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Process analytical technology (PAT): quantification approaches in terahertz spectroscopy for pharmaceutical

Huiquan Wu1, Edwin J Heilweil, Ajaz S Hussain

  • 1Division of Product Quality Research (DPQR, HFD-940), Office of Testing and Research, Office of Pharmaceutical Science, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993-0002, USA. huiquan.wu@fda.hhs.gov

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Terahertz (THz) spectroscopy combined with chemometrics accurately quantifies active pharmaceutical ingredients and excipients in tablets. This method offers a viable approach for process analytical technology (PAT) applications in pharmaceutical manufacturing.

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Area of Science:

  • Analytical Chemistry
  • Pharmaceutical Sciences
  • Spectroscopy

Background:

  • Quantitative determination of active pharmaceutical ingredients (APIs) and excipients in solid dosage forms is crucial for quality control.
  • Traditional methods may be time-consuming or destructive, necessitating the development of rapid, non-invasive techniques.
  • Terahertz (THz) spectroscopy offers unique capabilities for analyzing materials based on their vibrational modes in the 30-500 cm(-1) range.

Purpose of the Study:

  • To quantitatively determine API and excipient concentrations in pharmaceutical tablets using Terahertz (THz) spectroscopy.
  • To evaluate the influence of formulation composition and tablet hardness on spectral analysis.
  • To demonstrate the utility of chemometric methods for analyzing THz spectra and their application in Process Analytical Technology (PAT).

Main Methods:

  • Tablets containing theophylline (API) and various excipients (lactose, magnesium stearate, starch, Avicel) were prepared with varying concentrations and hardness.
  • Transmission THz spectra (30-500 cm(-1)) of polyethylene pellets derived from these tablets were acquired.
  • Analysis employed spectral superposition, spectral characteristic peak methods, and multivariate analysis (Principal Component Regression - PCR, Partial Least Squares 1 - PLS1).

Main Results:

  • Multivariate analysis (PCR and PLS1) effectively correlated THz spectra with tablet concentrations.
  • Predicted concentrations from multivariate models showed good agreement with nominal concentrations for independent samples.
  • The spectral characteristic peak method allowed for correction based on tablet hardness, while spectral superposition assessed component interactions.

Conclusions:

  • Terahertz spectroscopy, coupled with multivariate chemometric analysis, provides accurate quantification of pharmaceutical tablet components.
  • This integrated approach is feasible for real-time monitoring and demonstrates significant advantages for Process Analytical Technology (PAT).
  • The study validates the potential of THz spectroscopy and chemometrics for quality control in pharmaceutical manufacturing.