DESC:Technical Field Of the Invention:
The present invention relates to a composition comprising phytochemicals and bio-enhancing agents/self-dispersing agents derived from fresh plant extract, wherein said composition enhances the bioavailability of phytochemicals. The present invention also relates to a process for preparation of said composition .

Background Of The Invention:
Herbal medicine has made a major contribution to the drug discovery process and its use has increased worldwide due to their therapeutic effects and fewer adverse effects as compared to the modern medicines. Many herbal drugs and herbal extracts, however, despite their effective in-vitro findings demonstrate less or negligible in-vivo activity due to their poor solubility resulting in poor absorption and hence poor bio-availability leading to poor or decreased efficacy.

The phytochemicals with poor bioavailability in plant extracts belong to phenolic compounds, xanthophyllic carotenoids, carotenoids, protoberberine group of benzylisoquinoline alkaloids, stilbenoids, isoflavones, monoamine alkaloids, flavonols, curcuminoids and many others which have proven to have several therapeutic benefits like anti-inflammatory, anti-oxidant, age-related macular degeneration, anti-cancerous, memory enhancing among many other medicinal activities. However, very less has been achieved with respect to said phytochemicals for prevention and treatment of diseases due to their poor bioavailability and lack of sustained release in the body.

The further developments in the art observed that the main issue which needs to be addressed with the phytochemicals is not only the bioavailability but also their availability in the systemic circulation for longer period of time in biologically active form for sustained efficacy. This will also help in reducing the dosages thus making the treatment cost effective, minimize drug toxicity and is patient compliant.

Bioavailability enhancing activity of natural compounds have several mechanisms of action and is mainly attributed to mechanisms such as P-glycopotein (P-gp) inhibition activity, non-specific mechanisms promoting rapid absorption of drugs such as increased blood supply to the gastrointestinal tract, decreased hydrochloric acid secretion, non-specific mechanisms inhibiting enzymes participating in metabolism of drugs to list the few.

‘Bioavailability enhancers’ are facilitators capable of increasing the intestinal absorption, enhancing bioavailability and bio-efficacy of a particular drug or phytochemical with which it is combined, without any typical pharmacological activity of its own at the dose used.

The term ‘bioavailability enhancer’ was first coined by Indian scientists at the Regional Research Laboratory, Jammu (RRL, now known as Indian Institute of Integrative Medicine, Jammu), who discovered and scientifically validated piperine as the world's first bioavailability enhancer in 1979 [Atal CK. A breakthrough in drug bioavailability-a clue from age old wisdom of Ayurveda. IDMA Bulletin. 1979; 10:483–484].

The use of herbal bio-enhancers is widely appreciated as a means for bioavailability enhancement because these are safe, non-toxic, economical, easily procured, pharmacologically inert and non-allergenic in nature.

WO03/049753 relates to a bio-enhancing composition containing extract and/or bioactive fraction/isolate from the plant Zingiber officinale in combination with drugs, nutrients, nutraceuticals, micronutrients and herbal drugs/products and optionally containing piperine as a extract/active fraction obtained from Piper nigrum, Piper longum or its oleoresin as a bioavailability enhancer and its process for producing the extract or fractions from the plant source.

US5536506 discloses use of piperine to increase the bioavailability of nutritional compounds. US’506 further discloses a composition and method for the improvement of gastrointestinal absorption and systemic utilization of nutrients and nutritional supplements, wherein the composition comprises an extract from the fruit of Piper containing a minimum of 98% of pure alkaloid piperine.

WO2015/025263 discloses a composition containing curcumin along with soluble proteins, dietary fiber, fixed oil and essential oil from turmeric that increases absorption of curcumin in the blood and results in better dispersibilty upon oral consumption, which is useful for treatment of various diseases.

Article titled, “Bioavailability enhancing activities of natural compounds from medicinal plants” by Myung Joo Kang et. al., published in Journal of Medicinal Plants Research Vol. 3(13), pp. 1204-1211, December, 2009 disclose the natural compounds such as quercetin, genistein, naringin, sinomenine, piperine, glycyrrhizin and nitrile glycoside for improving the drug bioavailability.

Though bio-enhancers in drug delivery are known, challenge still persists to provide safe herbal bio-enhancers for increasing the bioavailability of herbal origin/phytochemicals that are non-toxic, non-irritating, rapid acting with predictable activity. Another problem encountered in the art is large scale production of such formulations containing the herbal compound and the bio-enhancer.

Object of the Invention:
In view of the shortcomings of the art, the object of the present invention is to provide a potential solution for enhancing the bio-availability of phytochemicals using bio-enhacing/self-dipersing agents derived from extract of fresh plant parts.

Summary Of The Invention:
To achieve the above objective, in an aspect, the present invention provides a composition for enhancing the bioavailability of phytochemicals comprising;
a) phytochemicals selected from the group consisting of carotenoids, stilbenoid, isoflavones, terpenes, isoquinoline alkaloids, phenolic compounds, saponins, flavonoids, quinones, fatty acids and their derivatives either alone or mixtures thereof; and
b) bio-enhancing agents/self-dispersing agents derived from extract of fresh plant parts selected from Turmeric, Beetroot, Potato, Aloe vera, Carrot, Mango, Topioca, and Coconut either alone or mixtures thereof.

