QbD-guided development and optimization of a rapid-disintegrating sublingual film of olanzapine.

AIM: Olanzapine is an atypical antipsychotic used to treat chronic schizophrenia and bipolar I disorder, including mixed/manic episodes. It is a BCS class II medication, and thus there is a potential for sublingual administration allowing rapid absorption. This may potentially result in a faster onset of action compared to oral tablets. The aim of this work was to formulate a fast-dissolving sublingual film of olanzapine with rapid disintegration.

MATERIALS AND

METHODS

Hydroxypropyl methylcellulose E5, polyethylene glycol 400, and Transcutol HP were optimized using a QBD approach based on disintegration time, folding endurance, weight variation, content uniformity, and in vitro drug release of films.

RESULTS

The drug was completely soluble with the above-mentioned ingredients. Optimized film was further evaluated for drug content, pH, and dissolution studies. The optimized film disintegrated within 30 s, showed smooth surfaces on SEM and AFM analysis. The drug content was found to be 88% for optimized film formulation, and the in vitro dissolution studies estimated the release to be 94.79% in 10 min.

CONCLUSION

This novel approach may offer a promising alternative in terms of reduced dosage; however, further investigations and in vivo assessment of the film are warranted to prove enhanced permeation indicating quicker absorption sublingually, leading to an increase in bioavailability.