DESC:FIELD OF INVENTION
The present invention relates to a nutritional supplement and method for preparing the same. More particularly the present invention relates to a nutritional supplement and method for preparing a stable fluid supplement of dietary fatty acids, vitamins, minerals and choline in syrup or a drop form containing the same.

BACKGROUND OF THE INVENTION
Omega-3 fatty acids constitute a family of polyunsaturated fatty acids that are recognized as providing a wide range of health benefits when consumed as a regular part of the human diet. The most well known omega-3 fatty acids include alpha-linolenic acid (ALA) that is found in soybean oil, canola oil and flax seed oil, as well as docosahexaenoic acid (DHA), and eicosapentaenoic (EPA) commonly found in fish oil and other marine oils. All of these fatty acids contain multiple carbon-carbon double bonds including one double bond in the omega-3 or third position inward from the distal end of the fatty acid chain that is attached at its opposite end by an ester linkage to the glycerol backbone of the triglyceride molecule.
Though the human body is not capable of synthesizing omega-3 fatty acids from other nutrients, it is able to convert some of the dietary alpha-linolenic acid, to the longer carbon chain EPA and DHA molecules. These are termed "essential nutrients" because they are largely obtained from foods rather than synthesized by the body.
Following is a study, n–3 long-chain polyunsaturated fatty acids for optimal function during brain development and ageing, done byAlan D DangourPhD and Ricardo UauyMD PhD, Nutrition and Public Health Intervention Research Unit, London School of Hygiene & Tropical Medicine (LSHTM). London, United Kingdom, Public Health Nutrition Division, Instituto Nutricióny Tecnología de Alimentos (INTA), Universidad de, Chile. Santiago, Chile. Studies demonstrate that provision of n–3 long chain polyunsaturated fatty acids (n–3 LCPs) in preterm and term babies is associated with retinal electrical responses to light stimuli, and to brain cortex related visual acuity maturation, that are similar to those observed in human milk fed infants. The studies suggest that in young children neurodevelopment and cognitive abilities are also enhanced by early provision of n–3 LCPs through breast milk or DHA-fortified foods. Breast fed infants also require n–3 LCPs after weaning to achieve optimal visual acuity at 12 months of age. Good quality evidence supporting a role for n–3 LCP consumption to enhance learning and/or behaviour in school-age children is currently lacking. Evidence supporting the potential importance of n–3 LCP consumption for good cognitive health in older age is now beginning to emerge. Recent cross-sectional surveys have reported that higher fatty fish/n–3 LCP consumption and or higher n–3 LCP blood concentrations are associated with reduced risk of impaired cognitive function. Similarly, prospective cohort studies have shown that increased fish consumption and higher n–3 LCPs in blood lipid sub-fractions are associated with decreased risk of dementia in older people.

Studies are being conducted in a large randomised controlled trial in a group of adults aged 70-79 years to assess whether an n–3 LC supplement will preserve retinal function and prevent age related cognitive decline. For nearly 80 years, researchers have known that specific components of fat may be necessary for the proper growth and development of animals and humans, and the concept of the essentiality of certain fats is now well understood. Deficiencies of n–3 fatty acids were shown to result insubtle clinical symptoms such as skin changes, abnormalvisual function and peripheral neuropathy and these findings underpinned the concept that n-3 fatty acids were key to adequate development and functioning of the retina and the central nervous system. The relatively high concentrations of n–3 long chain polyunsaturated fatty acids (n-3 LCPs), specifically docosahexaenoic acid (DHA), in the cerebral cortex and the retina further supported this view.

Indeed, the dry weight of the human brain is predominantly lipid, with 22% of the cerebral cortex and 24% of white matter consisting of phospholipids. Importantly, while the protein composition in the brain is fixed by the genetic code, fatty acid composition of brain phospholipids is modifiable by diet.Essential fatty acids play crucial structural roles in brain tissue especially in cell membranes, and much research has been conducted into functional implications associated with diet-induced compositional changes. Furthermore, the oxidative products of polyunsaturated fatty acids act as key cellular mediators of inflammation, allergy and immunity, oxidative stress, bronchial constriction, vascular responses and thrombosis. There is also a growing body of evidence to show that LCPs can affect the expression of genes that regulate cell differentiation and growth and may thereby have a profound and long lasting impact on human health.

Indeed, via this mechanism, early diet may influence the structural development of organs, as well as the formation of neurologic and sensory functions. In a study, the current evidence linking n–3 LCPs with measures of brain function in infancy, childhood and later life was reviewed. Given space limitations, the review is necessarily non-systematic, but reference is made, where possible, to current relevant systematic reviews.
The foetus is entirely dependent on maternal supply of essential fatty acids for its growth and development, and a total of approximately 600g of essential fatty acids are transferred from mother to foetus during a full term gestation.

The progressive enrichment in the concentrationof n–6 arachidonic acid (AA) and DHA in circulating lipids and brain tissue in the foetus that takes place during the third trimester makes preterm infants potentially vulnerable to fatty acid deficiencies.

