FORM 2
THE PATENT ACT 1970
(39 OF 1970)
&
THE PATENT RULES, 2003
COMPLETE SPECIFICATION
(SEE SECTION 10 AND RULE 13)
1 TITLE OF THE INVENTION :
A skin-care composition for reduction of acne and removal of acne
scars and a method of making it.
2 APPLICANT (S)
Name : Geno Pharmaceuticals Pvt. Ltd.
Nationality : Address : Indian Company
Plot No. 4, Pharmaceutical Complex, Tivim Industrial
Estate, Karaswada, Mapusa, Goa-403526, India
3 PREAMBLE TO THE DESCRIPTION
COMPLETE
The following specification particularly describes the invention and the manner in which it is
to be performed.

TITLE
[0001] A skin-care composition for reduction of acne and removal of acne scars and a method of making it.
FIELD OF INVENTION
[0002] The present invention relates to a skin care composition to be applied to skin for reduction of acne and removal of scars formed due to acne, and a method of making the said formulation.
BACKGROUND
[0003] Acne is a skin condition that occurs when hair follicles become plugged with oil and dead skin cells, and can affect people of all ages. Acne can be of form whiteheads, blackheads or pimples and can be persistent.
[0004] Each pore of skin opens to a follicle which is made up of a hair and a sebaceous (oil) gland. The oil gland releases sebum (oil), which travels up the hair, out of the pore, and onto skin. Sebum helps keeps the skin lubricated and soft. Acne occurs when the pores of the skin become blocked with oil, dead skin, or bacteria.
[0004] In this lubrication process, when the follicles produce too much oil, or dead skin cells accumulates and bacteria build up in the pores,

lead to pimples, which develop when bacteria grow in a clogged pore and the oil cannot escape, then hair follicles gets clogged and this skin condition acne formation happens.
[0006] Acne skin condition leads to skin discoloration, including dark patches or spots (hyperpigmentation) and redness, swelling and inflammation and pain and tenderness, uneven texture and rough skin.
[0007] The most affected / prone areas of body are face and neck, back, shoulders and chest. This acne skin condition can be controlled/ reduced through reduced subcutaneous secretion and to stop further inflammation and also to inhibit the bacterial growth on skin. Further there is a need to normalize the already blocked pores through removal of dead skin and inhibition of bacterial growth.
[0008] There are skin care compositions/ formulations available in the market for acne and acne scars but no formulation is effective to address all the conditions, such as, to reduce the subcutaneous secretion, stop further inflammation, and to inhibit bacterial growth on skin and reduction of overproduction of melanin to remove/ reduce acne scars. Thus there is a need for skin-care formulations which addresses all these conditions through a single formulation.

SUMMARY
[0009] The present invention provides a novel skin-care composition for reduction of acne and removal of acne scars and a method of making the composition. The present composition is capable to the address all the conditions of acne and acne scars formation, that is, reduction of subcutaneous secretion, prevents further inflammation, inhibit bacterial growth, reduce melanin formation to remove/ reduce acne scars.
[0010] The skin care composition in accordance with the present invention comprises a first component of properties antibiotic by weight percentage of 1% to 3%.
[0011] Preferably the composition further comprises a second component of properties retinoid by weight percentage of 0.05% to 0.2%.
[0012] Preferably the composition further comprises a third component of properties antibacterial and anti-inflammatory by weight percentage of 4% to 5%.
[0013] Preferably additives and purified water are properly added.
[0014] Preferably purified water weight percentage is between 59% to 64% is added.

[0015] A method of making the skin care composition comprising steps:
a. Heating of purified water;
b. Dissolving Disodium Edetate;
c. Stirring and gradual addition of Carbopol 980 and further stirring to
form smooth slurry;
d. Adding respectively Sodium Methyl Paraben, Sodium Propyl Paraben
and Sodium Hydroxide under stirring;
e. Dissolving Sodium Hydroxide in purified water and adding it to phase
vessel under stirring;
f. Preparing slurry of Clarithromycin in Propyelene Glycol and adding it
to phase vessel under continuous stirring;
g. Dissolving Adapalene in Propylene Glycol and adding to the phase
vessel; and
h. Adding Barbados Aloe to the phase vessel under continuous stirring.
[0016] The present invention has the following synergistic effect /advantages which is not achievable through single or combination of any of the 2 disclosed component:
a. acts on the pimples, acne to reduce the subcutaneous secretion;
b. stops further inflammation;
c. inhibits bacterial growth on skin;
d. treats skin infections;
e. reduces the look of blemishes and acne, fading of spots and marks
of previous acne breakouts;

