Title of Invention

ORAL REHYDRATION COMPOSITION

Abstract An Oral Rehydration Composition and method for producing an improved fruit juice based oral rehydration solution is disclosed. The oral rehydration solution of the invention is Ready-to-Drink, Palatable and Patient friendly fluid, containing water, electrolytes and carbohydrates. The oral rehydration product is a fruit based, energy electrolyte drink made available in aseptic packing, packed on state of the art, automatic packing lines. The product is designed to treat individuals with severe diarrhoea brought about by cholera or other causes.
Full Text

TITLE
Oral Rehydration Composition
FIELD OF INVENTION
The present invention relates to an Oral Rehydration Composition.
This invention envisages an Oral Rehydration Solution, which is Ready-to-Drink, Palatable and Patient friendly fluid, containing water, electrolytes and carbohydrates and a process for the production of Oral Rehydration Solution.
INTRODUCTION
Dehydration is a clinical state in which the body does not retain sufficient fluids to maintain the normal functions of blood circulation, excretion of waste products through kidneys, temperature regulation and individual cell performance.
Approximately, sixty percent of our body weight is made up of water since all the cells that make up tissues, muscles, bones vessels and even blood are chiefly composed of water. Normally, water enters the body via the gastrointestinal tract. About 50- 60 % of the water is taken in as liquids and 40-50% is contained in the solid foods we consume. Oxidation processes taking place in the body also produce water which constitutes about 10-12 % of the water content of the body.
Water and electrolyte loss from the body occurs, under normal conditions, as (a) liquid loss (60-65%) through urine and faeces, majority being through urine; (b) vapour loss (35-40%) by exhalation of moist air from the lungs and perspiration through the skin.
An adult human should consume about 2-2.5 litres of water a day to compensate the fluid losses from the body. If all water intake stops and the body continues to loose water, it results in about 2% loss in body weight.

Electrolytes are ionised mineral elements and salts equally vital to normal body functioning. Electrolytes are essential for development of electrical potentials across cell membranes, thus affecting muscle contraction and nerve conduction, each electrolyte has specific functions e.g. Sodium regulates body fluid volume, blood volume and helps in maintaining the required acid-base balance, Potassium helps to regulate body fluids and mineral balance in and out of body cells and is involved in maintaining blood pressure, transmitting nerve impulses, and helping muscles and heart to contract.
Carbohydrates are a quick energy source to the body. Besides, carbohydrate containing beverages assist in rapid absorption of fluids in the gastro-intestinal tract.
Dehydration occurs due to either loss of excessive fluids from the body or inability of the patient to intake fluids as is found in the following conditions: -
• Enhanced physical activity, such as sports, strenuous exercise;
• Vomiting or diarrhoea due to gastroenteritis, food poisoning and the
like;
• Morning sickness / Hyperemesis gravidarum
• Pregnancy fatigue
• During the process of/just after child birth
• Post blood donation
• Post-surgery
• Post dental extraction
• Physiological dehydration as in sunstroke, exhaustion etc.
Dehydration results not only in body water loss, but also electrolyte
imbalance.
Symptoms of dehydration are muscle cramps, aches and soreness.
Dehydration and resultant low blood volume can lead to hypotension and
dizziness.
Dehydration can result in impaired mental activity, slow decision-making,
impaired judgement, difficulty in recall, fatigue, irritability, and thirst.

Prolonged dehydration can lead to coma and finally death specially in the case of infants and children.
The signs of dehydration are:
• Sunken cranial fontanel (in infants)
• Fast, weak pulse
• Increased respiratory rate
• Loss of skin elasticity
• Sunken, dry eyes
• Reduced amount of urine
• hyperthermia
Fluid and electrolyte replacement is vital here.
Dehydration is corrected by rehydration.
In order to help persons in dehydrated and/or energy deficit states, a
nutritional supplement is needed which can provide water, electrolytes
and energy readily.
Various substances have been tried since ancient times to help
dehydrated subjects. Some of them are as follows-
3000-1000 BC - Folk remedies (washed rice and honey, salt and
molasses).
1832 - First global cholera pandemic. Intravenous therapy introduced by
Latta.
1930fs - Hartman uses lactate in IV solution to prevent acidosis.
1940's - First oral rehydration solution (ORS) developed by Harrison and
Darrow.
1950's to early 1960's - Phillips and Wallace at US NAMRID in Taiwan
evolve modern IV therapy for cholera patients based on electrolyte
content of cholera stools.
1964 - Glucose-sodium co-transport mechanism characterized. Phillips
and Wallace use ORT (oral rehydration therapy) at US NAMRID in Taiwan.
1965-1970 - ORT developed further at Pakistan-SEATO Cholera Research
Laboratory, Dhaka and Johns Hopkins University International Center for
Medical Research and Training, Calcutta.

