DESC:Technical field of the Invention:
The present invention relates to a stable, synergistic composition for enhancing the solubility/dispersibility, bioavailability and immediate release of active compounds. The present invention also relates to a process for preparation of said synergistic composition.

Background and Prior art of the Invention:
Natural products and extracts of natural products have a wide range of applications in food, nutraceutical and pharmaceutical industries. Most of the crude natural extracts are in viscous liquid form compared to the highly purified extracts and are very difficult to handle while formulating or manufacturing. It also cost a lot to the manufacturer in terms of product loss and other cleaning and processing expenses. However, these crude liquid extracts contain several synergistic active compounds as compared to their purified versions and may have higher safety and synergistic efficacy. On the other hand, the purified extracts are hydrophobic in nature and not soluble/dispersible in aqueous phase. Hence, formulating them into beverages and ready to drink beverages is difficult.

Currently, conventional methods such as plating and encapsulation are used to convert these crude liquid extracts into powders using excipients such as maltodextrin and acacia gum. The drawback of these technologies and excipients involve low actives loading efficiency leading to the products with very low content of actives and poor bioavailability. Many of the excipients are water insoluble and hence the finished products are not suitable for beverage application limiting their usage.

The dry extracts are not dispersible or soluble in the aqueous media and hence will have poor absorption in the gastro intestinal system, which will lead to lower efficacy.

Excipients such as maltodextrin has higher glycemic index and hence not suitable for people with diabetes as it may spike blood glucose levels. Certain ingredients of high oil absorption capacity such as silicon dioxides are limited in the products.

The gums and mucilage when used individually are low in oil absorption capacity and often leads to the unstable, poorly soluble, bioavailable and oily products with low actives. They are oily and hygroscopic which hampers their use in manufacturing the finished products or filling into the capsules etc.

Additionally, gums and mucilage will have limited application in enhancing the solubility/dispersion of the dry extracts with unacceptable solution/suspension stability.

Mucilage’s when used along with the active compounds will give high viscosity products which are difficult to dissolve in aqueous solutions making it unsuitable for supplement, food and beverage applications. This will lead very poor release of actives, poor bioavailability and reduced efficacy.

The extract loading capacity is the efficiency of the composition or an ingredient to convert liquid or oil or dry extract in to free flowing powder with high physico chemical properties such as free flowing, non-hygroscopic products with high actives and complete water solubility/dispersion. Although, many of the ingredients or excipients are having high oil absorption or loading capacity, they always lead to hygroscopic, oily, water insoluble, products with low suspension stability and poorly bioavailable products.

For better biological efficacy of the product, both the concentration of actives and its aqueous solubility/suspension with good stability are essential. Many of the products with low actives have to be dosed in higher quantities which is not acceptable to the general population and also may have side effects due to higher levels of excipients.

It is important to increase the oil or extract content in the product to have higher active without compromising the powder physical properties, water solubility/ dispersibility, stability and bioavailability. This will enable to reduce the daily dose without compromising the product efficacy. The product which are high in actives and having good flow properties are preferred over oily and products with low actives due to convenience and cost saving while manufacturing the finished products. These products will have higher efficacy due to high actives, quick release, complete water solubility/dispersibility, higher bioavailability and lower dose levels which are convenient to the consumers. This cannot be achieved using a single ingredient or excipient due to their inefficiency when used individually.

Surfactants/emulsifiers are used for enhancing the solubility or bioavailability but are least preferred in supplements or food product due their side effects.

There are some literatures that describe powder compositions with oily/liquid extracts.
US20110081330 discloses a composition comprising gum ghatti and one or more fat-soluble active ingredients, wherein the composition comprises less than 40 weight % oil, based on the total composition in dry matter. The said composition additionally comprises one or more oligosaccharides such as maltodextrin and said composition is used for the enrichment, fortification and/or coloration of food beverages, animal feed, cosmetics or pharmaceutical compositions.

US20080102131 disclose a particulate composition wherein an oil component (A) comprising a water-insoluble bioactive substance is poly-dispersed while forming a domain in a matrix comprising of a water-soluble excipient based on a water-soluble polymer, and wherein the sphericity of the particulate composition is not less than 0.9 micron and a method of producing the same.

However, none of the prior arts achieve the product which is high in active content along with additional characteristics such as non-hygroscopicity, high water solubility/dispersibility, enhanced bioavailability and quick release of active.

Achieving all these properties in single product without the use of any surfactants or synthetic emulsifiers, solvents, carrier oils is impossible. Hence, there is a need for the solution which can make the oily or hydrophobic molecules dispersible in aqueous media with additional benefits of high actives, non-hygroscopicity, quick release of active and higher absorption.

The present invention therefore aims to provide a solution that overcomes the problem of low actives content in the product, hygroscopicity, stability, water solubility/dispersibility, quick release, enhanced absorption of active from the product which are not recognized in the art. This remains the objective of the invention.

Summary of the Invention:
In accordance with the above objective, the present invention provides a highly potent/high active, free flowing, non-hygroscopic, stable, water soluble/dispersible, quick release and highly bioavailable synergistic composition comprising soluble fiber, soluble protein and mucilage; wherein, said composition comprises high actives due to high active loading capacity, complete water solubility/dispersibility, quick release and high bioavailability of active ingredient/compounds.
In an aspect, the present invention provides a stable, synergistic composition for enhancing the solubility/dispersibility, stability, bioavailability and quick release of active ingredient comprising;
i. Soluble fiber in an amount ranging from 0.1% to 80% of the total composition;
ii. Soluble protein in an amount ranging from 0.1% to 80% of the total composition; and
iii. Mucilage in an amount ranging from 0.1% to 55% of the total composition;
wherein said active ingredient is present in an amount of 5% to 98% of the total composition; and
wherein said composition is free of emulsifier, glidant and organic solvents.

The active compounds/ingredient of the present synergistic composition is selected from extracts, oleoresins, essential oils and purified phytochemicals selected from Ginger root extract, Turmeric extract, Marigold extract, Rosemary extract, Ashwagandha extract, Cannabis extract, Hemp oil, Garlic extracts, Beetroot extract, clove extract, cinnamon extract, cardamom extract, Black seed (Nigella sativa) extract, Lycopene extract, Vitamin D/D3 from animal or lichen source, Vitamin A, Vitamin E, Vitamin C, Vitamin K2, DL- Alpha tocopherol, sea buckthorn oil, Omega fatty acids (3,6,7 &9) sourced from fish, Algae, Krill and Buglossoides arvensis, Boswellia serrata extract, Capsicum extract, Palmitoylethanolamide (PEA), Piper nigrum extract, Fenugreek saponins, Co-enzyme Q10, plant sterols, vitamin K7, Citrus bioflavonoids, Mulberry leaf extract, valerinic acid, beta-caryophyllene, white turmeric extract (Curcuma zedoaria Rosc), leaves of Murraya koenigii (Curry leaf), roots of Rhodiola rosea (Roseroort/Golden root), Black Ginger extract, melatonin, pomegranate seed oil, Alpinia galanga extract, saffron extract, Astaxanthin and Sceletium tortuosum extract.
The soluble fiber of the present synergistic composition is selected from galactomannans, fructooligosaccharides, inlulin, xyloglucan, beta-glucan from Albizia zygia, tamarind, Cochlospermum religiosum, Chondrus cryspus, Cassia tora Linn, Cyamompsis tetraganolobus, Acacia Arabica, Acacia Senegal, Anogeissus latifolia, Astragalus gummifer, Sterculia urens, Khaya grandifolia, Xanthomonas lempestris, Pseudomonas elodea, guar gum, xanthan gum, Tapioca, Aloe vera and the like.
The soluble protein of the present synergistic composition is selected from rhizomes of Curcuma longa (turmeric), seeds of Oryza sativa L. (Brown rice), stems of Bambusa vulgaris (Bamboo), aerial part of Pisum sativum (pea protein), fruit of Tamarindus indica (Tamarind), tubers of Dioscorea villosa (Wild Yam), Macroalgae (Seaweed), kernels of Triticum (wheat protein), seeds of Helianthus annuus (Sunflower seeds), seeds of Chenopodium quinoa (Quinoa) and the like.
The mucilages of the present synergistic composition are selected from arabinogalactans such as rhamno-galacturonan, arabinoxylan, galactoglucomannan, glucogalactomannan, galacto-glucoarabinomannan, from psyllium, Flax seed, chia seeds, Basil seeds, Chan seeds, Abelmoschus esculentus (okra), Phoenix, Cassia tora, gum spinach, Cordia obliqua, Ocimum americanum, Aloe species, Lepidum sativum, Ocimum canum, Trigonella foenum graecum, Hibiscus esculentus Linn, Plantago psyllium, Plantago ovata, Leucaena leucocephata, Ocimum gratissimum Linn, Asparagus racemosus, Tamarindus indica and the like.

