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. -
SKIN LIGHTENING COMPOSITION
2. Applicant(s)
(a) NAME: ZYDUS WELLNESS LIMITED
(b) NATIONALITY: INDIAN
(c) ADDRESS: SIGMA COMMER ZONE, NEAR iSCON
CROSS ROAD, B/H GALLOPS MALL, AMBLI-BOPAL ROAD, Dist.: AHMEDABAD-380 018, GUJARAT, INDIA
The following specification particularly describes the invention and the manner in which it is to be performed.

SKIN LIGHTENING COMPOSITION
FIELD OF THE INVENTION
The invention relates to a skin lightening cosmetic composition, a cosmetic procedure and a skin-whitening kit.
BACKGROUND OF THE INVENTION:
From the ancient time many thing are tried for skin lightenings, like combination milk and different herbs, different soils. Now a days skin lighteners contain kojic acid, hydroquinone, arbutin, niacinamide, salicylic acid, hydroquinone and that were found some disadvantages, such as instability, side effects caused by skin irritation, lack of effectiveness have led to the use of various plant extracts, the effectiveness should be improved.
In EP 2092837 discloses the problem occurred in terms of stability and color changes. Although the addition of antioxidant like vitamin C also showed improvement effects for skin whitening, but had no sufficient stability.
In case of pure plant extracts such as the Magnolia sieboldii extract described in WO 2009/069 839 showed only after 8 weeks according desirable lightening effects.
Many products available in the market having skin lightening effect, which needs to be applied daily on skin to maintain the effect. Hence there exists a need to develop a stable skin lightening composition which is effective and less irritant, and need not be daily applied on skin.
SUMMARY OF THE INVENTION:

The invention has the object to provide a stable skin lightening composition, with a particularly rapid effectiveness, while a long-lasting effect is achieved without skin irritation.
Therefore, the first object of the present invention is a skin lightening composition comprising Lotus extract, Vit. B3 and along with active botanical complex. Preferably, the skin lightening composition is a cosmetic composition or a pharmaceutical composition. Most preferably, it is a peel-off mask. It has surprisingly been found that in the present invention combinatorial unit not only the expected whitening effect on the skin shows but that (a) is an substantial amount of skin lightening occurs already after a very short application time, eg. Twice a week after 1 - 2 weeks, (b) the whitening effect will last for a long time with using once a week after 2 weeks, (c) neither the treatment period nor after significant skin irritation occur (d) any unwanted colour changes during the treatment period and thereafter occur.
In this case, the concentration of the lotus extract in the range of 0.001 to 5.0 % w/w, Vit. B3 in the range of 0.01 to 10. 0 %w/w, botanical complex in the range of 0.001 to 5.0% w/w based on the total weight of composition.
In another embodiment, the weight ratio of Vit. B3/lotus extract is comprised between 0.001 and!
In another embodiment, the skin lightening composition comprising Lotus extract, Vit. B3, botanical complex and along liposome complex:
In another embodiment, the Skin lightening composition according to the present invention comprises between 0.0001 and 1 wt.-% botanical complex, based on the total weight of the composition, and the weight ratio Vit. B3/lotus extract is comprised between 0.001 and 1.
In another embodiment, the skin lightening composition according to the present invention is characterized in that it comprises at least one additional skin lightening agent and/or UV screening agent, and a conventional carrier.

DETAILED DESCRIPTION OF INVENTION:
Accordingly, the present invention provides a novel stable skin lightening composition comprising niacinamide and lotus extract along with the botanical complex.
"Skin Lightening Composition" as used herein, is meant to include a composition for topical application to skin of mammals, especially humans. Such a composition may be generally classified as leave-on or rinse off, preferably rinse off. It includes any product applied to a human body for getting improved appearance, cleansing, odor control, photoprotection or general aesthetics and is especially useful for providing improved appearance of human skin viz. skin lightening. The composition of the present invention is preferably in the form of a mask, preferably filmogenic mask and may applied with an implement. "Skin" as used herein is meant to include skin on the face and neck.
"Vitamin B3" means, Vitamin B3 as a compound or its derivative e.g. niacin, nicotinic acid, niacinamide or mixture thereof.
The term "botanical complex" is the extract of the plant, selected from Saxifagra Sarmentosa extract, Grape Fruit extract, Mulberry extract, Morus Bombycis Root extract, Scutellaria Barcalensis Root extract or mixture thereof which is separately prepared mixture is introduced into the skin lightening composition.
The skin lightening composition of the invention may additionally comprise another skin lightening agent. The skin lightening agent is preferably chosen from aloe extract, ammonium lactate, azelaic acid, kojic acid, butyl hydroxy anisole, butyl hydroxy toluene, citrate esters, 2, 5 dihydroxybenzoic acid and its derivatives, ellagic acid, gluconic acid, glycolic acid, green tea extract, hydroquinone, 4-hydroxy benzoic acid derivatives, hydroxycaprylic acid, lemon extract, linoleic acid, magnesium and/or sodium ascorbyl phosphate, salicylic acid, or vitamins like vitamin B6, vitamin B12, vitamin C, vitamin A, hydroxycarboxylic acid like lactic acid and their salts e.g. sodium lactate, and mixtures thereof.

