SAME

Field of the Invention

This invention, in general relates to a herbal skin care composition. In particular, 5 the present invention provides a herbal skin care composition comprising of various herbal extracts along with dehydroxanthan gum and cosmeceutically acceptable preservatives and excipients and the method of preparing the same.

Background of the Invention

Most of the personal care gel formulations for skin contain synthetic materials I O like acrylate polymers. Acrylate polymers are non-biodegradable and further the gels prepared employing them are not stable at lower pH range.

Gelling agents are substances which form a gel and when added to an aqueous mixture, increase its viscosity without modifying its other properties. They increase stability and improve suspension of added ingredients. The agents are materials used to 1 5 thicken and stabilize liquid solutions. They dissolved in the liquid phase as a colloid mixture that forms a weakly cohesive internal structure. Thickening agents used in cosmetics include polyethylene glycol, synthetic polymers like polyacrylic acid and vegetable gums etc. Some thickening agents also function as stabilizers.

Synthetic PVP/carbomer formulas provide relatively clear gels. This technology, 0 however, has several limitations. First they are derived from non renewable synthetic source and are non biodegradable. Carbomer thickeners also have drawbacks from a formulation and manufacturing standpoint. These include poor compatibility with ionic ingredients, lack of salt tolerance and poor UV stability. They require addition of neutralizing agents like alkali, which destabilizes most of the herbal actives. Therefore 5 low pH gels (~ 5- 6 pH) are more suitable for the stability and efficiency of the herbal actives.

There are many natural gums which can be used for thickening/ gelling in personal care formulations. Examples include xanthan gum, acacia gum, guar gum, carrageenan, starch etc. 0 Dehydroxanthan gum is a multifunctional ingredient that serves as the fixative, thickener and gelling agent for gels. Dehydroxanthan gum is an anionic, off-white colored powder, physically modified xanthan gum that is derived from a heat treatment process. The polymer disperses quickly in water and does not require neutralization or the addition of a separate thickener, resulting in reduction in manufacturing time and a better gel compared to traditional gel systems. Gels containing dehydroxanthan gum stay where applied and will not flow thus providing ease of application. As a gelling agent and a 5 conditioning agent it is one of the best as compared to the conventional gelling agents. It is therefore an important aspect to develop a herbal formulation that is made of natural ingredients to provide better efficacy and safety. Accordingly, the present invention provides improved formulations to obviate drawbacks associated with the prior art.

Prior Art

I O US Patent Application no. 20080260869A 1 by Faller et al. discloses a skin care composition to treat skin conditions such as telangiectasia, eye circles, wrinkles and puffy eyes. The composition comprising herbal extract selected from Magnolia, Humulus hφulus, Gotu kola, Centella asiatica, Cucumis sativa, Morus alba, Citrus medica limonum, Avena sativa, Artemisia abrotanum, Vitis vinifera, Hibiscus sabdariffa and

1 5 Citrus grandis in combination with methyl chalcone, dipeptide valyl-tryptophane, palmitoyl tetrapeptide-3, hydrolyzed soy protein or apigenin.

US Patent Application no. 20050191267A l by Luanratana discloses a composition comprising Mulberry extract, preservative and solvent. The disclosed is included in a cosmetic, wherein said cosmetic includes bar soap, liquid soap, cream, 0 lotion, eye cream or gel, sun-screen, anti-wrinkle cream, face mask cream, lip gloss, lipstick, deodorant, aftershave, shampoo, cream rinse, anti-inflammatory medicine, anti- itching medicine and supplementary food.

US Patent Application no. 20040191330A 1 by Keefe et al. discloses a skin care regimen that includes an eye cream for treating facial skin surrounding one's eyes. The 5 composition contains a bio-herbal blend comprising plant extracts selected from among a group consisting of comfrey, cucumber, birch leaf, watercress, clover, ginseng and St. John's wort.

Summary of the Invention In accordance with one embodiment of the present invention, there is provided a0 herbal skin care composition comprising extracts of herbs along with dehydroxanthan gum and cosmeceutically acceptable preservatives and excipients. In accordance with one other embodiment of the present invention, there is provided a herbal skin care composition comprising extracts of herbs along with dehydroxanthan gum and cosmeceutically acceptable preservatives and excipients, wherein the extract of herbs is obtained from a blend of herbs selected from Cipadessa 5 baccifera, Bergenia ligulata, Rhodomyrtus tomentose, Woodfordia fruiticosa or in various combinations thereof.

