You are on page 1of 9

ANNEXURE-III

Technological functions of
Multi Vitamin & Multi Mineral Gummies
B Vitamin Functions
Vitamin

Name

Structure

Function

Thiamine

Thiamine plays a central role in the generation


of energy from carbohydrates. It is involved
in RNA and DNA production, as well as nerve
function. Its active form is a coenzyme
called Thiamine pyrophosphate (TPP), which
converts pyruvate to acetyl Coenzyme A (CoA)
in metabolism.[1]

Vitamin
Riboflavin
B2

Riboflavin is involved in the energy production


for the electron transport chain, the citric acid
cycle, as well as the catabolism of fatty acids
(beta oxidation)[2]

Vitamin
B1

Vitamin
B3

Niacin

Niacin is composed of two structures: nicotinic


acid and nicotinamide. There are two coenzyme forms of niacin: nicotinamide adenine
dinucleotide(NAD) and nicotinamide adenine
dinucleotide phosphate (NADP). Both play an
important role in energy transfer reactions in the
metabolism of glucose, fat and alcohol.[3]
NAD carries hydrogens and their electrons
during metabolic reactions, including the
pathway from the citric acid cycle to the electron
transport chain. NADP is a coenzyme in lipid

Confidential
For Regulatory Submission of FSSAI Application

and nucleic acid synthesis [4]

Vitamin Pantotheni
B5
c Acid

Pantothenic Acid is involved in the oxidation of


fatty acids and carbohydrates. Coenzyme A,
which can be synthesised from panothenic acid,
is involved in the synthesis of amino acids, fatty
acids, ketones, cholesterol,[5] phospholipids,
steroid hormones, neurotransmitters (such
as acetylcholine) andantibodies.[6]

Vitamin
Pyridoxine
B6

Pyridoxine is usually stored in the body as


pyroxidal-5-phosphate (PLP), which is the coenzyme form of vitamin B6. Pyridoxine is
involved in the metabolism of amino acids and
lipids; in the synthesis
of neurotransmitters [7] and haemoglobin, as well
as in the production of nicotinic acid (vitamin
B3).[8] Pyridoxine also plays an important role in
gluconeogenesis

Vitamin
B7

Biotin

Biotin plays a key role in the metabolism of


lipids, proteins and carbohydrates. It is a critical
co-enzyme of four carboxylases: acetyl CoA
carboxylase, which is involved in the synthesis
of fatty acids from acetate; propionyl CoA
carboxylase, involved in gluconeogenesis; methylcrotonyl Coa carboxylase, involved in the
metabolism of leucin; and pyruvate CoA
carboxylase, which is involved in the metabolism
of energy, amino acids and cholesterol.[9]

Folic Acid

Folic acid acts as a co-enzyme in the form


of tetrahydrofolate (THF), which is involved in
the transfer of single-carbon units in the
metabolism of nucleic acids and amino acids.
THF is involved in pyrimidine nucleotide
synthesis, so is needed for normal cells division,
especially during pregnancy and infancy, which
are times of rapid growth. Folate also aids
in erythropoiesis, the production of red blood
cells.[10]

Vitamin
B9

Confidential
For Regulatory Submission of FSSAI Application

Vitamin
Cobalamin
B12

Vitamin B12 is involved in the cellular metabolism


of carbohydrates, proteins and lipids. It is
essential in the production of blood cells in bone
marrow, nerve sheaths and proteins.[11] Vitamin
B12 functions as a co-enzyme in intermediary
metabolism for the methionine synthase reaction
withmethylcobalamin, and the methylmalonyl
CoA mutase reaction with adenosylcobalamin[12]

Vitamin A
Vitamin A supplementation
Global efforts to support national governments in addressing vitamin A deficiency are
led by the Global Alliance for Vitamin A (GAVA), which is an informal partnership
between A2Z, the Canadian International Development Agency, Helen Keller
International, the Micronutrient Initiative, UNICEF, USAID, and the World Bank. Joint
GAVA activity is coordinated by the Micronutrient Initiative.
While strategies include intake of vitamin A through a combination of breast feeding and
dietary intake, delivery of oral high-dose supplements remain the principal strategy for
minimizing deficiency.[33] A meta-analysis of 43 studies showed that vitamin A
supplementation of children under five who are at risk of deficiency reduces mortality by
up to 24%.[34] About 75% of the vitamin A required for supplementation activity by
developing countries is supplied by the Micronutrient Initiative with support from the
Canadian International Development Agency Food fortification approaches are
becoming increasingly feasible[36] but cannot yet ensure coverage levels.

