WO2020213003A1

WO2020213003A1 - A composition of wheatgrass and process for preparation thereof

Info

Publication number: WO2020213003A1
Application number: PCT/IN2020/050335
Authority: WO
Inventors: Iqbal Singh KINGRA
Original assignee: Kingra Iqbal Singh
Priority date: 2019-04-19
Filing date: 2020-04-07
Publication date: 2020-10-22

Abstract

The present invention discloses a composition of wheatgrass juice as a food, drink, or dietary supplement, with wheatgrass as an active ingredient. More particularly, the invention relates to a stable and taste masked wheatgrass juice composition along with suitable excipients which retains all or most of the bioactive and phenolic components. The invention also provides various formulations and methods of preparing the same.

Description

A COMPOSITION OF WHEATGRASS AND PROCESS FOR PREPARATION

THEREOF

FIELD OF THE INVENTION

The present invention relates to a composition of wheatgrass juice as a food, drink, or dietary supplement, with wheatgrass as an active ingredient. More particularly, the invention relates to a stable and taste masked wheatgrass juice composition along with suitable excipients which retains all bioactive metabolites and phenolic components. The invention also relates to methods of preparing the wheatgrass formulations. The invention also provides various formulations and methods of preparing the same.

BACKGROUND OF THE INVENTION

Healthy diets are a key for good nutrition and necessary for a long and healthy life. Eating nutrient dense foods and balancing energy intake with the necessary physical activity to maintain a healthy weight is essential at all stages of life. Thus, to keep up with the increasing consumer demand for healthier eating options current trends in the food industry are moving towards convenient foods that can be consumed on the go with enhanced nutritional profile.

One of the main targets while making healthier products is to add ingredients to result in nutritionally-enhanced foods that provide health benefits beyond basic nutrition. Therefore, while selecting ingredients for healthier products, it is essential to consider the effect that they may have on processing and handling, and product quality and food safety.

Also, a critical parameter in manufacturing healthy foods is to make nutrient(s) more available by pushing the limits of inclusion in particular products to increase availability, while maintaining palatability. One important aspect of food consumption that the health food industry tends to miss upon is the enjoyment and pleasure value imparted by various foods to the consumers. Many foods, in fact, are consumed almost entirely for the pleasure value they impart. The ever increasing consumer demand for the‘healthy alternative’ food has left many manufacturers in a quandary. Consumers do not expect the‘healthy’ alternative to taste the same as the standard recipe, consequently, discouraging many to switch to a health beneficial food due to its unpalatable characteristics. Simultaneously, appearance and aroma are two vital factors along with the taste and flavour in determining the acceptance of a food product. Many consumers associate food or beverages with superior aroma and an aesthetically appealable colour with high quality. On the other hand, foul smelling or washed out appearing products give the opposite impression. Thus, if food producers are able to successfully optimize the perceived sensory attributes of a product, it will automatically help increase the perceived value among consumers. Wheatgrass is a kind of grass belonging to Gramineae family with it’s above ground parts serving medicinal purposes. Further, the freshly sprouted leaves of the common wheat plant are used as a nutritional food, drink, or dietary supplement. It is rich in the content of vitamin A, vitamin C, vitamin E, iron, calcium, magnesium and amino acids. It is also commonly used for a variety of conditions including inflammatory bowel syndrome, diabetes, high cholesterol, and many more problems related to blood and can be taken as a health drink.

Wheatgrass also has many of the most potent antioxidants known as carotenoids, which are known to prevent damage to DNA by preventing free radical induced mutations in the fundamental regulators of cell growth. Indeed, diets rich in antioxidants have been associated with longevity of life and with a decreased risk of many cancer types. Wheatgrass drinks are thus an important source of natural vitamins, antioxidants and phytochemicals that are often overlooked in the usual diet. The scientists have also observed that wheat-grass possesses the activity to prevent damage to cells from cancer causing chemicals. However, the odd unpalatable grassy odor and taste is being a major concern for its consumption.

Furthermore, with the passage of time, the aroma, appearance and taste of a food product also gets adversely affected, which in turn negatively impacts the consumption of the product. The natural products present are often prone to deterioration, especially during storage, leading to loss of active components, production of metabolites with no activity and, in extreme cases, production of toxic metabolites. This area needs to be addressed in order to determine the efficacy of the formulation. Hence, a prolonged stability is a desirable characteristic in a product to increase its consumption.

While many attempts were made to commercially preserve wheatgrass juice through various processes, not limited to forced air solar drying, sun drying, shade drying, solar drying with natural air draft, forced air shade drying, and vacuum drying processes, yet there have been difficulties in achieving wheatgrass juices and its products which would retain their nutritious values over a prolonged period of time. Furthermore, the elevated temperatures to which the product was exposed during such processing, resulted in products that were inconsistent in composition, had a poor flavor, and were diminished in nutrient assay, particularly showing a marked decrease in levels of viable enzymes. Thus, there have been many efforts for the modification in formulations of wheatgrass or method for the preparation of wheatgrass formulation to overcome the aforementioned problems. There are a number of documents that mention various compositions or formulations of wheatgrass or modification thereof.

WO1995006459 A1 relates to a composition containing wheat sprout juice and thyme oil. The composition is suitable for both cosmetic and pharmaceutical uses and it is preferably formulated as a cream preparation. The invention further relates to a process for producing the composition, and to a process for stabilizing wheat sprout juice or a composition containing wheat sprout juice and thyme oil.

CN101220387A relates to a wheat grass protein polypeptide extraction technique. The invention adopts a biological enzymolysis method for the extraction and preparation of wheat grass protein and adopts a two-step enzymolysis method; the cellulase is firstly adopted to damage the cell walls and other fibrous materials in the wheat grass, which is conducive to the dissolution and the action of the protein, thus the invention cannot only improve the utilization ratio of the protein to lead the utilization ratio of the protein to achieve more than 90 percent, but also can solve the solubility and the grass taste problems of a traditional extraction technology.

US20100075009A1 relates to a method and apparatus for the rapid preparation of frozen fruit and vegetable juices into a liquid form and in particular to a method and apparatus to increase the surface area of the frozen products during preparation.

CN102415472B relates to a process for preparing frozen drinks of wheat and fresh ginger juice, said frozen drinks comprising 30 to 40 parts by weight of wheat juice, 5 to 20 parts by weight of fresh ginger, sweet substance 10 to 30 parts by weight, stabilizers 0.05 to 0.5 parts by weight, 0.1 to 0.5 parts by weight of an acidity regulator.

