Vitmiplex Syp

FERROUS BISGLYCINATE
Iron (Fe) deficiency is probably the most common single nutrient deficiency throughout the world. It is estimated that more than 500 million people throughout the world suffer from severe iron deficiency anaemia.
Iron deficiency anemia is better controlled along with diet rich in iron source and supplementation of external source of Iron formulations. Various iron salts are available for supplementation in the treatment of anaemia. They are ferrous sulfate, fumarate, gluconate, succinate, glutamate and lactate
Despite being efficacious and cheap with good bioavailability, ferrous salts have several disadvantages particularly the high incidence of gastrointestinal side effects (~23 %). times less than that of ferrous sulphate

Ferrous bisglycinate consists of one molecule of ferrous iron bound to two molecules of glycine Ferrous bisglycinate has been successfully sold in the United States as dietary supplement for over 25 years and has received GRAS (Generally Recognized as Safe) approval from the US FDA. Many countries like the Canada, United Kingdom, the Netherlands, Spain, Denmark, France, Italy, China and Japan have approved ferrous bisglycinate. Ferrous bisglycinate enjoys the privilege of being a highly absorbable iron supplement exceeding ferrous salts.
Following oral administration, ferrous bisglycinate is absorbed intact into the mucosal cells of the intestine, and is subsequently hydrolysed into its iron and glycine components. The iron component of ferrous bisglycinate is metabolised like any other source of iron. The solubility of iron from ferrous bisglycinate is not affected by changes in pH. The bioavailability of the ferrous bisglycinate chelate and ferrous sulfate is 90.9% and 26.7%. Ferrous bisglycinate has a relatively higher bioavailability in the presence of dietary inhibitors like tannins and oxalates.
Advantages of Ferrous Bisglycinates
Absorbed intact
Easily absorbed into the mucosal tissue
Highest bioabsorption
High bioavailability even in presence of phytates, tannates, oxalates etc.
Less likely to cause intestinal side effects such as nausea, constipation and bloating
Does not interact with multivitamins
The scientifically advanced Iron formulation. Sefest -XT, the combination of Ferrous Bisglycinate, Metylcobalamin Zinc Bisglycinate and Folic acid. Chelated structure of IRON and non-interaction with dietary inhibitors provide higher bioavailability and faster haemoglobin and Ferritin rise. Methylcobalamin and Folic acid help in maturation of RBC AND THERE IS INTERACTION FREE ABSOPTION OF IRON AND ZINC DUE TO CHELATION. Sefest XT is well tolerated, can be given safely to infants, does not cause nausea, constipation and bloating unlike other Ferrous salts and complexes and there is no report of iron over load in children. . There is a marked reduction in the prevalence of anaemia in children and adolescents with Ferrous Bisglycinate, significant rise in HB LAVELS from 8.2% to 9.6% in 6 weeks in pregnant woman and rapid rise in HB LAVELS from 1.8% to 2.5% in 28 days in infants
Mode of Action:
Ferrous Bisglycinate is a compound made of an iron molecule chelated to two glycine molecules. This chelate gives ferrous bisglycinate the ability to be absorbed at a rate higher than the other ferrous salts. After absorption into the mucosal cells, the iron is hydrolysed and the distributed, reversibly bound to transferrin, for use in proteins, including storage proteins (eg. Ferritin), transport proteins (eg. tranferrin), haemoglobin containing proteins (eg. Haemoglobin) and enzymes.
b)Absorption:
The absorption of ferrous bisglycinate in the intestine would be expected to follow the general mechanism of absorption for amino acid-metal chelates whereby ferrous bisglycinate is absorbed intact and subsequently hydrolysed into its respective iron and glycine components in the intestinal mucosa.
c) Distribution :
After absorption into the mucosal cells, the iron is hydrolysed and then distributed, reversibly bound to transferrin, for use in proteins, including storage proteins (e.g. ferritin and haemosiderin), transport proteins (e.g. transferrin and lactoferrin), haem-containing proteins (e.g. haemoglobin, myoglobin, and cytochromes), and enzymes (e.g. ironcontaining and activated non-haem enzymes, iron-sulphur enzymes or flavoproteins)
5. Indications:
It is indicated for the prevention and treatment of iron deficiency anemia in children, adults, in women before, during and after pregnancy and during lactation.