1971-1973 - ORT was successfully used on large scale in cholera outbreak in Bangladesh by Mahalanabis and colleagues.
1975 - WHO and UNICEF promote a single solution (WHO ORS) for world wide use.
1980 - WHO initiates Diarrhoeal diseases Control Program in effort to promote global use of ORS.
Thus Oral Rehydration Solution is an ideal supplement for fluid, electrolytes and energy deficit states.
Therefore, Rehydration is achieved in the following ways:-
(a) administration of intravenous or subcutaneous fluids - This method
needs hospitalisation of the individual, special equipment and
trained nursing staff which may not be available in villages &
outdoor areas at all. It also carries the risk of introducing infection
at the injection site &/or in the blood. This method is used only in
severe cases of dehydration and in cases where patient is not able
to ingest fluids orally due to excessive vomiting, unconsciousness
etc.
(b) introduction of liquids into the colon by enema since colon readily
absorbs fluids - This method also needs special equipment and
trained personnel and is quite uncomfortable to the patient.
(c) oral rehydration therapy where a mixture of water, electrolytes and
carbohydrates is administered orally. This method does not need
any hospitalisation, special equipment or trained personnel. It can
be used readily anywhere in the world, villages or cities, outdoors
or indoors. Oral consumption of fluids also leads to quenching of
thirst and satiety.
BACKGROUND OF THE INVENTION
Oral rehydration solutions are mixtures of water, electrolytes and carbohydrates used as nutritional supplements, to restore water and

electrolyte imbalance and to provide energy for subjects in a dehydration state.
United States Patent Application 20030194448 discloses a rehydration composition and oral delivery system that allows for enhanced functional ingredient delivery when ingested orally as water based solution. The rehydration composition comprises a low fiber colloidal hydrolyzed rice carbohydrate ingredient having, on a dry weight basis, less than 0.1% fiber and between 0.5% and 1.0% protein and between 0-0.5% and 1.0% fat, and having a dextrose equivalency (DE) value within the approximate range of 20-30 (commonly DE 25), and electrolytes such as sodium, potassium, citrate, and/or bicarbonate. The rehydration composition, which is concentrated or dried, becomes an oral rehydration solution (ORS) when mixed with water for oral consumption. The rehydration composition, when mixed with active ingredients such as vaccines, drugs, amino acids, mineral salts, vitamins, nutraceuticals, probiotics, prebiotics, flavours, or nutritive or non-nutritive sweeteners, is referred to as an oral delivery system. This oral delivery system may then be further diluted in a water base to produce an oral delivery solution that is suitable for oral ingestion by a user.
United States Patent 5164192 discloses an effervescent product for the preparation of an oral rehydration solution for the treatment of diarrhoea. The product comprises oligosaccharides and/or disaccharides, and/or monosaccharide's and/or amino acids as energy carriers, and (bi)carbonate and a bicarbonate precursor as alkalizing substances. The product has the form of a tablet or a powder.
United States Patent Application 20050008685 discloses a rehydration composition and oral delivery system that allows for enhanced functional ingredient delivery when ingested orally as water based solution. The rehydration composition comprises a liposomed electrolyte composition comprised of sodium, potassium, citrate, and/or bicarbonate. The rehydration composition, which is concentrated or dried, becomes an oral rehydration solution (ORS) when mixed with water for oral consumption. The rehydration composition may optionally contain carbohydrates, or functional ingredients, liposomed or not, such as vaccines, drugs, amino

acids, mineral salts, vitamins, nutraceuticals, probiotics, prebiotics, flavours, or nutritive or non-nutritive sweeteners. These oral rehydration compositions may then be concentrated to greater than 78% solids or dried to less than 5% moisture. The composition may also be concentrated to less than 78% solids and packaged aseptically or stabilized with preservative agents.
United States Patent 5489440 discloses a method for producing an improved rice flour-based oral rehydration solution using the enzymes cellulase and protease. The oral rehydration solution of the invention has low viscosity, low osmolality, and can be ingested through the nipple of a bottle. The oral rehydration product can also be dried into powder form before packaging and reconstituted at the time of use. The product is designed to treat individuals with severe diarrhoea brought about by cholera or other causes.
United States Patent Application 20040071793 discloses an improved oral rehydration solution comprising standard formulae of sugars, mineral salts and bicarbonates in combination with Croton species materials with or without the inclusion of material from the Uncaria species. The botanical components are concentrated biologically active materials and thus enhance therapeutic benefit. The Croton component functions as an effective non-paralytic agent in managing diarrhoea that is superior to loperamide resulting in a lower stool output. The functionality of the Uncaria species is as an effective anti-inflammatory agent via NF-DB activation inhibition and protecting gastrointestinal epithelial cells from oxidant-induced death.
United States Patent 5498408 discloses an oral rehydration formula containing a conventional carbohydrate, rice flour and carrot powder as carbohydrate sources. A formulated rehydration composition in powder form for oral administration consisting essentially of carbohydrates from rice flour, carrot powder, and conventional carbohydrates selected from the group consisting of maltodextrines, glucose polymers or mixtures thereof and electrolytes, wherein the weight ratio of rice flour to carrot powder in said composition ranges from 5:1 to 1:5, and the weight ratio of carbohydrates originating from rice flour and carrot powder to conventional carbohydrates ranges from 1:1 to 1:7, and wherein said