US5820916 discloses a method for growing and preserving nutrients in plant material, particularly wheatgrass, which produces a nutritional supplement for humans and non-human animals having optimally high enzyme, mineral, and trace mineral contents, as well as a minimum protein content of 40%.

KR20120022211 A discloses a composition containing wheatgrass extract for preventing and treating diabetes. The wheatgrass extract is prepared by freeze-drying, adding purified water to wheatgrass powder, and extracting at 2-5°C for 12-36 hours.

US20140308377A1 relates to a pharmaceutical composition and a dietary supplement for treating and preventing obesity, containing a wheatgrass extract as an active ingredient.

CN103314997B discloses a wheatgrass soilless cultivation nutrient solution, which is the technical solution of the following components: calcium nitrate tetrahydrate, potassium nitrate, ammonium dihydrogen phosphate, magnesium sulfate heptahydrate, ammonium nitrate, boric acid, manganese sulfate, seven zinc sulfate, ammonium molybdate, copper sulfate heptahydrate, ferric edetate disodium, yeast hydrolyzate, chitosan, humic acid and sodium selenite. The cultivation nutrient solution also contains a number of amino acids, glutathione, glucans, nucleic acids, chitosan sugar, humic acid and selenium.

Wheatgrass has many nutritional advantages, but there are several disadvantages in the existing preparation and preservation methods due to which, wheatgrass has not been widely used. One such disadvantage is that wheatgrass juice or extract starts losing its nutrient potency almost immediately after the cutting or extraction process begins. Also, the wheatgrass juice has a grassy odor and taste which discourages its consumption. Currently known processes for producing a sterile juice include treatment with heat, which in turn results in loss of the bioavailable vitamins and other micro nutrients and bioactive components. Accordingly, there exists an unmet need of providing pleasant tasting wheatgrass juice or drink which retains all bioactive components of wheatgrass over a prolonged period of time. There also exists a need for a process for preparing pleasant tasting wheatgrass juice or drink which retains all bioactive components of wheatgrass over a prolonged period of time, which avoids using a heat process, and also retains most of the bioactive compounds, phenolic components and vitamins, from the wheatgrass.

Therefore, the inventor(s) of the present invention have endeavored to find the effective way to use the wheatgrass composition as a food, drink, or dietary supplement in an economic and effective way by providing a novel stable wheatgrass composition with taste and aesthetics appealable to a consumer, even over a prolonged period of time, and a process for eliminating odd unpalatable grassy odor and taste of wheatgrass juice for user- compliance, and retaining most of the bioactive components in high amounts.

OBJECTIVES OF THE INVENTION

An object of the present invention is to provide a formulation of wheatgrass juice.

Another object of the present invention is to provide a process for preparation of a formulation of wheatgrass juice composition for oral consumption. Yet another object of the present invention is to provide a process for eliminating odd unpalatable grassy odor of wheatgrass from its juice for the preparation of various formulations of wheatgrass juice.

A preferred object of the present invention is to provide a stable composition of wheatgrass juice by retaining most of the bioactive compounds/components and phenolic components during and after the manufacturing process for a long period of time. It is yet another object of the invention to provide a process for eliminating odd unpalatable grassy odor of wheatgrass from its juice, which does not require addition of additives to eliminate or mask the unpalatable odor.

It is yet another object of the invention to provide a process for eliminating odd unpalatable grassy odor of wheatgrass from its juice by using hollow fiber filter so as to retain all or most of the bioactive components of the juice.

It is yet another object of the invention to provide various pharmaceutical, veterinary, food, drink, functional drink, nutraceutical, ayurvedic, or dietary supplement, using wheatgrass juice of the present invention as a base additive/ingredient.

SUMMARY OF THE INVENTION

The present invention relates to a taste masked stable formulation useful for oral consumption as pharmaceutical, veterinary, food, drink, functional drink, nutraceutical, ayurvedic, or dietary supplement, wherein the formulation comprises of an active amount of wheatgrass juice and suitable excipients.

The present invention also describes a stable formulation useful as pharmaceutical, veterinary, food, drink, functional drink, nutraceutical, ayurvedic, or dietary supplement, the formulation comprising of an aqueous wheatgrass juice, wherein the wheatgrass juice is in the range of 5 to 98 % v/v, wherein the formulation optionally comprises of suitable excipients.

The present invention also relates to a taste masked stable carbonated formulation consisting of: (a) 5 to 98 % v/v wheatgrass juice; (b) carbon dioxide in a concentration ranging from greater than one up to five gas volume of carbon dioxide; (c) 0.1 to 1 % w/v acidulants; (d) suitable excipients; and wherein the pH of the formulation ranges between 3 and 6.

The present invention also provides a process for preparing taste masked stable wheatgrass juice which can be utilized for preparation of various formulations/compositions of wheatgrass. The process comprises of: (a) sorting of harvested wheatgrass; (b) washing wheatgrass; (c) cutting and/or chopping wheatgrass; (d) juicing the cut/chopped wheatgrass to obtain wheatgrass juice; (e) homogenizing the wheatgrass juice; (f) filtering the wheatgrass juice; (g) sterilizing the filtered wheatgrass juice to obtain taste masked stable wheatgrass juice; and (h) optionally freeze drying the sterilized wheatgrass juice to obtain freeze dried wheatgrass juice powder. In one feature of the invention, the sterilized wheatgrass juice obtained in step (g) can be utilized for immediate preparation of various formulations and compositions. In another feature of the invention, the freeze dried wheatgrass juice powder obtained in step (h) is stored in suitable containers under aseptic conditions for later use in preparation of various formulations and compositions.

The present invention also provides a process for preparation of a taste masked stable formulation, the process comprising of: (a) sorting of harvested wheatgrass; (b) washing of wheatgrass; (c) cutting and/or chopping wheatgrass; (d) juicing the cut/chopped wheatgrass to obtain wheatgrass juice; (e) filtering the wheatgrass juice to separate chlorophyll from wheatgrass juice; (f) optionally homogenizing the wheatgrass juice obtained in step (e); (g) optionally filtering the homogenized wheatgrass juice; (h) optionally sterilizing the filtered wheatgrass juice of step (e) or (g); (i) optionally adding chlorophyll obtained in step (e) to the wheatgrass juice of step (h); (j) adding suitable excipients to the wheatgrass juice of step (h), or (i) to obtain the taste masked stable formulation.

