(203m) Continuous Manufacturing of Oral Disintegrating Films: A Quality By Design Approach
- Conference: AIChE Annual Meeting
- Year: 2017
- Proceeding: 2017 AIChE Annual Meeting
- Group: Pharmaceutical Discovery, Development and Manufacturing Forum
Monday, October 30, 2017 - 3:15pm-4:45pm
The ODFs of ondansetron were prepared in-house using the solvent casting method in a continuous tape caster. These films were characterized in-line, at-line or off-line for drug assay, content uniformity, disintegration, dissolution, morphology, surface roughness, wettability, thickness, % moisture uptake, % moisture content, mechanical properties.
Principles of QbD along with appropriate design of experiments (DoE) were used to obtain a comprehensive understanding about the effect of critical material attributes (CMAâs) such as % w/w of plasticizer, surfactant and critical process parameters (CPPâs) such as mixing speed, coat thickness, air flowrate and drying temperature on the quality and performance of ondansetron ODF. Suitable Design of Experiments (DoE) was used to screen and optimize critical parameters that impact the product quality of ODFs.Â Data analysis using ANOVA and multifactor analysis was performed in elucidating interactions between different variables, rank order the various CMAâs and CPPâs, and help provide a predictive model for the process. A design space was established and verified by performing a failure mode analysis.