DESC:IMMUNOMODULATOR COMPOSITION AND METHOD OF PREPARATION THEREOF
FIELD OF THE INVENTION

[001] The present invention relates to a composition and a method to prepare an immunomodulator composition comprising of colloidal alkyl polyglucoside ester fused with essential oils (CPEE).

BACKGROUND OF THE INVENTION

[002] Essential oils are hydrophobic liquids obtained mainly from plants. These oils are extracted by various methods like Steam Distillation, Solvent Extraction, CO2 Extraction, Maceration, Enfleurage, Cold Press Extraction, and Water Distillation. These essential oils are used for multiple purposes like to relieve congestion and promote healthy sleep patterns. Various prior arts have also reported analgesic and anti-inflammatory properties of essential oils. Essential oils like tea tree find wide usage in skin care, peppermint oil has been proven to improve respiratory function, orange oil helps in relieving stress and anxiety; similarly, there are various essential oils which have proven to treat one or more ailments.
[003] There are various prior arts based on Modern Sciences and traditional Ayurvedic Sciences that have studied efficacies and effects of individual essential oils separately. Certain prior arts have also studied the alkyl polyglucoside esters (APE). However, the research on APE has been mainly focused on its surfactant activity. Further, there is limited research on efficiency of polyglucoside infused with essential oils.
[004] Currently there is extensive research being conducted to convert molecules into nano size by using heavy metals. However, the resultant molecules tend to be nano rods, nano stars, nano flowers, nano reefs, nano whiskers, nano fibers and nano boxes and in non-spherical chains and geometries (not as stable), with only the narrowest part in nanometers and the rest of the molecule in micrometers. These molecules tend to be highly carcinogenic, unstable, and not truly nano in nature and in all dimensions. In addition, the scientific community is trying to create APE-like carriers for Solid Nanoparticle Lipids (SNL). This is in ideation stage and none have been able to successfully produce an SNL, yet alone an effective SNL.
[005] Hence, there is a need for a stable and highly bioavailable product for positive immunomodulation.

OBJECT OF THE INVENTION
[006] Primary object of the present invention is to provide an immunomodulatory composition comprising of at least one or more essential oils and infused with polyglucoside ester (APE).
[007] Another object of the present invention is to provide a method to prepare an immunomodulatory composition.

SUMMARY
[008] In an aspect of the present disclosure, a composition for boosting immune system has been disclosed. The composition comprises of APEs fused with at least one or more plurality of essential oils along chelating agent and vegetable oils. The vegetable oils and essential oils are solubilized in water to obtain a homogenous mixture.
[009] Another aspect of the present invention discloses a method for preparation of said immunomodulator composition. The method comprises the steps of blending plurality of vegetable oils and at least one APEs in a vessel A while being stirred at a suitable RPM, for at least an hour. Blending plurality of vegetable oils along with plurality of alkyl poly glucoside esters in a vessel B while being stirred at a suitable RPM for at least an hour. Blending plurality of essential oils along with chelating agent and APEs in a vessel C while being stirred at a suitable RPM. All the vessels are maintained at ambient temperature and suitable pressure to ensure uniform mixing. Once the mixing and blending is complete, all the tanks are allowed to settle, followed by blending together contents of vessel A, B and C at suitable temperature and pressure while being constantly stirred. At the time of blending of components from all the three vessels, plurality of essential oils, sweetener, and water are added and are allowed to blend for at least an hour. The final blend is then homogenized and passed through a nano sieve under pressure, maintained at an appropriate temperature.

BREIF DESCRIPTION OF DRAWINGS
[0010] Figure 1 illustrates Transmission Electron Micrograph (TEM) image of the product demonstrating its size of around 1 nm
[0011] Figure 2 illustrates data representing antimicrobial activity of the immunomodulator composition.

