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We perform non-destructive three-dimensional analysis of pharmaceutical products using X-ray submicron computed tomography (Submicron CT). The method provides exceptionally high spatial resolution and contrast, enables imaging of structures smaller than one micrometer, and requires minimal or no sample preparation.
Method
Submicron CT enables detailed evaluation of the microstructure of solid dosage forms, which significantly influences disintegration, dissolution rate, bioequivalence, and therapeutic equivalence. Non-destructive 3D visualization of the internal structure provides valuable information for manufacturing optimization, formulation development, and quality control investigations.
The method is also suitable for the development of new pharmaceutical products, allowing rapid identification of discrepancies between expected and actual sample properties and accelerating the development process.
Typical applications include:
- Product morphological and structural analysis
- Coating thickness analysis
- Porosity and pore network analysis
- Crystallinity and crystalline phase analysis
- Aggregate detection
- Active pharmaceutical ingredient (API) distribution analysis
- Dissolution process evaluation
- Detection of manufacturing defects, such as cracks or coating thickness variations
Equipment
The analyses are performed using the Rigaku nano3DX X-ray microscope, a state-of-the-art laboratory solution for submicron computed tomography. The system employs a high-powered rotating anode X-ray source, a high-resolution sCMOS detector, and adaptive X-ray spectra with selectable anode materials (Cr, Cu, Mo, and W). With a voxel size of up to 325 nm, quasi-parallel beam geometry, and interchangeable optical lenses, it enables rapid data acquisition and imaging at exceptionally high resolution.
