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Examples of NIR based real time release in tablet manufacturing.

E T S Skibsted¹, J A Westerhuis, A K Smilde

¹Biosystems Data Analysis, Swammerdam Institute for Life Sciences, University of Amsterdam, Nieuwe Achtergracht 166, 1018 WV Amsterdam, The Netherlands.

Journal of Pharmaceutical and Biomedical Analysis

|December 15, 2006

Summary

Real-time release (RTR) testing ensures pharmaceutical products meet quality standards immediately after manufacturing. This study explores practical RTR applications using near-infrared and process data from tablet production.

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Area of Science:

Pharmaceutical Manufacturing
Process Analytical Technology (PAT)

Background:

Real-time release (RTR) represents a significant shift in pharmaceutical manufacturing, ensuring product quality is met upon completion of the final step.
Traditional batch release testing is time-consuming and costly, necessitating advanced approaches for efficient quality assurance.

Purpose of the Study:

To present practical examples of implementing real-time release (RTR) systems within a pharmaceutical manufacturing context.
To demonstrate the application of near-infrared (NIR) spectroscopy and process data for RTR in tablet manufacturing.

Main Methods:

Utilized near-infrared (NIR) spectroscopy for in-line data acquisition during tablet manufacturing.
Employed process data analytics to monitor and evaluate critical quality attributes.
Assessed the monitoring, control, and RTR capabilities of the developed system.

Main Results:

Successfully demonstrated the feasibility of RTR using NIR and process data in a tablet manufacturing setting.
Validated the effectiveness of the RTR framework in assuring final product release criteria are met in real-time.
Highlighted the importance of rigorous testing for monitoring, control, and RTR capabilities.

Conclusions:

Real-time release (RTR) systems, integrating PAT tools like NIR, offer a viable paradigm for modern pharmaceutical manufacturing.
The presented practical examples underscore the potential of RTR to enhance efficiency and ensure product quality.
Further development and validation of RTR systems are crucial for widespread adoption in the pharmaceutical industry.