Numerous studies have therefore investigated whether supplementation of preterm infants with LCPs effects plasma and tissue composition and/or visual and cognitive function. Results of these studies have been mixed and a Cochrane systematic review published in 2004, including 11 randomised controlled trials, concluded that there was no evidence that supplementation of formula with n–3 and n–6 LCPs had any long-term benefit for the infant. The review noted however that the infants enrolled in the trials were relatively mature and healthy preterm infants, and also that differences between the trials made meta-analysis difficult. A relatively recent study, published after the Cochrane review, compared the effect among preterm infants of LCP supplementation of formula milk with AA fungal oils and DHA from either fish (n=130) or algal (n=112) sources, with control unsupplemented milk (n=199), on various measures of development. The DHA supplemented infants had significantly greater scores than the infants fed the control formula, in the mental and psychomotor development indices of the Bayley Scales of Infant Development (second edition) at 18 months after term. All values stayed significantly below those of the reference sample of 105 term breast fed infants. Longer term follow up of these infants or those from other studies has not been reported. Accretion of DHA in brain tissue continues after birth, reaching a total of 4g of DHA in the brain between two and four years of age, suggesting that n–3 LCP intake in the early years may also be important for brain development. Again, several studies have investigated the effect of LCP supplementation, although these studies are hard to design among term infants because of the influence of the mother’s choice of mode of feeding. A Cochrane review of the available trial evidence conducted in 2001, included 10 trials and concluded that LCP supplementation conferred a possible beneficial effect on information processing in term infants, although larger and more long term trials were still required. A few recent trials have suggested a positive benefit on mental processing in term infants of supplementation of the mother during pregnancy.

Furthermore, more persistent benefits of LCP supplementation for both visual acuity and mental development have also been demonstrated. The lack of a consistent pattern of results in the trials conducted among both pre-term and term infants are not wholly surprising given the complexities of such studies. A good discussion of methodological problems, such as differences in the level, nature and duration of supplementation, the use of tools that are insufficiently sensitive to measure small changes in performance, and the complexities caused by the longevity and reversibility of die induced changes in developmental outcomes has been published.

Despite widespread interest in the potential use of n–3 LCP supplementation to enhance development and behavior among school-age children, there has to-date been no published trial on healthy children. A recent systematic review identified five randomised controlled trials that examined the effect of n–3 LCP supplementation on learning and behaviour in childhood, but all five trials were conducted among children with neurodevelopmetal disorders (dyspraxia and attention-deficit hyperactivity disorder ADHD). Study subjects were aged between 5and 13 years, study samples were small (40-117 participants), and intervention periods ranged from 2-4 months. Two studies assessed biochemical markers of fatty acid status.

Stevens found correlations between blood concentrations of n–3 LCPs and behaviour but only small improvements in 2 out of 16 subjective behaviour and education assessments, while Voigt showed an increase in the n–3 LCP blood concentrations in the intervention group but no differences in behavioural or education outcomes between the intervention and control group. Richardson found small improvements in 3 out of 14 subjective parental behaviour scores in the intervention group, and Hirayama found no difference between the intervention and control groups. The Oxford-Durham study was the only study to report consistent improvements in objective and subjective assessments in the intervention group, although there were no measured gains in motor skills. Quite understandably, the systematic review authors concluded that “there remain too many inconsistencies between studies to reliably inform any conclusion” and generalisability of any findings from these trials to a mainstream population of healthy children is not possible. Given the public interest in this field, large scale properly designed trials are urgently needed.

LCP concentrations in brain tissues appear to decrease with age and it has been proposed that these changes in lipid composition are associated with changes in central nervous system function. While the underlying cause of these changes in n–3 LCP concentrations in the ageing brain is largely unknown there is clearly a role for dietary intake throughout life in determining lipid composition. For example, consumption of large amounts of n–6 fats can reduce synthesis of n–3 LCPs, while consumption of diets containing 20 or 22 carbon polyunsaturated fatty acids might increase n–3 LCP concentrations. Information on the effects of n–3 LCP supplementation on cognitive health in older age is quite scarce and a recent systematic review identified only four cohort studies and one randomised control trial that investigated the effect of n–3 LCPs on cognitive health. The four cohort studies suggested a positive impact of increased n–3 LCP (fish and total n–3) consumption on risk of impaired cognitive function, dementia or Alzheimer’s disease.

The one trial included in the review was small, conducted among demented older people and was of poor quality. A recent Cochrane review found no published randomised controlled trials investigating the effect of n–3 LCP supplementation on cognitive function among healthy older adults. Since the publication of the review, two further cohort studies and one randomised controlled trial have N–3 fatty acids and optimal brain function been published. A 5-year follow up of 210 surviving males in the Zutphen Elderly Study cohort who were aged 70-89 at baseline demonstrated that fish consumers had significantly less 5-year cognitive decline than non-fish consumers, and that this could be directly related to n–3 LCP intake. Older men who consumed approximately 400mg n–3 LCP a day had less cognitive decline (1.1 point less on the 30 point Mini Mental State Examination [MMSE] scale) than men who consumed only 20mg n–3 LCP a day.41 While this analysis from the long-running Zutphen Elderly Study presented very detailed information on dietary intake, it did not present any information on biochemical markers of fatty acid status.

