DESC:TOPICAL ANTI-ITCH COMPOSITION
TECHNICAL FIELD OF THE INVENTION
The present application relates to a topical anti-itch compositions comprising butters or moisturizers, zinc oxide, pramoxine or its pharmaceutically acceptable salt, emulsifying agents, purified water and other ingredients to form useful therapeutic, dermatological, pharmaceutical, medical or cosmetic compositions for treatment of skin maladies and disorders, namely itchiness associated with the dry skin, eczema and restores the affected areas of skin to a normal condition. The present invention also relates to the process for preparing such compositions.
BACKGROUND OF THE INVENTION
Anti pruritics (anti-itch medications) have been used for years for a variety of causes, but the world lacks a safe treatment that will provide relief for most or all of these nuisance or painful conditions.
Antihistamines such as diphenhydramine (Benadryl), corticosteriods such as 1% hydrocortisone cream on the OTC market and Topicort 0.25% or 0.05% desoxymetasone by prescription, local anesthetics such as benzocaine topical cream (Lanacane®), and counter-irritants such as mint oil, menthol or camphor have been used for treatment of disorders associated with the dry skin. Dilute ammonium hydroxide is marketed for use on mosquito bites, where it can neutralize the acid component of the sting. Benzyl alcohol and pramoxine hydrochloride are often used at 10% and 1% concentrations respectively. Benadryl® is an itch stopping spray containing active ingredients identified as diphenhydramine hydrochloride 2% as a topical analgesic and zinc acetate 0.1% as a skin protectant, and reference is made to its use for insect bites, poison ivy, mosquito bites, sunburn and minor cuts and scrapes.
Antihistamines are used sometimes for treatment of bee and wasp stings, as these often cause allergies. Some folks are allergic to Benzocaine in products such as Lanacane, which sometimes is a cause for itching of skin or headaches, according to the Mayo Clinic.
The old-time anti-itch treatments of Epsom salts (magnesium sulfate solution in water) and calamine lotion (calcium hydroxide solution, and zinc oxide dispersion in water, sometimes with a tint of ferric oxide) are of particular interest. However, it appears that these formulations are very limited in ability to deliver any useful chemicals to nerve endings. Their deficiencies are in the use of water for delivery of the cations. Water does not readily penetrate the skin, lest swimmers and bathers become balloons or become Michelin Men.
Thus there always remains a need for a topical anti-itch composition comprising combination of moisturizers, emulsifying agents, zinc oxide, pramoxine and other ingredients which reduces itching of the skin due to dryness, eczema or any other dry skin related conditions and which can offer minimal or no systemic side effects, and also with minimum or no irritancy to the skin.
OBJECT OF THE INVENTION
The present invention relates to a topical anti-itch compositions comprising butters or moisturizers, zinc oxide, pramoxine or its pharmaceutically acceptable salt, emulsifying agents, vehicle or base and process for preparing such compositions.
In one aspect the present invention relates to a topical anti-itch composition comprising:
i) Butters or moisturizing agents,
ii) zinc oxide
iii) pramoxine or its pharmaceutically acceptable salt
iv) emulsifying agent
v) and a base / vehicle

In another aspect the present invention relates to a topical anti-itch composition comprising:
i) Butters or moisturizing agents
ii) zinc oxide
iii) pramoxine or its pharmaceutically acceptable salt
iv) emulsifying agents
v) emollient
vi) humectant and
vii) a base/vehicle comprising of purified water along with one or more pharmaceutically acceptable excipients.
In still another aspect the present invention relates to a topical anti-itch composition comprising:
(i) one or more Butters or Moisturizing agents,
(ii) zinc oxide
(iii) pramoxine or its pharmaceutically acceptable salt
(iv) one or more Emulsifying agents
(v) one or more emollients
(vi) one or more humectant
(vii) And a base/vehicle comprising purified water along with one or more pharmaceutically acceptable excipients.