In another aspect, the present invention provides a process for preparation of the composition for enhancing the bioavailability of phytochemicals comprises the steps of;
a) slicing the fresh plant parts selected from turmeric, beet root, potato, aloe vera, carrot, mango, tapioca and coconut either alone or mixtures thereof into small pieces and extracting the fresh liquid extract from them to obtain the bio-enhancing agents/self-dispersing agents; followed by filtering the liquid extract to remove sedimentable particles;
b) adding phytochemicals selected from the group consisting of carotenoids, stilbenoid, isoflavones, terpenes, isoquinoline alkaloids, phenolic compounds, saponins, flavonoids, quinones, fatty acids and their derivatives to the liquid extract of step (a);
c) homogenizing the mixture of step (b) for 30 to 60 minutes between 25oC to 80°C at 200 to 10000 RPM to obtain slurry; and
d) vacuum drying the slurry of step (c) at 60oC to 85oC for 8 hours followed by milling the flakes to obtain free flowing powder (particle size >120 mesh) of the composition.

Brief Decription of the Figures:
Figure 1: Release profile of Lutein composition of Example 1 Vs. unformulated lutein extract
Figure 2: Comparative self-dispersion profile of Lutein extract composition of Example 1 vis-à-vis Standard unformulated lutein extract
Figure 3: Comparative self-dispersion profile of Boswellia extract composition of Example 13 vis-à-vis Standard unformulated boswellia extract
Figure 4: Release profile of Pepper extract Composition of Example 16 Vs. Standard unformulated pepper extract (95% Piperine)
Figure 5: Comparative self-dispersion profile of Pepper extract composition of Example 16 vis-à-vis Standard unformulated pepper extract
Figure 6: Comparative self-dispersion profile of Coenzyme Q10 Composition of Example 22 vis-à-vis Standard unformulated Coenzyme Q10 extract

Detailed Description of the Invention:
The present invention will now be described in detail in connection with certain embodiments, so that various aspects thereof may be fully understood and appreciated.

Source of Phytochemicals used in the Invention:
The phytochemicals used in the invention are procured from the vendors. The details of which are provided as follows:

Lutein: Sourced from Plant Lipids Private Limited Kolenchery, Cochin - 682 311, Kerala, India.

Lycopene: Sourced from SV Agrofood, India C-9/150,Yamuna Vihar, Delhi - 53, India.

Astaxanthin: Sourced from Bio-gen Extracts Pvt. Ltd. Plot No. 57, 1st Stage, Sompura Industrial Area, Dobaspet, Bangalore - 562 111, Karnataka, India.
Piperine: Sourced from Plant Lipids Private Limited Kolenchery, Cochin - 682 311, Kerala, India

Boswellia: Sourced from Sami Labs Limited, 19/1, 1st Main Rd, 2nd Phase, Nalagadderanahalli, Peenya, Bengaluru, Karnataka - 560058, India.

Beta-carotene: Sourced from SV Agrofood, India C-9/150,Yamuna Vihar, Delhi - 53, India.

Berberine: Sourced from Kuber Impex Ltd 304-5 / The Magnate tower 16/1 New Palasia Indore Madhya Pradesh - 452001, India.

Resveratrol: Sourced from Kuber Impex Ltd 304-5 / The Magnate tower 16/1 New Palasia Indore Madhya Pradesh - 452001, India.

Genistein: Sourced from Kuber Impex Ltd 304-5 / The Magnate tower 16/1 New Palasia Indore Madhya Pradesh - 452001, India.

Coenzyme Q10: Sourced from SV Agrofood, India C-9/150,Yamuna Vihar, Delhi-53, India.

Palmitoylethanolamide (PEA): Sourced from Wuxi Cima Science Co. Ltd, 288, Shi Ba Wan Road, Wuxi 214064, Jiangsu, China.

Vitamin D: Sourced from Supreme Pharmaceuticals Mysore Pvt. Ltd. #73,74 &48 P-1 KIADB Industrial Area, Nanjangud - 571302, India.

Source and Geographical origin of the biological material (Plants) used in the Invention:

Curcuma Longa (Turmeric)
Geographical Origin: Native to the Indian subcontinent and Southeast Asia
Sourced from local vendor of Tamil Nadu, India

Beta Vulgaris (Beetroot)
Geographical Origin: Native to the seacoasts of the Mediterranean and Europe
Sourced from local vendor of Tamil Nadu, India

Solanum tuberosum (Potato)
Geographical Origin: Native to southern Peru and extreme northwestern Bolivia
Sourced from local vendor of Tamil Nadu, India

Aloe barbadensis (Aloe vera)
Geographical Origin: Native to Arabian Peninsula
Sourced from local vendor of Tamil Nadu, India

Daucus carota (Carrot)
Geographical Origin: Native to the Southwestern Asia and Europe.
Sourced from local vendor of Tamil Nadu, India

Mangifera indica (Mango)
Geographical Origin: Native to the India, Pakistan and South Asia
Sourced from local vendor of Tamil Nadu, India

Manihot esculenta (Tapioca)
Geographical Origin: Native to the Asia, Africa, North and central west region of Brazil, South America.
Sourced from local vendor of Tamil Nadu, India

Cocos nucifera (Coconut)
Geographical Origin: Native to the Indian subcontinent and Southeast Asia.
Sourced from local vendor of Tamil Nadu, India

The term ‘phytochemical’ refers herein is as any of the various biologically active compound found in plants.

The term ‘bio-enhancing agent’ or ‘self-dispersible agent’ refers herein is an extract derived from fresh plant parts that spontaneously disperse the phytochemical(s) into an aqueous phase and forms uniform suspension without any external force applied to make it disperse and enhances the bio-availability of phytochemical in the composition.

The present invention arises from the need to enhance the bioavailability of plant derived phytochemicals using natural self-dispersing agents so that phytochemicals can easily be absorbed in the systemic circulation, remains for longer period of time in biologically active form for sustained efficacy for various therapeutic, preventative and general health supplement applications in animals and human beings with higher safety profile.

