WO2013124860A1

WO2013124860A1 - Potent revital formulation

Info

Publication number: WO2013124860A1
Application number: PCT/IN2013/000020
Authority: WO
Inventors: Kamlesh Rajnikant Zota; Ketan Chandulal Zota; Sanjay Agrawal; Manukant Chandulal Zota; Himanshu Muktilal Zota
Original assignee: Zota Health Care Ltd
Priority date: 2012-02-23
Filing date: 2013-01-10
Publication date: 2013-08-29

Abstract

This invention is based on a potent revital formulation which comprises two or more active ingredients such as taurine and racemethionine along with essential dietary supplements such as vitamins, iron, minerals, trace elements and pharmaceutically acceptable excipients preferably in oral dosage form.

Description

TITLE OF THE INVENTION- "POTENT REVITAL FORMULATION."

FIELD OF THE INVENTION- The present invention relates to efficient oral pharmaceutical composition which comprises main active ingredients such as taurine and race methionine along with multivitamins, minerals, trace elements some pharmaceutically acceptable excipients preferably in oral dosage form.

BACKGROUND OF THE INVENTION

Alcohol is a powerful liver toxin that harms (damages) the liver in three stages: alcoholic fatty liver, alcoholic hepatitis, and alcoholic cirrhosis. About 20 percent of alcoholics and heavy drinkers develop fatty liver, or steatosis. The rate of mortality in severe cases is about 50 percent. If heavy drinking continues, about 40 percent of cases of alcoholic hepatitis will develop into cirrhosis.

According to US Patent 5906811 wherein said The combination of several synergistic antioxidants, enzymatic co-factors and amino acids in appropriate delivery vehicles employed in aerosol carriers, mist and pump oral sprays, solutions, such as oral irrigators, mouth rinses and mouthwashes, or gels and solid compositions as a means of preventing and ameliorating signs and symptoms and complications to the oro-pharyngeal cavity and mouth including buccal mucosa, gums and tongue and the upper respiratory tract from damage caused by free radical species induced by tobacco smoke, smokeless tobacco, ingested or chewed noxious, malodorous or harmful substances and other inhaled environmental pollutants and particulate matter, including tobacco to secondary smokers.

According to United States Patent 5817695 wherein said A nutritional product is provided for cancer patients comprising, as per caloric requirement, a low concentration of carbohydrate, a high concentration of fat and an imbalance of amino acids wherein L-phenylalanine, L- tyrosine and L-methionine are present in the below normal concentrations and L-leucine is present in substantial excess of normal concentrations to suppress cancer growth and as an adjunct to conventional cancer therapies

According to European Patent EP1408988 wherein said Provided is a synergistic combination of nutritional supplements classified as Nutraceuticals and further combined with antioxidant vitamins and minerals that, when orally administered to mammals, provides optimal delivery of vital metabolic precursors necessary for the production and repair of articular cartilage. Specifically provided is a unique combination of chondroitin sulfate sodium, methylsulfonylmethane, glucosamine potassium, glucosamine hydrochloride, glucosamine sulfate sodium, N-acetyl D-Glucosamine, sodium absorbate and chelated manganese proteinate compounded through agitation. The provided compositions and methods of administration are designed to effectively elevate and sustain blood levels of said compounds in turn enhancing the body's natural chondroprotective mechanisms while providing an efficient delivery mechanism which optimizes cellular uptake of glucosamine and chondroitin. This process of forming specified synergistic relationships between vital metabolic precursors increases the body's production of proteoglycans, chondrocytes, hyalauron glycosaminoglycans and collagen, facilitating the repair and regeneration of articular cartilage and symptomatic relief from pain and inflammation associated with articular degeneration.

According to WO 2006/062273 Al, wherein said the present invention relates to a health supplement food utilizing, in particular, branched amino acids from among essential amino acids. More specifically, the present invention relates to: a health supplement food comprising branched chain amino acids (herein after, referred to as LIV) composed of leucine (L), isoleucine (I) and valine (V) which is made to have a composition similar to essential amino acids contained in naturally-occurring milk, eggs, soybeans, beef and the like, and enhancing instant impact power under anaerobic conditions, via addition of L- glutamine and taurine which are essentially required when a person is exposed to excessive exercise, stress or overwork; a health supplement food for improving a weak constitution, comprising herbal materials such as ginseng, red ginseng and Acanthopanax; and a diet food or beverage further comprising dietary fibres such as insulin, polydextrose and crystalline cellulose, and carnitine and hydroxy citric acid.

