Title of Invention

NOVEL METASTABLE CHELATE COMPLEX OF CALCIUM MAGNESIUM LACTATE GLUCONATE AND PROCESS FOR ITS PRODUCTION

Abstract

The present invention discloses a novel, metastable chelate complex of calcium magnesium lactate gluconate, prepared by the reaction of calcium lactate and magnesium gluconate or magnesium lactate and calcium gluconate in aqueous medium at high temperature. The product is isolated by spray drying methods. The invention also covers various nutrient compositions and food preparations containing calcium magnesium lactate gluconate and process for the preparation of such compositions thereof.

Full Text

FIELD OF THE INVENTION The present invention relates to an organic mineral complex of calcium and magnesium and process for its production and more particularly relates to a novel chelate complex of calcium magnesium lactate gluconate, process for its production and nutrient compositions comprising it. BACKGROUND OF THE INVENTION Calcium and magnesium deficiency continues to be a common nutritional problem at the present time. Calcium deficiency is a major problem in all countries and almost all segments of population throughout life time. It is particularly prevalent in infants, child bearing women, and post-menopausal women. Majority of the body's calcium (99%) is found in the skeletal system and a small amount(l%) circulates in bloodstream where it is vital to biochemistry. Mild calcium deficiency causes nerve sensitivity, muscle twitching, irritability, palpitations and insomnia. Children can suffer from rickets, bone deformities and growth retardation. In adults, deficiency can lead to osteomalacia, muscle weakness, osteoporosis and delayed fractures. Osteoporosis, a degenerative bone disease, is recognized as a major public health problem, results in a significant burden to the population in terms of quality of life and medical expense. Dietary calcium deficiency has been determined by medical authorities to be an important risk factor for osteoporosis. The need for calcium in our daily diet has been extensively documented in medical and scientific journals. In addition, many government and public health agencies have recommended that individuals strive to include optimal amounts of calcium in their diet to reduce risk for osteoporosis. Several strategies have been proposed to reduce the prevalence of calcium deficiency. Although calcium supplements are effective, logistics and compliance are major problems. In addition, the prevalence of calcium deficiency is not usually high enough to justify the use of medicinal calcium. Current scientific research shows evidence that calcium plays a role in protecting against high blood pressure and colon cancer. If there are inadequate amounts of calcium from dietary sources, skeletal calcium will be sacrificed to satisfy the metabolic needs of the soft tissues. Thus, when dietary calcium intake is inadequate, skeletal metabolism is compromised. Under this circumstance, less bone is accumulated during growth and calcium is withdrawn from the adult skeleton with a concomitant reduction of bone strength. Both of these situations appear to predispose a person to osteoporosis and its consequent fractures. One of the major sources of available calcium for dietary purposes are dairy products. Since fluid milk provides about 300 milligrams calcium per 240 milliliter (8 ounce) serving, the consumption of approximately of a liter of milk would be necessary to provide the present minimum recommended amounts of calcium (based on the USA recommended daily allowance (R.D.A)). Moreover calcium utilization is affected in absence of Magnesium. Adequate amounts of magnesium are required for the absorption and utilization of calcium, favoring the deposition of calcium in bones where it belongs and preventing deposition of calcium in the soft tissues and kidneys where it does not belong. Without magnesium, high doses of calcium will lead to calcification of soft tissues, kidney stone formation, and decreased bone strength. Further, magnesium is required in adequate amounts for the normal activity of 300 enzymes, including those involved in the transfer of energy from foods to physical and mental activities. Early signs of magnesium deficiency include loss of appetite, nausea, vomiting, fatigue, and weakness. As magnesium deficiency worsens, numbness, tingling, muscle contractions and cramps, seizures, personality changes, abnormal heart rhythms, and coronary spasms can occur . Severe magnesium deficiency can result in low levels of calcium in the blood (hypocalcemia). Magnesium deficiency is also associated with low levels of potassium in the blood (hypokalemia) . Magnesium levels should be one half of calcium or calcium will not deposit properly and much will be lost. But taking more calcium is not the answer; it only amplifies the problem. In fact, excessive calcium intake and insufficient magnesium can contribute to both of the aforesaid diseases. Magnesium taken in proper dosages can solve the problem of calcium deficiency. When calcium level is elevated in the blood it stimulates the secretion of a hormone called calcitonin and suppresses the secretion of the parathyroid hormone (PTH). These hormones regulate the levels of calcium in our bones and