In yet another aspect, the present invention relates to the process of preparing the topical anti-itch compositions of the present invention

In yet another aspect, the present invention relates to use of topical anti-itch composition for treating and preventing psoriasis, atopic dermatitis or other skin disorders such as dry skin, eczema, red skin, inflamed skin, and/or cracked skin, for the relief of itching and the restoration of the affected areas of skin to a normal condition.
DESCRIPTION OF INVENTION
The present invention relates to topical anti-itch compositions comprising butters, moisturizers, zinc oxide, pramoxine or its pharmaceutically acceptable salt, emulsifying agents, vehicle or base and process for preparing such compositions.
In one aspect the present invention relates to a topical anti-itch composition comprising:
i) Butters or moisturizing agents,
ii) zinc oxide
iii) pramoxine or its pharmaceutically acceptable salt
iv) emulsifying agent
v) and a base / vehicle

In one aspect the present invention relates to a topical anti-itch composition comprising:
i) Butters or moisturizing agents
ii) zinc oxide
iii) pramoxine or its pharmaceutically acceptable salt
iv) emulsifying agents
v) emollient
vi) humectant and base/vehicle comprising of purified water along with one or more pharmaceutically acceptable excipients.

In one aspect the present invention relates to a topical anti-itch composition comprising:
(i) one or more Butters or Moisturizing agents,
(ii) zinc oxide
(iii) pramoxine or its pharmaceutically acceptable salt
(iv) one or more Emulsifying agents
(v) one or more emollients
(vi) one or more humectant; and
(vii) a base/vehicle comprising purified water along with one or more pharmaceutically acceptable excipients.

