Preparation of porous cellulose-based ODFs for drug delivery application by thermally induced porogen decomposition in solvent-cast films

Orally dispersible films (ODFs) represent a promising pharmaceutical formulation aimed at enhancing ease of use and, consequently, improving patient compliance with therapy. In this study, we developed a novel method for preparing porous cellulose-based films by modifying the solvent casting technique. Unlike the original method, which is limited to water-insoluble polymers, our approach successfully integrated a porogen insoluble in an organic solvent. Subsequently, this porogen was removed through film heating and thermal decomposition. Several parametric studies were conducted to investigate the impact of various components of the formulation on film properties, including porogen, drug, and disintegrant content, and the mass ratio of the film former to thickener. A notable finding was significant reduction of disintegration time by an increase of the porogen content in the ODF, where the disintegration time decreased from 53.9 ± 2.4 s for samples with a porogen mass fraction of 0.27–4.3 ± 0.1 s for samples with a porogen mass fraction of 0.72. Furthermore, our results confirm that the presence of the porogen and its subsequent removal did not interfere with active pharmaceutical ingredient (API), which was Tadalafil, nor produce any toxic byproducts, underscoring the viability of prepared material as an alternative to current pharmaceutical forms.