Design, characterization and evaluation of oral fast dissolving polymeric films of isradipine inclusion complex

This study aimed to enhance the dissolution rate of isradipine and to avoid the problem of first-pass metabolism using oral fast dissolving films (OFDFs). Isradipine was complexed with hydroxypropyl-beta-cyclodextrin (HP-β-CD) using the solvent co-evaporation technique to produce an isradipine inclusion complex with increased solubility. This complex was evaluated for its solubility and dissolution behavior compared with the free drug. Then, the inclusion complex was formulated in OFDFs. The fabricated films were evaluated for their drug content uniformity, surface pH, thickness, tensile strength, percent elongation, disintegration time and in vitro drug release profile. Additionally, Fourier transform infrared spectroscopy and differential scanning calorimetry were utilized to characterize the medicated films and the corresponding physical mixture as well as the individual components. The results indicated that the inclusion complexation of isradipine enhances its solubility and dissolution rate. Films were found to be faint yellow, elastic, compatible and palatable and to have acceptable tensile strength. The complexed drug with HP-β-CD in the presence of a high level of disintegrants enhanced the drug dissolution compared to the plain film.