In yet another aspect, the present invention relates to the process of preparing the topical anti-itch compositions of the present invention
In yet another aspect, the present invention relates to use of topical anti-itch composition for treating and preventing psoriasis, atopic dermatitis or other skin disorders such as dry skin, eczema, red skin, inflamed skin, and/or cracked skin, for the relief of itching and the restoration of the affected areas of skin to a normal condition.
The term "comprising" (and its grammatical variations) as used herein is meant to be open ended and used in the inclusive sense of "having" or "including" and not in the exclusive sense of “consisting only of." The term "consists essentially of," as used herein means the claimed elements and others, but is meant to exclude things that are inconsistent with the basic and novel characteristics of the inventions.
As used herein, the term “topical" is used in its conventional sense to mean delivery of a drug or pharmacologically active agent to the skin or mucosa, as in, for example, the treatment of various skin disorders. Topical administration, in contrast to transdermal administration, primarily provides a local rather than a systemic effect.
The term "composition" is intended to encompass a combination including active ingredients and judiciously selected pharmaceutically acceptable excipients. The term "excipient" or "pharmaceutically acceptable excipient" means a component of a pharmaceutical product that is not a pharmacologically active ingredient, such as filler, diluent, carrier, preservative, etc. The excipients that are useful in preparing pharmaceutical compositions are generally safe, non- toxic, and are acceptable for veterinary use as well as human pharmaceutical or cosmetic use. The term includes both one and more than one such excipients. The skin care composition of the present invention may be in the form of lotions, liquids, creams, gel, etc. that are suitable for topical administration.
Useful pharmaceutical acceptable excipients of the present invention include, but are not limited to vehicles or diluents, moisturizers, plasticizers, film forming agents, chelating agents, thickening or gelling agents, neutralizers, emulsifying agents, emollients, humectants, preservatives, antioxidants, solvents, fragrance imparting agents, and the like, including any combinations of two or more thereof.
In an aspect of the, the topical anti-itch composition of the present application comprises one or more base(s) or vehicle to prepare pharmaceutically acceptable topical dosage form.
In another aspect, the topical anti-itch composition of the present application comprises one or more materials used as vehicle. The vehicle includes, but are not limited to, water or water-miscible solvents such as glycerin or propylene glycol and the like thereof.
In an aspect of the above embodiments, the topical anti-itch composition of the present application comprises one or more base(s) or vehicle in an amount from about 2% w/w to about 98% w/w, in an amount from about 5% w/w to about 95% w/w, in an amount from about 10% w/w to about 90% w/w, in an amount from about 15% w/w to about 90% w/w, in an amount from about 20% w/w to about 90% w/w, in an amount from about 30% w/w to about 90% w/w, in an amount from about 40% w/w to about 90% w/w, in an amount from about 50% w/w to about 90% w/w, in an amount of about 50% w/w, about 55% w/w, about 60% w/w, about 65% w/w, about 70% w/w, about 75% w/w, about 80% w/w, about 85% w/w or about 90% w/w, or about 95% w/w based on total weight of the composition.
The term “anti-itch” skin conditions as used herein refers to the dry skin condition that for example may arise from a bug bite, allergies, cold weather, a chronic skin condition like eczema, dermatitis, dry skin condition as such.
In an embodiment the pramoxine or it’s pharmaceutically acceptable salts i.e., hydrochloride salts is added as a penetration enhancer in addition to its anti-itch property. Pramoxine HCl provide short-term relief from itching by stopping nerves from sending pain signals. Pramoxin or pramoxine HCl is present in concentrations ranging from about 0.1%w/w to about 10% w/w of the total weight of the composition, about 1% w/w, about 2% w/w, about 3% w/w, about 4% w/w or about 5% w/w of the total weight of the composition.
In an embodiment the composition of the present invention comprises zinc oxide. It is generally a mild astringent and topical protectant with some antiseptic action. In other embodiments, in lieu of, or in addition to, zinc oxide, one or more of the following may be used: oxozinc; amalox; and the like. Zinc oxide is present in concentrations ranging from about 0.1%w/w to about 5% w/w of the total weight of the composition, about 0.1% w/w, about 0.2% w/w, about 0.5% w/w, about 3% w/w or about 5% w/w of the total weight of the composition.
The term butters and moisturizing agents or mositurizers are used as synonymously.
The topical anti-itch compositions of the present invention include one or more butters as an excipient. Butters play a main role in healing the conditions, due to their unique fatty acid profiles and high contents of vitamins E and A that contribute to its protective and hydrating properties. Some butters also have natural UV protection which helps in effective skin moisturization and visibly reduces the appearance of fine lines and wrinkles. Butter helps to nourish and rejuvenate skin cells making the skin feel soft, silky and smooth. Representative examples of the butters that are usable in the context of present invention include, but are not limited to, cocoa butter, Shea butter, mango butter, aloe butter, pumpkin seed butter, kokum butter, mowrah butter, coconut lime verbena body butter, cranberry butter, Coconut Butter and Oil etc.
Shea butter has a unique fatty acid profile and the high content of vitamins E and A contributes to its protective and hydrating properties. Clinical trials have shown that Shea butter provides natural ultraviolet (UV) radiation protection, is an effective skin moisturizer, and visibly reduces the appearance of fine lines and wrinkles. It may be used in concentrations ranging from about 1% to about 7% w/w.
Cocoa butter is the cream-colored fat extracted from cacao seeds (cocoa beans) and used to add flavor, scent, and smoothness to chocolate, cosmetics, tanning oil, soap, and a multitude of topical lotions and creams. Cocoa butter has been called the "ultimate moisturizer," and has been used to keep skin soft and supple. It is one of the most stable, highly concentrated natural fats known, and melts at body temperature so that it is readily absorbed into the skin. Cocoa butter is often recommended for treatment of skin conditions such as eczema and dermatitis. When applied topically, it creates a barrier between sensitive skin and the environment and also helps retain moisture. It may be used in concentrations ranging from about 1% to about 7% w/w.
Mango butter has natural emollient properties, high oxidative ability, wound healing, and regenerative activity. Mango butter has been traditionally used in the rainforests and tropics for its skin softening, soothing, moisturizing and protective properties, and to restore flexibility and reduce degeneration of skin cells. It has a protective effect against UV radiation. It is used to treat eczema and dermatitis. It may be used in concentrations ranging from about 1% to about 7% w/w.