soft tissues and are, therefore, directly related to both osteoporosis and arthritis. PTH draws calcium out of the bones and deposits it in the soft tissues, while calcitonin increases calcium in our bones and keeps it from being absorbed in our soft tissues. Sufficient amounts of magnesium determine this delicate and important balance. As magnesium suppresses PTH and stimulates calcitonin it helps put calcium into our bones, preventing osteoporosis, and helps remove it from our soft tissues eliminating some forms of arthritis. A magnesium deficiency will prevent this chemical action from taking place in our bodies, and no amount of calcium can correct it. While magnesium helps our body absorb and retain calcium, too much calcium prevents magnesium from being absorbed. So taking large amounts of calcium without adequate magnesium may either create malabsorption or a magnesium deficiency whichever occurs, only magnesium can break the cycle. Stomach acid is required to convert inorganic calcium (carbonate, phosphate, oyster shell, coral or bone meal) into a soluble, ionized state so it can be absorbed in the small intestine. Organic forms of calcium (gluconate, lactates) are already in a soluble, ionized state and dc not require stomach acid. Scientists are in agreement that bioavailability of inorganic minerals may be as low as 20%, but does not exceed to 30%. Supplement manufacturers increase the dosage of inorganic minerals hoping to offset this process and increase the mineral percentage uptake. However, the increase in inorganic mineral content only leads to an increase of gelatinous magma, which lines the mucous membrane of the small intestine. This lining blocks absorption of all minerals and vitamins, causing gastrointestinal (GI) distress such as diarrhoea and constipation. Active transport sites are located at the beginning of the small intestine. They require the presence of adequate amounts of vitamin D and are limited to between 225 and 450 mg of calcium absorption at any one time. Therefore, when calcium consumption is low, this site can account for a substantial part of absorbed calcium, however, when calcium intake is high, this site plays only a minor role. Passive diffusion sites are located throughout the alkaline environment of the small intestine particularly at the end of the small intestine where the pH is highest. These sites allow much greater calcium absorption as the absorption rate stays the same regardless of dosage. They do not rely on stomach acid levels, vitamin D intake, age, gender or hormone status and are limited only by intestinal transit time. The absorption rate of calcium at these sites is 48%; however only soluble forms of calcium such as gluconate and lactate, can take advantage of passive diffusion sites as they are able to stay dissolved in this alkaline environment. Only those minerals that are dissolved can move through the passive diffusion sites. Though, a composition with magnesium and calcium is the best choice to maximize calcium utilization, calcium-fortification with insoluble calcium salts have resulted in products that have low calcium concentrations, suspension settlement issues, require exceptionally long processing times, have unacceptable off flavors that are described as bitter, metallic, chalky, and "minerally", poor textures or a combination of these drawbacks. For example, insoluble calcium salts need to be added to products as a suspension, but this often leads to negative changes in taste and texture as well as suspension settlement. In addition, insoluble calcium sources are generally less bioavailable than soluble forms. Although some inorganic salts of calcium, such as calcium salts of bicarbonate, chloride, sulfate and some phosphates, possess a solubility which allows relatively high levels of calcium to be added to beverages, they produce unacceptable off tastes. While attempts have been made to cover up the off flavors or poor textures of previous calcium fortified beverages, such efforts have required the addition of materials such as sugars, artificial sweeteners, and flavorings. This results in the addition of calories and/or other (off) flavors. Therefore supplements of calcium and magnesium presently known in the patent and non-patent literature are not very suitable in view of the drawbacks as mentioned above. The higher the elemental weight of calcium in a compound, the less soluble the calcium is. Calcium magnesium lactate gluconate with the low elemental weights have the high solubility, which allows for absorption at all three sites along the digestive tract. Any calcium from the undissolved portion of the supplement will be eliminated via the colon, possibly causing constipation, gas, and bloating. A liquid solution is highly soluble and does not need to be broken down, providing approximately 98% of its elemental calcium. Liquid solutions can use much lower doses then solid supplements while still providing as much or more utilizable calcium but without the waste. A solution means the minerals are dissolved in the liquid, which is what gives it its enhanced absorption. Many Salts and complexes of calcium and magnesium have been disclosed as mineral supplements and some of them are described below: Certain forms of calcium citrate-malate are disclosed for use as mineral supplements, including beverages; for example Japanese Application No. Sho 54-173172, date of application 28 Dec. 1979, laid-open No. Sho 56-97248, 5 Aug., 1981; and see also French Pat. No. 2,219,778 (Application No.73.08643). U.S. Pat. No. 2,325,360, to Ayres et al, issued July 27, 1943, discloses a method for replacing gases removed during deaeration of fruit juices, such as orange juice, with carbon dioxide. In this method, dry calcium carbonate, or a mixture of calcium carbonate and citric acid, is dropped into a can, which is then filled with deaerated orange juice. (Other organic acids such as malic and tartaric acid can be used in place of citric acid.) U.S. Pat. No. 3,657,424, to Akins et al, issued Apr. 