Static and in-situ synchrotron X-ray microtomography analysis of pharmaceutical tablets

Area of Science:

• Pharmaceutical sciences
• Materials science
• Imaging technology

Background:

• Pharmaceutical solid dosage forms require precise control over drug release for efficacy and safety.
• Quality control is crucial to detect manufacturing defects like cracks or porosity that compromise performance.
• Conventional X-ray computed microtomography (µCT) may lack the resolution and speed for dynamic analysis.

Purpose of the Study:

• To highlight the capabilities of synchrotron radiation-based µCT (SR-µCT) for pharmaceutical solid dosage form analysis.
• To demonstrate high-throughput structural analysis and time-resolved dissolution monitoring using SR-µCT.
• To present a novel flow-through chamber for dynamic disintegration studies.

Main Methods:

• Utilized SR-µCT for high-resolution structural analysis of a pantoprazole tablet, assessing porosity and coating thickness.
• Employed a new flow-through chamber for dynamic disintegration studies under sink conditions.
• Performed fast dynamic time-resolved SR-µCT to analyze disintegration speeds and swelling in sustained-release formulations.

Main Results:

• SR-µCT enabled detailed structural analysis, including defect detection, at various resolutions.
• Dynamic SR-µCT revealed disintegration speeds of compacted tablets (5 µs tomogram recording) and swelling in sustained-release formulations.
• Quantified active pharmaceutical ingredient (API) size and shape distribution during dissolution.

Conclusions:

• SR-µCT significantly enhances the non-destructive analysis of pharmaceutical solid dosage forms.
• The technique provides unprecedented insights into dynamic processes like dissolution and disintegration.
• SR-µCT is a powerful tool for quality control and formulation development in the pharmaceutical industry.