FORMULATION AND EVALUATION OF FAST DISSOLVING ORAL FILM LOADED WITH AMBRISENTAN FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) AS A NOVEL DRUG DELIVERY SYSTEM

Ambrisentan is an endothelin receptor antagonist for rapid administration during early disease progression to provide therapeutic benefit. This study aimed to develop Ambrisentan as a fast-dissolving oral film (FDOF) and evaluate the physicochemical and performance characteristics of the formulated films. The FDOFs were prepared using film-forming polymers, including hydroxypropyl methylcellulose (HPMC E6 LV) and 2-hydroxypropyl β-cyclodextrin (HPβCD), with xanthan gum and propylene glycol 400 at varying concentrations. Eleven formulations were developed and evaluated for parameters including film color, thickness, brittleness, peelability, transparency, surface smoothness, tackiness, film-forming capacity, content uniformity, dispersion time, and dissolution behaviour. The optimized formulation (F9) showed excellent film properties, with content uniformity of 99.6 ± 0.8%, dispersion time of 15 ± 2 s, and dissolution rate of 98.2 ± 1.08% within 12 min. Fourier transform infrared spectroscopy revealed no physicochemical interaction between Ambrisentan and polymers. Differential scanning calorimetry showed no significant changes in the melting endotherm of the pure drug and optimized formulation, indicating drug-excipient compatibility. Comparative dissolution studies demonstrated that formulation F9 exhibited superior dissolution performance compared with the marketed oral tablet of Ambrisentan.