Preparation of Microsponge Drug Delivery System (MSDDS) Followed by a Scale-Up Approach.

Highlights: The goal is to optimize the microsponge drug delivery system's preparation. Scaling up ensures product repeatability. FTIR, DSC, and SEM confirmed the drug-loaded microsponge particles' compatibility and porous shape. The final gel dosage had shear-thinning rheology, suggesting dermal use. Ultimately, it supports and advances the UN's sustainable development goals and G20. In 1987, Won invented the solid-phase porous microsphere (MS), which stores bioactive compounds in many interconnected voids. Spherical particles (5–300 μm), MS, may form clusters of smaller spheres, resulting in many benefits. The current investigation focussed on gel-encased formulation, which can be suitable for dermal usage. First, quasi-emulsion (w/o/w) solvent evaporation was used to prepare 5-fluorouracil (5 FU) MS particles. The final product was characterized (SEM shows porous structure, FTIR and DSC showed drug compatibility with excipients, and gel formulation is shear-thinning) and further scaled up using the 8-fold method. Furthermore, CCD (Central Composite Design) was implemented to obtain the optimized results. After optimizing the conditions, including the polymer (600 mg, ethyl cellulose (EC), eudragit RS 100 (ERS)), stirring speed (1197 rpm), and surfactant concentration (2% w/v), we achieved the following results: optimal yield (63%), mean particle size (152 µm), drug entrapment efficiency (76%), and cumulative drug release (74.24% within 8 h). These findings are promising for industrial applications and align with the objectives outlined in UN Sustainable Development Goals 3, 9, and 17, as well as the goals of the G20 initiative. [ABSTRACT FROM AUTHOR]