A recent report from the Framingham Heart study presented data on a 9 year follow-up of 899 men and women with a median age of 76 years at baseline. Plasma fatty acid status was assessed at baseline and the primary outcome for the analysis was the development of all-cause dementia and Alzheimer’s disease. Over the follow-up period, 99 new cases of dementia (including 77 Alzheimer’s disease) were diagnosed, and study participants in the highest quartile of plasma phosphatidylcholine DHA concentration were 47% less likely to develop all cause dementia and 39% less likely to develop Alzheimer’s disease than participants in the lowest three quartiles. Highest quartile intakes were in the region of 200mg DHA per day. The best randomised controlled trial conducted to date, assessing the impact of n–3 LCP supplementation oncognitive function in later life, recruited 174 participants with mild to moderate Alzheimer’s disease. The study participants, who had a mean age of 74 years and an MMSE score of 15 points or more (30 being the highest),were provided with 2.3g n–3 LCP per day, or placebo, for 6 months. After 6 months of intervention the decline incognitive function as assessed by MMSE did not differ between the two trial arms. However, in a sub-group of 32 participants with mild cognitive function loss (MMSE> 27 points), the rate of cognitive decline in the n–3 LCP intervention arm was significantly slower than that in the placebo arm. While these results, suggesting that n–3 LCP supplementation can delay cognitive function loss are exciting, they must be confirmed by larger and more long term studies. We are currently conducting a large randomised controlled trial – the OPAL study – which is investigating the effect of 0.7g n–3 LCP supplementation for 24 months on a cohort of 868 healthy adults aged 70-79 years at baseline. The results of the trial are due in late 2008. In contrast to their proposed actions in childhood, where n–3 LCPs are required for healthy development of brain tissue, in older age n–3 LCPs are more like to act in a protective and health-maintaining manner. For example, n–3 LCPs are known to inhibit hepatic triglyceride synthesis and, by modifying eicosanoid function, cause vascular relaxation, a diminished inflammatory process and decreased platelet aggregation. Furthermore, some new protective actions of DHA have recently been discovered that may well be directly related to its effects in maintaining cognitive health in older age.

