DESC:FIELD
The present disclosure relates to an anti-oxidant and immune boosting formulation and a process for its preparation.
DEFINITIONS
As used in the present disclosure, the following terms are generally intended to have the meaning as set forth below, except to the extent that the context in which it is used indicates otherwise.
Antioxidantsare the substance(s) or compounds that can prevent or slow down the cell damages caused by free radicals (unstable molecules that the body produces as a reaction to environmental and other pressures). They are sometimes called “free-radical scavengers.”
High purity water is processed water of utmost purityobtained by using reverse osmosis, ultra-filtration, deionization, and UV treatment.
Meso dosing, here “Meso” can be referred as “Middle” or in between “Nutrients” and Dosing is supplementation of meso nutrients in small amounts which are involved in important metabolic functions of the body.
BACKGROUND
The background information herein below relates to the present disclosure but is not necessarily prior art.
Everyday human is subjected to a variety of toxins, radiations, and exposure which contribute to the formation of free radicals in the body. Free radicals are unstable molecules produced in the body as a reaction to environmental and other pressures. The free radical formation is a chain reaction wherein a first free radical takes an electron from a molecule, the molecule becomes the free radical in return, and this triggers a chain reaction. Ultimately, this cycle of free radical formation damages a living cell and results in many alterations in the body. Exposure to free radicals is unavoidable in today’s fast-paced world. Over the time free radicals, accumulate in human bodies and negatively affect on the same. Oxidative stress determines structure modifications and function modulation in nucleic acids, lipids and proteins. The imbalance between the oxidant species and the antioxidant defense system may trigger specific factor responsible for oxidative damages in the cell such asover expression of oncogenes, generation of mutagen compounds, promotion of atherogenic activity, and senile plaque occurrence or inflammation. This leads to serious diseases like cancer, neurodegeneration, cardiovascular diseases, diabetes, and kidney diseases.There are various energy drinks available in the market, however, there is always development required in this area to opt for a better result. Further, conventionalbeverageshave manydisadvantages such as minimum shelf life, less stability and the like.
Therefore, there is felt a need for a formulation which mitigates the drawbacks mentioned hereinabove.
OBJECTS
Some of the objects of the present disclosure, which at least one embodiment herein satisfies, are as follows.
An object of the present disclosure is to ameliorate one or more problems of the prior art or to at least provide a useful alternative.
An object of the present disclosure is to provide an anti-oxidant and immune boosting formulation.
Another object of the present disclosure is to provide a formulation that is devoid of free radicals and ensures a property of scavenging free radicals.
Still another object of the present disclosure is to provide a formulation in the form of a high oxygen radical absorbance capacity (ORAC) drink for good health andgivesahigh level of satiety.
Another object of the present disclosure is to provide a formulation that provides complete nutrition.
Yet another object of the present disclosure is to provide a formulation that is palatableand ensuresindividual’scompliance.
Yet another object of the present disclosure is to provide a process for the preparation of the anti-oxidant and the immune boosting formulation.
Another object of the present disclosure is to provide a formulation in the form of aseptic tetra pack for a ready to drink formulation that is stable and preserves the product characteristics with enhanced shelf life and is free from preservatives.
Yet another object of the present disclosure is to provide the acid brix ratio of the formulationwherein taste and palatability is enhanced by scientifically adjusting brix and acidity ratio for excellent uniformity and for compliance of the organoleptic properties of the formulation.
Other objects and advantages of the present disclosure will be more apparent from the following description, which is not intended to limit the scope of the present disclosure.
SUMMARY
The present disclosure relates to an anti-oxidant and immune boosting formulation. The formulation comprises a) anorange juice concentrate in an amount in the range of 5 wt% to 15 wt%; b) an emblica officinalis in an amount in the range of 1 wt% to 2 wt%; c) vitamins in an amount in the range of 0.01 wt% to 1.5 wt%; d) mineral salts in an amount in the range of 0.05 wt% to 1.5 wt%; e) citric acidin an amount in the range of 0.1 wt% to 1 wt%; f) at least one additivein an amount in the range of 80 wt% to 90 wt%; and q.s.water, wherein the amounts are in respect of the total amount of the components a) to f) and wherein a brix of the formulation is in the range of 12 % to 14% and an acidity of the formulation is in the range of 0.15 % to 0.3%.The ratio of the amount of water to the total amount of the components (a) to (f) is in the range of 5.5 wt% to 6.5 wt%.
The present disclosure further relates to a process for the preparation of the anti-oxidant and immune boosting formulation. The process comprises the step of mixing a predetermined amountof emblica officinalisfreeze dried powderina first predetermined amount of water havinga temperature in the range of 60 oC to 70 oCin a first tankunder stirring for a time period in the range of 10 minutes to 15 minutesto obtain a uniform slurry. The uniform slurry is transferred to a second tank containing a second predetermined amount of water under stirring at a speed in the range of 10rpm to 20 rpm for a time period in the range of 10 minutes to 15 minutes to obtain a uniform blend. The uniform blend so obtained is passed through ahomogenizerunder apressure ranging from 2000psi to 3000psi to obtain a homogenized blend. The homogenized blend is filtered through a filter selected from a line filter and a kitten filterhaving a pore size in the range of 350 microns to 500 microns to obtain a first blend.
Separately, in a third tank containing a third predetermined amount of waterhaving a temperature in the range of 80 oC to 85oC, mixing a predetermined amount of sweetening agent, vitamin-C (ascorbic acid), mineral salts, citric acid, orange juice concentrate and a coloring agent to obtain a clear blend. The clear blend is then filtered through a filter selected from a line filter and a kitten filter having a pore size in the range of 350 microns to 500 microns to obtain a second blend. The mineral salts are selected fromthe group consisting of calcium lactate, magnesium sulphate heptahydrate,manganese sulphate, zinc sulphate heptahydrate, ferrous gluconate anhydrous,and sodium selenate. Thecoloring agent used is sunset yellow to obtain a clear solution.
Thefirst blend and the second blend are transferred through a pump to a fourth tankand mixed thoroughlyto obtain a resultant solution.
Further, to the resultant solution a predetermined amount of vitamins selected from beta carotene, vitamin B1 (thiamine hydrochloride), vitamin B2(riboflavin sodium phosphate), vitamin B3 (nicotinamide), Vitamin B5 (calcium pantothenate), vitamin B6 (pyridoxine hydrochloride), vitamin B9 (folic acid), vitamin E (tocopheryl acetate) and a pre-determined amount of a flavoring agent are added to obtain a bulk solution. The bulk solution ismade the volume up to a desired batch size by adding a fourth predetermined amount of purified water and mixedthoroughly,followed by filtering through a filter selected from a line filter and a kitten filter having a pore size in the range of 350 microns to 500 microns and transferring to RBT (Ready Beverage Tank) to obtain the formulation with a desired batch size.
BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWING
The present disclosure will now be described with the help of the accompanying drawing, in which:
Figure 1illustrates a flow chart illustrating the process for preparing the formulation in accordance with an embodiment of the present disclosure.
DETAILED DESCRIPTION
Embodiments, of the present disclosure, will now be described with reference to the accompanying drawing.
Embodiments are provided so as to thoroughly and fully convey the scope of the present disclosure to the person skilled in the art. Numerous details are set forth, relating to specific components, and methods, to provide a complete understanding of embodiments of the present disclosure. It will be apparent to the person skilled in the art that the details provided in the embodiments should not be construed to limit the scope of the present disclosure. In some embodiments, well-known processes, well-known apparatus structures, and well-known techniques are not described in detail.
The terminology used, in the present disclosure, is only for the purpose of explaining a particular embodiment and such terminology shall not be considered to limit the scope of the present disclosure. As used in the present disclosure, the forms “a,” “an,” and “the” may be intended to include the plural forms as well, unless the context clearly suggests otherwise. The terms "comprises," "comprising," “including,” and “having,” are open ended transitional phrases and therefore specify the presence of stated features, integers, steps, operations, elements, modules, units and/or components, but do not forbid the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof. The particular order of steps disclosed in the method and process of the present disclosure is not to be construed as necessarily requiring their performance as described or illustrated. It is also to be understood that additional or alternative steps may be employed.
