Isosorbide Dinitrate Orally Disintegrating Films Cyclodextrins/HPMC Based: Mechanical, Optical, and Physicochemical Studies

Abstract

Orally disintegrating films (ODFs) were prepared from hydroxypropyl methylcellulose (HPMC E6 1.5%, 2.0%, and 2.5%), plasticizers ((glycerin (Gly), propylene glycol (PP), or polyethylene glycol (PEG)), and isosorbide dinitrate using the solvent casting method. Design of experiments (DoE) was used considering the amount of film-forming agent (HPMC) and the nature of the plasticizers as independent variables and thickness, mechanical properties, disintegration time, and dissolution efficiency as dependent variables. The best formulation was selected based on the desirability function (𝑓 𝐷 ). Color analysis was performed using CIE-𝐿𝑎𝑏 coordinates. DSC curves and XRPD diffractograms showed ISDN amorphization, probably due to complexation with polymers (HPMC E6 and HPβCD). The polymer (HPMC E6) and plasticizer played a critical role in the mechanical and optical properties of the films; however, these factors had no significant effect on the dissolution efficiency of ISDN. Principal component analysis revealed a more defined distinction HIGHLIGHTS• Orally films Cyclodextrins/HPMC based films were prepared by solvent casting.• Films for oral delivery of ISDN were prepared by 3 2 factorial designs.• Mechanical, optical, and dissolution properties were evaluated.• The experimental design allowed to optimize the formulations.• The best formulation was obtained by means of the desirability function. •• .• Insert a highlight no longer than 85 characters.