Process monitoring and visualization solutions for hot-melt extrusion : a review

Objectives: Hot-melt extrusion (HME) is applied as a continuous pharmaceutical manufacturing process for the production of a variety of dosage forms and formulations. To ensure the continuity of this process, the quality of the extrudates must be assessed continuously during manufacturing. The objective of this review is to provide an overview and evaluation of the available process analytical techniques which can be applied in hot-melt extrusion. Key Findings: Pharmaceutical extruders are equipped with traditional (univariate) process monitoring tools, observing barrel and die temperatures, throughput, screw speed, torque, drive amperage, melt pressure and melt temperature. The relevance of several spectroscopic process analytical techniques for monitoring and control of pharmaceutical HME has been explored recently. Nevertheless, many other sensors visualizing HME and measuring diverse critical product and process parameters with potential use in pharmaceutical extrusion are available, and were thoroughly studied in polymer extrusion. The implementation of process analytical tools in HME serves two purposes: (1) improving process understanding by monitoring and visualizing the material behaviour and (2) monitoring and analysing critical product and process parameters for process control, allowing to maintain a desired process state and guaranteeing the quality of the end product. Summary: This review is the first to provide an evaluation of the process analytical tools applied for pharmaceutical HME monitoring and control, and discusses techniques that have been used in polymer extrusion having potential for monitoring and control of pharmaceutical HME

Hot-melt co-extrusion for the production of fixed-dose combination products with a controlled release ethylcellulose matrix core

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Near infrared and Raman spectroscopy for the in-process monitoring of pharmaceutical production processes

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A Probabilistic Risk Analysis for Taipei Seismic Hazards: An Application of HAZ-Taiwan with its Pre-processor and Post-processor

This paper employs probabilistic risk analysis to estimate exceedance probability curves, average annual loss (AAL) and probable maximum loss (PML) for seismic hazards. It utilizes and event-driven loss estimation model, HAZ-Taiwan, and develops its pre-processing and post-processing software modules. First, the pre-processingmodule establishes a set of hazard-consistent scenarios. Then, the HAZ-Taiwan modelextimates hazards, vulnerabilities and economic losses for each scenario. Finally, the aggregate and occurrence exceedance probability curves for losses and theirconfidence intervals are simulated using the Monte Carlo simulation in thepost-processing module. The methodology is then applied to analyze seismic risks in Taipei. It is found that the exceedance probability of an aggregate loss of NT$40.398 billion is 0.001. This amount of loss is approximately 2.78$37.41-43.12 billion. The average annual loss of buildings in Taipei is NT$1.06 billion r approximately 0.07% of the total stock.probabilistic risk analysis, Hazard analysis, vulnerability analysis, exceedance probability curve, HAZ-Taiwan

Ariel - Volume 12 Number 1

Executive Editors David G. Polin Larry H. Pastor Business Manager Alex Macones Jean Lien Editorial Page Editor Sam Markind Photography Editors Ken Yonemura Lois Leach Sports Editor Todd Hoove