In another aspect, the present invention discloses a synergistic composition comprising (a) Active ingredient standardized to contain 1 to 99% actives, in an amount ranging from 5% to 98%; (b) soluble fibers, standardized to contain >80% soluble and indigestible fiber and >1- 10% protein, in an amount ranging from 0.1% to 80% (c) soluble protein, standardized to contain >80% protein and < 15 % of polysaccharides, in an amount ranging from 0.1% to 80% and (d) mucilage, standardized to contain >80% soluble polysaccharides and >5% protein, in an amount ranging from 0.1% to 55%.

In another aspect, the present invention describes a highly potent, high active, free flowing, stable, non-hygroscopic, completely water soluble, quick release, and highly bioavailable synergistic composition comprise high actives (oil/liquid/dry extracts) and combination of soluble fiber, soluble protein and mucilage; wherein, said synergistic composition is free of emulsifier, glidant and any processing solvents.

In another aspect, the present invention describes a process for preparation of said synergistic composition comprising;
a) Adding mixture of soluble fiber(s) to water;
b) Homogenizing the mixture of step (a) at temperature 40ºC to 80ºC, followed by addition of soluble protein and mucilage;
c) Homogenizing the mixture of step (b) at temperature 40ºC to 80ºC, followed by addition of active ingredient;
d) Homogenizing the mixture of step (c) at temperature 40ºC to 80ºC and RPM of >1400;
e) Drying the mixture of step (d) in vacuum oven having temperature at 40ºC to 80ºC and pressure at 1-20 mBar or tray dryer with temperature at 40ºC to 80ºC to obtain dry flakes; and
f) Milling the dried flakes of step (e) to obtain free-flowing powder.

Description of drawings:
Figure 1 (a) depicts the product composition of Example 1 and the product composition of Example 2 to 4
Figure 1 (b) depicts the Comparative solubility profile of Example 1 to 4
Figure 2 (a) depicts the product composition of Example 7 and the product composition of Example 8
Figure 2 (b) depicts the Comparative solubility profile of Example 7 and example 8
Figure 3 (a) depicts the product composition of Example 10 and the product composition of Example 11
Figure 3 (b) depicts the Comparative solubility profile of Example 10 and 11
Figure 4 (a) depicts the product composition of Example 12 and the product composition of Example 13
Figure 4 (b) depicts the Comparative solubility profile of Example 12 and 13
Figure 5 (a) depicts the product composition of Example 14 and the product composition of Example 15
Figure 5 (b) depicts the Comparative solubility profile of Example 14 and example 15
Figure 6 (a) depicts the product composition of Example 16 and the product composition of Example 17
Figure 6 (b) depicts the Comparative solubility profile of Example 16 and 17
Figure 7 (a) depicts the product composition of Example 19 and the product composition of Example 20
Figure 7 (b) depicts the Comparative solubility profile of Example 19 and 20
Figure 8 (a) depicts the product composition of Example 22 and the product composition of Example 23
Figure 8 (b) depicts the Comparative solubility profile of Example 22 and 23
Figure 9 (a) depicts the product composition of Example 25 and the product composition of Example 26
Figure 9 (b) depicts the Comparative solubility profile of Example 25 and 26
Figure 10 (a) depicts the product composition of Example 28 and the product composition of Example 29
Figure 10 (b) depicts the Comparative solubility profile of Example 28 and 29
Figure 11 (a) depicts the product composition of Example 31 and the product composition of Example 32
Figure 11 (b) depicts the Comparative solubility profile of Example 31 and 32
Figure 12 (a) depicts the product composition of Example 34 and the product composition of Example 35
Figure 12 (b) depicts the Comparative solubility profile of Example 34 and 35
Figure 13 (a to d) depicts the product composition of Example 37 to 40
Figure 14 (a) depicts the product composition of Example 41 and the product composition of Example 42
Figure 14 (b) depicts the Comparative solubility profile of Example 41 and 42

Detailed description of the Invention:
Source of the Biological materials used in the Invention:
The biological materials used in the demonstration of the invention are sourced as samples from the vendors. The details of which are provided as follows:
1. Ginger Oleoresin - Sourced from Synthite Industries (P) Ltd Synthite Valley, Kolenchery Kerela, 682311, India.
2. Acacia Senegal - Sourced APD Foods India Pvt Ltd Shed No. A1/37 Plot No. 507, 100 shed area, Degam road, G.I.D.C, Vapi-396195, Gujrat., India.
3. Mucilage (Fenugreek) - Sourced from Mahesh Agro Food Industries RIICO Industrial Area, RICCO Housing Colony, Barmer, Rajasthan 344001, India.
4. Beetroot Extract - Sourced from Botanic Healthcare Pvt. Ltd Plot No. 35, Mani Mansion, 1st Floor , street -1, Tarnaka, Secunderabad, Telangana -500017, India.
5. Ashwagandha Extract - Sourced from Sami Labs Limited, 19/1, 1st Main Rd, 2nd Phase, Nalagadderanahalli, Peenya, Bengaluru, Karnataka 560058, India.
6. Vitamin D oil - Sourced from Vitashine Creation House, 50-72 Gauntley Street, Nottingham, United Kingdom.
7. Astaxanthin Extract - Sourced from Bio-gen Extracts Pvt. Ltd. Plot No. 57, 1st Stage, Sompura Industrial Area, Dobaspet, Bangalore-562 111, Karnataka, India.
8. Lycopene - Sourced from SV Agrofood, India C-9/150, Yamuna Vihar, Delhi-53, India.
9. Turmeric Oleoresin - Sourced from Plant Lipids Private Limited Kolenchery, Cochin - 682 311, Kerala, India
10. Marigold Oleoresin - Sourced from Synthite Industries (P) Ltd Synthite Valley, Kolenchery Kerela, 682311, India.
11. Rosemary Oleoresin - Sourced from Botanic Healthcare Pvt. Ltd Plot No. 35, Mani Mansion, 1st Floor , street -1, Tarnaka, Secunderabad, Telangana -500017, India.
12. Buglossoides oil - Sourced from Nature Crops International 5535 Robinhood Village Dr, Unit 124 Winston-Salem, NC 27106, USA
13. DL-Alpha Tocopherol - Sourced from DSM Nutritional Products 2nd Floor ,6/33 Perumal Street, Butt Road St. Thomas mount , Chennai -600016, India.
14. Palmitoylethanolamide - Sourced from Biogen Extracts Private limited, No. 254/1-9, Biogen House, 3rd Floor, 11th Main Rd, 3rd Stage, Peenya, Bengaluru, Karnataka 560058, India.
15. Murraya koenigii - sourced from Biomed Ingredients Private Limited Plot No. 1. SC 1/48, Phase 1, Verna Industrial Estate, Verna, Kelosim, Goa 403722
16. Melatonin powder - sourced from Apionex Pharma Pvt Ltd1206, Ghanshyam Enclave, near lalji Pada Police Station new Link Road, Kandivali West, Kandivali, W, Mumbai, Maharashtra 400067

The terms “high potency” or “high actives” herein refers to the higher concentration of biologically active compounds present in the synergistic composition which is in the range of 5 to 98% w/w of the total composition.

