Preparation and Evaluation of Novel Expandable Drug Delivery System.
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Date
2013-10
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Abstract
Aims: The purpose of this research is to develop a novel expandable gastroretentive
dosage form (GRDF), based on unfolding mechanism. It consists of a drug loaded bilayer
polymeric film, folded into a hard gelatin capsule. Gastric retention is achieved due to
unfolding of the dosage form within 15-20 min. Furosemide is selected as the drug
candidate for this work. Due to its narrow absorption window, Furosemide has to be
administered to the upper parts of the intestine in order to maintain sustained therapeutic
levels. This may be achieved by a GRDF.
Methodology: Films were prepared by solvent-casting technique using Ethyl cellulose,
HPMC E15 and Eudragit RLPO as polymers and dibutyl phthalate as the plasticizer in
both layers. The film with zigzag folding in the capsule was shown to unfold in the gastric
juice and provide drug release up to 12 h in the acidic medium. The films were evaluated
for weight & thickness variation, mechanical properties, in vitro drug release and unfolding
behavior based on the mechanical shape memory of polymers. Absence of drug polymer
interaction and uniform drug dispersion in the polymeric layers was revealed by DSC,
XRD studies and SEM. The GRDF location in the gastrointestinal tract was determined by
X-ray studies.
Results: X-ray studies revealed that the GRDF is retained in the stomach up to 6± 0.5 h
in fasting condition and 8 h in fed state. Conclusion: The polymers used in the development of GRDFs were safe and proper
combination of these polymers will yield a novel expandable GRDF with good in vitro drug
release in acidic media, mechanical properties, and unfolding behaviour. These outcomes
demonstrate that the GRDF may be used to improve furosemide therapy and can be
applied to extend the absorption of other narrow absorption window drugs that require
continuous input.
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Keywords
Furosemide, expandable drug delivery systems, gastric retention, mechanical properties, hydroxy propyl methyl cellulose, ethyl cellulose
Citation
Sathish D, Himabindu S, Kumar P Pavan, Rao Y Madhusudan. Preparation and Evaluation of Novel Expandable Drug Delivery System. British Journal of Pharmaceutical Research. 2013 Oct; 3(4): 1079-1093.