Abstract: This specification is a continuation of or addition/improvement to the granted patent (IN 247946 ) granted towards application No. 458/CHE/2005 on 21st April, 2005, entitled "Oral Rehydration Composition." The disclosure herein is meant to augment the taste of citrus fruit juice flavoured varieties of the Oral Rehydration Composition (ORC) as disclosed in the parent patent. The invention seeks to improve compliance to rehydration by improving the palatability of the ORC , which has a pre-determined formulation to enhance rehydration of individuals during hydration stress caused either through pathological or non-pathological reasons. It is particularly pertinent for use in hydration stress caused through intense physical activity in hot and humid climates. The citrus varieties of this original composition is further improved by enhancing the flavour and mouth feel of the composition by retaining a precise sub-threshold level of bitter principles in the juices added. This is done by initially adding de-bittered juices and subsequently after measuring the amounts of bitter principle in said juice adding the right amount of bitter principles such that the total concentration of such principles do not exceed 6-7 ppm. In order to maintain the natural taste/flavour and mouth feel, care has been taken to ensure that the added principles are identical to the ones found in the given juice in the natural state . Further, the proportions of the bitter principles so added are also in proportions as found in the given juice naturally.
Title: Oral Rehydration Composition
Preamble:
The following specification is a continuation of or addition/improvement to the 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 due to a pathology or physiological stress. Taste has been scientifically found to be the cardinal factor in consumers' compliance with rehydration behavior and therefore the said disclosure is an important addition to the art. To this anvil the inventors have improved the taste of citrus flavoured versions of the ORC by controlling the bittering agents found in the citrus juices flavouring the ORC to scientifically proven threshold levels. By doing so the unique flavours imparted by the bitterness component is retained while the consumer does not taste the bitterness. It has been established thatbitterness components maintained at certain levels in citrus juices improve flavour, taste and mouth feel. As the bitterness quotient is controlled, additional citrus fruit juice namely Grapefruit juice and the juice of Citrus, limetta have also been included. 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 Composition,that is a palatable and consumer friendly fluid, containing water, electrolytes and carbohydrates. The inventive step of the original disclosure has been clearly and completely described and it will be apparent to workers in the art that the inventors have taken pains to standardize/ improve palatability of the ORC irrespective of the juice used as flavouring agent. The inventors continue to improve this invention with respect to palatability by making a variation in the taste of the ORC flavoured by citrus juices by way of this patent of addition.
It is well known in the art that citrus juices such as lemon, orange, sweet lime and grapefruit have some chemical constituents like Limonin, Nimonin, Naringin, Quercetin, Nobiletin ,Sinensetin, Hisperidin, Tangeretin and so on that impart an undesirable bitterness to these juices. The bitter taste becomes more apparent when the time between juice production and consumption increases. In the current commercial packaged juice market it is virtually impossible to reach consumers immediately after juice extraction. Hence, a lot of workers for over almost four decades have devised several methods to reduce or nullify the bittering components to improve taste. Nevertheless it is important to understand that these bittering agents also contribute to enhanced flavour and mouth feel when present within scientifically verified threshold levels.
The inventors endeavor to further improve the aforementioned patented invention through this said additional modification that would controlthe bitterness factor of citrus flavoured versions of thepatent disclosed in No. 458/CHE/2005. Additional fruit juiceflavours namely juices of Grapefruit and Citrus.limetta have also been included to the cache of natural flavours to the composition. The important inventive step adopted is to ensure that the bitterness components found in the said juices are controlled at sub- threshold taste levels, which would allow the consumer enjoy the flavour and mouth feel fostered by the bitterness components while they do not taste an undesirably high level of bitterness.To this anvil debittered juices are added to the composition as flavouring agents and subsequently bittering agents that may be found in the original fruit are added in the same proportion as that found in the said fruit to a concentration not exceeding 6 to7ppm .
It is pertinent to note that the original disclosure could not accommodate Grapefruit,although it is known to be healthy and flavorful. Grapefruit was nevertheless associated with unwelcome bitterness and usually avoided in commercial drinks. With the new additional improved method the inventors have succeeded in developing a more tasteful composition of the ORC using citrus flavoured juices.
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, 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
This additional patent application filed in respect of the granted original patent IN 247946 aims to further improve taste of said ORC that are flavoured with citrus juices. Post-processing bitterness is a common problem in citrus fruit juices, which has been veritably tackled in the art using various physical, chemical or microbial methods.
