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

Abstract

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.

Keywords:

• Critical quality attributes
• critical process parameters
• orodispersible films
• quality by design

Disclosure statement

The authors report no declarations of interest.

Funding

Funded by FCT grant, reference SFRH/BDE/51271/2010 and by QREN SI-I&DT Empresa Individual Project No.18472.