The fundamental cause of serious diseases including cancer, neurodegeneration, cardiovascular diseases, diabetes, and kidney diseases is oxidative stress, which in turn results in cell damages and serious alterations in the body and finally lead to serious diseases. Hence, there is an unmet need for a novel formulation that provides a daily dose of meso-nutrients with anti-oxidant and immune boosting properties and relieves oxidative stress. Conventional approach and traditional knowledge do provide options for anti-oxidant formulations with meso-nutrients, but they are not efficacious due to their unpalatability and poor compliance.There is a definite need for technology which provides a daily dose of meso-nutrients with anti-oxidants and is readily consumed by people for relieving oxidative stress.
The formulation of the present disclosure fills this exact technical gap in the market place. The anti-oxidant formulation as disclosed in the present disclosure is a tasty drink that contains several ingredients which would achieve the goal of wellness and compliance.
Also,the present disclosure provides a brix acid ratio (brix and acidity) which is an inventive step in adjusting andstandardizing palatabilityof the formulation. The brix and acidity ratio is required for excellent uniformity and improved organoleptic properties of the formulation for individual’s compliance.
The present disclosure provides an anti-oxidant and immune boosting formulation and a process for its preparation.
In an aspect, the present disclosure provides an anti-oxidant and immune boosting formulation.The anti-oxidant and immune boosting formulation comprises (a) an orange juice concentrate in an amount in the range of 5 wt% to 15 wt%; (b) an emblica officinalis in an amount in the range of 1 wt% to 2 wt%; (c)vitamins in an amount in the range of 0.01 wt% to 1.5 wt%; (d) mineral salts in an amount in the range of 0.05 wt% to 1.5 wt%; (e)citric acidin an amount in the range of 0.1 wt% to 1 wt%; (f) at least one additivein an amount in the range of 80 wt% to 90 wt%; and qs. water, wherein the amounts are in respect of the total amount of the components (a) to (f); and wherein a brix of the formulation is in the range of 12 % to 14% and an acidity of the formulation is in the range of 0.15 % to 0.3%. The ratio of the amount of water to the total amount of the components (a) to (f) is in the range of 5.5 wt% to 6.5 wt%. In an exemplary embodiment, the ratio of the amount of water to the total amount of the components (a) to (f) is 6.1 wt%.
In an embodiment of the present disclosure, the vitamins are selectedfrom beta carotene, vitamin B1 (thiamine hydrochloride), vitamin B2(riboflavin sodium phosphate), vitamin B3 (nicotinamide), vitamin B5 (calcium pantothenate), vitamin B6 (pyridoxine hydrochloride), vitamin B9 (folic acid), vitamin C (ascorbic acid) and vitamin E (tocopheryl acetate).
In an embodiment of the present disclosure, the mineral saltsare selected from calcium lactate pentahydrate, magnesium sulphate heptahydrate, manganese sulphate, zinc sulphate heptahydrate, ferrous gluconate anhydrous, and sodium selenate.
In an embodiment of the present disclosure, theadditive is selected from a sweetening agent, a coloring agent, and a flavoring agent, wherein the sweetening agent is selected from the group consisting of sugar, dextrose, natural fruit sugar, fructose, honey and stevia; the coloring agent is selected from sunset yellow and tartrazine; and the flavoring agent is selected from orange flavor.
In an exemplary embodiment, the formulation comprises (a) 9 wt% of Orange juiceconcentrate; (b) 1.2 wt% of an emblica officinalis freeze dried powder; (c ) 1 wt% of beta carotene; (d) 0.0009 wt% of vitamin B1 (thiamine hydrochloride),(e ) 0.0012 wt% of vitamin B2(riboflavin sodium phosphate); (f) 0.004 wt% of vitamin B3(nicotinamide); (g) 0.004 wt% of vitamin B5(calcium pantothenate); (h) 0.0007 wt% of vitamin B6(pyridoxine hydrochloride); (i) 0.0002 wt% of vitamin B9(Folic Acid); (j) 0.4 wt% of vitamin C (ascorbic acid); (k) 0.005 wt% of vitamin E(tocopheryl acetate); (l) 0.6 wt% of calcium lactate penta hydrate; (m) 0.3 wt% of magnesium sulphate heptahydrate; (n) 0.0004 wt% of manganese sulphate; (o) 0.007 wt% of the zinc Sulphate heptahydrate; (p) 0.0015 wt% of ferrous gluconate anhydrous; (q) 0.000004 wt% of sodium selenate; (r) 0.5 wt% of citric acid; (s) 80 wt% of a sweetening agent; (t) 0.03 wt% of a coloring agent; and (u) 0.2 wt% of a flavoring agent, and qs. water, wherein the amounts are in respect of the total amount of the components (a) to (u).
In another exemplary embodiment, the formulation comprises (a) 13 wt% of the orange juice concentrate; (b) 1.7 wt% of an emblica officinalis; (c ) 1 wt% of beta carotene; (d) 0.0008 wt% of vitamin B1(thiamine hydrochloride); (e ) 0.0006 wt% of vitamin B2(riboflavin sodium phosphate); (f) 0.004 wt% of vitamin B3(nicotinamide); (g) 0.002 wt% of vitamin B5(calcium pantothenate); (h) 0.0006 wt% of vitamin B6(pyridoxine hydro chloride); (i) 0.0003 wt% of vitamin B9(folic Acid); (j) 0.30 wt% of vitamin C (ascorbic Acid); (k) 0.004 wt% of vitamin E (tocopheryl acetate); (l) 0.10 wt% of calcium lactate pentahydrate; (m) 0.0040 wt% of magnesium sulphate heptahydrate; (n) 0.0002 wt% of manganese sulphate; (o) 0.0021 wt% of zinc sulphate heptahydrate; (p) 0.0021 wt% of ferrous gluconate anhydrous; (q) 0.000006 wt% of the sodium selenate; (r) 0.08 wt% of the citric acid; (s)85wt% of a sweetening agent; (t) 0.0509 wt% of a coloring agent; (u) 0.3 wt% of a flavoring agent; and qs. water, wherein the amounts are in respect of the total amount of the components (a) to (u).
In an embodiment of the present disclosure, the formulation is in the form of a tetrapak drink.
In accordance with the embodiments of the present disclosure, the orange juice concentrateis obtained from varieties of Citrus reticulata,tangerine, sinensis, valencia, clementineand combinations thereof.
Citrus reticulata (Rutaceae) is a botanical name of orange, also known as the mandarin. It is a small citrus tree with fruit bearing and fruits are smaller and oblate, rather than spherical. The taste is considered less sour, as well as sweeter. A ripen fruit is firm to slightly soft, heavy for its size, and pebbly-skinned. The peel is thin, with little white mesocarp, so they are usually easier to peel and to split into segments. It is grown in tropical and subtropical areas.
Major chemical constituents of mandarin orange include-Vitamin C (Ascorbic Acid) - 52.89%, Citric Acid-0.37% to 1.44%, Hesperetin, Naringin, Naringenin, Narirutein, a-b-carotene-0.007%.
TABLE.1- DETAILED CLASSIFICATION OF CHEMICAL CONSTITUENTS OF CITRUS RETICULATA:
S. No Major components
Derivatives/ Mesonutrients:
1. Flavonoids Hesperedin,
Naringin,
Naringenin,
Zeaxanthin,
Lutein,
Citric Acid.
a-ß carotene
TABLE.2 - DETAILEDNUTRITIVE VALUE PER 100GM OF ORANGE JUICE (All Varieties):
Orange Juice: Nutritive value per 100 gm.
(Ref: USDA National nutrient data base)
Principle Nutrient Value Percentage of RDA(Recommended Daily Allowance)
Energy 49 Kcal 2.5%
Carbohydrates 11.89 g 9%
Protein 0.94 g 1.5%
Total Fat 0.30 g 0.5%
Cholesterol 0 mg 0%
Dietary Fiber 2.50 g 6%
Vitamins
Folates 39 µg 10%
Niacin 0.274 mg 2%
Pantothenic acid 0.250 mg 5%
Pyridoxine 0.063 mg 4.5%
Riboflavin 0.040 mg 3%
Thiamine 0.087 mg 7.5%
Vitamin-C 48.5 mg 81%
Vitamin-A 230 IU 8%
Electrolytes
Sodium 0 mg 0%
Potassium 179 mg 4%
Minerals
Calcium 40 mg 4%
Copper 39 µg 4%
Iron 0.09 mg 1%
Magnesium 10 mg 2.5%
Manganese 0.023 mg 1%
Zinc 0.06 mg 1%
In one embodiment orange juice concentrate is imported commercially from Brazil and South Africa through the supplier in India.
In accordance with the embodiments of the present disclosure, Amla (Emblica officinalis) freeze dried powder is used.
In an exemplary embodiment the freeze dried amla powder is procured commercially fromsuppliers in India and Source of Amla (Emblica officinalis) is from East Gujarat, West Bengal, and Southern part of India.
Emblica officinalis (Euphorbaceae): Amalaki (Indian Gooseberry) is a deciduous tree. Amla is native to India and also grows in tropical and subtropical regions of Pakistan, Uzbekistan, Sri Lanka, South East Asia, China, and Malaysia. The tree is medium in height reaching up to 8-18 meters high. It bears a spherical fruit, which is light yellow in color with green undertones. Fruits are fleshy, almost depressed to globose shape, 2.1-2.4 cm in diameter, 5.3-5.7 g in weight, 4.5-5.0 ml in volume. The stone of the fruit is 6 ribbed, splitting into three segments each containing usually two seeds; seeds are 4-5 mm long and 2-3 mm wide. The fruit “Amla” is a super fruit having multiple health benefits and rich in multiple chemical components hidden in the fruit which act synergistically in all the metabolic functions of the body. Also, it is a very popular ingredient used in an Ayurvedic preparation called “Chyavanprash” as a wonderful antioxidant which has got a good role in anti-ageing and immune boosting.
A major chemical constituent of amla includes- Ascorbic acid (Vitamin C): 0.38%-0.50% i.e. (478.56 mg/100 g). Total Tannins: 13.75% out of which it contains, Emblicanin A (37%), & B (33%), Total Polyphenols: 90.5 to 385 mg, Gallic Acid: 2.10%, Quercetin: 28%, Kaempherol, ß-sitosterol.
TABLE.3 - PROVIDES A CLASSIFICATION OF CHEMICAL CONSTITUENTS OF EMBLICA OFFICINALIS:
S.No Major components
Derivatives/Mesonutrients:
1. Total Polyphenols Gallic Acid
Quercetin
Rutin
Chebulic acid
2. Total Tannins Emblicanin A, B
Phyllantine
Punigluconin
Pedunculagin
3. Triterpenoides gibberellin A-1
lupeol
4.
Flavonoids
Kaempherol
kaempherol-3
Quercetin
5. Sterols ß-sitosterol
TABLE-4:DETAILED NUTRITIVE VALUE PER 100GM OF AMLA: (REF: ICMR, NIAN)
Principle Nutrient Value
Energy 58 Kcal
Carbohydrates 13.7 g
Proteins 0.5 g
Total fats 0.1 g
Cholesterol 0 mg
Dietary fiber 3.4 g
Vitamins
Folates 6 mcg
Niacin 0.200 mg
Pantothenic acid 0.286 mg
Pyridoxine 0.080 mg
Riboflavin 0.010 mg
Thiamine 0.030 mg
Vitamin A 9 mcg mg
Vitamin C 478mg-600mg
Minerals
Sodium 5 mg
Potassium 225 mg
Minerals
Calcium 50 mg
Copper 0.070 mg
Iron 0.31 mg
Magnesium 10 mg
Manganese 0.144 mg
Phosphorous 20 mg
Zinc 0.12 mg