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. U.S. Pat. No. 3,114,641, to Sperti et al, issued Dec. 17, 1963, discloses extended orange juice products obtained by diluting single-strength orange juice or concentrated orange juice. To maintain the flavor of the diluted orange juice product, materials such as calcium chloride, magnesium chloride, sodium or potassium citrates, tartaric and malic acids (or their salts) are included. British patent specification No. 2,095,530, published Oct. 6, 1982, discloses a process for obtaining an acid beverage enriched in protein, particularly a fruit juice or fruit- flavored beverage. In this process, an aqueous suspension of soy protein is prepared using water and/or fruit juice. Calcium in a concentration of from 5 to 50 mM is added, after which the pH of the suspension is reduced and the insoluble material separated to yield a protein solution. A fruit juice or fruit flavoring can then be added to this protein solution . The calcium can be added in the form of the chloride, acetate, tartrate, malate or lactate salt. European patent application No. 75,114, published Mar. 30, 1983, discloses protein- containing fruit juice drinks enriched with vitamins and minerals. These drinks contain 30-90% fruit juice (a mixture of 20-70% apple juice, 4-40% white grape juice, 1-10% passionfruit juice and 5-25% lemon juice), 2 to 20% whey protein concentrate, and a mineral salt mixture of potassium, sodium, magnesium, calcium and phosphate. Calcium is present in these drinks at 0.01 to 0.3%, preferably at 0.02 to 0.03%. US published patent application No. 2005/0158425A1 discloses use of a calcium(lactate) gluconate citrate as dietary calcium supplement in thin mouthfeel calcium-fortified beverages. US published patent application No. 2005/0153021A1 discloses use of a calcium (lactate) gluconate citrate in calcium-fortified protein based-beverage. US patent 6,261,610 to Sher et al. discloses a metastable calcium Lactate-Citrate or Calcium-MagnesiumLactate-Citrate complex , their preparation and use in fortified liquid food beverage product. But this describes only the in-situ preparation of the complex and the complex is not isolated, thus the application is restricted. The intestine prefers to absorb the most soluble form of calcium and magnesium. There was a long felt need to have a supplement which is organic, enriched with both calcium and magnesium having high solubility and where the organic magnesium helps in calcium deposition. Calcium lactate and magnesium gluconate are the most soluble organic forms of calcium and magnesium suitable for use and are highly soluble throughout the entire digestive tract Although physical admixture of calcium lactate and magnesium gluconate have been known to be used for sometime as mineral food supplements, the present invention for the first time provides for an organic mineral complex of calcium magnesium lactate gluconate that has a much superior solubility, absorption and taste profile compared to said physical admixture of calcium lactate and magnesium gluconate. SUMMARY OF THE INVENTION The present invention provides a novel, metastable chelate complex of calcium magnesium lactate gluconate (herein referred to as "CMLG") of the formula I or II, as shown below. The process of manufacturing of said calcium magnesium lactate gluconate according to the invention involves the reaction of calcium lactate with magnesium gluconate OR calcium gluconate with magnesium lactate in aqueous medium at 60 to 80°C. Once the complex is formed the product is either isolated by crystallization OR the solution is instantly spray dried to get the dry solid product of CMLG. The aforesaid complex, formed after the reaction is complete, is thermodynamically an intermediate complex, which is a metastable chelate. As used herein the term "metastable" means that the material is not at equilibrium, and is a mixture of crystalline and amorphous forms in varied proportions. It is known in the literature that the metastable complexes of calcium and other mineral salts tend to loose their metastability, when allowed to crystallize from aqueous solutions over a long period of time, leading to the formation of fully hydrated crystalline forms that have low water solubility, limiting their use in industrial applications. In case of the product, being the aforementioned complex, if that is allowed to crystallize from water, it forms a more crystalline product, when isolated in dry form, and has very less water solubility ( 10% w/v); whereas, if the solution containing the metastable chelate complex is instantly spray dried to get dry powder, it retains the metastable form and hence the water solubility of spray dried product is very high ( 25 % w/v). The physical and chemical data of this product is consistent with the theory that there are non-crystalline regions within the powdered material which can hydrate to the point of behaving like a solution. It is important for the solubility characteristics of the calcium magnesium lactate gluconate, that the required metastable structure be achieved in powder form. Hence, the metastable form of calcium magnesium lactate gluconate of the present invention is instantly isolated by spray drying technology, so as to obtain the product in powder form, which has very high water solubility and is most suitable for all industrial applications. The said novel, metastable chelate complex in accordance with the invention has improved solubility, better taste and enhanced absorption profile. The following analytical characterization of the product according to the invention - by NMR, Mass, FTIR & C, H & N analysis, establishes the novelty of the metastable chelate complex of calcium magnesium lactate gluconate, represented by formula I or II The product of the invention of Formula-I is characterized by NMR, Mass spectra and C, H & N analysis, whose details are given below. The mass spectra showed a M+1 peak at 633.4, that corresponds to the molecular weight of Formula -I, which has the molecular formula of C18H32O20 Ca Mg. The 13C NMR and 1H NMR spectra of the sample under study rightly corresponds to! the structure of the product, as represented by the aforesaid Formula-I. Also, the peak to peak comparison has revealed that there are no extra peaks in the sample under. study and hence the spectra is fully compliant with the claimed structure. The elemental contents of the concerned sample match closely with that of the theoretical values. However a small variation, particularly in the hydrogen and oxygen content in the sample, with respect to that of theoretical values observed, may be due to traces of moisture present in the product and / or experimental errors. The absorption properties of of the said calcium magnesium lactate gluconate (hereinafter referred to as CMLG complex) was studied using "Franz diffusion cell" at 36°C. The following table gives the details of the diffusion study. The membrane used is the non-Reinforced silicone membrane (SilasticR, poly dimethyl siloxane, type 500 -1, Laboratorie Perouse Implant, Bornel, France) of 0.125mm thickness was used for the experiment. The quantities of CMLG in solution were calculated based on the amount of calcium and magnesium present in the solution, which was measured by using Atomic Absorption Spectroscopy (AAS). Based on the diffusion experiments carried out, it is clear that about 90% of the CMLG was found to be diffused through the membrane, indicating better bioavailability index. BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWINGS FIG.1: gives the formula (I) of the organic mineral complex of the invention. FIG.2: is a flowchart showing the manufacturing process steps for preparing the organic mineral complex of the invention. FIG.3: illustrates of reaction scheme for the production of organic mineral complex of the invention by reaction of calcium lactate with magnesium gluconate. FIG.4: illustrate an alternative reaction scheme for the production of organic mineral complex of the invention by reaction of calcium gluconate with magnesium lactate, DETAILED DESCRIPTION OF THE INVENTION The present invention involves the conjoint use of nutritionally-supplemental amounts of calcium and magnesium. By "nutritional" or "nutritionally-supplemental amount" herein is meant that the mineral sources used in the practice of this invention provide a nourishing amount of said minerals. In mineral supplements such as powders, this supplemental amount will comprise at least 35-50% of the Recommended Daily Allowance (RDA) of the daily intake of said mineral, as defined in The United States of America (Recommended Daily Dietary Allowance-Food and Nutrition Board, National Academy of Sciences-National Research Council). More generally, mineral supplements will contain at least 10% more typically 35% to 50%, of the RDA per unit dose of the supplement. Of course, it is recognized that the preferred daily intake of any mineral may vary with the user. For example, pregnant, lactating, or post-menopausal females may require an increased intake of calcium, over the usual RDA. In general, the RDA (calcium) will range from 360 mg/6 Kg for infants to 1200 mg/54-58 Kg female, 1000 mg/70 kg adult male, depending somewhat on age. The RDA (magnesium) ranges from 10mg per Kg for infants to 300mg/55 Kg female, and 350mg for adult male, depending somewhat on age. The present invention provides an organic mineral complex of calcium and magnesium, namely calcium magnesium lactate gluconate, which has higher solubility, better bioavailability and neutral taste, thus useful in various applications. The invention is also directed to a process during which calcium lactate and magnesium gluconate are dissolved in water, mixed in a reaction vessel, filtered, spray