Title: Oral Rehydration Composition
Preamble:
The following specification is a continuation Of or addition to a granted patent IN 247946 granted towards application No. 458/CHE/2005 on 21st April, 2005 in favour of Jagdale Industries Ltd. The specification particularly describes an Oral Rehydration Composition (ORC) for restoring hydration in humans during a hydration stress. The hydration stress may be caused by a pathology or physiological caused due to heat or physical activity. The said additional disclosure (as it was with the parent patent) emphasizes the need for taste enhancement that has emerged as the preponderant consideration in selection of a drink by consumers. Taste has also been scientifically found to be the cardinal factor in consumers' compliance with rehydration prescriptions and is therefore an important addition to the art. The said ORC is particularly formulated to address the physiological needs of people under hydration stress in hot and humid conditions. The other special features and inventiveness behind the invention will become apparent upon reading the detailed description that follows.
Field & Use of invention
The present invention is a further addition /improvement over the granted patent IN 247946 that relates to an Oral Rehydration Composition and a method of making the same. This invention envisages a ready-to-drink, high energy Oral Rehydration Solution, which is a Palatable and a consumer friendly.The said ORC contains water, electrolytes, carbohydrates in a formula devised to suit individuals in hot & humid conditions and also has a novel process for the production of Oral Rehydration Solution. 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. This can be a potentially dangerous situation when left unattended which has also been known to cause fatalities. It has been estimated that dehydration arising from lack of access to clean & safe fluids accounts for approximately 1.8 Million deaths per annum.
Dehydration is a common malady especially in hot tropical countries such as India where access to clean and healthy rehydration fluid resources are scarce and infection rates are very high. For instance even plain potable water as a rehydration resource is not available to 1.3 Billion people in India & China alone. Scientific literature quoted below however confirm that in instances where heat is an additional factor during dehydration, water alone is insufficient to address rehydration needs and the situation will have to remedied by infusing electrolytes as well. Compounded to this problem is patient compliance as addition of electrolytes leave an unpleasant metallic taste in the mouth which deters people from compliance to the rehydration program. This is particularly true of very young subjects who do not understand consequences and will need taste as an incentive for rehydration compliance. Therefore many workers have studied the effects of taste of the composition and compliance and concluded that they collude positively.

In addition to this, patients in third world countries such as India are vastly malnourished complicate the problems of coping with dehydration. Dehydration may be through gut/non-gut pathology, drug induced, induced due to surgical procedures such as in a dental procedure, non-pathological yet physically challenging situations such as pregnancy/child birth or even when engaged in sports/exercise wherein the individual is unable to meet energy needs by eating solids and need not only fluids but also a source of instant energy for recovery. In such situations, a drink that is rich in electrolytes, aseptic, tasty, and high on instant energy while being economically accessible serves as a boon to consumers.
The scope of the present invention therefore encompasses rehydration needs of all age groups, especially in hot and humid countries and in any individual who may face a risk of dehydration either through pathology or otherwise as mentioned earlier.
Priorart&Problem to be solved
The prior art described hereunder, has already been stated in the parent specification IN 247946 and has been extracted for ready reckoning.
Dehydration as a risk to survival has been known to man for thousands of years. Various substances have been tried since ancient times to help dehydrated subjects. Some of them are as follows-
As early as 3000-1000 BC-Folk remedies using washed rice and honey, salt and molasses were used. It was perhaps the first recorded global cholera epidemic 1832 - First global cholera pandemic that made a strong case for the need for a clean effective rehydration option .Latta in 1930 developed an Intravenous Therapy as remedy for rehydration and this was further enhanced by Hartman through addition of lactate in the IV rehydration solution in order to prevent acidosis.
Intravenous therapy introduced by Latta. 1930's- 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.l971-1973-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 worldwide use.
1980 - WHO initiates Diarrhoeal diseases Control Program in effort to promote global use of ORS.
The WHO recommended formula thus became a benchmark around which many other modifications have been made for several other types of rehydration needs. The WHO formula, is well known and is adapted to treat people experiencing dehydration due to gut pathology, for example diarrhea/vomiting or both. This is typically isotonic with blood and such an osmotic strength's potency as a rehydrating

