Several distinct novel drug delivery systems are being employed for effective delivery of medications to patients. Oral delivery is by far the most preferable route of drug delivery and oral sustained-release gastroretentive drug delivery systems offer several advantages. These drug delivery systems are beneficial for drugs with absorption from the upper parts of the gastrointestinal tract and for those acting locally in the stomach, improving the bioavailability of these drugs. Floating drug delivery systems (FDDS) are one of the gastroretentive drug delivery systems used to achieve prolonged gastric residence time. Multiple unit FDDS avoid the “all-or-none” gastric emptying nature of single unit systems. In the present research study, floating formulation as solid (capsule) or liquid (in situ gel) drug delivery systems were developed for improving the gastric residence time of the anti-emetic agent metoclopramide hydrochloride. Floating capsules were prepared using combinations of various natural and synthetic polymers. Simultaneously, in situ gel was prepared using completely bio-degradable natural polymers. Both systems were able to sustain drug release for up to 8 hours. These formulations were compared with marketed forms and found to be more convenient from a patient as well as a biopharmaceutical standpoint. To assess the stability of these formulations, accelerated stability testing was conducted as per ICH guidelines. Both formulations were found to be stable upon completion of the accelerated stability period.
The purpose of this research was to fabricate and optimize Gastro-retentive drug delivery system for Metoclopramide Hydrochloride. The effect of ethyl cellulose and sodium alginate on the drug release profile and floating properties was evaluated. Sodium carbonate was incorporated as gas generating agent. The addition of ethyl cellulose reduces the drug dissolution rate due to its hydrophobic nature. A D-Optimal Technique was applied systematically to optimize the drug release profile. The amounts of ethyl cellulose (X 1) and sodium alginate (X 2) were selected as independent variables. The cumulative percent of drug released at 8, 12 and 16 hours were selected as dependent variables. The study shows that, tablet composition and mechanical strength have great influence on floating properties and drug release. All formulations were evaluated for dimensional analysis, duration of buoyancy, floating lag time, drug content and invitro drug release. Optimized formulation's data was subjected to various release kinetic models. The drug release was sufficiently sustained for 24 hours. Model equations of zero and first order, Higuchi, Hixson-Crowell and Peppas, intended to elucidate the drug release mechanism, were fitted to the release data. The zero order release was observed with r 2 values of 0.98. The difference in the release pattern and kinetics can be explained by the different swelling and erosion behaviors.
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