Development and Evaluation of Taste-Masked Fast-Dissolving Oral Films Containing Fenugreek Seed Extract

Objective: The present research work was aimed to develop and formulate fast-dissolving oral films containing fenugreek (Trigonella foenum-graecum) seed extract as an alternative oral dosage form and to evaluate their physicochemical properties, disintegration characteristics, drug release behaviour, and taste-masking effectiveness. Methods: Fenugreek seed crude extract was obtained through Soxhlet extraction using ethanol and assessed for its visual characteristics, pH level, and extraction yield. The extract was then incorporated into fast-dissolving films using a solvent casting technique. These films underwent physicochemical evaluation. Additionally, the in vitro residence time was measured using a disintegration apparatus, while in vitro drug release studies were conducted using a USP Type II (paddle) dissolution apparatus. The taste-masking effectiveness of the formulations was assessed in healthy human volunteers. Results: The prepared fast-dissolving oral films showed acceptable physicochemical characteristics, including uniform thickness, surface pH, folding endurance, and rapid disintegration. All formulations disintegrated within 40 seconds and demonstrated nearly complete drug release within 60 seconds. Among the formulations evaluated, F3, F6, F8, and F9 demonstrated superior taste-masking performance, exhibiting the lowest bitterness scores (2.00±0.00 to 2.33±0.50) during in vivo sensory evaluation in healthy volunteers. Formulations F3 and F9 showed acceptable drug content and overall performance characteristics, while formulation F6 exhibited comparatively lower drug content. Conclusion: The study demonstrated the feasibility of developing taste-masked fast-dissolving oral films containing fenugreek seed extract with acceptable physicochemical properties, rapid disintegration, efficient drug release, and improved palatability. Further studies are required to establish the therapeutic efficacy, safety, and clinical utility of the developed formulation.