agents have been questioned by workers later. While Osmolarity required for proper hydration is a much debated issue with varying opinions propounded by various scholars, the need for replenishing the lost sodium, potassium and water along with adequate simple sugars for energy has found common consensus. Sodium and Potassium are ions that are critical for intra and extra cellular fluid balance. The balance of these ions are normally lost when there is loss of fluid from the body by way of fluid loss due to gut pathology/non-gut pathology), blood loss (as found during surgery/surgical procedures/parturition and so on) or even fluid loss due sweat or dehydration through heat stress. In such instances, ingestion of water alone after body fluid loss is inadequate to restore fluid balance.
Shirreffs SM, Taylor AJ, Leiper JB, Maughan RJ. (SourceDepartment of Environmental and Occupational Medicine, University Medical School, Aberdeen, Scotland.) in their paper entitled "Post-exercise rehydration in man: effects of volume consumed and drink sodium content" have stated: "A drink volume greater than sweat loss during exercise must be ingested to restore fluid balance, but unless the sodium content of the beverage is sufficiently high this will merely result in an increased urinary output." Hence the importance of a fluid regulatory formula directed towards specific needs is imperative to restore and maintain fluid balance.
It is clearly seen that majority of the Oral Rehydration Salts available in the market especially in India 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 and so on are not available readily. There is also a risk of introducing gastrointestinal infection and further worsening the situation. Reconstitution of powders is therefore, a challenge in countries like India with low literacy rates, lack of access to potable water and access to germ free utensils. 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.
The other issue with powdered forms pertains to their effectiveness which is dependent on accuracy with which consumers following pack instructions. Several studies have affirmed that preparations made at home do not conform to electrolyte, osmolarity and other types of parameters intended through the formula. In the paper entitled "The management of Diarrhoeal diseases" by Guerin N [Child Trop, 1985 ;(158):20-30] a analysis of home-made remedies for rehydration in the event of a diarrhea. The author opines that while such remedies abound and are well known for a long time, they lack precision in formulation. These remedies are not standardized for electrolyte/sugar/pH.
Even taste enhancers by arbitrarily mixing the powders in more palatable fluids such as juices when done at home seem to be less effective. Nijssen-Jordan C in his paper entitled "Can oral rehydration solution be safely flavored at home?" [PediatrEmerg Care. 1997 Dec;13(6):374-5.] concludes that adding flavours in the form of fruit juices and other forms of flavours available in households to unsweetened Oral Rehydration Solutions unfavourably alter the electrolyte content and osmolarity. Another study by D. Moroeska to Loo, Fedd Van der Graaf and Walter TjonA.Ten entitled, " The effect of flavouring Oral Rehydration Solution on its Composition and Palatability" confirms the same findings and they have

quantified the extent of change in electrolytes and osmolarity. This therefore indicates a need for a regulated approach in conferring taste to Oral Rehydration Compositions.
A standardized formula that will consistently give desirable results in rehydration is required.
It has also been found that the taste of the rehydration solution is an important factor that determines compliance to the rehydration regimen. Scientific studies have objectively found the same results. Maughan RJ, Leiper JB, Shirreffs SM. (Br J Sports Med. 1997 Sep;31(3):175-82. Source University Medical School, Scotland, United Kingdom.) in their paper entitled, "Factors influencing the restoration of fluid and electrolyte balance after exercise in the heat," say "Palatability of drinks is important in stimulating intake and ensuring adequate volume replacement." Maughan&Shirreffs in another study "Recovery from prolonged exercise: restoration of water and electrolyte balance." [J Sports Sci. 1997 Jun;15(3):297-303.].
In the paper "Limitations to fluid replacement during exercise" [Can J Appl Physiol. 1999 Apr;24(2):173-87.] Maughan RJ, Leiper JB have concluded : "The amount of fluid ingested by athletes is normally much less than can be tolerated, therefore issues such as palatability and practising drinking during training are important."
In another paper entitled "Recovery from prolonged exercise: restoration of water and electrolyte balance,"(J Sports Sci. 1997 Jun;15(3):297-303.) Maughan RJ &Shirreffs SM also reiterate that recovering fluid balance after exercise is through replacement of lost fluids via sweat. Sweating is more profuse when the climatic conditions are hot and humid. In order to rehydrate people in such conditions the volume of fluid consumed must be greater than the volume of sweat lost so that intestinal clearance is offset. This would mean that the volume of beverage consumed should be very high and the authors opine that the palatability of the beverage is an important factor that determines adequate consumption of fluids inorderto ensure recovery of fluid balance after exercise.
In yet another paper entitled "Exercise condition affects hedonic responses to sodium in a sport drink," [Appetite. 2009Jun;52(3):561-7. doi: 10.1016/j.appet.2009.01.008. Epub 2009 Jan 30.,] the authors Passe DH, Stofan JR, Rowe CL, Horswill CA, Murray R. make the identical connection between taste and fluid intake.
While most rehydration fluids and those especially meant for patients have a formulae that claim rehydration by varying means, the taste factor has rarely been addressed.
Some well-known sports drinks for example make an effort to infuse a desired taste. Most such drinks nevertheless have low osmolarity with low electrolyte and sugar content as they are perceived to address the weight loss needs of the consumer. This formula makes them unsuitable for ubiquitous application in all types of situations especially for exercisers under heat stress. For example, people living in hot and humid countries have a pertinent problem of excessive loss of fluids via sweat. It is generally known that to achieve rehydration in such situations high electrolyte containing drinks that can provide instant energy through adequate amounts of simple carbohydrates is essential. Besides, in