Methods of debittering orange juice were developed as early as 1957 and the art has advanced considerably in the present time. The most popular methods for removing bitter principles in citrus juices is the use of selective adsorbents made from varying types of polymers such as cellulose acetate, nylon based matrices, porous polymers , ion exchangers and so on. They are useful because they are inert mediums that do not change the flavour of the juices in any manner. Besides, they are very economical as the columns may be reused and the bittering principles extracted for other commercial uses. Debittered juices are available in the market for different types of juices. However, the bitter components are not usually completely removed and the residual amounts present would usually vary depending upon the source of fruit, the season, methods used for extraction/processing, the efficiency of the debittering methods used and so on.
Further, it has also been found through taste tests that complete removal of bitterness principles do not augur well for flavour /taste and mount feel.lt has been scientifically attested that flavour impact of citrus flavoured foods improvewhen sub-threshold taste levels of bittering components are retained. Canadian patent CA 1190796 A 1 discloses the threshold levels of bitter ingredients that need to be present in different food substances to impart better flavour. It has also been scientifically documented that sugar and acidity mask perceived bitterness. Accordingly, European patent EP 2494874 Al discloses the method of controlling flavour through bitter constituents in citrus juices. In the present invention the basic teachings found herein will be adapted to render the said ORC more flavourful by the addition of a precise quantum of bitter ingredients (6 to7ppm)into the citrus juice flavouring. This amount will decided in tandem with the bitterness level found in the juice along with the Brix: acid ratio that has been set between 50-52 in the said ORC. Additionally, it has been envisaged that retaining the original bitter principles (as found in a given fruit) and in proportions similar to that found in a given fruit would allow the taste to be true to expected flavour.
Further, 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. 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.
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.
Sheriffs SM, Taylor A J, 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 reiterates 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 inorder to ensure recovery of fluid balance after exercise.
In yet another paper entitled "Exercise condition affects hedonic responses to sodium in a sport drink," [Appetite. 2009 Jun;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 aformulae 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, neutraceuticals, 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, neutraceuticals, 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 osmolarity 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 an 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
ofnatural 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 pH values.
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.
An important additional objective is to enhance taste in the citrus flavour versions of the Oral Rehydration Composition as disclosed in IN247946.
A further object of the invention is to provide the additional improvement to Patent Number IN 247946 through the addition of debittering of citrus juices added as flavouring agent.
Another novel objective of the invention is to ensure that bitterness principles are reconstituted in the saidflavouring to sub-threshold taste levels(6 to 7ppm) as is scientifically affirmed by workers in the art.
One more novel objective of the invention is that the bitter principles so added toreconstitute bitterness at sub-threshold taste levels are the same as found in the said fruit and in proportions similar that found in the respective fruit in the natural condition.
A vital objective of the invention is the improvement of mouth feel by retaining all bitter principles found in the natural fruit at sub-threshold taste levels.
One more object of the invention is the use of the inventive step as disclosed in IN 247946 for performing /altering the process during the process of making the said ORC.
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 as 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.
Further it is well known that citrus juices would normally acquire bitterness when the time between juice production and consumption is long. Hence, much work has been done to avoid this problem in commercially prepared citrus juices by simply employing a process to cause the debittering of said citrus juices. Hence, in order to improve the taste factor in citrus flavoured variety of ORC, the use of debittered citrus fruit juice flavouring has been proposed. Additionally, as per patent documents cited herein above, consumer taste enhancement is better achieved by calculated retention/addition of bitterness principles to sub-threshold taste levels. While, this level is ordinarily between 4-6ppm, the inventors of the said invention have assigned a slightly higher level of between 6 to 7 ppmsince the Brix: acid ratio of the ORC is high and is expected to offset this threshold.
As an additional effort to improve the natural mount feel imparted by the flavour, steps have been taken to ensure that constituents of bitter principle added are identical to those found in a given fruit and the proportions of each of the constituents are similar to that found in a given fruit in the natural state.
Detailed description of the invention
The invention described hereunder is an addition to the Patent already granted is in respect of an invention (IN 247946). This additional disclosure aims to improve the taste and mouth feel of citrus flavoured varieties of said composition by controlling the amount of bitter ingredients found in the citrus juices added as flavouring. Grapefruit juice, universally accepted as a wonderful health booster and yet is not a preferred flavour because of the bitterness associated with it. Likewise all citrus juices during the post-extraction period show a steady increase in bitter ingredients. As per scientific studies described hereinabove, the presence of sub-threshold levels of bitter principles in fact enhance taste. The practice of the invention by selectively retaining a sub-threshold levelof bitterness (a level at which tasters have not detected bitterness) will improve taste and increase compliance to rehydration. As per the reference provided, inventors say, "a low level of bitterness may provide a desirable contribution to the organoleptic properties and characteristics of juice for many consumers. Such consumers enjoy the piquant flavor note of a low level of bitterness. However, most consumers also agree that excessive bitterness adversely affects the organoleptic properties and characteristics of juice, making it unpleasant to consume."
