The effect that product and process variability has on microparticle is essential for successful development, optimization, and scale-up of an encapsulation process. A MicroEmulsion example from the US FDA is discussed during the presentation.
The main factors that affect the microencapsulation procedure and final microparticles are:
- Matrix material level, composition, and inherent viscosity
- Physiochemical properties of the active ingredient being entrapped
- Matrix/active ingredient ration
- Nature of the solvent employed
- Level and properties of the stabilizer used
- Shearing stress and the temperature of the emulsification
A MicroEmulsion example from the US Food and Drug Administration (FDA) is used during the presentation to show how to:
- Understand the droplet system's response when changing process parameters.
- Optimize the process by choosing conditions which ensure consistent endpoints, batch repeatability and process stability.
- Scale-up the particle distribution while avoiding batch failure or inconsistency process performance and product quality.