Orally disintegrating films focusing on formulation, manufacturing process, and characterization


Orally disintegrating films (ODF) has recently become one of the most popular forms of drug administration due to its excellent patient convenience and compliance. The main advantage of the dosage form arises from rapid disintegration: it can be placed on the tongue without the need of water. Compared to conventional oral dosage forms, ODFs usually result in enhanced bioavailability with faster onset of action. In addition, ODFs are flexible. Unlikely to orally disintegrating tablets, they do not require any special packaging for protection during transportation and storage. The critical quality attributes (CQAs) of ODFs should be carefully considered during the development process. These properties are not only inherent to the formulation but are also significantly influenced by the manufacturing processes. This review provides a brief overview of the advantages, formulation considerations, critical manufacturing processes and methods, characterization, and CQAs of ODFs, which might be beneficial to understand the dosage form better in a comprehensive way.