Accordingly, in a preferred aspect, the present invention discloses a composition for enhancing the bioavailability of phytochemicals comprising;
a) phytochemical selected from the group consisting of carotenoids, stilbenoid, isoflavones, terpenes, isoquinoline alkaloids, phenolic compounds, saponins, flavonoids, quinones, fatty acids and their derivatives either alone or mixtures thereof; and
b) bio-enhancing agents/self-dispersing agents derived from extract of fresh plant parts selected from Curcuma longa (Turmeric), Beta vulgaris (Beetroot), Solanum tuberosum (Potato), Aloe barbadensis (Aloe vera), Daucus carota (Carrot), Mangifera indica (Mango), Manihot esculenta (Tapioca) and Cocos nucifera (Coconut) either alone or mixtures thereof.

The phytochemicals/phytochemicals derivatives/biologically active compounds consist of carotenoids such as Lutein, Zeaxanthin, Lycopene, astaxanthin, beta-carotene; isoquinoline alkaloids such as berberine; cannabinoids, stilbenoid such as resveratrol; isoflavones such as genistein; coenzyme Q10, Palmitoylethanolamide (PEA), Piperine, boswellic acids, Chlorogenic acids, Silymarin, silibinin, Catechin, Gingerols, Shogaols, ellagic acid, Quercitin, caffeine, caffeic acid derivatives, Iron, calcium, Ecdysteroids/ecdysterone, Rosavins, Salidroside, Curculigosides Omega-3-fatty acids, Echinasea, Gymneric acids, S-Allyl-Cystein, Melatonin, Forskolin, Huperzine, Hypericin, hyperforin, Phytoestrogens, Ginsenosides, Valerenic acid, Vitamin D, Vitamin E, Menthol and Theacrine and the like.

The preferable phytochemicals/phytochemicals derivatives/biologically active compounds includes lutein, astaxanthin, piperine, cannabinoids, boswellic acid, coenzyme Q10, palmitoylethanolamide, berberine and vitamin D.

The phytochemicals in the composition of the present invention may be obtained either naturally and/or by synthetic and/or semi synthetic process; and can be either purified molecule(s) or extract(s).

The bio-enhancing agents/self-dispersing agents in the composition of the present invention are derived from the extracts of fresh plant parts selected from rhizomes of Curcuma longa (Turmeric), taproots of Beta vulgaris (Beet root), tubers of Solanum tuberosum (Potato), leaf of Aloe barbadensis (Aloe vera), taproots of Daucus carota (Carrot), fruits of Mangifera indica (Mango), roots of Manihot esculenta (Tapioca) and fruits of Cocos nucifera (Coconut).

The bio-enhansing agent/self-dispersing agent enhances the biovailability of phytochemicals through self-dispersion.

The preferable bio-enhancing agents/self-dispersing agents derived from extracts of fresh plant parts includes rhizomes of Curcuma longa (Turmeric), taproots of Beta vulgaris (Beet root) and tubers of Solanum tuberosum (Potato).

The exatracts of fresh plant parts are obtained without the use of any solvents.

In another preferred embodiment, the present composition comprises phytochemicals in an amount ranging from 1% to 99%, preferably, 5% to 95% of the total composition.

In another preferred embodiment, the present composition comprises bio-enhancing agents/self-dispersing agents in an amount ranging from 1% to 99%, preferably, 5% to 95% of the total composition.

In another embodiment, the present invention discloses a method for enhancing the bioavailability of phytochemicals using bio-enhansing agent/self-dispersing agent derived from extracts of fresh plant parts; wherein said method comprises extraction of fresh plant parts followed by homogenizing the plant extracts with phytochemicals at higher temperature and drying, powdering to get the free-flowing powder of self-dispersible composition.

In another preferred embodiment, the present invention discloses a process for preparation of composition for enhancing the bioavailability of phytochemicals comprises the steps of;
a) Slicing the fresh rhizome Curcuma longa, taproot of Beta vulgaris, tuber of Solanum tuberosum, leaf of Aloe barbadensis, taproot of Daucus carota (Carrot), fruit of Mangifera indica (Mango), root of Manihot esculenta (Tapioca) and fruit of Cocos nucifera (Coconut) either alone or mixtures thereof into small pieces and extracting the fresh extract using low rpm screw extruder with 0.5mm to 1mm mesh/filter press to obtain the extract of bio-enhancing agent/self-dispersing agent;
b) filtering the extract of step (a) using 100-500 micron filter to remove sedimentable particles followed by heating the extract for 30 minutes at 30-60oC with continuous stirring using a homogenizer;
c) adding phytochemicals selected from the group consisting of carotenoids, stilbenoid, isoflavones, terpenes, isoquinoline alkaloids, saponins, flavonoids, quinones, fatty acids and their derivatives either alone or mixtures thereof to the extract of step (b); and
d) homogenizing the mixture of step (c) at 200 to 10000 RPM for 30 to 60 minutes at 25oC to 80oC followed by vaccum drying at 60oC to 85oC, and powdering to obtain free-flowing powder (particle size >120 mesh) of self-dispersible composition.

According to the process, fresh plant parts selected from rhizomes of? Curcuma longa, taproot of Beta vulgaris, tubers of Solanum tuberosum, leaf of Aloe barbadensis, taproot of Daucus carota (Carrot), fruit of Mangifera indica (Mango), root of Manihot esculenta (Tapioca) and fruit of Cocos nucifera (Coconut) either alone or mixtures thereof are cut into small pieces and the fresh extract was seperated using low rpm screw extruder with 0.5mm to 1mm mesh/filter press at 20 to 35oC. Optionally cooled the freshly produced exatrct to <40C temeparture to precipitate and remove the unwanted salts.

The fresh plant part extract is filtered to get enhanced dispersion and bioavailablity of the phytochemicals.