The skin lightening composition may preferably additionally comprise one or more liposome complex, like liposome Arbutin, Sodium Ascorbyi Phosphate or mixture thereof.
The skin lightening composition may preferably additionally comprise one or more UV sunscreens. The UV sunscreens may be inorganic or organic. The composition preferably comprises from about 0.1 % to about 10%, more preferably from about 0.1 % to about 5% by weight of a sunscreen agent. Useful inorganic sun-blocks are also preferably used in the present invention. These include, for example, zinc oxide iron oxide, silica, such as fumed silica, and titanium dioxide.
The skin lightening composition may preferably additionally comprise one or more exfoliating agents (chemical or physical), such as N-acetyl glucosamine, mannose phosphate, hydroxy acids, lactobionic acid, peach kernels, or sea salts; self-tanning agents, such as dihydroxyacetone; and biologically active peptides, such as palmitoyl pentapeptide or argireline natural or synthetic phyllosilicates, particularly smectic clays such as montmorillonite, nontronite, beidellite, volkonskoite, laponite, hectorite, saponite, sauconite, magadite, kenyaite, stevensite and the like, as well as vermiculite, halioysite, aluminate oxides, hydrotalcite and the like. These swellabie clays generally comprise particles containing a plurality of silicate platelets having a thickness of 8-12 .ANG., and contain exchangeable cations such as Na.sup.+, Ca.sup.+2, K.sup.+ or Mg.sup.+2 present at the interlayer surfaces.
The skin lightening composition of the present invention comprises water as a diluent. Other diluents are aqueous alcohol from 5% to 95%. Diluents other than water and aqueous alcohol can include liquid or solid emollients, solvents, humectants, thickeners and powders. The cosmetically acceptable base is usually from 5 to 99.9%, preferably from 50 to 99% by weight of the composition, and can, in the absence of other cosmetic adjuncts, form the balance of the composition.
The skin lightening compositions of the present invention can comprise a wide range of other optional components. Examples include: antioxidants, binders, biological additives, buffering agents, colorants, thickeners, polymers, astringents, fragrance, humectants, opacifying agents, conditioners, exfoliating agents, pH adjusters,

preservatives, natural extracts, essential oils, skin sensates, skin soothing agents, and skin healing agents
The skin lightening composition according to the invention, preferably in the form of a filmogenic mask thus obtained, is intended for:
1) reducing skin ageing, be it photoinduced or not photoinduced, to reduce pigmentations, wrinkles, skin firming;
2) treatment of dermatologicai affections linked to a keratinization disorder (acne in its different forms;
The treatment consists in the uniform application of the mask, with a circular center-to-outside motion or with the help of applicator, said mask to be left in place to dry for about 30 min. As soon as it is dry, the mask should be uniformly removed with a top-to-bottom motion towards the chin, wash off if required. The treatment is to be repeated twice a weekly for at least 2-3 weeks; thereafter a maintenance session once a week is advisable. An example of composition of filomogenic mask according to the invention is given below, by way of illustration and without any limitative purpose:
The mask has the following chemico/physical reference characteristics: pH comprised in the range 3 - 7 viscosity comprised between 5,000 - 20,000 cps.
Tests carried out on this mask - and reported hereinafter - highlighted the following properties: 1) absence of allergic sensibilization which include irritation, erythema, urticaria
3) stable during shelf life period
4) produce skin lightening effect
5) reduce skin aging
Table 1

