DESC:Field of Invention:
The invention is in the field of personal care products. More particularly, the current invention relates to antidandruff composition for hair.

Background of the Invention:
Symptomatically, Dandruff is a scaly thing that is shed either while combing or due to ruffling of hair. Dandruff is the problem for many people around the world. However, it is still unclear what causes dandruff to occur.

According to a number of studies the yeast of Malassezia genus are the most significant causative agents of dandruff, more particularly the causative agent is yeast Malassezia furfur. The cells of stratum corneum fall out as white or gray scales due to the over-proliferation of the yeast in the stratum corneum triggered by the growth of Malassezia on the scalp.

An ideal anti-dandruff agent must not only relive the flaking and itching symptoms of dandruff, but also must be substantive to the skin and hair. In market, the most common anti-dandruff agent is an organometallic ingredient known as Zinc pyrithione (also known as ZPTO or ZnPTO). This being an organometallic ingredient it has certain ill-effects, which include harshness to skin, causes stinging/burning of scalp, skin peeling which leads to irritation of the skin. Besides, being semi-metallic and of granular nature, it is insoluble in water / oil, and hence difficult to formulate and deliver substantively on to the hair. Therefore, it is highly desirable to opt for natural origin vegetable oil based and water-soluble alternatives, which are comparatively milder, as well as simpler to formulate and deliver substantively on to the hair.

The current milder options include, hair oils containing herbal extracts which are available in the market to treat dandruff. However, most of these hair oils contain light liquid paraffin, which, as per the literature, is bad for your hair. Accordingly, long-term use of liquid paraffin on hair can lead to build-up on scalp and cause itching or eczema. Further, with scalp build-up due to mineral oil, it additionally clogs pores which cause rapid hair loss.

One viable alternative has been disclosed in U.S. Patent No. 11771634B2, corresponding to Indian Patent Application ? 202121002118, filed by the current Applicant. The US ‘634/IN ‘118 discloses a water soluble, scalp and skin compatible and effective antifungal compound referred to as “Ginophos CD”. The anti-dandruff active as disclosed in US ‘634/IN ‘118 shows enhanced bioavailability on the scalp surface. Further, Ginophos CD® significantly benefits the hair and scalp.

Therefore, the current inventors strive to provide such a composition which combine benefit of hair oil and a mild, but effective natural origin vegetable oil derived anti-dandruff agent which also effectively relieves itchiness caused by dandruff and keeps scalp moisturized.

Summary of Invention:
With a view of overcoming the above problems current inventors provide oil based antidandruff composition which comprises a water soluble, scalp and skin substantive antifungal agent.

In an aspect, the invention is an antidandruff hair oil composition which is free from paraffin for use in personal care products particularly hair care products based on green ingredients, such as vegetable oil derived ingredients.

Detailed Description of the Invention:
Unless specified otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art, to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the invention, the preferred methods and materials are described. To describe the invention, certain terms are defined herein specifically as follows.

Unless stated to the contrary, any of the words "including," "includes," "comprising," and "comprises" mean "including without limitation" and shall not be construed to limit any general statement that it follows to the specific or similar items or matters immediately following it. The term "consists essentially of” means excluding other materials that contribute to function.

Embodiments of the invention are not mutually exclusive, but may be implemented in various combinations. The described embodiments of the invention and the disclosed examples are given for the purpose of illustration rather than limitation of the invention as set forth in the appended claims.

Described herein is water soluble, scalp and skin substantive antidandruff composition comprising of a green antifungal agent and which is free from paraffin.

Further, the composition is used in personal care products, particularly, hair care products based on green ingredients.

In an embodiment, the antidandruff composition of the invention comprises of a phospholipid based antidandruff agent which is derived from vegetable oil. It is cost effective and highly substantive for scalp and skin. Accordingly, the active is a combination of Undecylenamidopropyl PG – Dimonium chloride phosphate and Sophorolipids.

The composition of the invention further comprises a paraffin free oil base, wherein the paraffin-free oil base is a vegetable oil selected from Coconut oil, Argan oil, Castor Oil, Soybean oil, Jojoba oil, Almond Oil, Sunflower oil, Mustard oil, Meadowfoam oil and similar cosmetically acceptable vegetable oils and blends thereof.

Further to the above embodiment, the anti-dandruff hair oil composition comprises of natural antimicrobial preservatives (Mixed Glycerides), is selected from, Glyceryl Mono Undecylenate, Glyceryl Mono Laurate, Glyceryl Mono Caprylate, Glyceryl Mono Caprate, Glyceryl Mono Caprylate-Caprate and related vegetable oil based fatty acid (Carbon Numbers C8 to C18, Saturated and Unsaturated) glyceride esters, and their blends thereof.