order to ensure that rehydration is effective the individual must ingest a greater volume of fluid compared to the loses through sweat.
In the case of exercise/sports personnel especially working out in hot conditions, it has been proven that carbohydrates are essential to boost performance, in the paper entitled "Postexercise rehydration in man: the effects of osmolality and carbohydrate content of ingested drinks." (Nutrition. 2009 Sep;25(9):905-13. doi: 10.1016/j.nut.2008.12.014. Epub 2009 May 31.) Evans GH, Shirreffs SM, Maughan RJ also concluded " following the rehydration protocol used, hypertonic glucose-sodium drinks may be more effective at restoring and maintaining hydration status after sweat loss than more dilute solutions when the sodium concentration is comparable." In another paper by Hubing KA, Bassett JT, Quigg LR, Phillips MD, Barbee JJ, Mitchell JB [ "Exercise-associated hyponatremia: the influence of pre-exercise carbohydrate status combined with high volume fluid intake on sodium concentrations and fluid balance," ] conclude that "a high-CHO status may provide some protection against exercise-associated hyponatremia."
Maughan RJ, Noakes TD. Have also concluded that "Carbohydrate ingested during exercise appears to be readily available as a fuel for the working muscles, at least when the exercise intensity does not exceed 70 to 75% of maximum oxygen uptake. Carbohydrate-containing solutions appear to be more effective in improving performance than plain water." [ "Fluid replacement and exercise stress. A brief review of studies on fluid replacement and some guidelines for the athlete," Source Department of Environmental and Occupational Medicine, University Medical School, Foresterhill, Aberdeen, Scotland.]
Further, in many situations like dehydration during a fever, parturition, recovery period after tonsillitis, dental procedures and so on the patient is unable to /unwilling to consume food. In such instances sugars in the rehydration fluid are essential to provide energy.
Many patent disclosures teach formulae and the method of preparation of Oral Rehydration Solutions for varying uses. 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 that 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 as 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. While the solution is prescriptive there is not incentive for compliance by way of taste.

United States Patent 5164192 discloses an effervescent product for the preparation of an oral rehydration solution for the treatment of diarrhea. 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. This technology requires further intervention by way of water addition to make it an oral drink for consumption. Such practices, it has been found may be ineffective as the reformulation requires precision and also a method to avoid bacterial colonization as the solution contains sugar. The disclosure does not seem to have references to replenishment in Sodium/Potassium that ensure electrolyte infusion while rehydration.
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. This disclosure also suffers from the above mentioned drawbacks of the need for reconstitution as well as lack of taste.
United States Patent 5489440 discloses a method for producing an improved rice flour-based oral rehydration solution using the enzymes cellulose 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 diarrhea brought about by cholera or other causes. Low osmolality is typically used when treating people with severe gut pathology. The enzymes are necessary in such situations and the formula is apt for the section of people described in the patent. However, it will not serve effectively to rehydrate normal individuals /individuals without gut pathology and especially individuals with heat induced or exercise dehydration.
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 diarrhea 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-oB activation inhibition and protecting gastrointestinal epithelial cells from oxidant-induced death. However, this formula is for a specific indication and will not serve the purpose of rehydration in normal individuals.

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 power form for oral administration consisting essentially of carbohydrates from rich 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 ration of carbohydrates originating from rice flour and carrot powder to conventional carbohydrates ranges from 1:1 to l;and 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 42m Equivalents of K+, from 25 to 35 m Equivalents of CI, and from 1220 to 360 kcal/liter and has an osmolarity of from 210 to 290 mOsm/liter. This disclosure is also a powder and has no references to taste enhancement.
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. Such compositions are predominantly meant to provide easy administration in persons afflicted by severe gut pathology. The formula is not comparable with the said inventive disclosure and does not find ubiquitous utility such as rehydration in sports people.
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 diarrhea (also known as pseudomembranous colitis) has been recognized as Clostridium difficile. It is believed that the indigenous microflora of a healthy individual suppresses the normally present C. Difficile. However, when the indigenous microflora are disrupted (e.g.,during antibiotic treatment) over growth of C difficial may occur causing diarrhoea and colitis. Treatment of diarrhoea related to C difficial with rehydration therapy and antibiotics has proven effective, but many times relapse occurs. It has been suggested that normalization of the microflora will inhabit C. difficile relapse. Indigestible oligosaccharides have been shown to inhabit C difficile infection. This disclosure is targeted towards restoring biotic balance in the intestine during a pathology induced imbalance in addition to claims of rehydration. It is notable that the gel does not have simple sugars.
PCT/EP2004/009266 discloses ah energy drink with taurine and caffeine and is not strictly useful for rehydration during exercise. The caffeine may be counter-productive in individuals with ailments.
PCT/IB2008/003380 also teaches a fruit juice based formula for rehydration that is pasteurized. However, the sugar used in the formula in Inulin. Inulin is a sugar that is often rejected by the human system and can stimulate anaphylaxis. The inventor also uses a branded energy source for formulating the drink and the disclosure does not have means for aseptic storage.
PCT/US2010/022823 uses citrus phytochemicals that is bitter but masked in microcapsules. The method is expensive and unwarranted.

