WO2023175629A1

WO2023175629A1 - Topical herbal cream composition

Info

Publication number: WO2023175629A1
Application number: PCT/IN2023/050245
Authority: WO
Inventors: Jaspreet SUTHAR
Original assignee: Yushuna Healthcare Pvt Ltd
Current assignee: Yushuna Healthcare Pvt Ltd
Priority date: 2022-03-15
Filing date: 2023-03-15
Publication date: 2023-09-21
Anticipated expiration: 2024-09-15

Abstract

The present invention relates to topical composition comprising herbal juice, useful for the management of skin conditions. More particularly, the present invention relates to topical cream compositions comprising herbal juice that does not freeze even at -25⁰C.

Description

“TOPICAL HERBAL CREAM COMPOSITION”

Technical field:

The present invention relates to topical composition comprising herbal juice, useful for the management of skin conditions. More particularly, the present invention relates to topical cream compositions comprising herbal juice that does not freeze even at -25°C.

Background and prior art:

A topical formulation is a medication that is applied to body surfaces such as the skin or mucous membranes to treat various conditions, diseases or disorders of skin. These formulations are used for the localized effects produced at the site of their application by drug penetration into the underlying layer of skin or mucous membrane. These topical formulations such as creams, foams, gels, lotions, and ointments are designed to deliver drug into the skin in treating dermal disorders, with the skin as the target organ.

Often, skin diseases cause rashes or other changes in the skin’s appearance. Some of the most common skin diseases include acne, chronic wounds due to bacterial or fungal infections, atopic dermatitis (eczema), dry, itchy skin that leads to swelling, cracking or scaliness, psoriasis, scaly skin that may swell or feel hot, pimples, skin allergies due to some medications etc.

Therefore, skin diseases or disorders require special medications, which should be gentle, smooth, safe, non-irritating, effective and natural as preferred by most of the consumers.

There are a variety of skin creams and lotions available in the market which are used to soften skin, repair lesions, combat dryness and redness, and reduce swelling and roughness in irritated skin. It is very common that everyone has experienced the discomfort of skin disorders at one time or another. Topical formulations are made up in a vehicle, or base, which may be optimized for a particular site of the body or type of skin condition. These products are designed to be moisturizing or to maximize the penetration of an active ingredient into or through the skin. There are various topical dosage formulations available such as solution, Lotion, Cream, Ointment, Gel, Paste, Aerosol foam or spray, Powder Solid, Transdermal patch etc. Most of the skin disorder conditions involves wet or oozy skin, where creams and lotions are most suitable, while for dry, scaly skin, ointments and oils are appropriate. For inflamed skin, post use of wet compresses and soaks, creams or ointments are recommended.

Topical Creams are semi-solid emulsions of oil and water. Most of the topical cream formulations contain more than 20 per cent of water and volatiles and/or less than 50 per cent of hydrocarbons, waxes, or polyethylene glycols as the vehicle for external skin application. In a topical cream formulation, ingredients are dissolved or dispersed in either a water-in-oil (W/O) emulsion or an oil-in- water (O/W) emulsion. Topical cream formulation penetrates through the skin by transcellular route, intercellular route, or trans-appendageal route.

Advantages of cream formulation includes; moistening and emollient properties; more spreadable, gives prolonged contact at the site of application and easily water washable & easy to wipe away. However, there are also disadvantages of cream formulation which include, less hydrating than ointments, greasy feel for longer time post application, appearance of white greasy patches after applications, which stays on skin for longer time. In addition to these disadvantages, depending on the subzero temperatures, ice crystals will be formed in the cream formulations that does not give smoothening effect when applied by the user.

Herbal medicines are being used by about 80% of the world population primarily in the developing countries and also in developed countries for primary health care, due to its safety and lesser side effects when compared to chemically synthesized drugs. Also, application of topical formulations with plant juices/extracts minimizes oxidative stress in the skin and thereby delays skin aging by reducing the wrinkles, protects against UV radiation, and prevents degradation of collagen.

There is ample literature available on the use of herbal medicines in topical cream formulations, for the treatment of variety of skin disorders. One such disclosure could be found from US6261574B1, which discloses a cream formulation for topical application that consisting of: (a) an Aloe vera gel; (b) zinc compound; (c) vitamin E and (d) a balance of said cream formulation being made up of water, organic solvents, carriers and emollients. However, this patent does not address the problems of stability, greasiness and formation of ice crystals or the precipitation of the active in the formulation at lower temperatures.

US4725438A describes a stabilized ointment comprising about 80 to 95 percent by weight of ointment base and from about 5 to about 20 percent by weight of the gel of the Aloe vera plant. However, this patent does not address the problems of stability, greasiness and formation of ice crystals or the precipitation of the active in the formulation at lower temperatures.