DETAILED DESCRIPTION
[0012] An embodiment of the present invention discloses a colloidal immunomodulator composition which comprises of at least one or more essential oils and one or more vegetable oils fused with colloidal alkyl polyglucoside ester (APE) of natural origin. The vegetable oils and essential oils are solubilized in water to obtain a homogenous mixture. The essential oils may be selected from ylang ylang oil, agar oil, rose oil, tea oil, spearmint oil, rosewood oil, peppermint oil, orange oil, nutmeg oil, rosemary oil, rosewood oil, lemon oil, camphor oil, thyme oil, vetiver oil, basil oil, cardamom seed oil, cedar oil, frankincense oil, lemon oil, eucalyptus oil, coriander oil, lavender oil, clove oil, cinnamon oil and Lemongrass oil. Further the APE may be selected from Coconut APE, Rice APE, Potato APE, Palm APE, Corn APE and/or Sugarcane APE. The vegetable oils are selected from Oregano oil, palm oil, coconut oil, canola oil, soyabean oil, sunflower oil, neem oil, blackseed oil. Present invention is not limited by the list of essential oil, glucoside esters and vegetable oils indicated above, as the above list is indicative and not exhaustive. The composition may further comprise of anti-oxidants, chelating agents, sweeteners (artificial/natural), emulsifying agents and thickening agents.
[0013] Another embodiment of the present invention discloses an immunomodulator composition, the composition comprises of plurality of Alkyl Polyglucoside esters (APE) fused with plurality of vegetable oils, essential oils, sweetening agent, chelating agent and water. The concentration of herbal APE is in the range of 1% to 10% v/v, concentration of vegetable oils is in the range of 0.01% to 5% v/v, concentration of essential oils is in the range of 0.01% to 5% v/v, concentration of chelating agent is in the range of 0.05% to 0.15% v/v, and concentration of water is in the range of 70% to 96% v/v.
[0014] EXAMPLES: Below examples illustrates the immunomodulator composition along with the concentration of each ingredient in the working range.
[0015] Example 1:
Sr No. Ingredients Composition (%v/v)
1 Coconut APE 4.5
2 Corn APE 3.0
3 Sugarcane APE 5.0
4 Blackseed oil 0.12
5 Cinnamon oil 0.015
6 Clove oil 0.025
7 Coconut oil 0.18
8 Coriander oil 0.015
9 Eucalyptus oil 0.042
10 Frankincense oil 0.3
11 Lavender oil 0.8
12 Lemon oil 0.28
13 Lemongrass oil 0.49
14 Neem oil 0.25
15 Orange oil 0.1
16 Oregano oil 0.55
17 Peppermint oil 0.08
18 Rosemary oil 0.15
19 Spearmint oil 0.08
20 Tea oil 0.016
21 Thyme oil 0.018
22 EDTA 0.1
23
Water 83.89

[0016] Example 2:
Sr No. Ingredients Composition (%v/v)
1 Potato APE 3.5
2 Corn APE 4.3
3 Sugarcane APE 4.0
4 Blackseed oil 2.8
5 Cinnamon oil 0.04
6 Coconut oil 4.20
7 Eucalyptus oil 0.08
8 Frankincense oil 0.58
9 Lavender oil 0.03
10 Lemongrass oil 0.45
11 Neem oil 3.22
12 Orange oil 0.02
13 Oregano oil 0.55
14 Peppermint oil 0.05
15 Rosemary oil 0.014
16 Tea oil 0.02
17 Thyme oil 0.016
18 EDTA 0.1
19 Water 76.03
[0017] Example 3:

Sr No. Ingredients Composition (%v/v)
1 Corn APE 1.8
2 Sugarcane APE 2.5
3 Canola 1.4
4 Cinnamon 0.29
5 Eucalyptus 0.45
6 Frankincense 0.58
7 Lemongrass 0.05
8 Neem 0.10
9 Orange 0.02
10 Peppermint 0.05
11 Rosemary 0.48
12 EDTA 0.1
13 Sucralose
14 Water 92.18