PCT/US2012/050594 uses fruit bits as taste enhancers. Fruit bits may be difficult to bite into for patients with dental problems or those who have undergone surgical procedures such as tonsillitis. Many more such beverages are disclosed and much of them are hypotonic with low sugar and electrolytes that may not be the correct formula for hot humid countries such as India.
US patent 6730337 discloses a juice based ORS solution that he claims to be most suitable for use in children between the ages of 6 and 12. This invention uses a variety of juices and sources of sugar for achieving a total sugar amount of about 8% by weight, which is less than the amount found in the said disclosure. '337 also admits the use of artificial colours, artificial sweeteners and chemical preservatives which are generally avoidable for anyone and especially children. Disclosure '337 lacks clarity in the amounts of sugar used different types of juices while the total carbohydrate content is claimed to be maintained between 5%-7.5% by weight, which is presumably the chosen Brix.
Brix and pH values as experts in the art will know are scientifically verified indicators of taste whereas no reference to this has been made in '337. There is also no disclosure on the method of working the invention and no reference to how the Brix value is maintained with addition of different types of juices. It is common knowledge that every fruit juice (and may be even with every lot of the same fruit) has a different amount of sugar. Therefore, the only logical explanation for keeping the total carbohydrate and the thence the osmolarity (300-380mOsm/kg) a constant with different juices is by varying the amounts of artificial sweeteners. Artificial sweeteners apart from bringing up the Brix value to the goal of between 5-7.5, also keep the osmolarity low through their low molecular weights. Besides, except for a single example that indicates that the Brix to 8.1, there are no other references to an organized approach towards enhancing the taste. While the intent to increase rehydration compliance through taste may be similar, US patent 6730337 does not achieve this the all-natural way. The method does not disclose how a comparable Brix:acid ratio may be arrived at to keep the taste factor a standard with different juices. A need for a tasty drink using natural ingredients as sugar and additive with no chemical preservatives is still lacking in the art.
U.S. Patent 3,657,424 by Akins et al. issued April 18,1972, discloses the fortification of citrus juices, including orange juice, with sodium, calcium and chloride ions in amounts beyond what is naturally present in the juice. Calcium salts which can be used in fortification include the chlorides, citrates or phosphates, although calcium chloride is preferred for providing the desired chloride ion. The maximum amounts of calcium salts permitted in these fortified citrus juices is up to about 0.04%. (This calculates to about 0.015% calcium in the juice if calcium chloride is used.) The citrus juices fortified can be single-strength, diluted or frozen concentrates. Here it is clearly seen that this is not a formulated composition but only a method to fortify a naturally found juice. The patent disclosure of '424 claims only aims to enhance /augment the levels of those electrolytes normally present in the juice within allowable limits. The examples exemplify different methods for practicing the invention with different types of fruits and differing Brix values. In every single example, the inventors have used an artificial preservative; namely Sodium Benzoate . The other aspect of the invention disclosed carries references to the use of saccharin, an artificial sweetener wherever required to achieve the desired Brix value. There has been no attempt made to engineer taste through the Brix:acid ratio. '424 therefore cannot be compared with the said disclosure which is an original formula specially formulated to achieve a given Brix value and where fruit