The term “soluble fiber” herein refers to hydrolysed/unhydrolysed fiber from natural or synthetic origin which is standardized to contain >80% soluble and indigestible fiber and >1-10% protein of the total composition.

The term “soluble protein” herein refers to hydrolysed/unhydrolysed protein from natural or synthetic origin which is standardized to contain >80% protein and <15% of polysaccharides of the total composition.

The term “Mucilage” herein refers to hydrolysed/unhydrolysed mucilage standardized to contain >5% protein and >80% polysaccharides.

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

In one preferred embodiment, the present invention discloses a synergistic composition comprising soluble fiber, soluble protein and mucilage that provides high efficiency in terms of actives loading capacity beside providing a high potency, high actives, free flowing, complete water solubility/dispersibility, stability, non-hygroscopic, quick release and high bioavailability of active ingredient.

Accordingly, the present invention provides a synergistic composition for enhancing the solubility, stability, bioavailability and quick release of active ingredient comprising;
i. Soluble fiber in an amount ranging from 0.1% to 80% of the total composition;
ii. Soluble protein in an amount ranging from 0.1% to 80% of the total composition; and
iii. Mucilage in an amount ranging from 0.1% to 55% of the total composition;
wherein said active ingredient is present in an amount of 5% to 98% of the total composition; and
wherein said composition is free of emulsifier, glidant and organic solvents.

The active ingredient of synergistic composition is obtained from plant and animal source. The active compounds/ingredient includes extracts, oleoresins, essential oils and purified phytochemicals selected from Ginger root extract, Turmeric Oleoresin, Turmeric essential oil, Marigold extract, Rosemary extract, Ashwagandha extract, Cannabis extract (Cannabinoids), Hemp oil, Garlic extracts, Beetroot extract, clove extract, cinnamon extract, cardamom extract, , Black seed (Nigella sativa) extract, Vitamin D/D3, Vitamin A, Vitamin E, Vitamin C, Vitamin K2, DL- Alpha tocopherol, sea buckthorn oil, Omega fatty acids (3, 6, 7 & 9) sourced from fish, krill, Algae, Buglossoides arvensis , Boswellia serrata extract, Capsicum extract, DHA (Docosahexaenoic acid), EPA (Eicosapentaenoic acid), Palmitoylethanolamide (PEA), Piper nigrum extract, Fenugreek saponins, Co-enzyme Q10, plant sterols, vitamin K7, Citrus bioflavonoids, Mulberry leaf extract valerinic acid, beta-caryophyllene, white turmeric extract, Black turmeric extract, leaves of Murraya koenigii (Curry leaf) , roots of Rhodiola rosea, melatonin, Black Ginger extract, pomegranate seed oil, Alpinia galangal extract, saffron extract, Astaxanthin and Sceletium tortuosum extract.

The soluble fiber, soluble protein and mucilage of present synergistic composition is obtained from plant source.

The hydrolysed/unhydrolysed soluble fiber of present synergistic composition are selected from arabinogalactans such as rhamno-galacturonan, arabinoxylan, galactoglucomannan, glucogalactomannan, galactoglucoarabinomannan, fructooligosaccharides, inlulin, xyloglucan, beta-glucan from Albizia zygia, tamarind, Cochlospermum religiosum, Chondrus cryspus, Cassia tora Linn, Cyamompsis tetraganolobus, Acacia Arabica, Acacia Senegal, Anogeissus latifolia, Astragalus gummifer, Sterculia urens, Khaya grandifolia, Xanthomonas lempestris, Pseudomonas elodea xanthan gum Tapioca , Aloe vera and guar gum.

The hydrolysed/unhydrolysed mucilages of present synergistic composition are selected from arabinogalactans such as rhamno-galacturonan, arabinoxylan, galactoglucomannan, glucogalactomannan, galacto-glucoarabinomannan, galactomannans from psyllium, Flax seed, chia seeds, Basil seeds, Chan seeds, Abelmoschus esculentus (okra), , Phoenix, Cassia tora , gum spinach, Cordia obliqua , Ocimum americanum, Aloe species, Lepidum sativum, Ocimum canum, Trigonella foenum graecum, Hibiscus esculentus Linn, Plantago psyllium, Plantago ovata, Leucaena leucocephata, Ocimum gratissimum Linn, , Asparagus racemosus and Tamarindus indica.

The soluble protein of the present synergistic composition is selected from rhizomes of, leaf of Aloe barbadensis (aloe vera), seeds of Oryza sativa L. (Brown rice), stems of Bambusa vulgaris (Bamboo), aerial part of Pisum sativum (pea protein), fruit of Tamarindus indica (Tamarind), Macroalgae ( Seaweed), kernels of Triticum ( wheat protein) , seeds of Helianthus annuus (Sunflower seeds) , seeds of Chenopodium quinoa (Quinoa) and the like.
In an embodiment, the present invention discloses a synergistic combination of standardized soluble fibers, soluble protein and mucilage to overcome the problem of active loading, low concentration/low active loadings, poor flow properties, very oily powders, water insolubility, poor actives release and poor bioavailability. The present synergistic composition has high efficiency in terms of actives loading besides being quick release, highly bioavailable, completely water soluble, and forms stable solution/suspension in aqueous media for up to two years.

In another embodiment, the said hydrolysed/ unhydrolysed soluble fiber of natural origin used in the synergistic composition is standardized to contain glycoprotein and arabinogalacto protein equivalent to1 to 10% protein and, >80% soluble fiber and indigestible fiber which is very important for enhancing the solubility.

In another embodiment, the said soluble protein used in the synergistic composition is standardized to contain >80% protein and, <15% polysaccharide.

In another embodiment, the said mucilage used in the present synergistic composition is standardized to contain >5% protein and >80% polysaccharides.

The soluble fiber, soluble protein and mucilage lead to the high active composition in powder form without hampering the solubility and suspension stability of the composition in water for more than 2 years. The final composition is free flowing powder with higher solubility, bioavailability and stability.

In another embodiment, the present invention discloses a synergistic combination of Soluble fiber, soluble protein and mucilages; wherein, said composition is free of emulsifier, glidant and any organic solvents.

In another embodiment, the active ingredient in combination of mucilage, protein and soluble fiber gives a soluble free-flowing powder; however, in the absence of these ingredients, the process results in a non free-flowing/moist product that is unable to be used further.

In another embodiment, the present invention discloses a synergistic composition which forms stable solution/suspension in water without any sedimentation or precipitation and is stable for more than 2 years and at high temperature up to 90ºC.