The World Health Organization estimates that Vitamin A supplementation has averted
1.25 million deaths due to vitamin A deficiency in 40 countries since 1998.[37] In 2008 it
was estimated that an annual investment of US$60 million in vitamin A and zinc
supplementation combined would yield benefits of more than US$1 billion per year, with
every dollar spent generating benefits of more than US$17.[38] These combined
interventions were ranked by the Copenhagen Consensus 2008 as the worlds best
development investment

Confidential
For Regulatory Submission of FSSAI Application

Zinc
Zinc is an essential trace element. Zinc salts are used for supplementation to correct
zinc-deficiency conditions such as acrodermatitis enteropathica, as an astringent to
relieve minor eye irritations, and for therapy with penicillamine (e.g., such as that used
for Wilson's disease). Other disease entities associated with zinc-depletion are anorexia
nervosa, arthritis, diarrhea, eczema, recurrent infections, and recalcitrant skin problems.
Other illnesses where efficacy, safety, and standardized dose of zinc have yet to be
established include sickle cell disease, thalassemia, senile dementia, the common cold,
diabetes mellitus, virile potency disturbances, acne vulgaris, neoplasia, and infertility.
Indications & Usage

Approved by the FDA for:


Zinc deficiency
Unproven Uses
Zinc supplements are used for numerous conditions, including the following: acne
vulgaris, acrodermatitis enteropathica, Alzheimer's disease, common cold, dental
hygiene, diabetes mellitus, diarrhea, eczema, eye irritation, growth, Hansen's disease,
herpes simplex infection, hypertension, hypogeusia (decreased sense of taste),
immunodeficiency, impotence, infertility, leg ulcers, lipid peroxidation, macular
degeneration, necrolytic migratory erythema, parasites, peptic ulcer disease, psoriasis,
scalp dermatoses, schistosomiasis, sepsis, sickle cell anemia, stomatitis, thalassemia
major, trichomoniasis, Wilson's disease, and wound healing.

Copper sulfate
Copper sulfate, also known as cupric sulfate or copper sulphate, is the chemical
compound with the chemical formula CuSO4. This salt exists as a series of compounds
that differ in their degree of hydration. Wikipedia
Formula: CuSO4
Molar mass: 159.62
g/mol
Melting point: 110 C
IUPAC ID: Copper(II)
sulfate
Confidential
For Regulatory Submission of FSSAI Application

Density: 3.60 g/cm


Soluble in: Water
REGULATORY STATUS

Copper sulfate is classified as a general use material by the U.S. Environmental


Protection Agency (EPA). The warning signal "DANGER" must appear on the labels of
all copper sulfate end-products containing 99% active ingredient in crystalline form.
INTRODUCTION

Copper sulfate is a fungicide used to control bacterial and fungal diseases of fruit,
vegetable, nut and field crops. Some of the diseases that are controlled by this fungicide
include mildew, leaf spots, blights and apple scab. It is used in combination with lime
and water as a protective fungicide, referred to as Bordeaux mixture, for leaf application
and seed treatment. It is also used as an algaecide, an herbicide in irrigation and
municipal water treatment systems, and as a molluscicide, a material used to repel and
kill slugs and snails. Copper sulfate is a naturally-occurring inorganic salt and copper is
an essential trace element in plant and animal nutrition It is available in the following
formulations: dusts, wettable powders, and fluid concentrates

Manganese sulfate
Manganese is a mineral that is found in several foods including nuts, legumes, seeds,
tea, whole grains, and leafy green vegetables. It is considered an essential nutrient,
because the body requires it to function properly. People use manganese as medicine.
Manganese is used for prevention and treatment of manganese deficiency, a condition
in which the body doesnt have enough manganese. It is also used for weak bones
(osteoporosis), a type of tired blood (anemia), and symptoms ofpremenstrual
syndrome (PMS).
Manganese is sometimes included with chondroitin sulfate and glucosamine
hydrochloride in multi-ingredient products promoted for osteoarthritis.
Look out for manganese that is hidden in some supplements. Certain supplements,
including those commonly used for osteoarthritis (e.g., CosaminDS), contain
manganese. When using these products, its important to follow label directions
Confidential
For Regulatory Submission of FSSAI Application

carefully. At doses slightly higher than the recommended dose, these products provide
more than the Tolerable Upper Limit (UL) for adults, 11 mg of manganese per day.
Consuming more than 11 mg per day of manganese could cause serious and harmful
side effects.
Manganese is an essential nutrient involved in many chemical processes in the body,
including processing of cholesterol, carbohydrates, and protein. It might also be
involved in bone formation.

Structure
Like many metal sulfates, manganese sulfate forms a variety of hydrates: monohydrate,
tetrahydrate, pentahydrate, and heptahydrate. The monohydrate is most common. All of
these salts dissolve to give faintly pink solutions of the aquo complex [Mn(H2O)6]2+. The
pale pink colour of Mn(II) salts is highly characteristic.