According to WO 2007/115112 A2wherein said an exemplary dried, meat-based product includes meat and plant seed where the plant seed comprises at least approximately 3% caffeine by weight. For example, an exemplary product includes guarana plant seed. According to various products and processes, plant seed may be provided as a powder According to US 2009/0005320 Al wherein said The invention relates to compositions comprising one or more ionic salts, each of said ionic salts consisting of a bicarbonate anion and a cation selected from the group consisting of an amino acid, an amino acid derivative, a di-peptide and a tri-peptide, and to methods of making and using said compositions.

Certain amino acids have found to play a promising role in preventing and treating a majority of these liver diseases due to their antitoxic and antioxidant properties. Racemethionine and Taurine are vital amongst them.

SUMMARY OF THE INVENTION

In one aspect, the invention is to provide commercially viable and efficient formulation.

In one aspect, the invention is to provide safe and effective dosage form with taurine and racemethionine composition and other ingredients such as multivitamins, minerals, trace elements which are using as dietery supplements.

In one aspect, the invention is to provide different release drug profile such as Sustained or controlled or retard formulation available in oral formulation (capsule, tablet, powder and in liquid thereof)

In one aspect, the invention is to protect chronic illness or malnutrition may be due to defective nutrition, wherein patient is not able to take vitamins/ minerals / trace elements leads to poor performance of vital organs.

In one aspect, it will provide instant energy and work like prophylactic total health care.

DETAILED DESCMPTION OF THE INVENTION

The invention will now be described in detail in connection with certain preferred and optional embodiments. So that various aspects thereof may be more fully understood and appreciated.

Generally liver protecting medication consists of amino acids, minerals, vitamins thereof can form spontaneously and are therefore thermodynamically stable.

The present invention discloses the efficiency pharmaceutical composition in oral dosage form. This comprises therapeutically effective amount of taurine, racemethionine multivitamins, minerals thereof so as to make the formulation stable.

According to the oral pharmaceutical composition of the present invention, the said oral pharmaceutical composition is available in various forms such as tablet, capsule, sachet, powder (liquid) thereof. It is useful supplementation in patients suffering from liver diseases and may also provide valuable benefits in patients suffering from cardiovascular diseases, diabetes, neurological disorders and others.

In preferred embodiment, Essential Amino Acids cannot manufacture these Amino Acids in body. These amino acids have antioxidant, antitoxic property which is useful in organ protection and detoxification of harmful substances. Racemethionine and Taurine are the examples of such amino acids.

In embodiment of the invention, Taurine, a liver protecting amino acid, It is essential for formation of bile acids and thus for detoxification processes, it reduces the secretion of apolipoprotein B100 and lipids in Hepatic G2 cells and is effective in removing fatty liver deposits, preventing liver disease, and reducing cirrhosis. Importantly taurine has protective and preventive role in portal hypertension, the major cause of death in cirrhotic liver conditions. It is useful in treating people with alcohol dependency and is a detoxifying agent with antioxidant action that helps protect liver cells against various toxins.

In the case of liver health wherein Taurine is known that the liver is the main organ for taurine biosynthesis and also an important target organ for taurine's many biological activities. It is essential for formation of bile acids and thus for detoxification processes. In a clinical study, taurine has been shown to reduce the secretion of apolipoprotein B100 and lipids in Hepatic G2 cells and is effective in removing fatty liver deposits, preventing liver disease, and reducing cirrhosis. Importantly taurine has protective and preventive role in portal hypertension, the major cause of death in cirrhotic liver conditions.

Taurine plays following important roles in hepatoprotection -

-It Combines and removes of toxic chemicals and metabolites.

-Antioxidant action

-Taurine increases levels of antioxidant enzymes like glutathione peroxidase, superoxide dismutase and catalase in liver and thus protects hepatocytes from free radical and ROS induced damages

-As essential component of cell membranes wherein it enhances transport of important ions across hepatocytes thus improving their functions and recovery. A deficiency of taurine can lead to electrolyte imbalance due to impaired mineral transport across cell membranes and this reduces the ability of the liver to remove toxic substances.