dried and sieved. The product is an organic mineral complex of calcium lactate and magnesium gluconate. The process produces a free flowing composition which can be commercially manufactured, having higher solubility, better bioavailability and neutral taste. Organic magnesium salt given with calcium results in better absorption. Fig. 1 is a manufacturing flowchart which describes the general pathway for producing the product of invention. A desired amount of a calcium salt, such as calcium lactate or gluconate is first added to purified water in a reaction vessel at around 70-80 deg.C. Also useful for this steps is to keep the mixture for 30 mins to complete dissolution. After a clear solution is obtained a magnesium salt is added preferably gluconate or lactate. The salts are preferably in powder form to speed dissolution. The solution is kept for around 1.5 hrs to ensure complete complex formation. Visible check is done by taking 150 ml solution in a 250ml beaker. The solution is clear with no undissolved matter. The pH of the solution at this stage is between 6.00 to 7.00. Next charcoal is added slowly and a wait for a period of 30 mins at a temperature of around 60 deg. C. Activated Charcoal treatment removes the colored impurities in the final complex solution. The temperature is kept at check at all stages during the process. The optimum quantity of charcoal powder that can be used to get good quality product, as described in examples 1 to 4 hereinafter, is between 2 to 20 gms, most preferably 5 to 10 grams, which is best suitable for complete removal of color and other impurities from the reaction solution. Now the complex of calcium and magnesium is ready for filtration. The complex solution is filtered for which a filter press, membrane filter and Nutsche filter may be used. The temperature at this stage shall be maintained at 70 deg.C. The insoluble residues are removed by filtration and the clear filtrate is transferred to a storage vessel. Different types of dryers may be utilized which require specific conditions. One such method used here is spray drying. Spray drying requires the solution to be maintained at a temperature that keeps solution in a liquid state. Adjustment of pumping rate, the inlet and- outlet air temperatures in the spray drier is done. Solution is forced through the inlet where it is converted to droplets and dries in presence of hot air. At the bottom of spray drier the dried composition has LOD 5-6%.Other methodsof drying are also used for producing this organic mineral complex. Different ratios of calcium and magnesium with various salts of organic acids can be produced by using the same manufacturing process as described above. Coloring agents used are selected from quinine yellow, Ponceau 4R, Allura Red, Carmoisine, Chocolate brown HT, Erythrosine, etc...or any other food grade color permissible for such uses. Some Preparatory examples for production of organic mineral complex of the invention are given below: Example 1: Calcium lactate pentahydrate 200 gms was added to 1000 ml of purified water. After clear solution is obtained 264 gms of magnesium gluconate is added. Activated charcoal gms is added to adsorb the color. The said solution is filtered and spray dried at a temperature between 60-90 deg.C. The complex formed is 350 gms of calcium magnesium lactate gluconate. It has solubility of 30% at 25 deg. C and provides 6.68% of elemental calcium and 3.54 % of elemental magnesium. The said complex produced by the process described in Example 1 is a white free flowing powder, neutral in taste, a 10% w/v aqueous solution is clear and colorless to nearly colorless solution with following physico-chemical characteristics : The pH of 5% w/v solution is 6-8. • Bulk density is 0.25-0.55 g/cc. • Solubility: Take 30g sample in 250ml Erlenmeyer flask, add 100ml of water (20-25 deg.C.Swirl the solution to dissolve completely. It is soluble. • Note: Estimation of elemental calcium and magnesium content in calcium magnesium lactate gluconate-Done by Atomic Absorption Spectrophotometry: Test, Standard and Blank solutions are prepared using 20%NaCl solution HC1 and lanthanum chloride. Determination of the absorbance of blank, standards and test solution was done at 422.7nm for calcium and 285.2nm for magnesium in atomic absorption spectrometer. Examples 2-4 given below are further examples for preparing the organic mineral complex of the invention following the same route and conducting similar tests for solubility and content of elemental calcium and magnesium. Example 2: Calcium Lactate pentahydrate 100 gms was added to 1000 ml of purified water. After clear solution is obtained 364 gms of Magnesium Gluconate is added. Activated charcoal 5gms is added to adsorb the color. The said solution is filtered and spray dried at a temperature between 60-90 deg.C. The complex formed is 370 gms of Calcium Magnesium Lactate Gluconate. It has solubility of 30% at 25 deg. C and provides 3.31% of elemental Calcium and 4.37 % of elemental Magnesium. Example 3: Calcium Lactate pentahydrate 340 gms was added to 1000 ml of purified water. After clear solution is obtained 124 gms of Magnesium Gluconate is added. Activated charcoal 5gms is added to adsorb the color. The said solution is filtered