6. Dosage & Administration:
Adults: one tablet aday or as prescribed or after meal (for independent absorption). In more severe cases, two tablets may be required.
Pediatric patients: Safety and effectiveness in paediatric patients have been established
8. Contraindications:
●. Hemochromatosis (iron accumulation) in the tissues and hemosiderosis.
10. Pregnancy and Lactation:
Recommended for pregnancy and lactation. While prescribing this drug for pregnant women, nursing mothers or for women prior to conception, their medical condition and other drugs, herbs and/ or supplements consumption to be considered.
11. Possible side Effects:
Ferrous bisglycinate is generally well tolerated. However, sensitive patients may report gastrointestinal irritation and nausea, sometimes dark stools. Rarely constipation or diarrhea may occur.
12. Drug Interactions:
Ferrous bisglycinate is a chelate form of metal, amino acid chelates are absorbed intact in gut, hence there is no reported drug drug interaction with the said drug.
13. Storage Need:
Store in a dry and dark place at temperature not exceeding 250 C. Protect from moisture.
15. Safety & Efficacy of Ferrous Bisglycinate over the available products:
Ferrous bisglycinate has been used in field trials as a source of iron for food enrichment and fortification purposes in various countries, including Brazil (Queiroz & Torres, 1995; Fisberg et al., 1995; Gualandro & Name, 1996; Ashmead et al., 1997; Iost et al., 1998; Giorgini et al., 2001; Szarfarc et al., 2001), Guatemala (Pineda et al., 1994; Pineda & Ashmead, 2001), New Zealand (Heath et al., 2001), Saudi Arabia (Osman & al-Othaimeen, 2002) and the United Republic of Tanzania (Latham et al., 2001). These studies have shown that the use of ferrous bisglycinate (or Sefest XT ferrous bisglycinate) as a dietary supplement or iron fortificant in foods is efficacious in reducing the prevalence of iron deficiency and iron deficiency anaemia in humans.

FAQs- FERROUS BIS-GLYCINATE
1. What is the most common cause of anaemia globally?
Iron deficiency is the most common cause of anaemia globally.
2. Which group of people are under the highest risk of iron deficiency anaemia(IDA)?
3. Around 47% of pre-school children and 42% of the pregnant women are under highest risk of IDA.
Other groups include, 30% of non-pregnant women and 12.7% of men are suffer from IDA.
4. What are the integral part (goals) of correcting and preventing IDA?
The goals of correcting and preventing IDA are to providing oral iron supplements and to supply sufficient iron to replenish haemoglobin deficits and restore normal iron stores.
5. What are the requirements of an ideal iron supplement/ hemoglobin (Hb) enhancer?
Higher bioavailability even in presence of food or other cations like calcium and zinc.
Enhanced absorption in presence of inhibitor Gastric compliance, minimum side effects like gastric irritation, constipation, etc. Quick Hemoglobin rise and sustaining effect Ferritin rise No iron overload, thus shows no iron toxicity.Safe and well tolerated.
6. What is a chelate?
A molecule is called a chelate when a metal ion is covalently bound with two or more amino acids. Natural process of converting minerals into a biologically absorbable form. Natural means for body to transport minerals across the intestinal wall , Higher bioavailability,Does not interact with other nutrients and food , Better tolerance
7. What is Ferrous bis-glycinate (FBG)?
Unique chelated structure in which two glycine molecules are covalently bound with ferrous ion.
Nutritionally active chelate with low molecular weight i.e. 204 Daltons.
Highly bioavailable iron supplement
8. What are the unique features of FBG?
No interaction with calcium, phytates, multivitamins, oxalates or tannates.