In another embodiment, the present invention discloses synergistic composition which is physically and chemically stable in solid powder form and in aqueous solution for more than 2 years.

In another embodiment, the present invention discloses a synergistic composition is formulated using suitable carriers into various dosage forms such as tablets, capsules, syrups, strips, gummies, beverages, ready to drink beverages, milk based products/beverage/fortified products such as curd, yogurt, energy drinks, for applications as nutraceuticals, pharmaceuticals, food or food supplements/additives.

In another embodiment, the present invention discloses a synergistic composition which is useful in the treatment of inflammatory diseases, respiratory diseases, heart diseases, cognitive diseases, eye diseases, skin diseases, digestive diseases/discomfort and stress.

In another preferred embodiment, the present invention discloses a process for preparation of stable water soluble synergistic composition comprising;
a) Adding mixture of soluble fiber(s) to water;
b) Homogenizing the mixture of step (a) at temperature 40ºC to 80ºC, followed by addition of soluble protein and mucilage;
c) Homogenizing the mixture of step (b) at temperature 40ºC to 80ºC, followed by addition of active ingredient;
d) Homogenizing the mixture of step (c) at temperature 40ºC to 80ºC and RPM of >1400;
e) Drying the mixture of step (d) in vacuum oven having temperature at 40ºC to 80ºC and pressure at 1-20 mBar or tray dryer with temperature at 40ºC to 80ºC to obtain dry flakes; and
f) Milling the dried flakes of step (e) to obtain free-flowing powder.

The above process for preparation of a synergistic composition is a solvent free process. The obtained free flowing powder has good flow property, complete water solubility /dispersibility, quick release of actives and high bioavailability of active ingredient. The solution prepared from the said free-flowing powder is stable for up to 2 years at high temperature (25 to 80o) as well as at low temperature (4 to 8oC).

Examples:
Some typical examples illustrating the embodiments of the present invention are provided; however, these examples are exemplary only and should not be regarded as limiting the elements of the present invention.

Composition and process of the high oil loading actives:

Example 1 to 4:
Product composition comprising Ginger Oleoresin
Example 1 Example 2 Example 3 Example 4
Sr. No. Ingredients Quantity(g/ 100g) Quantity(g/ 100g) Quantity(g/ 100g) Quantity(g/ 100g)
1 Ginger Oleoresin 45.00 45.00 45.00 45.00
2 Soluble fiber (from Acacia senegal) 47.50 - 55.00 -
3 Mucilage (Fenugreek) 7.00 55.00 - -
4 Rice protein 0.50 - - 55.00
Total 100g 100g 100g 100g
Process for preparation of Example 1:
a) Adding mixture of Soluble fiber to water in the ratio of 1:3 respectively;
b) homogenizing the mixture of step (a) for 10 minutes, followed by addition of, soluble protein and mucilage;
c) homogenizing the mixture of step (b) for 10 minutes, followed by addition of ginger oleoresin;
d) homogenizing the mixture of step (c) for another 20 to 30 minutes at RPM of >1400;
e) drying the mixture of step (d) in vacuum oven having temperature at 60ºC and pressure at 1mBar for 8 hours to obtain dry flakes; and
f) milling the dried flakes of step (e) to obtain free-flowing powder.

Process for preparation of the composition of Examples 2 to 4:
a) Adding mixture of Mucilage/Soluble fiber/Soluble protein to water in the ratio of 1:2.5 respectively;
b) Homogenizing the mixture of step (a) for 10 minutes, followed by addition of ginger oleoresin;
c) homogenizing the mixture of step (b) for another 20 to 30 minutes at RPM of >1400;
d) drying the mixture of step (c) in vacuum oven having temperature at 60ºC and pressure at 1mBar for 8 hours to obtain dry flakes; and
e) milling the dried flakes of step (d).
The obtained free flowing powder from Example 1 is represented in the figure 1(a) in comparison with the compositions represented from Example 2 to 4 (Reference samples).
Example 5: Comparative solubility data profile of ‘Ginger Oleoresin composition of Example 1 vis-à-vis ‘Example 2 to 4
The final product of Example 1 is free flowing, stable, non-hygroscopic with very good flow property, shows actives loading capacity, better solubility and quick release over the products represented in Examples 2 to 4 and highly potent product and show the synergistic effect of the mucilage and soluble fiber. The composition demonstrated in Examples 2 to 4 forms a sticky paste, forms lumps which is not water-soluble product (as illustrated in Figure 1).

Moreover, the product prepared from of example 1 was stable for 24 Months at room temperature (25 to 28 ºC), at higher temperature of 40 ºC ± 2 ºC and at low temperature of 4 ºC to 8 ºC. The stability data of Example 1 is further explained below and represented as Example 6.
Example 6:
Comparative stability data of Ginger Oleoresin (Single Ingredient) and composition of Example 1
The stability study was done as per the ICH (International Conference on Harmonization) guidelines for real time stability at room temperature conditions. The samples were withdrawn at initial time point, 3rd and 6th months, and analyzed for the content of total Gingerols by using the HPLC method. The formulated product of the composition in example 1 having a concentration of total Gingerols more than 10% in the product of the present invention has been found to be more stable when compared to the unformulated liquid ginger oleoresin having a concentration of total Gingerols more than 39% in the product. The reduction in active content (Total gingerols) was 1.23 % with the formulation of present invention (Example 1), whereas, the reduction in active content was 19.22% with the liquid ginger oleoresin which was not formulated. The results described in Table 1 show the percentage of total gingerols in each product over the entire 6 months period. However, the stability study was continued for the formulated product and the product was found to be stable till 24 months at room temperature (25 to 28 ºC),
Table 1: Comparative stability study data of total Gingerols in Ginger Oleoresin unformulated liquid with formulated powder of example 1.
S.No. Time Period Unformulated Liquid Ginger Oleoresin.
% total Gingerols Formulated powder of Example 1
% total Gingerols
1. Initial 45.90% 11.39%
3. 3rd Month 41.44% 11.30%
4. 6th Month 37.08% 11.25%

Example 7 and 8: Composition comprising Beetroot extract
Example 7 Example 8
Sr. No. Ingredients Quantity (g/100g) Quantity (g/100g)
1. Beetroot Extract 60 60
2. Soluble fiber (from Acacia senegal) 38 -
3. Soluble protein (Silybum marianum) 1 -
4. Mucilage (Fenugreek) 1 40
Total 100 100

Process for Preparation of Example 7:
a) Adding mixture of Soluble fiber to water in the ratio of 1:1.5 respectively;
b) homogenizing the mixture of step (a) for 10 minutes at temperature 60ºC, followed by addition of soluble protein and mucilage;
c) homogenizing the mixture of step (b) for 10 minutes at temperature 60ºC, followed by addition of fresh beet root extract;
d) homogenizing the mixture of step (c) for another 20 to 30 minutes at temperature 60ºC and RPM of >1400;
e) drying the mixture of step (d) in vacuum oven having temperature at 60ºC and pressure at 1mBar for 8 hours to obtain dry flakes; and
f) milling the dried flakes of step (e) to obtain free-flowing powder.