The present invention also describes a taste masked and stable formulation(s) containing wheatgrass juice as an essential ingredient, wherein said formulation is useful for enhancing the production of red blood cells, lowering blood pressure, enhancing immunity, restoring energy and vitality, detoxifying body, curing of anemia; and in preventing, and treating weight loss, cancer, graying of hair, and obesity in humans or mammals; and their use as an antioxidant, for removing free radicals and reducing inflammation, as an anti-ulcer as an anti- arthritic, and as an anti-inflammatory for humans or mammals.

DETAILED DESCRIPTION OF THE INVENTION

While the invention has been described and illustrated with reference to certain embodiments thereof, those skilled in the art will appreciate that various adaptations, changes, modifications, substitutions, deletions, or additions of procedures and protocols may be made without departing from the spirit and scope of the invention. The present invention can be more readily understood by reading the following detailed description of the invention and study of the included examples.

As used herein, the term“composition”, is intended to encompass an active ingredient comprising wheatgrass juice, and the other inert ingredient(s) (acceptable excipients). Such compositions, depending upon the context, are also synonymous with“formulation” and “dosage form”. These formulations containing wheatgrass juice may be prepared in any form, such as solid and liquid dosage form. The solid dosage form includes oral dosage form (powder, tablet, capsule, soft capsule, aqueous medicine, pill, powder, sachet, granule, effervescent tablets, lozenges, etc.) and liquid formulation include health drinks, soft drinks, solution, suspension, emulsion, carbonated beverages, still beverages, syrup, elixirs, juice cordials etc.

The composition of the present invention can also be in the form of pharmaceutical compositions or dosage forms/formulations, and also may be used alone or in appropriate association, as well as in combination with other pharmaceutically active compounds or their pharmaceutically acceptable salts. The desirable dose of the inventive composition varies depending on the condition and the weight of the subject, severity, drug form, route and period of administration, and may be chosen by those skilled in the art.

The term“excipient” or“suitable excipient” means a pharmacologically inactive component such as a diluent, lubricant, surfactant, carrier, or the like. The excipients that are useful in preparing a pharmaceutical composition are generally safe, non-toxic and are acceptable for human as well as veterinary pharmaceutical use. Reference to an excipient includes both one and more than one such excipient. Co-processed excipients are also covered under the scope of the present invention.

The present invention is directed to formulations of wheatgrass juice and a process for preparation thereof.

The present invention describes a formulation of wheatgrass juice having enhanced stability, resulting in a good shelf life for its products.

The present invention describes a formulation of wheatgrass juice with suitable excipients retaining all or most of the bioactive and phenolic components.

The present invention describes a formulation of wheatgrass juice which retains its nutritional potency over a prolonged period of time.

The present invention describes a formulation of wheatgrass juice which is used as a food, drink, or dietary supplement.

The present invention describes a formulation of wheatgrass juice which has anti- oxidant activity.

The present invention describes a formulation of wheatgrass juice which is used in the treatment of diabetes, cancer, and inflammation.

The present invention describes a formulation of wheatgrass juice which is taste masked composition with agreeable odor, appearance, and taste.

The present invention also discloses a process for preparation of a formulation of wheatgrass juice to result in a formulation which has good organoleptic characteristics and thus increases consumer acceptance and compliance. The present invention also discloses a process for preparation of a formulation of wheatgrass juice, wherein no heat is applied in the process.

The present invention also discloses a method for the preparation of formulation of wheatgrass juice, wherein most of the bioactive components are retained in high amounts.

The present invention advantageously provides a stable composition of wheatgrass juice by retaining most of the bioactive compounds and phenolic components of wheatgrass.

In one embodiment, the present invention is directed to formulation of wheatgrass juice and a process for eliminating odd unpalatable grassy odor of wheatgrass juice for the preparation of formulation of wheatgrass juice. In one embodiment, the present invention relates to a formulation of wheatgrass juice retaining all bioactive and phenolic components of wheatgrass.

In one embodiment, the formulation of wheatgrass juice has enhanced stability which allows for retaining of pleasant smell, appearance and taste over a prolonged period of time.

In one embodiment, the formulation of wheatgrass juice has enhanced stability which allows for retention of nutritional value of the wheatgrass composition over long time duration.

In one embodiment, the formulation of wheatgrass juice is used as an antioxidant for removing free radicals and reducing inflammation, as an anti-ulcer, anti -arthritic, and an anti- inflammatory.

In one embodiment, the formulation of wheatgrass juice is a taste masked formulation. In one embodiment, the present invention discloses a formulation of wheatgrass juice with enhanced stability.

In a preferred embodiment, the formulation of wheatgrass juice is a taste masked stable formulation.

In one embodiment, the taste masked stable formulation is useful for oral consumption as pharmaceutical, veterinary, food, drink, functional drink, nutraceutical, ayurvedic, or dietary supplement, wherein the formulation comprises of an active amount of wheatgrass juice and suitable excipients.

In one embodiment, the active amount of wheatgrass juice in the formulation is present in the range of 5 to 98 % v/v.

In one embodiment, the excipients are selected from acceptable pharmaceutical, veterinary, food, drink, functional drink, nutraceutical, ayurvedic, or dietary supplement grade excipients. In one embodiment, the wheatgrass juice is obtained from wheatgrass of Gramineae family and the like, wherein the wheatgrass is cultivated post germination for a period of 8 to 35 days at a temperature in the range of about -4°C to 30°C. In a preferred embodiment, the wheatgrass is cultivated post germination for a period of 8 to 25 days at a temperature in the range of about 10°C to 30°C. In one embodiment, the pharmaceutical, veterinary, food, drink, functional drink, nutraceutical, ayurvedic, or dietary supplement is provided as a solid dosage form or a liquid dosage form.

The present invention also provides a stable formulation useful as pharmaceutical, veterinary, food, drink, functional drink, nutraceutical, ayurvedic, or dietary supplement, the formulation comprising of an aqueous wheatgrass juice, further comprising suitable excipients, wherein the wheatgrass juice is in the range of 5 to 98 % v/v.

In a preferred embodiment, the formulation of wheat grass juice is a stable formulation.

