Formulation and Characterization of a Novel Fast Dissolving Oral Wafer Drug Delivery System of Linagliptin

Background: Conventional oral formulations such as tablets & capsules show swallowing difficulties to old & pediatric candidates, prompting interest to fast dissolving oral wafers (FDOWs) that disintegrate rapidly in buccal area, bypass hepatic initial metabolism, & make patient compliance. Objective: To formulate and evaluate fast dissolving oral wafers of Linagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor used in type II diabetes mellitus, using hydroxypropyl methylcellulose (HPMC). Methods: Nine wafer batches (F1–F9) formulation done via SCT using HPMC K4 & K15 in varying ratios with SSG, CCS & CP as superdisintegrants. Mainly appearance, thickness, Wt. uniformity, FE, DT, TS, MC, DC & in-vitro DR (USP type II, PB pH 6.8); release kinetics & short-term stability of the optimized batch were also assessed. Results: Formulation F7 emerged as final optimized batch, showing fastest DT (14±4 sec.), highest folding endurance (178±6), 99.47±0.78% drug content & the greatest cumulative drug release (99.48% within 10 minutes). Release from F7 best fitted the Korsmeyer–Peppas model (r² = 0.993). The optimized batch retained 98.50±0.74% assay after 3 months of stability testing. Conclusion: FDO wafers of Linagliptin formulation done via SC particularly formulation F7, offer a mechanically robust, rapidly disintegrating alternative to conventional oral dosage forms which improve onset of action & make better patient compliance in type II diabetes control.