and spray dried at a temperature between 60-90 deg.C. The complex formed is 330 gms of Calcium Magnesium Lactate Gluconate. It has solubility of 30% at 25 deg. C and provides 11.49% of elemental Calcium and 1.66 % of elemental Magnesium. Example 4: Calcium Lactate pentahydrate 200 gms was added to 1000 ml of purified water. After clear solution is obtained 264 gms of magnesium gluconate is added. Activated charcoal 5gms is added to adsorb the color. The said solution is filtered and vacuum dried at a temperature between 100-120 deg.C. The complex formed is 280 gms of calcium magnesium lactate gluconate. It has solubility of 10% at 25 deg. C and provides 6.35% of elemental Calcium and 3.41 % of elemental Magnesium. The same composition when product taken via crystallization route the product obtained has lower yield and the has 5% solubility at 25 deg.C. Nutrient Composition Different nutrient composition can be prepared by use of organic mineral complex of the present invention. Examples 5 and 6 given below are to such examples of nutrient compositions. Said compositions are prepared by blending in double cone blender and/or ribbon blender and/or planetary mixer, Example 5: 52.5 gms of Citric Acid and 40 gms of Malic acid are subjected to grinding and blended. Then blended with 500 gms of calcium magnesium lactate gluconate in parts.7.5 gms of Sucralose can be added as sweetner and color and orange flavour for taste. The composition can be added to a glass of water and is a ready to drink beverage. It provides 325 mg of elemental calcium and 150 mg of elemental magnesium per serving of 6 gms. Example 6: 3.5 gms of Malic acid and 3.5gms of Citric acid are subjected to grinding and dissolved in 700 ml of liquid sorbitol .272 gms of calcium magnesium lactate gluconate is added. Cranberry extract as flavour and sodium benzoate as preservative is added. This solution may be used to administer calcium and magnesium to children. Nutrient Additive; Examples 7-9 are given below are for use of the organic mineral complex of the invention as nutrient additive. Example 7: Apple juice 200ml fortified with 3gms of calcium magnesium lactate gluconate provides in one serving of 200 ml 350 mg of elemental calcium and 150mg of elemental magnesium. The apple juice was neutral in taste with no off flavors. It provides 35% RDA of Calcium and 50% RDA of Magnesium in 2 servings per day. Example 8: Vegetable soup 100 ml fortified with 3gms of calcium magnesium lactate gluconate is neutral in taste and provides 17.5% RDA of Calcium and 25% RDA of Magnesium in a single serving of 100 ml. Example 9: 5gms of calcium magnesium lactate gluconate added to 1 liter of milk is neutral in taste and stable when 0.4% of sequestering agent is added with it,-* Benefits of Organic Mineral Complex of Calcium Magnesium Lactate Gluconate: Most soluble form of calcium and magnesium. > Can be taken away from meals or by people with low stomach acid. > Easily absorbed by absorption sites throughout the intestine (active, passive and colon). > 30 times more soluble than calcium carbonate. > Can be dissolved in a liquid solution and is absorbed regardless of dosage, stomach acid, hormone, status, nutrition, or age. > Inhibits kidney stone formation. > Increases the solubility and absorption of magnesium. > The product has improved organoleptic properties. Industrial Applicability The bi-molecular organic mineral complex of calcium and magnesium according to the present invention in view of its excellent solubility and taste profile and high absorption profile in the biological system makes it an ideal candidate as an additive in food and beverage for consumption by human beings and animals and in nutrient compositions useful as food or feed supplement. From the foregoing description, one skilled in the art can easily ascertain the essential characteristics of this invention and, without departing from the spirit or scope thereof, can make various changes and modifications of the invention to adapt it to various usages and conditions. It is intended that all matter contained in the description above shall be interpreted as illustrative and not in a limiting sense. Moreover, other embodiments of the invention will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. WE CLAIM: 1. A novel, metastable chelate complex of calcium magnesium lactate gluconate of the formula I or II, as shown below: 2. The complex as claimed in claim 1, wherein the weight ratio of calcium to magnesium in the complex is 2:1. 3. The complex as claimed in claim 1, which is used as an ingredient for the human food or animal feed or as a supplement in an individual serving size that provides at least 350mg of elemental calcium and 175 mg of elemental magnesium. 4. A process for the preparation of the metastable chelate complex of calcium magnesium lactate gluconate as claimed in claim 1, said process comprising the following steps of: a) dissolving calcium lactate in water at 70 to 80°C to obtain a clear solution; b) adding magnesium gluconate to the clear solution obtained from step(a); c) maintaining the final solution thus obtained in step (b) for 1.5 hours to ensure complete complex formation; d) adding charcoal powder in an amount, such as herein described, to the solution containing the complex obtained in step (c) keeping the solution at 60°C so as to remove the colored impurities; e) filtering the product of step (d) preferably at 70°C, to obtain clear filtrate solution of the complex, and f) spray drying of the clear filtrate of step (e) to get a dry powder of metastable form of calcium magnesium lactate gluconate complex. 