NIR Monitoring of a Hot-Melt Extrusion Process - - Spectroscopy
Process analytical technology (PAT) and hot-melt extrusion (HME), commonplace in the food and polymer industries, are becoming increasingly deployed in the pharmaceutical industry. Herein the application of in-line, transmission mode, Fourier-transform near-infrared (FT-NIR) spectroscopy to the HME manufacturing platform for a drug product in development is detailed. NIR spectroscopy and partial least squares (PLS) models were developed for real-time active pharmaceutical ingredient (API) loading (%wt/wt) and surfactant loading predictions. These predictions were used for fault detection, isolation of suspect material, and real-time troubleshooting during HME. Additionally, the NIR/PLS output was used for real-time release of the intermediate drug product. Extrusion is the process of shaping a material (extrudate) by forcing the material through an orifice (die) using pressure. Although extrusion has been used for decades in the plastics and food industries, it is relatively new to the pharmaceutical industry, with most of the activity occurring within the last decade (1–3). Hot-melt extrusion (HME) is the term usually applied to pharmaceutical applications of extrusion in which temperatures above the glass transition of that being extruded are used. HME is used for the preparation of drug formulations when the active pharmaceutical ingredient (API) has low solubility (Biopharmaceutics Classification System II/IV), assisting in the solubilization in vivo. This is achieved via conversion of a poorly soluble crystalline API to a more soluble amorphous form. The result is a solid dispersion of the amorphous drug substance stabilized within a polymer matrix. This increase in in-vivo solubility yields the potential for enhanced bioavailability in that the API dissolves more rapidly and maintains concentration, allowing greater adsorption potential compared with the parent crystalline form (2).
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