f. loosens cells on the skin surface which unblocks the clogged pores
decreasing pimples, spots, whiteheads and blackheads
g. increases the production of new skin cells and helps in the natural
exfoliation of the skin outer layer.
h. promoting quick healing of pimples. i. restores your skin's natural texture and tone
j. reduce the overproduction of melanin, a darker pigment that can make acne scars more noticeable.
Clear transparent smooth get for topical application.
BRIEF DESCRIPTION OF THE DRAWINGS
[0017] None
DETAILED DESCRIPTION
[0018] The present disclosure is best understood with reference to the detailed description set forth herein. Various embodiments have been discussed Those skilled in the art will readily appreciate that the detailed descriptions provided herein are merely for explanatory purposes, as the methods and compositions may extend beyond the described embodiments. For instance, the teachings presented and the needs of a particular application may yield multiple alternative and suitable approaches to implement the functionality of any detail described herein.

Therefore, any approach may extend beyond certain implementation choices in the following embodiments.
[0019] References to “one embodiment,” “at least one embodiment,” “an embodiment,” “one example,” “an example,” “for example,” “preferred embodiment” and so on indicate that the embodiment(s) or example(s) may include a particular feature, structure, characteristic, property, element, or limitation but that not every embodiment or example necessarily includes that particular feature, structure, characteristic, property, element, or limitation.
[0020] Acne skin condition that occurs when hair follicles become plugged with oil and dead skin cells, and can affect people of all ages forming whiteheads, blackheads or pimples and can be persistent. Secretion of sebum keeps skin lubricated and soft, but when the follicles produce too much oil, or dead skin cells accumulates and bacteria build up in the pores, lead to pimples, which develop when bacteria grow in a clogged pore and the oil cannot escape, then hair follicles gets clogged and this skin condition acne formation happens. Skin become blocked with oil, dead skin, or bacteria.
[0021] Skin becomes discoloured, dark patches or spots (hyperpigmentation) forms and redness, swelling and inflammation and pain and tenderness, uneven texture and rough skin happens.

[0022] The present invention provides a novel skin-care composition for reduction of acne and removal of acne scars and a method of making the composition. The present composition is capable to the address all the conditions of acne and acne scars formation, that is, reduction of subcutaneous secretion, prevents further inflammation, inhibit bacterial growth, reduce melanin formation to remove/ reduce acne scars.
[0023] The skin care composition in accordance with the present invention comprises a first component active ingredient of properties antibiotic by weight percentage of 1% to 3% range. The first component is preferably Clarithromycin.
[0024] Preferably the composition further comprises a second component active ingredient of properties retinoid by weight percentage of 0.05% to 0.2% range. The second component is preferably Adapalene.
[0025] Preferably the composition further comprises a third component active ingredient of properties antibacterial and anti-inflammatory by weight percentage of 4% to 5% range. The third component is preferably Barbados aloe.

[0026] Preferably additives and purified water are properly added. The additive includes components by different weight percentages as follows:
0.9 % of Carbopol 980 emulsifier; 0.1 % of Sodium Hydroxide for adjustment of pH; 0.2% of Sodium Methyl Paraben as preservative; 0.02% of Sodium Propyl Paraben as preservative; 0.01% of Disodium Edetate as chelating agent; and 30% of propylene Glycol as solvent.
[0027] Preferably purified water weight percentage is between 59% to 64% is added as vehicle.
[0028] A method of making the skin care composition comprising steps:
a. Heating of purified water in phase vessel;
b. Dissolving of Disodium Edetate;
c. Stirring and gradual addition of Carbopol 980 in the phase vessel,
and further stirring for about 3 hours to form smooth slurry;
d. Adding respectively Sodium Methyl Paraben, Sodium Propyl Paraben
and Sodium Hydroxide under stirring;
e. Dissolving Sodium Hydroxide in purified water and adding it to phase
vessel under stirring;
f. Preparing slurry of Clarithromycin in Propyelene Glycol and adding it
to phase vessel under continuous stirring;
g. Dissolving Adapalene in Propylene Glycol and adding to the phase
vessel; and