5. A process for the preparation of the metastable chelate complex of calcium magnesium lactate gluconate of Formula-II, as claimed in claim 1, said process comprising the following steps of: a) dissolving magnesium lactate in water at 70 to 80°C to obtain a clear solution; b) adding calcium gluconate to the clear solution obtained from step(a); c) maintaining the final solution thus obtained in step (b) for 1.5 hours to ensure complete complex formation; d) adding charcoal powder in an amount, such as herein described, to the solution containing the complex obtained in step (c) keeping the solution at 60°C so as to remove the colored impurities; e) filtering the product of step (d) preferably at 70°C, to obtain clear filtrate solution of the complex, and f) spray drying of the clear filtrate of step (e) to get a dry powder of metastable form of calcium magnesium lactate gluconate complex. 6. The process as claimed in claim 4 or 5, wherein the pH of the solution in step (c) is maintained preferably between 6.0 to 7.0. 7. The process as claimed in claim 4 or 5, wherein the filter used in step (e) is selected from filter press, sparkler filter, plate and frame filter, leaf filter, membrane filter or nutche filter. 8. The process as claimed in claim 4 or 5, wherein the dry powder obtained in step (f) has LOD (loss on drying) between 5.0 to 6.0%. 9. A nutrient composition comprising : a) 52.5g citric acid; b) 40g malic acid; c) 500g of metastable chelate complex of calcium magnesium lactate gluconate as claimed in claim 1, and, optionally in association with d) a sweetener, such as herein described, and/or, e) a coloring agent, such as herein described, and/or, f) a flavoring agent such as herein described, and/or, g) a preservative, such as herein described. 10. The nutrient composition as claimed in claim 9, wherein the sweetener used is sucralose or any other low calorie sweeteners, flavoring agent used is cranberry extract or any other edible fruit extracts, and the preservative used is sodium benzoate or any other preservative, approved for used in food preparations. 11. The nutrient composition as claimed in claim 9, wherein the sweetener, coloring agent, flavoring agent and/or preservative is/are added in quantity/quantities sufficient to impart the required, sweetness, desired color and/or flavor, and the quantity of the preservative used is less than that of its permissible quantity allowed in the nutrient composition. 12. The nutrient composition as claimed in any of claims 9 to 11, which is prepared by blending in double cone blender and/or ribbon blender and/or a planetary mixer. 13. An infant nutrient composition comprising a) 3.5g of citric acid; b) 3.5g of malic acid; c) 0.272g of metastable chelate complex of calcium magnesium lactate gluconate as claimed in claim 1, and, d) a requisite quantity of cranberry extract as flavoring agent and sodium benzoate as preservative. 14. An infant nutrient composition as claimed in claim 13, wherein grounded or finely powdered citric acid and malic acid are dissolved in 700ml of liquid sorbitol before addition of the calcium magnesium lactate gluconate complex, flavoring agent and preservative, to obtain the final product. 15. A fortified fruit juice or vegetable soup or milk fortified with the metastable chelate complex of calcium magnesium lactate gluconate as claimed in claim 1. 16. The fortified fluit juice as claimed in claim 15, wherein 200ml of apple juice is fortified with 3g of the calcium magnesium lactate gluconate complex, providing 350 mg of elemental calcium and 150 mg of elemental magnesium. 17. The fortified juice as claimed in claim 15, wherein the fortification maintains 35% of RDA for calcium and 50% RDA for magnesium in two servings per day (RDA= Recommended Daily Dietary Allowances, as per Food and Nutrition Board, USA). 18. The fortified vegetable soup as claimed in claim 15, wherein 100ml of soup is fortified with 3 gms of the calcium magnesium lactate gluconate complex that provides 17.5% RDA of calcium and 25% RDA of magnesium in a single serving of 100 ml. (RDA = Recommended Daily Dietary Allowances, as per Food and Nutrition Board, USA). 19. The fortified milk as claimed in claim 15, wherein at least 5g of the calcium magnesium lactate gluconate complex is added to each liter of milk. ABSTRACT NOVEL METASTABLE CHELATE COMPLEX OF CALCUIUM MAGNESIUM LACTATE GLUCONATE AND PROCESS FOR ITS PRODUCTION The present invention discloses a novel, metastable chelate complex of calcium magnesium lactate gluconate, prepared by the reaction of calcium lactate and magnesium gluconate or magnesium lactate and calcium gluconate in aqueous medium at high temperature. The product is isolated by spray drying methods. The invention also covers various nutrient compositions and food preparations containing calcium magnesium lactate gluconate and process for the preparation of such compositions thereof.

