FORM 2
THE PATENTS ACT, 1970
(39 of 1970)
&
The Patents Rules, 2003
COMPLETE SPECIFICATION
(See section 10; rule 13)
1. Title of the invention -"A STABLE CHEMICAL PEELING COMPOSITION"
2. Applicant(s)
(a) NAME :Brillare Science
(b) NATIONALITY :An Indian Company
(c) ADDRESS :Brillare Science, D-603 Ganesh Meridian,
Nr.Gujarat High Court, S.G.Highway, Ahmedabad-3 80060, Gujarat, INDIA
3. PREAMBLE TO THE DESCRIPTION
The following specification particularly describes the invention and the manner in which it is to be performed:

A STABLE CHEMICAL PEELING COMPOSITION
FIELED OF THE INVENTION
The present invention relates a stable chemical peeling composition comprising glycolic acid and an auxiliary diluent which is less irritant and stable at high temperature without any anti-oxidant or any other stability enhancing additives or buffering system.
BACKGROUND OF THE INVENTION
Chemical peel is a body treatment technique used to improve and smooth the texture of the facial skin using a chemical solution that causes the dead skin to slough off and eventually peel off. The regenerated skin is usually smoother and less wrinkled than the old skin. Thus the term chemical peel is derived.
There are several types of chemical peels known in the market
Alpha hydroxy acid peels
Alpha hydroxy acids (AHAs) are naturally occurring carboxylic acids such as glycolic acid, a natural constituent of sugar cane juice and lactic acid, found in sour milk and tomato juice. This is the mildest of the peel formulas and produces light peels for treatment of fine wrinkles, areas of dryness, uneven pigmentation and acne. Alpha hydroxy acids can also be mixed with a facial wash or cream in lesser concentrations as part of a daily skin-care regimen to improve the skin's texture. There are five usual fruit acids: citric acid, glycolic acid, lactic acid, maleic acid and tartaric acid. Many other alpha hydroxy acids exist and are used. AHA peels may cause stinging, skin redness, skin irritation, and dryness and therefore genrally advisable to use in low concentration.
Beta hydroxy acid peels
It is becoming common for beta hydroxy acid (BHA) peels to be used due to BHA's ability to get deeper into the pore than AHA. Studies show that BHA peels

control sebum excretion, acne as well as remove dead skin cells to a certain extent. Salicylic acid is a beta hydroxy acid.
Jessner's peel
Jessner's peel solution, formerly known as the Coombe's formula, was pioneered by Dr Max Jessner, a German-American dermatologist. Dr Jessner combined 14% salicylic acid, lactic acid, and resorcinol in an ethanol base. It is thought to break intracellular bridges between keratinocytes. It is very difficult to "overpeel" the skin due to the mild percentages associated with the acid combination.
Retinoic acid peel
Retinoic acid is a retinoid. This type of facial peel is also performed in the office of a plastic surgeon or a dermatologist in a medical spa setting. This is a deeper peel than the beta hydroxy acid peel and is used to remove scars as well as wrinkles and pigmentation problems. It is usually performed in conjunction with a Jessner; which is performed right before, in order to open up the skin, so the retinoic acid can penetrate on a deeper level. The client leaves with the chemical peel solution on their face. The peeling process takes place on the third day. More dramatic changes to the skin require multiple peels over time.
Trichloroacetic acid peels
Trichloroacetic acid (TCA) is used as an intermediate to deep peeling agent in concentrations ranging from 20-50%. Depth of penetration is increased as concentration increases, with 50% TCA penetrating into the reticular dermis. Concentrations higher than 35% are not recommended because of the high risk of scarring.
Phenol peels
Phenol is the strongest of the chemical solutions and produces a deep skin peel. Some publications claim that phenol peel effect could be due to the action of croton oil and that phenol would not be effective without this oil. In reality, many phenol peel solutions exist that do not contain croton oil. This last is only a

penetration enhancer, acting at the epidermal very superficial layers. Croton oil is not the only penetration enhancer that can be used.
Phenol peels may pose a risk of arrythmias if applied without following strict rules, permanently remove facial freckles, many formulas cause permanent skin lightening by reducing the ability to produce pigment require increased protection from the sun permanently.
Glycolic acid is the main acid which is used generally for the chemical peeling. In general practice the glycolic acid cannot be used directly as it may cause irritation as well as skin damages due to its acidic nature. In normal practice the glycolic acid has to be diluted with water in presence of little humectants and buffering system. When the glycolic acid is diluted with water, it poses the stability problem on long time storage and also on exposure to high temperature. Further for the better effect or deep peeling high concentration of glycolic acid needs to be used but on other side high concentration of glycolic acid gives more irritation to the skin and can also damages skin badly. Further to prevent the unstabilization and maintain pH, the buffering systems needs to be added which further adds the cost as well as compatibility issue with the glycolic acids. Further glycolic acid poses stability issues at higher concentration as well at higher temperature in presence of water.
US5961999 relates to a skin care composition and method of skin care using a preparation containing a betaine ester and an alpha-hydroxy acid for care of the skin.
CN102018632 discloses a high-efficiency moisturizing composition and a preparation method and application thereof in cosmetics. The high-efficiency moisturizing composition contains chitosan glycolate and trimethylglycine. In the invention, glycolic acid is utilized for modifying the chitosan, chitosan glycolate the water solubility of which is improved is obtained, and the composition combines good moisturizing effect of the water soluble chitosan and good skin care effect of glycolic acid. In the invention, the chitosan glycolate is