The process for preparation of Example 8 is same as Example 7 except the step of addition of soluble protein and soluble fiber and the mucilage to water ratio is 1:1.5.
Results:
The product of Example 7 is free –flowing, non-sticky, non-hygroscopic and soluble and releases actives very quickly when provided as solution whereas the composition obtained from example 8 shows a sticky paste of the final product (as illustrated in figure 2).
Further, the product of example 7 is stable for 24 Months at room temperature (25 to 28 ºC), at higher temperature of 40 ºC ± 2 ºC.
Example 9: Composition comprising Ashwagandha Extract
Sr. No. Ingredients Quantity (g/100g)
1. Ashwagandha Extract 50
2. Soluble fiber (from Acacia senegal) 47
3. Mucilage (Fenugreek) 2.5
4. Rice protein 0.5
Total 100
Process for Preparation of Example 9:
a) Adding mixture of Soluble fiber to water in the ratio of 1:1.5 respectively;
b) homogenizing the mixture of step (a) for 10 minutes at temperature 50ºC, followed by addition of, soluble protein and mucilage;
c) homogenizing the mixture of step (b) for 10 minutes at temperature 50ºC, followed by addition of ashwaganda root and leaf water extract;
d) homogenizing the mixture of step (c) for another 20 to 30 minutes at temperature 50ºC and RPM of >1400;
e) drying the mixture of step (d) in vacuum oven having temperature at 60ºC and pressure at 1mBar for 8 hours to obtain dry flakes; and
f) milling the dried flakes of step (e) to obtain free-flowing powder.
The obtained free flowing powder had complete water solubility /dispersibility, non-hygroscopicity, flow property, quick release of withanolides. Also, this product is stable for 24 Months at room temperature (25 to 28 ºC), at higher temperature of 40 ºC ± 2 ºC .
Example 10 and 11: Composition comprising Vitamin D oil
Example 10 Example 11
Sr.No. Ingredients Quantity (g/100g) Quantity (g/100g)
1. Vitamin D oil 43 43
2. Soluble fiber (from Acacia senegal) 53.5 -
3. Mucilage 2 -
4. Rice protein 1.5 57
Total 100 100
Process for Preparation of Example 10:
a) Adding mixture of Soluble fiber to water in the ratio of 1:1.5 respectively;
b) homogenizing the mixture of step (a) for 10 minutes at temperature 40ºC, followed by addition of, soluble protein and mucilage;
c) homogenizing the mixture of step (b) for 10 minutes at temperature 40ºC, followed by addition of vitamin D oil;
d) homogenizing the mixture of step (c) for another 20 to 30 minutes at temperature 40ºC and RPM of >1400;
e) drying the mixture of step (d) in vacuum oven having temperature at 60ºC and pressure at 1mBar for 8 hours to obtain dry flakes; and
f) milling the dried flakes of step (e) to obtain free-flowing powder.

The process for preparation of Example 11 is same as Example 10 except the step of addition of mucilage and soluble fiber and the protein to water ratio is 1:1.5

Results:
The product of Example 10 is free -flowing, non-sticky, non-hygroscopic and soluble and releases actives very quickly when provided as solution whereas the composition obtained from example 11 has shown a sticky paste of the final product (as illustrated in Figure 3).
Also, this product is stable for 24 Months at room temperature (25 to 28 ºC), at higher temperature of 40 ºC ± 2 ºC.
Example 12 and 13: Composition comprising Asthaxanthin extract
Example 12 Example 13
Sr.
No. Ingredients Quantity
(g/100g) Quantity
(g/100g)
1. Asthaxanthin extract 45 45
2. Soluble fiber (from Acacia senegal) 43 55
3. Mucilage (Fenugreek) 7 -
4. Rice Protein 5 -
Total 100 100
Process for Preparation of Example 12:
a) Adding mixture of Soluble fiber to water in the ratio of 1:1.5 respectively;
b) homogenizing the mixture of step (a) for 10 minutes at temperature 40ºC, followed by addition of soluble protein and mucilage;
c) homogenizing the mixture of step (b) for 10 minutes at temperature 40ºC, followed by addition of Asthaxanthin extract;
d) homogenizing the mixture of step (c) for another 20 to 30 minutes at temperature 40ºC and RPM of >1400;
e) drying the mixture of step (d) in vacuum oven having temperature at 60ºC and pressure at 1mBar for 8 hours to obtain dry flakes; and
f) milling the dried flakes of step (e) to obtain free-flowing powder.
The process for preparation of Example 11 is same as Example 12 except the step of addition of soluble protein and mucilage and the soluble fiber to water is 1:1.5
Results:
The product of Example 12 is free -flowing, non-sticky, non-hygroscopic and soluble and releases actives very quickly when provided as solution whereas the composition obtained from example 13 has shown a sticky paste of the final product (as illustrated in Figure 4).
Also, this product is stable for 24 Months at room temperature (25 to 28 ºC), at higher temperature of 40 ºC ± 2 ºC.
Example 14 and 15: Composition comprising Lycopene extract
Example 14 Example 15
Sr.No.
Ingredients Quantity (g/100g) Quantity (g/100g)
1. Lycopene extract 45 45
2. Soluble fiber (from Acacia senegal) 40 -
3. Mucilage (Fenugreek) 13 55
4. Rice protein 2 -
Total 100 100
Process for Preparation of Example 14:
a) Adding mixture of Soluble fiber to water in the ratio of 1:1.5 respectively;
b) homogenizing the mixture of step (a) for 10 minutes at temperature 40ºC, followed by addition of, soluble protein and mucilage;
c) homogenizing the mixture of step (b) for 10 minutes at temperature 40ºC, followed by addition of Lycopene extract;
d) homogenizing the mixture of step (c) for another 20 to 30 minutes at temperature 40ºC and RPM of >1400;
e) drying the mixture of step (d) in vacuum oven having temperature at 60ºC and pressure at 1mBar for 8 hours to obtain dry flakes; and
f) milling the dried flakes of step (e) to obtain free-flowing powder.

The process for preparation of Example 15 is same as Example 14 except the step (a) of addition of soluble protein and soluble fiber and the mucilage to water ratio is 1:4.5.
Results:
The product of Example 14 is free -flowing, non-sticky, non-hygroscopic and soluble and releases actives very quickly when provided as solution whereas the composition obtained from example 15 has shown a sticky and paste nature of the final product (as illustrated in Figure 5).
Also, this product is stable for 24 Months at room temperature (25 to 28 ºC), at higher temperature of 40 ºC ± 2 ºC.
Example 16 and 17: Composition using Turmeric Extract
Example 16 Example 17
Sr. No. Ingredients Quantity (g/100g) Quantity (g/100g)

1 Turmeric extract 40 40
2 Soluble fiber (from Acacia senegal) 30 -
3 Guar Gum 20 60
4 Mucilage (Fenugreek) 5 -
5 Rice Protein 5 -
Total 100g 100g
Process for preparation of composition of Example 16:
a) Adding mixture of Soluble fiber to water in the ratio of 1:2 respectively;
b) homogenizing the mixture of step (a) for 10 minutes, followed by addition of guar gum, soluble protein and mucilage;
c) homogenizing the mixture of step (b) for 10 minutes, followed by addition of turmeric oleoresin;
d) homogenizing the mixture of step (c) for another 20 to 30 minutes and RPM of >1400;
e) drying the mixture of step (d) in vacuum oven having temperature at 60ºC and pressure at 1mBar for 8 hours to obtain dry flakes; and
f) milling the dried flakes of step (e) to obtain free-flowing powder.
The process for preparation of Example 17 is same as Example 16 except the step of addition of soluble protein and mucilage and the soluble fiber to water ratio is 1:2.5.
Results:
While the product of Example 16 results in free -flowing soluble and non-sticky, non-hygroscopic and facilitates quick release of curcuminoids whereas the product of example 17 results in a sticky paste form as a final product(as illustrated in Figure 6).
Also, this product is stable for 24 Months at room temperature (25 to 28 ºC), at higher temperature of 40 ºC ± 2 ºC.
Example 18: Comparative solubility data profile of Turmeric extract composition of Example 16 vis-à-vis Example 17
The final product of Example 16 is free flowing, water soluble, stable, and highly potent product, which shows the synergistic effect of the soluble fiber and mucilage in the composition of the invention. However, in the absence of soluble fiber and mucilage in the composition as demonstrated in Example 17 results in sticky paste, which is not water soluble and forms lumps (Figure 6 (b)).