Although the prior art literature and the marketed products, provides the topical cream formulations containing of herbal extracts, however, none of these formulations discuss the problem of formation of ice crystals or crystallization of the active ingredients at subzero temperatures. Therefore, it is important that the topical cream formulation remains stable with content uniformity during its shelf life and should not crystalize at subzero temperature thereby provides the user a smooth feeling during application of the cream.

In the light of the above, it is an objective of the present invention to provide a topical herbal cream formulation which is not only stable with content uniformity during its entire shelf life irrespective of varied temperatures but also provides non-greasiness and smooth feel to the user as it lacks water crystals and thereby provides healing for skin cracks and lesions, while softening and moisturizing the lesions.

Summary of the present invention:

In line with the above objective, the present invention provides a topical herbal cream composition which is not only stable with content uniformity during its entire shelf life irrespective of varied temperatures but also provides smooth feel to the user as it lacks water crystals and further provides healing for skin cracks and lesions, while softening and moisturizing the lesions.

Accordingly, in an aspect, the invention provides topical herbal cream formulation which comprises a) vitamin C enriched herbal juice characterized by having a pH in the range of 3.5 ± 0.5 in an amount of 25 to 65%; b) a cream base comprising of thickening agent, moisturizing agent, humectant, solubilizer, emulsifier and vegetable oils in an amount of 35 to 75%, wherein the pH of the formulation is maintained at 5.5 ± 0.5 and stable at 0°C, -10°C or -25°C,.

The herbal juice as used in the topical herbal cream formulation is selected from the group consisting of Aloe vera juice, Cucumber juice, Watermelon juice, Papaya juice, Pomegranate juice, Amla juice, Orange juice, Grape juice, Muskmelon juice, Cantaloupe juice, Honeydew juice, Casaba melon juice, Bitter melon juice, Pineapple juice, Peach juice, Apple juice, Tomato juice, Coconut juice (coconut water + coconut cream), berry fruits such as Strawberry juice, Blueberry juice, Cranberry juice etc.

In one of the preferred aspects, the vitamin C enriched herbal juice is Aloe vera juice.

Accordingly, in one of the aspects, the invention provides a process for preparation of vitamin C enriched Aloe vera juice, which process comprises; a) Soaking the cleaned chopped leaves in small pieces in cold water at 8°C ± 2°C for 15 mins; followed by removing the outer green layer of the Aloe vera leaf and separating the gel from other green leaf parts to ensure the complete removal of latex; b) Soaking the extracted gel in cold water at 8°C ± 2°C for 15 mins followed by blending the extracted gel with cold water used for soaking purpose to obtain homologous slurry; c) Filtering the homogenous slurry to separate the Aloe vera juice by using the muslin cloth and then through nutch filter; d) Acidifying the juice with 15% ascorbic acid solution (either alone or in combination with Citric acid / Lactic acid / Tartaric acid / Propionic acid etc.) under continuous stirring to adjust the pH to 3.5 ± 0.5; e) stirring of juice for 30 minutes and maintained the pH at 3.5 ± 0.5 to ensure the stabilization of juice to obtain vitamin C enriched Aloe vera juice.

The vitamin C enriched Aloe vera juice is then used for the preparation of creams & ointments, as demonstrated in the present invention.

The topical herbal formulation, thus prepared using vitamin C enriched herbal juice characterized by having a pH in the range of 3.5 ± 0.5, and stable at 0°C, - 10°C or -25°C, as demonstrated herein below in the detailed description.

Description of drawings:

Figure 1 depicts significant decreases in severity of scaly skin in male mice of Group IV to VI on 4th, 7th, 11th & 15th day at 95% confidence interval. Note: Minimal rise in severity of scaly skin score on 7th day, it may be due to other factor (i.e. skin contact with bedding material, aggressive behaviour of animals).

Figure 2 depicts significant decreases in severity of scaly skin in female mice of Group IV to V on 4th, 7th, 11th & 15th day at 95% confidence interval. Figure 3 depicts significant decreases in skin inflammation in male mice of Group IV to VI on 4th, 7th, 11th & 15th day at 95% confidence interval. Note: Minimal rise in reduction in inflammation score on 7th day, it may be due to other factor (i.e. skin contact with bedding material, aggressive behaviour of animals).

Figure 4 depicts significant decreases in skin inflammation in female mice of Group IV to V on 7th, 11th & 15th day at 95% confidence interval.

Figure 5 depicts significant decreases in scaly skin patches in male mice of Group IV to VI on 4th, 7th, 11th & 15th day at 95% confidence interval. Note: Minimal rise in reduction in patches score on 7th day, it may be due to other factor (i.e. skin contact with bedding material, aggressive behaviour of animals).