compounded with the amino acid moisturizing agent trimethylglycine, thus further improving the moisturizing effect in cosmetics and achieving synergism. The high-efficiency moisturizing composition can be applied to preparation of cosmetics, and the prepared cosmetics have good moisturizing effect.
US20090069213 discloses a microalgal skin care compositions and methods of improving the health and appearance of skin. Also provided are methods of using polysaccharides for applications such as topical personal care products, cosmetics, and wrinkle reduction compositions. The invention also provides novel decolorized microalgal compositions useful for improving the health and appearance of skin.
JP2002179528 discloses a peeling cosmetic comprises an alpha-hydroxy acid lactide and/or an alpha-hydroxy acid anhydride such as glycolic acid anhydride as an essential component. Especially the alpha-hydroxy acid lactide and/or the alpha-hydroxy acid anhydride is formulated with a placenta essence, sodium hyaluronate, an aloe essence, squalane, collagen, a licorice essence, etc.
WO200592285 discloses a preparation to be applied externally to the skin which contains an inositol derivative in which an inositol and a saccharide are combined. The invention aims to provide an external skin preparation that can be spread over skin without causing a granular feeling and has excellent moisturising effects and of keeping the skin healthy.
Hence there is long felt need in the society for a stable and less irritant chemical peeling composition with minimum ingredients and easy to prepare without any compatibility and stability as well as compliance issue.
The inventors of the present inventions have surprisingly found that the concentrated but still stable and less irritant chemical peeling composition of glycolic acid can be prepared by use of auxiliary diluent and also rules out the use of anti oxidants, preservatives and buffering system.

SUMMARY OF THE INVENTION
Main aspect in the broadest sense of the present invention is a stable chemical peeling composition comprising alpha hydroxy acid and an auxiliary diluent which gives less irritation to the skin on application and also exhibits stability at high temperature without any addition of anti oxidant, preservatives and buffering system.
Further aspect in the broadest sense of the present invention is a stable chemical peeling composition comprising glycolic acid and an auxiliary diluent which gives less irritation to the skin on application and also exhibits stability at high temperature without any addition of anti oxidant, preservatives and buffering system.
Another aspect of the present invention is a stable chemical peeling composition comprising 10 to 70% w/w of glycolic acid and 90 to 30% w/w of an auxiliary diluent.
Yet another aspect of the present invention is a stable chemical peeling composition comprising 20 to 50% w/w of glycolic acid and 50 to 80% w/w of an auxiliary diluent.
Yet one more aspect of the present invention is a stable chemical peeling composition comprising 10 to 70% w/w of glycolic acid and 90 to 30% w/w of xylitylglucoside and anhydroxylitol and xylitol.
Another aspect of the present invention is a stable chemical peeling composition comprising 10 to 70% w/w of glycolic acid and 90 to 30% w/w of xylitylglucoside and anhydroxylitol and xylitol.
Further aspect of the present invention is a stable chemical peeling composition comprising 20 to 50% w/w of glycolic acid and 50 to 80% w/w of xylitylglucoside and anhydroxylitol and xylitol.

One more aspect of the present invention is process for preparing the chemical peeling composition.
Further aspects and embodiments of the present invention will be provided in the detailed description below with more detailed explanation and will apparent to persons skilled in the art after reading the specification or can be learned from the practicing the embodiment of the present invention. The features and advantages of the present invention may be apparent and obtained as presented in the claims. As will be realized, the composition of the present invention can be practiced with different modification and alterations, all without departing from the scope of present invention. The description is to be considered as illustrative only and not as a restrictive manner.
DETAILED DESCRIPTION OF THE INVENTION
Chemical peeling involves the application of skin care formulation to the skin in a controlled manner, producing controlled tissue death. The desired depth of the wound is dependent upon the condition to be treated. After the peel, the skin regenerates. The damaged skin likely regenerates through the growth of cells from deeper layers of the epidermis or from undamaged hair follicles
The term "auxiliary diluent" as used herein means the vehicle or diluent used for the dilution of glycolic acid.
The term "about" as described herein means that values slightly outside the cited values, i.e., plus or minus 5 to 10%.
The composition of present invention can be used for chemical peeling with mild exfoliation and to remove dead skin accumulation.
%w/w as used herein means the % w/w of the ingredient to be calculated with respect to weight of total composition.

