dc.description.abstract | Metformin hydrochloride (MH) is a binguanide,
used to treat type 2 diabetes by oral administration
as first line drug choice. MH is a hydrophilic
drug, which facilitates glucose utilization by
peripheral tissue and reduces glucose production
in the liver. Objective of the study was to develop
the formulation of MH sustained released tablet
locally. Eight different formulations of MH
sustained release tablet were developed one by
one, according to the drug releasing property
of previous formulation with MH, hydrophilic
drug releasing polymers, maize starch and
magnesium stearate through wet granulation
method. Twenty tablets from each formulation
were tested for uniformity of weight, friability,
hardness, thickness and diameter according to
British Pharmacopeia (BP) standard. In-vitro
drug release studies were carried out according
to United State Pharmacopeia (USP) standard.
The sample was withdrawn at end of 1st, 2nd,
4th, 6th, 8th and 10th hours from medium of
phosphate buffer (pH 6.8) in vessel of dissolution
tester and released amount of drug measured
through UV-visible spectrophotometer. Tablet
assay was done through High Performance
Liquid Chromatography (HPLC) according USP
standard. The physical testing and tablet assay
of all developed formulations complied with BP
and USP standard. Drug releasing profile of four
formulations out of eight complied USP standard
limits. One formulation was the best formulation
out of eight. All formulations had same amount of
MH and they were manufactured according to the
same procedure. However, drug releasing profile
defers in each formulation due to combination
and ratio of hydrophilic polymers. Finally,
MH sustained release tablet was developed
successfully through a series of trials. The
combination and ratio of drug releasing polymers
in formulation affect the drug releasing property
of the tablet. | en_US |