Figure 6 depicts significant decreases in scaly skin patches in female mice of Group IV to V on 4th, 7th, 11th & 15th day at 95% confidence interval.

Figures 7 and 8 depict Histopathological changes in male and female mice respectively after the application of various test items. In histopathological evaluation of skin tissue, group I, II & III showed moderate to severe increase in epidermal thickness, acanthosis, hyperplasia and odema with cellular infiltrations. In group IV and VI showed mild to moderate increase epidermal thickness, acanthosis, hyperplasia and odema. Group V showed major histological improvements with normalisation of epidermal thickness, which is helpful for strengthening epithelial barrier and bring normalcy to skin layers.

Detailed description of the invention:

The invention will be described in detail in connection with certain preferred and optional embodiments, so that various aspects thereof may be fully understood and appreciated.

The embodiments herein and the various features and advantageous details thereof are explained with reference to the non-limiting embodiments in the following description. Descriptions of well-known components and processing techniques are omitted so as to not unnecessarily obscure the embodiments herein. The foregoing description of the specific embodiments so fully reveals the general nature of the embodiments herein that others can, by applying current knowledge, readily modify and/or adapt for various applications such specific embodiments without departing from the generic concept, and, therefore, such adaptations and modifications should and are intended to be comprehended within the meaning and range of equivalents of the disclosed embodiments. It is to be understood that the phraseology or terminology employed herein is for the purpose of description and not of limitation. Therefore, while the embodiments herein have been described in terms of preferred embodiments, those skilled in the art will recognize that the embodiments herein can be practiced with modification within the spirit and scope of the embodiments as described herein.

Source of biological materials used in the invention:

Aloevera leaves were procured from Prakruti Products Pvt. Ltd, Karwar, Karnataka, India.

Watermelon Juice, Cucumber juice, and Turmeric extract were procured from Prakruti Products Pvt. Ltd, Karwar, Karnataka, India.

Vegetable oils such as coconut oil, sesame oil, olive oil, canola oil, almond oil are procured from local market.

The use of the expression “at least” or “at least one” suggests the use of one or more elements or ingredients or quantities, as the use may be in the embodiment of the disclosure to achieve one or more of the desired objects or results.

The expression “Juice-based” as referred in the entire specification means and includes the Vitamin C enriched Aloe vera juice based cream provided in accordance with the example 1.

The use of expression “Water based cream” as referred in the entire specification means and includes the cream composition provided in accordance with the example 4. The use of expression “Turmeric based cream” as referred in the entire specification means and includes the Vitamin C enriched Aloe vera juice based cream incorporated with turmeric extract, as additional herbal ingredient, provided in accordance with the example 5.

Accordingly, the invention provides topical herbal cream composition which comprises; a) vitamin C enriched herbal juice characterized by having a pH in the range of 3.5 ± 0.5 in an amount of 25 to 65%; b) a cream base consisting of thickening agent/emulsifier, moisturizing agent, humectant, solubilizer, emulsifying agent and vegetable oils in an amount of upto 25 to 65%, wherein the pH of the formulation is maintained at 5.5 ± 0.5 and stable at 0°C, -10°C or - 25°C.

The herbal juice as used in the topical herbal cream formulation is selected from the group consisting of Aloe vera juice, Cucumber juice, Watermelon juice, Papaya juice, Pomegranate juice, Amla juice, Orange juice, Grape juice Muskmelon juice, Cantaloupe juice, Honeydew juice, Casaba melon juice, Bitter melon juice, Pineapple juice, Peach juice, Apple juice, Tomato juice, Coconut juice (coconut water + coconut cream), berry fruits such as Strawberry juice, Blueberry juice, Cranberry juice etc. etc.

In one of the preferred embodiments, the herbal juice is Aloe vera juice.

The thickening agents/emulsifiers are selected from the group consisting of Cetostearyl Alcohol, Stearic Acid, Sodium Polyacrylate Dimethicone, shea butter and the like, present in the formulation in an amount of 4 to 10% by weight of the total formulation.

The moisturizing agent may be selected from the group consisting of Petroleum Jelly (White Soft Paraffin), shea butter, Cocoa butter, glycerin or in combinations thereof present in the formulation in an amount of 2 to 10% by weight of the total formulation.

The solubiliser may be selected from the group consisting of ethylene glycol, propylene glycol, polyethylene glycol, Polyoxyethylene (23) Lauryl Ether or combination thereof present in the formulation in an amount of 5 to 10% by weight of the total formulation.

The humectant may be selected from the group consisting of Glycerol (Glycerin), Light Liquid Paraffin, or combination thereof present in the formulation in an amount of 15 to 20% by weight of the total formulation.