The inclusion of taurine in a liver supplementation is beneficial for the above reasons.

In the case of Taurine deficiency and liver injuries (study on mice) wherein Taurine deficiency can trigger hepatitis and liver fibrosis, probably due to a diminished antioxidant defence, increase in inflammatory reactions and mitochondrial dysfunction in hepatocytes.

Taurine deficiency increases free radicals

ROS mediated oxidative damages and formation of toxic metabolites in liver cells. This can be seen as there is a 6-fold increase in the TNFA plasma levels. Tissue necotising factor alpha is a marker for inflammatory processes that leads to cell death. Taurine supplementation prevents these damages and protects cells.

Severe toxicities cause death of more and more hepatocytes. These cells are replaced by formation of new cells. If the cell destruction is high, the newly formed cells are immature and abnormal in shape (oval shape). Development of these cells is associated with liver dysfunction.. Taurine protects liver tissue from necrosis (cell death), inflammation, and fibrosis, and helps protect cells from damage.

This effect is observed in a rat study which used carbon tetrachloride as toxicant. Taurine pre- treatment induced a marked beneficial effect regarding the prevention of hepatocellular necrosis and atrophy as demonstrated morphologically. In conclusion, these results suggest that taurine pre-treatment prevents the morphologic damage caused by CC14 in the early stages.

Further taurine helps for normal hepatocyte structures and prevents formation of extracellular matrix which otherwise leads to liver fibrosis.

Taurine in alcoholic liver disorders wherein Taurine reverses the hepatic steatosis (deposition of fat) and lipid peroxidation caused by chronic alcohol consumption in rats

As per clinical study, Taurine has been shown to be useful in treating people with alcohol dependency involving over 3,000 alcohol dependent people who were given taurine showed that taurine is more effective than placebo at preventing alcohol relapse.

Taurine increases urine excretion of homocysteine during alcohol withdrawal. Rise in blood homocysteine (hyperhomocysteinaemia) was observed in chronic alcoholics who underwent withdrawal from alcohol. Homocysteine has excitatory effects in brain and is associated with nervous restlessness and other psychotic episodes seen during alcohol withdrawal. Taurine being an inhibitory neurotransmitter reduces excitatory signals. It also reduces hyperhomocysteinaemia by excreting homocysteine through kidneys. This dual effect helps in alcohol withdrawal.

Twenty-two patients undergoing treatment for alcohol withdrawal were given 1 gram of taurine three times per day orally for seven days. When compared to retrospective controls, significantly fewer of the taurine-treated patients had psychotic episodes (14% vs. 45%, p < 0.05). The number of psychotic cases after admission who had also been psychotic before admission was 1/16 for the taurine group and 11/17 for the controls (p < 0.001).

The inhibitory amino acid taurine may constitute an important protective mechanism against excitotoxicity and thus protects against neuronal damage. In embodiment of the invention, racemethionine (2-amino-4-methylsulfanylbutanoic acid (C5H11N02S) is a lipotropic amino acid in hepatoprotection. It is a potent methyl donor, powerful antioxidant and a major source of other liver detoxificants including glutathione and S-Adenosyl Methionine (SAMe).

Racemethionine is also the precursor for taurine and thus its levels are reduced due to consumption for formation of taurine. Taurine supplementation along with methionine increases liver taurine levels and spares methionine for other vital functions. This makes the combination of Taurine and Methionine as a viable (effective) combination with synergistic action.

It contains Methionine which has Methyl (-CH3) donor important in metabolic processes where methyl group is transferred to other compound (methylation). A precursor to other important substances like S-adenosyl methionine (SAMe), glutathione and amino acids like taurine and cysteine. Methionine levels determine the liver's concentration of sulfur- containing antioxidant compounds like SAMe and glutathione which improve and normalize liver functions. Methionine itself has a protective effect on glutathione and prevents depletion during toxic overload, which can protect the liver from the damaging effects of toxic compounds. Methionine residues on the surface of proteins (like enzymes) offer antioxidant protection and thus prevent degradation of proteins by reactive oxygen species and free radicals. Liver contains maximum amounts of enzymes and thus methionine concentration in liver is important for protection against toxic free radicals.

