Factorial design approach to fabricate and optimize floating tablets based on combination of natural polymer and rice bran wax

Abstract

Background: The aim of the present research work was to fabricate a novel gastroretentive drug delivery system in the form of tablets using a combination of natural polymer and rice bran wax with an intention to control drug delivery and to enhance the gastric residence time of the model drug Famotidine in the gastrointestinal tract. Results: The results of the preliminary trial batches prepared by using the hot melt granulation technique resulting in six different formulations showed good physicochemical characteristics and tablets conformed to the Pharmacopoeial specifications. Gastroretentive tablets containing natural polymer showed prolonged drug release comparable to Methocel. The optimized formulation (C3) using 32 factorial design showed FLT 27 ± 2.47 s, SI 92.68 ± 1.36% and % CDR 98.89 ± 0.39% at 12 h. The stability studies indicated the stability of the formulation during storage. Conclusions: It was concluded that the release profile fitted best to zero-order equation with non-Fickian diffusion mechanism of drug release which demonstrates swelling-controlled drug release mechanism. Thus, the formulated tablets have the potential for improved release and gastroretentive properties. Graphical Abstract: [Figure not available: see fulltext.]