Example Exam. 1 Exam. 2 Exam. 3 Exam. 4 Exam. 5

Sr. No. Name of Ingredient Quantity {% w/w
par tablet) Quantity (% w/w par tablet) Quantity {% w/w par tablet) Quantity {% w/w par tablet) Quantity <%w/w par tablet)
1 Polyvinyl Alcohol 11.000 11.000 11.000 11.000 11.000
2 Geilan Gum 0.035 0.035 0.035 0.035 0.035
3 Preservative 0.200 0.200 0.200 0.200 0.200
4 PEG 1500 1.500 1.500 1.500 1.500 1.500
5 Propylene glycol 1.000 1.000 1.000 1.000 1.000
7 Potassium Lactate 0.700 0.700 0.700 0.700' 0.700
8 Ethano! 9'5 % 12.000 12.000 12.000 12.000 12.000
9 Fragrance Q.S. Q.S. Q.S. Q.S. Q.S.
10 Niacinamide 3.500 1.500 2.500 3.500 3.500
11 Botnical complex* 0.500 1.500 0.500 0.500 0.500
12 Color Q.S. Q.S. Q.S. Q.S. Q.S.
14 Calcium
aluminium
Borosilicate, CI
77891
(Titanium Dioxide
), Silica Jin
Oxide Q.S. Q.S. Q.S. Q.S. Q.S.
15 Liposome complex 0.00001
16 Nelumbo Nucifera Flower Extract 0.500 1.000 1,500 0.500 0.500
17 P. Water Q.S. Q.S. Q.S. Q.S. Q.S.

* Botnical complex is mixture of Saxifagra Sarmentosa Extract, Grape Fruit Extract, Mulberry Extract, Scutellaria Barcaiensis Root Extract.
# Liposome complex is mixture of Polyvinyl Alcohol, Lactic Acid , Glycolic Acid, Arbutin, Sodium Ascorbyl Phosphate in liposome.
Table 2

Reference Example Ref.
Exam.
1 Ref.
Exam.
2 Ref.
Exam.
3 Ref.
Exam.
4 Ref.
Exam.
5 Ref.
Exam.
6 Ref. Exam.
7
Sr. No Name of Ingredient Quantit
y(%
w/w par tablet) Quantit
y{%
w/w par tablet) Quantit
y(%
w/w par tablet) Quantit
y{%
w/w par tablet) Quantit
y{%
w/w par tablet) Quantit
y(%
w/w par tablet) Quantit
y(%
w/w par tablet)
1 Polyvinyl Alcohol 11.000 11.000 11.000 11.000 11.000 11.000 11.000
2 Gellan Gum 0.035 0.035 0.035 0.035 0.035 0.035 0.035
3 Preservativ e 0.200 0.200 0.200 0.200 0.200 0.200 0.200
4 PEG 1500 1.500 1.500 1.500 1.500 1.500 1.500 1.500
5 Propylene glycol 1.000 1.000 1.000 1.000 1.000 1.000 1.000
7 Potassium Lactate 0.700 0.700 0.700 0.700 0.700 0.700 0.700
8 Ethanol 95 ■ % 12.000 12.000 12.000 12.000 12.000 12.000 12.000
9 Fragrance Q.S. Q.S. Q.S. Q.S. Q.S. Q.S. Q.S.
10 Niacinamid e 3.500 2.500 2.500 2.500
11 Botnical complex* 3.500 0.500 1.000

12
Color Q.S. Q.S. Q.S. Q.S. Q.S. Q.S. Q.S.
Calcium
aluminium Borosilicat e.CI Q.S. Q.S. Q.S. Q.S. Q.S. Q.S. Q.S.
14 77891 (Titanium Dioxide), Silica Jin Oxide
15 Liposome complex 0.0000
1
Nelumbo - - 1.500 - 0.500 1.500 0.500
16 Nucifera
Flower
Extract
17 P. Water Q.S. Q.S. Q.S. Q.S. Q.S. Q.S. Q.S.
* Botnical complex is mixture of Saxifagra Sarmentosa Extract, Grape Fruit Extract, Mulberry Extract, Scutellaria Barcalensis Root Extract.
# Liposome complex is mixture of Polyvinyl Alcohol, Lactic Acid , Glycolic Acid, Arbutin, Sodium Ascorbyl Phosphate in liposome.
Procedure:
1) Prepared PVA gel in D. M. Water & heated to 900C.
2) Add Gellan Gum at 600C.
3) Add Other ingredients below 500C.

3) Mix and cool.
4) At 450C add Alcohol, Glitters , Perfume, and store in a well closed container.
Compositions as shown in table 1 to 6 were prepared and the skin lightening efficacy was testing using the protocol as described below.