Thus, it is concluded that there is now a growing body of evidence that supports the general hypothesis that n–3 LCPs are crucial for brain development and for the maintenance of good cognitive function in later life.
A variety of medical conditions have been reported to be ameliorated by regular dietary consumption of DHA. Some of these conditions include improvement in blood circulation, control of heart arrhythmias, beneficial control of clot formation, reduction in blood pressure, beneficial reduction of blood triglyceride levels, reduced risk of primary and secondary heart attacks and improvements covering wide range of inflammatory diseases including rheumatoid arthritis. DHA is the nervous system of cell growth and sustain a major element of the brain and retina.
DHA through diet intake can improve cells involved in fetal formation and development of nerve cell axon extension. It also has an important role to maintain normal physiological activity of nerve cells of the brain involved in thinking and memory formation. Plenty of DHA is important for vision, cognition, memory and learning abilities. Thus, the rapid development of the fetal brain requires a lot of DHA. Fetal brain developed in the lack of maternal DHA, leads to fetal brain cell lipid deficiency, mental development will be limited, which can affect their growth and development of brain cells.
Further DHA is involved during the children's brain development and growth. It enhances memory and thinking ability, improves intelligence and other more significant role. Lack of DHA can cause a range of symptoms, including growth retardation, mental disorders.
For adults, thinking ability depends on the control of information transmitted via brain cells, synapses and other nervous tissue function, namely, information transmission in the nervous system within the scope, direction and effect. In the nerve tissue DHA is about 25% of the fat content, synaptic transmission is a key component of the control information, and a gap is formed by the synaptic membranes, DHA contribute to its structural integrity functioning. Therefore, adult need plenty of DHA, to improve memory and thinking skills.
In order to respond to these and problems to be solved, some companies have products on the market containing DHA. At present, the common market, uses fish oil emulsion formulations and fish oil capsules, but most adults and children do not like the smell of fish oil emulsion, so consumers are always tend to find good taste DHA supplements. Fish oil capsules, although doesn’t have unpleasant odor, but most of the children find capsules difficult to swallow. Some products smell light and easy to swallow but then DHA content is low, i.e. not provide adequate DHA. Pregnant women, lactating women, children and adults cannot get enough DHA in common situations.
Secondly DHA from the fish oil is not preferred by the vegetarian society, in order to solve this problem the DHA is now extracted from algae and are available in oil or capsule forms. Thus it does not have any odor. But study shows people who eat animal products acquire omega-3 easily, whereas vegetarians consume much less than their bodies require.
In the prior art candy gelatin microencapsulated fish oil DHA is known where microencapsulation technology is used. Microencapsulated DHA fish oil, then add to gelatin, gums, prepare a new health candy. However, the microencapsulation method is cumbersome, the need of gum sol, mixed with fish oil, followed by emulsification, condensation reaction, centrifugal separation, dehydration, sugar collapse, refrigeration and other too many steps make it difficult to control the quality of products, ultimately DHA content of prepared products is low.
It is known also known, for instance from US 2,948,658 and references cited therein, that DHA solutions can be produced by fermentative oxidation of glycerol, but the stability of these solutions is a problem. Upon storage of such solutions the DHA content decreases and by-products are formed. Furthermore, DHA is obtained by fermentative oxidation of glycerol as a colored product and therefore should be decolorized, for instance by treatment with active carbon.
A method for obtaining decolorized DHA was disclosed in US 4,076,589, wherein the crude DHA was subjected to a cation exchange and an anion exchange process. According to this procedure isolation of DHA was performed with cation exchange resin Amberlite IRC-120, followed by anion exchange resin Amberlite IRA-401S. It is stressed that this method was only used to decolorize crude DHA to colorless DHA, which was immediately crystallized to obtain a stable crystalline product.
It is therefore one of the objective of the invention is to provide a method for obtaining DHA and at the same time such method should provide stable DHA in liquid form. It was now found that the method of US 4,076,589, apart for its use to decolorize crude DHA, could also be used for obtaining a stable liquid product. However, it was also found that upon such longer shelve periods the liquid DHA was found to decompose to colored and colorless decomposition products.
Various different vitamins, minerals, and other nutritional elements have been found to be desirable for the prenatal development of a child. For example, vitamins such as A, folic acid, B1, B2, niacinamide, B6, B12, C, D, E and K, and minerals such as calcium, copper, iron, zinc, and magnesium, are all considered to be desirable and even essential for pregnant/lactating women. In addition to the desirable transfer of such vitamins, minerals, and nutritional elements to the developing child, the compositions are also desirable for replenishing the vitamin, mineral and/or other nutritional deficiencies in the mother's body.
Supplementing with a prenatal multi-vitamin during pregnancy is important to help support a healthy pregnancy and the baby’s development. Key nutrients such as DHA, Folic Acid, and Iron are essential nutrients in prenatal supplement. DHA plays a crucial role in fetal brain and eye development because DHA is directly transferred from the mother to the fetus during these developmental stages. Folic acid may reduce a woman’s risk of having a child with a brain or spinal cord birth defect and the body’s need for iron nearly doubles during pregnancy.
DHA Liquid combined with all of the key nutrients from a prenatal multivitamin is ideal for expecting and nursing mothers who are looking for a prenatal supplement that includes DHA. Multivitamins, DHA and mineral combination provides vitamins and minerals to the body to help meet nutritional requirements. Any such supplements help in treating or preventing a lack of vitamins or minerals before, during, and after pregnancy and while breast-feeding. It is also used by children to fulfill the growing needs of their body.
US 7704542 B2 discloses the Compositions containing the fatty acid docosahexaenoic acid (DHA) in combination with at least one vitamin and mineral are provided to supplement nutrition in a mammalian diet. DHA is present in the composition in concentrated amounts, advantageously in a carrier such as marinol oil, to allow for quantities of DHA sufficient to supply expectant and new mothers and their children as recommended on a daily basis. This DHA may also be used to treat a variety of disorders in children and adults. The compositions advantageously include vitamins, minerals, and optionally other nutrients to provide a nutritional supplement which may be convenient to swallow and taken once a day.
The prior art disclose many supplements having DHA but the DHA supplement contains one or the other vitamin or minerals. This come to pass problems of having to take more than one tablet/capsule of more than one supplement to get the recommended dose of DHA and other needed vitamins and minerals exists with every person, whether child or adult. Thus, it is further desirable to provide a nutritional regimen for other persons, besides mothers and developing or newborn infants, which supplies the necessary vitamins, minerals, and DHA in recommended dosages with more convenience than supplements of the prior art.
In General, the previous technologies nutritional supplements have the following defects:
(1) Heavy odor of fish oil, which is not acceptable to most consumers.
(2) Low DHA content, which cannot provide sufficient DHA.
(3) Capsules and tablets available are difficult to swallow by children, prone to danger.
(4) The production steps involved in preparation are complicated, and stability is not high.
(5) The DHA in combination with multivitamins and minerals as per body requirement is less available, use of more than one supplement to get the recommended dose.
(6) No DHA preparation available with Minerals especially with Zinc.

