Building quality into a coating process

Abstract

An effective approach towards optimal development strategy is to use the quality by design principle. However, this approach can first be implemented when possible risks impacting critical quality attributes are defined and interactions between those are fully understood. The objective of this study was to identify critical variables that affect the final modified release product performance using a risk management approach with supporting statistical tool. After risk ranking and filtering a full mixed factorial experimental design of coating experiments was performed. Experimental design clearly indicated that studied critical processes parameters have a great impact on coat integrity and hence on drug release.

Keywords::

• Quality by design
• design of experiments
• coating
• critical process variables
• risk analysis
• coat integrity
• critical quality attributes

Acknowledgments

The authors wish to acknowledge Particle Analytical for helping with the porosity measurements and Colorcon Ltd. (Dartford, Kent, UK) for supplying the Surelease^® E-7-19010/ E-7-19040 coating dispersion.

Declaration of interest: The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.