Orodispersible films — Pharmaceutical development for improved performance: A review

Abstract

Orodispersible films (ODFs) have recently emerged as innovative dosage form which provides distinct advantages in the patient centric pharmaceutical drug product design due to inherent dosing flexibility and improved patient acceptability. Although their potential advantages in pharmacotherapy are well recognized, there is still a lot of research work to be done in order to explore and understand complex relationships among different formulation factors, film mechanical properties, and their bioperformance. Lack of standardized characterization methods and relevant specifications pose additional limitation for their wider application. In the present study, in-depth review of the available body of data published on ODF development and characterization was performed. In total, 112 papers published between November 2008 and April 2022 were taken into consideration for dataset building. Data collected have been critically evaluated and compiled into the representative dataset formed around three domains, namely: (A) Manufacturing method and composition; (B) ODF characteristics; and (C) ODF sensory attributes. Based on the investigated dataset, an attempt was made to identify the acceptable range of Critical Quality Attributes (CQA) values and propose ODF specific Quality Targeted Product Profile (QTPP) as a foundation which should guide and facilitate pharmaceutical development.