COMPLETE SPECIFICATION
FIELD OF THE INVENTION
The present invention relates to the pharmaceutical composition used for the patients having iron deficiency. The iron supplement used in the - present combination is highly bioavailable having lesser side effects.
PRIOR ART RELATED TO THE INVENTION
Indian Patent No. 237073 discloses the Synergistic pharmaceutical compositions for the treatment of iron deficiency and prophylaxis of anemia comprising effective amount of ferrous ascorbate and folic acid.
Indian Patent No. 224286 relates to a synergistic pharmaceutical composition for enhancing haemoglobin synthesis and zinc assimilation. The composition consists of L-Histidine Hydrochloride, Lysine Hydrochloride, Glycine, Vitamins, Ferrous fumerate and Zinc sulphate. Pharmaceutically acceptable adjuvants or carriers may also be added.blending 3 amino acids that go in the making of hemoglobir> synthesis, B group of vitamins, vitamin C, and a source of zinc and a source of iron with known pharmaceutically acceptable adjuvants and for excipients.
PROBLEMS IN THE PRIOR ART-
The major problem in the prior art is the low absorption of iron. Side effects of therapy with iron are most often diarrhea or constipation and epigastric abdominal discomfort. Taken after a meal, side effects decrease but there is an increased risk of interaction with other substances.
OBJECTIVES OF THE INVENTION
The objective of the invention is to provide a formulation, the ingredients of which works in synergistic manner to each other.
Yet another object of the invention is to provide the treatment for the patients suffering from Iron deficiency and related complications.

Yet_another object of the invention is to provide the Iron composition having fewer side effects.
Yet another object of the invention is to provide the Iron composition having higher bioavailability and efficacy.
DETAILED DESCRIPTION OF THE INVENTION
Iron deficiency (sideropenia or hypoferremia) is one of the most commonly known forms of nutritional deficiencies. In the human body, iron is present in all cells and has several vital functions—as a carrier of oxygen to the tissues from the lungs irk the form of hemoglobin, as a transport medium for electrons within the cells in the form of cytochromes, and as an integral part of enzyme reactions in various tissues. Too little iron can interfere with these vital functions and lead to morbidity and death.
The body needs iron to make hemoglobin. If there isn't enough iron available, hemoglobin production is limited, which in turns affects the production of red blood cells (RBCs). A decreased amount of hemoglobin and RBCs in the bloodstream is known as anemia. Because RBCs are needed to carry oxygen throughout the body, anemia results in less oxygen reaching the cells and tissues, affecting their function.
Iron-deficiency anemia (IDA), often caused by insufficient iron intake, is the major cause of anemia in childhood. It has become much less common in the United States over the past 30 years, primarily due to iron-fortified infant formulas and cereals.'
Iron-deficiency anemia doesn't develop immediately. Instead, a person progresses through stages of iron deficiency, beginning with iron depletion, in which the amount of iron in the body is reduced while the iron in RBCs remains constant. If iron depletion isn't corrected, it progresses to iron deficiency, eventually leading to IDA.

Causes of IDA
Iron-deficiency anemia can be the consequence of several factors, including insufficient iron in the diet, poor absorption of iron by the body, ongoing blood loss, most commonly from menstruation or from gradual blood loss in the intestinal tract periods of rapid growth
A diet low in iron is most often behind IDA in infants, toddlers, and teens. Kids who don't eat enough or who eat foods that are poor sources of iron are at risk for developing the condition. Poverty is a contributing factor to IDA because families living at or below the poverty level may not be getting enough iron-rich foods.
Iron deficiency can also cause the body to absorb more lead, which increases the risk of lead poisoning in kids, especially those living in older homes. The combination of IDA and lead poisoning can make kids very ill and can put them at risk for learning and behavioral problems.
During infancy and adolescence, the body demands more iron. Kids are at higher risk for IDA through these periods of rapid growth because they may not be getting enough iron in their diet to make up for the increased needs.
The present invention relates to a pharmaceutical formulation comprises Ferrous orotate, Folic acid, Methylcobalamin and zinc in pharmaceutical accepted salts.
Ferrous orotate contains orotic acid. Orotic acid is an intermediate in the pyrimidine biosynthesis, which is required for DNA and RNA synthesis. It was
originally introduced as a vitamin, called vitamin B13, but essentiality has not
been demonstrated.

