This Tablet is Controlled release (CR) dosage form which, by virtue of formulation and product design, provide drug release in a modified form i.e., distinct from that of the conventional dosage forms. Drug release can either be delayed or extended in nature.

1. Presented by:
Divyanshu Raval
Technical Director
Walpar Healthcare
Thursday, February 27, 2020 1

2. PREVALENCE OF ANEMIA IN PREGNANCY
 According to world Health Organization estimates, up to 56% of all
women living In developing countries are anemic. In India, National
Family Health Survey -2 shows that 54% of women in rural and
46% women in urban areas are anemics.1
 The relative prevalence of mild, moderate, and severe anemia are
13%, 57% and 12% respectively in India (ICMR data).1
 According to WHO, hemoglobin level below 11gm/dl in pregnant
women constitutes anemia and hemoglobin below 7gm/dl is severe
anemia. The Center for Disease Control and Prevention (1990)
defines anemia as less than 11gm/dl in the first and third trimester
and less than 10.5gm/dl in second trimester. Serum Ferritin of 15
micro gm/L is associated with iron deficiency anemia.1
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4. PREVALENCE OF ANEMIA IN PREGNANCY
 Iron deficiency anemia (IDA) is the commonest type of anemia
in pregnancy.
 As most women start their pregnancy with anemia or low iron
stores, so prevention should start even before pregnancy.
 Based on the clinical studies done worldwide, The Ministry of
Health, Government of India has now recommended intake of
100 mg of elemental iron along with folic acid in the second
half of pregnancy for a period of at least 100 days.
 Women who receive daily antenatal iron supplementation are
less likely to have iron deficiency anemia at term.
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5. Why Combination of Ferrous Ascorbate, Folic Acid & Zinc ???
 Iron deficiency results in anemia, impaired psychomotor
development, reduced physical and work capacity, impaired
immunity, and adverse pregnancy outcomes.
 According to scientific articles & subsequent studies published
in well known journals, Iron absorption increases when you
give it along with ascorbic acid.2
 Folic Acid supplements during pregnancy have resulted in
increased’ birth weight in cases of malnutrition.1
 Zinc deficiency is associated with fertility reduction, poor
pregnancy outcomes, mental and behavioral changes, impaired
immunity, increased morbidity and mortality, and perhaps
linear growth retardation.
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6. Introduction
 Our Tablet is Controlled release (CR) dosage form which,
by virtue of formulation and product design, provide
drug release in a modified form i.e., distinct from that of
the conventional dosage forms. Drug release can either be
delayed or extended in nature.
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7.  Our tablet is designed to release their medication in
controlled manner, at pre-determined rate, duration and
location in the body to achieve and maintain optimum
therapeutic blood levels of drug.
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8. Rationale for Controlled release formulation
 Active ingredients that are not inherently long lasting require
multiple daily dosing to achieve the desired therapeutic effects.
 Multiple daily dosing is often inconvenient and can result in
missed doses, made-up doses and patient non-compliant with
therapeutic regimen.
 Blood levels of active ingredients from conventional immediate-
release dosage forms taken more than once daily following
definite schedule usually demonstrate sequential peaks and
troughs (valleys) associated with each dose.
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9. Rationale for Controlled Release formulation
 Our Controlled Release tablet is taken only once daily
compared with the conventional dosing of 2 to 4 times
daily
 This products is designed to provide an immediate release of drug
which promptly produces the desired therapy, followed by gradual and
continual release of additional amounts of drug to maintain this effect
over a predetermined period of time.
 The need for night dosing is eliminated
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10. Advantages of our formulation over Conventional Forms
 Reduction in drug blood level fluctuations
 Reduction in frequency of dosing
 Enhanced patient compliance
 Reduction in incidence of adverse side effects such as nausea
and vomiting.
 Reduction in overall healthcare costs.
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11. Technology used to produce our controlled release tablet
 Here we have embedded active ingredients in
slowly eroding/hydrophilic/hydrophobic matrix
system – The design comprises of the drug substance
plus highly sophisticated biodegradable excipient
material to create hydrophobic and hydrophilic matrix
that slowly erodes and swells in the body fluids
thereby progressively releasing the active molecule
for absorption.
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12. Schematic representation of technology driven drug
release from our matrix tablet
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13. Kinetics of Drug release
 Drug release from conventional dosage forms, like the other
processes of ADME (absorption, distribution, metabolism and
excretion), are governed by the first-order kinetics model.
 In First-order model, drug release is dependent on the amount
of drug available for release and therefore the rate of release
declines exponentially with time.
 However in our timed release dosage forms, drug release is
governed by zero-order kinetics in which the rate of release is
independent of amount of drug remaining in the dosage form.
 Therefore a constant amount of drug will be released over time.
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14. Graphical representation of CR release and conventional release
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c= drug concentration in blood & t= time

15. References:
 Anemia in Pregnancy, J.B.Sharma, Meenakshi Shankar,
Department of Obstetrics & Gyneocology, All India Institute
of Medical Science, Ansari Nagar, New Delhi, India, JIMSA
October - December 2010 Vol. 23 No. 4.
 The role of vitamin C in iron absorption, Hallberg L, Brune
M, Rossander L, Int J Vitam Nutr Res Suppl. 1989;30:103-8.
 Actiferon: Slow Relese Iron Therapy for Better Absorption
and Bioavailability, Govind shukla*, M. Sarika, D Saritha, C.J
Sampath Kumar, Asian Journal of Chemical and
Pharmaceutical Research, AJCPR, 2014, Vol.2(1): 100-102,
www.pharmaresearchlibrary.com/ajcpr.
 Ferrograd C 325mg/500mg Prolonged release Tablets.
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16. CONTROLLED RELEASE DOSAGE FORM
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