Outlining critical quality attributes (CQAs) as guidance for the development of orodispersible films

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.

This study aimed characterize marketed orodispersible films in order to provide essential information about a clear definition of product critical quality attributes (CQAs).

Several commercial orodispersible films were evaluated in terms of thickness, residual water content, disintegration time and mechanical and thermal properties.

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%].

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.