FORM 2
THE PATENTS ACT, 1970
(39 OF 1970)
&
PATENTS RULES, 2003
(COMPLETE SPECIFICATION)
TITLE OF THE INVENTION- "AN ORAL FORMULATION WITH ANTIOXIDANT PROPERTIES FOR THE TREATMENT OF HEPATIC DISEASES."
NAME OF APPLICANT- ZOTA HEALTH CARE LTD.
ADDRESS OF APPLICANT- ZOTA HEALTH CARE LTD,
ZOTA HOUSE,
2/896, HIRA MODI STREET, SAGRAMPURA, SURAT 395002 (GUJARAT), INDIA.
The following specification particularly describes the nature of the invention and the manner in which it is to be performed.

FIELD OF THE INVENTION- The present invention relates to efficient oral pharmaceutical composition which comprises main active ingredients such as taurine and glutathione along with some pharmaceutically acceptable excipients preferably in oral dosage form.
BACKGROUND OF THE INVENTION
Liver is the largest organ inside the body. It is also one of the most important. The liver has many jobs, including changing food into energy and cleaning alcohol and poisons from the blood. The liver also makes bile, a yellowish-green liquid that helps with digestion.
There are many kinds of liver diseases. Viruses cause some of them, like hepatitis A, hepatitis B and hepatitis C. Others can be the result of drugs, poisons or drinking too much alcohol. If the liver forms scar tissue because of an illness, it's called cirrhosis. Jaundice, or yellowing of the skin, can be one sign of liver disease.
fn 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.
In 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-pheny I alanine, 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

Certain amino acids have found to piay a promising role in preventing and treating a majority of these liver diseases due to their antitoxic, osmoregulatory effects and antioxidant properties. Glutathione and Taurine are vital amongst them.
SUMMARY OF THE INVENTION
In one aspect, the invention is to provide safe and effective dosage form with taurine and glutathione and other ingredients
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 thereof)
In one aspect, it will provide instant energy with the treatment of hepatic disorders along with various properties such as active antioxidant properties antitoxic, and osmoregulatory effects.

DETAILED DESCRD7TION 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.
The present invention discloses an efficiency pharmaceutical composition in oral dosage form. This comprises therapeutically effective amount of taurine, glutathione 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 thereof.
It is useful supplementation in patients suffering from liver diseases and may also provide valuable benefits with antioxidant properties.
In embodiment of the invention, taurine, a liver protecting amino acid, It is essential for formation of bile acids and thus for detoxification processes.
In the case of liver health, taurine is an active detoxificant 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. 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 deficiency increases free radicals, ROS mediated oxidative damages and formation of toxic metabolites in liver cells. Tissue necotising factor alpha is a marker for inflammatory processes that leads to cell death. Taurine supplementation prevents these damages and protects cells.
Taurine protects liver tissue from necrosis (cell death), inflammation, and fibrosis, and helps protect cells from damage.

In the case of liver health , taurine is an active hepatoprotecter wherein taurine plays important roles in hepatoprotection such as 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 and 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. Further taurine helps for normal hepatocyte structures and prevents formation of extracellular matrix which otherwise leads to liver fibrosis.
In the case of liver health, taurine is a key organic osmolyte in most cells, the possibility that the effects of taurine on ion transport could be related to its osmoregulatory activity. The effects of taurine, cell swelling and cell shrinkage on the activities of key ion channels and ion transporters. The phosphorylation cascades initiated by osmotic stress with some of the phosphorylation events triggered by taurine depletion or treatment. As per the data reveal that certain actions of taurine are probably caused by the activation of osmotic-linked signalling pathways. Nonetheless, some of the actions of taurine are unique and appear to be correlated with its membrane modulating and phosphorylation regulating activities.
In embodiment of the invention, the major source of other liver protective agent (detoxificants) such as glutathione.
Body has several mechanisms to reduce toxins build-up and to prevent or quench free radicals. This is achieved either by removing toxins from the body or by detoxifying them with the help of antioxidant enzymes and specific antioxidant amino acids like glutathionine and taurine.
In embodiment of the invention, 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. This powerful antioxidant helps to detoxify the liver cells. With increased stress on the body, the levels of glutathione begin to decline. Glutathione also helps to neutralize molecules called free radicals that can cause damage and death to cells if they are not kept under control.

In the case of liver health, glutathione 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.
In the case of liver health, 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.
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.
In the case of liver health, 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.
EXAMPLES-

INGREDEIENT
S Example 1 Example
2 Example
3 Example 4 Example 5
Glutathione 250 mg 200 mg 300 mg 400 mg 500 mg
Taurine 200 mg 250 mg 300 mg 400 mg 700 mg

CLAIMS,
We claim,
.1. An efficient oral formulation comprises two or more active ingredients such as taurine and glutathione along with pharmaceutical acceptable excipients.
2. An efficient oral formulation as claimed in claim 1 wherein it is available in various forms such as tablet, capsule, sachet, and powder thereof.
3. An efficient oral formulation as claimed in claim 1 wherein the concentration of taurine is 200 mg to 700 mg, preferably 600 mg.
4. An efficient oral formulation as claimed in claim 1 wherein the concentration of glutathione is 250mg to 500 mg , preferably 450 mg.
5. An efficient oral formulation as claimed in claim 1 wherein the combination of taurine and glutathione provide antioxidant properties.
6. An efficient 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. An efficient oral formulation as claimed in claim 1 wherein taurine plays important roles in hepatoprotection such as Combines and removes of toxic chemicals and metabolites, Antioxidant action.
8. An efficient oral formulation as claimed in claim 1 wherein taurine is an active detoxificant 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.

9. An efficient oral formulation as claimed in claim 1 wherein 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.
10. An efficient oral formulation as claimed in claim 1 wherein some of the actions of taurine are unique and appear to be correlated with its membrane modulating and phosphorylation regulating activities.