In accordance with one other embodiment of the present invention, there is provided a herbal skin care composition comprising extracts of herbs along with dehydroxanthan gum and cosmeceutically acceptable preservatives and excipients,

I O wherein the blend is used in the range of 0.01 % to 60 %.

In accordance with one other embodiment of the present invention, there is provided a herbal skin care composition comprising extracts of herbs along with dehydroxanthan gum and cosmeceutically acceptable preservatives and excipients, wherein the dehydroxanthan gum is used in the range of 0.01% to 10%.

15 In accordance with yet another embodiment of the present invention, there is provided a herbal skin care composition, wherein said composition is formulated in any kind of skin care formulation preferably under eye gel and anti-ageing gel formulation. In accordance with yet another embodiment of the present invention, there is provided an eye gel formulation comprising herbal blend extract of herbs Cipadessa baccifera and 0 Bergenia ligulata along with dehydroxanthan gum and cosmeceutically acceptable preservatives and excipients.

In accordance with yet another embodiment of the present invention, there is provided an anti-ageing gel formulation comprising herbal blend extract of herbs Rhodomyrtus tomentose, and Woodfordia fruiticosa along with dehydroxanthan gum and 5 cosmeceutically acceptable preservatives and excipients.

In accordance with yet another embodiment of the present invention, there is provided a herbal skin care composition, wherein said composition is prepared by a method comprising blending the herbs and extracting the resultant herbal blend employing SCFE, mixing the resultant extract of blend with dehydroxanthan gum and0 cosmeceutically acceptable preservatives and excipients. In accordance with yet another embodiment of the present invention, there is provided a herbal skin care composition, wherein said composition is prepared by a method comprising blending the herbs and extracting the resultant herbal blend employing percolation or soxhalation using water, mixing the resultant extract of blend

5 with dehydroxanthan gum and cosmeceutically acceptable preservatives and excipients.

In accordance with yet another embodiment of the present invention, there is provided a herbal skin care composition, wherein said composition is prepared by a method comprising blending the herbs and extracting the resultant herbal blend employing solvent-solvent percolation, mixing the resultant extract of blend with

I O dehydroxanthan gum and cosmeceutically acceptable preservatives and excipients.

In accordance with yet another embodiment of the present invention, there is provided a herbal skin care composition, wherein said composition is prepared by a method comprising blending the herbs and extracting the resultant herbal blend employing solvent-solvent percolation, mixing the resultant extract of blend with 1 5 dehydroxanthan gum and cosmeceutically acceptable preservatives and excipients, wherein the solvent used herein are organic solvents, selected from group consisting n- hexane, chloroform, dichloromethane, ethyl acetate, acetone, alcohol or water, either alone or in various combinations thereof.

In accordance with yet another embodiment of the present invention, there is 0 provided a herbal skin care composition, wherein said composition is prepared by a method comprising blending the herbs and extracting the resultant herbal blend employing solvent-solvent percolation, mixing the resultant extract of blend with dehydroxanthan gum and cosmeceutically acceptable preservatives and excipients, wherein the solvent used herein are n-hexane, acetone, ethyl alcohol, methanol, ethyl 5 alcohol or water either alone or combination thereof.

Description of the Invention

While this specification concludes with claims particularly pointing out and distinctly claiming that, which is regarded as the invention, it is anticipated that the invention can be more readily understood through reading the following detailed0 description of the invention and study of the included examples. According to the present invention, a herbal skin care composition is provided, wherein said composition comprising extracts of herbs along with dehydroxanthan gum and cosmeceutically acceptable preservatives and excipients, wherein the extract of herbs is obtained from a blend of herbs selected from Cipadessa baccifera, Bergenia ligulata, Rhodomyrtus tomentose, Woodfordia fruiticosa or in various combinations thereof.

In the present invention the various skin care compositions are prepared and formulated such as gel formulations were prepared with these natural gums and different parameters like pH, clarity, viscosity, texture and appearance were evaluated.