The phytochemicals added to the extract consisting of carotenoids which include Lutein, Zeaxanthin, Lycopene, astaxanthin, beta-carotene; isoquinoline alkaloids such as berberine; cannabinoids, stilbenoid such as resveratrol; isoflavones such as genistein; coenzyme Q10, Palmitoylethanolamide (PEA), Piperine, boswellic acids, Chlorogenic acids, Silymarin, silibinin, Catechin, Gingerols, Shogaols, ellagic acid, Quercitin, caffeine, caffeic acid derivatives, Iron, calcium, Ecdysteroids/ecdysterone, Rosavins, Salidroside, Curculigosides Omega-3-fatty acids, Echinasea, Gymneric acids, S-Allyl-Cystein, Melatonin, Forskolin, Huperzine, Hypericin, hyperforin, Phytoestrogens, Ginsenosides, Valerenic acid, Vitamin D, Vitamin E, Menthol and Theacrine, either alone or mixtures thereof in suitable proportion and the mixture is homogenized at 200 to 10000 RPM for about 30 to 60 minutes at 25-80oC. The mixture is then vacuum dried and powdered to obtain free-flowing powder of the present composition.

In an embodiment, the process of the present invention is solvent free.

In another embodiment, the composition of the present invention comprising one or more said phytochemicals and one or more said bio-enhancing agents/self-dispersing agent can be formulated into various dosage forms such as tablets, capsules, pills, solutions, paste, lozenges, instant mixes, beverages and the like.

In another embodiment, the present invention discloses the release profile of lutein composition; wherein the results exhibit the increased solubility and release profile for lutein composition compared to ‘unformulated lutein extract’. The same is depicted in Figure 1.

In another embodiment, the present invention discloses the comparative self-dispersion study between Lutein extract composition and standard unformulated lutein extract; wherein the result show that Lutein extract composition dispersed easily without any mechanical stirring and exhibiting enhanced self-dispersion compared to standard unformulated lutein extract which floats on top of the water. The dispersion result is given in Figure 2.

In another embodiment, the present invention discloses the comparative self-dispersion study between Boswellia extract composition and standard unformulated boswellia extract; wherein the result show that Boswellia extract composition dispersed easily without any mechanical stirring and exhibiting enhanced self-dispersion compared to standard unformulated boswellia extract which floats on top of the water. The dispersion result is given in Figure 3.

In another embodiment, the present invention discloses the release profile of pepper extract composition; wherein the results exhibit the increased solubility and release profile for pepper extract composition compared to ‘unformulated pepper extract’. The same is depicted in Figure 4.

In another embodiment, the present invention discloses the comparative self-dispersion study between Pepper extract composition and standard unformulated pepper extract; wherein the result show that pepper extract composition dispersed easily without any mechanical stirring and exhibiting enhanced self-dispersion compared to standard unformulated pepper extract which floats on top of the water. The dispersion result is given in Figure 5.

In another embodiment, the present invention discloses the comparative self-dispersion study between Coenzyme Q10 composition and standard unformulated Coenzyme Q10 extract; wherein the result show that Coenzyme Q10 composition dispersed easily without any mechanical stirring and exhibiting enhanced self-dispersion compared to standard unformulated Coenzyme Q10 extract which floats on top of the water. The dispersion result is given in Figure 6.

In an optional embodiment, the composition of the present invention comprising anti-oxidants, wetting agents, glidants selected from ascorbic acid, silicon dioxide and the like.

In another embodiment, the present invention discloses a method of treating inflammatory diseases, respiratory diseases, heart diseases, sexual diseases, cognitive diseases, eye diseases, skin diseases and stress by administering therapeutically effective amount of present composition comprising one or more phytochemical and one or more bio-enhancing agent/self-dispersing agent derived from extract of fresh plant parts to a subject in need thereof; wherein the therapeutically effective amount is 5 to 1000 mg/per day.

In yet another embodiment, the present invention discloses the composition comprising one or more phytochemical and one or more bio-enhancing agent/self-dispersing agent derived from extract of fresh plant parts used in the treatment of inflammatory disease, respiratory diseases, heart diseases, sexual diseases, cognitive diseases, eye diseases, skin disease and stress related to animal and human beings.

In yet another embodiment, the composition of the present invention comprises phytochemical and bio-enhancing agent/self-dispersing agent derived from extract of fresh plant parts, wherein said extract from fresh plant parts can be used as/act as self-dispersing agent to enhance the bioavailability of phytochemicals, minerals and vitamins such as Iron and Vitamin D.
Example:
Some typical examples illustrating the embodiments of the present invention are provided; however, these are exemplary only and should not be regarded as limiting the elements of the present invention.

Example 1: Bioavailable Lutein Composition
Sr. No. Ingredients Quantity
1. Lutein extract (Standardized to 80%) 25g
2. Fresh turmeric rhizome extract (on dry basis) 75g
Total 100g

Example 2: Process for preparation of Bioavailable Lutein Composition of Example 1
a) Washing 1000g of fresh turmeric rhizome with RO water followed by exatraction using low speed screw extruder with 0.5mm to 1mm mesh to separate the liquid extract and filtering the extract with 100-500 micron filter;
b) heating the fresh turmeric liquid extract obtained in step (a) for 30 minutes at 40oC with continuous stirring using a homoziniser;
c) slowly adding 25g of lutein extract to the liquid extract (75g of fresh turmeric rhizome extract on dry basis) of step (b) with continuous stirring;
d) homogenizing the mixture of fresh turmeric liquid extract and lutein extract of step (c) at 2000 RPM at 400C for 30 to minutes to obtain viscous slurry;
e) vacuum drying the slurry of step (d) at 40oC for 8 hours using Rotary Vacuum Dryer (RVD); and
f) milling the flakes of step (e) to obtain free flowing powder (particle size >120 mesh) of self-dispersible Lutein composition.
Yield of fresh turmeric liquid extract: 750g

Example 3: Release profile of Lutein Composition
The composition was tested for lutein solubility and release in phosphate buffer. 400mg of Lutein composition from Example 1 was added into the 400 ml phosphate buffer (pH 6.8) under intermittent stirring at 37oC. Samples were drawn for up to four hours, filtered and tested for absorbance at 446nm using UV-Vis spectrophotometer. The results show the increased solubility and release profile for lutein composition compared to ‘unformulated lutein extract’. Absorbance vs. time graph was plotted as illustrated in Figure 1.