In one embodiment, the stable formulation is useful as pharmaceutical, veterinary, food, drink, functional drink, nutraceutical, ayurvedic or dietary supplement, the formulation comprising of an aqueous wheatgrass juice, wherein the wheatgrass juice is in the range of 5 to 98 % v/v, wherein the formulation optionally comprises of suitable excipients.

In one embodiment, the stable formulation is useful as pharmaceutical, veterinary, food, drink, functional drink, nutraceutical, ayurvedic, or dietary supplement, the formulation consisting of an aqueous wheatgrass juice, wherein the wheatgrass juice is in the range of 5 to 98 % v/v.

In a preferred embodiment, the formulation of wheatgrass juice is a taste masked stable carbonated formulation consisting of:

(a) 5 to 98 % v/v wheatgrass juice;

(b) carbon dioxide in a concentration ranging from greater than one up to five gas volume of carbon dioxide;

(c) 0.1 to 1 % w/v acidulants;

(d) suitable excipients; and

wherein the pH of the formulation ranges from between 3 and 6.

In a preferred embodiment, the taste masked stable carbonated formulation comprises of carbon dioxide in a concentration ranging from greater than 2 to 5 gas volume.

In one embodiment, the suitable excipient comprise of:

(a) 0 to 94% v/v water; (b) 0 to 1% w/v acidulants;

(c) 0 to 2% w/v preservatives;

(d) 0 to 1% w/v sweetners;

(e) 0 to 1 % w/v stabilizers;

(f) 0 to 0.5 % w/v flavors;

(g) 0 to 0.5 % w/v colors; and

(h) 0 to 25 % w/v sugar,

wherein the excipient(s) are present either alone or in an appropriate combinations thereof.

The present invention also describes a process for preparing wheatgrass juice.

In one embodiment, the present invention describes a process for preparing wheatgrass juice, wherein no heat is applied during the process and hence, no damage is done to the active constituents of the wheatgrass.

The present invention also provides a process for preparing stable wheatgrass juice which can be utilized for preparation of various formulations/compositions of wheatgrass. The process comprises of:

(a) sorting of harvested wheatgrass;

(b) washing wheatgrass;

(c) cutting and/or chopping wheatgrass;

(d) juicing the cut/chopped wheatgrass to obtain wheatgrass juice;

(e) homogenizing the wheatgrass juice;

(f) filtering the wheatgrass juice;

(g) sterilizing the filtered wheatgrass juice to obtain stable wheatgrass juice; and

(h) optionally freeze drying the sterilized wheatgrass juice to obtain freeze dried wheatgrass juice powder.

In one feature of the invention, the sterilized wheatgrass juice obtained in step (g) is utilized for immediate preparation of various formulations and compositions. In another feature of the invention, the freeze dried wheatgrass juice powder obtained in step (h) is stored in suitable containers under aseptic conditions for later use in preparation of various formulations and compositions.

The present invention also provides a process for preparation of a taste masked stable formulation, the process comprising of: (a) sorting of harvested wheatgrass;

(h) washing of wheatgrass;

(c) cutting and/or chopping wheatgrass;

(d) juicing the cut/chopped wheatgrass to obtain wheatgrass juice;

(e) filtering the wheatgrass juice to separate chlorophyll from wheatgrass juice;

(f) optionally homogenizing the wheatgrass juice obtained in step (e);

(g) optionally filtering the homogenized wheatgrass juice;

(h) optionally sterilizing the filtered wheatgrass juice of step (e) or (g);

(i) optionally adding chlorophyll obtained in step (e) to the wheatgrass juice of step (h);

(j) adding suitable excipients to the wheatgrass juice of step (h), or (i) to obtain the taste masked stable formulation.

In a further preferred feature of the present invention, the process for preparation of a taste masked stable formulation comprises of:

(a) sorting of harvested wheatgrass;

(b) washing of wheatgrass;

(c) cutting and/or chopping wheatgrass;

(d) juicing the cut/chopped wheatgrass to obtain wheatgrass juice;

(f) optionally homogenizing the wheatgrass juice obtained in step (e);

(g) optionally filtering the homogenized wheatgrass juice;

(h) optionally sterilizing the filtered wheatgrass juice of step (e) or (g);

(i) adding chlorophyll obtained in step (e) to the wheatgrass juice of step (h);

(j) adding suitable excipients to the wheatgrass juice of step (h) or (i) to obtain wheatgrass formulation;

(k) homogenizing the formulation; and

(l) sterilizing the formulation of step (k) to obtain the taste masked stable formulation.

In a preferred feature of the present invention, the washing of wheatgrass is performed multiple times, preferably comprising 2 to 5 washings. Washing is conducted using water selected from RO water, mineral water (natural), naturally carbonated water, Capacitive Deionized Water or any combination thereof. In a more preferred embodiment, the washing water contains a disinfectant selected from chlorine, hydrogen peroxide, or peracetic acid, in suitable concentrations.

In another preferred feature of the invention, the juicing of cut/chopped wheatgrass is conducted by centrifugation or cold pressing. The cold pressing can be selected from hydraulic pressing or screw pressing, or any other method known to a person ordinarily skilled in the art.

In another preferred feature of the invention, the filtering is performed using a filter selected from the group consisting of hollow fiber membrane filter, ceramic filter, sparkler filter, filter press, nuesch filter, candle filter. The suitable filters can be used either alone or in any suitable combination thereof. The pore size of the filters is in the range of 5 to 15 microns.

In a preferred feature of the invention, the filtering step to separate chlorophyll from wheatgrass juice is performed using a hollow fiber membrane filter having a pore size of about 0.2 microns.

In a further preferred feature of the invention, the homogenizing is carried out at about 200 to 2000 bar. The homogenizing step can be carried out in multiple passes depending upon the yield of grass.

In yet other preferred feature of the invention, the sterilizing is carried out by sterile filtration. The sterile filtration is carried out using a nylon film filter, having a pore size of 0.2 microns.

In a further preferred embodiment of the present invention, the chlorophyll when added to wheatgrass juice for making various formulations is added in an amount of 0.5 to 20 % w/v of the wheatgrass juice.

The process for preparation of wheatgrass juice and various formulations and compositions of wheatgrass juice is carried out in a controlled environment having a temperature in the range of 1 to 5°C.

