Formulation and Evaluation of Fast Dissolving Oral Film of Imipramine

Abstract

Fast dissolving oral film is a new emerging solid dosage form in which it consists of thin strips administered orally and dissolved in mouth within the seconds. The study is purposed to use water soluble polymers to provide rapid film disintegration as the films are hydrated in mouth and to find the best polymer type and its concentration to formulate the drug. Initially, placebo films were prepared using solvent casting method then two formulations from the prepared placebo films were selected to formulate imipramine. The excipients were dissolved in water then the drug solution was prepared by dissolving 150 mg of drug in 5 ml of water then mixed with the excipients and they were mixed gently and casted in disposable Petri dishes and left for 24 h in oven to provide film dryness. Then, the films removed from Petri dish and cut to 2 cm × 2 cm small strips. Then, the tests were performed. Successful films were prepared by 45% hydroxypropyl methyl cellulose (HPMC) and 50% sodium carboxymethyl cellulose (NaCMC). The films were smooth, easily removed from Petri dish without tearing and homogenous. The thin films were mechanically stable that they could be handled without breaking due to their good folding endurance which was more than 400. The pH of the films was accepted since they were around saliva pH (5.3–6.9). The films disintegration time was <60 min since water-soluble polymers were used and this property provided rapid drug release from the formulation in which it was 15–20 min for both of the drug-containing films, while dissolution time for the imipramine conventional tablet was about 60 min. Imipramine can be formulated as a new dosage form (fast dissolving film) using 45% HPMC and 50% NaCMC as polymer using solvent casting method to ease the drug administration for psychotic and pediatric patients since no water is required for this solid dosage for administration.