SUMMARY OF THE INVENTION
The present invention solves the above mentioned problems and provides an odourless, high level of DHA nutritional fluid in combination with vitamins and minerals, making it a complete nutritional supplement. Such nutritional supplements can be administered to mammals while maintaining or increasing the stability of the components while they are contained in the supplement. The present invention also relates to method for preparing nutritional supplements resulting in a controlled, stable and effective product quality. The present invention provides a water-soluble formulation, containing dietary fatty acid, vitamins, minerals, non-ionic surfactant, taste masking agent flavoring agent, and water. The omega 3 fatty acid used in the present invention is algal derived to make it free from any type of contamination such as mercury.
BRIEF DESCRIPTION OF THE DRAWINGS
An embodiment of the present invention is described in greater detail below and more fully appreciated as the same becomes better understood when considered in conjunction with the accompanying drawings:
FIGURE 1, shows the process flow diagram along with the equipments required in manufacturing of the nutritional supplement formulation in syrup form.
FIGURE 2, shows the process flow diagram along with the equipments required in manufacturing of the nutritional supplement formulation in drop form.
DESCRIPTION OF THE INVENTION
The present invention is explained in detail below. This description is not intended to be a detailed catalogue of all the different ways in which the invention may be implemented, or all features that may be added to the instant invention. For example, features illustrated with respect to one embodiment may be incorporated into other embodiments, and features illustrated with respect to a particular embodiment may be deleted from that embodiment. In addition, numerous variations and additions to the various embodiments suggested herein will be apparent to those skilled in the art in light of the instant disclosure, which do not depart from the instant invention. Hence, the following specification is intended to illustrate some particular embodiments of the invention, and not to exhaustively specify all permutations, combinations and variations thereof.
Omega-3 fatty acid Docosahexaenoic acid (DHA) is of crucial importance in the first two years of life. DHA accumulates in human brain tissue at a rapid rate during the third trimester and at birth, DHA represents approximately 9% of total cortical fatty acid composition, and increases by an additional 6% over the following 20 years until adulthood. Remarkably, after only the first year of life the brain has almost reached adult mass. Although DHA continues to be of importance after infancy and into childhood and adolescence, but at the same time vitamins and minerals are very important. Vitamins and minerals become much more important than it was during infancy as it boosts the human immune system and promote normal growth and development. Bodies require vitamins and minerals so as to function properly. There are 13 vitamins the human body needs, A, C, D, E, K and the B vitamins (thiamine, riboflavin, niacin, pantothenic acid, biotin, vitamin B-6, vitamin B-12 and foliate whereas the minerals needed include calcium and sodium.
Vitamins are classified as either water-soluble or fat-soluble. Out of 13 vitamins, 4 are fat-soluble (A, D, E, and K) and 9 are water-soluble (8 B vitamins and vitamin C). Water-soluble vitamins dissolve easily in water and, in general, are readily excreted from the body, to the degree that urinary output is a strong predictor of vitamin consumption. As they are not readily stored, more consistent intake is important. Fat-soluble vitamins are absorbed through the intestinal tract with the help of lipids. Thus they are more likely to accumulate in the body.
Lipid-based delivery systems are finding increasing application in the oral delivery of poorly water-soluble, lipophilic drugs as they enhance intestinal drug solubilisation and improve oral bioavailability.
The object of the present invention is to provide a fluid supplement that provides essential vitamins and nutrients along with DHA to the children, adults, mother and the developing fetus. Another object of the present invention is to provide a fluid supplement that is easy to consume. Yet another object of the present invention is to provide a fluid supplement that is relatively simple to manufacture, and is relatively cost effective.
The present invention involves vitamins, minerals, nutritional supplements, and flavor-enhancing ingredients in specific ranges to meet the objectives disclosed above. Each of the ingredients is provided for a specific reason to benefit the health and well-being of the mother, the developing fetus, or both. The omega 3 fatty acid used in the present invention is algal derived to make it free from any type of contamination such as mercury.
In the preferred embodiment the present invention is to make a nutritional syrup and nutritional drop including at least one vitamin and at least one mineral in addition to DHA and amino acid which is well acceptable to consumers. However, it is beneficial to include more than one vitamin, or their pharmaceutically accepted salts, in the composition. The vitamins and minerals are generally included in amounts suitable to supplement an average diet and to overcome average deficiencies. Other desirable components may also be included in the composition.
In one of the embodiments, the excipients required for preparing syrup or suspension is a sweetening agent, solublizer, suspending agent, viscosity modifying agent, preservatives, antioxidants, chelating agents and flavours.
Typically, all of the following ingredients are included in the following amounts to produce the fluid supplement of the present invention. The ingredients listed below are all mixed with water to produce the preferred embodiment of the fluid supplement of the present invention. The amount disclosed is according to one of the embodiments, ideal amount of the disclosed ingredients and may vary.
In an embodiment, the formulation of Syrup is shown in Table A.
TABLE A
SYRUP
Range
S.No. Ingredients Lower Higher
Each 5 ml contains:
1 DHA 0 50 mg
2 Vitamin A (As Palimitate) 500 1500 IU
3 Vitamin B1 (Thiamie Hydrochloride) 0.1 1 mg
4 Vitamin B2 (Riboflavin Phosphate) 0.1 1 mg
5 Vitamin B3 (Niacinamide) 1 10 mg
6 Vitamin B5 (D-Panthenol) 0.5 2 mg
7 Vitamin B6 (Pyridoxine HCl) 0.1 5 mg
8 Vitamin B12 (Cyanocobalamin) 0.1 5 mcg
9 Vitamin C (Ascorbic Acid) 10 70 mg
10 Vitamin D3 (Cholecalciferol) 100 1000 IU
11 Vitamin E (Tocopherol acetate) 1 10 IU
12 L-Lysine 5 50 mg
13 Zinc (as Zinc Gluconate) 2 20 mg
14 Choline 2 20 mg
15 Folic Acid 10 150 mcg
16 Iodine (as Potassium Iodide) 15 150 mcg
17 Glutamine 1 15 mg
18 Selenium (as Sodium Selenate) 5 100 mcg