The emulsifying agent may be selected from the group consisting of Glycerol Monostearate, Stearic Acid or combinations thereof present in an amount of 3 to 10% by weight of the total formulation.

The vegetable oils as skin conditioning agents may be selected from the group consisting of coconut oil, sesame oil, olive oil, canola oil, almond oil or combinations thereof present in an amount of 2 to 5% by weight of the total formulation.

The topical cream formulation optionally further comprises chelating agents such as Disodium Edetate, antioxidants such as BHT, penetration enhancers such as Isopropyl Myristate, Emulsifying Wax, suitable fragrance, menthol, vitamins such as vitamin A, vitamin E, vitamin B5 and appropriate minerals, in appropriate amounts as needed.

In one of the embodiments, the invention provides a process for preparation of vitamin C enriched Aloe vera juice, which process comprises; a) Soaking the cleaned chopped leaves in small pieces in cold water at 8°C ± 2°C for 15 mins; followed by removing the outer green layer of the Aloe vera leaf and separating the gel from other green leaf parts to ensure the complete removal of latex; b) Soaking the extracted gel in cold water at 8°C ± 2°C for 15 mins followed by blending the extracted gel with cold water used for soaking purpose to obtain homologous slurry; c) Filtering the homogenous slurry to separate the Aloe vera juice by using the muslin cloth and then through nutch filter; d) Acidifying the juice with 15% ascorbic acid solution (either alone or in combination with Citric acid / lactic acid / Tartaric acid / Propionic acid etc.) under continuous stirring to adjust the pH to 3.5 ± 0.5; e) stirring of juice for 30 minutes and maintained the pH at 3.5 ± 0.5 to ensure the stabilization of juice to obtain the processed Aloe vera juice is then used for the preparation of creams & other ointments.

Thus, the water free Aloe vera juice derived topical cream prepared according to the present invention provides better hydration, stability for longer time especially for skin disorders/ diseases involving dry, patchy, inflamed, infected skin.

The Aloe vera juice-based cream provided according to the invention helps stimulate both collagen and elastin fibers, boosting the elasticity of the skin, delivers vitamins, minerals, as well as amino acids to the skin if required, faster absorption and non-greasy, helps to absorb active ingredients due to Aloe vera juice-base, integrates the vegetable oils such as virgin coconut oil, sesame oil, shea butter etc. into the cream, ability to fight free radicals that are damaging the skin, gently moisturizes the skin without stripping it of its natural oils and better hydration.

According to the present invention, the high content of Aloe vera juice as used in the topical formulation of the present invention works as cooling agent and provides benefit to skin health and further avoids the formation of ice crystals, at subzero temperatures. Also, Aloe vera juice prepared according to the process of the invention is free from harsh chemicals, preservatives, steroids etc.

The topical herbal formulation thus prepared using vitamin C enriched Aloe vera juice provides faster absorption & vanishing nature due to high concentration of Aloe vera juice and thus Skin becomes light and non-waxy post application.

Similar process is employed to prepare Watermelon juice, Papaya juice, Pomegranate juice, Amla juice, Orange juice, Grape juice, Cucumber juice Muskmelon juice, Cantaloupe juice, Honeydew juice, Casaba melon juice, Bitter melon juice, Pineapple juice, Peach juice, Apple juice, Tomato juice, Coconut juice (coconut water + coconut cream), berry fruits such as Strawberry juice, Blueberry juice, Cranberry juice etc. etc. by acidifying the extracted juice with ascorbic acid solution to adjust the pH to 3.5 ± 0.5, followed by stirring of juice for 30 minutes to ensure the stabilization of juice to obtain the processed juice respectively, which is then used for the preparation of creams & other ointments. In this context, the present invention has provided vitamin C enriched Cucumber juice cream as well as vitamin C enriched Watermelon juice cream under examples 2 and 3.

The topical herbal formulation thus prepared using vitamin C enriched herbal juice is stable and does not crystallize at 0°C, -I0°C or -25°C, for 30 days of exposure to lower temperature as demonstrated herein below in the examples.

In yet another embodiment, the present invention provides Aloe vera topical cream formulations by incorporating various suitable herbal active ingredients along with few minerals and vitamins as required in the aloe vera juice cream base for enhancing the efficacy of the treatment of specific skin conditions such as psoriasis, eczema, skin rashes, Rosacea, varicose veins, piles and as skin cream or anti-pollution cream. In an embodiment, various suitable herbal active ingredients that can be added to enhance the efficacy of the cream compositions are selected from the group consisting of Curcuma longa & related species, A adirachta indica & related species, Santalum album & related species, Randia uliginsa & related species, Acacia macrophylla & related species, Solarium virginianum & related species, Cissus quadrangularis & related species, Ficus benghalensis & related species, Mimosa pudica & related species, Mesua ferrea & related species, Zinc Calyx, Pterocarpus marsupium & related species, Artemisia vulgaris & related species, Salix alba & related species, Piper cubeba & related species, Boswellia serrata & related species, Orchrocarpus longifolia & related species, Spaheranthus indicus & related species, Saussurea costus & related species etc.