In another aspect, there is provided a process for the preparation of anti-oxidant and immune boosting formulation. The process is described in details as:
In a first step,a predetermined amount ofemblica officinalis freeze dried powder is mixed in a first predetermined amount of water having a temperature in the range of 60 oC to 70 oC in a first tank under stirring for a time period in the range of 10 minutes to 15 minutes to obtain a uniform slurry. The uniform slurry is transferred to a second tank containing a second predetermined amount of water under stirring at a speed in the range of 10rpm to 20 rpm for a time period in the range of 10 minutes to 15 minutes to obtain a uniform blend. The uniform blend so obtained is passed through a homogenizer under a pressure ranging from 2000 psi to 3000 psi to obtain a homogenized blend. The homogenized blend is filtered through a filter selected from a line filter and a kitten filter having a pore size in the range of 350 microns to 500 microns to obtain a first blend.
In an embodiment, the emblica officinalis powder is freeze dried powder.
The predetermined amount of emblica officinalis powder is in the range of 1wt% to 2 wt% with respect of the total weight of the components (devoid of water amount). In an embodiment, the predetermined amount of emblica officinalis is in the range of 1.2 wt% to 1.7 wt% with respect of the total weight of the components (devoid of water amount). In one exemplary embodiment, the predetermined amount of emblica officinalis freeze dried powder is 1.2 wt%. In another exemplary embodiment, the predetermined amount of emblica officinalis freeze dried powder is 1.7wt%.
The first predetermined amount of water used is in the range of 3wt% to 5 wt% with respect of the total amount of water and the second predetermined amount of water used is in the range of 18wt% to 22 wt% with respect of the total amount of water. In an embodiment, the first tank is a mixing tank and the second tank is a blending tank.
Separately, in a third tank containing a third predetermined amount of waterhaving a temperature in the range of 80 oC to 85oC,mixing a predetermined amount of a sweetening agent, vitamin-C (ascorbic acid), citric acid, mineral salts, orange juice concentrate and coloring agent to obtain a clear blend. The clear blend is filtered through a filter selected from a line filter and a kitten filter having a pore size in the range of 350 microns to 500 microns to obtain a second blend.
In an embodiment, the mineral salts are selected from calcium lactate, magnesium sulphate heptahydrate, manganese sulphate, zinc sulphate heptahydrate, ferrous gluconate anhydrous, and sodium selenate. The colorant isselected from sunset yellow to obtain a clear blend in the form of clear solution.
In an embodiment, the third tank is a blending tank.
Thethird predetermined amount of water is in the range of 48wt% to 52 wt% with respect to the total amount of water.
The predetermined amount of orange juice concentrateis in the range of 5wt% to 15wt% with respect of the total weight of the components (devoid of water amount). In an embodiment, the predetermined amount of orange juice concentrateis in the range of 9 wt% to 13 wt% with respect of the total weight of the components (devoid of water amount). In one exemplary embodiment, the predetermined amount of orange juice concentrateis 9 wt%. In another exemplary embodiment, the predetermined amount of orange juice concentrateis 13wt%.
The predetermined amount of mineral saltsis in the range of 0.05wt% to 1.5wt% with respect of the total weight of the components (devoid of water amount). In an embodiment, the mineral salts are selected from 0.6 wt% of calcium lactate penta hydrate; 0.3 wt% of magnesium sulphate heptahydrate; 0.0004 wt% of manganese sulphate; 0.007 wt% of Zinc Sulphate heptahydrate; 0.0015 wt% of ferrous gluconate anhydrous; and 0.000004 wt% of sodium selenate. In another embodiment, the mineral salts are selected from 0.10 wt% of calcium lactate pentahydrate; 0.0042 wt% of magnesium sulphate heptahydrate; 0.0002 wt% of manganese sulphate; 0.0021 wt% of zinc sulphate heptahydrate; 0.0021 wt% of ferrous gluconate anhydrous; and 0.000006 wt% of the sodium selenate. The amount is in respect of the total components (devoid of water amount).
In an embodiment, the predetermined amount of the citric acidis in the range of 0.1 wt% to 1 wt% with respect of the total weight of the components (devoid of water amount). In one exemplary embodiment, the predetermined amount of the citric acidis 0.5wt%. In another exemplary embodiment, the predetermined amount of the orange juice concentrateis 0.55wt%.
In an embodiment, the predetermined amount of the sweetening agentis in the range of 80 wt% to 90 wt% with respect of the total weight of the components (devoid of water amount). In one exemplary embodiment, the predetermined amount of the sweetening agentis 80 wt%. In another exemplary embodiment, the predetermined amount of the sweetening agent is 85 wt%.
In an embodiment, the predetermined amount of the ascorbic acidis in the range of 0.2 wt% to 0.5 wt% with respect of the total weight of the components (devoid of water amount). In one exemplary embodiment, the predetermined amount of the ascorbic acidis 0.3 wt%. In another exemplary embodiment, the predetermined amount of the ascorbic acideis 0.4wt%.
The first blend and the second blend are transferred through pump to a fourth tank and mixed thoroughly to obtain a resultant solution. In an embodiment, the fourth tank is bulk tank.
Further, to the bulk solution a predetermined amount of vitamins selected from Beta carotene, vitamin B1 (thiamine hydrochloride), vitamin B2(riboflavin sodium phosphate), vitamin B3 (nicotinamide), Vitamin B5 (calcium antothenate), vitamin B6 (pyridoxine hydrochloride), vitamin B9 (folic acid), vitamin E (tocopheryl acetate) and a pre-determined amount of flavoring agent is added and volume make up as per the batch size by addinga fourth predetermined amount of water and mixedthoroughlyfollowed by filtering through a filter selected from a line filter and a kitten filter having a pore size in the range of 350 microns to 500 microns and transferring to RBT (Ready Beverage Tank) to obtain the formulation with a desired batch size.
In an embodiment, the fourth predetermined amount of water is in the range of 25wt% to 28 wt% with the total amount of water.
In an embodiment, the predetermined amount of vitamins is in range of 0.01 wt% to 1.5wt%. In an exemplary embodiment 1 wt% of beta carotene; 0.0009 wt% of vitamin B1 (thiamine hydrochloride); 0.0012 wt% of vitamin B2 (riboflavin sodium phosphate); 0.004 wt% of vitamin B3 (nicotinamide); 0.004 wt% of vitamin B5 (calcium pantothenate); 0.0007 wt% of vitamin B6 (pyridoxine hydrochloride); 0.0002 wt% of vitamin B9(Folic Acid); and0.005 wt% of vitamin E (tocopheryl acetate) of the total weight of the components (devoid of water amount). In another exemplary embodiment, the predetermined amount of vitamins are selected from 1 wt% of beta carotene; 0.0008 wt% of vitamin B1 (thiamine hydrochloride); 0.0006 wt% of vitamin B2 (riboflavin sodium phosphate); 0.004 wt% of vitamin B3 (nicotinamide); 0.002 wt% of vitamin B5 (calcium pantothenate); 0.0006 wt% of vitamin B6 (pyridoxine hydro chloride); 0.0003 wt% of vitamin B9 (folic Acid); and 0.004 wt% of vitamin E (tocopheryl acetate) with respect of the total amount of the components (devoid of water amount).
In an embodiment, the predetermined amount of the flavoring agentis in the range of 0.1 wt% to 0.3 wt% with respect of the total weight of the components (devoid of water amount). In one exemplary embodiment, the predetermined amount of the flavoring agentis 0.2 wt%. In another exemplary embodiment, the predetermined amount of the flavoring agent is 0.3wt%.
In accordance with the present disclosure, the first tank is a mixing tank, the second tank is a blending tank, the third tank is a blending tank, and the fourth tank is a bulk tank.
The formulation of the present disclosure fills this exact technical gap in the market place. The formulation of the present disclosure synergistically provides a very high ORAC value (oxygen radical absorbance capacity) that promotes good health.
In accordance with the preset disclosure a brix of the formulation is in the range of 12 % to 14% and an acidity of the formulation is in the range of 0.15 % to 0.3%.
The present disclosure provides a brix acid ratio (brix and acidity) which is an inventive step in adjusting and standardizing palatability of the formulation. The brix and acidity ratio is required for excellent uniformity and improved organoleptic properties of the formulation for individual’s compliance.
In accordance with the present disclosure, the Emblica officinalis is in the form of freeze dried powder, where the freeze drying, also known as lyophilisation or cryodesiccation, is a low temperature dehydration process that involves freezing the product/powder by lowering pressure and then removing the so formed ice by sublimation. This is in contrast to dehydration by most conventional methods that evaporate water using heat.
Freeze drying results in a high quality product due to the low temperature used in processing the powder. The original shape of the product is maintained and quality of the rehydrated product is excellent.