The composition of present invention works by below mechanisms;
- Causes reduction of pH of the skin sufficiently to cause a superficial shock to the cells
- Decreases the thickness of the superficial layer by weakening the bonds between the cells of the superficial layer (stratum corneum) resulting in uniform exfoliation
- Increases the elasticity of deeper layers.
Although the chemical peeling composition of the present invention is highly concentrated, due to its novel composition it is comparatively stable and less irritant to the skin.
a-Hydroxy acids, or alpha hydroxy acids (AHAs), are a class of chemical compounds that consist of a carboxylic acid substituted with a hydroxyl group on the adjacent carbon. They may be either naturally occurring or synthetic.
Alpha hydroxy acids of the present invention are selected from glycolic acid, lactic acid, tartric acid, malic acid, mandelic acid and citric acid. Preferred alpha hydroxy acid is glycolic acid.
Alpha hydroxy acid is present in the range of 10 to 70% w/w, preferably 20 to 50% w/w and more preferably 30 to 40% w/w of the total composition. Most preferably alpha hydroxy acid in the present invention is about 30% w/w of the total composition.
Auxiliary diluent
Auxiliary diluent is the diluent of vehicle to be used for the dilution of the alpha hydroxyl acid to prepare the final chemical peeling composition. Auxiliary diluent is natural skin humectants which ensures the hydra level optimization for newly exfoliated skin and prevents it from over drying and brings down the irritation to newly exfoliated skin after the removal of dead skin.

The auxiliary diluent for the present invention is selected from selected from xylitylglucoside anhydroxylitol xylitol available as AQUAXYL™, cocoglyceride, cyclomethicone, benzoic acid ester of C9-C15 alcohols, dimethicone, dicapryl maleate, caprylic/capric triglyceride, isopropyl myristate, octyl stearate, mineral oil, lanolin oil, coconut oil, cocoa butter, olive oil, avocado oil, aloe extract, jojoba oil, castor oil, fatty acid such as oleic and stearic, fatty alcohol such as cetyl and hexadecyl, diisopropyl adipate, hydroxybenzoate esters, , isononyl iso-nonanoate, alkane such as mineral oil, silicone such as dimethyl polysiloxane, ether such as polyoxypropylene butyl ether and polyoxypropylene cetyl ether, C12-C15 alkyl benzoate, octyldodecyl neopentanoate, di-PPG-3 myristyl ether adipate, dipentaerythritol hexa C5-9 acid ester, tribehenin, cetyl palmitate, serine, glutamine, sorbitol, mannitol, pyrrolidone-sodium carboxylate, glycerin, propylene glycol, 1,3-butylene glycol, ethylene glycol, polyethylene glycol (polymerization degree n=2 or more), polypropylene glycol (polymerization degree n=2 or more), polyglycerin (polymerization degree n=2 or more, 1,3 -propanediol, cholesterol and cholesterol ester, carboxyvinyl polymers, polyaspartate, tragacanth, xanthane gum, methyl cellulose, hydroxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, carboxymethyl cellulose, water-soluble chitin, chitosan, dextrin, polyvinylpyrrolidone-eicosene copolymers, polyvinylpyrrolidone-hexadecene copolymers, nitrocellulose. Most preferred auxiliary diluent is xylitylglucoside anhydroxylitol xylitol.
Auxiliary diluent is present in the range of 90 to 30% w/w preferably 50 to 80% w/w and more preferably 70 to 60% w/w of the total composition. Most preferably auxiliary diluent in the present invention is about 70% w/w of the total composition.
The composition of the present invention is prepared using normal dilution method by taking alpha hydroxy acid and diluting it with auxiliary diluent to make 100%.

The composition does not require any additional buffering system or any other ingredients to provide the effective chemical peeling and/or stabilize the composition and thus rule out other complicated procedure, rules out compatibility issue due to absence of any more ingredients.
It is obvious for a person skilled in the art to add any other beneficial ingredient to the composition of present invention for one or more beneficial effect to the skin based in the general knowledge available in the art about the beneficial activity of many natural as well as synthetic ingredient and all are covered in the scope of the present invention.
The composition of present invention exfoliates skin with gentle care & without
much irritation, Inhibits hyper pigmentation, microbial Proliferation & dead skin
accumulation.
The composition can also be used for spot and tone lightening, skin surface
restructuring, post acne correction and skin lightening
EXAMPLES
Ingredient %v/v
Glycolic acid 30
xylitylglucoside and anhydroxylitol and xylitol 70
Example 1
Procedure: 30 % v/v Glycolic acid was taken in a vessel and diluted by xylitylglucoside and anhydroxylitol and xylitol up to 100%.
Example 2