Accordingly, in an embodiment, the juice based cream was prepared using additional herbal ingredient, Curcuma longa and provided the same as example 5, which is also evaluated as a test item for the treatment group VI.

Thus, the present topical cream formulations give flexibility to the formulator to include Aloe vera juice upto 65% w/w, thereby prevent the freezing of the formulation at -25°C as cream is frost-resistant especially for colder regions such as EU, North America and CIS countries etc. The topical cream formulations deliver essential nutrients including vitamins & minerals, better hydration as compared to water base cream and exhibit faster absorption and vanishing nature without leaving any patches on the skin post application.

In an additional embodiment, salicylic acid based cream employed for the group II mice (as positive control) was prepared as follows. Salicylic acid (API) was purchased from BLD Pharma. 1.15% of salicylic acid cream was freshly prepared and used in group II mice. 1.15% salicylic acid cream was prepared as water based cream, wherein salicylic acid was slowly added in water based cream during homogenization process. After addition of salicylic acid, the cream was homogenized for 15 mins to ensure complete dispersion as well as homogenous mixture of salicylic acid based cream. In a further embodiment, the present topical Vitamin C enriched Aloe vera juicebased cream (example 1) and Vitamin C enriched Aloe vera juice-based cream with turmeric (example 5) were evaluated for the efficacy vis-a-vis various other topical creams viz., salicylic acid cream, water based cream, on Patchy, Scaly and Inflamed red Skin in Mice. This study was designed to provide information on efficacy of Topical cream on Imiquimod induced scaly skin inflammation in mice. For induction of scaly skin all animals were treated with 62.5mg of 5% Imiquimod cream for 5 days, then grouped into 6 different groups A total of 55 mice (30 Male & 25 Female) weighing 20-3 Ogm were divided into 6 groups. Group-I- Untreated Control; Group-II- Positive Control- Salicylic acid cream once a day; Group- III- Water based cream 2 times a day; Group-IV- Vitamin C enriched Aloevera Juice based cream 2 times a day; Group-V- Vitamin C enriched Aloe vera Juice based cream 3 times a day; and Group-VI- Vitamin C enriched Aloevera Juice based cream with Turmeric 2 times a day. n=5.

The experimental design of the study is as follows:

Animals from Group- 1 were not treated for 15 days treatment period. Group II to group III were treated with Salicylic acid cream and respectively, Vitamin C enriched Aloe vera juice based creams in groups IV and V and Vitamin C enriched Aloe vera Juice based cream with Turmeric in group VI were applied topically, as per the above study design on back side scaly skin area of animals consecutively for 15 days. All the animals from Group I to VI survived up to schedule termination. All the animals were subjected to mortality/morbidity check twice a day till terminal sacrifice. Body weight of all animals from all the groups was measured on weekly basis. All the animals from all groups were subjected for evaluation of severity of scaly skin, reduction in inflammation & patches, skin repair effects and moisturizing effect. All animals (group I to group VI) were sacrificed on last day of treatment and skin tissue was collected and processed for histopathological evaluation and qualitative measurement of keratinocytes level. The results of the test are discussed herein below and also in tables 1 to 7 and figures 1 to 8.

Results:

• All animals developed scaly skin and were randomized into 6 groups.

• All animals survived throughout the treatment period of 15 days.

• Reduction in severity of scaly skin, inflammation and patches were observed in Group IV, V & VI from 7th day of treatment period (figure 1, table 1, 2 and 3).

• No abnormal body weight loss was observed during treatment period.

• Improvement in skin moisturizing effect was observed in Groups II to VI (Treatment groups) as compared to Group I (Untreated control). Measurement of moisture content of outermost layer of skin (stratum comeum) measured by Comeometer on 7th & 15th day. Water content was measured by applying probe to cervico-dorsal region of skin (Tables 4).

• Skin repair effect was observed in treatment Group V when compared to other groups III, IV, & VI on 7^th day (Table 5).

• Histopathological improvements were observed in treatment Group IV, V & VI as compared to Group I (table 6). Table 1: Summary of Severity of scaly skin

Note: Significant decreases in severity of scaly skin in Group IV to VI on 4^th, 7^th, 11^th & 15^th day at 95% confidence interval.

Table 2: Summary of Reduction in inflammation

Note: Significant decreases in skin inflammation in Group IV to VI on 4^th, 7^th, 11^th & 15^th day at 95% confidence interval.