[0018] The above disclosed ingredients may be formulated into nanoemulsions or nanocolloids which are in the size range of 1-30 nanometers (refer Figure no. 1). The present composition is effective against variety of pathogens including but not limited to bacteria (Refer Figure no. 2), fungus, viruses, parasites and it may also act as an anti-neoplastic agent. The composition may change (especially concentration of essential oils) based on the intended applications and the particular efficacies of different oils against different pathogens. The composition comprising of colloidal polyglucoside ester fused with essential oils (CPEE) is highly bioavailable, due to its small globule size (1-30 nm). CPEE are very selective and effectively act on pathogens and are not known to harm the human body. This makes them very safe for use with no known adverse effects. The Colloidal Polyglucoside Esters fused with essential oils (CPEE) enter via the lymphatic system and enhance the immune system (immunomodulatory effect) of the body. Infected sites tend to have a lower pH than normal/ uninfected sites in the body, the CPEE are attracted to those sites. Here, the CPEE:
a. Increase the pH of the site and decreases proliferation of the pathogen (incl. replication, distribution, attachment, penetration/ fusion, etc.)
b. Cordon the damaged area and acts as antioxidants. The radicals released from the infected/ damaged sites are absorbed by the CPEE thus preventing them from entering and damaging the rest of the body.
c. Increases the efficacy of the innate and adaptive immune system and controls the cytokines.
The increased pH also controls the cytokine related acidity at the infected sites. This prevents a cytokine storm in the body and keeps the cytokines focused. Colloidal Polyglucoside Esters fused with Essential Oils are very stable nanoparticles. They are spherical in shape, which is the most stable form; this is further substantiated by the zeta potential test. These particles are stable for over two years at room temperature. The oral toxicity of the CPEE is above measurable limits (i.e., >5000ppm and very safe) and is not known to have any side effects. Humans and animals who have been administered CPEE have not reported any side effects. Furthermore, CPEE are not known to have any contraindications. CPEE assists the body regain physiological stability. CPEE aids regulate immunity and acts as an immunomodulator. Various ancient vedic and Ayurvedic scripts and modern science literatures also confirm and re-affirm the same for all individual Essential Oils. CPEE attack the pathogens by lowering their ability to reproduce, attach, fuse, and proliferate in a non-mutagenic manner. Thus, the pathogens are not put under environmental pressure that causes them to mutate.
[0019] The present composition is also efficacious in treatment of COVID-19 when administered along with standard care treatment. The composition was found to be greater than 99.9% safe without any side effects. Further, there were no occurrences of drug-to-drug interaction when given concomitantly with Standard Care of Treatment in mild symptomatic covid-19 patients. The reduction in viral load (inferred by increase in CT value of E gene and RDRP gene) in case of treatment with the present composition was found to be statistically significant (p<0.01) as compared to Standard of Care alone. Further, within a week, the percent recovery was 15.38 % more in case of the treatment group treated with present composition as compared to Standard of Care medications alone.
[0020] Another aspect of the present invention discloses a method for synthesizing the immunomodulator composition or CPEE. The method comprises the steps of mixing plurality of essential oils, vegetable oils and APEs in a vessel A while being stirred at a suitable RPM, for at least an hour. Blending plurality of essential and vegetable oils along with plurality of alkyl polyglucoside esters in a vessel B while being stirred at a suitable RPM for at least an hour. Blending plurality of essential oils along with chelating agent and APEs in a vessel C while being stirred at a suitable RPM. All the vessels are maintained at an appropriate temperature and pressure to ensure uniform mixing. Once the mixing and blending is complete, all the vessels are allowed to settle, followed by blending together contents of vessel A, B and C at an appropriate temperature and suitable pressure while being constantly stirred. At the time of blending of components from all the three vessels, plurality of essential oils, water, and sweeteners are added and are allowed to blend for at least an hour. The final blend is then homogenized and passed through a nanosieve at an appropriate temperature and suitable pressure to obtain the immunomodulator composition in the form of nanoemulsions or nanocolloids .
[0021] Yet another aspect discloses a method to synthesize a nanoemulsions comprising of colloidal polyglucoside ester fused with essential oil (immunomodulator composition). The method comprises of mixing sunflower oil, corn APE and canola oil in a vessel A while being constantly stirred at a rate of 20-80 rotations per minute (RPM), the temperature of the vessel may be maintained in the range of 30-60°C to ensure effective mixing. In vessel B agar oil, soyabean oil, coconut APE and sugarcane APE are blended together while being constantly stirred at a rate of 40-100 RPM; the temperature of the vessel is maintained in the range of 30-60°C. In vessel C essential oils including but not limited to lemongrass oil, cinnamon oil, frankincense oil, eucalyptus oil, lavender oil, rosemary oil, thyme oil, tea oil, Ethylenediaminetetraacetic acid (EDTA), sucralose and sugarcane APE are mixed while being constantly stirred at a rate of 40-80 RPM, the temperature of the vessel is maintained in the range of 30-60°C. All the three vessels are then allowed to settle before mixing the contents of all the three vessels together. Mixing of the contents from vessel A, B and C is done at appropriate temperature in the range of 24-30°C while being constantly stirred at a rate in the range of 70-100 RPM. The pressures of the tanks (5-25 mPa) are regulated at the time of mixing. At the time of blending of components from all the three vessels, one or more essentials oils selected from Sweet Orange Oil, Coriander Oil, Lemon oil, Spearmint Oil, Peppermint Oil, Clove Oil, Sucralose and water are added at appropriate temperature (23°C to 35°C) & pressure (80-120 kPa) and are allowed to blend for at least an hour. The mixture is then homogenized to obtain nanoemulsions and further the mixture is passed through a nanosieve at an appropriate temperature in the range of 23-50 °C. The composition may change (especially the essential oils) based on the intended applications and the particular efficacies of different oils against different pathogens. The chelating agents, sweetening agents and APE are not limited only to those mentioned in the present application.
[0022] Although the present disclosure has been described in the context of certain aspects and embodiments, it will be understood by those skilled in the art that the present disclosure extends beyond the specific embodiments to alternative embodiments and/or uses of the disclosure and obvious implementations and equivalents thereof. Thus, it is intended that the scope of the present disclosure described herein should not be limited by the disclosed aspects and embodiments above.
,CLAIMS:We Claim:
1. An immunomodulator composition, the composition comprising:
plurality of Alkyl Polyglucoside esters (APE) fused with plurality of vegetable oils, essential oils, sweetening agent, chelating agent and water wherein,
concentration of herbal APE is in the range of 1% to 10% v/v,
concentration of vegetable oils is in the range of 0.01% to 5% v/v,
concentration of essential oils is in the range of 0.01% to 5% v/v,
concentration of chelating agent is in the range of 0.05% to 0.15% v/v, and
concentration of water is in the range of 70% to 96% v/v.
2. The immunomodulator composition as claimed in claim 1, wherein the herbal alkyl polyglycolide esters are selected from Sugarcane APE, Coconut APE and Corn APE.
3. The immunomodulator composition as claimed in claim 1, wherein the vegetable oils are selected from Oregano oil, palm oil, coconut oil, canola oil, soyabean oil, sunflower oil, neem oil and blackseed oil.
4. The immunomodulator composition as claimed in claim 1, wherein the essential oils are selected from ylang ylang oil, agar oil, rose oil, tea tree oil, spearmint oil, rosewood oil, peppermint oil, orange oil, nutmeg oil, rosemary oil, rosewood oil, lemon oil, camphor oil, thyme oil, vetiver oil, basil oil, cardamom seed oil, cedar oil, frankincense oil, lemon oil, eucalyptus oil, coriander oil, lavender oil, clove oil, tea oil, Lemongrass, and cinnamon oil.
5. The immunomodulator composition as claimed in claim 1, wherein the chelating agent is Ethylenediaminetetraacetic acid (EDTA).
6. The immunomodulator composition as claimed in claim 1, wherein the vegetable oils and essential oils are solubilized in water to obtain a homogenous mixture.
7. A method for preparation of immunomodulator composition, the method comprising the steps of:
blending plurality of vegetable oils and at least one herbal APE in a vessel A while being stirred at a suitable RPM, for at least an hour;
blending plurality of vegetable oils along with plurality of alkyl poly glucoside esters in a vessel B while being stirred at a suitable RPM for at least an hour;
blending plurality of essential oils along with chelating agent and APEs in a vessel C while being stirred at a suitable RPM;
allowing all the tanks to settle;
blending together contents of vessel A, B and C at suitable temperature and pressure while being constantly stirred and simultaneously mixing plurality of essential oils, sweeteners, and water to obtain a final blend; and
homogenizing and passing the final blend through a nano sieve under pressure, maintained at a suitable temperature.