Example 4: Comparative self-dispersion profile of ‘Lutein extract composition of Example 1’ vis-à-vis ‘Standard unformulated lutein extract’
A comparative self-dispersion study was carried out between the ‘Composition of Example 1 (Test product)’ and ‘Standard unformulated lutein extract (Reference product)’. The dispersion profile is given in Figure 2. The result shows that the ‘Test product’ dispersed easily without any mechanical stirring whereas the ‘Standard unformulated lutein extract’ was non-dispersible as it was floating on top of the water.

Example 5: Bioavailable Astaxanthin Composition
Sr. No. Ingredients Quantity
1. Asthaxanthin extract (Standardized) 25g
2. Fresh turmeric rhizome extract (on dry basis) 75g
Total 100g

Example 6: Process for preparation of Bioavailable Asthaxanthin Composition of Example 5
a) Washing 1000g of fresh turmeric rhizome with RO water followed by extraction using low speed screw extruder with 0.5mm to 1mm mesh to separate the liquid extract and filtering the extract with 100-500 micron filter;
b) heating the fresh turmeric liquid extarct obtained in step (a) for 30 minutes at 60oC with continuous stirring using a homogenizer;
c) slowly adding 25g of asthaxanthin extract to the liquid extract (75 g of fresh turmeric rhizome extract on dry basis) of step (b) with continuous stirring;
d) homogenising the mixture of fresh turmeric liquid extract and asthaxanthin extract of step (c) at 2000 RPM and 40ºC for 30 minutes to obtain viscous slurry; and
e) vaccum drying the slurry of step (d) at 60oC for 8 hours using Rotary Vacuum Dryer (RVD); and
f) milling the flakes of step (e) to obtain free flowing powder (particle size >120 mesh) of self-dispersible Asthaxanthin composition.
Yield of Fresh turmeric liquid extract: 750g

Example 7: Bioavailable Lutein Composition
Sr. No. Ingredients Quantity
1. Lutein extract (Standardized to 80%) 25g
2. Fresh beetroot extract (on dry basis) 75g
Total 100g

Example 8: Process for preparation of Bioavailable Lutein Composition of Example 7
a) Washing 1000g of fresh taproots of beet with RO water followed by extraction using low speed screw extruder with 0.5mm to 1mm mesh to separate the liquid extract and filtering the extract with 100-500 micron filter;
b) heating the fresh beetroot liquid extract obtained in step (a) for 30 minutes at 40oC with continuous stirring using a homogenizer;
c) slowly adding 25g of lutein extract to the liquid extract (75g of fresh beetroot extract on dry basis) of step (b) with continuous stirring;
d) homogenizing the mixture of fresh beetroot liquid extract and lutein extract of step (c) at 2000 RPM and 40oC for 30 minutes to obtain viscous slurry;
e) vacuum drying the slurry of step (d) at 40oC for 8 hours using Rotary Vacuum Dryer (RVD); and
f) milling the flakes of step (e) to obtain free flowing powder (particle size >120 mesh) of of self-dispersible Lutein composition.
Yield of Fresh beetroot liquid extract: 750g

Example 9: Bioavailable Lutein Composition
Sr. No. Ingredients Quantity
1. Lutein extract (Standardized to 80%) 25g
2. Fresh potato extract (on dry basis) 75g
Total 100g

Example 10: Process for preparation of Bioavailable Lutein Composition of Example 9
a) Washing 1500g of fresh potato tubers with RO water followed by exatraction using low speed screw extruder with 0.5mm to 1mm mesh to separate the liquid extract and filtering the extract with 100-500 micron filter;
b) heating the fresh potato liquid extract obtained in step (a) for 30 minutes at 40oC with continuous stirring using a homogenizer;
c) slowly adding 25g of lutein extract to the liquid extract (75g of fresh potato extract on dry basis) of step (b) with continuous stirring;
d) homogenizing the mixture of fresh potato liquid extract and lutein extract of step (c) at 2000 RPM and 40oC for 30 minutes to obtain viscous slurry;
e) vacuum drying the slurry of step (d) at 40oC for 8 hours using Rotary Vacuum Dryer (RVD); and
f) milling the flakes of step (e) to obtain free flowing powder of self-dispersible Lutein composition.
Yield of Fresh potato liquid extract: 1000g

Example 11: Boswellia Extract Composition
Sr. No. Ingredients Quantity
1. Boswellia extract (Standardized to 70%) 32g
2. Fresh turmeric rhizome extract (on dry basis) 68g
Total 100 g