juices are only added as taste enhancers and where a constant Brix:pH value is maintained to ensure that all flavours will have taste standard. Besides being a method of simple fortification, '424 also uses artificial preservatives and sweeteners once again reiterating the need for an all-natural product in this space.
European patent EP0587972, discloses an invention wherein they do not add artificial sugars/natural sugar. A variety of fruit juices are taken in calculated quantities to provide a Brix between a solubilized sugar amount between 1%-14%. The drink also contains electrolytes (Sodium) and minerals (Calcium and Magnesium) and is intended to impart a desirable taste. The desired taste however, is not induced from the fruit juice. The inventors intervene to make the juice flavor neutral (paragraph 0013) by reducing natural juice acidity artificially. To this juice with reduced acidity, a desirable flavours of natural or artificial origin are added. The teaching here while valid is inappropriate for claims of being all natural as artificial flavours are added through human intervention and natural fruit juice flavours are suppressed. Hence the taste which is a combined effect of Brix and pH is not conferred in an all-natural way. There is no mention of an attempt to arrive at a Brix:acid ratio while artificially neutralizing flavor. The other interesting anomaly is related to claims of no added sugar in the title and the field of invention, when in fact in the description we find that the ratio of dextrose and fructose is kept constant (0.2 to 1.4). When the inventor uses different types of fruits there is a question as to how the inventor brings about the desired Brix without adjusting sweetness by adding sugars. More particularly it lacks clarity on how the glucose to fructose ratio is maintained within the range declared without adjusting sugars . This is also reiterated in examples found in paragraph 060. Claim 1 (a) also talks about taking adequate juices to have a "solubilized" sugar amount of 1% to 14% and has not disclosed how this is achieved in the various different fruits. Also the invention focuses more on altering or reducing the natural flavours and textures of fruit juices for imparting any desired flavor component. As per the Espace Bibliographic data this patent filed in 1992 and published but has not been granted but withdrawn.
Therefore, there is a great need for a ready-to-drink, palatable and patient friendly fluid, containing water, electrolytes and carbohydrates in the right proportions that are useful for patients and normal people alike. Much of the beverages available are either catering to the unwell populace or for hydration in healthy exercisers. In tropical countries such as India there is a great need for a well formulated drink that is suitable for all age groups and safe for administration in patients as well as one that address the body's response to very hot conditions. Indian conditions will also need a rehydration drink that is made available in aseptic packing for treatment of dehydration/euhydration. While flavours enhance taste a standard method for imparting taste with different fruit juices has never been attempted before. Such a measure will go long way in filling consumer expectations of good taste. The said invention with all that is described below in detail is envisage to fill these gaps in technology.

OBJECT OF THE INVENTION
The principle 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.
One more object of the invention is to ensure that the Oral Rehydration Composition is in a ready-to drink state.
Yet another object of the invention is to ensure that the said drink germ free.
Another object of the invention is to improve compliance through enhanced taste.
A further object of the invention is to ensure taste is achieved scientifically by adjusting Brix and Acidityvalues.
A further object of the invention is to provide instant energy while rehydrating.
One more object of the invention is to provide an Oral Rehydration composition that is completely natural having natural sugars/additives and free from chemical preservatives.
An additional object of the invention is to provide rehydration &euhydration in normal healthy subjects.
A further object is to provide rehydration in subjects dehydrated in pathological/non-pathological circumstances.
A special object of the invention is to enhance taste through the use of real natural fruit juices as a flavouring taste enhancer.
An important object of the invention is to provide an addition to the disclosure already protected via Patent Number IN 247946
A further object of the invention is to provide the additional improvement through a change in the raw materials used in flavouring.
One more object of the invention is the use of the inventive step as disclosed in IN 247946 for performing /altering the process with the change in the raw material for flavouring.
Statement of the invention
A patent was granted by the Controller's office at Chennai for an Oral Rehydration Composition (IN 247946). The formulation was specific for rehydration /euhydration in the event of a hydration stress especially in hot and humid conditions.As there is supporting scientific evidence to show that taste enhances patient/consumer compliance to rehydration, the intent of this invention is to assure better palatability albeit through natural means.The said ORC protected by a patent (IN 247946) has natural flavouring consisting of different types of fruit juices namely apple, lemon, orange and pineapple.The

inventive step lies in the maintenance of a uniform Brix:Acid ratio between 50 and 52 irrespective of the natural juice used. It is well known in the art that no two types of fruits or even two batches of the same fruit could give a uniform brix acid ratio. This problem has been solved through the patent as disclosed in IN 247946.After being well received in the market it was found that there is further need for addressing the more issues related to palatability and compliance. It is therefore an intent of the present disclosure to present an important addition to the art by performing the inventive step in more types of juice flavours. Accordingly, the present disclosure wherein there has been a change in raw materials in the formulation and processing of the ORC will be an excellent addition to the existing granted patent IN 247946.
Detailed description of the invention
The invention described hereunder as addition to the Patent already granted is in respect of an invention (IN 247946).
According to this invention, there is provided an oral rehydration composition, comprising:
a) An 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 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
ofthe solution.
The disclosure herein also describes the novel process by which the said inventive formula is prepared to ensure that the resultant drink has a constant Brix value between 12.1 to 12.3 regardless of the type of fruit juice used. A further aspect of the inventive process is that taste is enhanced by scientifically adjusting Brix and acidity to have a constant value between 50-52 for every type of juice. The drink is processed in a zero bacterial setting through an automated state-of the-art facility & packing without human intervention.
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 another embodiment ofthe 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 parts 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 parts 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 Litchi,Peach, Tomato and Cranberry wherein the mass of the fruit juices are optimized during processing to obtain a brix value between 12.1 to 12.3 .
In Example 1, the mass of the Litchi fruit Juice / Pulp ranges from about 5 to about 10 parts per 100 parts of the solution.
In example 2 the mass of the Peach fruit Juice ranges from about 1 to about 10 parts per 100 parts of the solution.
In example 3 the mass of the Tomato fruit Juice ranges from about 1.0 to about 10 parts per 100 parts of the solution.
In example 4 the mass of the Cranberry fruit Juice ranges from about 1.0 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.

