Design Optimization and Evaluation of Patented Fast-Dissolving Oral Thin Film of Ambrisentan for the Treatment of Hypertension.

Abstract

Background: Cardiovascular diseases, including hypertension, are the prominent source of death globally. High blood pressure is responsible for heart failure and also damages the vital organs of the body, which also creates mortality. The activation of the sympathetic nervous system in the primary sunrise period is a highly critical condition, and several persons have lost their tissue due to the unavailability of medicine at this time.

Objective: The present research deals with the progress of fast-dissolving oral thin film (OTF) of Ambrisentan for the prevention and cure of hypertension.

Methods: The OTF was established using the solvent casting method. The compatibility of Ambrisentan with film former HPMC E15 was checked with FTIR and DSC. The optimization was assessed using the design of the experiment using 32 Box-Behnken designs. The independent parameters were filmed former (X1: HPMC E15), plasticizer (X2: PEG 400), and super disintegrant (X3: cross povidone) and dependable parameters were disintegration time (Y1) and dissolution release (Y2).

Results: The optimized batch F7 showed the least disintegration time (9 sec), folding endurance of (99), content uniformity (98.57 %), pH (6.4), and dissolved within 5 min. The scanning electron microscopy confirmed the evenness and smoothness of the film with a particle size of 10 μm. Patent related with OTF (Indian- 202321050359), US (11701339).

Conclusion: The investigation indicated that fast dissolving oral thin film of Ambrisentan improves the solubility and therapeutic efficacy in the prevention and treatment of cardiovascular complications. The prompt release of Ambrisentan minimizes the mortality associated with heart attack and hypertension.