IN VITRO STUDY OF (IRON+FOLIC ACID) TABLETS AS SUSTAINED RELEASE FROM BIOPOLYMERIC HYDROPHILIC POLYMER
IN VITRO STUDY OF (IRON+FOLIC ACID) TABLETS AS SUSTAINED RELEASE FROM BIOPOLYMERIC HYDROPHILIC POLYMER
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Date
2015-04-06
Authors
Mohammed, KHALIL
Journal Title
Journal ISSN
Volume Title
Publisher
UOFK
Abstract
The objective of the present research was to design a suitable uncoated matrix tablet that
contains ferrous fumarate + folic acid. This tablet was designed in a way to be capable of
giving the least release of drug in the first hour in acidic medium 0.1N HCl which simulated
the gastric fluid. Moreover, it should be capable of giving not less than 90% in the maximum
time in D.M Water at pH 6 dissolution medium which was considered to simulate the
intestinal fluid. This sustained release dosage form would decrease gastro intestinal
disturbances most likely caused by increasing the drug release in shorter time. Especially that
combination is used second and third trimester of pregnancy asprophylaxis of iron & folic
acid deficiency.
In this research, several formulations containing hydrophilicpolymer HPMC, were prepared
by wet granulation technique. Statistical Taguchi experimental method was used to study the
impact of different content levels of HPMC, MCC, Starch and Lactose in: (1) physical
characterization for granules and matrix tablet. Also (2) Drug release rate and its kinetics for
hydrophilic matrix tablets compared with conventional tablets when studied in a variety of
dissolution media, pH buffer media with and without addition of various surfactants, to
perform this in vitro studies, USP paddle method II was used. The spectrophotometry method
was used to analyse all withdrawn dissolution samples to determine the percentage of iron
(Fe
+2
) released in the pre-determined times using spectrometer UV\VIS double beam at
wavelength 510nm.
The granules for all preparedformulations showed satisfactory flow and compressibility
properties. All tablets showed acceptable pharmacotechmical properties and complied with inhouse specifications for tested parameters. The conventional tablet released all drug (Fe
+2
) in
acidic medium by the end of the 1
st
hour compared with about only 40% of the drug release
for hydrophilic matrix tablets at the same time. Also, conventional tablets released all drug in
about 4 hours in D.M Water at pH 6 whereas most of the hydrophilic matrix tablets released
all the drug by the end of the 17
th
hour in D.M Water at pH 6. All the tablets showed slower
drug (Fe
+2
) release in acidic medium (pH 4.5) and gives no drug release in dissolution medium
pH 6.8. There is no significant difference in drugrelease of hydrophilic matrix tablets if the
concentration of polymers HPMC increased whereas the increase in the concentrations of
MCC, Starch, or Lactose affect drug (Fe
+2
) release profiles. Release profiles for most of
hydrophilic matrix tablets showed a tendency to follow zero order kinetic (Non-fiction - Case
II) Analysis with Taguchi experimental method showed that the best combination that gives
the least drug release in the acidic medium at the 1
st
hour, and required time for 90% of drug
release was found to be the one containing 25% HPMC, 5% MCC, 5.46% Starch and 5.46%
Lactose out of total tablet weight.
The release profile and kinetic ofdrug release were functions of physio-chemical nature of
drug (e.g. solubility) and types of selected excipients used. Swelling rate of the matrix tablets
and quantity of fluid penetration in the matrix tablets were found to be influenced by the
excipients (MCC, Starch, and Lactose). Food has strong influence in drug release profile.
Description
173page
Keywords
Molecular formula,Hydrophilic Matrix Systems