In the case of Liver protection wherein Cells in the liver and kidneys especially need methionine for regeneration. It helps in protection against the destruction of delicate liver tissues. Methionine helps maintain the health of the liver by removing toxins and giving protection.

In the case of Alcoholic liver disorder wherein Alcohol is a major cause of liver disease and disrupts methionine and oxidative balances.

As per the clinical trials on rats following steps obtained

Alcohol feeding to rats that were submitted to a jejunoileal bypass operation has been shown to result in liver damage being comparable with alcohol-induced liver disease in man. In a study, a striking effect of free methionine consumption on histological liver injury, triglyceride accumulation, and energy-rich nucleoside content in the liver of rats with a jejunoileal bypass is demonstrated.

Methionine was found to strongly improve the alcohol-induced histological changes in the liver. Triglyceride content of the liver was found to decrease in a dose-dependent manner with increasing methionine ingestion.

Hepatic adenosine triphosphate content increased significantly with higher methionine consumption.

These results underscore the impairment of the transmethylation/transsulfuration pathway in the development of alcohol-induced liver diseases.

Due to above observation, its clarify that Methionine is the precursor for other important antioxidant substances like SAMe and glutathione.

SAMe is an active compound made from methionine and adenosine triphosphate (ATP). It acts as a methyl donor in a variety of biochemical pathways. Methylation reactions are essential for the detoxification of harmful products of metabolism, and the synthesis of numerous physiological agents including neurotransmitters, cartilage, and glutathione. The role of SAMe for intrahepatic cholestasis associated with liver disease has been observed.

In the case of liver protection wherein SAMe improves and normalizes liver function. SAMe is used in the treatment of cirrhosis and liver damage caused by alcohol. Through methylation, SAMe increases membrane fluidity, restoring several factors that promote bile flow. Treatment with SAMe helps decrease serum bilirubin (pigment in the blood that can cause jaundice) in patients with elevated serum bilirubin level.

In the case of alcoholic liver disorder wherein SAMe is to be useful therapeutically in alcoholic liver injury including cholestasis, and in the devastating consequences of excessive liver fibrosis (leading to cirrhosis).

S-Adenosyl-L-methionine (SAMe) exerts major key functions in the liver, including serving as a precursor for cysteine and glutathion. SAMe is particularly important in opposing the toxicity of free oxygen radicals generated by various pathogens, including alcohol, which causes oxidative stress largely by the induction of cytochrome P4502E1 (CYP2E1) and by its metabolite acetaldehyde. SAMe also acts as the main methylating agent in the liver.

SAMe in vivo is associated with beneficial effects on liver function and structure and resulted in a corresponding attenuation of ethanol-induced liver injury as shown by less-striking glutathione depletion and lesser increases in plasma aspartate transaminase. SAMe also shows hepatocyte mitochondrial protection. As per the observation on rats, SAMe decreased ethanol-induced fat accumulation. Thus, SAMe was shown to be useful for opposing the oxidative stress and the alcohol-induced liver injury.

Membrane alterations are common in alcoholic liver injury and are also associated with a decrease in phosphatidylcholine, the backbone of the membranes. SAMe increases phosphatidylcholine concentrations in the liver membranes by methylation reactions and thus protects hepatocytes from damages.

The ability of Racemethionine to reduce the liver-toxic effects of hepatotoxins such as acetaminophen and methotrexate has led to the suggestion that it should be added to acetaminophen products. It is thought that metabolism of high doses of acetaminophen in the liver lead to decreased levels of hepatic glutathione and increased oxidative stress.

The liver produces glutathione. A deficiency of hepatic GSH and other antioxidants and/or an increase in oxidative stress, may contribute to the progression of liver disease. Glutathione is important in the management of patients with alcoholic liver disease and viral hepatitis, particularly those with hepatitis C.

Glutathione protects cells in several ways. It neutralizes oxygen molecules (free radicals) before they can harm cells. Together with selenium, it forms the enzyme glutathione peroxidase, which neutralizes hydrogen peroxide. It is also a component of another antioxidant enzyme, glutathione-S-transferase which is a broad-spectrum liver-detoxifying enzyme.

