Formulation and in Vitro evaluation of Gastroretentive drug delivery system of Cefixime Trihydrate

A gastroretentive, controlled release drug delivery system of Cefixime trihydrate was formulated in an effort to increase the gastric retention time of the dosage form and to control drug release. Various grades of HPMC viz., HPMCK100M, HPMCK15M, HPMCK4M were incorporated for gel forming properties. Buoyancy was achieved by adding an effervescent mixture of sodium bicarbonate and anhydrous citric acid. In vitro drug release studies were performed, and drug release kinetics was evaluated using the zero order, first order, Higuchi’s model and Korsmeyer-peppas kinetic models. The kinetic study results suggested that the drug was released by fickian diffusion in case of all the developed floating matrix tablet formulations of Cefixime trihydrate. The optimized intragastric floating tablet composed of 15% w/w of HPMC K4M exhibited 94.71±0.20% drug release in 12 h, while the buoyancy lag time was < 1 min, and the tablets remained buoyant for >12 h. All the formulations showed hardness, friability, weight variation and drug content values well within the prescribed limits, indicating that the prepared tablets were of standard quality. FTIR studies of the pure drug, its physical mixture with polymer blend showed that no polymorphic changes occurred during manufacturing of tablets. Optimized tablet formulation exhibited no significant change in physical appearance, drug content, total buoyancy time, or in vitro dissolution pattern after storage at 40°C/75% relative humidity for 3 month

Author(s): Yash Paul, Manoj Kumar and Bhupinder Singh

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