As is evident from the above, the composition of Example 16 shows better oil loading capacity and better solubility over the product represented in Example 17.

Example 19 and 20: Composition comprising Melatonin Powder
Example 19 Example 20
Sr. No. Ingredients Quantity(g/100g) Quantity(g/100g)
1. Melatonin powder 90 90
2. Soluble fiber (from Acacia senegal) 5.0 -
3. Mucilage 2.5 10
4. Rice protein 2.5 -
Total 100 100
Process for Preparation of Example 19:
a) Adding mixture of Soluble fiber (from Acacia senegal) to water in the ratio of 1:1.5 respectively;
b) homogenizing the mixture of step (a) for 10 minutes at temperature 60ºC, followed by addition of, soluble protein and mucilage;
c) homogenizing the mixture of step (b) for 10 minutes at temperature 60ºC, followed by addition of Melatonin powder;
d) homogenizing the mixture of step (c) for another 20 to 30 minutes at temperature 60ºC and RPM of >1400;
e) drying the mixture of step (d) in vacuum oven having temperature at 60ºC and pressure at 1mBar for 8 hours to obtain dry flakes; and
f) milling the dried flakes of step (e) to obtain free-flowing powder.
The process for preparation of Example 20 is same as Example 19 except the step of addition of soluble protein and soluble fiber and the mucilage to water ratio is 1:1.5.
The product of Example 19 is free -flowing soluble and non-sticky, non-hygroscopic and releases actives very quickly when provided as solution whereas the composition obtained from example 20 has shown a sticky and paste nature of the final product (as illustrated in Figure 15).
Also, this product is stable for 24 Months at room temperature (25 to 28 ºC), at higher temperature of 40 ºC ± 2 ºC.
Example 21: Comparative solubility data profile of ‘Melatonin composition of Example 19 vis-à-vis Example 20
The final product of Example 19 is free flowing, water soluble, stable, and highly potent. However, in the absence of these ingredients as mentioned in Example 20, the composition forms a sticky paste product which is not water soluble.

Example 22 and 23: Composition using Marigold extract
Example 22 Example 23
Sr. No. Ingredients Quantity(g/100g) Quantity(g/100g)
1. Marigold extract 48 48
2. Soluble fiber (from Acacia senegal) 49 52
3. Mucilage (Fenugreek) 1.50 -
4. Rice protein 1.50 -
Total 100g 100
Process for preparation of Example 22:
a) Adding mixture of Soluble fiber to water in the ratio of 1:1.5 respectively;
b) homogenizing the mixture of step (a) for 10 minutes, followed by addition of soluble protein and mucilage;
c) homogenizing the mixture of step (b) for 10 minutes, followed by addition of marigold oleoresin;
d) homogenizing the mixture of step (c) for another 20 to 30 minutes at temperature 40ºC and RPM of >1400;
e) drying the mixture of step (d) in vacuum oven having temperature at 60ºC and pressure at 1mBar for 8 hours to obtain dry flakes; and
f) milling the dried flakes of step (e) to obtain free-flowing powder.
The process for preparation of Example 23 is same as Example 22 except the step of addition of soluble protein and mucilage and the soluble fiber to water ratio is 1:2.5.
Results:
The product from Example 22 is free –flowing and non-sticky, non-hygroscopic and results in quick release of lutein whereas the product of example 23 has shown a sticky paste of the product, as shown in figure 8a. Thus the texture of the composition shows that active ingredient in combination of mucilage and soluble fiber gives a free flowing powder; however, in the absence of these ingredients viz., mucilage and soluble fiber, the product formed is of sticky paste in nature and thus unable to be used further.
Also, this product is stable for 12 Months at room temperature (25 to 28 ºC).
Example 24: Comparative solubility data profile of ‘Marigold extract composition of Example 22 vis-à-vis Example 23
The final product of Example 22 is free flowing, water soluble, stable, and highly potent product, which demonstrates the synergistic effect of soluble fiber and mucilage in the composition. However, in the absence of these ingredients as stated in Example 23 results in a sticky paste and moreover, the product is not water soluble and forms lumps (as illustrated in Figure 8(b)).

Example 25 and 26: Composition using Rosemary extract
Example 25 Example 26
Sr. No. Ingredients Quantity(g/ 100g)
Quantity(g/100g)

1. Rosemary extract 48 48
2. Soluble fiber (from Acacia senegal) 48 -
3. Tragacanth Gum 0.50 -
4. Mucilage (Fenugreek) 1.00 52
5. Pea protein 2.50 -
Total 100g 100g
Process for preparation of Example 25:
a) Adding mixture of Soluble fiber (from Acacia senegal) to water in the ratio of 1:1.5 respectively;
b) homogenizing the mixture of step (a) for 10 minutes, followed by addition of tragacanth gum soluble protein and mucilage;
c) homogenizing the mixture of step (b) for 10 minutes, followed by addition of rosemary oleoresin;
d) homogenizing the mixture of step (c) for another 20 to 30 minutes at RPM of >1400;
e) drying the mixture of step (d) in vacuum oven having temperature at 60ºC and pressure at 1mBar for 8 hours to obtain dry flakes; and
f) milling the dried flakes of step (e) to obtain free-flowing powder.
The process for preparation of Example 26 is same as Example 25 except the step of addition of soluble protein and soluble fiber and the mucilage to water ratio is 1:2.5
Results:
The product from Example 25 is free -flowing and non-sticky, nom-hygroscopic and results in quick release of active whereas the product of example 26 has shown a sticky paste nature (as illustrated in Figure 9(a)).
Also, this product is stable for 24 Months at room temperature (25 to 28 ºC), at higher temperature of 40 ºC ± 2 ºC.
Example 27: Comparative solubility data profile of ‘Rosemary extract composition of Example 25 vis-à-vis Example 26
The final product of Example 25 is free flowing, water soluble, stable, and highly potent product, hows better oil loading capacity and better solubility which shows the synergistic effect of the soluble fiber and mucilage in the composition. However, in the absence of these ingredients, Example 26 forms a sticky paste, which is a not water-soluble product and forms lump (as illustrated in Figure 9(b)).