Irorj, one of the most abundant metals on Earth, is essential to most life forms and to normal human physiology. Iron is an integral part of many proteins and* enzymes that maintain good health. In humans, iron is an essential component of proteins involved in oxygen transport. It is also essential for the regulation of cell growth and differentiation. A deficiency of iron limits oxygen delivery to ceils, resulting in fatigue, poor work performance, and decreased immunity. On the other hand, excess amounts of iron can result in toxicity and even death.
Almost two-thirds of iron in the body is found in hemoglobin, the protein in red blood cells that carries oxygen to tissues. Smaller amounts of iron are found in myoglobin, a protein that helps supply oxygen to muscle, and in enzymes that assist biochemical reactions. Iron is also found in proteins that store iron for future needs and that transport iron in blood. Iron stores are regulated by intestinal iron absorption.
Folic acid is a member of the vitamin B group. It is necessary for the normal production of red blood-cells, including maturation of megaloblasts into normoblasts. Folic acid a member of the B-complex vitamins is a water-soluble vitamin that is unstable in heat and light.
Folic acid is required for DNA synthesis and cell growth and is important for red, blood cell formation, energy production as well as the forming of amino acids. Folic acid is essential for creating haeme, the iron containing substance in hemoglobin, crucial for oxygen transport. It is important for healthy cell division and replication, since it is acts as a coenzyme for RNA and DNA synthesis. It is also required for protein metabolism and in treating folic acid anemia. Folic acid also assists in digestion, and the nervous system, and works at improving mental as well as emotional health. This nutrient may be effective in treating depression and anxiety. Folic acid is very important in the development of the nervous system of a developing fetus.

Methylcobalamin is a coenzyme involved in nucleic acid metabolism, red blood cell synthesis, methyl transfer, and myelin synthesis and repair. Absorption of vitamin B12 is dependent upon gastric secretion of the glycoprotein intrinsic factor. Among aging adults, secretion of intrinsic factor is often reduced, leading to an increased risk of vitamin B12 deficiency and the related pernicious anemia. The liquid form of B12 in Methyl Protect allows patients to bypass the intrinsic factor-dependent pathway for enhanced absorption. Vitamin B12 deficiency is also common among strict vegans and those who have undergone long-term treatment with certain antibiotics. Long-term insufficient intake of vitamin B12 can lead to megaloblastic anemia, impaired folate metabolism, and many neurological disorders including depression, paresthesias, and memory loss. Remethylation of homocysteine to methionine also requires the methylcobalamin form of B12.
Zinc has a range of functions. Zinc functions as an antioxidant and is involved in many critical biochemical reactions. Zinc plays an important role as a component of many enzymes and the catalysts of enzyme systems regulating cell growth, DNA and protein synthesis, energy metabolism, regulation of gene transcription, hormone levels, and growth factor metabolism. For many years, zinc has been used as an atringent, an antiseptic and a skin protectant. Zinc is an important mineral which is essential for protein synthesis and which helps to regulate the production of cells in the body's immune system. By boosting the immune system, zinc may a|so protect against fungal infections and various infectious disorders, such as conjunctivitis and pneumonia. Zinc also has some antioxidant properties, which means that it helps protect cells in the body from the potential damage caused by free radicals. Zinc is especially important in the prostate and may protect it from early damage that could lead to cancer. As a component of many enzymes, zinc is involved in the metabolism of proteins, carbohydrates, lipids and energy. Zinc is important in the metabolism of vitamin A and collagen, cellular immunity, maintenance of taste acuity, and the development of reproductive organs. Zinc assists in maintaining the proper concentration of