Ingredient _%v/v
Glycolic acid 55
xylitylglucoside and anhydroxylitol and xylitol 45
Procedure: As per example 1

Example 3

Ingredient %v/v
Malic acid 25
xylitylglucoside and anhydroxylitol and xylitol 75
Procedure: As per example 1 Example 4
Ingredient %v/v
Lactic acid 40
xylitylglucoside and anhydroxylitol and xylitol 60
Procedure: As per example 1 Comparative example

Ingredient %v/v
Glycolic acid 30
Water 70
Procedure: As per example 1
Stability study
Stability study was performed for composition of example 1 and comparati
example as per below;
Methodology: As per ICH guideline
Condition: Accelerated (40 ± 2 °C, 75 % ± 5 % RH)
Duration: 6 months
Result

Example 1 Comparative example
Assay (%)
Initial 97.34 89.56
6 months 87.84 55.33

Irritation Study
Irritation study was performed on composition of example 1 and comparative example by applying both composition to ten human volunteer on face and performed chemical peeling for 7 to 10 minutes and evaluated irritation based on the feedback from volunteers.
Result

Volunteer Example 1 Comparative example
1 Mild Moderate
2 Mild High
3 Mild Moderate
4 Moderate High
5 Mild High
6 Mild Moderate
7 Moderate High
8 Mild Moderate
9 Mild High
10 Mild Moderate

CLAIMS
We claim,
1. A stable chemical peeling composition comprising alpha hydroxyl acid and an auxiliary diluent.
2. A stable chemical peeling composition comprising 10 to 70% v/v of alpha hydroxy acid and 90 to 30% v/v of an auxiliary diluent
3. A stable chemical peeling composition comprising 20 to 50% v/v of alpha hydroxy acid and 50 to 80% v/v of an auxiliary diluent.
4. The composition according to any previous claims, where in the alpha hydroxy acid is selected from group consisting from glycolic acid, lactic acid, tartric acid, malic acid, mandelic acid and citric acid.
5. The composition according to claim 4, where in the alpha hydroxy acid is glycolic acid.
6. The composition according to any previous claims, wherein the auxiliary diluent is selected from the group consisting of xylitylglucoside anhydroxylitol xylitol, cocoglyceride, cyclomethicone, benzoic acid ester of C9-C15 alcohols, dimethicone, dicapryl maleate, caprylic/capric triglyceride, isopropyl myristate, octyl stearate, mineral oil, lanolin oil, coconut oil, cocoa butter, olive oil, avocado oil, aloe extract, jojoba oil, castor oil, fatty acid such as oleic and stearic, fatty alcohol such as cetyl and hexadecyl, diisopropyl adipate, hydroxybenzoate esters, , isononyl iso-nonanoate, alkane such as mineral oil, silicone such as dimethyl

polysiloxane, ether such as polyoxypropylene butyl ether and polyoxypropylene cetyl ether, C12-C15 alkyl benzoate, octyldodecyl neopentanoate, di-PPG-3 myristyl ether adipate, dipentaerythritol hexa C5-9 acid ester, tribehenin, cetyl palmitate, serine, glutamine, sorbitol, mannitol, pyrrolidone-sodium carboxylate, glycerin, propylene glycol, 1,3-butylene glycol, ethylene glycol, polyethylene glycol (polymerization degree n=2 or more), polypropylene glycol (polymerization degree n=2 or more), polyglycerin (polymerization degree n=2 or more, 1,3-propanediol, cholesterol and cholesterol ester, carboxyvinyl polymers, polyaspartate, tragacanth, xanthane gum, methyl cellulose, hydroxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, carboxymethyl cellulose, water-soluble chitin, chitosan, dextrin, polyvinylpyrrolidone-eicosene copolymers, polyvinylpyrrolidone-hexadecene copolymers and nitrocellulose.
7. The auxiliary diluent according to claim 5, is xylitylgmcoside and anhydroxylitol and xylitol.
8. A stable chemical peeling composition comprising 10 to 70% v/v of alpha hydroxy acid and 90 to 30% v/v of xylitylglucoside and anhydroxylitol and xylitol.
9. A stable chemical peeling composition comprising 20 to 50% v/v of alpha hydroxy acid and 50 to 80% v/v of xylitylglucoside and anhydroxylitol and xylitol.
10. A stable chemical peeling composition comprising 10 to 70% w/w of glycolic acid and 90 to 30% w/w of xylitylglucoside and anhydroxylitol and xylitol.

11. A stable chemical peeling composition comprising 20 to 50% v/v of glycolic acid and 50 to 80% v/v of xylitylglucoside and anhydroxylitol and xylitol.