Glutathione protects the body from free radical damages as it contains Sulphur donating amino acid- Cysteine (formed from methionine) which helps to destroy harmful toxic materials from the body. Cysteine also functions as an effective binder of harmful heavy metals in the body, the depletion of Cysteine -an essential part of Glutathione can result in frequent sicknesses and damages to the liver. Glutathione has several health benefits. Optimal amounts of glutathione are necessary for supporting the immune system, and, in particular, glutathione is required for replication of the lymphocyte immune cells. Glutathione also helps the liver to detoxify chemicals, such as acetaminophen, copper, and cadmium.

Glutathione protects not only individual cells but also the tissues of the arteries, brain, heart, immune cells, kidneys, lenses of the eyes, liver, lungs, and skin against oxidant damage. It plays a role in preventing cancer, especially liver cancer, and may also have an anti-aging effect.

Glutathione conjugation is an important step in detoxification process that produces water- soluble substances which are excreted via the kidneys. The elimination of fat-soluble compounds, especially heavy metals like mercury and lead, is dependent upon adequate levels of glutathione, which in turn is dependent upon adequate levels of methionine and cysteine. When increased levels of toxic compounds are present, more methionine is utilized for cysteine and glutathione synthesis. Methionine and cysteine have a protective effect on glutathione and prevent depletion during toxic overload. This, in turn, protects the liver from the damaging effects of toxic compounds and promotes their elimination.

Oxidative stress was shown to play a major pathogenic role in multiple disease states ranging from the hepatotoxicity of alcohol to the carcinogenicity of many compounds. The major natural defence mechanism against oxidative stress is reduced by glutathione, which traps the excess of free radicals. The most important role of Glutathione in alcoholic liver disorders is following:

The microsomal ethanol-oxidizing system has been the subject of extensive research. A 4- fold induction of cytochrome P4502E1 (CYP2E1) was found in liver biopsy samples from recently alcohol drinking subjects. CYP2E1 activates some xenobiotics (such as acetaminophen) to toxic metabolites. It also generates several species of active oxygen species. Glutathione provides one of the cell's fundamental mechanisms for the scavenging of toxic free radicals.

Alcohol causes liver disease through a variety of pathogenic mechanisms. The major mechanisms include interactions with nutrition and toxic manifestations through generation of oxidative stress and production of the toxic metabolite acetaldehyde. The combination of Racemethionine and Taurine shows a synergistic effect on targeted diseases.

Both Racemethionine and Taurine are concentrated in liver and plays an important role in liver function, detoxification of harmful substances and hepatocyte protection. Many of their functions are independent of each other.

When taurine is used up for metabolic reactions, it is biosynthesized from methionine. Thus methionine is used up in this process. During stressed conditions or increased liver function requirements more and more methionine may be used up for taurine formation causing methionine depletion. Supplementation of taurine reduces the need for conversion of methionine to taurine thus allowing methionine for its other important functions especially for the liver protection.

Further, in some patients excess methionine has been reported to increase homocysteine levels. Increased homocysteine levels may be associated with abnormal cardiovascular functions. It is found that taurine causes excretion of homocysteine via kidney and thus prevents its damages, if arty.

Thus the combination of Racemethionine and Taurine is a synergistic combination useful in various liver diseases and others.

Thus according to preferred aspect, oral pharmaceutical composition of the present invention comprising dietary supplements, for replacing a necessary substance not found in large enough quantities in the diet, Preventing or decreasing the risk of developing a disease or condition, Boosting the immune system and improving general health, Boosting energy levels, Improving mental or physical performance, Reducing symptoms of a disease or health condition.

In another embodiment of the present invention the said composition also comprises dietary ingredients may include vitamins, minerals, herbs, amino acids, enzymes, organ tissues, glandulars, and metabolites. These are following -

Selenium Wherein it acts as an anti-oxidant and protects from free radicals supports the functions of anti-oxidants.

Chromium wherein it supports the bodies efforts to maintain normal glucose levels. The only "food" truly rich in Chromium is brewer's yeast, so it's rarely available in marketed products.

