Abstract
The purpose of this investigation was to prepare a gastroretentive drug delivery system of ranitidine hydrochloride. Currently, floating tablets are one of the important categories of drug delivery systems with gastric retentive behavior. Ranitidine is a H2 blocker and absorbed from the upper part of GIT and hence there is need to develop a dosage form that releases the drug in stomach so that it can be absorbed from upper part of GIT leading to improved bioavailability. Six different gastroretentive tablets of ranitidine HCl were prepared by direct compression using different concentrations of Hydroxy propyl methyl cellulose (HPMC K4M), Carbopol, Sodium carboxy methyl cellulose, sodium bicarbonate and citric acid. The formulations were coded as HE1, HE2, HC1, HC2, HEC1 and HEC2. The formulations were evaluated for pharmacopoeial quality control tests and all the physical parameters evaluated for quality control were within the acceptable limits of Pharmacopoeia. All the formulations were subjected to in vitro drug release study and compared with that of marketed formulation. The floating lag time of the prepared formulations is good except for one formulation (HC1) and the floating time for all the formulations was >12 hours except HC1 which does not float at all. In conclusion, effervescent is essential for the formulation to have good floating property and carbopol retards the drug release in floating formulations. The statistical analysis of the parameters dissolution efficiency of dissolution data, floating behavior and drug content after storage at 40°C and 75% RH for three months showed no significant change by Student’s t-test indicating that formulation (HEC1) could provide a minimum shelf life of 2 years.
Published Version
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