In another embodiment, the formulation of Syrup is shown in Table B.
TABLE B
S.No. Ingredients Label Claim Unit
Each 5 ml contains:
1 DHA 35% 20 mg
2 Vitamin A (As Palimitate) 1250 IU
3 Vitamin B1 (Thiamie Hydrochloride) 0.7 mg
4 Vitamin B2 (Riboflavin Phosphate) 0.75 mg
5 Vitamin B3 (Niacinamide) 7.5 mg
6 Vitamin B5 (D-Panthenol) 1.25 mg
7 Vitamin B6 (Pyridoxine HCl) 0.5 mg
8 Vitamin B12 (Cyanocobalamin) 0.5 mcg
9 Vitamin C (Ascorbic Acid) 25 mg
10 Vitamin D3 (Cholecalciferol) 400 IU
11 Vitamin E (Tocopherol acetate) 2.5 IU
12 L-Lysine 20 mg
13 Zinc (as Zinc Gluconate) 5 mg
14 Choline 5 mg
15 Folic Acid 25 mcg
16 Iodine (as Potassium Iodide) 38 mcg
17 Glutamine 3 mg
18 Selenium (as Sodium Selenate) 15 mcg

In an embodiment, the formulation of Drops is shown in the Table C.
TABLE C
DROPS

S.No. Ingredients
Each 5 ml contains: Lower Higher
1 DHA 0 50 mg
2 Vitamin A (As Palimitate) 500 1500 IU
3 Vitamin B1 (Thiamie Hydrochloride) 0.1 1 mg
4 Vitamin B2 (Riboflavin Phosphate) 0.1 1 mg
5 Vitamin B3 (Niacinamide) 1 10 mg
6 Vitamin B5 (D-Panthenol) 0.5 2 mg
7 Vitamin B6 (Pyridoxine HCl) 0.1 5 mg
8 Vitamin B12 (Cyanocobalamin) 0.1 5 mcg
9 Vitamin C (Ascorbic Acid) 10 70 mg
10 Vitamin D3 (Cholecalciferol) 100 1000 IU
11 Vitamin E (Tocopherol acetate) 1 10 IU
12 L-Lysine 5 50 mg
13 Zinc (as Zinc Gluconate) 2 20 mg
14 Choline 2 200 mcg
15 Folic Acid 10 150 mcg
16 Iodine (as Potassium Iodide) 15 150 mcg

In another embodiment, the formulation of Drops is shown in Table D.
TABLE D
S.No. Ingredients Label Claim Unit
Each ml contains:
1 DHA 35% 10 mg
2 Vitamin A (As Palimitate) 800 IU
3 Vitamin B1 (Thiamie Hydrochloride) 0.3 mg
4 Vitamin B2 (Riboflavin Phosphate) 0.4 mg
5 Vitamin B3 (Niacinamide) 5 mg
6 Vitamin B5 (D-Panthenol) 1 mg
7 Vitamin B6 (Pyridoxine HCl) 0.4 mg
8 Vitamin B12 (Cyanocobalamin) 0.2 mcg
9 Vitamin C (Ascorbic Acid) 25 mg
10 Vitamin D3 (Cholecalciferol) 400 IU
11 Vitamin E (Tocopherol acetate) 2.5 IU
12 L-Lysine 10 mg
13 Zinc (as Zinc Gluconate) 2.5 mg
14 Choline 25 mcg
15 Folic Acid 25 mcg
16 Iodine (as Potassium Iodide) 38 mcg