In a preferred embodiment, the process further comprises a primary filtration step of filtering the wheatgrass juice with a filter to remove undesired particles. Preferably, the wheatgrass juice is filtered with a filter of about 5 to 15 microns in primary filtration. In a preferred embodiment, the juice is filtered with a filter of about 10 microns. In a preferred embodiment, the filter in the primary filtration is carried out using candle filter, or any other suitable filter known to a person ordinarily skilled in the art. In one embodiment, in the sterile filtration, the filter has a pore size in the range of 0.1 to 0.5 micron. In a preferred embodiment of sterile filtration, the filter has a pore size of 0.2 micron. Sterile filtration is preferably carried out using nylon filter. Preferably, absolute nylon filter of pore size ranging from 0.2 to 0.45 micron is used for sterile filtration.

In a preferred embodiment, the process further comprises of drying the sterile filtered wheatgrass juice to obtain a powder.

In one embodiment, the drying is done by, but not limited to, spray drying, freeze drying, tray drying, sun or solar drying, drum drying, osmotic drying, microwave drying, convection drying, lyophilizing, vacuum drying or suitable combination thereof.

In a preferred embodiment, the filtration is done using a hollow fiber membrane filter made of Polyvinylidene fluoride (PVDF). In another embodiment, the filtration is done with hollow fiber membrane filter made up of Polyvinylidene fluoride (PVDF) or some other same/similar type of material which neutralizes and blands the grassy taste of wheatgrass juice while retaining all the good values of the juice.

In a preferred embodiment, the wheatgrass juice obtained by the process of the present invention is stable and does not have a grassy odor.

In another preferred embodiment, the wheatgrass is used in the process for preparing the formulation of wheatgrass juice. In yet another preferred embodiment, the formulation of wheatgrass juice is the taste masked formulation. In another preferred embodiment, the formulation of wheatgrass juice is the stable formulation.

During the homogenizing step of the process unfilterable part of juice is homogenized under a pressure of 200 to 2000 bar to break them down. The homogenizing is done once or twice, based upon the requirement or yield of juice to pass from the filter.

The passing of juice through the filter during sterile filtration results in production of a juice which is sterile, i.e., free from microbes. Since the juice is filtered and not heated in the present process, the process allows the juice to retain its inherent micro nutrients and essential minerals.

In a preferred embodiment, the present invention provides a process for preparing stable wheatgrass juice, wherein the process comprises of:

(a) sorting of harvested wheatgrass;

(b) washing wheatgrass with RO water, optionally containing a disinfectant selected from chlorine, hydrogen peroxide or peracetic acid, and repeating the washing step at least thrice; (c) cutting and/or chopping the wheatgrass so obtained;

(d) juicing the cut/chopped wheatgrass by centrifugation or screw pressing to obtain wheatgrass juice;

(e) homogenizing the wheatgrass juice at about 200 to 2000 bar;

(f) filtering the wheatgrass juice to obtain wheatgrass juice having reduced or no grassy odour;

(g) sterilizing the filtered wheatgrass juice with nylon membrane filter having a pore size of about 0.2 microns, to obtain stable wheatgrass juice; and

(h) optionally freeze drying the sterilized wheatgrass juice to obtain freeze dried wheatgrass juice.

In one preferred embodiment, the sterilized wheatgrass juice obtained in step (g) is utilized for immediate preparation of various formulations and compositions. In another embodiment of the invention, the freeze dried wheatgrass juice obtained in step (h) is stored in suitable containers under aseptic conditions for later use in preparation of various formulations and compositions hi a preferred embodiment, the process of the present invention further comprises of adding carbon dioxide to the stable wheatgrass juice obtained by the above process to obtain a taste masked stable carbonated formulation.

In a further preferred embodiment, the present invention provides a process for preparation of a taste masked stable formulation, wherein the process comprises of:

(a) sorting of harvested wheatgrass;

(b) washing of wheatgrass with RO water, optionally containing a disinfectant selected from chlorine, hydrogen peroxide or peracetic acid, and repeating the washing step at least thrice;

(c) cutting and/or chopping the wheatgrass so obtained;

(e) filtering the wheatgrass juice with hollow fiber membrane filter having pore size of about 0.2 microns to separate chlorophyll from wheatgrass juice;

(f) optionally homogenizing the wheatgrass juice obtained in step (e) at 200 to 2000 bar;

(g) optionally filtering the homogenized wheatgrass juice with hollow fiber membrane filter having pore size of about 0.2 microns; (h) optionally sterilizing the filtered wheatgrass juice of step (e) or (g) with nylon membrane filter having a pore size of about 0.2 microns, to obtain sterilized wheatgrass juice;

(i) optionally adding chlorophyll obtained in step (e) to the wheatgrass juice of step (h), in an amount of about 0.5 to 20 % w/v of the wheatgrass juice; and

In a still further preferred embodiment of the present invention, the process for preparation of a taste masked stable formulation comprises of:

(a) sorting of harvested wheatgrass;

(b) washing of wheatgrass with RO water containing disinfectant selected from chlorine, hydrogen peroxide or peracetic acid, and repeating the washing step at least thrice;

(c) cutting and/or chopping the wheatgrass so obtained;

(d) juicing the cut/chopped wheatgrass by centrifugation to obtain wheatgrass juice;

(f) homogenizing the wheatgrass juice obtained in step (e) at about 200 to 2000 bar;

(g) filtering the homogenized wheatgrass juice with hollow fiber membrane filter having pore size of about 0.2 microns;

(h) optionally sterilizing the filtered wheatgrass juice of step (g) with nylon membrane filter having a pore size of about 0.2 microns, to obtain sterilized wheatgrass juice;

(i) adding chlorophyll separated in step (e) to the wheatgrass juice of step (g) or (h) in an amount of about 0.5 to 20 % w/v of the wheatgrass juice;

(j) adding suitable excipients to the wheatgrass juice of step (i) to obtain wheatgras s formulation ;

(k) homogenizing the formulation at about 200 to 2000 bar; and

(l) sterilizing the formulation of step (k) with nylon membrane filter having a pore size of about 0.2 microns, to obtain the taste masked stable formulation. In preferred embodiments, the whole process is carried out at chilling temperature, preferably between 1 to 5°C.

In a preferred embodiment, the above process further comprises of adding carbon dioxide to the taste masked stable formulation to obtain a taste masked stable carbonated formulation.