Applications and production


Typically, manganese ores are purified by their conversion to manganese(II) sulfate.
Treatment of aqueous solutions of the sulfate with sodium carbonate leads to
precipitation of manganese carbonate, which can be calcined to give the oxides MnOx.
In the laboratory, manganese sulfate can be made by treating manganese
dioxide with sulfur dioxide:[2]
MnO2 + SO2 MnSO4
Manganese sulfate is a by-product of various industrially significant oxidations that
use
manganese
dioxide,
including
the
manufacture
of hydroquinoneand anisaldehyde.[1]
Electrolysis of manganese sulfate yields manganese dioxide, which is called EMD for
electrolytic manganese dioxide. Alternatively oxidation of manganese sulfate with
potassium permanganate yields the so-called chemical manganese dioxide (CMD).
These materials, especially EMD, are used in dry-cell batteries.[1]

Potassium iodide
Potassium iodide is the potassium salt form of iodide, a naturally occurring substance.
Potassium iodide is an expectorant. It thins mucus secretions in the respiratory tract that
may be caused by chronic respiratory problems such as asthma, chronic bronchitis, and
Confidential
For Regulatory Submission of FSSAI Application

emphysema. Potassium iodide is also used to protect the thyroid gland from radiation
injury before and following administration of radioactive iodide (e.g., for diagnostic
purposes) and in radiation emergencies (e.g., accidental exposure to radiation).
Potassium iodide also b used for purposes other than those listed here.
Precautions:

a history of previous allergic reaction to iodide, iodine, or other medicines;


Addison's disease;
dehydration;
a high level of potassium in the blood (hyperkalemia);
cystic fibrosis;
tuberculosis;
thyroid problems;
goiter (enlargement of the thyroid gland); or
kidney problems.

Require a dosage adjustment or special monitoring during treatment.


Potassium iodide is in the FDA pregnancy category D. This means that it is known to be
harmful to an unborn baby. Do not take potassium iodide without first talking to your
doctor if you are pregnant or could become pregnant during treatment.
Potassium iodide passes into breast milk and may affect a nursing baby. Do not take
potassium iodide without first talking to your doctor if you are breast-feeding a baby.
Dosage
Take potassium iodide exactly as directed. If you do not understand these instructions,
ask your doctor, nurse or pharmacist to explain them to you.
To ensure you get the correct dose, measure the liquid with a dose-measuring spoon or
cup, not with a regular table spoon. If you do not have a dose-measuring device, ask
your pharmacist where you can get one.
Take the oral solution with water or another beverage as directed by your doctor.
It is important to take potassium iodide regularly to get the most benefit.
Your doctor may want you to have blood tests or other medical evaluations during
treatment with potassium iodide to monitor progress and side effects.
Store potassium iodide at room temperature away from moisture and heat.
Confidential
For Regulatory Submission of FSSAI Application

Sodium selenite
Sodium selenite is a salt, a colourless solid, and the most common watersoluble selenium compound. It has the formulas Na2SeO3 and
Na2SeO3(H2O)5 (CAS#26970-82-1). Respectively, these are the anhydrous salt and
its pentahydrate. This hydrated salt is the more common one. The hydrated and
anhydrous salts behave identically for most purposes, although their molar masses
differ.

Synthesis and fundamental reactions


Sodium selenite usually is prepared by the reaction of selenium dioxide with sodium
hydroxide:
SeO2 + 2 NaOH Na2SeO3 + H2O
Acidification of selenium dioxide gives selenous acid, which, unlike sulfurous acid,
can be isolated at room temperature
Akin to the related salt sodium sulfite, Na2SeO3 features a pyramidal dianion SeO2
3 with a trigonal (C3v) symmetry. Oxidation of this anion gives sodium selenate,
Na2SeO4.

Applications
The US Food and Drug Administration approved a selenium supplement to animal
diets, however the most common form is sodium selenite for pet foods. According to
one article, "not much was known about which selenium compounds to approve for
use in animal feeds when the decisions were made back in the 1970s .. At the time
the regulatory action was taken, only the inorganic selenium salts (sodium selenite
and sodium selenate) were available at a cost permitting their use in animal feed.

Safety
Selenium is toxic in high concentrations. The chronic toxic dose for human beings is
about 2.4 to 3 milligrams of selenium per day.
Sodium Selenite, an inorganic salt of the mineral selenium, is very often used as a
dietary supplement. The salt of themicronutrient sodium Selenite works as
an antioxidant stabilizing the free radicals that damages the body.
Confidential
For Regulatory Submission of FSSAI Application

Benefits of Sodium Selenite Supplement


Sodium Selenite supplement which acts as an antioxidantcan:
prevent premature ageing
be used to treat cardiovascular disease and sexual dysfunctioning.
boost the immune system and reduce the occurrence of diseases.
Sodium Selenite supplement has been found effective in reducing the chance of
occurrence of colorectal and prostate cancer. The supplement is also found to improve
the health of the skin and in treating a number of skin diseases.
Who can benefit from taking Sodium Selennite Supplement
Selenium deficiency is very rare in human beings but those having compromised
intestinal function can have a deficiency of this micronutrient due to the inappropriate
absorption of selenium. In such cases, a supplement of the Sodium Selenite can help to
attain the proper functioning of the body.
Similarly, the amount of selenium in the soil is decreasing and hence the food has a
lower level of the mineral calling for a supplement of it along with the food. Same way,
anyone wishing for a good health and slow ageing can also take the supplement on
doctors prescription.

Confidential
For Regulatory Submission of FSSAI Application

You might also like