8. The method as claimed in claim 7, wherein the herbal alkyl polyglycolide esters are selected from Potato APE, Sugarcane APE, Coconut APE and Corn APE.
9. The method as claimed in claim 7, wherein the vegetable oils are selected from Oregano oil, palm oil, coconut oil, canola oil, soyabean oil, sunflower oil, neem oil and blackseed oil.
10. The method as claimed in claim 7, wherein the essential oils are selected from ylang ylang oil, agar oil, rose oil, tea tree oil, spearmint oil, rosewood oil, peppermint oil, orange oil, nutmeg oil, rosemary oil, rosewood oil, lemon oil, camphor oil, thyme oil, vetiver oil, basil oil, cardamom seed oil, cedar oil, frankincense oil, lemon oil, eucalyptus oil, coriander oil, lavender oil, clove oil, tea oil, Lemongrass, and cinnamon oil.
11. The method as claimed in claim 7, wherein the temperature is in the range of 30°C - 60°C.
12. The method as claimed in claim 7, wherein the pressure in the range of 5-25 mPa.
13. The method as claimed in claim 7, wherein mixing is done at a temperature in the range of 23-35°C.
14. The method as claimed in claim 7, wherein simultaneous mixing of plurality of essential oils, sweeteners, and water is done at a pressure in the range of 80 to 120 kPa.
15. The method as claimed in claim 7, wherein homogenizing and sieving is carried out under pressure of 5 mPa to 30 mPa and at a temperature in the range of 23 to 50°C.