In one embodiment, the taste masked stable carbonated formulation comprises of gas in the range of 2 to 5 gas volume.

“Optional” or “optionally” means that the subsequently described event or circumstance may or may not occur, and that the description includes instances where said event or circumstance occurs and instances where it does not.

In one embodiment, the present invention describes a process for preparation of a formulation of wheatgrass juice, wherein the process involves no heat process and retains most, or more than 80% of the bio active compounds/components, phenolic components and vitamins, from the wheatgrass. Juicing of wheatgrass is an important step which involves the usual steps of harvesting and sorting the wheatgrass and pre-cooling at about 3°C. The aforementioned sorted samples are then subjected to washing and juicing in two stage process which involves no heat process and retains most, or more than 80%, of the bio active compounds, phenolic components and vitamins, from the wheatgrass. The process involves cutting of grass in smaller parts, and further chopping of the grass in an impeller blade system followed by jacketed centrifuge system which controls the temperature of the grass to 3°C to 5°C and helps to get juice from centrifuge with the principal of centrifugal force. The range of centrifuging bag may vary from 1 to 20 micron. In another embodiment, said juicing process may also be done using hydraulic press or using expeller.

Storage of the juice in the intermediate processing is done in an insulated tank under vacuum, which maintains the temperature of chilled juice ranging from 3°C to 5°C.

Such filtered juice of wheatgrass is directly used to prepare various compositions, formulations and/or beverages. In a preferred feature, the filtered juice is further processed by carbonation with addition of various types of flavors, extract and food additives to make a soft drink. The by-product of filter juice can also be used in various compositions.

In one embodiment, the present invention relates to taste masked composition of wheatgrass juice that has a palatable color, and appearance. In one embodiment of the present invention, the formulation of wheatgrass juice is a pharmaceutical composition, a nutraceutical composition, an ayurvedic composition, or a veterinary composition.

In one embodiment of the present invention, the formulation of wheatgrass juice is a part of food, drink, or dietary supplements.

Various drinks or other products are made with the formulation of wheatgrass juice or the wheatgrass juice as base, such as for soft drinks, still drinks, probiotic drinks, dairy products, frozen desserts, toothpaste, oral care products, extruded products, cosmetic, bakery and confectionary, reconstituted powder, spreads etc.

In an embodiment of the present invention, the formulation of wheatgrass juice or the wheatgrass juice is used in beverages (soft and still), oral care products, extruded products, confectionary and bakery, dairy products, cosmetic, and spreads.

The various compositions/formulations/products of wheat grass juice of the present invention are sterilised through sterile filtration. In a preferred feature to increase shelf life, the sterile filtration is performed using different pore size ranging from 0.1 micron filter to 0.5 micron sterile membrane to achieve sterile filtrate product which is free from micro flora, and improves the shelf life of product without involving heat process or giving any kind of treatment to the product.

In an embodiment of the present invention, retentate of filtered wheatgrass juice is used in soft drinks, still drinks, probiotic drinks, dairy products, meat products, food additives, frozen desserts, toothpaste, oral care products, extruded products, cosmetic, bakery and confectionary, dairy products, reconstituted powder, spreads and natural pigments etc.

In one embodiment of the present invention, the present invention discloses a formulation or composition of the wheatgrass juice, comprising: wheatgrass juice (fil tered/unfil tered) in range from 1 to 98% or preferably 1-95% or more preferably 5-98% v/v; sweeteners (natural and artificial); acidulants; preservatives; water; flavors, juices and concentrates; natural pigments and artificial food grade dyes; sugars; and stabilizers.

In an embodiment of the present invention, the composition of filter wheatgrass juice (5-98%) in soft drink comprises:

(a) wheatgrass juice according to the present invention;

(b) acidulants selected from, but not limited to, citric acid, malic acid, tri- sodium citrate, phosphoric acid, ascorbic acid, tartaric acid, and any combinations thereof; and (c) preservatives selected from, but not limited to, sodium benzoate, potassium sorbate, dimethyl dicarbonate, and combinations thereof.

It would be evident to a person skilled in the art that the preservatives can include other miscellaneous preservatives known in the art.

In an embodiment of the present invention, the water is present in range of 1-94% and is selected from but not limited to RO water, mineral water (natural), naturally carbonated water, Capacitive Deionized Water or any combination thereof.

In an embodiment of the present invention, the formulation of wheatgrass juice contains added CO: to preserve juice from getting oxidized after filtering the micro flora from sterile membranes which also gives a fizzy taste to drink and bubbly experience.

In an embodiment of the present invention, the formulation of wheatgrass juice has gas volume in the range of 1.5 to 5 gas volume.

In an embodiment of the present invention, the sweeteners in wheatgrass formulation is selected from the group consisting of table sugar (sucrose), maltose, fructose, dextrose, high fructose com syrup, invert sugar, honey, artificial sweeteners, natural sweeteners, other materials known to one of ordinary skill in the art, and any combination thereof.

In an embodiment of the present invention, the artificial sweeteners is selected from the group consisting of acesulfame potassium, aspartame, sucralose, saccharine, other materials known to one of ordinary skill in the art, and any combination thereof.

In an embodiment of the present invention, the natural sweeteners is selected from the group consisting of stevia, erythritol, and other sugar alcohol, agave syrup, de-ionized apple concentrate, brown sugar, molasses, cane sugar, beet root sugar, maple syrup, isomalt, monk fruit, dextrose or other materials known to one of ordinary skill in the art, and any combination thereof.

In an embodiment of the present invention, the sugar is selected, but not limited to, fructose, galactose, glucose, lactose, maltose, sucrose, xylose, and any combination thereof.

In an embodiment of the present invention, the stabilizers is selected from the group consisting of pectin, xanthum gum, guar gum, carboxymethyl cellulose, gum acacia, gellan gum or other gums, other materials known to one of ordinary skill in the art, and any combination thereof.

In an embodiment of the present invention, the flavors and colors is selected from the group consisting of all fruit concentrates, all veg concentrates, all fruit/veg. juices, all fruit/veg extract, all fruit/veg flavors, plant and herb extracts all fruits/veg powders, other materials known to one of ordinary skill in the art, and any combination thereof.

In an embodiment of the present invention, the flavors are nature identical or natural or artificial.

In an embodiment of the present invention, the colors and pigments/dyes are natural or artificial.

