• Mohit Sharma
• Vinod Dhote
• Kanika Dhote
• Surendra Jain

The present study focuses on the preformulation, characterization, and development of fast-dissolving oral films of Trelagliptin, aiming to enhance patient compliance and achieve rapid drug release for the effective management of type 2 diabetes mellitus. Preformulation studies confirmed the drug’s identity, purity, and stability through organoleptic evaluation, solubility profiling, FTIR spectroscopy, loss on drying, and melting point analysis. Trelagliptin exhibited versatile solubility in both aqueous and organic solvents and showed excellent linearity (r² = 0.999) in UV spectrophotometric analysis at 276 nm. Nine formulations (F1–F9) of oral films were prepared using different polymers and evaluated for physicochemical and mechanical properties. All formulations demonstrated uniform appearance, consistent thickness, and satisfactory film characteristics. Among them, formulation F6 was identified as the optimized batch, exhibiting the shortest disintegration time (55±7 sec), highest drug release (97.65% in 10 min), maximum folding endurance (185±5), and excellent assay value (99.12±0.18%). Drug release from F6 followed first-order kinetics with non-Fickian diffusion, indicating a combination of diffusion and polymer relaxation mechanisms. Stability studies under accelerated conditions over three months confirmed the formulation’s robustness, with minimal changes in drug content and physical attributes. In conclusion, the optimized Trelagliptin fast-dissolving film (F6) demonstrated promising attributes such as rapid onset of action, high drug release, and improved patient convenience, offering a stable and effective alternative dosage form for type 2 diabetes treatment.

Trelagliptin, Fast-dissolving oral films, Preformulation studies, Drug release kinetics, Non-Fickian diffusion, Type 2 diabetes mellitus

"Formulation and evaluation of Trelagliptin loaded fast-dissolving oral films", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.12, Issue 9, page no.e136-e147, September-2025, Available :http://www.jetir.org/papers/JETIR2509416.pdf

"Formulation and evaluation of Trelagliptin loaded fast-dissolving oral films", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.12, Issue 9, page no. ppe136-e147, September-2025, Available at : http://www.jetir.org/papers/JETIR2509416.pdf