Example 28 and 29: Composition using Buglossoides oil
Example 28 Example 29
Sr.No. Ingredients Quantity (g/100g) Quantity (g/100g)
1. Buglossoides oil 48 48
2. Soluble fiber (from Acacia senegal) 48.50 52
3. Mucilage (Fenugreek) 2 -
4. Rice protein 1.50 -
Total 100g 100g
Process for preparation of Example 28:
a) Adding mixture of soluble fiber to water in the ratio of 1:1.5 respectively;
b) homogenizing the mixture of step (a) for 10 minutes, followed by addition of, soluble protein and mucilage;
c) homogenizing the mixture of step (b) for 10 minutes, followed by addition of buglossoides oil;
d) homogenizing the mixture of step (c) for another 20 to 30 minutes at RPM of >1400;
e) drying the mixture of step (d) in vacuum oven having temperature at 60ºC and pressure at 1mBar for 8 hours to obtain dry flakes; and
f) milling the dried flakes of step (e) to obtain free-flowing powder.
The process for preparation of Example 29 is same as Example 28 except the step of addition of soluble protein and mucilage and the soluble fiber to water ratio is 1:2.5.
Results:
The product from Example 28 is free –flowing, soluble and non-sticky, non-hygroscopic and further facilitates quick release of active whereas the product of example 29 was in the form of sticky and paste form (as illustrated in Figure 10(a))..
Also, this product is stable for 24 Months at room temperature (25 to 28 ºC), at higher temperature of 40 ºC ± 2 ºC.
Example 30: Comparative solubility data profile of ‘Buglossoides oil composition of Example 28 vis-à-vis Example 29
The final product of Example 28 is free flowing, water soluble, stable, and highly potent product due to the synergy of the combination of soluble fiber and mucilage present in the composition. Although mucilage is present, however, in the absence of soluble fiber, the product of example 29 forms a sticky paste which is not water soluble and forms lumps (as illustrated in Figure 10(b)).

Example 31 and 32: Composition using DL- Alpha tocopherol
Example 31 Example 32
Sr. No. Ingredients Quantity (g/100g) Quantity (g/100g)
1. DL- Alpha tocopherol 42 42
2. Soluble fiber (from Acacia senegal) 55.25 58
3. Mucilage (Fenugreek) 0.75 -
4. Rice protein 2 -
Total 100g 100g

Process for preparation of Example 31:
a) Adding mixture of Soluble fiber to water in the ratio of 1:1.5 respectively;
b) homogenizing the mixture of step (a) for 10 minutes, followed by addition of, soluble protein and mucilage;
c) homogenizing the mixture of step (b) for 10 minutes, followed by addition of DL- Alpha tocopherol;
d) homogenizing the mixture of step (c) for another 20 to 30 minutes at RPM of >1400;
e) drying the mixture of step (d) in vacuum oven having temperature at 60ºC and pressure at 1mBar for 8 hours to obtain dry flakes; and
f) milling the dried flakes of step (e) to obtain free-flowing powder.
The process for preparation of Example 32 is same as Example 31 except the step of addition of soluble protein and mucilage and the soluble fiber to water ratio is 1:2.5.
Results:
The product of Example 31 is non-hygroscopic, is free -flowing soluble and non-sticky and facilitates a quick release of active whereas the product of example 32 is a sticky paste in nature (as illustrated in Figure 11(a)).
Also, this product is stable for 24 Months at room temperature (25 to 28 ºC), at higher temperature of 40 ºC ± 2 ºC.
Example 33: Comparative solubility data profile of ‘DL- Alpha tocopherol composition of Example 31 vis-à-vis Example 32
The final product of Example 31 is free flowing, water soluble, stable, and highly potent product due to the synergistic effect of mucilage and soluble fiber present in the composition. However, due to the absence of combination of mucilage and soluble fiber; the product of Example 32 is sticky paste, which is not water soluble and forms lumps as illustrated in Figure 11(b).

Example 34: Product composition using Palmitoylethanolamide, soluble protein and soluble fiber
Example 34 Example 35
Sr. No. Ingredients Quantity (g/100g) Quantity (g/100g)
1. Palmitoylethanolamide 95 95
2. Soluble Protein (Brown rice ) 4 -
3. Soluble fiber (from Acacia senegal) 0.50 5
4. Mucilage (Fenugreek) 0.50 -
Total 100g 100g
Process for preparation of Example 34:
a) Adding mixture of Soluble fiber to water in the ratio of 1:1.5 respectively;
b) Homogenizing the mixture of step (a) for 10 minutes, followed by addition of, soluble protein and mucilage;
c) Homogenizing the mixture of step (b) for 10 minutes, followed by addition of Palmitoylethanolamide
d) Homogenizing the mixture of step (c) for another 20 to 30 minutes at RPM of >1400;
e) drying the mixture of step (d) in vacuum oven having temperature at 60ºC and pressure at 1mBar for 8 hours to obtain dry flakes; and
f) milling the dried flakes of step (e) to obtain free-flowing powder.
The process for preparation of Example 35 is same as Example 34 except the step of addition of soluble protein and mucilage and the soluble fiber to water ratio is 1:1.5.
Results:
The product of Example 34 is free -flowing soluble and non-sticky, non-hygroscopic and facilitates a quick release of active whereas the product of example 35 is a non-free flowing / moist in nature (as illustrated in Figure 12 (a)).
Also, this product is stable for 24 Months at room temperature (25 to 28 ºC), at higher temperature of 40 ºC ± 2 ºC.
Example 36: Comparative solubility data profile of ‘Palmitoylethanolamide’ composition of Example 34 vis-à-vis Example 35
The final product of Example 34 is free flowing, water soluble/dispersible, stable, and highly potent product due to the synergy of the combination of soluble fiber and soluble protein present in the composition. Although soluble fiber is present, in the absence of soluble protein, the product of example 35 forms a non-free flowing / moist which is not water soluble and forms lumps (as illustrated in Figure 12(b)).

Therefore, the composition of Example 34 shows better active loading capacity and better solubility over the composition represented in Example 35.

Example 37 to 40: Composition comprising Palmitoylethanolamide Powder (PEA)
Example 37 Example 38 Example 39 Example 40
Sr.No. Ingredients Quantity(g/100g) Quantity(g/100g) Quantity(g/ 100g) Quantity(g/ 100g)
1. Palmitoylethanolamide 90 90 90 90
2. Soluble fiber (from Acacia senegal) 5.0 - 10 -
3. Mucilage 2.5 10 - -
4. Rice protein 2.5 - - 10
Total 100 100 100 100
Process for Preparation of Example 37:
a) Adding mixture of Soluble fiber to water in the ratio of 1:1.5 respectively;
b) homogenizing the mixture of step (a) for 10 minutes at temperature 60ºC, followed by addition of, soluble protein and mucilage;
c) homogenizing the mixture of step (b) for 10 minutes at temperature 60ºC, followed by addition of PEA powder;
d) homogenizing the mixture of step (c) for another 20 to 30 minutes at temperature 60ºC and RPM of >1400;
e) drying the mixture of step (d) in vacuum oven having temperature at 60ºC and pressure at 1mBar for 8 hours to obtain dry flakes; and
f) milling the dried flakes of step (e) to obtain free-flowing powder.
Process for Preparation of Example 38 to 40:
a) Adding mixture of Soluble protein /mucilage/ Rice protein to water in the ratio of 1:2.5 respectively;
b) homogenizing the mixture of step (a) for 10 minutes at temperature 60ºC, followed by addition of PEA powder;
c) homogenizing the mixture of step (b) for another 20 to 30 minutes at temperature 60ºC and RPM of >1400;
d) drying the mixture of step (c) in vacuum oven having temperature at 60ºC and pressure at 1mBar for 8 hours to obtain dry flakes; and
e) milling the dried flakes of step (d) to obtain non free-flowing/moist powder.