composition supplies after dissolution in water a total amount per liter of from 30 to 90 g carbohydrates, from 30 to 90 m Equivalents of Na+, from 18 to 42 m Equivalents of K+, from 25 to 35 m Equivalents of citrate ions from trisodium citrate dihydrate, from 30 to 90 m Equivalents of CI", and from 120 to 360 kcal/liter and has an osmolarity of from 210 to 290 mOsm/liter.
United States Patent 6572898 discloses a gel rehydration electrolyte composition providing a convenient and effective way of replenishing lost fluid and electrolytes. The gel rehydration electrolyte composition masks unpleasant taste of electrolyte and is readily consumed by young children and elderly who cannot tolerate the liquid or frozen forms of electrolytes. United States Patent 5733579 discloses an oral rehydration solution having indigestible oligosaccharides. Diarrhoea related dehydration requires fluid and electrolyte replacement. The primary etiology of antibiotic-associated diarrhoea (also known as pseudomembranous colitis) has been recognized as Clostridium difficile. It is believed that the indigenous micro flora of a healthy individual suppresses the normally present C. difficile. However, when the indigenous microflora are disrupted (e.g., during antibiotic treatment) overgrowth of C. difficile may occur causing diarrhoea and colitis. Treatment of diarrhoea related to C. difficile with rehydration therapy and antibiotics has proven effective, but many times relapse occurs. It has been suggested that normalization of the microflora will inhibit C. difficile relapse. Indigestible oligosaccharides have been shown to inhibit C. difficile infection.
Majority of the Oral Rehydration Salts available in the market are in powder form. These powder mixtures have to be reconstituted by adding water at the time of consumption. Thus it cannot be used if a source of clean, potable water and utensils like a bowl/tumbler/stirrer is not available readily. There is also a risk of introducing gastrointestinal infection and further worsening the situation. Most of oral rehydration powders are hygroscopic, deteriorating on exposure to moisture in the atmosphere; thus the product has a very short shelf life, besides being patient non-compliant especially with children because of bad taste.

Therefore, there is a great need for a ready-to-drink, palatable and patient friendly fluid, containing water, electrolytes and carbohydrates, made available in aseptic packing for treatment of dehydration.
OBJECT OF THE INVENTION
The object of the invention is to provide an oral rehydration composition.
Yet another object of the invention is to provide a process for the preparation of an oral rehydration composition.
SUMMARY OF THE INVENTION
The present invention provides a fruit based, energy electrolyte drink made available in aseptic packing, packed on state of the art, automatic packing lines.
According to this invention, therefore there is provided an oral rehydration composition, comprising
a) a therapeutically effective amount of electrolytes having mass of
about 0.05 to about 0.80 part per 100 parts of the solution;
b) at least one Natural fruit Juice dissolved in a water base having
mass of about 1 to about 10 parts per 100 parts of the solution;
c) Vitamin-C having mass of about 0.0425 to about 0.125 part per
100 parts of the solution;
d) Dextrose having mass of about 2 to about 3 parts per 100 parts
of the solution;
e) at least one Natural Sweetener having mass of about 0.025 to
about 15 parts per 100 parts of the solution.
In accordance with one embodiment of the invention, the electrolyte is a salt consisting of at least one compound selected from a group of salts consisting of Chloride Salts, Citrate Salts, Sodium Salts and Potassium Salts.
In accordance with one embodiment of the invention, the Chloride Salt is at least one compound selected from a group of compounds consisting of Calcium Chloride, Ammonium Chloride, Potassium Chloride, Sodium Chloride and Magnesium Chloride.

