Context: Orodispersible films have gained increasing relevance as a novel dosage form. Associated to their particular processing and multicomponent composition, there are a vast number of reasons to establish helpful development guidance, gathering simultaneously the recent pharmaceutical regulatory trends. Objective: This study aimed characterize marketed orodispersible films in order to provide essential information about a clear definition of product critical quality attributes (CQAs). Materials and methods: Several commercial orodispersible films were evaluated in terms of thickness, residual water content, disintegration time and mechanical and thermal properties. Results: The orodispersible films exhibit a broad range of thickness [40–140 μm], probably associated with the height gap used on the cast of orodispersible films production. The majority of orodispersible films dissolved within [32–105s]. In general, a broad range of values were found for all the properties studied, residual water content [2.91–9.75%], Young’s Modulus [51.25–1827 Mpa], tensile strength [1.47–33.91 Mpa] and tensile strain [0.32–38.2%]. Discussion and conclusions: Despite the orodispersible films’ complex composition, it was possible to establish correlations about the impact of the main excipients on the final product characteristics. Acceptable values for the CQAs were also defined, working as acceptance criteria for the development of new oral film formulations.

Objectives: To develop orodispersible films (ODF) based on hydrophobic polymers with higher stability to ordinary environmental humidity conditions without compromising their fast disintegration time. Methods: A quality by design approach was applied to screen three different formulations each one based on a different hydrophobic polymer: polyvinyl acetate, methacrylate-based copolymer and shellac. The screening formulations were characterized regarding their mechanical properties, residual water content, disintegration time and appearance, in order to find a suitable ODF formulation according to established critical quality attributes. The selected critical process parameters for the selection of appropriate ODF formulations were the percentage of the different excipients and the plasticizer type. Results: Three hydrophobic-based matrices with fast disintegration were developed. These were generically composed by a hydrophobic polymer, a stabilizer, a disintegrant and a plasticizer. It verified that the common components within the three different formulations behave differently depending on the system/chemical environment that they were included. Conclusions: It was shown that it is possible to develop oral films based on hydrophobic polymers with fast disintegration time, good texture and appearance, breaking a paradigm of the ODF research field.