Documents:

00742-kol-2006-abstract-1.1.pdf

00742-kol-2006-abstract.pdf

00742-kol-2006-assignment.pdf

00742-kol-2006-claims.pdf

00742-kol-2006-correspondeence(other).pdf

00742-kol-2006-correspondence-1.1.pdf

00742-kol-2006-description(complete).pdf

00742-kol-2006-description(provisional).pdf

00742-kol-2006-drawings-1.1.pdf

00742-kol-2006-drawings.pdf

00742-kol-2006-form 2.pdf

00742-kol-2006-form 3.pdf

00742-kol-2006-form-1.pdf

00742-kol-2006-form-2-1.1.pdf

00742-kol-2006-form-5.pdf

00742-kol-2006-power of auth0rity.pdf

742-KOL-2006-(08-11-2011)-AMANDED CLAIMS.pdf

742-KOL-2006-(08-11-2011)-AMANDED PAGES OF SPECIFICATION.pdf

742-KOL-2006-(08-11-2011)-CORRESPONDENCE.pdf

742-KOL-2006-(11-06-2012)-AMANDED PAGES OF SPECIFICATION.pdf

742-KOL-2006-(11-06-2012)-CORRESPONDENCE.pdf

742-KOL-2006-ABSTRACT 1.1.pdf

742-KOL-2006-AMANDED CLAIMS.pdf

742-KOL-2006-AMANDED PAGES OF SPECIFICATION.pdf

742-KOL-2006-ASSIGNMENT.pdf

742-KOL-2006-CANCELLED PAGES.pdf

742-KOL-2006-CORRESPONDENCE 1.2.pdf

742-KOL-2006-CORRESPONDENCE-1.1.pdf

742-KOL-2006-CORRESPONDENCE.pdf

742-KOL-2006-DESCRIPTION (COMPLETE) 1.1.pdf

742-KOL-2006-DRAWINGS 1.1.pdf

742-KOL-2006-EXAMINATION REPORT REPLY RECIEVED.pdf

742-KOL-2006-EXAMINATION REPORT.pdf

742-KOL-2006-FORM 1-1.1.pdf

742-KOL-2006-FORM 13.pdf

742-KOL-2006-FORM 18.pdf

742-KOL-2006-FORM 2-1.1.pdf

742-KOL-2006-GRANTED-ABSTRACT.pdf

742-KOL-2006-GRANTED-CLAIMS.pdf

742-KOL-2006-GRANTED-DESCRIPTION (COMPLETE).pdf

742-KOL-2006-GRANTED-DRAWINGS.pdf

742-KOL-2006-GRANTED-FORM 1.pdf

742-KOL-2006-GRANTED-FORM 2.pdf

742-KOL-2006-GRANTED-FORM 5.pdf

742-KOL-2006-GRANTED-SPECIFICATION-COMPLETE.pdf

742-KOL-2006-OTHERS 1.1.pdf

742-KOL-2006-PA.pdf

742-KOL-2006-REPLY TO EXAMINATION REPORT.pdf