Aloe butter is a soft solid butter at room temperature, which melts on contact at skin temperatures. Aloe butter may be used for cutaneous dryness, to assist in moisturization after exposure to sun and other harsh elements. It may be used in concentrations ranging from about 1% to about 7% w/w.
The topical anti-itch compositions of the present invention include one or more emulsifying agents. Examples of emulsifying agents that are useful for preparing compositions of the present invention include, but are not limited to, sodium lauryl sulfate, sodium laureth sulfate (or sodium lauryl ether sulfate), polysorbate 60, polysorbate 80, emulsifying wax, fatty acids having 12-18 carbon atoms, such as undecylenic acid, lauric acid, myristic acid, palmitic acid, stearic acid, cetostearyl alcohol, isostearic acid, aracel, oleic acid, hydroxyoleic acid, linoleic acid, and their derivatives, glyceryl stearate, Mono & Di glycerides NF (GMS Type II), propylene glycol monostearate, sorbitan monolaurate, sorbitan monopalmitate, sorbitan monostearate, sorbitan tristearate, sorbitan monooleate or sorbitan trioleate or mixtures thereof. In some embodiments, the emulsifying agent includes mixture of glyceryl stearate and polyethylene glycol-100 stearate (ARLACEL 165). Useful emulsifying agents further include emulsifying wax flakes, cetyl alcohol, acacia, carbomers, carrageenan, cetostearyl alcohol, ceresin wax, ceteareth-20, steareth-2, stearyl alcohol and any combinations thereof.
In an aspect of the above embodiments, the topical anti-itch compositions of the present application comprises one or more emulsifying agent(s) or emulsifier in an amount from about 0.1% w/w to about 30% w/w, in an amount from about 0.5% w/w to about 20% w/w, in an amount from about 1% w/w to about 10% w/w, in an amount of about 1% w/w, about 2% w/w, about 2.5% w/w, about 3% w/w, about 3.5% w/w, about 4% w/w, about 4.5% w/w, about 5% w/w, about 5.5% w/w, about 6% w/w, about 6.5% w/w, about 8% w/w, about 9% w/w, or about 10% w/w based on total weight of the composition.
The topical anti-itch compositions of the present invention may comprise a solubilizer. Suitable solubilizers include hexylene glycol, propylene glycol, polyethylene glycol or mixtures thereof. Preferred solubilizer includes propylene glycol. The amount of solubilizers employed in the composition is in the range of 1% to 20% (w/w) of total composition, e.g. 3% (w/w), 5% (w/w).
The topical anti-itch compositions of the present invention may comprise an emollient or mixture of emollients. Suitable emollients include, for example, stearyl alcohol, glyceryl monooleate, glyceryl monoricinoleate, glyceryl monostearate, cetyl alcohol, ispropyl isostearate, stearic acid, isobutyl palmitate, isocetyl stearate, oleyl alcohol, isopropyl laurate, hexyl laurate, decyl oleate, octadecan-2-ol, isocetyl alcohol, cetyl palmitate, dimethylpolysiloxane, di-n-butyl sebacate, isopropyl palmitate, isopropyl stearate, butyl stearate, polyethylene glycol, triethylene glycol, lanolin alcohol, sesame oil, coconut oil, arachis oil, castor oil, acetylated lanolin alcohols, petroleum, mineral oil, butyl myristate, isostearic acid, palmitic acid, isopropyl linoieate, lauryl lactate, myristyl lactate, decyl oleate, myristyl myristate, and mixture thereof. In some embodiments the emollient includes mixture of polysorbate 80, cetyl acetate, stearyl acetate, oleyl acetate acetylated lanolin alcohol (Crodalan AWS) or mixtures thereof.
In an aspect of the above embodiments, the topical anti-itch compositions of the present application comprises one or more emollients in an amount from about 0.1% w/w to about 30% w/w, in an amount from about 0.5% w/w to about 20% w/w, in an amount from about 1% w/w to about 10% w/w, in an amount of about 1% w/w, about 2% w/w, about 2.5% w/w, about 3% w/w, about 3.5% w/w, about 4% w/w, about 4.5% w/w, about 5% w/w, about 5.5% w/w, about 6% w/w, about 6.5% w/w, about 8% w/w, about 9% w/w, or about 10% w/w based on total weight of the composition.
The topical anti-itch compositions of the present invention may comprise aqueous base as required. The oil phase excipients include the butters, emollients, emulsifying agents and others. The emulsifying agents help the dispersion of oil phase and aqueous phase. The amount of water employed in the compositions is in the range of 3% to 20% (w/w) of total composition, e.g. 5% (w/w), 10% (w/w).
The topical anti-itch compositions of the present invention may further comprise a humectant. Examples of humectants that are useful in the context of the present invention include, but are not limited to, glycerin, propylene glycol, cyclomethicones, dimethicones, sorbitol, xylitol, urea, sugars and starches, sugar and starch derivatives (e.g., alkoxylated glucose), D-panthenol, hyaluronic acid, lactamide monoethanolamine, acetamide monoethanolamine, 2-pyrrolidone-5-carboxylic acid, urea, and any mixtures thereof.
In an aspect of the above embodiments, the topical anti-itch compositions of the present application comprises one or more humectants in an amount from about 0.1% w/w to about 30% w/w, in an amount from about 0.5% w/w to about 20% w/w, in an amount from about 1% w/w to about 10% w/w, in an amount of about 1% w/w, about 2% w/w, about 2.5% w/w, about 3% w/w, about 3.5% w/w, about 4% w/w, about 4.5% w/w, about 5% w/w, about 5.5% w/w, about 6% w/w, about 6.5% w/w, about 8% w/w, about 9% w/w, or about 10% w/w based on total weight of the composition.
The topical anti-itch compositions of the present invention may further comprise a thickener. Suitable thickeners include carboxylic acid polymers like carbomers (e.g. Carbopol.RTM. 954), acrylates/vinyl neodecanoate crosspolymer (e.g. Aculyn 38), natural gums (e.g. guar, xanthan), cellulose derivatives (e.g. carboxy methylcellulose, methyl cellulose), PEG 6000, polyvinyl alcohol and mixtures thereof.
The topical anti-itch compositions of the present invention may comprise one or more preservatives. Examples of preservatives include, but are not limited to, benzalkonium chlorate, bronopol, chlorhexidine, chlorocresol and its derivatives, mixture of methylisothiazolinone and phenoxyethanol (NEOLONE™ PE), phenoxyethanol, ethylic alcohol, phenethylic alcohol, potassium sorbate, diazolidinylurea, benzylic alcohol, parabens alone or in mixture.
The topical anti-itch compositions of the present invention may comprise one or more pH adjusting agents. Such ingredients include dermatologically acceptable acids, bases and buffers. The pH of the compositions can range from about 4 to about 10, but preferably is in the range of about 5 to about 8, in particular from about 5 to about 7.5.
The topical anti-itch compositions of the present invention may contain additional ingredients to improve the composition. Such ingredients include film formers, chelating agents, neutralizers, antioxidants, buffering agents. Examples of such ingredients are well known in the art.
The topical anti-itch compositions of the present invention can be manufactured using a method comprising:
a) preparing an oil phase by combining the oil soluble ingredients;
b) preparing an aqueous phase by combining water soluble ingredients in warm water, and adding a preservative;
and c) combining the aqueous phase of step b) and the oil phase of step a), followed by homogenization.