Another embodiment of the present invention is to mask the taste the typical taste of Vitamin E; typical taste of Vitamin A and Fishy smell of DHA and to add Minerals such as Zinc, selenium, & Iodine in Omega 3 fatty acid to prepare a nutritional syrup and nutritional drop, at the same time to prevent oxidation of Omega 3 fatty acid from these metals so as to have a stable fluid supplement.
The typical smell or the fishy smell of DHA is masked using a formulation prepared by adding suspension of DHA, Vitamin A and Vitamin E with nonionic surfactants preferably span 80.
According to present invention the critical step is the preparation of suspension of DHA with Butylated hydroxyl toluene (BHT), Vitamin E and Vitamin A which is solved by the procedure disclosed in the present invention. With the disclosed ingredients and their respective amounts as shown in the above tables, the following steps are carried out which result into an odorless and stable DHA fluid supplement.
Emulsion preparation
A nonionic surfactant, preferably Span 80 is added with Butylated hydroxyl toluene (BHT) while stirring followed by addition of Vitamin A and Vitamin E further followed by addition of DHA. After thorough mixing water is added drop wise with continuous stirring until oil in water emulsion is prepared.
Syrup preparation:
A weighed quantity of sugar is added to the boiling water with continuous heating till a syrup solution is prepared which is transferred to the main manufacturing vessel.
Manufacturing process:
In one of the preferred embodiments, the batch manufacturing process is disclosed thereof.
Methylparaben Sodium (MPS), Propylparaben Sodium (PPS), Ethylene di amine tetra acetate (EDTA) and Bronopol are dissolved in water separately and transferred to batch manufacturing vessel while stirring. All the vitamins except Vitamin E and Vitamin A are dissolved in water and then the solution is transferred to manufacturing container. Thereafter, Folic acid, Choline, Lysine and Zinc Gluconate are added to the vessel and continuously stirred until all the added materials get dissolved and a clear yellow solution is obtained which is further transferred to the manufacturing vessel. Further above prepared sugar syrup is added to batch manufacturing vessel while stirring. Glycerine is taken in a separate container and Xanthan gum is dispersed in it and kept it as such for an hour until Xanthan gum is completely hydrated; then this dispersion of Xanthan gum is transferred to vessel while stirring. Separately, Butylated hydroxyanisole (BHA) is dissolved in Propylene glycol and transferred to the batch manufacturing vessel while stirring followed by transfer of Sorbitol solution to the Batch manufacturing vessel. Above prepared DHA emulsion is added to manufacturing vessel while stirring. Finally, flavour Raspberry or Mango is added to the vessel while stirring. Flavour Raspberry or Mango is also an additional ingredient which makes the drop taste more acceptable. Flavour Raspberry or Mango is preferred over other flavours because when other flavours were used the taste was not as acceptable.
The following steps are required to be followed for the preferred embodiment to work in efficient manner:
Step 1:Vitamins, except vitamin A and vitamin E in a measured quantity are added to purified water with continuous stirring to form a solution; followed by addition of Sodium Selenate, Glutamine, Folic acid, choline, lysine, zinc Gluconate in the above said solution while stirring.
Step 2: Methylparaben Sodium (MPS), Propylparaben Sodium (PPS), Ethylene di amine tetra acetate (EDTA) and Bronopol are dissolved in water individually followed by addition of the above said solution followed by addition of water which is dissolved in sucralose and further followed by addition of Xanthan gum dispersed in glycerin;
Step 3: Syrup is prepared by addition of water and sucrose followed by addition of citric acid to the syrup and is allowed to cool to 30 C and followed by addition of the syrup to the above mixture of step 2 after cooling further followed by addition of Sorbitol to the mixture of step 2;
Step 4 Butylated hydroxyl anisole (BHA) is dissolved with propylene glycol and then added to the mixture of Step 2.
Step 5 Water in oil emulsion is prepared by mixing nonionic surfactants preferably span 80, vitamin A, vitamin E, Butylated hydroxyl toluene (BHT) and DHA while continuous stirring till Butylated hydroxyl toluene (BHT) is completely dissolved followed by making its emulsion using water and adding the emulsion to the mixture of Step 2.
Step 6 Add measured quantity of Flavour Raspberry or Mango to the mixture of Step 2.
Water in oil emulsion is prepared by mixing nonionic surfactants preferably span 80, vitamin A, vitamin E, Butylated hydroxyl toluene (BHT) and DHA while continuous stirring till Butylated hydroxyl toluene (BHT) is completely dissolved followed by making its emulsion using water and adding the emulsion to the above mixture; and
Then the measured quantity of flavouring agent is added to the above mixture.
Referring to FIGURE 1, a detailed process of manufacturing the above formulation in syrup form is described.
Referring to FIGURE 2, a detailed process of manufacturing the above formulation in drop form is described.
In the preferred embodiment the mixture of desired vitamins, minerals, DHA and other ingredients is a liquid. Compositions of the present invention containing DHA in combination with desired vitamins and minerals, in accordance with the principles of the present invention fishy odor of DHA was successfully masked. Raspberry or Mango flavor is an additional reason to improve the taste of preparation. Sour taste due to Vitamin C is also helpful in the taste improvement of the formulation.
The above formulation has been suggested to be used as follows:
In Syrup Form: It is recommended for the age group 2-12 years as 5ml daily dosage or as directed by the physician.
In Drop Form: It is recommended for the age group 0 – 2 years as 1ml daily dosage or as directed by physician.
The above formulation is available in the following packing:
In Syrup Form– 100 ml pet bottle pack
In Drop Form – 15 ml pet bottle pack, and
The above formulation has the following indications Brain Development, Boost up immunity, Weakness associated with Infection & Fever, Nutritional deficiencies and Proper Physical Growth of Infants
Compositions of the present invention have many uses for example, the DHA, in a desirable concentration and content and in combination with one or more vitamins and minerals, may be provided in the present composition to assist in the prevention of attention deficit/hyperactivity disorder in children.
In one embodiment of the present invention, the compositions containing DHA in combination with desired vitamins and minerals, in accordance with the principles of the present invention, may be used for combating and preventing cardiovascular disorders, such as heart disease, and/or lowering the level of undesirable triglycerides in the blood. In
addition, DHA has been found to make platelets in the blood less likely to stick thereby reducing the potential for clotting and lessening the chance of a heart attack.
In another embodiment, the present composition provides DHA in a desirable concentration and content, in combination with one or more vitamins and minerals, to inhibit or treat central nervous system disorders. In a further embodiment, the present composition provides DHA in a desirable content and concentration in combination with one or more vitamins and minerals, for inhibiting or treating inflammatory disorders. More particularly, the present compositions may be used or specifically directed to combat and reduce the effects of rheumatoid arthritis and inflammatory bowel disorder.
In one embodiment of the invention, available Syrup and Drops can be indicated in Diabetes & cardiovascular disease, arthritis, depression and Alzheimer’s disease, pregnancy, lactation, pre-term labour, pre-eclampsia & post partum depression.
Under the conditions in which the invention is described was evaluated and in the sample of volunteers studied, the data allow the conclusion that the compatibility of the product is considered very good.
While at least some exemplary embodiment has been presented in the foregoing detailed description of the invention, it should be appreciated that a vast number of variations exist. It should also be appreciated that the exemplary embodiment are not intended to limit the scope, applicability, or configuration of the invention in any way. It is being understood that various changes may be made in the function and arrangement of elements described in an exemplary embodiment without departing from the scope of the invention.

