Pulmonary Arterial Hypertension - A Concept Change in Drug Delivery

In urgent medical situations such as Pulmonary Arterial Hypertension (PAH), immediate medication is crucial. The oral route remains the primary method for administering drugs. This study utilized a combination of film-forming polymers, including Hydroxy propyl methyl cellulose (HPMC E15LV) and 2-Hydroxy propyl Beta cyclodextrin (HPBCD), along with Xanthan gum and propylene glycol 400 in varying concentrations. Ten formulations were developed and assessed for their fast-dissolving oral film (FDOF) characteristics, such as film colour, thickness, brittleness, peeling ability, transparency, surface smoothness, tackiness, and film-forming capacity, as well as content uniformity, dispersion time (DT), and dissolution rate. The optimized FDOF (F2) demonstrated excellent properties, with content uniformity of (98.3±0.3), a DT of (13±3) seconds, and a dissolution rate of (99.2±2.0) within 10 minutes. Infrared (IR) spectroscopy was conducted to detect any physicochemical interactions between the drug and polymer, revealing no interaction. Differential scanning calorimetry (DSC) was used to examine any changes in the melting points of the active pharmaceutical ingredients (API) and excipients in F2. The DSC thermograms indicated no significant change in the melting endotherm of the pure drug and the drug in the optimized formulation F2. A comparative analysis with the marketed formulation of Macitentan fast-dissolving oral tablet (OPSUMIT 10) showed that F2 possess a promising dissolution property comparable to the marketed formulation.