In an embodiment of the present invention, the ingredients used in the formulation or composition are water soluble.

Additionally, the present invention discloses a medium to grow wheatgrass in farming technology. In a preferred feature, the present invention provides growing of wheatgrass in special soil mixture having specific mineral content which act as growth promoters and special soil mixture which retains good amount of water and help in growing of wheatgrass with less water consumption In a preferred feature, the soil is combined with cocopeat to achieve the desired results. In another feature, the present invention provides growing of wheatgrass by hydroponics using water only, with cocopeat, with cocomat, with added nutrients either alone or in combinations thereof or by aeroponics method, or by conventional agricultural methods.

In an embodiment of the present invention, the growing cycle parameters for harvesting are measured on a Feekes scale, the value on scale for harvesting being of 5-7. The duration is usually about 8-35 days at ambient temperatures, which is usually around -4°C to 30°C.

In an embodiment of the present invention, the harvesting of wheatgrass is done, but not limited to, manually with knife or with rubber type cutter or with automated type scissors or with a combined type cutter.

In an embodiment of the present invention, the sorting of wheatgrass is performed by removal of weed or by removal of over and undergrown grass.

In an embodiment of the present invention, the pre-cooling of wheatgrass is performed at 5-10°C. This step is usually carried out to control respiration and field heat.

In an embodiment of the present invention, the transportation of wheatgrass is done at controlled temperatures in the range of 3°C to 5°C and at relative humidity (RH) of about 80% to 90%.

In an embodiment of the present invention, the water for washing is selected from the group consisting of RO water, ozonated water and water with added permitted disinfectants. In an embodiment of the present invention, the compositions or products of wheatgrass are stable for about 3 months to 2 year.

In a preferred embodiment, the products according to the present invention have a shelf-life of about 3 months in polyethylene terephthalate (PET) packaging materials, about 6 months in glass packaging materials and about 1 year in can containers.

The present invention further relates to a taste masked stable formulation containing wheatgrass juice as an essential ingredient, wherein the formulation is useful in enhancing the production of red blood cells, lowering blood pressure, enhancing immunity, restoring energy and vitality, detoxifying body, weight loss; and preventing and treating cancer, preventing graying of hair, curing of anemia in humans or mammals, and preventing and treating obesity in humans or mammals.

Some illustrative non-limiting examples of the present invention are described below.

Having described the invention with reference to certain preferred embodiments, other embodiments will become apparent to one skilled in the art from consideration of the specification. The invention is further defined by reference to the following examples describing in detail method for the preparation and testing of formulations of wheatgrass juice. It will be apparent to those skilled in the art that many modifications, both to materials and methods, may be practiced without departing from the scope of the invention. Following examples are set out to illustrate the invention and do not limit the scope of the present invention.

Some of the exemplary compositions /formulations of the present invention are described below:

Composition/F ormulation 1:

Composition/F ormulation 2:

General Process for preparation of the formulations of the present invention:

A process for preparing a wheatgrass juice comprising steps of: (a) harvesting and sorting wheatgrass; (b) pre-cooling at 3°C; (c) washing and chopping the wheatgrass; (d) centrifuging at 3-5°C; and (e) homogenizing at 200 to 2000 bar to obtain the juice.

In one embodiment the present invention describes a process for preparing a taste masked stable composition, comprising steps of: (a) cutting and juicing wheatgrass to obtain a wheatgrass juice; (b) sterilizing the wheatgrass juice obtained in step (a) by sterile filtration to obtain a sterile filtered wheatgrass juice; and (c) adding carbon dioxide to the sterile filtered wheatgrass juice of step (b) to obtain the taste masked stable composition.

Examples

It is understood that the foregoing examples are merely illustrative of the present invention. Certain modifications of the articles and/or methods employed may be made and still achieve the objectives of the invention. Such modifications are contemplated within the scope of the claimed invention.

Collection of Material: Wheatgrass for preparing the wheatgrass juice was collected from Barn Sahib, Himachal Pradesh.

Example 1

Example 2

Example 3

Example 4

Example 5

Example 6

Example 7

Example 8

Example 9

EXAMPLE 10: STABILITY STUDY

1. Stability study of Example 7:

The accelerated Shelf life study for the Example 7 was conducted for 60 Days. The parameters of the study are as follows:

• Parameter: Shelf Life, Days (at (i) 37°C and RH* 75%, and (ii) at 40°C and RH 80%)

• Test Result: 60 Days

*RH: Relative Humidity

The details of the analysis are tabulated in Table 1.

Table 1: Analysis Report of Example 7

U = Unobjectionable, O = Objectionable, NMT=not more than

2. Stability study of Example 8:

The accelerated Shelf life study for the Example 8 was conducted for 45 Days. The parameters of the study are as follows:

• Parameter: Shelf Life, Days ((i) at 37°C and RH* 75%, and (ii) at 40°C, and RH 80%)

• Test Result: 45 Days

*RH: Relative Humidity

The details of the analysis are tabulated in Table 2.

Table 2: Analysis Report of Example 8

U = Jnobiectionable ', O = Objectionable, NMT=not more than

3. Stability study of Example 9:

The accelerated Shelf life study for Example 9 was conducted for 48 Days. The parameters of the study are as follows:

• Parameter: Shelf Life, Days ((i) at 37°C and RH* 75% and (ii) at 40°C and RH

80%)

• Test Result: 48 Days

*RH: Relative Humidity The details of the analysis are tabulated in Table 3.

Table 3: Analysis Report of Example 9

U = Unobjectionable

EXAMPLE 11: QUALITATIVE/QUANTITATIVE CHEMICAL INVESTIGATION OF WHEATGRASS JUICE AND POWDER

The nutrients of the obtained wheatgrass juice and powder were assessed. The procedure followed and the results are tabulated below in Table 4.

Table 4: Nutrient Contents

HPLC method was performed for analysis of vitamins the wheatgrass juice and powder obtained in the present invention. The obtained results are tabulated below in Table 5. Table 5: Vitamin Contents

EXAMPLE 12: ANTIOXIDANT ACTIVITY OF WHEATGRASS JUICE AND

POWDER

Diphenyl -picryl-hydrazyl Assay (DPPH) to assess the antioxidant activity (In-vitro) of methanolic and water extract of obtained the wheatgrass juice powder was done. The exhibited antioxidant activity is tabulated in table 6.