Potassium wherein it is Responsible for acid-base balance and osmotic pressure, Maintains proper function of cell walls in conjunction with sodium. Supports the activity of magnesium and Promotes cellular equilibrium thereof.

Magnesium wherein its Primary function is enzyme activation, Supports the maintenance of a healthy heart. It has a critical role in energy production, Important to the metabolically active tissues, mainly found in bone, muscles and vital organs. It is also prevents bone loss.

Manganese wherein it Supports the maintenance of healthy bone mass and Supports the maintenance of a healthy reproductive system. It helps in the absorption of calcium and maintain bone mineral density.

Zinc wherein Supports cell respiration, Supports the functions of antioxidants, Supports the immune system. It helps in the maintance of bone density .

Copper wherein it supports the maintenance of healthy cell respiration and the functioning of antioxidants. It helps in protection against free radicals.

Biotin wherein the function is same as Vitamin B7, Supports muscles and the circulatory system. It helps in the maintance of body and beauty

Vitamin K wherein it needed by the liver to produce a blood-clotting factor and for improving bone mineralisation.

Vitamin C wherein improves body's ability to absorb calcium and iron, and excrete copper, lead and mercury; assists in absorption of certain amino acids, Converts cholesterol into bile acids, thereby lowering it in the body, Helps in neutralise nitrosamines (carcinogenic substances), Powerful antioxidant, supports immune system and its response to infections by boosting antibody function, Speeds healing of wounds and strengthens blood vessels. It helps in formation of collagen, a basic substance of connective tissue.

Vitamin E has a great affinity for oxygen, it is so effective in preventing free radicals formation, Improves cell respiration and increases muscle efficiency, Protects fat-soluble vitamins; acts as an anti-coagulant, blood thinner, and helps to decrease cholesterol, Improves blood circulation and supports immune system, Involved in production of substance that delivers nerve impulses to muscles.

Vitamin B6 (Pyridoxine) is Important in many metabolic functions, including the release of glycogen from the liver when muscles need energy, Helps regulate body fluids by helping to balance potassium and sodium, This is also important for nerve and muscle function, Helps to synthesize red blood cells, Can help prevent formation of oxalic acid salts (lead to kidney stones) when combined with magnesium, Inhibits release of histamine beneficial for allergy sufferers. Also helps in the formation of certain neurotransmitters.

Vitamin B3 (Niacin) wherein Assists in breaking down nutrients, Helps lower cholesterol and triglycerides and improves blood circulation, Vital to healthy nervous system, Releases histamine thereof.

Vitamin Bl (Thiamine) wherein Helps to overcome stress and promotes a feeling of optimism, Stabilises the appetite and stomach secretions, Helps to maintain normal heart function, Important for growth and Improves nerve function.

Vitamin B2 (Riboflavin) wherein Part of the enzyme system involved in breakdown of carbohydrates, fats, and proteins; also involved in synthesis of nucleic acids, Helps with Iron absorption, Key in regeneration of glutathione, an important antioxidant.

Folic Acid wherein Along with B12, takes part in synthesis of nucleic acids, formation of red blood cells and certain amino acids, Stimulates stomach secretions and aids digestion, Helps body synthesise neurotransmitters; maintains nervous system. It maintains the concentration of homocystein.

Vitamin D wherein Promotes the absorption of Calcium & Phosphorus, it helps assimilation.

Vitamin A, Maintains a healthy nervous system, normal heartbeat and efficient blood clotting.

Vitamin B 12 (as cyanocobalamin) wherein Supports the development of red blood cells,

Supports the nervous system, Supports the digestive system, and Supports the production of bone marrow. Calcium wherein Supports the maintenance of healthy bone mass ,helps in the performance of nervous system, blood coagulation, synthesis of neurotransmitters.

Above formulation is also protects chronic illness or malnutrition may be due to defective nutrition, wherein patient is not able to take vitamins / minerals / trace elements leads to poor performance of vital organs. It reduces lack of energy, due to poor eating. It will provide instant energy and work like prophylactic total health care.