Table 3: Summary of Reduction in patches

Note: Significant decreases in scaly skin patches in Group IV to VI on 4^th, 7^th, 11^th & 15^th day at 95% confidence interval.

Table 4: Summary of Moisture content measurement

Note: Significant increase in moisture content of skin in Group IV to VI on 7^th & 15^th day at 95% confidence interval.

Note: Normal range for moisture content of skin is 40 % to 70 %.

Table 5: Summary of Skin repair effect

Vote for Male group: Complete skin repaired effect was observed in group V on 7^th day, in group IV & VI on 15^th day.

Note for Female group: Complete skin repaired effect was observed in group V on 7^th day, in group IV on 15^th day.

Abbreviations: +++ : Severe patchy, scaly inflamed red skin, ++ : Moderate patchy, scaly/inflamed red skin, + Mild patchy/scaly/inflamed red skin, — : Normal skin structure (No observed any scaly, patchy, inflamed red skin).

Description- Skin repair effect was evaluated through visual examination of severity scaly, patchy and inflamed red skin area.

Table 6: Summary of Histopathological evaluation (On 15^th Day)

Sex: Male

Note: Histopathological improvements were observed in Group III, IV, V and VI.

Sex: Female

Note: Histopathological improvements were observed in Group II, IV and V. Abbreviations: 0- Within normal limit; 1- Minimal; 2- Mild; 3- Moderate; 4- Severe.

As is evident from the above, In histopathological evaluation of skin tissue, group I, II & III were showed moderate to severe increase in epidermal thickness, acanthosis, hyperplasia and oedema with cellular infiltrations. In group IV and VI

were showed mild to moderate increase epidermal thickness, acanthosis, hyperplasia and oedema. Group V was showed major histological improvements with increase in epidermal thickness which is helpful for strengthening epithelial barrier.

The summarized results of the efficacy of all the test items are provided in the table 7 below.

Table 7:

Severe»» moderate»> mild» minimal> normal

As is evident from the above data, application of Vitamin C enriched Aloe vera Juice based cream (as per example 1) 3 times a day was most effective in earliest recovery from scaly skin inflammation, followed by application of Aloe vera Juice based cream (example 1) 2 times a day than the application of vitamin C enriched Aloe vera Juice based cream Turmeric 2 times a day and lastly Water based cream 2 times a day.

Conclusion:

Based on the results, it was concluded that the test item ‘Juice based cream’ showed reduction in scaly skin inflammation on 2 times and 3 times topical application a day for 15 days. Based on the findings, Juice based cream was found to be efficacious against patchy, scaly skin inflammation.

When compared with the untreated control, all the treated groups showed positive improvements in the patchy, scaly and inflamed red skin condition but the best and earliest recovery was observed in the Juice based cream when applied 3 times a day, followed by Juice based cream applied twice a day, then turmeric based cream and lastly by the water based cream. The juice-based cream was most effective in reverting the scaly skin condition on 4th day and to normalized skin with 3 times application showing full recovery by 7th day and twice daily application showing recovery in most of the parameters by 11th day and all parameters by 15th day.

By day 15 almost all parameters showed 100% recovery and scaly skin condition was fully reversed back in all the groups IV to VI. Based on the earliest recovery,

the juice based cream with 3 times a day application is considered the best for the treatment of scaly skin condition.

Encouraged with the above results, the present inventors have conducted Anecdotal Studies in Human subjects, the details are described below.

1) A subject with moderate atopic dermatitis applied the Vitamin C enriched Aloe vera juice-based cream three times a day in accordance with the present disclosure; as obtained from Example 1. It was found that severity of atopic dermatitis patches of the subject was reduced substantially during one week of treatment three times a day.

2) Anti-psoriasis efficacy of the Vitamin C enriched Aloe vera juice-based cream of Example 1 with respect dry and inflamed skin was established in a male patient of 23 years of age and a body weight of 74kg presenting psoriasis in skin beneath right ear. The test subject exhibited significant reduction in patch of plaque psoriasis, with two times application of the cream.

The subject was told to continue the application of the juice-based cream two times per day post one week of three times application and for a period of 30 days. The patient had achieved a 50% reduction in the Psoriasis Area and Severity Index (PASI 50) score within a month of treatment.

3) A female subject of 62 years with moderate rashes applied juice based cream for 3 times a day and it was found that after a period of 14 days, the subject has reported with reduced severity of rashes consistently post 7 days of application of juice based cream. Thereafter under the same conditions, the subject was continued to apply juice based cream two times a day for next 15 days and rashes were significantly reduced and subject got relief permanently from skin rashes.