Does not even interact with milk and milk proteins
Absorbed intact- Easily absorbed into the mucosal tissue
Maximum bioavailability
Improved Ferritin levels along with Hb
Minimal gastrointestinal disturbances
9. Explain intestinal absorption and distribution of iron? How does FBG help in increase and maintenance of Hb level?
FBG in the gastric lumen does not interact with any of the phytates, oxalates, tannates or multivitamins and is absorbed intact into the mucosal cells of the intestine. Subsequently iron is dissociated from FBG and then distributed, reversibly bound to transferrin for utilisation in proteins, including storage proteins and in bone marrow for RBC production.
10. How is FBG better than ferrous sulphate (conventional ferrous supplement) in terms of bioavailability?
According to a clinical study conducted the bioavailability of FBG was seen to 90.9% as compared to ferrous sulphate which just 26.7%.
11. Compare FBG and ferrous sulphate?
60mg of FBG is equivalent to 100mg of ferrous sulphate.
12. Compare the GI side effects shown by FBG as compared the other iron supplements?
The therapeutic dose of FBG (60mg) shows minimum side effects i.e. around 9% as compared to other iron supplements like, iron poly-maltose complex (120mg) shows GI side effects up to 14% and ferrous sulphate (120mg) shows 34% incidence of GI disturbances.
13. Explain the established clinical efficacy of FBG?
Studies show that FBG can be safely used in pregnancy, infants, children and adolescents with minimum side effects.
14. To what extent does FBG help in reducing the prevalence of severe anaemia?
FBG has shown to reduce the prevalence of severe anaemia from 20.4% to 5.2% and general anaemia from 62.3% to 26.5% in a 12months treatment
. 15. Is FBG recognized by any of the authorized authority?
Yes, FBG is the only iron amino acid chelate to get a GRAS (Generally recognized as safe) status by USFDA and also by EFSA (European Food Safety Authority). It is also considered as highest NOAEL (No- Observed- Adverse- Effects- Level) Toxicological studies.
16. How does FBG absorb in the body?
After taking FBG, it does not dissociate in the intestinal lumen. As a result it does not interact with Calcium, Phytates or Tannates , Vitamins, Zinc and offers maximum bio-availability. As it does not dissociate in the gastric lumen, FBG goes into mucosa as a single ingredient and dissociation takes place in the mucosa and release Fe++ ion , convert into Fe +++ which is carried by Transferrin to the bone for the formation of Haemoglobin and the rest improves iron storage i.e. Ferritin level in the tissue.
17. Compare the elemental iron, Bioavailable iron and Absorbed iron in the body of different iron salts , complex and chelateFerrous sulfate has 33% elemental iron and 26.7% of the same is absorbed in the body i.e. 9 mg Similarly elemental iron of ferrous ascorbate is 12% and 40% of the same is absorbed in the body i.e. 4.8 mg Elemental iron of IPC is 30% and only 3.9% of the same is absorbed in the body i.e 12 mg. Elemental iron of Ferrous Fumerate is 32% and 28% of the same is absorbed in the body i.e. 8.9 mg. The elemental iron of Carbonyl iron 98% but only5- 20% of the same is absorbed in the body i.e. 4.9- 19.6 mg whereas the elemental iron of Ferrous Bisglycinate is 19-21% and 90.9% of the same is absorbed in the body i.e. 17-19 mg.In a nutshell half dose of Ferrous Bisglycinate is equivalent to full dose of ferrous salt which means 50 mg of Ferrous Bisglycinate is equivalent to 100 mg of Ferrous Sulfate.
18. What does WHO recommend for low birth weight infants?
According to WHO, low birth weight infants less than 2.5 mg should routinely receive iron supplements i.e. FBG in the first yr for a healthy life.
19. What should be the dose of FBG?
IDA Prevention 2 mg/kg of body weight OD. IDA Treatment 3-4 mg/kg of body weight OD
20. What should be the dose of Ferrous Bisglsinate?
1 tablet a day
21. What is the role of , Folic acid and Vitamin B12 in Ferrous Bisgglsinate
Folic acid and Vitamin B12 help in maturation of RBC.
