Gastroretentive Drug Delivery System of Ranitidine Hydrochloride Based on Osmotic Technology: Development and Evaluation

Authors: Kumar, P.; Singh, S.; Mishra, B.

Source: Current Drug Delivery, Volume 5, Number 4, October 2008 , pp. 332-342(11)

Publisher: Bentham Science Publishers

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Abstract:

Gastroretentive drug delivery systems (GRDDS) of Ranitidine hydrochloride (RHC) has been designed based on the osmotic technology, with the floating and swelling features in order to prolong the gastric retention time. The developed system consisted of osmotic core (containing drug, osmotic agent and hydrophilic polymers), coated with semipermeable membrane (SPM) which is then further coated with compression coating of gelling agent (HPMC K4M) containing gas generating agent (citric acid). All the developed formulations were evaluated for floating lag time, duration of floating, drug content and in-vitro drug release profile. Formulation variables like levels of hydrophilic polymer (0-18.26%w/w), type of plasticizer (PEG-400, Dibutyl phthalate), coat thickness of SPM (60-100μm), were found to affect the drug release from the developed formulations. Drug release was directly proportional to hydrophilic nature of plasticizer but inversely proportional to the levels of hydrophilic polymer and coat thickness of SPM. Drug release from developed formulations was independent of level of gas generating agent in compression coat, pH and agitation intensities of release media but dependent on osmotic pressure of the release media. All the developed formulation showed floating lag time of less than 2 min (desired) and were floated for more than 12 hr. Floating lag time was inversely related to level of citric acid in compression coat and directly related to the density of the developed formulations. The manufacturing procedure was found to be reproducible and formulations were stable after 3 months accelerated stability study. Prediction of steady state levels showed the plasma concentrations of RHC to be within desired range.

Keywords: Gastroretentive; floating; osmotic system; ranitidine; hydrophilic polymer

Document Type: Research article

DOI: http://dx.doi.org/10.2174/156720108785914943

Publication date: 2008-10-01

More about this publication?
  • The aim of Current Drug Delivery is to publish peer-reviewed articles, short communications, short and in-depth reviews in the rapidly developing field of drug delivery. Modern drug research aims to build in delivery properties of a drug at the design phase, however in many cases this ideal cannot be met and the development of delivery systems becomes as important as the development as the drugs themselves.

    The journal aims to cover the latest outstanding developments in drug and vaccine delivery employing physical, physico-chemical and chemical methods. The drugs include a wide range of bioactive compounds from simple pharmaceuticals to peptides, proteins, nucleotides, nucleosides and sugars. The journal will also report progress in the fields of transport routes and mechanisms including efflux proteins and multi-drug resistance.

    The journal is essential for all pharmaceutical scientists involved in drug design, development and delivery.
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