STOMACH SPECIFIC GASTRORETENTIVE FLOATING TABLET OF ANTI-HYPERLIPIDEMIC DRUG: FORMULATION DEVELOPMENT AND IN-VITRO CHARACTERIZATION
*Kapoor D, Patel M, Vyas RB, Chaitali Lad, Sharma S
ABSTRACT
The aim of the present study to develop the various processing
parameters and formulations aspects for developing a pharmaceutical
equivalent, stable, cost improved and quality improved formulation of
floating tablet of Simvastatin comparable with innovator and optimize
certain process parameters to get maximum yield of the product during
large scale manufacturing. Being a Class II drug, Simvastatin shows
slow dissolution rate, limited oral absorption and high variability in
pharmacological effects. Gastro retentive floating tablet of Simvastatin
was prepared by direct compression technique using HPMC K15M as
the rate controlling polymer. The hydrophilic cellulose derivative,
HPMC K15M was evaluated for its gel forming and release controlling
properties. Sodium bicarbonate and citric acid were incorporated as gas generating agents.
The effects of soluble components (sodium bicarbonate and citric acid) and gel forming
agents on drug release profile and floating properties were investigated. The tablets from all
formulations were evaluated for thickness, diameter, weight variation, hardness, and
friability. In vitro drug release, kinetic data and related stability studies after optimization of
promising formulation of selected drug are being done to exhibit diffusion dominant drug
release and its stability may be attributed to that the present problem certainly will be helpful
and surely will open an avenue for new trend of control drug delivery system. The release
mechanisms were explored and explained with zero order, first order, Higuchi, Hixon
Crowell and Korsmeyer equations. The release rate, extent and mechanisms were found to be governed by the polymer content. It was found that the mean dissolution time, percentage
drug release, release rate constant and diffusion exponent were influenced significantly by the
amount of polymer incorporation.
Keywords: Floating, Simvastatin, HPMC K15M, Sustained rlelease, in-vitro release studies.
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