To this anvil an additional improvement is being provided to the citrus flavoured version of the ORC by the addition of pre-treated citrus juices as flavouring agents. The said juices are procured in de¬bittered form and to this bitter principles are added until they reach a sub-threshold level between 6 to 7ppm. The bitter constituents and the respective proportions added in a given juice are matched with the types and proportions of different bitter principles found in the fruit in the natural state. This
is because taste itself is in part an interplay of varying bitter components. By simply increasing the concentration of one component it does not linearly increase bitterness and vice versa. Hence, it is important that improved mouth feel may be achieved only by adding all types of bitter components found in the fruit in its natural form. Therefore, the invention is practiced by adding bitter components to the debittered juices as per the rationale provided in the tables Al, A2, A3 and A4 found below. The said levels /proportion of varying bitter principles that are added to the de-bittered juices have been calibrated by the inventors to achieve the objective of the invention.
Table A-l: Grape Fruit Juice.
Source for data on the types and amounts of bitter principle: American Journal of Clinical
Nutrition[2000;72:1424-35].
Table A-2: Lemon Fruit Juice
Source for data on the types and amounts of bitter principle: American Journal of Clinical
Nutrition[2000;72:1424-35].
Table A-3: Orange Fruit Juice
Source for data on the types and amounts of bitter principle: American Journal of Clinical
Nutrition[2000;72:1424-35].
Table A-4: Sweet lime (Citrus limetta) fruit juice flavour
Source for data on the types and amounts of bitter principle: "Studies on debittering of Sweet Orange
juice," by A. N Siddiqui, D.N Kulkarni, K.D. Kulkarni and M. Z. Mulla [World Journal of Diary &
Food Sciences 8 (2):185-189,2013 and from independent experimental verification done at the Central
Food & Technological Research India(CFTRI), India.
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 debitteredNatural 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 of the 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 11 -14 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 for processing & 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 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 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, in at least one natural de-bittered citrus fruit Juiceis selected from a group consisting of such as but not limited to orange, lemon ,grape fruit and sweet lime.
In accordance with another embodiment of the invention at least on quantitative tests applicable for the respective juice is performed as described herein under to ascertain the amount of the different residual bitter principle in the de-bittered juice.
In one more embodiment of the present invention, bittering components identical to those found in a given citrus fruit juice flavour are added in the same proportions as found in the juice in the natural state so as to collectively reach a sub-threshold level that does not exceeding 6-7 ppm.
Method of Analysis for detecting levels of Naringin:
Name of the Method.HFLC
Column:ODS 1
Column temperature: 40°C
Mobile Phase: Gradient - 2 % Acetic acid (pH - 2.5 )(Component A ) and Acetonitrile (Component B) as shown in table
Detector - UV, Wavelength - 285 nm
The Sample (juice) and Standard Naringin (from Sigma) was prepared with Dimethyl Sulpha oxide (DMSO).
Then injected 20 ul both Sample and Standard .The area of Sample and Standard determined and based on the area calculated the content of Naringin.
Sample Area x Dilution of Std.xPurity of Std.
xlOO = /100 ml.
Std. Area x Dilution of Samplex 10
Method of analysis For detecting levels of Limonin: Name of the Method.HfLC
Column : C18 - 15 cm x 4.6 mm ID
MobelPhase :Acetonitrile,Tetrahydrofuran and Water in the ratio - 17.5:17.5:65
Flow rate: 1 ml/minute
Detector: UV
Wavelength : 225 nm
Preparation of Standard Solution:
A standard solution of Limonin of 100 ppm was prepared by dissolving 100 mg of Limonin crystals in 100 ml Absolute Ethanol.Then the solution is further diluted to the concentration of 10,25, & 50 ppm with Mobile Phase.
Preparation of Sample Solution:
A 2.5 ml of the juice is taken in a 10 ml clean & dry volumetric flask,to this added 2ml of Acetonitrile mix and make up the volume upto the mark with distillted water and mix well.Filter the solution through 0.25 micron filter.
Procedure:
Then inject 20 \i\ both Sample and Standard solution.The area of Sample and Standard determined, based on the area and calculated the content of Limonin.