TABLE.5-RM SPECIFICATION AMLA (EMBLICA OFFICINALIS):
RAW MATERIAL SPECIFICATIONS - EMBLICA OFFICIANALIS
Storage Condition: R.T, Cool and dry place away from direct sunlight
Packing: Air tight sealed container
Ref. Std.: IH Stds Shelf Life: 12 Months
PHYSICO-CHEMICAL ANALYSIS
S. NO. TEST PARAMETERS SPECIFICATIONS
01 Appearance Freeze dried, Free-flowing, Light brown colored Powder free from Clumps.
02 Aroma & Taste Characteristic of Amla.
03 Solubility Soluble in Water
04 Moisture(Karl Fischer Method) Not More Than 7.00 %
05 pHof 1% Solution 2.5 - 4.0
06 Total Ash not more than 5.00 %
07 Heavy Metals:
A) Arsenic
B)Lead
a) not more than2 ppm
b)not more than 2 ppm
08 Actives:
a. Gallic Acid
b. Ascorbic Acid
c. Tannins
-Not less than 0.25% w/w
-Not less than 0.5% w/w
-Not less than 15% w/w
09 Particle Size (60 Mesh) Material should pass through 60 mesh Sieve completely during filtration.
10 MICROBIAL ANALYSIS
Total Plate Count Not more than1000 cfu/g
Yeast And Mould Count Not more than10 cfu/g
Coli form Absent/g
E.Coli Absent /g
Salmonella Absent/g

