Formulation and In-Vitro Evaluation of Tadalafil Oral Disintegrating Strips for Enhanced Bioavailability

Background: Erectile dysfunction (ED) is a prevalent disorder affecting men worldwide, often managed with oral phosphodiesterase type-5 (PDE5) inhibitors such as tadalafil. However, its limited oral bioavailability (~28%) necessitates the exploration of novel dosage forms. Oral disintegrating strips (ODS) provide a promising alternative due to rapid disintegration, improved patient compliance, and avoidance of first-pass metabolism. Aim: To formulate and evaluate tadalafil oral disintegrating strips (ODS) using solvent casting method for enhanced dissolution and bioavailability. Methods: Six formulations (F1–F6) were prepared using hydroxypropyl methylcellulose (HPMC K15) as film-forming agent, glycerol as plasticizer, Tween 80 and sodium lauryl sulphate (SLS) as surfactants, citric acid as saliva stimulator, and sucrose with vanillin as sweetening/flavoring agents. The strips were evaluated for thickness, folding endurance, weight variation, drug content, disintegration time, in-vitro dissolution, and stability as per ICH guidelines. Drug–excipient compatibility was assessed via FT-IR. Results: Among all formulations, F4 demonstrated superior performance with 92.83% drug content, disintegration time <30 seconds, and 94.2% cumulative drug release within 30 minutes. FT-IR spectra confirmed no significant drug–excipient interactions. Stability studies at 40±2°C/75% RH for 2 months showed no major changes in physicochemical parameters. Conclusion: Tadalafil ODS prepared by solvent casting demonstrated improved dissolution and patient-friendly properties, indicating its potential as a novel therapeutic system for ED management in both pediatric and geriatric populations