CLAIMS:
1. A nutritional supplement comprising :
docosahexaenoic acid (DHA), Vitamin A, Vitamin B1, Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin B12, Folic Acid, Vitamin C, Vitamin D3, Vitamin E, Zinc, Choline, Iodine, Selenium, Glutamine and L-Lysine.

2. The nutritional supplement as claimed in claim 1, wherein the supplement is a stable fluid supplement in syrup or a drop form.

3. The nutritional supplement as claimed in claim 1, wherein the docosahexaenoic acid (DHA) is combined with zinc.

4. The nutritional supplement as claimed in claim 1, wherein typical smell of docosahexaenoic acid (DHA) is masked by adding suspension of docosahexaenoic acid (DHA), Vitamin A and Vitamin E with nonionic surfactants preferably span 80.

5. The nutritional supplement as claimed in claim 1, wherein the docosahexaenoic acid (DHA) is obtained from algae, vitamin A is obtained from palimitate, vitamin B1 is obtained from thiamie hydrochloride, vitamin B2 is obtained from riboflavin phosphate, vitamin B3 is obtained from niacinamide, vitamin B5 is obtained from D-panthenol, vitamin B6 is obtained from pyridoxine HCl, vitamin B12 is obtained from cyanocobalamin, vitamin C is obtained from ascorbic acid, vitamin D3 is obtained from cholecalciferol, vitamin E is obtained from tocopherol acetate, zinc is obtained from zinc gluconate, iodine is obtained from potassium iodide and selenium is obtained from sodium selenate.

6. The nutritional supplement as claimed in claim 1, wherein the supplement in form of a syrup comprises of 0-50 mg of DHA, 500-1500 IU of Vitamin A, 0.1-1 mg of Vitamin B1, 0.1-1 mg of Vitamin B2, 1-10 mg of Vitamin B3, 0.5-2 mg of Vitamin B5, 0.1-5 mg of Vitamin B6, 0.1-5 of mcg of Vitamin B12, 10-70 mg of Vitamin C, 100-1000 IU of Vitamin D3, 1-10 IU of Vitamin E, 5-50 mg of L-Lysine, 2-20 mg of Zinc, 2-20 mg of Choline, 10-150 mcg of Folic Acid, 15-150 mcg of Iodine, 1-15 mg of Glutamine and 5-100 mcg of Selenium.

7. The nutritional supplement as claimed in claim 1, wherein the supplement in form of a drop comprises of 0-50 mg of DHA, 500-1500 IU of Vitamin A, 0.1-1 mg of Vitamin B1, 0.1-1 mg of Vitamin B2, 1-10 mg of Vitamin B3, 0.5-2 mg of Vitamin B5, 0.1-5 mg of Vitamin B6, 0.1-5 mcg of Vitamin B12, 10-70 mg of Vitamin C, 100-1000 IU of Vitamin D3, 1-10 IU of Vitamin E, 5-50 mg of L-Lysine, 2-20 mg of Zinc, 2-200 mcg of Choline, 10-150 mcg of Folic Acid and 15-150 mcg of Iodine.

8. A method for preparing the nutritional supplement as claimed in claim 1, comprising the steps of,
dissolving all vitamins, except vitamin A and vitamin E in purified water with continuous stirring to form a solution;
dissolving Sodium Selenate, Glutamine, Folic acid, choline, lysine, zinc Gluconate in the above said solution while stirring;
dissolving Methylparaben Sodium (MPS), Propylparaben Sodium (PPS), Ethylene di amine tetra acetate (EDTA) and Bronopol in water individually and adding of the above said solution;
adding of sucralose water followed by addition of Xanthan gum dispersed in glycerin of the above said solution;
preparing Syrup by adding water and sucrose followed by adding citric acid to the syrup
the syrup is allowed to cool to 300C and adding the syrup to the above solution;
adding Sorbitol to the above solution after cooling further;
dissolving Butylated hydroxyl anisole (BHA) with propylene glycol and then adding to the above solution;
preparing water in oil emulsion by mixing nonionic surfactants preferably span 80, vitamin A, vitamin E, Butylated hydroxyl toluene (BHT) and DHA while continuous stirring till Butylated hydroxyl toluene (BHT) is completely dissolved and adding the emulsion to the above solution; and
adding the flavouring agent to the above solution.