In accordance with the present disclosure, the orange juice concentrate is used.Concentrated juice extract is approximately five times more concentrated than squeezed juice. Concentration is useful because it extends the shelf life of the juice and makes storage and shipping more economical.

TABLE.6:RM SPECIFICATION (ORANGE JUICE CONCENTRATE)
RAW MATERIAL SPECIFICATIONS - ORANGE JUICE CONCENTRATE
Storage Condition: To be stored under freeze temperature at -160C to -180C
Packing: Air tight sealed container
Ref. Std.: IH Stds Shelf Life: 24 Months.
PHYSICO-CHEMICAL ANALYSIS
SL. NO. TEST PARAMETERS LIMITS
01 Appearance
Varieties A Viscous/Frozen Yellow colored liquid. Free from dust, insects, fungal infestations.
02 Smell/Aroma/Taste Characteristic of Orange Fruit
03 Brix / Total Soluble Solids 620-680
04 pH of 1% Solution 3.0 – 5.0
05 Specific Gravity 1.30 – 1.32
06 Acidity 3.0 – 7.0 %
07 Heavy Metals:
A) As
B) Pb A) Not More Than 2 PPM
B)Not More Than 2.5 PPM
08 Citric Acid(As % Citric Acid Anhydrous) 3 – 7%
09 MICROBIAL ANALYSIS
Total Plate Count Not more than 1000cfu/g
Yeast And mould Count Not more than 100cfu/g
Coliform Absent
E.Coli Absent
Salmonella Absent
In an embodiment the process for obtaining the formulation at commercial scale is depicted in the flow chart of Figure-1.
Explaining the ingredient preparation:
A) A special process of preparation of Emblica officinalis slurry
B) Dry blending of vitamin mixture under specific conditions as described herein under;
a. Vitamin-B1(thiamine hydrochloride),vitamin-B2(pyridoxine Hydrochloride), vitamin-B3(nicotinamide), vitamin B5(calcium pantothenate) in atmospheric condition of RH- ranging 50%-60% and temperature ranging from 30° C to 32°C in normal light radiation.
b. Natural betacarotene (10 % Dispersible), vitamin B2(Riboflavin sodium Phosphate) andvitamin B9(Folic Acid) in atmospheric condition of RH- ranging 50%-60% and temperature ranging from 30° C to 32°Cwithout visible radiation.
C) The vitamins are dry blended in the manner are weighed individually and; packed in resistant double lined polythene bag and mixed thoroughly and finally sealed and labelled with the batch details.
D) The minerals salts such as calcium lactate penta hydrate, magnesium sulphate heptahydrate, manganese sulphate, zincsulphate, ferrous gluconate and sodium selenate are dry blended in atmospheric condition of RH- ranging 50%-60% and temperature ranging from 30° C to 32°C in normal light conditions; weighed individually; and packed in resistant doublelined polythene bag & mixed thoroughly and finally sealed and labelled with the batch details.
E) Additives such as sunset yellow (mixture of sunset yellow) colour is weighed in an atmospheric condition of RH- ranging 40%-60% and temperature ranging from 30° C to 32°C in normal light conditions; and packed in resistant double lined polythene bag and mixed thoroughly and finally sealed and labelled with the batch details.
F) Flavours andvitamin E(Tocopheryl acetate) and other are wet blended in an atmospheric condition of RH- ranging from 40% to 60% and temperature ranging from 30° C to 32°C in normal light conditions; measured individually using the certified measuring; and transferred intoglass bottles and mixed thoroughly; sealed with ROPP Cap (Roll-On-Pilfer-Proof Intention Cap) to ensure leak proof and airtight sealing and labelled with the batch details.
In an exemplary embodiment of the present disclosure Amla freeze dried powder is transferred into the mixing tank consisting100 litershigh purity hot water having a temperature in the range of 60°C to 70°C are mixed by stirring for 10min and recirculationwith the help of circulation pump, to obtain a uniform slurry. The slurry is transferred to BT-2 (Blending Tank-2) consisting of 200 to 300liters of high purity water and agitated at a speed of 10 to 20 rpm for 10 min to 15min to obtain a uniform blend. The obtained blend is finally passed through homogenizerwith a pressure ranging from 2000 psi to3000psiand filtered througha kitten filter with a pore sizein the range of 350 microns to 500 microns with flushing completely with high purity water to obtain afirst blend.
Further in Blending Tank-1 a predetermined quantity of sugar, dextrose, citric acid, vitamin-C(ascorbic acid), mineral saltsand sunset yellow (coloring agent) are added through the feed hopper with the following steps.
• A known quantity (800-1000litre) ofhigh purity waterhaving a temperature in the range of 80oC to 85oCis taken in Blending Tank-1, adding sugar, dextrose and citric acid with stirring and recirculationand mixed well till the solution is clear.
• To the above the predetermined quantity of orange juice concentrate is added and mixed well to get a uniform solution and recirculated.
• Then add vitamin C (ascorbic Acid) and mineral saltsand sunset yellow (coloring agent) mixed well till the solution is clear.
After blending of all the ingredients, the obtained uniform solution is filtered through line filters and kitten filters with pore size of 400 micron forming a second blend and is transferred into a bulk tank andflushes the tank and lines with high purity water.
Mixing first blend and second blend ina bulk tank obtaining a bulk Solution.
Further to the above the addition of predetermined quantity vitamin mixture and orange flavour (Nature identical flavour) slowly to bulk tankconsisting third blend and mixed for 10min to 15min at the agitator at a speed 10 to 20 rpm forminguniform bulk solution and volume makeup as per the batch size with high purity water is done and mixed for10 to 15 minutesthoroughly.
Then, batch standardisation is done by checking the bulk solution for sensory test like, colour, appearance and taste and physical properties like brix or TSS (Total Soluble Solids), acidity and pH (refer to final product specifications for ranges for the mentioned parameters).Once the parameters are ok, it is cleared for further processing.
Filtration and transferring the product to (Ready Beverage Tank) RBT and the procedure consisting of:
• Bulk Solution is filtered, through kitten filter with a pore size of 400microns.
• Transferred into ready beverage tank (RBT).
• Draw samples and check for sensory test like, colour, appearance and taste and physical properties like TSS, Acidity and pH.
Sterilization–HTST(High Temperature Short Time) of the product as per specification contained below:
TABLE.7: STERILIZATION SPECIFICATIONS:
Parameters Specification
Equipment Name for Sterilization Spira flow Sterilizer
Hot water temp Inlet/ Outlet Max.90° C
Product flow rate 5,500 L/hr
Inlet Temp of holding coil 106oC±1oC
Outlet Temp of holding coil 106oC±1oC
Holding pipe length 41.76 m
Hold Time 51Seconds
Product temperature for filling 25 to 30°C.
The foregoing description of the embodiments has been provided for purposes of illustration and not intended to limit the scope of the present disclosure. Individual components of a particular embodiment are generally not limited to that particular embodiment, but, are interchangeable. Such variations are not to be regarded as a departure from the present disclosure, and all such modifications are considered to be within the scope of the present disclosure.
The present disclosure is further described in light of the following experiments which are set forth for illustration purpose only and not to be construed for limiting the scope of the disclosure. The following experiments can be tested to scale up to industrial/commercial scale and the results obtained can be extrapolated to the industrial scale.
EXPERIMENTAL DETAILS:
EXPERIMENT 1: FACTORTY TRIAL OF 1000 LITRES BEVERAGE:
Freeze dried powder of Emblica officinalis(2kg)was added in a first tank (mixing tank) containing40ltr of water having temperature 70°C and weremixed under stirringfor 10min and recirculatedwith the help of circulation pump,to obtain a uniform slurry. The uniform slurry was transferred to asecond tank (BlendingTank-2) containing200literswater and stirred at a speed of 20rpm for 15min to obtain a uniform blend. The uniform blend was passed through a homogenizer at 2500psito obtain a homogenized blend. The homogenized blend was filtered through a kitten filter with a pore size of 400micron with the high purity water to obtain a first blend.
Separately, in a third tank (Blending Tank-1) containing500liters of high purity water having a temperature of 82oC,130 kg of sugar, 900 g of citric acid , 608g of vitamin C(Ascorbic acid), 10kg of dextrose, and 15.2 kg of orange juice concentrate, 976g of calcium lactate pentahydrate, 520g of magnesium sulphate hepta hydrate, 780 mg of manganese sulphate, 11.2 g of zinc sulphate heptahydrate, 23.2g of ferrous gluconate anhydrous, 18.2 mg of sodium selenate, and 60 g ofsunset Yellow(colorants)were added and mixed in Blending Tank-1under recirculation to obtain a clear blend. The clear blend was filtered through a line filter and a kitten filter of 400microns with flushing the lines and tank completely with high purity waterto obtain a second Blend.
The first blend and the second blend was transferred toa fourth tank (Bulk tank) and mixed thoroughly to obtain a resultant solution.
Further, separately,vitamins such as 1.68 kg ofbeta carotene, 1.6g of vitamin B1(Thiamine Hydrochloride), 1.86g of vitamin B2(riboflavin sodium phosphate), 6.1g of vitamin B3(Nicotinamide), 6g of vitamin B5(calcium pantothenate), 1.2g vitamin B6(pyridoxine hydrochloride), 0.345g vitamin B9(folic acid), 7.5 g of vitamin E (tocopheryl acetate); and 380mlorange flavor (flavoring agent)were added to the bulk tankand stirred under 20 rpm for 10min to obtain a bulk solution.A volume makeup to the desired batch size was done with high purity water,followed by batch standardisation by checking the bulk solution for sensory test like, colour, appearance, and taste; and physical properties like Brix or TSS (Total Soluble Solids), Acidity and pH. By the addition of citric acid and sugar and adjusting the acidity, pH, Brix,followed by filtering through a kitten filter with the pore size of 400micron transferred to RBT once again checked for the standardization parameters before sterilization.
The formulation was finally transferred to a spiraflow sterilizer and then packed in the Tetrapak of 125ml/200ml.
In one aspect of the present disclosure, the product is filled in the fill seal in the tetra pack laminate and labelled.
TABLE.8 STABILITY STUDIES: (LONG TERM)
STABILITY STUDY REPORT
Study: Long Term
Frequency of the study: 0, 1, 2,3, 6, 9,12 months Storage Condition:300 C ± 2 0 C / 65 % RH ± 5 % RH
Batch No.: MOAB –049 Mfg. Date:14/11/2019 Packing: 200 ml Tetrapak

