Formulation Evaluation and Optimization of Fast Dissolving Oral Strips of Isosorbide Mononitrate

Fast dissolving oral films (FDOFs) are the most advanced form of oral solid dosage form due to more flexibility and comfort. Fast dissolving film is a dosage form which when placed in the oral cavity, quickly gets hydrated, sticks onto the site of application and then disintegrates to release the drug. Fast dissolving oral films of isosorbide mononitrate were prepared by solvent casting method. Optimization was carried out to study the effect of independent variables (different polymer and plasticizer concentration) such as HPMC E5 and HPMC E50 as polymer and PEG 400 as a plasticizer on the dependent variables like T90% (sec), in-vitro disintegration time (sec) & % moisture absorption (%). Design expert software (version 8.0.1.6) was used to optimize the formulation. Prepared films were subjected to different evaluation parameters such as surface pH, weight uniformity, thickness of strip, % moisture absorption, % moisture loss, swelling index, drug content, in-vitro disintegration time, in-vitro drug release, stability studies and mechanical properties like folding endurance, tensile strength.