The obtained free flowing powder from Example 37 is represented in figure 13(a to d) in comparison with the composition represented as Example 38-40.
The product of Example 37 is non-hygroscopic , is free -flowing soluble, non-sticky and releases actives very quickly when provided as solution whereas the composition obtained from example 38-40 has shown a sticky paste nature of the final product and not soluble(as illustrated in Figure 13 (a to d)).
Also, this product is stable for 24 Months at room temperature (25 to 28 ºC), at higher temperature of 40 ºC ± 2 ºC.
Example 41 and 42: Composition comprising Murraya koenigii
Example 41 Example 42
Sr No. Ingredients Quantity (g/100g) Quantity (g/100g)
1. Murraya koenigii leaf extract 43 43
2. Soluble fiber (from Acacia senegal) 53.5 -
3. Mucilage 2 -
4. Rice protein 1.5 57
Total 100 100
Process for Preparation of Example 41:
a) Adding mixture of Soluble fiber to water in the ratio of 1:1.5 respectively;
b) homogenizing the mixture of step (a) for 10 minutes at temperature 60ºC, followed by addition of, soluble protein and mucilage;
c) homogenizing the mixture of step (b) for 10 minutes at temperature 60ºC, followed by addition of Curry leaf extract;
d) homogenizing the mixture of step (c) for another 20 to 30 minutes at temperature 60ºC and RPM of >1400;
e) drying the mixture of step (d) in vacuum oven having temperature at 60ºC and pressure at 1mBar for 8 hours to obtain dry flakes; and
f) milling the dried flakes of step (e) to obtain free-flowing powder.

The process for preparation of Example 42 is same as Example 41 except the step of addition of soluble fiber and mucilage and the soluble protein to water ratio is 1:1.5.
The product of Example 41 is non-hygroscopic, is free -flowing soluble and non-sticky and releases actives very quickly when provided as solution whereas the composition obtained from example 42 has shown a sticky and paste nature of the final product(as illustrated in Figure 14).
Also, this product is stable for 24 Months at room temperature (25 to 28 ºC), at higher temperature of 40 ºC ± 2 ºC.
,CLAIMS:Claim,
1. A stable, synergistic composition for enhancing the solubility, stability, bioavailability and quick release of active ingredient comprising;
i. Soluble fiber in an amount ranging from 0.1% to 80% of the total composition;
ii. Soluble protein in an amount ranging from 0.1% to 80% of the total composition; and
iii. Mucilage in an amount ranging from 0.1% to 55% of the total composition;
wherein said active ingredient is present in an amount of 5% to 98% of the total composition; and
wherein said composition is free of emulsifier, glidant and organic solvents.
2. The composition as claimed in Claim 1, wherein the
i. Soluble fiber is hydrolysed/unhydrolysed soluble fiber selected from the group consisting of arabinogalactans such as rhamno-galacturonan, arabinoxylan, galactoglucomannan, glucogalactomannan, galactoglucoarabinomannan, fructooligosaccharides, inlulin, xyloglucan, beta-glucan from Albizia zygia, tamarind, Cochlospermum religiosum, Chondrus cryspus, Cassia tora Linn, Cyamompsis tetraganolobus, Acacia Arabica, Acacia Senegal, Anogeissus latifolia, Astragalus gummifer, Sterculia urens, Khaya grandifolia, Xanthomonas lempestris, Pseudomonas elodea, xanthan gum Tapioca, Aloe vera and guar gum;
ii. Soluble protein is hydrolysed/unhydrolysed soluble protein which selected from the group consisting of rhizomes of Curcuma longa (turmeric), seeds of Oryza sativa L. (Brown rice), aerial part of Pisum sativum (pea protein), fruit of Tamarindus indica (Tamarind), kernels of Triticum ( wheat protein) , seeds of Helianthus annuus (Sunflower seeds) , seeds of Chenopodium quinoa (Quinoa) and the like;
iii. mucilages is hydrolysed/unhydrolysed soluble form which selected from arabinogalactans such as rhamno-galacturonan, arabinoxylan, galactoglucomannan, glucogalactomannan, galacto-glucoarabinomannan, galactomannans from psyllium, Flax seed, chia seeds, Basil seeds, Chan seeds, Abelmoschus esculentus (okra), Phoenix, Cassia tora , gum spinach, Cordia obliqua , Ocimum americanum, Aloe species, Lepidum sativum, Ocimum canum, Trigonella foenum graecum, Hibiscus esculentus Linn, Plantago psyllium, Plantago ovata, Leucaena leucocephata, Ocimum gratissimum Linn, Asparagus racemosus and Tamarindus indica; and
iv. active ingredient is selected from the group consisting of active compounds, extracts, oleoresins, essential oils and purified phytochemicals selected from Ginger root extract, Turmeric extract, Marigold extract, Rosemary extract, Ashwagandha extract, Cannabis extract (Cannabinoids), Hemp oil, Garlic extracts, Beetroot extract, clove extract, cinnamon extract, cardamom extract, Black seed (Nigella sativa) extract, Lycopene extract, Vitamin D/D3 from animal or lichen source, Vitamin A, Vitamin E, Vitamin C, Vitamin K2, DL- Alpha tocopherol, sea buckthorn oil, Omega fatty acids (3,6,7 and 9) sourced from fish, krill, Algae, Buglossoides arvensis, Boswellia serrata extract, Capsicum extract, DHA (Docosahexaenoic acid), EPA (Eicosapentaenoic acid), Palmitoylethanolamide (PEA), Piper nigrum extract, Fenugreek saponins, Co-enzyme Q10, plant sterols, vitamin K7, Citrus bioflavonoids, valerinic acid, beta-caryophyllene, Curcuma zedoaria extract, Black Ginger extract, Pomegranate seed extract, melatonin, Alpinia galanga extract, saffron extract, Astaxanthin and Sceletium tortuosum extract
3. The composition as claimed in Claim 2, wherein the
i. Soluble fiber is standardized to contain glycoprotein and arabinogalacto protein equivalent to 1 to 10% protein and, >80% soluble fiber and indigestible fiber;
ii. Soluble protein is standardized to contain protein equivalent to >80% protein and, <15% polysaccharide;
iii. Mucilage is standardized to contain >5% protein and >80% polysaccharides; and
iv. Active ingredient is standardized to contain 1 to 99% actives, in an amount ranging from 5% to 98%.
4. The composition as claimed in Claim 1, wherein the extract loading capacity of said synergistic composition is in the range of 5 to 85% by weight of the total composition.
5. The composition as claimed in Claim 1, wherein the composition is formulated using suitable carriers into various dosage forms such as tablets, capsules, syrups, strips, gummies, beverages, ready to drink beverages, milk based products/beverage/fortified products such as curd, yogurt, energy drinks, for applications as nutraceuticals, pharmaceuticals, food or food supplements/additives.
6. The composition as claimed in Claim 1, wherein the composition is useful in the treatment of inflammatory diseases, respiratory diseases, heart diseases, cognitive diseases, eye diseases, skin diseases, digestive diseases/discomfort and stress.
7. A solvent free process for preparation of stable water soluble synergistic composition comprising;
i. Adding mixture of soluble fiber(s) to water;
ii. Homogenizing the mixture of step (a) at temperature 40ºC to 80ºC, followed by addition of soluble protein and mucilage;
iii. Homogenizing the mixture of step (b) at temperature 40ºC to 80ºC, followed by addition of active ingredient;
iv. Homogenizing the mixture of step (c) at temperature 40ºC to 80ºC and RPM of >1400;
v. Drying the mixture of step (d) in vacuum oven having temperature at 40ºC to 80ºC and pressure at 1-20 mBar or tray dryer with temperature at 40ºC to 80ºC to obtain dry flakes; and
vi. Milling the dried flakes of step (e) to obtain free-flowing powder.