THz-TDS transflection measurements as a process analyser for tablet mass
Moritz Anuschek1, Thomas Kvistgaard Vilhelmsen2, J Axel Zeitler3
1Department of Pharmacy, University of Copenhagen, Copenhagen, Denmark; Novo Nordisk A/S, ET Oral Product Development, Måløv, Denmark.
International Journal of Pharmaceutics
|September 26, 2024
Summary
Terahertz time-domain spectroscopy (THz-TDS) offers a novel, rapid method for measuring tablet mass, crucial for drug product quality. This technique enables real-time monitoring of tablet weight and height during manufacturing.
Area of Science:
- Pharmaceutical Technology
- Analytical Chemistry
- Spectroscopy
Background:
- Tablet content uniformity is critical for drug efficacy and market release.
- Current methods for controlling tablet mass lack robustness, sensitivity, and speed.
- Process analytical technology (PAT) is essential for real-time pharmaceutical manufacturing control.
Purpose of the Study:
- To investigate terahertz time-domain spectroscopy (THz-TDS) as a process analytical tool for tablet mass measurement.
- To assess the feasibility of using THz-TDS for in-line monitoring of tablet physical attributes.
- To explore the potential of THz-TDS for simultaneous measurement of tablet mass and height.
Main Methods:
- Utilized terahertz time-domain spectroscopy (THz-TDS) in a reflection setup to analyze tablets.
- Measured the time delay of frontside reflection and backside transflection signals.
- Correlated the time delay of the backside transflection with tablet mass.
Main Results:
- An increase in tablet mass directly correlated with an increased time delay of the backside transflection signal.
- Achieved root mean squared errors of approximately 1 mg for tablet mass determination.
- Demonstrated the potential for high acquisition rates (50 Hz) for rapid analysis.
- Showcased simultaneous measurement of tablet height using frontside reflection.
Conclusions:
- THz-TDS is a viable and sensitive method for indirect tablet mass measurement.
- The technique enables in-line monitoring of tablet mass and height, supporting content uniformity strategies.
- This methodology facilitates real-time control of the tablet compression process based on physical attributes.
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