Example 12: Process for preparation of Boswellia Extract Composition of Example 11
a) Washing 1000g of fresh turmeric rhizome with RO water followed by exatractionusing low speed screw extruder with 0.5mm to 1mm mesh to separate the liquid extract and filtering the extract with 100-500 micron filter to obtain the bio-enhancing/self-dispering agent;
b) heating the fresh turmeric liquid extract obtained in step (a) for 30 minutes at 40oC with continuous stirring using a homogenizer;
c) slowly adding 32g of boswellia extract to the liquid extract (68g of fresh turmeric rhizome exarct on dry basis) of step (b) with continuous stirring;
d) homogenizing the mixture of step (c) at 2000 RPM for 30 minutes at 40oC to obtain uniform viscous slurry;
e) vacuum drying the slurry of step (d) at 60oC for 8 hours using Rotary Vacuum Dryer (RVD); and
f) milling the flakes of step (e) using communiting mill to obtain free flowing powder of self-dispersible Boswellia extract composition.
Yield of fresh turmeric liquid extract: 680g

Example 13: Boswellia Extract Composition
Sr. No. Ingredients Quantity
1. Boswellia extract (Standardized to 70%) 75g
2. Fresh turmeric rhizome extract (on dry basis) 25g
Total 100 g

Example 14: Process for preparation of Boswellia Extract Composition of Example 13
a) Washing 300g of fresh turmeric rhizome with RO water followed by squeezing using low speed screw extruder with 0.5mm to 1mm mesh to separate the liquid extarct, and filtering the extract with 100 micron filter to obtain the bio enhancing/self dispering agent;
b) heating the fresh turmeric liquid extract obtained in step (a) for 30 minutes at 40oC with continuous stirring using a homogenizer;
c) slowly adding 75g of boswellia extract to the liquid extract (25g of fresh turmeric rhizome exarct on dry basis ) of step (b) with continuous stirring;
d) homogenizing the mixture of step (c) at 2000 RPM for 30 minutes at 40°C to obtain uniform slurry;
e) vacuum drying the slurry of step (d) at 80oC for 8 hours using Rotary Vacuum Dryer (RVD); and
f) milling the flakes by using communiting mill of step (e) to obtain free flowing powder (particle size >120 mesh) of self-dispersible Boswellia extract composition.
Yield of Fresh turmeric liquid extract: 250g
Example 15: Comparative self-dispersion profile of ‘Boswellia extract composition of Example 13’ vis-à-vis ‘Standard unformulated boswellia extract’
A comparative self-dispersion study was carried out between the ‘Composition of Example 13 (Test product)’ and ‘Standard unformulated boswellia extract (Reference product)’. The dispersion profile is given in Figure 3. The result shows that the ‘Test product’ dispersed easily without any mechanical stirring where as the ‘Standard unformulated boswellia extract’ was non-dispersible as it was floating on top of the water.

Example 16: Pepper Extract Composition
Sr. No. Ingredients Quantity
1. Pepper extract (Standardized to 95%) 85g
2. Fresh turmeric rhizome extract (on dry basis) 15g
Total 100 g

Example 17: Process for preparation of Pepper Extract Composition of Example 16
a) Washing 250g of fresh turmeric rhizome with RO water followed by exatraction using low speed screw extruder with 0.5mm to 1mm mesh to separate the liquid extarct, and filtering the extract with 100-500 micron filter to obtain the bio-enhancing /self dispering agent;
b) heating the fresh turmeric liquid extract obtained in step (a) for 30 minutes at 40oC with continuous stirring using a homogenizer;
c) slowly adding 85g of pepper extract (95% of piperine) to the liquid extract (15g of fresh turmeric rhizome extract on dry basis) of step (b) with continuous stirring;
d) homogenizing the mixture of step (c) at 2000 RPM for 30 minutes at 40oC to obtain viscous uniform slurry;
e) vaccum drying the slurry of step (d) at 80oC for 8 hours using Rotary Vacuum Dryer (RVD); and
f) milling the flakes by using communiting mill of step (e) to obtain free flowing powder (particle size >120 mesh) of self-dispersible Pepper extract composition.
Yield of fresh turmeric liquid extract: 200g

Example 18: Release profile of ‘Pepper extract Composition of Example 16’ Vs. ‘Standard unformulated pepper extract (95% Piperine)’
Solubility of piperine from ‘Pepper extract composition of Example 16 (test composition)’ was done in phosphate buffer 6.8 in comparison with standard unformulated pepper extract (95% Piperine). 250mg each of each sample was added into 400ml of 6.8 buffer in separate beakers kept in water bath at the temperature of 37°C with continuous stirring at 50 rpm. Samples were collected at regular intervals of 0, 1, 2, 3, 4 and 5 hrs and filtered using 0.22µm micro filter. The absorbance of the read at 343 nm using UV-Spectrophotometer. Absorbance over time graph is given in Figure 4. Increased absorbance corresponds to the increased solubility of piperine from the composition. This test clearly proves that the test composition has superior solubility over unformulated extract.

Example 19: Comparative self-dispersion profile of ‘Pepper extract composition of Example 16’ vis-à-vis ‘Standard unformulated pepper extract’
A comparative self-dispersion study was carried out between the ‘Composition of Example 16 (Test product)’ and ‘Standard unformulated Pepper extract (Reference product)’. The dispersion profile is given in Figure 5. The result shows that the ‘Test product’ dispersed easily without any mechanical stirring whereas the ‘Standard unformulated Pepper extract’ was non-dispersible as it was floating on top of the water.
Example 20: Pepper Extract Composition
Sr. No. Ingredients Quantity
1. Pepper extract (Standardized to 95% ) 80g
2. Fresh turmeric rhizome extract (on dry basis) 20g
Total 100g