Table 3

Sr. No. Composition Allergic
Sensitization Stability

40°C/75 % RH for 6 months 50°C for 1 month
1 Ex. 1 Absent Stable Stable
2 Ex.2 Absent Stable Stable
3 Ex.3 Absent Stable Stable
4 EX.4 Absent Stable Stable
5 EX.5 Absent Stable Stable
6 Reference Ex. 1 Absent Stable Stable
7 Reference Ex. 2 Absent Stable Stable
8 Reference Ex. 3 Absent Stable Stable
9 Reference Ex. 4 Absent Stable Stable
10 Reference Ex. 5 Absent Stable Stable
11 Reference Ex. 6 Absent Stable Stable
12 Reference Ex. 7 Absent Stable Stable
Short-term method: Visual assessment for skin lightening
This was a double-blind design, in which the study subjects as well as the study personnel applying the products were unaware of the test product composition. Individuals belonging to skin photo type IV and V, a skin colour of 6.5 to 8.0 on a visual numerical scale and no marks / scars / blemishes were chosen for the studies. Both the inner forearms (area from the elbow to wrist), were marked (1 sq cm area) for both treatment and control sites. Application of products was randomized over these sites in order to avoid any positional effects. It is parallel, madamized, twice a weekly for 2 week and after two week, once a week application for next 3 weeks. Color measurements were conducted at baseline (day 0) and after 1st week, 2nd week, 3rd week, 4th week and 5th week by trained visual assessor. A visual numerical scale (VNS) was used by the assessor to score the skin shades. In this scale, a score of 1 was fairest and 10 were darkest. Skin color was assessed by expert

evafuators after 1st week, 2nd week, 3rd week, 4th week and 5th week of each formulation.
Table 4

Sr. Composition Skin Lightening effect
No.
1st week 2nd week 3rd week 4th week 5th week
1 Ex. 1 3 2 2 2 2
2 Ex.2 3 2 2 2 2
3 Ex.3 4 3 3 2 2
4 EX.4 3 2 2 2 2
5 EX.5 2 1 1 1 1
6 Reference Ex. 1 8 7 7 7 7
7 Reference Ex, 2 9 7 7 7 7
8 Reference Ex. 3 9 8 8 7 7
9 Reference Ex. 4 8 7 7 8 7
10 Reference Ex. 5 8 8 7 7 7
11 Reference Ex. 6 8 7 8 7 8
12 Reference Ex. 7 8 7 7 8 7
Short-term method: Visual assessment for skin aging
This was an open label, randomized, non-compoarative study in adult, human male subject to evaluate the efficacy and safty of skin lightening composition for 5 consecutive days including 5 visits (Day 01 to 05). The designated area was exposed to the sun continuously for 40 minutes between 11.00 am to 2.00pm for five consecutive days after applying sufficient quantity of composition on forearm according to the randomization schedule.
Table 5

Sr.
No. Composition Erythema at 40 min.

Erythema No

(no. of subjects) erythema (no. of subjects)
1 Ex. 1 15% 85%
2 Ex.2 18% 82%
3 Ex.3 13% 87%
4 EX.4 11% 89%
5 EX.5 10% 90%
6 Reference Ex. 1 25% 75%
7 Reference Ex. 2 32% 68%
8 Reference Ex. 3 30% 70%
9 Reference Ex. 4 28% 72%
10 Reference Ex. 5 33% 67%
11 Reference Ex. 6 30% 70%
12 Reference Ex. 7 31% 69%
The data in table 3, 4 and 5 indicates that a skin lightening composition as per the invention (example 1,2,3,4 and 5) provides for better skin lightening and vastly faster kinetics of skin lightening efficacy, more stable and less irritant as compared to reference.

We Claim:
1. A skin lightening composition comprising Lotus extract, Vit. B3 and botanical complex.
2. The skin lightening composition according to the preceding claims comprises botnical complex, one or more selected from Saxifagra Sarmentosa Extract, Grape Fruit Extract, Mulberry Extract, Morus Bombycis Root Extract, Scutellaria Barcalensis Root Extract
3. The skin lightening composition according to east one of the preceding claims further comprises liposome complex, one or more selected from liposome of arbutin, ascorbyl Phosphate salt.
4. The composition according to at least one of the preceding claims, in the form of a mask or kit thereof.
5. The skin lightening composition according to at least one of the preceding claims, having filmogenic action for professional and home use.
6. The skin lightening composition according to at least one of the preceding claims, characterized in that its viscosity is comprised between 5000 and 20000 cps, and in that its pH is comprised between 3 and 7.
7. The skin lightening composition according to at least one of the preceding claims, further comprising ethyl alcohol in a ratio of between 5 and 50 % by weight with reference to the total weight of the composition.
8. The skin lightening composition according to at least one of the preceding claims, further comprising glitter, perfume and colur.
9. The skin lightening composition according to at least one of the preceding claims, use to reduce pigmentations or spot, wrinkles.
10. A method of production of the composition according to claims 1 to 9 comprising
the following steps:

a. prearranging aqueous binder solution at a temperature comprised between 60 and
95° C;
b. adding other ingredients below 50°C;
constant stirring of the mixture of step b) until reaching a viscosity comprised between 5000 and 20000 cps.