In one example, typically the mass of the Mannitol ranges from about 5.5 to about 11 parts per 100 parts of the solution.
In another example, typically, the mass of the Glucose ranges from about 3 to about 5 parts per 100 parts of the solution.
In a third example, typically, the mass of the Fructose ranges from about 5 to about 10 parts per 100 parts of the solution.
In a fourth example, typically, the mass of the Sucrose ranges from about 7.5 to about 15 parts per 100 parts of the solution.
In a fifth example, typically, the mass of the Stevia ranges from about 0.025 to about 0.030 part per 100 parts of the solution and this may be used as an additive with other sugars.
In a sixth example, typically, the mass of the Honey ranges from about 3 to about 8 parts per 100 parts of the solution
In example seven wherein, a mixture of glucose and fructose in the ranges between 3 parts and 8 parts respectively.
In example eight wherein, a mixture of glucose and sucrose in the ranges between 3.5 parts and 7.5 parts respectively.
In example nine wherein, a mixture of fructose and glucose in the ranges between 6 parts and 5 parts respectively.
In example ten wherein, a mixture of fructose and sucrose in the ranges between 5 parts and 7.5 parts respectively.
All the quantities in the aforementioned examples have been optimized to ensure that the Brix value of juices would remain a constant for the said Oral Rehydration Composition.
In accordance with another embodiment of the invention, there is provided a means of preparing an Oral Rehydration Composition that has a scientifically calibrated method for imparting a standard taste measure even while different juices are added as flavouring agents.
The standardization may be mathematically expressed by the formula:
°BRIX VALUE
PERCENTAGE ACID OR