vitamin E in the blood. Zinc also plays a role in the regulation of appetite, stress level, taste, and smell. It is essential for normal growth and development, and for most aspects of reproduction in both males and females. Zinc also supports normal growth and development during pregnancy, childhood, and adolescence. The present invention relates to the composition comprising Ferrous orotate, Folic acid, methylcobalamin and zinc in pharmaceutically acceptable salts for the treatment of patients suffering from iron deficiency and related disorders. The present invention can be formulated, but not limited to, in the following manner-
WEIGHMENT SHEET
FOR PART A
1) Sieve the following ingredients-
(Table Removed)
2) Dry Mixing- Take sifted material of step 1 and mix manually for 10 minutes.
3) Binder Preparation- Take HPC Klucel exf 15.5 gm. Dissolve it in 250 ml Iso
propyl alcohol.
4) Wet mixing- Pour the binder of step 3 to the mixture of step 2. Add more solvent if required to get dough like consistency.
5) Wet milling- Pass the wet mass obtained in step 4 through sieve # 8.
Collect the sifted granules in clean containers.
6) Drying- Dry the wet granules in tray drier at 35°C for 60 minutes. Check
the LOD of dried granules by I.R. Moisture Balance at 105°C. If LOD is more
than the limit, again dry the granules. LOD found 3.01%.
7) Dry milling- Sift the dried granules obtained in step 6 through the sieve #
18. Collect the sifted granules in clean containers having PP bags.

PARTB
1) Sieve the following ingredients-
(Table Removed)
2) Dry Mixing- Take sifted material of step 1 and mix manually for 10 minutes.
3) Non- aqueous binder preparation- Take 0.25 gm ethyl cellulose (7 CPS). Dissolve it in 10 ml isopropyl alcohol and 5 ml methylene' chloride.
4) Wet mixing- Pour the binder of step 3 to the mixed material of step 2.
b) Wet milling- Pass the wet mass of step 4 through sieve # 8.
6) Drying- Dry the wet granules.
7) Dry Milling- Sift the dried granules of step 6 through sieve # 24. Collect the sifted granules in clean containers having PP bags.
8) Sieving of Lubricants-

(Table Removed)
Mix the granules obtained in PART A and Part B with lubricants and compress the mixture with suitable dies and punches to form tablets.
FILM COATING
1) Weigh the following ingredients
(Table Removed)
2) Disperse 36.3 gm of HPMC in 550 ml of Isopropyl alcohol.
3) Dissolve PEG-6000 6 gm in 400 ml methylene chloride.
4) Take 4.25 gm talc, 4.8 gm titanium dioxide and 1.8 gm color and mix
to the solution of step 2.
5) Mix the solution of step 3 and dispersion of step 4. Add remaining of
the methylene chloride and stir well for 10 minutes to get uniform
suspension.
6) Sieve this suspension using sieve # 100 muslin cloth.
Use the suspension obtained for coating tablets.

CLAIMS
1) A pharmaceutical formulation comprising Iron, Methylcobalamin, Folic
acid and Zinc wherein Iron in the form of Ferrous orotate is in the range
50 mg to 150 mg, Methylcobalamin 450 meg to 1500 meg, Folic acid 0.5
mg to 2.0 mg and Zinc sulphate monohydrate 50 mg to 100 mg, along
with pharmaceutically acceptable excipients.
2) The pharmaceutically acceptable excipients as claimed in claim 1 are selected from diluents, binding agents, disintegrants, and lubricants.
3) The diluents as claimed in claim 2 can be selected from lactose, sucrose, glucose, mannitol, sorbitol, calcium carbonate, and magnesium stearate.
4) The binding agents as claimed in claim 2 can be selected from
polyvinylpyrrolidone (PVP), polyethylene glycol (PEG), xylitol, sorbitol
and maltitol which are mixed with the appropriate solvent.
5) The solvent as claimed in claim 4 can be selected from purified water or
isopropyl alcohol or the mixture of both.
6) The disintegrants as claimed in claim 2 can be selected from
polyvinylpyrrolidone (crospovidone), crosslinked sodium carboxymethyl
cellulose (croscarmellose sodium) and sodium starch glycolate.
7) The lubricants as claimed in claim 2 can be selected from talc or silica,
and fats, e.g. vegetable stearin, magnesium stearate or stearic acid.
8) The formulation as claimed in claim 1 can be coated with Hydroxypropyl Methyl Cellulose, along with suitable plasticizer, opacifier, coloring agent and the solvent