Typically, the mass of the Chloride Salt ranges from about 0.05 to about
0.5 part per 100 parts of the solution.
In accordance with another embodiment of the invention, the Citrate Salt
is at least one compound selected from a group of compounds consisting
of Ammonium Citrate, Calcium Citrate, Sodium Citrate, Potassium Citrate
and Magnesium Citrate.
Typically, the mass of the Citrate Salt ranges from about 0.1 to about 0.8
part per 100 parts of the solution.
In accordance with another embodiment of the invention, the Sodium Salt is at least one compound selected from a group of compounds consisting of Sodium Bicarbonate, Sodium Citrate, Sodium Chloride and Sodium Lactate.
Typically, the mass of the Sodium Salt ranges from about 0.05 to about 0.8 part per 100 parts of the solution.
In accordance with another embodiment of the invention, the Potassium Salt is at least one compound selected from a group of compounds consisting of Potassium Bicarbonate, Potassium Chloride, Potassium Citrate and Potassium Gluconate.
Typically, the mass of the Potassium Salt ranges from about 0.1 to about
0.4 part per 100 parts of the solution.
In accordance with another embodiment of the invention, the Natural fruit
Juice is at least one fruit Juice selected from a group consisting of Lemon,
Apple, Orange and Pineapple.
Typically, the mass of the Lemon fruit Juice ranges from about 5 to about
10 parts per 100 parts of the solution.
Typically, the mass of the Apple fruit Juice ranges from about 1 to about
10 parts per 100 parts of the solution.
Typically, the mass of the Orange fruit Juice ranges from about 1.5 to
about 10 parts per 100 parts of the solution.
Typically, the mass of the Pineapple fruit Juice ranges from about 1.5 to
about 10 parts per 100 parts of the solution.

In accordance with another embodiment of the invention, the Vitamin-C is
at least one compound selected from Sodium Ascorbate and Calcium
Ascorbate.
In accordance with another embodiment of the invention, the Natural
Sweetener is at least one compound selected from a group of compounds
consisting of Mannitol, Glucose, Fructose, Sucrose, Stevia, and Honey.
Typically, the mass of the Mannitol ranges from about 5.5 to about 11
parts per 100 parts of the solution.
Typically, the mass of the Glucose ranges from about 3 to about 5 parts
per 100 parts of the solution.
Typically, the mass of the Fructose ranges from about 5 to about 10 parts
per 100 parts of the solution.
Typically, the mass of the Sucrose ranges from about 7.5 to about 15
parts per 100 parts of the solution.
Typically, the mass of the Stevia ranges from about 0.025 to about 0.030
part per 100 parts of the solution.
Typically, the mass of the Honey ranges from about 3 to about 8 parts per
100 parts of the solution.
In accordance with another aspect of the invention, there is provided a process for preparing an oral rehydration composition comprising the following steps
a) dissolving predetermined mass of sweetener in a
predetermined quantity of hot water in a dissolution tank;
b) adding fruit juice (Apple / Lemon / Orange / Pineapple) in the
dissolution tank and mixing well to get sweetened fruit juice;
c) dissolving the weighed quantity of Dextrose in a
predetermined quantity of water and adding electrolytes and
mixing well to get Dextrose and electrolytes solution;
d) adding Vitamin-C Salts to the Dextrose and electrolytes
solution and mixing well and adding to the sweetened fruit
juice and mixing well to get a bulk solution;
e) Filtering the bulk solution through online stainless steel filters
of 80 micron nylon and 120 micron in a blending tank to get
a filtered solution;

f) Optionally adding flavour through a clean filter cloth to the
filtered solution and mixing well and making up the volume
up to a mark with water and mixing well to get flavoured
solution;
g) pasteurising the flavoured solution and aseptically filled in an
automatic machine.
The present invention envisages an Oral Rehydration Solution, which is Ready-to-Drink, Palatable and Patient friendly fluid, containing water, electrolytes and carbohydrates.
More particularly, this invention further envisages a fruit based, energy electrolyte drink made available in aseptic packing, packed on state of the art, automatic packing lines.
A further aspect of this invention is that the product is made available in different flavours e.g. lemon, orange, apple, pineapple and the like making it more user friendly and palatable.
Still further, the product according to this invention is free from preservatives.
DETAILED DESCRIPTION OF THE INVENTION
This invention describes an oral rehydration solution made available in a ready -to-drink aseptic pack containing the following ingredients:-
1) Natural fruit Juice or Concentrate like Lemon, Apple, Orange and
Pineapple.
2) Sodium Chloride 0.05 to 0.50 parts per 100 parts.
3) Sodium Citrate 0.10 to 0.80 parts per 100 parts.
4) Potassium Chloride 0.10 to 0.40 parts per 100 parts.
5) Dextrose (anhydrous) -> 2 to 3 parts per 100 parts.
6) Vitamin C (Ascorbic acid) -» 0.0425 to 0.125 parts per 100 parts.
7) Sucrose - 7.5 to 15 parts per 100 parts.