°BRIX VALUE x 10 g/l acid
This ratio in the said inventive composition is maintained at /between the ranges of 50 and 52, which is high enough to impart a sweet tasting and suitable tangy taste making it a more acceptable formula for rehydration. The said taste ratio is achieved by adjusting the pH of the composition depending upon the juice added and ensuring that Brix remains constant as exemplified by the examples cited above.
In first example the Oral Rehydration Composition processed with a mass of Litchi pulpfrom about 1 to 10 parts per 100 parts of the solution and containing a mass of Dextrose that range from about 3 to 5 parts per 100 parts of the solution, Electrolytes 0.25 to 1.25 parts per 100 parts of the solution, of Vitamin C 0.04 to 0.125 parts per 100 parts of the solution and Sucrose 7.5 to 15 parts per 100 parts of the solution,and found to have a Brix value of about 11.8 and will be adjusted to about 12.1 to 12.3 with sucrose &acidity of about 0.18 % will be adjusted to 0.237 to 0.241 % by adding citric acid solution in order to get the standard Brix:acid ratio of 50 -52.
In second example the Oral Rehydration Composition processed with a mass of Peach fruit juice from about 1 to 10 parts per 100 parts of the solution and containing a mass of Dextrose that range from about 3 to 5 parts per 100 parts of the solution, Electrolytes 0.25 to 1.25 parts per 100 parts of the solution, of Vitamin C 0.04 to 0.125 parts per 100 parts of the solution and Sucrose 7.5 to 15 parts per 100 parts of the solution, and found to have a Brix value of about 11.8 and will be adjusted to about 12.1 to 12.3 with sucrose &acidity of about 0.2 % will be adjusted to 0.237 to 0.241 % by adding citric acid solution in order to get the standard Brix:acid ratio of 50 -52.
In third example the Oral Rehydration Composition processed with a mass of Tomato paste from about 1 to 10 parts per 100 parts of the solution and containing a mass of Dextrose that range from about 3 to 5 parts per 100 parts of the solution, Electrolytes 0.25 to 1.25 parts per 100 parts of the solution, of Vitamin C 0.04 to 0.125 parts per 100 parts of the solution and Sucrose 7.5 to 15 parts per 100 parts of the solution, and found to have a Brix value of about 11.8 and will be adjusted to about 12.1 to 12.3 with sucrose &acidity of 0.18 % will be adjusted to 0.237 to 0.241 % by adding citric acid solution in order to get the standard Brix:Acid ratio of 50 -52.
In fourth example the Oral Rehydration Composition processed with a mass of Cranberry fruit juice from about 1 to 10 parts per 100 parts of the solution and containing a mass of Dextrose that range from about 3 to parts per 100 parts of the solution, Electrolytes 0.25 to 1.25 parts per 100 parts of the solution, of Vitamin C 0.04 to 0.125 parts per 100 parts of the solution and Sucrose 7.5 to 15 parts per 100 parts of the solution, and found to have a Brix value of about 11.8 and will be adjusted to about 12.1 to 12.3 with sucrose &acidity of 0.18 % will be adjusted to 0.237 to 0.241 % by adding citric acid solution in order to get the standard Brix:Acid ratio of 50 -52.
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 (Litchi/Peach/Tomato/Cranberry) 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 adjust brix acid ratio by 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 filter 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 a naturally flavoured solution;
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 (pasteurization).
Pasteurizing the flavored solution and aseptically filled in an automatic machine.
It is ensured that OP (clean in place) is completed before reprocessing.
The Tetrapak laminate is passed through Hydrogen Peroxide solution and subsequently dried at 120°C.
The pasteuriesed 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.
A further aspect of this invention is that the product is made available in different flavour e.g.Litchi, Peach, Tomato andCranberry the like making it more user friendly and palatable.
Still further, the product according to this invention is free from preservatives.
One more aspect of the process technology is that it is fully automated to remove human error and ensure zero pathogen risk.
In another embodiment of the invention the product formulated and processed as described is packed and sealed asceptically. The pack sizes being moderate enough to allow for consumption immediately after opening to avoid bacterial colonization. Large pack sizes typically have a problem of bacterial colonization immediately after opening the pack especially when there are no preservatives.
Method of performing the invention
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 odour, Brix at room temperature, acidity (w.r.t citric Acid), pH and the brix acidity ratio is scientifically adjusted to get a ratio of 50 to 52.
The tested QA/QC results should match the following criteria-
The ingredients that are present in this solution are:
Fruit Juices: The invented preparation contains one or more of the following:
LitchiPulp-ltolO% Peach Juice Concentrate 1-10% Tomato paste 1 -10% Cranberry juice 1-10%

Salts: Each 100 parts of the invented solution contains
(a) Sodium<:hloride 0.05 toO.SO parts
(b) Potassium Chloride 0.10 to 0.4O parts
(c) SodiumCitrate 0.10 to 0.80parts
(d) Dextrose 2 to 3 parts
Further, the source of Chloride Salts would-beCalcium Chloride, AmmoniumChloride, Potassium Chloride, Sodium Chloride, Magnesium Chloride etc.
The source of Sodium Salt is at least one compound selected from a group of compounds consisting of Sodium Bicarbonate, Sodium Citrate, Sodium Chloride and Sodium Lactate.
The source of Citrate Salts that could be used is Ammonium Citrate, Calcium Citrate, Sodium Citrate, Potassium Citrate, Magnesium Citrate etc.
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.S to 15 parts
Stevia - -.025 to 0.030 parts
Honey - 3 to 8 parts
Method of performing the invention
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 ju(ce/pulp/paste(l'itchi, Peach, Tomato, and Cranberry) and mix well.

2. Preparation of bulk solution:
Dissolve the weighed quantity of Dextrose in a known quantity of water. To this, add Salts or Electrolytes and mix well.
To the above solution, add Vitamm-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 flavor through a clean filter doth and mix well. Make up 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 pasteurized and aseptkally 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 or Electrolytes 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/pulp/paste (Litchi, Peach, Tomato& Cranberry) 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 pasteurized and asepticatly filled on automatic machine.
METHOD - 3
1. Preparation o Syrup:
Dissolve known quantity of Sweetener in known quantity of hot water in a dissolution tank. To this, add fruit juice/pulp/paste (Lttchi, Peach, Tomato, and Cranberry) 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 or Electrolytes 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 flavor 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
G) Brix
(k) PH
(I) Acidity (as citric acid)
The solution is pasteurized and aseptically filled on automatic machine.
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, 200mlLitchi pulp was added and mixed well.
2. Preparation of bulk solution:
40 gm Dextrose was dissolved in a S00 ml of water. To this, 5gm 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 sted fitters of 80 micron nylon and 120 micron in to the blending tank.
To the filtered solution, Litchi flavour was added through a clean filter cloth and mixed well. Volume of this solution was made up to 2 liters with water and mixed well.
Samples were drawn and analyzed for the following parameters.
(a) Description
(b) Brix
(c) pH
(d) Acidity {as Citric acid)
The solution is pasteurized 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 50oC in a dissolution tank.
To this, 200ml fruit juice (Peach) 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,Peachflavour was added through a clean filter cloth and mixed well. The volume of solution was made up to 2 liters with water and mixed well.
Samples were drawn and analyzed for the following parameters.
(e) Description
(f) Brix
(g) PH
(h) Acidity (as Citric acid)
The solution is pasteurized and aseptically filled on automatic machine.