Table 6: Antioxidant Activity of Wheatgrass Juice and Powder

Wheatgrass contains chemicals shown to have antioxidant and anti-inflammatory properties. The efficacy of wheatgrass in the management of bone and joint disorders is due to its powerful anti-inflammatory effect. Wheat grass juice has been used clinically to treat ulcerative colitis, aid breast cancer patients undergoing chemotherapy, as an antioxidant and use to cure many health issues. Currently the formulation of the present invention is undergoing different in-vitro and in-vivo anti-oxidant, anti-inflammatory and anti-cancer studies (animal studies) to evaluate said properties of the present invention.

While the invention has been described and illustrated with reference to certain particular embodiments thereof, those skilled in the art will appreciate that various adaptations, changes, modifications, substitutions, deletions, or additions of procedures and protocols may be made without departing from the spirit and scope of the invention. For example, effective dosages other than the particular dosages as set forth herein above may be applicable as a consequence of variations in responsiveness of the mammal being treated for any of the indications with the compounds of the invention indicated above. The specific pharmacological responses observed may vary according to and depending upon the particular active compounds selected or whether there are present pharmaceutical carriers, as well as the type of formulation and mode of administration employed, and such expected variations or differences in the res tills arc contemplated in accordance with the objects and practices of the present invention. It is intended, therefore, that the invention be defined by the scope of the claims which follow and that such claims be interpreted as broadly as is reasonable.

Claims

Claims:

1. A taste masked stable formulation useful for oral consumption as pharmaceutical, veterinary, food, drink, functional drink, nutraceutical, ayurvedic, or dietary supplement, wherein the formulation comprises of an active amount of wheat grass juice and suitable excipients.

2. The formulation as claimed in claim 1, wherein the active amount of wheatgrass juice in the formulation is present in the range of 5 to 98% v/v.

3. The formulation as claimed in claim 1, wherein the excipients are selected from acceptable pharmaceutical, veterinary, food, drink, functional drink, nutraceutical, ayurvedic or dietary supplement grade excipients.

4. The formulation as claimed in claim 1, wherein the wheatgrass juice is obtained from wheatgrass of Gramineae family and the like, wherein the wheatgrass is cultivated post germination for a period of 8 to 35 days at a temperature in the range of about - 4°C to 30°C.

5. The formulation as claimed in claim 1, wherein the pharmaceutical, veterinary, food, drink, functional drink, nutraceutical, ayurvedic, or dietary supplement is provided as a solid dosage form or a liquid dosage form.

6. The formulation as claimed in claim 5, wherein the solid dosage form is selected from powder, tablet, capsule, soft capsule, aqueous medicine, pill, sachet, granules, effervescent tablets, lozenges, and liquid dosage form can be functional drinks, soft drinks, solution, suspension, emulsion, carbonated beverages, still beverages, syrup, or elixirs.

7. A stable formulation useful as pharmaceutical, veterinary, food, drink, functional drink, nutraceutical, ayurvedic, or dietary supplement, the formulation comprising of an aqueous wheatgrass juice, wherein the wheatgrass juice is in the range of 5 to 98 % v/v, wherein the formulation optionally comprises of suitable excipients.

8. A taste masked stable carbonated formulation comprising of:

(a) 5 to 98 % v/v wheatgrass juice;

(b) carbon dioxide in a concentration ranging from greater than one up to five gas volume;

(c) 0.1 to 1 % w/v acidulants; and

(d) suitable excipients;

wherein the pH of the formulation ranges between 3 and 6.

9. The formulation as claimed in claims 7 or 8, wherein the suitable excipient comprise of:

(a) 0 to 94% v/v water

(b) 0 to 1% w/v acidulants;

(c) 0 to 2% w/v preservatives;

(d) 0 to 1% w/v sweetners;

(e) 0 to 1 % w/v stabilizers;

(f) 0 to 0.5 % w/v flavors;

(g) 0 to 0.5 % w/v colors; and

(h) 0 to 25 % w/v sugar,

10. A process for preparing a taste masked stable wheatgrass juice, the process comprising of:

(a) sorting of harvested wheatgrass;

(b) washing wheatgrass;

(c) cutting and/or chopping wheatgrass;

(d) juicing the cut/chopped wheatgrass to obtain wheatgrass juice;

(e) homogenizing the wheatgrass juice; and

(f) sterilizing the wheatgrass juice to obtain taste masked stable wheatgrass juice.

11. A process for preparing a taste masked stable formulation, the process comprising of:

(a) sorting of harvested wheatgrass;

(b) washing of wheatgrass;

(c) cutting and/or chopping wheatgrass;

(d) juicing the cut/chopped wheatgrass to obtain wheatgrass juice;

(f) optionally homogenizing the wheatgrass juice obtained in step (e);

(g) optionally filtering the homogenized wheatgrass juice;

(h) optionally sterilizing the filtered wheatgrass juice of step (g);

(i) optionally adding chlorophyll obtained in step (e) to the wheatgrass juice of step

(g) or (h); and

12. A process as claimed in claim 11, the process further comprising of adding carbon dioxide to obtain a taste masked stable carbonated formulation.

13. The process as claimed in claim 12, wherein the taste masked stable carbonated formulation comprises of carbon dioxide gas in the range of 1.5 to 5 gas volume.

14. The process as claimed in claim 10 or 11, wherein the filtering is carried out using a filter selected from hollow fiber membrane filter, ceramic filter, sparkler filter, filter press, nuesch filter, candle filter, or any suitable combination thereof.

15. The process as claimed in claim 14, wherein the filter has a pore size in the range of 0.1 to 10 micron or 0.1 to 0.5 micron.

16. The process as claimed in claim 10 or 11, wherein the sterilizing is carried out by sterile filtration using a nylon membrane filter having a pore size in the range of 0.1 to 0.5 micron.

17. A taste masked and stable formulation(s) containing wheatgrass juice as an essential ingredient, wherein the formulation is useful in enhancing the production of red blood cells, lowering blood pressure, enhancing immunity, restoring energy and vitality, detoxifying body, curing of anemia; and in preventing and treating weight loss, cancer, graying of hair, and obesity in humans or mammals.

18. Use of the formulation(s) as claimed in any of the preceding claims as an antioxidant for removing free radicals and reducing inflammation, anti-ulcer, anti-arthritic, and as an anti-inflammatory in humans or mammals.