Formulation and Evaluation of Budesonide-loaded Nanosponges for Colon-specific Drug Delivery Systems

Abstract

Abstract Background: The purpose of this work was to complex budesonide with cyclodextrin-based nanosponges to improve its solubility and stability. The current study focused on polysaccharide systems that have undergone minimal chemical alteration and have been used to target the colon. These targeted delivery and polysaccharide-based complexation methods are anticipated to aid in the creation of medication formulations for disorders affecting the colon, such as colorectal cancer. The goal of the current work was to use a Quality by Design (QbD) strategy to create budesonide-loaded nanosponges. The system consisted of nanosponges loaded with budesonide. Methods: Nanosponges were formulated through microwave-assisted synthesis. Studies on drug release were conducted with a method changing power of hydrogen (pH) with enzyme. Quality by Design-based optimization with a 32 full factorial design was applied for the optimization of the process parameters including the β-cyclodextrin:diphenyl carbonate ratio and the reaction time. Responses were measured for three dependent variables: practical yield, percentage drug release, and percentage drug release at the fifth hour. Results and Conclusions: The optimization model indicated a yield of 76.21%, a percentage drug release at the fifth hour of 24.61%, and a total drug release after 7 hours of 87.58%. The observed responses of the optimized process closely matched the predicted values. The above budesonide-loaded nanosponge formulations provide a targeted medicine for the colon and may be an effective method for treating colonic illness.