According to the present invention, the extract can be prepared using any parts of said herbs, preferably aerial parts of Rhodomyrtus tomentosa, aerial parts of Cipadessa baccifera, flower of Woodfordia fnύicosa and tender shoots of plant Bergenia ligulata.

According to the present invention, the skin care gel formulations comprise herbal blend extarcts and dehydroxanthan gum as thickening agent. The thickening agent is used in gels having acidic pH. The thickening agent can be employed for preparation of a wide range of skin care products like anti-ageing, under eye gels and so forth.

The following non-limiting example illustrates in detail about the invention. However, it is not intended to be limiting the scope of present invention in any way.

Example- 1

Table- 1 Under eye gel formulations with various natural polymers and enzymes as preservatives

Manufacturing details

I . Dispersed the thickener in glycerine. Ensure that no lumps were formed 2. Added the gum dispersion to the water in the main tank and mixed for 30 min. Ensure that the thickener was dispersed completely.

3. Dissolved herbal extract in 5 % of water and filtered through 10 micron filter paper.

4. Added the extract solution to the main tank and mixed for 10 minutes till the product was uniform.

5. Added biovert substrate solution followed by enzyme solution and mixed for 15 min.

6. Added Potassium Sorbate and mixed for 15 mins.

7. Allowed the formulations at room temperature for 24 hours to gain consistency and texture before evaluating.

Example-2 Evaluation of under eye gel formulations

All these formulations were analyzed for various parameters including viscosity evaluation in Brookefield Viscometer DV 11+ Model (USA) and the results were found as follows:

All eight formulations were checked for their pH .

The formulations were taken in clean and uniform glass containers to observe the clarity. Clarity was visually assessed and graded.

The feel on the skin was evaluated by 5 panelists. The product was applied on the forearm and the relative differences in terms of smoothness, absorption, tackiness and slip were recorded. Table 2

Comparison of Parameters of under eye gel formulations

Results : The formula I , which is with dehydroxanthan gum excels out best as compared to other formulations II to VIII .

Example-3 Table 3

Under eye formulations with various natural polymers

Manufacturing details

1 Dispersed the thickener in glycerine. Ensure that no lumps were formed. 2 , Added the gum dispersion to the water in the main tank and mixed for 30 min. Ensure that the thickener was dispersed completely.

3 Dissolved herbal extract in 5 % of water and filtered through 10 micron filter paper.

4 Added the extract solution to the main tankand mixed for 10 minutes till the product was uniform. Also added preservatives.

5 Allowed the formulations at room temperature for 24 hours to gain consistency and texture before evaluating.

Example-4 Evaluation of under eye gel formulations All these formulations were analyzed for various parameter including viscosity evaluation in Brookefield Viscometer DV 11+ Model (USA) and the results were found as follows:

All eight formulations were checked for their pH .

The formulations were taken in clean and uniform glass containers to observe the clarity. Clarity was visually assessed and graded.

The feel on the skin was evaluated by 5 panelists. The product was applied on the forearm and the relative differences in terms of smoothness, absorption, tackiness and slip were recorded.

Table 4 Comparison of Parameters of under eye gel formulations

Results : The formula I , which is with dehydroxanthan gum excels out best as compared to other formulations II to VIII.

Example-5

Table 5

Anti-ageing formulations with various natural polymers and enzymes as preservatives

Manufacturing details:

1 Dispersed the thickener in glycerine. Ensure that no lumps were formed

5 2 Added the gum dispersion to the water in the main tank and mixed for 30 min. Ensure that the thickener was dispersed completely.

3 Dissolved Rhodomyrtus tomentosa Extract and Woodfordia fruticosa Flower Extract in 5 % of water and filtered through 10 micron filter paper.

4 Added the extract solution to the main tankand mixed for 10 minutes till the 10 product is uniform.

5 Added biovert substrate solution followed by enzyme solution and mixed for 15 min.

6 Added Potassium Sorbate and mixed for 15 mins.

7 Allowed the formulations at room temperature for 24 hours to gain consistency

I 5 and texture before evaluating.

Example-6

Evaluation of the parameters:

All eight formulations were checked for their pH and viscosity. The formulations were taken in clean and uniform glass containers to observe the 0 clarity. Clarity was visually assessed and graded.

The feel on the skin was evaluated by 5 panelists. The product was applied on the forearm and the relative differences in terms of smoothness, absorption, tackiness and slip were recorded.