The oral rehydration solution according to this invention is manufactured by the following method: -
The ingredients are measured out in suitable proportion as mentioned
above.
Sweetener is dissolved in hot purified water and mixed well. To this, juice
or concentrate of the fruit of choice is added; then the electrolytes,
Dextrose and Ascorbic acid are added. The resultant mixture is stirred and
mixed well.
The solution so obtained is filtered through online SS steel filters of 80
microns Nylon and 120 micron into the blending tank.
The volume is made up by adding more purified water.
The solution so obtained is checked for appearance, taste and smell, Brix
at room temperature, acidity (w.r.t Citric Acid), pH and microbial count.
The results should match the following criteria-



After receiving the report, the bulk solution is passed through balance tank to regeneration coils, de-aerator, heating coils, holding coils, cooling and chilling coils (pasteurisation).
It is insured that CIP (clean in process) is completed before processing.
The Tetrapak laminate is passed through Hydrogen Peroxide solution and subsequently dried at 120°C.
The pasteurised solution is sent to TBA machine to fill into Tetrapak and sealed with overprinting of Batch Code, MRP and Date of Mfg. details.
The present invention contains about 200 ml of the solution aseptically packed in a Tetra Pak.
The ingredients that are present in this solution are:
Fruit Juices: The invented preparation contains one or more of the
following
Lemon: 5 to 10%
Apple: 1 - 10%
Orange: 1.5 - 10%
Pineapple: 1.5 to 10%
Salts: Each 100 parts of the invented solution contains
(a) Sodium Chloride 0.05 to 0.50 parts
(b) Potassium Chloride 0.10 to 0.40 parts
(c) Sodium Citrate 0.10 to 0.80 parts
(1) Dextrose 2 to 3 parts

Further, the source of Chloride Salts would be Calcium Chloride, Ammonium Chloride, Potassium Chloride, Sodium Chloride, Magnesium Chloride etc.
The source of Citrate Salts that could be used is Ammonium Citrate, Calcium Citrate, Sodium Citrate, Potassium Citrate, Magnesium Citrate etc.
The source of Sodium Salts is Sodium Bicarbonate, Sodium Citrate, Sodium Chloride, and Sodium Lactate.
The source of Potassium Salts is Potassium Bicarbonate, Potassium Chloride, Potassium Citrate, and Potassium Gluconate.
Vitamins: 100 parts of the invented preparation contains Vitamin - C in
the range of 0.0425 to 0.125 parts. The source of Vitamin-C could be
Sodium Ascorbate or Calcium Ascorbate.
Natural Sweeteners: 100 parts of the invented preparation contains one
or more of the following
Mannitol - 5.5 to 11 parts
Glucose - 3 to 5 parts
Fructose - 5 to 10 parts
Sucrose » 7.5 to 15 parts
Stevia - 0.025 to 0.030 parts
Honey - 3 to 8 parts
Manufacturing Process:
METHOD - 1
1. Preparation of Syrup:
Dissolve known quantity of Sweetener in known quantity of hot water in a dissolution tank.

To this, add fruit juice (Apple / Lemon / Orange / Pineapple) and mix well. 2. Preparation of bulk solution:
Dissolve the weighed quantity of Dextrose in a known quantity of water. To this, add Salts and mix well.
To the above solution, add Vitamin-C Salts, mix well and add to the stage-
1 and mix well.
Filter the above solution through online stainless steel filters of 80 micron nylon and 120 micron in to the blending tank.
To the filtered solution, add flavour through a clean filter cloth and mix well. Make up the volume up to the mark with water and mix well. Drawn samples for quality control testing and analyse for the following parameters.
(a) Description
(b) Brix
(c)pH
(d) Acidity (as Citric acid)
The solution is pasteurised and aseptically filled on automatic machine.
METHOD - 2
1. Preparation of bulk solution:
Dissolve the weighed quantity of Dextrose in a known quantity of water. To this, add Salts and mix well.
To the above solution, add Vitamin-C Salts, mix well and add to the stage-
2 and mix well.

2. Preparation of Syrup:
Dissolve known quantity of Sweetener in known quantity of hot water in a dissolution tank.
To this, add fruit juice (Apple / Lemon / Orange / Pineapple) and mix well.
Filter the above solution through online stainless steel filters of 80 micron nylon and 120 micron in to the blending tank.
To the filtered solution, add flavour through a clean filter cloth and mix well. Make up the volume up to the mark with water and mix well.
Drawn samples for quality control testing and analyse for the following parameters.
(e) Description
(f) Brix
(g)pH
(h) Acidity (as Citric acid)
The solution is pasteurised and aseptically filled on automatic machine.
METHOD - 3
1. Preparation of Syrup:
Dissolve known quantity of Sweetener in known quantity of hot water in a dissolution tank.
To this, add fruit juice (Apple / Lemon / Orange / Pineapple) and mix well.
2. Preparation of Bulk solution:
Preparation of Dextrose Solution:

Dissolve the weighed quantity of Dextrose in a known quantity of water and add to contents of stage-1 through a clean filter cloth and mix well.
Preparation of Salt Solution:
Dissolve salts in known quantity of Purified water. To this, add Vitamin-C Salts and mix well. Transfer the solution to stage -1 and mix well.
Filter the above solution through online stainless steel filters of 80 micron nylon and 120 micron in to the blending tank.
To the filtered solution, add flavour through a clean filter cloth and mix well. Make up the volume up to the mark with water and mix well.
Drawn samples for quality control testing and analyse for the following parameters.
(i) Description
(j) Brix
(k)pH
(I) Acidity (as Citric acid)
The solution is pasteurised and aseptically filled on automatic machine. Clinical Report
The experimental data from ORS-L administration has been clinically confirmed by a large team of Doctors and researchers, from different parts of the country.
A comparative blind study was conducted with other leading brands in the market viz. Electrol, Glucon-D along with the composition of this invention (ORS-L).
The study was carried out on 60 individuals (Males, Females and Children)

aged between 10-60 years, which also included Military Personnel, Sports Athletes. They were divided into 3 groups. One group of 20 individuals were administered with Electral, the second group of 20 individuals were administered with Glucon-D and the remaining 20 were administered ORS-L The therapeutic properties of ORS-L, Electrol, Glucon-D were studied in these individuals, with respect to hypotension, hygoglycaemia, diarrhoea, dehydration, febrile conditions, heat wave exhaustion, and fatigue.
It was found that ORS-L showed a significantly positive effect, when compared to the other groups in reducing fatigue. It also showed a better euphoric effect than the other groups.
Being a ready drink, easily available in aseptic Tetra Packs, ORS-L was found to be better compliant, refreshing and palatable than the other rehydrating supplements. Individuals showed signs of rehydration, refreshed and energised, normal blood pressure.
ORS-L was also found to be effective and reduced fatigue, when administered as a pre and post-operative drink. ADVANTAGES OF THIS INVENTION OVER PRIOR ART
1) Fruit based Energy, Electrolyte aqueous solution ready-to-drink, which
is excellent in taste.
2) Free from Preservatives.
3) State-of-the-art aseptic manufacturing and packing technology.
4) Tamper evident (pack blows up even if there is a microscopic hole)
5) Portable to carry.
EXAMPLES
Example - 1
1. Preparation of Syrup:
80 gm Glucose was dissolved in 500 ml of water at 50 °C in a dissolution
tank.
To this, 100 ml Apple fruit juice was added and mixed well.
2. Preparation of bulk solution:

40 gm Dextrose was dissolved in a 500 mi of water. To this, 5 gm Sodium
chloride, 4 gm Potassium Chloride, 8 gm Sodium Citrate was added and
mixed well.
To the above solution, 1.6 gm Sodium Ascorbate was added and mixed
well and added to the stage-1 and mixed well.
Above solution was filtered through online stainless steel filters of 80
micron nylon and 120 micron in to the blending tank.
To the filtered solution, apple flavour was added through a clean filter
cloth and mixed well. Volume of this solution was made up to 2 litres with
water and mixed well.
Samples were drawn and analysed for the following parameters.
(a) Description
(b) Brix
(c)pH
(d) Acidity (as Citric acid)
The solution is pasteurised and aseptically filled on automatic machine.



Example - 2
1. Preparation of bulk solution:
40 gm Dextrose was dissolved in 500 ml of water. To this, 5 gm Sodium chloride, 4 gm Potassium Chloride, 8 gm Sodium Citrate was added and mixed well.
To the above solution, 1.6 gm Sodium Ascorbate was added, mixed well and this solution was added to the stage-2 solution and mixed well.
2. Preparation of Syrup:
200 gm Sucrose was dissolved in 500 ml of water at 50 °C in a dissolution
tank.
To this, 140 ml fruit juice (Lemon) was added and mixed well.
The above solution was filtered through online stainless steel filters of 80
micron nylon and 120 micron in to the blending tank.
To the filtered solution, Lemon flavour was added through a clean filter
cloth and mixed well. The volume of solution was made up to 2 litres with
water and mixed well.
Samples were drawn and analysed for the following parameters.
(e) Description
(f) Brix
(9)pH
(h) Acidity (as Citric acid)
The solution is pasteurised and aseptically filled on automatic machine.


Example - 3
1. Preparation of Syrup:
80 gm Glucose was dissolved in 500 ml of water at 50 °C in a dissolution
tank.
To this, 100 ml fruit juice (Orange) was added and mixed well.
2. Preparation of Bulk solution:
Preparation of Dextrose Solution:
40 gm Dextrose was dissolved in 500 ml water and this solution was added to solution of stage-1 through a clean filter cloth and mixed well. Preparation of Salt Solution:
5 gm Sodium chloride, 4 gm Potassium Chloride, 8 gm Sodium Citrate was dissolved in 500 ml Purified water. To this, 1.6 gm Sodium Ascorbate was added and mixed well. This solution was transferred to stage -1 solution and mixed well.