Example 21: Process for preparation of Pepper Extract Composition of Example 20
a) Washing 300g of fresh turmeric rhizome with RO water followed by extratction using low speed screw extruder with 0.5mm to 1mm mesh to separate the liquid extarct and filtering the extract with 100-500 micron filter to obtain the bio-enhancing/self-dispering agent;
b) heating the fresh turmeric liquid extract obtained in step (a) for 30 minutes at 40oC with continuous stirring using a homogenizer;
c) slowly adding 80g of pepper extract (95% of piperine) to the liquid extract (20 g of fresh turmeric rhizome extract) of step (b) with continuous stirring;
d) homogenizing the mixture of step (c) at 2000 RPM for 30 minutes at 40oC to obtain viscous uniform slurry;
e) vacuum drying the slurry of step (d) at 80oC for 8 hours using Rotary Vacuum Dryer (RVD); and
f) milling the flakes by using communiting mill of step (e) to obtain free flowing powder (particle size >120 mesh) of self-dispersible Pepper extract composition.
Yield of fresh turmeric liquid extract: 200g

Example 22: Coenzyme Q10 Composition
Sr. No. Ingredients Quantity
1. Coenzyme Q10 (Standardized to 99%) 23g
2. Ascorbic acid 4g
3. Fresh turmeric rhizome extract (on dry basis) 73g
Total 100g

Example 23: Process for preparation of Coenzyme Q10 Composition of Example 22
a) Washing 1000g of fresh turmeric rhizome with RO water followed by exatraction using low speed screw extruder with 0.5mm to 1mm mesh to separate the liquid extract and filtering the extract with 100-500 micron filter to obtain the bio-enhancing/self-dispering agent;
b) heating the fresh turmeric liquid extract obtained in step (a) for 30 minutes at 60oC with continuous stirring using a homogenizer;
c) adding 23g of Coenzyme Q10 (standardized to 99%) to the liquid extract (73g of fresh turmeric rhizome extract on dry basis) of step (b) followed by adding 4g of ascorbic acid with continuous stirring;
d) homogenizing the mixture of step (c) at 2000 RPM for 30 minutes at 40oC to obtain viscous uniform slurry;
e) vacuum drying the slurry of step (d) at 50oC for 8 hours using Rotary Vacuum Dryer (RVD); and
f) milling the flakes by using communiting mill of step (e) to obtain free flowing powder of self-dispersible Coenzyme Q10 composition.
Yield of fresh turmeric extract liquid: 730g

Example 24: Comparative self-dispersion profile of ‘Coenzyme Q10 Composition of Example 22’ vis-à-vis ‘Standard unformulated Coenzyme Q10 extract’
A comparative self dispersion study was carried out between the ‘Composition of Example 22 (Test product)’ and ‘Standard unformulated Coenzyme Q10 Extract (Reference product)’. The dispersion profile is given in Figure 6. The result shows that the ‘Test product’ dispersed easily without any mechanical stirring whereas the ‘Standard unformulated Coenzyme Q10 extract’ was non-dispersible as it was floating on top of the water.
Example 25: Palmitoylethanolamide Composition
Sr. No. Ingredients Quantity
1. Palmitoylethanolamide 85g
2. Fresh turmeric rhizome extract (on dry basis) 15g
Total 100g

Example 26: Process for preparation of Palmitoylethanolamide Composition of Example 25
a) Washing 200g of fresh turmeric rhizome with RO water followed by exatraction using low speed screw extruder with 0.5mm to 1mm mesh to separate the liquid extarct, and filtering the extract with 100-500 micron filter to obtain the bio-enhancing/self dispering agent;
b) heating the fresh turmeric liquid extract obtained in step (a) for 30 minutes at 60oC with continuous stirring using a homogenizer;
c) adding 85g of palmitoylethanolamide to the liquid extract (15g of fresh turmeric rhizome extract on dry basis) of step (b) with continuous stirring;
d) homogenizing the mixture of step (c) at 2000 RPM for 30 minutes at 40oC to obtain viscous uniform slurry;
e) vaccum drying the slurry of step (d) at 60oC for 8 hours using Rotary Vacuum Dryer (RVD); and
f) milling the flakes by using communiting mill of step (e) to obtain free flowing powder (particle size >120 mesh) of self-dispersible palmitoylethanolamide composition.
Yield of fresh turmeric liquid extract: 150g

Example 27: Berberine Extract Composition
Sr. No. Ingredients Quantity
1. Berberine extract (Standardized) 50g
2. Fresh turmeric rhizome extract (on dry basis) 50g
Total 100g

Example 28: Process for preparation of Berberine Extract Composition of Example 27
a) Washing 600g of fresh turmeric rhizome with RO water followed by extratction using low speed screw extruder with 0.5mm to 1mm mesh to separate the liquid extarct and filtering the extract with 100-500 micron filter to obtain the bio-enhancing/self-dispering agent;
b) heating the fresh turmeric liquid extract obtained in step (a) for 30 minutes at 60oC with continuous stirring using a homogenizer;
c) slowly adding 50g of berberine extract to the liquid extract (50g of fresh turmeric rhizome extract) of step (b) with continuous stirring;
d) homogenizing the mixture of step (c) at 2000 RPM for 30 minutes at 40oC to obtain viscous uniform slurry; and
e) vacuum drying the slurry of step (d) at 40oC for 8 hours using Rotary Vacuum Dryer (RVD); and
f) milling the flakes by using communiting mill of step (e) to obtain free flowing powder of self-dispersible berberine extract composition.
Yield of fresh turmeric liquid extract: 500g

Example 29: Vitamin D Composition
Sr. No. Ingredients Quantity
1. Vitamin D 80g
2. Fresh turmeric rhizome extract (on dry basis) 20g
Total 100g

