Formulation Optimization and Evaluation of Immediate Release Tablet of Linagliptin

The present study focuses on the formulation, optimization, and evaluation of immediate release tablets of Linagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor used in the treatment of type 2 diabetes mellitus. The primary objective was to develop a robust and effective formulation that ensures rapid disintegration and optimal drug release to achieve prompt therapeutic action. Various formulations were prepared using wet granulation technique with different concentrations of superdisintegrants such as crosspovidone and Banana Powder. A Central Composite design (CCD) was employed to optimize the formulation parameters As well as Sixteen batches (LB1 to LB16) by Design of Expert software were done using binder (PVPK30) and natural super disintegrant (Banana Powder), Crosspovidone at different concentrations were formulated and evaluated for pre-compression and post-compression parameters. Batch LB1 is considered as optimized batch based on results analysis of responses mentioned in DOE Software. The tablets were evaluated for pre-compression and post-compression parameters including hardness, friability, weight variation, disintegration time, and in vitro drug release. The optimized formulation showed rapid disintegration within 35 seconds and 97.67% drug release within 60 minutes, indicating immediate release behavior. Stability studies conducted under and confirmed the physical and chemical stability of the optimized formulation. The study concludes that a carefully designed formulation strategy can significantly enhance the release profile of Linagliptin, improving patient compliance and therapeutic efficacy.