The above solution was filtered through online stainless steel filters of 80
micron nylon and 120 micron in to the blending tank.
To the filtered solution, Orange flavour was added through a clean filter
cloth and mixed well. The volume was made up to 2 litres with water and
mixed well.
Samples were drawn and analysed for the following parameters.
(i) Description
(j) Brix
(k)pH
(I) Acidity (as Citric acid)
The solution is pasteurised and aseptically filled on automatic machine.


Example - 4
1. Preparation of Syrup:
80 gm Glucose was dissolved in 500 ml water at 50 °C in a dissolution tank-To this, 100 ml Pineapple fruit juice was added and mixed well.
2. Preparation of bulk solution:
40 gm Dextrose was dissolved in a 500 ml of water. To this, 5 gm Sodium
chloride, 4 gm Potassium Chloride, 8 gm Sodium Citrate was added and
mixed well.
To the above solution, 1.6 gm Sodium Ascorbate was added mixed well
and this solution was added to the stage-1 solution and mixed well.
The above solution was filtered through online stainless steel filters of 80
micron nylon and 120 micron in to the blending tank.
To the filtered solution, Pineapple flavour was added through a clean filter
cloth and mixed well. The volume of solution was made up to 2 litres with
water and mixed well. Samples were drawn and analysed for the following
parameters.
(a) Description
(b) Brix
(c)pH
(d) Acidity (as Citric acid)
The solution is pasteurised and aseptically filled on automatic machine.






We claim
1. An oral rehydration composition, comprising
a) a therapeutically effective amount of electrolyte having mass of
about 0.05 to about 0.80 part per 100 parts of the solution;
b) at least one Natural fruit Juice dissolved in a water base having
mass of about 1 to about 10 parts per 100 parts of the solution;
c) Vitamin-C having mass of about 0.0425 to about 0.125 part per
100 parts of the solution;
d) Dextrose having mass of about 2 to about 3 parts per 100 parts
of the solution;
e) at least one Natural Sweetener having mass of about 0.025 to
about 15 parts per 100 parts of the solution.

2. An oral rehydration composition as claimed in claim 1, wherein the
electrolyte is at least one salt selected from a group of salts consisting
of Chloride Salts, Citrate Salts, Sodium Salts and Potassium Salts.
3. An oral rehydration composition as claimed in claim 2, wherein the
Chloride Salts is at least one compound selected from a group of
compounds consisting of Calcium Chloride, Ammonium Chloride,
Potassium Chloride, Sodium Chloride and Magnesium Chloride.
4. An oral rehydration composition as claimed in claim 2, wherein the
mass of the Chloride Salt ranges from about 0.05 to about 0.5 part per
100 parts of the solution.
5. An oral rehydration composition as claimed in claim 2, wherein the
Citrate Salt is at least one compound selected from a group of
compounds consisting of Ammonium Citrate, Calcium Citrate, Sodium
Citrate, Potassium Citrate and Magnesium Citrate.
6. An oral rehydration composition as claimed in claim 2, wherein the
mass of the Citrate Salt ranges from about 0.1 to about 0.8 part per
100 parts of the solution.
7. An oral rehydration composition as claimed in claim 2, wherein the
Sodium Salt is at least one compound selected from a group of
compounds consisting of Sodium Bicarbonate, Sodium Citrate, Sodium
Chloride and Sodium Lactate.

8. An oral rehydration composition as claimed in claim 2, wherein the
mass of the Sodium Salt ranges from about 0.05 to about 0.8 part per
100 parts of the solution.
9. An oral rehydration composition as claimed in claim 2, wherein the
Potassium Salt is at least one compound selected from a group of
compounds consisting of Potassium Bicarbonate, Potassium Chloride,
Potassium Citrate and Potassium Gluconate.
10. An oral rehydration composition as claimed in claim 2, wherein the
mass of the Potassium Salt ranges from about 0.1 to about 0.4 part
per 100 parts of the solution.
11. An oral rehydration composition as claimed in claim 1, wherein the
Natural fruit Juice is at least one fruit Juice selected from a group of
fruit Juices consisting of Lemon, Apple, Orange and Pineapple.
12. An oral rehydration composition as claimed in claim 11, wherein the
mass of the Lemon fruit Juice ranges from about 5 to about 10 parts
per 100 parts of the solution.
13. An oral rehydration composition as claimed in claim 11, wherein the
mass of the Apple fruit Juice ranges from about 1 to about 10 parts
per 100 parts of the solution.
14. An oral rehydration composition as claimed in claim 11, wherein the
mass of the Orange fruit Juice ranges from about 1.5 to about 10 parts
per 100 parts of the solution.
15. An oral rehydration composition as claimed in claim 11, wherein the
mass of the Pineapple fruit Juice ranges from about 1.5 to about 10
parts per 100 parts of the solution.
16. An oral rehydration composition as claimed in claim 1, wherein the
Vitamin-C is a compound selected from Sodium Ascorbate and Calcium
Ascorbate.
17. An oral rehydration composition as claimed in claim 1, wherein the
natural sweetener is at least one sweetener compound selected from a
group of compounds consisting of Mannitol, Glucose, Fructose,
Sucrose, Stevia, and Honey.
18. An oral rehydration composition as claimed in claim 17, wherein the
mass of the Mannitol ranges from about 5.5 to about 11 parts per 100
parts of the solution.

