QBD-BASED DEVELOPMENT OF ORODISPERSIBLE FILMS OF ANTIPSYCHOTIC DRUGS

Abstract

This review provides an overview of the application of the Quality by Design (QbD) approach in the formulation and evaluation of the orodispersible films (ODFs) of antipsychotic drugs. Quality by Design involves a well-defined approach with predefined objectives to develop the product or process based on quality risk management and sound science. It comprises the defining of Quality Target Product Profile (QTPP) and Critical Quality Attributes (CQAs), risk assessment, design and development, and evaluation of formulation. The Orodispersible films are ultra-thin, elegant, and portable dosage forms that do not require water to be ingested. It can be used for individuals who require special needs, such as for treating psychosis, schizophrenia, mania, and dysphagia. Hence, it holds tremendous potential in terms of patient compliance, convenience, and pharmacotherapy. They are fabricated by different techniques, which include solvent casting, hot-melt extrusion, 3D printing, and others discussed here. They are evaluated for different attributes like mechanical strength, dissolution, disintegration, tensile strength, folding endurance, and others discussed here. It also provides the significance of stability, packaging, shapes, and patent-related concepts of orodispersible films.