h. Adding Barbados Aloe to the phase vessel under continuous stirring.
[0029] When either of the component is used singly or in two of the components are used in combination, the result of the present composition was not achieved. But due to the synergistic effect of the components Clarithromycin, Adapalene, Barbados Aloe when combined in the preferred weight percentage range found to be highly effective in providing relief from acne formation, cures already existing acne, clears the scars formed due to previous acne breakouts when tested on subjects. 45 of subject out of 50 sample subject experienced the benefits of the present composition in the specified range.
[0030] In a preferred composition/ formulation found to be effective positively on 90% of subjects.
[0031] In a preferred composition, the stability testing protocol followed is as per ICH Guidelines Q1A(R2) and Q1E, WHO Guidelines TRS No. 953, 2009.
[0032] In a preferred composition is stable both under the Accelerated conditions and the Long Term Condition. Accelerated conditions being of Temperature 40°C ± 2°C, Relative Humidity 75%±5%RH stored for 6 months. Long Term condition being of Temperature 30°C ± 2°C, Relative Humidity 75%±5%RH stored for 48 months.

[0033] In a preferred composition random stability data is drawn from different batches under various temperature and relative humidity, and parameters, shown in the following tables


2

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TABLE – 6

WE CLAIMS:
1. A skin-care composition for reduction of acne and removal of acne
scars, comprising
a first component of properties antibiotic;
a second component of properties retinoid;
a third component of properties antibacterial and anti-inflammatory;
additives; and
purified water.
2. The skin-care composition for reduction of acne and removal of acne scars as claimed in claim 1, wherein the first component of properties antibiotic ranges in weight percentage between 1% to 3%.
3. The skin-care composition for reduction of acne and removal of acne scars as claimed in claim 1, wherein the first component of properties antibiotic is Clarithromycin.

4. The skin-care composition for reduction of acne and removal of acne scars as claimed in claim 1, wherein the second component of properties retinoid ranges in weight percentage between 0.05% to 0.2%.
5. The skin-care composition for reduction of acne and removal of acne scars as claimed in claim 1, wherein the second component of properties retinoid is Adapalene.
6. The skin-care composition for reduction of acne and removal of acne scars as claimed in claim 1, wherein the third component of properties antibacterial and anti-inflammatory ranges in weight percentage between 4% to 5%.
7. The skin-care composition for reduction of acne and removal of acne scars as claimed in claim 1, wherein the third component of properties antibacterial and anti-inflammatory is Barbados Aloe.
8. The skin-care composition for reduction of acne and removal of acne scars as claimed in claim 1, wherein the additives includes components by weight percentages as follows:
0.9 % of Carbopol 980; 0.1 % of Sodium Hydroxide; 0.2% of Sodium Methyl Paraben;

0.02% of Sodium Propyl Paraben; 0.01% of Disodium Edetate; and 30% of propylene Glycol.
9. The skin-care composition for reduction of acne and removal of
acne scars as claimed in claim 1, wherein the purified water weight
percentage is between 59% to 64%.
10. A method of making compound as claimed in claim 1, comprising
steps:
i. Heating of purified water in phase vessel;
j. Dissolving of Disodium Edetate;
k. Stirring and gradual addition of Carbopol 980 in the phase
vessel, and further stirring for about 3 hours to form smooth
slurry; l. Adding respectively Sodium Methyl Paraben, Sodium Propyl
Paraben and Sodium Hydroxide under stirring; m. Dissolving Sodium Hydroxide in purified water and adding it to
phase vessel under stirring; n. Preparing slurry of Clarithromycin in Propyelene Glycol and
adding it to phase vessel under continuous stirring; o. Dissolving Adapalene in Propylene Glycol and adding to the
phase vessel; and p. Adding Barbados Aloe to the phase vessel under continuous
stirring.