Sample Area x Dilution of Std.xPurity of Std.
xl00 = /100 ml.
Std. Area x Dilution of SamplexlOO
In accordance with yet another embodiment of the said invention the proportions bitter principles to be retained in the respective juice flavouring as per inferred calculations disclosed in Table A-l, A-2,A-3 orA-4.
Method of analysis for detecting levels of Hesperidin:
Name of the Method: HPLC
Column :Eurospher C18 coloumn - 250 x 4 mm ID
MobelPhase : 5 mM Ammonium acetate : Acetonitrile,75:25,adjusted to pH 4.45 with Acetic acid
Flow rate: 1 ml/minute
Detector: UV
Wavelength: 285 nm
Column temp - 40 deg.C
Preparation of Standard Solution:
A standard solution of Hesperidin is of 600 ppm was prepared by dissolving in Dimethylformamide.
Preparation of Sample Solution:
To 50 ml of the fruit juice, 1 ml each Carrez Solution 1 & Solution 2 are added, mixed .Then the
solution is centrifuged and supernatant liquid filtered through 0.45 micron membrane.
Procedure:
Then inject both Sample and Standard solution. The area of Sample and Standard determined, based on
the area and calculated the content of Hesperidin
Sample Area x Dilution of Std. xPurity of Std.
xl00 = /100 ml.
Std. Area x Dilution of SamplexlOO
Wherein the mass of the fruit juices are optimized during processing to obtain a brix value between 12.1 to 12.3 .
Typically In Example 1, the mass of the De bittered(6 to 7 ppm) Grape fruit Juice ranges from about 5 to about 10 parts per 100 parts of the solution.
Typically, In example 2 the mass of the Debittered(6 to 7 ppm)Lemon fruit Juice ranges from about 1 to about 5 parts per 100 parts of the solution.
Typically, In example 3 the mass of the (6 to 7 ppm ) Debittered Orange fruit Juice ranges from about 1.0 to about 10 parts per 100 parts of the solution.
Typically, In example 4 the mass of the Debittered (6 to 7 ppm )Sweet lime 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/1 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 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 the first example the Oral Rehydration Composition processed with a mass of Debittered Grape fruit Juice (6 to 7 ppm)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 0.18 % 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 Debittered Lemon fruit juice (6 to 7 ppm) from about 1 to 5 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 Debittered Orange fruit juice (6 to 7 ppm) 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 Debittered Sweet Lime fruit juice(6 to 7 ppm) 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) dissolving the weighed quantity of Dextrose in a predetermined quantity of water and adding electrolytes and mixing well to get Dextrose and electrolytes solution;
c) 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;
d) 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;
e) 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 flavoured solution and aseptically filled in an automatic machine.
It is ensured that CIP (clean in place) is completed before reprocessing.
The Tetrapak laminate is passed through Hydrogen Peroxide solution and subsequently dried at 120oC.
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 of debittered juices of 6 to 7 ppme.g. Grape Fruit juice,Lemon Fruit Juice,Orange Fruit Juice & Sweet Lime Juice 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 aseptically. 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, debittered juice (6 to 7 ppm) 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:
Debittered Fruit Juices: The invented preparation contains one or more of the following:
Debittered Grape Fruit JUice -1 to 10 % Debittered Lemon Juice 1-5% Debittered Orange Juice 1 - 10% Debittered Sweet Lime juice 1 -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 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 - 7.5 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, debittered fruit juice of 6 to 7 ppm (Grape fruit,Lemon fruit,Orange Fruit & Sweet lime) 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 flavor through a clean filter cloth 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 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 Sweetner in known quantity of hot water in a dissolution tank.
To this, add Debittered fruit juice6 to 7 ppm (Grape fruit,Lemon fruit,Orange Fruit & Sweet lime) 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 aseptically 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 Debittered fruit juice of 6 to 7 ppm (Grape fruit,Lemon fruit,Orange Fruit & Sweet lime) 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 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
0) Brix
(k) pH
(1) 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 50oC in a dissolution tank. To this, 100ml of Debittered Grape juice 6 to 7 ppm was added and mixed well.
2. Preparation of bulk solution:
40 gm Dextrose was dissolved in a 500 ml of water. To this, 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, Grape fruit 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, 50 ml Debittered Lemon juice 6 to 7 ppmwas 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 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 gm Glucose was dissolved in 500ml of water at 50oC in a dissolution tank. To this, 100ml Debittered Orange juice6 to 7 ppmwas 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 liters with water and mixed well.
Samples were drawn and analyzed for the following parameters.
