Key acceptability attributes of orodispersible films

Area of Science:

• Pharmaceutical Sciences
• Materials Science
• Biomedical Engineering

Background:

• Orodispersible films (ODFs) are patient-centric oral formulations gaining attention.
• Limited research exists on ODF characteristics impacting end-user acceptability.
• Predicting ODF acceptability requires understanding formulation-user interactions.

Purpose of the Study:

• To identify key ODF characteristics influencing end-user acceptability.
• To develop in vitro methods for predicting ODF acceptability.
• To correlate in vitro ODF properties with human panel data.

Main Methods:

• Four drug-free ODFs were prepared using poly(vinyl) alcohol (PVOH) and carboxymethylcellulose (CMC) of varying molecular weights.
• Film tack was assessed using Texture Analysis and Dynamic Mechanical Analysis (DMA).
• Disintegration time was measured using petri dish and drop methods.
• A human panel evaluated ODF acceptability, focusing on perceived stickiness and disintegration.

Main Results:

• DMA-derived adhesive force curve area correlated with perceived in vivo stickiness.
• Texture analysis for tack did not align with human perception.
• The drop method for disintegration time was more comparable to human panel data than the petri dish method.
• Participant Reported Outcomes (PROs) for stickiness and disintegration significantly differed between ODF samples.

Conclusions:

• DMA and the drop method are promising for predicting ODF end-user acceptability.
• Polymer type and molecular weight significantly influence perceived stickiness.
• Polymer molecular weight impacts perceived disintegration time.
• ODF stickiness and disintegration time are critical attributes for early-stage drug product design.