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Abstract: Recently many drugs are formulated as
floating drug delivery systems with an objective to
sustain release and restrict the region of drug release
to stomach. Present investigation highlights the
formulation and evaluation of floating tablets of
Ranitidine Hydrochloride. Two different grades of
hydroxy propyl methylcellulose namely Methocel K 100 M
and Methocel K 15 M were used. It was observed that
viscosity had a major influence on drug release from
hydrophilic matrices as well as on floating properties.
Dissolution profiles were subjected various kinetic drug
release equations and found that drug release from
hydrophilic matrices occurred via different mechanism
following square root of time profile (Higuchi
equation). Prepared tablets were evaluated for Hardness
(Kg/cm2), Thickness (MM), Average weight (mg), Weight
variation, Hardness (Kg/cm2), Friability (%), Drug
content (mg/tab.), Floating Lag Time (Sec.), and total
floating time (hr.). The granules were characterized for
Angle of repose, Bulk Density (gm/cm3), Tapped density
(gm/cm3), Carr’s index (%), and Hausners ratio, loss on
drying and porosity. In vitro drug release study of
these tablets indicated controlled sustained release for
Ranitidine HCL and 70 to 93% at the end of 10m hrs.
Hence, it is evident from this investigation that gas
powered floating matrix tablets could be promising
delivery system for RHCL with sustained release action
and improved drug availability. The formulations were
found to be stable at Rt/60o/75%+5%RH for the period of
three weeks.
Introduction
Ranitidine hydrochloride (RHCL) is histamine H2 –
receptor antagonist. It is widely prescribed in a active
duodenal ulcers, gastric ulcers, Zollinger- Ellison
syndrome, gastro esophageal reflux disease and erosive
esophagitis. The recommended adult oral dosage of
ranitidine is 150mg twice daily or 300mg once daily. The
effective treatment of erosive esophagitis requires
administration of 150mg of ranitidine 4 times a day. A
conventional dose of 150mg can inhibit gastric acid
secretion up to 5hrs. But not up to 10 hrs. An
alternative dose of 300mg leads to plasma fluctuations;
thus a sustained release dosage form of RHCL is
desirable. The short biological half- life of drug (~
2.5- 3hrs.) also favors development of a sustained
release formulation.
Several approaches are currently used to prolong gastric
retention time. These include floating drug delivery
systems; also known as hydro dynamically balanced
systems, swelling and expanding systems, polymeric
bioadhesive systems, modified- shape systems,
high-density systems, and other delayed gastric emptying
devices.
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