EXAMPLES
Example 1: Topical anti-itch compositions of the present invention
S.NO Name of Ingredients Example 1a
(%w/w) Example 1b
(%w/w) Example 1c
(%w/w) Example 1d
(%w/w)
1. Shea Butter 3 2 3 3
2. Mango Butter 1 2 2 1
3. Cocoa Butter 2 4 1 1
4. Aloe Butter 4 1 4 1
5. Cetyl Alcohol 1 1 3 2
6. Stearic Acid 1 - - 5
7. Emulsifying Wax 3 - - -
8. Steareth-21 - 1.5 1.0 -
9. Mono & Di glycerides - 3.1 2.5 -
10. Cyclomethicone 3 2 2 3
11. Dimethicone 10 Cst 1 1 - 1
12. Phenoxyethanol 1.5 0.1 2 0.5
13. Propylene Glycol 6 6 6 9
14. Glycerin 2 3 2 2
15. Disodium EDTA 0.2 0.2 0.2 0.2
16. Zinc Oxide 0.2 2 1.2 0.2
17. Fragrance 0.1 0.1 0.1 0.1
18. Pramoxine 1 2 3 2
19. Purified Water 70 69 67 69
100 100 100 100

Brief Manufacturing Process:
1. Aqueous Phase :
a) Purified Water is charged into aqueous phase vessel and heated
b) Weighed quantity of Propylene Glycol, Glycerin is added to step a
c) Added Disodium EDTA to the step 2 and stirred to form a clear solution
d) Pramoxine was added to step c under stirring and a clear solution is formed
e) Zinc oxide is added to step d under homogenization.
2. Oil Phase:
f) All ingredients of oil phase like butters and all are charged into oil phase vessel and heated with stirring until it gets melted and a clear solution is formed
3. Emulsification:
g) The oil phase was transferred to Aqueous Phase under stirring, cooled and homogenized
4. Final Mixing:
h) The preservative and fragrances were added to the above solution of step g and mixed uniformly.

Example 2:
Stability Study:
The stability of the topical composition as per the present specification was evaluated through accelerated stability studies. The composition prepared according to the formula and process of example 1and was subjected to stability study at 40 °C/75% RH. The compositions were found to be stable at accelerated conditions. Table 1 represents the study result data.
Table 1: Stability study of example 1
Example 1
Stability condition 40°C/75%RH
Time period Limits Initial 3M 6M 9M 12M
pH Between 4.0 -8.5 6.22 6.07 5.74 5.98 5.84
Assay NLT 80.0% 101.2 97.7 98.3 97.01 100.50
Viscosity(cP) Between 1500 – 9500 cP 3890 3585 3295 3365 3500