22. Is there any interaction between FBG and Zn?
No there is no interaction between FBG and Zn. It is interaction free absorption of iron and zinc due to chelation
The right combination of Multivitamins, Antioxidants Multiminerals and Amino acid.
• Multivitamins are dietary supplements that contain a combination of various vitamins.
• These are designed to fill potential nutrient gaps in a person's diet, especially when their regular food intake may not provide all the essential vitamins in adequate amounts.
Supporting Metabolism:
Vitamins such as B-complex vitamins (B1, B2, B3, B6, B12, etc.) are involved in energy metabolism and help convert food into energy.
Promoting Immune Function:
Vitamins like vitamin C and vitamin D are essential for a healthy immune system and can help in protecting against infections.
Maintaining Skin, Hair, and Nail Health:
Certain vitamins like biotin, vitamin E, and vitamin A play a role in maintaining healthy skin, hair, and nails.
Protecting Against Oxidative Stress:
Antioxidant vitamins (e.g., vitamin C, vitamin E, and beta-carotene) can help neutralize harmful free radicals and reduce oxidative damage in the body.
Essential Amino Acid
• Amino acids are the building blocks of proteins.
• There are two types: essential and non-essential.
• Essential amino acids cannot be synthesized by the body and must be obtained from the diet.
Functions
• Protein Synthesis:
• Amino acids are essential for building and repairing tissues, including muscles, organs, and skin. • Enzyme and Hormone Production: • Amino acids are involved in the production of enzymes and many hormones that regulate different body functions. • Neurotransmitter Synthesis:
• Some amino acids act as precursors for neurotransmitters, which are essential for proper brain function and mood regulation.
• Immune Function:
• Amino acids play a role in supporting a healthy immune system and antibody production.
Combidoxin offers Lysine which plays an essential role in the production of carnitine, a nutrient responsible for converting fatty acids into energy and helping to lower cholesterol. Lysine appears to help the body absorb calcium and plays an important role in the formation of collagen.
Multiminerals • Multiminerals are supplements that provide essential minerals that the body needs for various physiological functions.
• These minerals are essential because the body cannot produce them on its own.
Functions
• Bone Health:
Calcium and magnesium are crucial for maintaining healthy bones and teeth.
• Muscle Function:
Magnesium is involved in muscle function and relaxation.
• Enzyme Activity:
Minerals like zinc and selenium are essential components of many enzymes, which are essential for various biochemical reactions in the body.
• Electrolyte Balance:
Minerals like potassium and sodium help maintain proper fluid balance and support nerve and muscle function.
Folic Acid:
• Folic acid is a water soluble vitamin B9 or Folate (the naturally occurring form).
• Folate is necessary for proper brain function as it is concentrated in the spinal and extra cellular fluids.
• Folic acid plays an important role towards the production of RNA and DNA as it helps in the formation of red blood cells and nucleic acid.
Folic Acid as monoamine synthesis modulator
Folic Acid regulates serotonin synthesis, dopamine and norepinephrine synthesis.
Folic Acid prevents Neural tube defects
Folic Acid reduces excess homocysteine levels
Homocysteine is a sulpher containing amino acid, synthesized from methionine
• Folic Acid reduces excess homocysteine levels which otherwise could lead to negative pregnancy outcome like pre-eclampsia, miscarriages, congenital heart disease & pre-term birth
. • Suitable folate levels contribute to normal maternal tissue growth during pregnancy.
• Folate supplementation reduces the risk of NTD Vitamin B12
• Vitamin B12 deficiency during pregnancy is associated with pre-eclampsia, fetal growth restriction, pre-term labor, neural tube defects, neonatal megaloblastic anemia and neonatal neurological symptoms.
• A Vitamin B12 deficiency results in elevated concentrations of homocysteine in blood serum.

Vitamin B6
• It is important for baby's brain development and immune function.
• Helps in synthesis of epinephrine (adrenaline) and norepinephrine (noradrenaline).
• Promotes synthesis of niacin (vitamin B3).
• Converts cysteine into Glutathione (Endogenous antioxidants)
• Lack of pyridoxine in the body may also be a factor in causing nausea and vomiting during pregnancy.