Semisolid Pharmaceutical Product Characterization Using Non-invasive X-ray Microscopy and AI-Based Image Analytics.

Area of Science:

• Pharmaceutical Sciences
• Materials Science
• Imaging Technology

Background:

• Semisolid formulations' microstructure, particularly globule size distribution in emulsions, is crucial for product quality.
• Traditional methods like optical microscopy and light diffraction face limitations due to sample preparation bias and matrix interference.
• X-ray microscopy (XRM) imaging is an emerging technique for microstructure characterization in various pharmaceutical dosage forms.

Purpose of the Study:

• To evaluate the feasibility of X-ray microscopy (XRM) imaging for characterizing the microstructure of complex emulsion-based semisolid formulations.
• To assess XRM's capability in obtaining detailed microstructural parameters beyond traditional techniques.
• To explore the potential of XRM combined with AI for advanced formulation analysis.

Main Methods:

• Utilized X-ray microscopy (XRM) imaging to analyze two distinct semisolid formulations: a petrolatum-based ointment and an oil-in-water cream.
• Employed intelligent data processing, including AI-based image analysis, to interpret the XRM data.
• Quantified microstructural attributes such as globule size distribution, volume fraction, and spatial uniformity.

Main Results:

• XRM imaging successfully visualized and parameterized critical microstructure details, including globule size distribution, volume fraction, spatial distribution uniformity, inter-globule spacing, and globule sphericity.
• The technique demonstrated the ability to capture complex microstructural features in both tested semisolid formulations.
• Initial assessment confirmed the potential for rich, quantitative microstructure data generation.

Conclusions:

• X-ray microscopy (XRM) imaging, coupled with AI-driven image processing, is a feasible method for advanced characterization of semisolid formulation microstructures.
• This approach enables detailed 3D visualization and parameterization of globule attributes, offering richer insights than conventional methods.
• The validated technique holds promise for quantitative comparison of microstructure equivalence in semisolid formulations, potentially improving product development and quality control.