Polymeric topical film-forming sprays for sustained release of etoricoxib: formulation, optimization, and characterization

Abstract

Abstract The rising prevalence of chronic pain and inflammatory disorders necessitates the development of effective, safe, and patient-friendly drug delivery systems that can improve therapeutic outcomes and patient compliance. Etoricoxib, a selective cyclooxygenase-2 (COX-2) inhibitor, is extensively utilized in the treatment of acute and chronic inflammatory disorders, such as musculoskeletal pain and osteoarthritis; however, traditional oral administration frequently results in gastrointestinal side effects. Therefore, this study aimed to formulate and develop etoricoxib topical film-forming sprays using a quality by design (QbD) approach. Eudragit S-100 and PEG 400 were identified as critical formulation variables, and their influence on viscosity and drying time was systematically evaluated using a response surface methodology (RSM) quadratic model. ANOVA confirmed the significance of both variables, with PEG 400 exerting a dominant effect on drying time and Eudragit S-100 significantly influencing viscosity. The optimized formulations were further characterized. In vitro drug release studies demonstrated sustained release behavior, with 30.68% and 35.26% drug release over 8 h for Batch 1 and Batch 2, respectively. Overall, the findings point out the potential of etoricoxib film-forming sprays as an effective and patient-friendly topical drug delivery system for the management of inflammatory conditions. GRAPHICAL ABSTRACTFour labeled bottles of Eudragit formulations above an overlay plot graph with viscosity and drying time data.The figure showcases four clear bottles labeled with different Eudragit formulations, each filled with a pale liquid. Below them is an overlay plot graph tracking viscosity against drying time. It includes marked data points and regions: yellow for favorable viscosity and grey for less. Specific values of viscosity (0.336333) and drying time (14.34 seconds) are highlighted. A central green box has the title "ETORICOXIB FILM," with a risk assessment section summarizing critical quality attributes including drying time, viscosity, spray angle, and pH.