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Quantitative X-Ray Microcomputed Tomography Assessment of Internal Tablet Defects.

Edward Yost1, Pascal Chalus2, Shawn Zhang3

  • 1Small Molecule Pharmaceutics, Genentech, Inc., One DNA Way, South San Francisco, California 94080.

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X-ray microcomputed tomography (XμCT) offers a novel method for assessing internal tablet defects, overcoming limitations of traditional testing. This technique quantitatively analyzes tablet fractures, enhancing drug product development and manufacturing scale-up.

Keywords:
artificial intelligencecompactiondevelopabilitymechanical propertiesphysical characterizationquality by design (QBD)tableting

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Engineering

Background:

  • Traditional tablet testing methods (e.g., hardness, friability) fail to detect internal structural defects.
  • Existing methods lack objective, quantitative analysis of formulation and process variables crucial for Quality by Design (QbD).

Purpose of the Study:

  • To develop and validate an X-ray microcomputed tomography (XμCT) method for analyzing internal tablet defects.
  • To quantitatively assess the impact of formulation and process parameters on tablet integrity using QbD principles.

Main Methods:

  • Utilized X-ray microcomputed tomography (XμCT) on tablets from a design-of-experiment (DoE) study.
  • Investigated effects of roller compaction force, filler composition, and magnesium stearate levels.
  • Employed optical image processing for void volume and AI-based analysis for fracture characteristics.

Main Results:

  • XμCT successfully identified and quantified internal tablet defects not detectable by conventional methods.
  • The study established quantitative relationships between process variables and internal tablet fracture severity.
  • Enhanced formulation and process understanding was achieved, supporting manufacturing scale-up.

Conclusions:

  • XμCT provides a powerful, quantitative tool for assessing internal tablet defects within a QbD framework.
  • Integrating XμCT with AI analysis advances tableting knowledge from empirical to mechanistic understanding.
  • This approach enables better risk assessment and control of drug product quality.