Example 3:
Clinical Study Report of the present invention:
A monocentric, single group study to evaluate the effect of topical composition of the present invention was done in participants with pruritis (w.r.t. onset of action and duration of action) after application of the composition of the present invention.
32 participants including men and women between 18 and 55 years of age. (inclusive) diagnosed with chronic pruritus with dryness and participants with chronic itch for more than 6 weeks and the participants with itch score on Visual analog scale (mild to moderate – equal to or less than 7 on VAS), on at least 1 site were enrolled in the study trail. The primary end point of the study was based on the patient questionnaire response taken, based on 10-point VAS (0 = no pruritus, > 0-< 4 points = mild pruritus, = 4-< 7 points = moderate pruritus, = 7-< 9 points = severe pruritus, and = 9 points = very severe pruritus), at baseline, 3min, 5min, 10min 15 min, 30 Min, 60min, 90 min, 2 hrs, 4hrs, 6hrs, 8hrs post application of test product post application of test product and time point at which participants need to reapply Atarax test product or the Itch free period was calculated. No adverse events were observed during the study duration.
Table 2: Mean Itch score over duration of study
Duration (minute/Hours) Mean Itch Score
X¯ ± SD (N = 32) Percentage Reduction in the mean versus baseline
Itch score- Before Application 5.922 ± 0.908 -
Itch score-3 mins 4.366 ± 2.034 26.3%
Itch score-5 mins 4.400 ± 2.080 25.7%
Itch score-10 mins 4.281 ± 2.143 27.7%
Itch score-15 mins 4.250 ± 2.178 28.2%
Itch score-30 mins 4.109 ± 2.115 30.6%
Itch score-1 hr. 3.734 ± 1.942 36.9%
Itch score-90 mins 3.291 ± 1.822 44.4%
Itch score-2 hrs 3.044 ± 1.626 48.6%
Itch score-4 hrs 2.781 ± 1.460 53.0%
Itch score-6 hrs 2.459 ± 1.241 58.5%
Itch score-8 hrs 1.959 ± 1.380 66.9%

Conclusion: At the end of the study there was significant reduction in itching post application test product of the present invention in the participants with chronic pruritus and also the onset of action was at 3 min after application and significant reduction was observed in pruritus over duration of 8 hours.
,CLAIMS:We Claim:
1. A topical anti-itch composition comprising butters or moisturizers, zinc oxide, pramoxine or its pharmaceutically acceptable salt, emulsifying agents, vehicle or base and process for preparing such compositions.
2. The topical anti-itch composition, as claimed in claim 1, wherein the amount of pramoxine is in the range of 0.1 % w/w to 10 % w/w of total composition.
3. The topical anti-itch composition, as claimed in claim 1, wherein the amount of zincoxide is in the range of 0.1% w/w to about 5% w/w of total composition.
3. The topical anti-itch composition, as claimed in claim 1, wherein the butters are selected from cocoa butter, shea butter, mango butter, aloe butter, pumpkin seed butter, coconut lime verbena body butter, cranberry butter or mixtures thereof.
4. The topical composition as claimed in claim 3, wherein the butters are selected from cocoa butter, shea butter, mango butter, and aloe butter and combinations thereof.
5. The topical composition as claimed in claim 4, wherein the butters are selected from 1.0% w/w to 7% w/w of cocoa butter, 1.0% w/w to 7% w/w of shea butter, 1.0% w/w to 7% w/w mango butter, and 1.0% w/w to 7% w/w aloe butter and combination thereof.
6. The topical composition as claimed in claim 1, wherein the emulsifying agents are selected from sodium lauryl sulfate, sodium laureth sulfate (or sodium lauryl ether sulfate), polysorbate 60, polysorbate 80, emulsifying wax, fatty acids having 12-18 carbon atoms, cetostearyl alcohol, isostearic acid, aracel, oleic acid, hydroxyoleic acid, linoleic acid, glyceryl stearate, polyethylene glycol-100 stearate, propylene glycol monostearate, sorbitan monolaurate, sorbitan monopalmitate, sorbitan monostearate, sorbitan tristearate, sorbitan monooleate or sorbitan trioleate or mixtures thereof
7. The topical composition as claimed in claim 5, where in the emulsifying agents are present in an amount of 0.1 % w/w to about 30% w/w.
8. The topical anti-itch composition, as claimed in claim 1, further comprises, solubilizer and emollient.
9. The topical composition, as claimed in claim 4, wherein the solubilizers are selected from hexylene glycol, propylene glycol, polyethylene glycol or mixtures thereof and is present in an amount of 1% to 20% (w/w) of total composition.
10. The topical skin care composition as claimed in claim 1, wherein the composition is in the form of cream, lotion, gel.