Table 6 5 Comparison of Parameters

Results : The formula I , which is with dehydroxanthan gum excels out best as compared to other formulations Il to VIII.

Example-7

Table 7

Anti- ageing gel formulation with various natural polymers and without enzyme as preservatives

Manufacturing Procedure

1 . Weighed required quantity of DM Water (Phase A) in main mixer. Dissolved Disodium EDTA in main vessel properly. At 7O ⁰ C added Methyl Paraben and heated up to 8O ⁰ C

2. Weighed 2 % of DM Water and herbal extracts and heated up to 8O ⁰ C, then filtered it with nylon cloth and added in main vessel.

3. Dispersed dehydroxanthan gum in glycerin (Phase B). Ensure that no lumps were formed. Added phase B slowly to the main vessel at 8O ⁰ C with homogenizer and mixed it

I O for I Sminutes.

4. Weighed I % of DM water & dissolved Sodium Benzoate completely, then transferred to main vessel at 45 ⁰ C.

5. Added herbal extracts at 45 ⁰ C in main vessel. Mixed well thoroughly for 10 minutes.

Example-8

Evaluation of various parameters:

Table 8 Comparison of Parameters 0

Results : The formula I , which is with dehydroxanthan gum excels out best as compared to other formulations II to VIII.

Example-9

Preparation of extract from Cipadessa baccifera and Bergenia ligulata by Super Critical Fluid Extraction

The shade dried material of herbal blend of Cipadessa baccifera and Bergenia ligulata was pulverized to coarse powder and about 100 Kg of powdered herbal blend was placed in a SCF extractor at the temperature of 40-50 ⁰ C at high pressure of 300-350 bar using carbon dioxide as super critical fluid for extraction upto 4 to 6 hours and then the extract was collected in the collection vessel and evaporated at room temperature to remove any further residues of carbon dioxide. The extract thus obtained was free from any solvent residues and in highest pure form.

Example- 10

Preparation of extract from herbal blend of Cipadessa baccifera and Bergenia ligulata by Aqueous Extraction

The shade dried material of herbal blend of Cipadessa baccifera and Bergenia ligulata was pulverized to coarse powder and about 100 Kg of powdered herbal blend was placed in soxhalator using water as solvent of extraction at refluxing temperature and recycled the process until extraction is completed, then plant extracts were filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature. The herbal material was also placed in percolator and extracted with water at room temperature for 24 h to 48 h,, then plant extracts were filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature and under reduced pressure . Example- 1 1

Preparation of extract from herbal blend of Cipadessa baccifera and Bergenia Hsulata by Solvent -Solvent Percolation Method

The dried herbal blend of Cipadessa baccifera and Bergenia ligulata were pulverized to coarse powder and about 10 Kg of powdered material placed in different percolators and extracted with n-hexane, acetone, ethyl alcohol, methanol, ethyl alcohol and water ( 1 : 1 ), methanol and water (1 : 1 ) and water at room temperature for 24 h to 48 h, then plant extracts were filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature and under reduced pressure.

Example- 12

Preparation of extract from Rhodomyrtus tomentose and Woodfordia fruiticosa by Super Critical Fluid Extraction

The shade dried material of herbal blend of Rhodomyrtus tomentose and Woodfordia fruiticosa was pulverized to coarse powder and about 100 Kg of powdered herbal blend was placed in a SCF extractor at the temperature of 40-50 ⁰ C at high pressure of 300-350 bar using carbon dioxide as super critical fluid for extraction upto 4 to 6 hours and then the extract was collected in the collection vessel and evaporated at room temperature to remove any further residues of carbon dioxide. The extract thus obtained was free from any solvent residues and in highest pure form.

