloride 1.2
12 Hydroxy Propyl Methyl Cellulose 1.2
13 Colour Caramel 0.78
14 Glycerine 3.0
15 D-Panthenol 0.2
16 Shikakai Perfume AFF 0.3
17 Purified Water Qs to 1.5 Lt
Compositions of Example 4 to 10 were found to be excellent for consumers.

ADVANTAGES:
The composition of the present invention has the following advantages over the prior art:
a) The composition is capable of being easily delivered to the desired regions of the scalp.
b) The composition is retained on the desired region of the scalp for a longer duration.
c) The composition avoids usual side effects such as change in hair texture, blisters on scalp, dry skin, itching, oily or dry hair or scalp irritation, or stringing.
d) The composition has good consistency, smoothness, pleasant odour and good colour. WE CLAIM:

1) A novel hair care composition comprising an effective amount of ketoconazole, zinc pyrithione and an agent selected from Amisoft ECS 22 SB and Sodium PCA optionally with anti-microbial agents and acceptable excipients.
2) A composition as claimed in claim 1, wherein the physical form of the composition is selected from gel and shampoo.
3) A composition as claimed in claim 1, wherein the excipients are selected from a moisturizer, humectant, viscosity modifier, film former, emollient solvent, provitamin, perfume, gelling agent, thickener, surfactant, preservative and solubilizer.
4) A composition as claimed in claim 1, wherein the amount of ketoconazole is 0.5% to 5%.
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5) A composition as claimed in claim 1, wherein the amount of zinc pyrithione is about 0.1% to 10%.
6) A composition as claimed in claim 1, wherein the amount of Amisoft ECS 22 SB is about l%to 10%.
7) A composition as claimed in claim 1, wherein the amount of Sodium PC A is about 0.001% to 0.1%.
8) A composition as claimed in claim 1, wherein the gelling agent is an acrylic acid co-polymer.
9) A process for preparing a composition as claimed to claim 1, comprising the steps of:

a) preparing the dispersion of viscosity modifier / thickener/gelling agent in water;
b) adding preservative;
c) adding excipients and active ingredients to the mixture of step (b);
d) mixing; and
e) adjusting pH to obtain the composition of claim 1.
10) A hair care composition and a process for preparing the hair care composition
substantially as hereindescribed with reference to the examples.
Dated this 30m day of June, 2005.
[RAJESHWARI H.]
K & S PARTNERS
ATTORNEY FOR THE APPLICANTS
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