Example 30: Process for preparation of Vitamin D Composition of Example 29
a) Washing 300g of fresh turmeric rhizome with RO water followed by exatraction using low speed screw extruder with 0.5mm to 1mm mesh to separate the liquid extarct, and filtering the extract with 100-500 micron filter to obtain the bio-enhancing/self dispering agent;
b) heating the fresh turmeric liquid extract obtained in step (a) for 30 minutes at 60oC with continuous stirring using a homogenizer;
c) adding 80 g Vitamin D to the liquid extract (20g of fresh turmeric rhizome extract on dry basis) of step (b) with continuous stirring;
d) homogenizing the mixture of step (c) at 2000 RPM for 30 minutes at 40oC to obtain viscous uniform slurry;
e) vaccum drying the slurry of step (d) at 60oC for 8 hours using Rotary Vacuum Dryer (RVD); and
f) milling the flakes by using communiting mill of step (e) to obtain free flowing powder of self-dispersible Vitamin D composition.
Yield of fresh turmeric liquid extract: 200g
,CLAIMS:1. A composition for enhancing the bioavailability of phytochemicals comprises;
a) phytochemical selected from the group consisting of carotenoids, stilbenoid, isoflavones, terpenes, isoquinoline alkaloids, phenolic compounds, saponins, flavonoids, quinones, fatty acids and their derivatives either alone or mixtures thereof;
and
b) bio-enhancing agent/self-dispersing agent derived from extract of fresh plant parts selected from Curcuma longa (Turmeric), Beta vulgaris (Beetroot), Solanum tuberosum (Potato), Aloe barbadensis (Aloe vera) Daucus carota (Carrot), Mangifera indica (Mango), Manihot esculenta (Tapioca) and Cocos nucifera (Coconut) either alone or mixtures thereof.
2. The composition as claimed in claim 1, wherein the phytochemical are selected from carotenoids such as Lutein, Zeaxanthin, Lycopene, astaxanthin, beta-carotene; isoquinoline alkaloids such as berberine; cannabinoids, stilbenoid such as resveratrol; isoflavones such as genistein; coenzyme Q10, Palmitoylethanolamide (PEA), Piperine, boswellic acids, Chlorogenic acids, Silymarin, silibinin, Catechin, Gingerols, Shogaols, ellagic acid, Quercitin, caffeine, caffeic acid derivatives, Iron, calcium, Ecdysteroids/ecdysterone, Rosavins, Salidroside, Curculigosides Omega-3-fatty acids, Echinasea, Gymneric acids, S-Allyl-Cystein, Melatonin, Forskolin, Huperzine, Hypericin, hyperforin, Phytoestrogens, Ginsenosides, Valerenic acid, Vitamin D, Vitamin E, Menthol and Theacrine.
3. The composition as claimed in claim 1, wherein the fresh plant parts are selected from rhizomes of Curcuma longa (turmeric), taproots of Beta vulgaris (beet root), tubers of Solanum tuberosum (potato), leaf of Aloe barbadensis (aloe vera), taproots of Daucus carota (Carrot), fruits of Mangifera indica (Mango), roots of Manihot esculenta (Tapioca) and fruits of Cocos nucifera (Coconut).
4. The composition as claimed in claim 1 to 3, wherein the phytochemicals preferably includes lutein, astaxanthin, piperine, cannabinoids, boswellic acid, coenzyme Q10, palmitoylethanolamide, berberine and vitamin D; and bio-enhancing agents/self-dispersing agents preferably includes rhizomes of Curcuma longa (Turmeric), taproots of Beta vulgaris (Beet root) and tubers of Solanum tuberosum (Potato).
5. The composition as claimed in claim 1 to 4, wherein the phytochemicals are present in an amount ranging from 5% to 95% and bio-enhancing agents/self-dispersing agents are present in an amount ranging from 5% to 95% of the total composition.
6. The composition as claimed in claim 1 to 5, wherein the composition is formulated into dosage forms such as tablets, capsules, pills, solutions, paste, lozenges, instant mixes, and beverages.
7. The composition as claimed in claim 1, wherein the extract from fresh plant parts act as self-dispersing agent to enhance the bioavailability of phytochemicals, minerals and vitamins such as Iron and Vitamin D.
8. A process for preparation of composition for enhancing the bioavailability of phytochemicals as claimed in claim 1 comprises the steps of;
a) Slicing the fresh rhizomes of? Curcuma longa, taproots of Beta vulgaris, tubers of Solanum tuberosum, leaf of Aloe barbadensis, taproot of Daucus carota (Carrot), fruit of Mangifera indica (Mango), root of Manihot esculenta (Tapioca) and fruit of Cocos nucifera (Coconut) either alone or mixtures thereof into small pieces and extracting the fresh extract using low rpm screw extruder with 0.5mm to 1mm mesh/filter press to obtain the extract of bio-enhancing agent/self-dispersing agent;
b) filtering the extract of step (a) using using 100-500 micron filter to remove sedimentable particles followed by heating the extract for 30 minutes at 30 to 60oC with continuous stirring using a homogenizer;
c) adding phytochemicals selected from the group consisting of carotenoids, stilbenoid, isoflavones, terpenes, isoquinoline alkaloids, saponins, flavonoids, quinones, fatty acids and their derivatives either alone or mixtures thereof to the extract of step (b); and
d) homogenizing the mixture of step (c) at 200 to 10000 RPM for 30 to 60 minutes at 25oC to 80oC followed by vaccum drying at 60oC to 85oC and powdering to obtain free-flowing powder (particle size >120 mesh) of self-dispersible composition.
9. A method of treating inflammatory disease, respiratory diseases, heart diseases, sexual diseases, cognitive diseases, eye diseases, skin disease and stess by administering therapeutically effective amount of composition as claimed in claims 1 to 6 to a subject in need thereof.
10. The composition as claimed in claims 1 to 6, wherein the composition is useful in treating inflammatory diseases, respiratory diseases, heart diseases, sexual diseases, cognitive diseases, eye diseases, skin diseases and stress.