19. An oral rehydration composition as claimed in claim 17, wherein the
mass of the Glucose ranges from about 3 to about 5 parts per 100
parts of the solution.
20. An oral rehydration composition as claimed in claim 17, wherein the
mass of the Fructose ranges from about 5 to about 10 parts per 100
parts of the solution,
21. An oral rehydration composition as claimed in claim 17, wherein the
mass of the Sucrose ranges from about 7.5 to about 15 parts per 100
parts of the solution.
22. An oral rehydration composition as claimed in claim 17, wherein the
mass of the Stevia ranges from about 0.025 to about 0.030 part per
100 parts of the solution.
23. An oral rehydration composition as claimed in claim 17, wherein the
mass of the Honey ranges from about 3 to about 8 parts per 100 parts
of the solution.
24. A process for preparing an oral rehydration composition as claimed in
any one of the preceding claims comprising the following steps

a) dissolving predetermined mass of sweetener in a predetermined
quantity of water at temperature in the range of 30 to 80 °C in a
dissolution tank;
b) adding fruit juice (Apple / Lemon / Orange / Pineapple) in the
dissolution tank and mixing well to get sweetened fruit juice;
c) dissolving the weighed quantity of Dextrose in a predetermined
quantity of water and adding electrolytes and mixing well to get
Dextrose and electrolytes solution;
d) adding Vitamin-C Salts to the Dextrose and electrolytes solution
and mixing well and adding to the sweetened fruit juice and
mixing well to get a bulk solution;
e) filtering the bulk solution through online stainless steel filters of
80 micron nylon and 120 micron in a blending tank to get a
filtered solution;
f) optionally adding flavour through a clean filter cloth to the
filtered solution and mixing well and making up the volume up
to a mark with water and mixing well to get flavoured solution;

g) pasteurising the flavoured solution and aseptically filled in an
automatic machine.
25. A composition and a process for preparing the composition substantially as herein described and illustrated with reference to the examples.


Documents:

458-che-2005 amended claims 27-05-2011.pdf

458-che-2005 power of attorney 27-05-2011.pdf

458-CHE-2005 AMANDED CLAIMS 13-05-2010.pdf

458-che-2005 correspondence others 27-05-2011.pdf

458-CHE-2005 CORRESPONDENCE OTHERS 13-05-2010.pdf

458-CHE-2005 AMANDED PAGES OF SPECIFICATION 23-10-2009.pdf

458-CHE-2005 EXAMINATION REPORT REPLY RECEIVED 23-10-2009.pdf

458-CHE-2005 OTHER DOCUMENT 23-10-2009.pdf

458-che-2005-abstract.pdf

458-che-2005-claims.pdf

458-che-2005-correspondnece-others.pdf

458-che-2005-description(complete).pdf

458-che-2005-description(provisional).pdf

458-che-2005-form 1.pdf

458-che-2005-form 26.pdf

458-che-2005-form 3.pdf

458-che-2005-form 5.pdf


Patent Number 247946
Indian Patent Application Number 458/CHE/2005
PG Journal Number 23/2011
Publication Date 10-Jun-2011
Grant Date 06-Jun-2011
Date of Filing 21-Apr-2005
Name of Patentee JAGDALE INDUSTRIES LIMITED
Applicant Address #782, 15TH CROSS, 1ST PHASE, J.P. NAGAR, BANGALORE 560 078, KARNATAKA, INDIA
Inventors:
# Inventor's Name Inventor's Address
1 NAGRAJA RAO RADHAKRISHNARAO JAGDALE JAGDALE INDUSTRIES LTD, #782, 15TH CROSS, 1ST PHASE, J.P. NAGAR, BANGALORE 560 078, KARNATAKA, INDIA.
PCT International Classification Number A61K
PCT International Application Number N/A
PCT International Filing date
PCT Conventions:
# PCT Application Number Date of Convention Priority Country
1 NA