Example- 13

Preparation of extract from herbal blend of Rhodomyrtus tomentose and Woodfordia fruiticosa by Aqueous Extraction

The shade dried material of herbal blend of Rhodomyrtus tomentose and

Woodfordia fruiticosa was pulverized to coarse powder and about 100 Kg of powdered herbal blend was placed in soxhalator using water as solvent of extraction at refluxing temperature and recycled the process until extraction is completed, then plant extracts were filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature. The herbal material was also placed in percolator and extracted with water at room temperature for 24 h to 48 h, then plant extracts were filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature and under reduced pressure. Example- 14

Preparation of extract from herbal blend of Rhodomyrtus tomentose and Woodfordia fruiticosa by Solvent -Solvent Percolation Method: The dried herbal blend of Rhodomyrtus tomentose and Woodfordia fruiticosa were pulverized to coarse powder and about 10 Kg of powdered herbal blend placed in different percolators and extracted with n-hexane, acetone, ethyl alcohol, methanol, ethyl alcohol and water ( 1 : 1), methanol and water (1 : 1 ) and water at room temperature for 24 h to 48 h, then plant extracts were filtered and concentrated to dryness on rotatory evaporator or on steam bath at optimum temperature and under reduced pressure .

Example- 15

A clinical evaluation study to evaluate the safety and efficacy of Clear Vital gel in 5 wrinkled facial skin

AIM: This study was planned to evaluate the clinical efficacy of Clear Vital gel in the management of wrinkled facial skin.

Skin wrinkles typically appeared as a result of ageing process as a fold, ridge or

I O crease in the skin. Wrinkling in the skin was caused by habitual facial expressions, ageing, sun damage, smoking, poor hydration and various other factors.

MATERIALS AND METHODS: Hundred individuals of either sex, aged between 47- 70 years with facial wrinkles and who had given the consent to participate in the study were included in the study. All the subjects were given Clear Vital and

15 instructed to apply it twice daily all over the face for a period of 6 weeks. Subjects were assessed at entry, at the end of 2 ^nd week, 4 ^th week and at the end of 6 ^th week with Visual analogue score of scale 1 to 10. At each visit the subjects will be evaluated for reduction in the number of facial wrinkles, reduction in the depth of the facial wrinkles, reduction in the periorbital and nasolabial lines. Statistical analysis were performed using 0 students" test.

RESULTS: Ninety-four out of hundred subjects who had participated in the trial completed the 6 weeks of follow-up. Six patients could not complete the scheduled follow-up due to their personal problems in visiting the skin unit within the stipulated time. Demographic data including age, gender, history of smoking, alcohol consumption, 5 and diet were tabulated (Table 9). At the end of the study all the patients responded to the treatment (Table 10). The number of wrinkles reduced with an excellent response in 50 cases, good response in 48 and a poor response in 02 cases. The depth of the skin wrinkles reduced showing 66 cases excellent response, 28 cases good response and 6 cases poor response. Similarly there was also reduction in the periorbital and nasolabial0 lines. Softness of the skin increased in all the patients showing 32 with good response and 68 with excellent response. Moisturizing effect of the skin was exhibited by all the cases showing 40 cases with good response and 60 with excellent response.

Example- 16 Results of efficacy and safety of anti-wrinkle gel

A significant reduction of facial wrinkles was observed after 6 weeks of treatment with Clear Vital gels in patients of facial Blemishes. All volunteers displayed an adequate acceptance to the trial medications. None of the patients complained of any side effects or untoward reactions.

CONCLUSION

The natural gelling agents compared have their own limitations to be used for formulations containing herbal extracts. Most of them were translucent gels, aesthetically did not appeal to the consumer. Leave unpleasant residual tack on the skin during application, This tackiness could be a negative attribute, giving the consumer the perception that the product felt unclean and unnatural.

The natural gelling agents compared were translucent gels, except for carrageenan and dehydroxanthan gum. The hazy formulations aesthetically did not appeal to the 5 consumer. Acacia and guar gum gave a good consistency with the extracts but on application on skin the end feel was not satisfactory. The formulation with dehydroxanthan gum were not as tacky as the others gelling agents. The formulation was transparent and gave sufficient viscosity. pH of the gel was suitable for herbal extract stability. I O Gels containing dehydroxanthan gum are not as tacky as traditional gels containing recommended use levels. The formulation is transparent and gives sufficient viscosity. pH of the gel is suitable for herbal extract stability.

While this invention has been described in detail with reference to certain preferred embodiments, it should be appreciated that the present invention is not limited to those 1 5 precise embodiments. Rather, in view of the present disclosure, which describes the current best mode for practicing the invention, many modifications and variations would present themselves to those skilled in the art without departing from the scope and spirit of this invention. 0

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