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Hot Melt Extrusion as a Continuous Pharmaceutical Manufacturing Process

2013; Springer Nature; Linguagem: Inglês

10.1007/978-1-4614-8432-5_15

2210-738X

Daniel Franz Treffer, Patrick Wahl, Daniel Markl, Gerold Koscher, Eva Roblegg, Johannes Khinast,

Analytical Chemistry and Chromatography

The implementation of continuous manufacturing in the pharmaceutical industry has been of increasing interest over the last years. This chapter focuses on continuous hot melt extrusion (HME) processing as well as on the continuous downstream options that are available. Furthermore, process analytical technology (PAT) tools and the integration of such tools in process control environment are presented. In general, real-time pharmaceutical process verification is accomplished by monitoring univariate (temperature, pressure, etc.) and multivariate (spectra, images, etc.) process parameters and quality attributes, to provide an accurate state estimation of the process, required for advanced control strategies. This chapter describes the development and use of such tools for a continuous HME process, monitored with generic sensors and a near-infrared (NIR) spectrometer in real time, using SIPAT (Siemens platform to collect, display and extract process information) and additional components developed as needed.