4) A female subject of 70 years with severe atopic dermatitis applied Aloevera juice based cream with Turmeric three times a day and it was found that after a period of one month, the dermatitis patch of the subject reduced and normal skin was achieved. Thereafter under the same conditions, the subject applied Aloevera juice based cream with Turmeric, two times a day for 3 months. After three

months of treatment, the skin retained sufficient moisture content and repaired the skin to avoid relapse of Atopic dermatitis, which in normal situation, relapsed severely along with inflammation if the topical application stops.

The invention will now be illustrated with help of examples. The aforementioned embodiments and below mentioned examples are for illustrative purpose and are not meant to limit the scope of the invention. Various modifications of aforementioned embodiments and below mentioned examples are readily apparent to a person skilled in the art.

Examples

Example 1:

Vitamin C enriched Aloe vera based cream

pH of the above composition is in the range of 5.5 ± 0.5 and stable at 0°C, -10°C or -25°C

Example 2:

Vitamin C enriched Cucumber based cream

pH of the above composition is in the range of 5.5 ± 0.5.

Example 3:

Vitamin C enriched Watermelon based cream

pH of the above composition is in the range of 5.5 ± 0.5.

Example 4:

Water based cream

pH of the above composition is in the range of 6.5 ± 0.3

Example 5:

Vitamin C enriched Aloevera juice based cream with Turmeric

pH of the above composition is in the range of 5.5 ± 0.5.

Example 6:

Vitamin C enriched Aloe vera juice preparation procedure:

5 Kg of fresh, matured, green leaves of Aloe vera were subjected to cleaning to remove the dust and other superfluous particles from the leaves. Then the clean leaves are chopped into small pieces and then soaked in cold water at 8°C ± 2°C for 15 mins. The outer green layer of the chopped leaves was removed and separated the gel from other green leaf parts to ensure the complete removal of latex. Then the extracted gel (Approx. 1.5 - 2.5 Kg) was soaked in cold water at 8°C ± 2°C for 15 mins and blended the extracted gel with 1.5 Litre of cold water used for soaking purpose to obtain homologous slurry. This homogenous slurry was filtered to separate the Aloe vera juice by using the muslin cloth and then through nutch filter. This juice was acidified with 15% ascorbic acid solution ( either alone or in combination with Citric acid / lactic acid / Tartaric acid / Propionic acid etc.) under continuous stirring to adjust the pH to 3.5 ± 0.5. This Vitamin C enriched Aloe vera juice was continuously stirred for 30 minutes to ensure the pH and thus the stabilization to obtain Vitamin C enriched Aloe vera stabilized juice.

Yield: 4.0 Kg

Aloe vera content/potency in the juice: 50% - 60%

The Vitamin C enriched Aloe vera juice is then used for the preparation of creams

6 other ointments.

Example 7:

In this example, comparative experiments were conducted for evaluating the efficacy, stability and non-crystallinity of the topical creams formulated with Vitamin C enriched Aloe vera stabilized juice vis-a-vis the Traditional Aloe vera

based cream and water-based creams. The details of the formulations and its multifactorial efficacy are provided in below table.

TECHNICAL ADVANCEMENTS

The present disclosure described herein above has several technical advantages including, but not limited to, the realization of a base composition for dermatological products, that:

• is free from harsh chemicals, preservatives and steroids;

• has regenerative and nourishing properties;

• has an anti-inflammatory, anti-microbial and anti-oxidant property;

• is capable of controlling and treating a wide range of skin conditions and diseases including dry, patchy, rash, inflamed, infected skin, psoriasis, eczema, rosacea, varicose vein, piles, wart and the like.

Any discussion of documents, acts, materials, devices, articles or the like that has been included in this specification is solely for the purpose of providing a context for the disclosure. It is not to be taken as an admission that any or all of these matters form a part of the prior art base or were common general knowledge in the field relevant to the disclosure as it existed anywhere before the priority date of this application.

The numerical values mentioned for the various physical parameters, dimensions or quantities are only approximations and it is envisaged that the values higher/lower than the numerical values assigned to the parameters, dimensions or quantities fall within the scope of the disclosure, unless there is a statement in the specification specific to the contrary.

Having described and illustrated the principles of the present disclosure with reference to the described embodiments, it will be recognized that the described embodiments can be modified in arrangement and detail without departing from the scope of such principles.

While considerable emphasis has been placed herein on the components and component parts of the preferred embodiments, it will be appreciated that many embodiments can be made and that many changes can be made in the preferred embodiments without departing from the principles of the disclosure. These and other changes in the preferred embodiment as well as other embodiments of the disclosure will be apparent to those skilled in the art from the disclosure herein,

whereby it is to be distinctly understood that the foregoing descriptive matter is to be interpreted merely as illustrative of the disclosure and not as a limitation.