Results of the Analysis
SN Parameters Specification Initial Analysis Frequency in Months
1st 2nd 3rd 6th 9th 12th
01 Description A Orange Colored hazy liquid having sweet taste with typical characteristic of Orange Complies Complies Complies Complies Complies --- ---
02 Color Hazy Orange Color Complies Complies Complies Complies Complies
03 Taste Characteristic taste of Orange Complies Complies Complies Complies Complies
04 Flavor Characteristic Mango Orange Complies Complies Complies Complies Complies
Physical Parameters
05 Brix at RT 12.8 to 13.4 % 13.2% 13.2 % 13.2 % 13.2% 13.2% --- ---
06 Acidity as Citric Acid 0.19 to 0.23 % 0.21 % 0.21 % 0.21 % 0.21% 0.208 %
07 pH 3.2 to 4.0 3.34 3.32 3.32 3.30 3.32
Chemical Analysis
08 Vitamin C content – mg/200 ml NLT 65 mg/200 ml 118.5 118.7 118.46 118.4 118.32 --- ---
Microbiology Parameters
09 Total Microbial Count NMT 50 cfu/ml Nil Nil Nil Nil Nil --- ---
10 Yeast and Mould count NMT 2 cfu/ml Nil Nil Nil Nil Nil --- ---
11 Gram Negative Rods Absent/100 ml Absent/100 ml Absent/100 ml Absent
/100 ml Absent
/100 ml Absent
/100 ml --- ---
Month of Analysis Nov.2019 Jan. 2020 Feb.2020 Mar.2020 June 2020 --- ---

TABLE.9: STABILITY STUDIES: (ACCELERATEDCONDITION)
STABILITY STUDY REPORT
Study: Accelerated Condition
Frequency of the study: 0, 1, 3 & 6 months Storage Condition:400 C ± 20 C / 75 % RH ± 5 % RH
Batch No.: MOAB – 049 Mfg. Date:14/11/2019 Packing: 200 ml Tetrapak

Results of the Analysis
SN Parameters Specification Initial Analysis Frequency in Months
1st 3rd 6th
01 Description A Orange Colored hazy liquid having sweet taste with typical characteristic of Orange Complies Complies Complies Complies
02 Color Hazy Orange Color Complies Complies Complies Complies
03 Taste Characteristic taste of Orange Complies Complies Complies Complies
04 Flavor Characteristic Mango Orange Complies Complies Complies Complies
Physical Parameters
05 Brix at RT 12.8 to 13.4 % 13.2% 13.0 % 13.0 % 13.0%
06 Acidity as Citric Acid 0.19 to 0.23 % 0.21 % 0.21 % 0.20 % 0.20 %
07 pH 3.2 to 4.0 3.34 3.32 3.32 3.30
Chemical Analysis
08 Vitamin C content – mg/200 ml NLT 65 mg/200 ml 118.5 118.1 117.4 114.62
Microbiology Parameters
09 Total Microbial Count NMT 50 cfu/ml Nil Nil Nil Nil
10 Yeast and Mould count NMT 2 cfu/ml Nil Nil Nil Nil
11 Gram Negative Rods Absent/100ml Absent
/100ml Absent
/100ml Absent
/100ml Absent
/100ml
Month of Analysis Dec.2019 Jan.2020 Mar.2020 June 2020
Inference:The product complies with the all the IH specification with respect to Organoleptic Characters, Physical Parameters and Microbiological parameters) hence,the product is stable at accelerated & long term conditions prescribed as per the ICHGuidelines.
TABLE.10: FINISHEDPRODUCT SPECIFICATIONS:
Storage condition: cool and dry place away from direct sunlight.
Packing: Tetrapak Shelf life: 12 months.
PHYSICO-CHEMICAL ANALYSIS:
S.No TEST PARAMETERS SPECIFICATIONS
1 Appearance Orangecoloredhazy liquid with a pleasant taste and flavor of fresh juicy orange
2 Smell/aroma Characteristic orange citrus note.
3 Taste Sweetness with a slightly sour taste.
4 pH 3-3.5
5 Brix% 12.5-13.5
6 Acidity % 0.19- 0.25
7 Identification Chromatographic fingerprints are comparable to working standard.
8 Heavy metals
(hg, pb, Ar, cd) Under limit i.e. 5ppm
9 Assay for markers Tannins, Gallic acids, Vitamin-C/ Polyphenols, Flavonoids are assessed by HPLC methods.
10 ORAC value 5400µmol TE/200ml
Microbial analysis
S.No Parameters: Values:
1 Total plate count < 50 cfu/ml
2 Total plate count <10 cfu/ml
3 Coliform Absent
4 E. Coli Absent
5 Salmonella Absent
6 Incubation tests
370c for 10 days
550c for 7 days No change in the physical appearance of the pack
No change in pH. values

Experiment 2: Anecdotal studies
STUDY I
Aims and Objectives:
The safety and efficacy of the formulation of the present disclosure as the anti-oxidant/immune booster for general nutritional and health supplement for children and adults was evaluated.
Children:
• As an anti-oxidant provides resistance against diseases caused due to dust, pollution, heat, and cold.
• General malaise and weakness, reduced physical activity
• Provides soothing and refreshing feel owing to its natural orange juice
• supports immunity against simple infections, acts as an adaptogen.
• Improves resistance and immunity in allergies, post fever and convalescence period.

Adults:
• As an anti-oxidant provides resistance against diseases caused due to dust, pollution, heat, and cold.
• Increases the fatigue threshold
• Revives physical capacity in elderly patients
• Provides soothing and refreshing feel and energizes people with general weakness and prepares them for routine physical activities.
• combats day to day stressful conditions and general debility.
• Improves resistance and immunity in allergies, post fever, and convalescence Period.