EXAMPLES-

( Thiamin )

Vitamin B2 2.5 mg 2.5 mg 2.5 mg 2.5 mg 2.5mg ( Riboflavin)

Vitamin B3 2.5 mg 2.5 mg 2.5 mg 5mg 5mg ( Niacin )

Vitamin B6 0.5 mg 0.5 mg 0.5 mg 0.5 mg 0.5 mg ( Pyridoxin )

Folic Acid 100 meg 100 meg 100 meg 100 meg 100 meg

Vitamin B12 1.5 meg 1.5 meg 1.5 meg 1.5 meg 1.5 meg (Cyanocobalamin)

Biotin 7.5 meg 7.5 meg 7.5 meg 7.5 meg 7.5 meg

Pantothenic Acid 2.5 mg 2.5 mg 2.5 mg 2.5 mg 2.5 mg

Phosphorus 35 mg 35 mg 35 mg 27.25mg 25mg

Iodine 37.5 meg 37.5 meg 37.5 meg 37.5 meg 37.5mcg

Calcium 84 mg 84 mg 84 mg 84 mg 84mg

Magnesium 25 mg 25 mg 25 mg 25 mg 25 mg

Selenium 10 meg 10 meg 10 meg 17.5 meg 10 meg

Manganese 0.5 mg 0.5 mg 0.5 mg 0.5 mg 0.5 mg

Chromium 30 meg 30 meg 30 meg 30 meg 30 meg

Molybdenum 18.75 meg 18.75 meg 18.75 meg 18.75 meg 18.75 meg

Potassium 20 mg 20 mg 20 mg 20 mg 20 mg

Lycopene 0.075 mg 0.075 mg 0.075 mg 0.075 mg 0.075 mg DHA 25 mg 25 mg 25 mg 25 mg 25 mg

Rosemary 1 mg 1 mg 1 mg 1 mg 1 mg

EPA 25 mg 25 mg 25 mg 25 mg 25 mg

Claims

CLAIMS,

1. Potent revital oral formulation comprises two or more active ingredients such as taurine and racemethionine along with essential dietary supplements such as vitamins, iron, minerals, trace elements and pharmaceutical acceptable excipients.

2. Potent revital oral formulation as claimed in claim 1 wherein it is available in various forms such as tablet, capsule, sachet, and powder, liquid thereof.

3. Potent revital oral formulation as claimed in claim 1 wherein racemethionine is a lipotropic amino acid in hepatoprotection. It is a potent methyl donor, powerful antioxidant and a major source of other liver detoxificants including glutathione and S-Adenosyl Methionine (SAMe).

4. Potent revital oral formulation as claimed in claim 3 wherein that Methionine is the precursor for other important antioxidant substances like SAMe and glutathione .

5. Potent revital oral formulation as claimed in claim 3 & 4 wherein SAMe improves and normalizes liver function. SAMe is used in the treatment of cirrhosis and liver damage caused by alcohol.

6. Potent revital oral formulation as claimed in claim 1 wherein Taurine increases levels of antioxidant enzymes like glutathione peroxidase, superoxide dismutase and catalase in liver and thus protects hepatocytes from free radical and .ROS induced damages.

7. Potent revital oral formulation as claimed in claim 1 wherein Both Racemethionine and Taurine are concentrated in liver and play important role in liver function, detoxification of harmful substances and hepatocyte protection. Many of their functions are independent of each other.

8. Potent revital oral formulation as claimed in claim 1 wherein Selenium acts as an anti-oxidant and Supports the functions of anti-oxidants.

9. Potent revital oral formulation as claimed in claim 1 wherein Chromium supports the bodies efforts to maintain normal glucose levels.

10. Potent revital oral formulation as claimed in claim 1 wherein Potassium is Responsible for acid-base balance and osmotic pressure, Maintains proper function of cell walls in conjunction with sodium. Supports the activity of magnesium and Promotes cellular equilibrium thereof.

11. Potent revital oral formulation as claimed in claim 1 wherein Magnesium is Primary function as enzyme activation, Supports the maintenance of a healthy heart. It has a critical role in energy production, Important to the metabolically active tissues, mainly found in bone, muscles and vital organs. It is also maintained bone mineralisation.

12. Potent revital oral formulation as claimed in claim 1 wherein Manganese wherein it Supports the maintenance of healthy bone mass and Supports the maintenance of a healthy reproductive system. It maintained bone mineral density also.