Example - 3
1. Preparation of Syrup:
80 gmClucose was dissolved in 500ml of water at 50°C in a dissolution tank. To this, 200 ml fruit juice (Tomato) 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:
To this, 5 gm Sodium chloride, 4 gm Potassium Chloride, 8 gm Sodium citrate was added and mixed well 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, Tomato flavour was added through a clean filter cloth and mixed well. The volume was made up to 2 liters with water and mixed well.
Samples were drawn and analyzed for the following parameters.
(i) Description
(j) Brix
(k) pH
(I) Acidity (as Citric acid)
The solution is pasteurized and aseptically filled on automatic machine.

Example-4
1. Preparation of Syrup:
80 gm Glucose was dissolved in 500ml of water at 50°C in a dissolution tank. To this, 200ml Cranberryfruit juice was added and mixed well.
2. Preparation of Bulk solution
40 gm Dextrose was dissolved in 500 ml of water.To this, 5 gm Sodium chloride, 4gm 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, Cranberry flavour was added through a clean filter cloth and mixed well. The volume of solution was made up to 2 liters with water and mixed well. Samples were drawn and analyzed for the following parameters
(a) Description
(b) Brix

(c) pH
(d) Acidity (as Citric acid)
The solution is Pasteurized and aseptically filled on automatic machine.

Claims: We claim
1) An Oral Rehydration Composition and a method of preparing the same where:
a) The source of electrolyte is sodium chloride, sodium citrate and potassium chloride
b) The Flavouring constituent is selected from atleast one natural fruit juice consisting of Litchi,Peach, Tomato & Cranberry.
c) The sweetening agents may be one Natural Sweetener selected from the group of compounds consisting of Mannitol, Glucose, Fructose, Sucrose, Stevia or Honey.
d) The composition is fortified by at least one Vitamin-C selected from the group consisting of ascorbic acid, sodium ascorbate and calcium ascorbate.

2) An Oral Rehydration Composition wherein the electrolyte and sugar /carbohydrate levels that provide instant hydration benefits during a physiological hydration stress combined with heat stress.
3) The said rehydration composition being specially formulated for better compliance to rehydration through increased payability by maintaining a Brix :Acid ratio between 50 and 52.
4) The said rehydration composition flavoured as claimed in 1(b) ranges in concentrations between 10 parts per 100 parts of the solution by volume and is standardized to maintain the Brix value Betweenl2.1 and 12.3 and acidity percentage levels between 0.237 to 0.241 %.
5) Said inventive process as claimed in claim 1 wherein the Brix:acid value is maintained at 50 and 52 regardless of the type of juice or the batch of concentrate used.
6) A process for preparing an oral rehydration composition as claimed in claim 1 comprising the following steps.

a) Dissolving 0.025 to 15 parts by mass of sweetener per 100 parts of the rehydration solution in water, at temperature in the range of 30 to 80 °C in a dissolution tank, wherein the sweetener is selected from the group of compounds consisting of Mannitol, Glucose, Fructose, Sucrose, Stevia, and Honey.
b) Adding 1 to 10 parts per 100 parts of the oral rehydration solution by volume, at least one fruit juice selected from the group consisting of Litchi, Peach, Tomato & Cranberry in the dissolution tank and mixing well to get sweetened fruit juice.

c) Dissolving 2 to 3 parts by mass of Dextrose per 100 parts of the oral rehydration solution in water and adding electrolyte mixture and mixing well to get Dextrose and electrolytes solution wherein the electrolyte mixture comprise sodium chloride, sodium citrate and potassium chloride, wherein mass of sodium chloride is in the range of 0.05 to 0.50 parts per 100 parts, mass of sodium citrate is in the range of 0.10 to 0.80 parts per 100 parts, and mass of potassium chloride is in the range of 0.10 to 0.40 parts per 100 parts of the total solution
d) Adding Vitamin-C salts selected from the group consisting of ascorbic acid, sodium ascorbate and calcium ascorbate, said vitamin c having mass of 0.0425 to 0.125 part per 100 parts of the solution, to the Dextrose and electrolytes solution and mixing well and adding to the sweetened fruit 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) Pasteurizing the flavoured solution to get the oral rehydration solution and aseptically filling the pasteurized solution in an automatic machine.