Materials and Methods:
Level of Study: OPD
Center of Study: In an Ayurvedicclinic, Bangalore-560 074
Number of Groups: Single group, 15 patients for the study
Schedule of therapy:
The formulation of the present disclosurewas administered in the dose of one to two Tetrapaks, once a day for children and twice a day for adults, one hour after food.
Duration of Study:
The duration of study was two weeks, follow up every week for four consecutive weeks.
Inclusion criteria:
? Children including both male and female, aged between 10 - 16 years and whose parent or guardian had given the consent to participate in the clinical study were included in the trial
? Children with recurrent infections like cough, cold, allergies
? Children with post fever and convalescence period
? Children low on immunity, fussy eating
? Children and Adults with general weakness, fatigue, and debility
? Children low on physical activity
? Adults including both male and female, aged between 18-60 years
? Adults with general weakness, fatigue, also improve resistance and immunity in post fever and convalescence period
? Adults with routine stress leading to debility
Exclusion criteria:
? Children suffering from any cardiac, hepatic or renal failure or regularly on any treatment or concurrently taking medicines for any illness, any congenital anomaly like cleft lip, etc., which hampers food intake were excluded from the study. Those with a strong history of food or drug allergy of any kind and subjects parent not willing to provide informed consent or abide by the requirements of the study.
? Adults with the mental retardation, psychiatric drug use, narcotics, hypertension, hyperglycemia and malignancy.
Observation:
? 8 children were in the age group of 10-16 years. 4 of them were males and 4 were females.
? 7 adults were in the age group of 18-60 years. 4 of them were males and 3 were females.
Results:
? 75% of children showed good improvement in combating day to day infections, decrease in general malaise and weakness, increased physical activity, improvement in theresistance and the immunity in a post fever and convalescence period without any notable adverse reactions. The goodness of the orange juice was very much appreciated by majority of children.
? 25% of children showed mild to moderate improvement in the above said parameters.
? 80% of adults showed good improvement in combating infections, debility, general weakness, reviving physical capacity in elderly patients, Increase in the fatigue threshold, good immunity against fever and post fever convalescence and good physical activity without any notable adverse reactions.
? 20% of adults showed mild to moderate improvement in the above said parameters.

STUDY II

Healthy individuals between the ages of 7 to 60 years of both genders were included in the study. In order to assess the effectiveness of the formulation of the present disclosure, a specific assessment questionnaire was developed to collect the information from the participants.
All the participants were given a uniform self-assessment questionnaire to rate their feeling of satisfaction, to rate their feeling of fatigue, number of infections, period during which they felt sick, effect on the physical activity (improved/moderate) and the like. The self-assessment questionnaire also included time at which the drink was taken, time taken to feel fresh after consumption of the drink, physical activity- weak/moderate/high done before/after the drink and the feelings such as tiredness, energetic to do daily routine work etc.
The baseline data was collected from 90 participants that were selected for the study and were randomly divided into 3 groups, each group containing 30 individual ranging from the participants of age 7-60 years and roughly equally divided into males and females. The study was carried out for 12 months and follow up was done at the end of every week.
The drinks were administered in the dose of two tetra packs (200 ml + 200 ml) once/twice a day in between meals by Group I, Group II and Group III respectively as provided in Table 1.
The three groups are as depicted in table 1:
Table-1
Groups No of participants 200ml-drink/dose given to the individuals twice per day
Group I – Control Grp 30 Individuals
(7 to 60 years of both genders) Orange juice concentrate +water
Group II
Control Grp 30 Individuals
(7 to 60 years of both genders) Freeze dried amla powder +sugar + water
Group III 30 Individual
(7 to 60 years of both genders) Formulation of the present disclosure: Orange juice concentrate + freeze dried amla powder+ excipients + water

The self-assessment questionnaire for the participants of the age 7 to 16 was done by their parents/guardians and the participants of the age 18 to 60 years were done by themselves.
The participants were selected from children and adults who have recurrent coughs, colds, and general feeling of tiredness. Persons suffering from cardiac ailments, liver condition, kidney condition, diabetes or concurrently taking any other medicines for any illnesses were excluded. Also persons having food and drug allergies of any kind were also excluded.
The individuals from Group I (orange juice concentrate +water) mentioned that the organoleptic properties such as flavor and taste of the drink were very good. However, during monsoon season, 50% of the participants complained of cold, and cough with some level of fever. Although, there was a feeling of fullness and immediate freshness, but the tiredness feeling did not abate.
The individuals from Group II (freeze dried amla powder+sugar+water) mentioned that the organoleptic properties are not good. Most of the participants did not like the taste of the product and smell of the product. There was also poor participant compliance. Many of the participants left the study. However, it was observed that about 50 % of the participants who continued with study showed minor to moderate improvement in their cough, cold conditions and also some improvement in their energy level.
The individuals from Group III (composition of the present disclosure) mentioned that the organoleptic properties are very good. The taste and flavor were acceptable to participants and all the participants completed the study. More than 90% participants mentioned that they observed improvement in their physical activity, observed decreased infection even during rainy season, reviving physical capacity in elderly patients, feeling of fullness and satisfaction, and increased capacity to do physical activity. Only 5 participants complained about cough and cold. None of the participants in this group exhibited adverse effects.
Summary and Conclusion:
Amla (Emblica officinalis) with Orange juice concentrate with an optimum combination of essential vitamins and minerals in a juice base helps improve above parameters providing good palatability and compliance. One to two tetrapaks per day showed no adverse effects in the subjects and was consumed without any difficulty for 2 weeks of trial period.
TECHNICAL ADVANCES AND ECONOMICAL SIGNIFICANCE
The process of the present disclosure described herein above has several technical advantages including, but not limited to, the realization of;asimple,economical, environmentally friendly,andefficientprocess for the preparation of the formulation, andaformulation having immune boosting, and antioxidant properties.
The embodiments as described herein above, and various features and advantageous details thereof are explained with reference to the non-limiting embodiments in the following description.
Throughout this specification the word “comprise”, or variations such as “comprises” or “comprising”, will be understood to imply the inclusion of a stated element, integer or step, or group of elements, integers or steps, but not the exclusion of any other element, integer or step, or group of elements, integers or steps.
The use of the expression “at least” or “at least one” suggests the use of one or more elements or ingredients or quantities, as the use may be in the embodiment of the disclosure to achieve one or more of the desired objects or results.
The foregoing description of specific embodiments so fully reveal the general nature of the embodiments herein, that others can, by applying current knowledge, readily modify and/or adapt for various applications of such specific embodiments without departing from the generic concept, and, therefore, such adaptations and modifications should and are intended to be comprehended within the meaning and range of equivalents of the disclosed embodiments. It is to be understood that the phraseology or terminology employed herein is for the purpose of description and not of limitation. Therefore, while the embodiments herein have been described in terms of preferred embodiments, those skilled in the art will recognize that the embodiments herein can be practiced with modification within the spirit and scope of the embodiments as described herein. Further, it is to be distinctly understood that the foregoing descriptive matter is to be interpreted merely as illustrative of the disclosure and not as a limitation.
Having described and illustrated the principles of the present disclosure with reference to the described embodiments, it will be recognized that the described embodiments can be modified in arrangement and detail without departing from the scope of such principles.
While considerable emphasis has been placed herein on the components and component parts of the preferred embodiments, it will be appreciated that many embodiments can be made and that many changes can be made in the preferred embodiments without departing from the principles of the disclosure. These and other changes in the preferred embodiment as well as other embodiments of the disclosure will be apparent to those skilled in the art from the disclosure herein, whereby it is to be distinctly understood that the foregoing descriptive matter is to be interpreted merely as illustrative of the disclosure and not as a limitation.

