CHAPTER 6: In-line Extrusion Process and Product Evaluation of ProNeura® by Near-infrared Spectroscopy

The use of an extrusion process to create a matrix of active pharmaceutical ingredients (APIs) and inert polymers into subdermal, implantable rods for controlled, sustained release presents a number of analytical and quality driven challenges to ensure product consistency. The API loading within the implant is of critical importance to the product performance and safety. Current off-line analytical methods for payload evaluation offer high degrees of accuracy; however, these methods are tedious, destructive, and can only evaluate select samples. Within this chapter, the use of near-infrared spectroscopy applied in-line during extrusion of a select polymer and API matrix, ProNeura, will be discussed. This method has been shown to successfully determine process condition consistency and API loadings throughout the duration of an extrusion run and, therefore, is an effective in-line tool for quality control.