Formulation and Evaluation of Dapagliflozin Oral Dispersible Films for Rapid Antidiabetic Action

Abstract

This study intended to design and assess dapagliflozin oral dispersible films (ODFs) for quick antidiabetic efficacy and enhanced patient convenience. Seven formulations (DF1–DF7) were developed using solvent casting utilising advanced film-forming polymers pullulan, Lycoat® RS 720, and maltodextrin combined with PEG-400 as a plasticiser and appropriate palatability enhancers. Dapagliflozin demonstrated exceptional analytical linearity in pH 6.8 phosphate buffer (2–12 µg/mL, R² = 0.9987), validating dependable drug quantification. All films exhibited consistent thickness, elevated folding endurance, almost neutral surface pH, fast breakdown, and satisfactory drug content consistency. In vitro dissolution experiments demonstrated rapid and full drug release, with optimised formulations (DF6–DF7) attaining ≥83% release within 10 minutes and nearly 100% release within 20 minutes. FTIR analyses validated the compatibility between the medication and excipient. The stability assessment of DF7 over a 90-day period revealed no significant alterations in physical attributes or drug content. Dapagliflozin ODFs provide a swift-acting, stable, and patient-focused option for antidiabetic treatment.