Claims

We claim,

1. A topical herbal cream formulation which comprises; a) Vitamin C enriched herbal juice characterized by having a pH in the range of 3.5 ± 0.5 in an amount of 25 to 65%; and b) a cream base comprising of thickening agent, moisturizing agent, humectant, solubilizer, emulsifier and vegetable oils in an amount of 35 to 75%, wherein the pH of the formulation is maintained at 5.5 ± 0.5 and the formulation is stable at 0°C, -10°C or -25°C.

2. The topical herbal cream formulation as claimed in claim 1, wherein, the herbal juice is selected from the group consisting of Aloe vera juice, Cucumber juice, Watermelon juice, Papaya juice, Pomegranate juice, Amla juice, Orange juice, Grape juice, Muskmelon juice, Cantaloupe juice, Honeydew juice, Casaba melon juice, Bitter melon juice, Pineapple juice, Peach juice, Apple juice, Tomato juice, Coconut juice (coconut water + coconut cream), berry fruits such as Strawberry juice, Blueberry juice, Cranberry juice etc.

3. The topical herbal cream formulation as claimed in claim 1, wherein, the herbal juice is Aloe vera juice.

4. The topical herbal cream formulation as claimed in claim 1, wherein, the thickening agents/emulsifiers are selected from the group consisting of Cetostearyl Alcohol, Stearic Acid, Sodium Polyacrylate Dimethicone, shea butter and the like, present in the formulation in an amount of 4 to 10% by weight of the total formulation.

5. The topical herbal cream formulation as claimed in claim 1, wherein, the moisturizing agent may be selected from the group consisting of Petroleum Jelly (White Soft Paraffin), shea butter, Cocoa butter, glycerin or in combinations thereof present in the formulation in an amount of 2 to 10% by weight of the total formulation.

The topical herbal cream formulation as claimed in claim 1, wherein, the solubiliser may be selected from the group consisting of ethylene glycol, propylene glycol, polyethylene glycol, Polyoxyethylene (23) Lauryl Ether or combination thereof present in the formulation in an amount of 5 to 10% by weight of the total formulation. The topical herbal cream formulation as claimed in claim 1, wherein, the humectant may be selected from the group consisting of Glycerol (Glycerin), Light Liquid Paraffin, or combination thereof present in the formulation in an amount of 15 to 20% by weight of the total formulation. The topical herbal cream formulation as claimed in claim 1, wherein, the emulsifying agent may be selected from the group consisting of Glycerol Monostearate, Stearic Acid or combinations thereof present in an amount of 3 to 10% by weight of the total formulation. The topical herbal cream formulation as claimed in claim 1, wherein, the vegetable oils as skin conditioning agents may be selected from the group consisting of coconut oil, sesame oil, olive oil, canola oil, almond oil or combinations thereof present in an amount of 2 to 5% by weight of the total formulation. The topical herbal cream formulation as claimed in claim 1, wherein, the formulation optionally further comprises chelating agents such as Disodium Edetate, antioxidants such as BHT, penetration enhancers such as Isopropyl Myristate, Emulsifying Wax, suitable fragrance, menthol, vitamins such as vitamin A, vitamin E, vitamin B5 and appropriate minerals, in appropriate amounts. The topical herbal cream formulation as claimed in claim 1, wherein, the composition comprises a) Vitamin C enriched Aloe vera juice characterized by having a pH in the range of 3.5 ± 0.5 in an amount of 25 to 65%; and b) a cream base comprising of thickening agent, moisturizing agent, humectant, solubilizer, emulsifier and vegetable oils in an amount of 35 to

75%, wherein the pH of the formulation is maintained at 5.5 ± 0.5 and the formulation is stable at 0°C, -10°C or -25°C. A process for preparation of vitamin C enriched Aloe vera juice, which process comprises; a) Soaking the cleaned chopped leaves in small pieces in cold water at 8°C ± 2°C for 15 mins; followed by removing the outer green layer of the Aloe vera leaf and separating the gel from other green leaf parts to ensure the complete removal of latex; b) Soaking the extracted gel in cold water at 8°C ± 2°C for 15 mins followed by blending the extracted gel with cold water used for soaking purpose to obtain homologous slurry; c) Filtering the homogenous slurry to separate the Aloe vera juice by using the muslin cloth and then through nutch fdter; d) Acidifying the juice with 15% ascorbic acid solution (either alone or in combination with Citric acid / Lactic acid / Tartaric acid / Propionic acid etc.) under continuous stirring to adjust the pH to 3.5 ± 0.5; and e) stirring of juice for 30 minutes and maintained the pH at 3.5 ± 0.5 to ensure the stabilization of juice to obtain vitamin C enriched Aloe vera juice.