13. Potent revital oral formulation as claimed in claim 1 wherein Zinc wherein Supports cell respiration, Supports the functions of antioxidants, Supports the immune system.

14. Potent revital oral formulation as claimed in claim 1 wherein Copper supports the maintenance of healthy cell respiration and the functioning of antioxidants.

15. Potent revital oral formulation as claimed in claim 1 wherein Biotin wherein the function is same as Vitamin B7, Supports muscles and Supports the circulatory system.

16. Potent revital oral formulation as claimed in claim 1 wherein Vitamin needed by the liver to produce a blood-clotting factor and for improving bone mineralisation.

17. Potent revital oral formulation as claimed in claim 1 wherein Vitamin C improves body's ability to absorb calcium and iron, and excrete copper, lead and mercury; assists absorption of certain amino acids, Converts cholesterol into bile acids, thereby lowering it in the body, Helps neutralise nitrosamines (carcinogenic substances), Powerful antioxidant; supports immune system and its response to infections by boosting antibody function, Speeds healing of wounds and strengthens blood vessels. It helps in formation of collagen, basic substance of connective tissue.

18. Potent revital oral formulation as claimed in claim 1 wherein Vitamin E has a great affinity for oxygen, it is so effective in preventing free radical formation, Improves cell respiration and increases muscle efficiency, Protects fat-soluble vitamins; acts as an anti-coagulant, blood thinner, and helps to decrease cholesterol, Improves blood circulation and supports immune system, Involved in production of substance that delivers nerve impulses to muscles.

19. Potent revital oral formulation as claimed in claim 1 wherein Vitamin B6 (Pyridoxine) Important in many metabolic functions, including the release of glycogen from the liver when muscles need energy, Helps regulate body fluids by helping to balance potassium and sodium, This is also important for nerve and muscle function, Helps to synthesize red blood cells, it Can help prevents formation of oxalic acid salts (lead to kidney stones) when combined with magnesium, Inhibits release of histamine beneficial for allergy sufferers.

20. Potent revital oral formulation as claimed in claim 1 wherein Vitamin B3 (Niacin) Assists in breaking down nutrients, Helps in lower cholesterol and triglycerides and improves blood circulation, Vital to healthy nervous system, Releases histamine thereof.

21. Potent revital oral formulation as claimed in claim I wherein Vitamin Bl (Thiamine) helps to overcome stress and promotes a feeling of optimism, Stabilises the appetite and stomach secretions, Helps to maintain normal heart function, Important to growth and Improves nerve function.

22. Potent revital oral formulation as claimed in claim 1 wherein Vitamin B2 (Riboflavin) Part of the enzyme system involved in breakdown of carbohydrates, fats, and proteins; also involved in synthesis of nucleic acids, Helps with Iron absorption, Key in regeneration of glutathione, an important antioxidant

23. Potent revital oral formulation as claimed in claim 1 wherein Folic Acid Along with B12, takes part in synthesis of nucleic acids, formation of red blood cells and certain amino acids, Stimulates stomach secretions and aids digestion, Helps body synthesise neurotransmitters; maintains nervous system. It maintains the concentration of homocystein, prevent development of hypertension.

24. Potent revital oral formulation as claimed in claim 1 wherein Vitamin D promotes the absorption of Calcium & Phosphorus, Helps in assimilation.

25. Potent revital oral formulation as claimed in claim 1 wherein Vitamin A, Maintains a healthy nervous system, normal heartbeat and efficient blood clotting.

26. Potent revital oral formulation as claimed in claim 1 wherein Vitamin B12 (as cyanocobalamin) Supports the development of red blood cells, Supports the nervous system, Supports the digestive system, and Supports the production of bone marrow. It maintains the myelin sheath of neurones also.

27. Potent revital oral formulation as claimed in claim 1 wherein Calcium Supports the maintenance of healthy bone mass ,helps in the performance of nervous system, blood coagulation, synthesis of neurotransmitters.

28. Potent revital oral formulation as claimed in claim 1 wherein It protects chronic illness or malnutrition may be due to defective nutrition, wherein patient is not able to take vitamins / minerals / trace elements leads to poor performance of vital organs. It reduces lack of energy, due to poor eating. It will provide instant energy and work like prophylactic total health care.