,CLAIMS:WE CLAIM:
1. An anti-oxidant and immune boosting formulation comprising;
(a) an orange juiceconcentrate in an amount in the range of 5 wt% to 15 wt%;
(b) an emblica officinalisin an amount in the range of 1 wt% to 2 wt%;
(c) vitamins in an amount in the range of 0.01 wt% to 1.5 wt%;
(d) mineralsalts in an amount in the range of 0.05 wt% to 1.5 wt%;
(e) citric acid in an amount in the range of 0.1 wt% to 1 wt%;
(f) at least one additive in an amount in the range of 80 wt% to 90 wt%; and
(g) q. s water,
wherein the amounts are in respect of the total amount of the components (a) to (f), and
wherein a brix of said formulation is in the range of 12 % to 14% and an acidity in the range of 0.15 % to 0.3%
2. The formulation as claimed in claim 1, wherein the ratio of the amount of water to the total amount of the components (a) to (f) is in the range of 5.5 wt% to 6.5 wt%
3. The formulation as claimed in claim 1, wherein said vitamins are selected from beta carotene, vitamin B1 (thiamine hydrochloride), vitamin B2(riboflavin sodium phosphate), vitamin B3 (nicotinamide), vitamin B5 (calcium pantothenate), vitamin B6 (pyridoxine hydrochloride), vitamin B9 (folic acid), vitamin C (ascorbic acid), and vitamin E (tocopheryl acetate).
4. The formulation as claimed in claim 1, wherein said mineral salts are selected from calcium lactate pentahydrate, magnesium sulphate heptahydrate, manganese sulphate, zinc sulphate heptahydrate, ferrous gluconate anhydrous, and sodium selenate.
5. The formulation as claimed in claim 1, wherein said additive is selected from a sweetening agent, a coloring agent,and a flavoring agent.
6. The formulation as claimed in claim 5, wherein said sweetening agent is selected from the group consisting of sugar, dextrose, natural fruit sugar, fructose, honey and stevia; saidcoloring agent is selected from sunset yellow and tartrazine; and said flavoring agent is an orange flavor.
7. The formulation as claimed in claim 1, said formulation comprises:
a) 9 wt% of orange juice concentrate;
b) 1.2 wt% of emblica officinalis freeze dried powder;
c) 1 wt% of beta carotene;
d) 0.0009 wt% of vitamin B1(Thiamine hydrochloride);
e) 0.0012 wt% of vitamin B2(Riboflavin sodium Phosphate);
f) 0.004 wt% of vitamin B3(Nicotinamide);
g) 0.004 wt% of vitamin B5(Calcium pantothenate);
h) 0.0007 wt% of vitamin B6(Pyridoxine hydro chloride);
i) 0.0002 wt% of vitamin B9(Folic Acid);
j) 0.4 wt% of vitamin C (Ascorbic acid);
k) 0.005 wt% of vitamin E (Tocopheryl acetate);
l) 0.6 wt% of Calcium lactate penta hydrate;
m) 0.3 wt% of Magnesium sulphate heptahydrate;
n) 0.0004 wt% of Manganese sulphate;
o) 0.007 wt% of Zinc sulphate hepta hydrate;
p) 0.0015 wt% ofFerrous gluconate anhydrous;
q) 0.000004 wt% ofSodium selenate;
r) 0.5 wt% of citric acid;
s) 80wt% of a sweetening agent;
t) 0.03 wt% of a coloring agents;
u) 0.2 wt% of a flavoring agent;
v) q.s. water, and

wherein the amounts are in respect of the total amount of the components (a) to (u).

8. The formulation as claimed in claim 1, said formulation comprises:
a) 13 wt% of orange juice concentrate;
b) 1.7 wt% of emblica officinalis freeze dried powder;
c) 1 wt% of beta carotene;
d) 0.0008 wt% of vitamin B1(Thiamine hydrochloride);
e) 0.0006 wt% of vitamin B2(Riboflavin sodium Phosphate);
f) 0.004 wt% of vitamin B3(Nicotinamide);
g) 0.002 wt% of vitamin B5(Calcium pantothenate);
h) 0.0006 wt% of vitamin B6(Pyridoxine hyrdro chloride);
i) 0.0003 wt% of vitamin B9(Folic Acid);
j) 0.30 wt% of vitamin C (Ascorbic acid);
k) 0.004 wt% of vitamin E (Tocopheryl acetate);
l) 0.10 wt% of Calcium lactate penta hydrate;
m) 0.0042 wt% of Magnesium sulphate heptahydrate;
n) 0.0002 wt% of Manganese sulphate;
o) 0.0021 wt% of Zinc sulphate hepta hydrate;
p) 0.0021 wt% of Ferrous gluconate anhydrous;
q) 0.000006 wt% of Sodium selenate;
r) 0.55 wt% of the citric acid;
s) 85 wt% of a sweetening agent;
t) 0.0509 wt% of a coloring agents;
u) 0.3 wt% of a flavoring agent;
v) q.s water, and
wherein the amounts are in respect of the total amount of the components (a) to (u).
9. The formulation as claimed in any one of the preceding claims, wherein said formulation is in the form of a tetrapak drink.
10. A process for preparing the formulation as claimed in claim 1, wherein said process comprising the following steps:
(i) mixing a predetermined amount of emblica officinalis in a first predetermined amount of water having a temperature in the range of 60 oC to 70 oC in a first tank under stirring for a time period in the range of 10minutes to 15minutesto obtain a uniform slurry;
(ii) transferring the uniform slurry to a second tank containing a second predetermined amount of water understirringat a speed in the range of 10rpm to 20 rpm for a time period in the range of 10 minutes to 15 minutes to obtaina uniform blend;
(iii) passing said uniform blendthrough a homogenizer under a pressure in the range of 2000 Psi to 3000Psi to obtain a homogenized blend;
(iv) filtering said homogenized blend through a filter selected from a line filter and a kitten filterhaving a pore size in the range of 350 microns to 500 microns to obtain a first blend;
(v) separately, in a third tank containing a third predetermined amount of waterhaving a temperature in the range of 80 oC to 85oC, mixing a predetermined amountof a sweetening agent, vitamin C (ascorbic acid), citric acid,mineral salts,an orange juice concentrate and a coloring agent in to obtain a clearblend;
(vi) filtering said clear blend througha filter selected from line filter and kitten filter having a pore size in the range of 350 microns to 500microns to obtain a second blend;
(vii) transferring said first blend and said second blend in a fourth tank and mixed thoroughlyto obtain a resultant solution;
(viii) adding vitamins selected fromthe group consisting of beta carotene, vitamin B1 (thiamine hydrochloride), vitamin B2 (riboflavin sodium phosphate), vitamin B3 (nicotinamide), vitamin B5 (calcium pantothenate), vitamin B6 (pyridoxine hydrochloride), vitamin B9(folic acid), and vitamin E (tocopheryl acetate)and a flavoringagent tosaid resultant solution in said fourth tank to obtain a bulk solution;and
(ix) making up a volume of said bulk solution to a desired batch size byadding a fourth predetermined amount of water followed byfiltering by a filterselected from a line filter and a kitten filterhaving a pore size in the range of 350 microns to 500 microns and transferring to RBT (Ready Beverage Tank)to obtain said formulation with a desired batch size.
11. The process as claimed in claim 10, wherein said emblica officinalisis in the form of freeze dried powder.
12. The process as claimed in claim 10, wherein said first tank is a mixing tank.
13. The process as claimed in claim 10, wherein said second tank is a blending tank.
14. The process as claimed in claim 10, wherein said third tank is a blending tank.
15. The process as claimed in claim 10, wherein said fourth tank is a bulk tank.
16. The process as claimed in claim 10, wherein said first predetermined amount of water is in the range of 3wt% to 5wt%; said second predetermined amount of water is in the range of18wt% to 22 wt%; and said third predetermined amount of water is in the range of 48wt% to 52 wt%; and said fourth predetermined amount of water is in the range of 25wt% to 28 wt%, with the total amount of water.
17. The process as claimed in claim 10, wherein said flavoring agent is orange flavor, said sweetening agent is selected from the group consisting of sugar, dextrose, natural fruit sugar, fructose, honey, and stevia; and said coloring agent is selected from sunset yellow and tartrazine.
18. The process as claimed in claim 10, wherein water used is high purity water.
Dated this 8th day of September, 2020

MOHAN RAJKUMAR DEWAN
of R.K. DEWAN & COMPANY
IN/PA-25
APPLICANT’S PATENT ATTORNEY

TO,
THE CONTROLLER OF PATENTS
THE PATENT OFFICE, AT MUMBAI