Development and Characterization of a Rapid-Disintegrating Film of Olanzapine for Sublingual Delivery

Olanzapine is a second-generation atypical antipsychotic used to treat chronic schizophrenia and bipolar I disorder, including mixed or manic episodes. Olanzapine is a BCS class II medication and thus sublingual administration allows for rapid absorption of the medication into the bloodstream because of the thin mucous membranes under the tongue, having a rich blood supply and bypass the digestive system's first-pass metabolism in the liver. This can result in faster onset of action compared to oral tablets. The aim of this work is to formulate fast-dissolving sublingual films of olanzapine to improve its bioavailability. Sublingual films were prepared by solvent casting method. Hydroxypropyl methylcellulose E5, propylene glycol 400, and transcutol HP were optimized using QBD approach on the basis of disintegration time and folding endurance, weight variation, content uniformity and In-vitro drug release of films. The drug is completely soluble with the above-mentioned ingredients. In addition, the drug is completely soluble in acidic pH thus was directly added in the film formulation. Optimized film was further evaluated for drug content, pH, dissolution studies. The optimized film disintegrated within 30s, showed smooth surfaces on SEM & AFM analysis. The drug content was found to be 88% for optimised film formulation and the invitro dissolution studies estimated the release of 94.79% in 10 min. This novel approach would be much effective in terms of reduced dosage form and increased bioavailability. However, permeation studies of the film will be required to prove enhanced permeation indicating quicker absorption sublingually, leading to increase in bioavailability.