In an embodiment, the anti-dandruff hair oil composition comprises, besides the green antidandruff active, it also incorporates emulsifiers, emollients, antioxidants, cleansers, solubilizers, preservatives, moisturizers and conditioners in the previously mentioned choices of vegetable oil base.

In an preferred embodiment, the composition of the invention comprises of Undecylenamidopropyl PG – Dimonium chloride phosphate, biosurfactant, Coconut oil, Glyceryl Mono-Caprylate-Caprate (GMCC); Glyceryl Mono Caprylate (GMC); Glyceryl Mono Caprate; Glyceride Mono Laurate (GML); Glyceryl Mono Oleate (GMO), Glyceryl Mono Undecylenate (GMU), Ginomol ST® (Coco Caprylate Caprate (and) Hexadecane (and) Octadecane) and Polyglycerol esters for use mainly in personal care products particularly in hair care products and the compositions thereof.

In accordance to the above embodiment, the antidandruff hair oil composition of the invention comprise of 20 – 55% by weight vegetable oil base, 10 - 55% by weight emulsifier, 0.5 – 4 % by weight emollient, 2 – 5 % by weight Antidandruff agent and cleanser. Optionally, fragrance, antioxidant and colour can be incorporated in the composition.

In one of the embodiments, the antidandruff hair oil composition of the invention further comprises antioxidant, Vitamin E in the range of 0.1-1.

In one of the embodiments, the invention further provides a process for manufacturing the antidandruff hair oil composition of the invention. Said process comprises of:
Step A: Heating paraffin-free oil base to 50 – 80°C to obtain Phase A;
Step B: mixing natural antimicrobial preservatives;
Step C: heating the mixture of Step B to 60–70°C;
Step D: maintaining the temperature of the mixture of Step C and stirring continuously till homogeneous solution is obtained;
Step E: adding the anti-dandruff agent under stirring to the solution of Step D to obtain Phase B;
Step F: adding Phase A of Step A to Phase B of Step E;
Step G: adding the emollient to solution of Step F under stirring;
Step H: cooling the mixture to room temperature, and
Step I: adding the antioxidant to the mixture of Step H, once the mixture cools to 40°C to obtain the antidandruff hair oil composition of the invention;

EXAMPLES
Several examples are set forth below to further illustrate the nature of the invention and the manner of carrying it out. However, the invention should not be considered as being limited to the details thereof.

Example 1:
Ingredients %Wt. range
Coconut Oil 30 – 55
Glyceryl Mono Undecylenate 10 – 25
Glyceryl Mono-Caprylate-Caprate 40 – 50
Coco Caprylate Caprate(and)Hexadecane (and) Octadecane -
Undecylenamidopropyl PG -Dimonium chloride phosphate and Sophorolipids 2 – 5
Vitamin E 0.1-1

Process:
1. Phase A
o Add Coconut Oil and heat to 60°C.
2. Phase B
o Add GMCC (Glyceryl Mono-Caprylate-Caprate) and GMU (Glyceryl Mono Undecylenate), then heat to 60–70°C.
o Maintain the temperature and stir continuously for 30 minutes.
o Add Undecylenamidopropyl PG -Dimonium chloride phosphate and Sophorolipids under stirring.
o Once the mixture becomes homogeneous, proceed to the next step.
3. Combination & Final Processing
o Add Phase A into Phase B and mix using high-speed mixing.
o Cool the mixture down to room temperature while stirring.
o Once below 40°C, add Vitamin E.
o Check for the desired specifications and ensure the formulation is consistent and meets quality criteria.

Example 2:
Ingredients %Wt. range
Coconut Oil 20 – 50
Glyceryl Mono Undecylenate 10 – 25
Glyceryl Mono-Caprylate-Caprate 30 – 50
Coco Caprylate Caprate(and)Hexadecane (and) Octadecane 0.5 – 4
Undecylenamidopropyl PG – Dimonium chloride phosphate and Sophorolipids 2 – 5
Vitamin E 0.1-1

Process:
1. Phase A
o Add Coconut Oil and heat to 60°C.
2. Phase B
o Add GMCC (Glyceryl Mono-Caprylate-Caprate) and GMU (Glyceryl Mono Undecylenate), then heat to 60–70°C.
o Maintain the temperature and stir continuously for 30 minutes.
o Add Undecylenamidopropyl PG -Dimonium chloride phosphate and Sophorolipids under stirring.
o Once the mixture becomes homogeneous, proceed to the next step.
3. Combination & Final Processing
o Add Phase A into Phase B and mix using high-speed mixing.
o Add Coco Caprylate Caprate(and)Hexadecane (and) Octadecane under stirring
o Cool the mixture down to room temperature while stirring.
o Once below 40°C, add Vitamin E.
o Check for the desired specifications and ensure the formulation is consistent and meets quality criteria.