(i) Description
(j) Brix
(k) pH
(1) 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 50oC in a dissolution tank.
To this, 100ml Debittered Sweet Lime juice 6 to 7 ppm 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, 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, Sweet Lime 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 agent is selected from at least one debittered natural citrus fruit juice consisting of Grape fruit /Lemon /Orange/Sweet lime.
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 palatability 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 inwater, 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 Grape Fruit, Lemon Fruit, Orange Fruit & Sweet Lemon 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.
7) An Oral rehydration composition as claimed in claim 1(b) wherein
(a) The debittered citrus juices so added as flavouring are tested for residual bitterness before addition of natural flavouring factor in to the said ORC.
(b) The said flavoured ORC as claimed in 7(a) is reconstituted with bitter principles natural bitter principles found in a given citrus fruit juice flavour in order to allow the specific bitter principles of a given juice reach a sub-threshold taste level between 6-7 ppm.
c) The said ORC as claimed in claim 7(b) containing bitter principles in sub-threshold taste levels between 6-7 ppm wherein the proportions of the different bitter principles found in a given fruit flavour are kept at proportions that may be found in the natural state.
8) An ORC as claimed in claims 1 through 7 that is enhanced through a citrus fruit juice flavouring
wherein the undesirable bitterness of citrus juices are removed while a refreshing amount of bitter
principles are retained at scientifically attested sub-threshold taste levels that improves taste and mouth
feel and imparts better rehydration properties.
| # | Name | Date |
|---|---|---|
| 1 | 3363-CHE-2014 FORM-5 08-07-2014.pdf | 2014-07-08 |
| 2 | 3363-CHE-2014 FORM-3 08-07-2014.pdf | 2014-07-08 |
| 3 | 3363-CHE-2014 FORM-2 08-07-2014.pdf | 2014-07-08 |
| 4 | 3363-CHE-2014 FORM-18 08-07-2014.pdf | 2014-07-08 |
| 5 | 3363-CHE-2014 FORM-1 08-07-2014.pdf | 2014-07-08 |
| 6 | 3363-CHE-2014 DESCRIPTION (COMPLETE) 08-07-2014.pdf | 2014-07-08 |
| 7 | 3363-CHE-2014 CORRESPONDENCE OTHERS 08-07-2014.pdf | 2014-07-08 |
| 8 | 3363-CHE-2014 CLAIMS 08-07-2014.pdf | 2014-07-08 |
| 9 | 3363-CHE-2014 ABSTRACT 08-07-2014.pdf | 2014-07-08 |
| 10 | 3363-CHE-2014 POWER OF ATTORNEY 16-12-2014.pdf | 2014-12-16 |
| 11 | 3363-CHE-2014 FORM-6 16-12-2014.pdf | 2014-12-16 |
| 12 | 3363-CHE-2014 FORM-1 16-12-2014.pdf | 2014-12-16 |
| 13 | 3363-CHE-2014 CORRESPONDENCE OTHERS 16-12-2014.pdf | 2014-12-16 |
| 14 | 3363-CHE-2014 ASSIGNMENT 16-12-2014.pdf | 2014-12-16 |
| 15 | Other Document [12-07-2017(online)].pdf | 2017-07-12 |
| 16 | Form 13 [12-07-2017(online)].pdf | 2017-07-12 |
| 17 | 3363-CHE-2014-FER.pdf | 2019-08-29 |
| 18 | 3363-CHE-2014-FER_SER_REPLY [29-02-2020(online)].pdf | 2020-02-29 |
| 19 | 3363-CHE-2014-CLAIMS [29-02-2020(online)].pdf | 2020-02-29 |
| 20 | 3363-CHE-2014-FORM 13 [02-06-2022(online)].pdf | 2022-06-02 |
| 21 | 3363-CHE-2014-AMENDED DOCUMENTS [02-06-2022(online)].pdf | 2022-06-02 |
| 22 | 3363-CHE-2014-US(14)-HearingNotice-(HearingDate-20-09-2022).pdf | 2022-08-23 |
| 23 | 3363-CHE-2014-REQUEST FOR ADJOURNMENT OF HEARING UNDER RULE 129A [15-09-2022(online)].pdf | 2022-09-15 |
| 24 | 3363-CHE-2014-US(14)-ExtendedHearingNotice-(HearingDate-01-11-2022).pdf | 2022-09-23 |
| 25 | 3363-CHE-2014-US(14)-ExtendedHearingNotice-(HearingDate-10-11-2022).pdf | 2022-10-31 |
| 1 | search_29-08-2019.pdf |