Example 3: Microbial analysis of the formulation of the invention:
The formulations as described in Example 1 and Example 2 were tested to determine the Minimum inhibitory concentration of formulation required for inhibiting the test organism Malassezia furfur.
The result for Example 1 is depicted in Table 1B:
Table 1A
Sr. PARAMETERS SPECIFICATIONS RESULTS
1. Batch No -
2. Quantity - 50 Gram
3. MIC Broth Dilution Method Given Below table

Table 1B
Results:-
Concentrations
(PPM) 100
PPM 500
PPM 1000
PPM 3000
PPM 5000 PPM 7000 PPM 10000 PPM
Organism Date Performed 02/01/24
M. furfur MIC
(%) 12.60 34.45 57.98 76.45 91.59 100 100

The result for Example 2 is depicted in Table 2B:
Table 2A:
Sr. PARAMETERS SPECIFICATIONS RESULTS
1 Batch No -
2 Quantity - 50 Gram
3 MIC Broth Dilution Method Given Below table

Table 2B:
Results:-
Concentrations
(PPM) 100
PPM 500
PPM 1000
PPM 3000
PPM 5000 PPM 7000 PPM 10000 PPM
Organism Date Performed 02/01/24
M. furfur MIC
(%) 11.76 25.21 48.73 77.31 86.55 100 100

Result:
Antifungal Efficacy of the Present Inventions by (MIC):
The minimum inhibitory concentration (MIC) of above-mentioned compositions against the Test Organism Malassezia Furfur is as under
MIC (in ppm) = 7000
,CLAIMS:1. A green, paraffin-free anti-dandruff composition for hair comprising:
a. a combination of Undecylenamidopropyl PG – Dimonium chloride phosphate and Sophorolipids as active agent;
b. a paraffin-free oil base, and
c. cosmetically acceptable excipients.

2. The anti-dandruff composition as claimed in Claim 1, wherein the composition further comprises an antioxidant.

3. The anti-dandruff composition as claimed in Claim 2, wherein the antioxidant is Vitamin E.

4. The anti-dandruff composition as claimed in Claim 2, wherein the antioxidant is present in range of 0.1 – 1 %.

5. The anti-dandruff composition as claimed in Claim 1, wherein the active agent is present in range of 2 – 5%.

6. The anti-dandruff composition as claimed in Claim 1, wherein the paraffin-free oil base is a vegetable oil selected from Coconut oil, Argan oil, Castor Oil, Soybean oil, Jojoba oil, Almond Oil, Sunflower oil, Mustard oil, Meadowfoam oil or blends thereof.

7. The anti-dandruff composition as claimed in Claim 6, wherein the paraffin-free oil base is Coconut oil.

8. The anti-dandruff composition as claimed in Claim 1, wherein the paraffin-free oil base is present in range of 10 – 55%.

9. The anti-dandruff composition as claimed in Claim 1, wherein the cosmetically acceptable excipients are selected from emulsifiers, emollients, antioxidants, cleansers, solubilizers, preservatives, moisturizers and conditioners.

10. The anti-dandruff composition as claimed in Claim 1, wherein the anti-dandruff composition comprises:
a. 20 – 55% by weight paraffin-free oil base;
b. 10 - 55% by weight emulsifier;
c. 0.5 – 4 % by weight emollient;
d. 2 – 5 % by weight Antidandruff agent, and
e. Cleanser.

11. A process for manufacturing the anti-dandruff composition as claimed in Claim 1, wherein the process comprises:
Step A: Heating paraffin-free oil base to 50 – 80°C to obtain Phase A;
Step B: mixing natural antimicrobial preservatives;
Step C: heating the mixture of Step B to 60–70°C;
Step D: maintaining the temperature of the mixture of Step C and stirring continuously till homogeneous solution is obtained;
Step E: adding the anti-dandruff agent under stirring to the solution of Step D to obtain Phase B;
Step F: adding Phase A of Step A to Phase B of Step E;
Step G: adding the emollient to solution of Step F under stirring;
Step H: cooling the mixture to room temperature, and
Step I: adding the antioxidant to the mixture of Step H, once the mixture cools to 40°C to obtain the antidandruff hair oil composition of the invention;