X-ray Microscopy

X-ray microscopy, in the family of X-ray micro-CT techniques, adds local tomography capabilities to zoom into a small area within a larger sample.

Microstructure CQAs
Tablet
X-ray Microscopy

X-ray microscopy analysis for drug product development

Historically within the pharmaceutical and biotech industries,  micro-CT technologies have mostly been applied for small-animal imaging. As the leader in digital transformation for drug products, we have expanded its application usage significantly, studying nearly all drug product dosage forms. The applications of X-ray microscopy analysis for drug development are endless, the only limitation being the ease of studying liquid solutions and suspensions. Dosage forms we frequently study include tablets, capsules, powders, implants, topicals, and microspheres. The local tomography enabled with XRM is ideal for studying formulations within their original containers, such as lyophilized cakes within glass vials or a lotion inside an aluminum tube. Uniquely, XRM enables true non-destructive and non-invasive inspection of microstructures within the final drug product. Example attributes include drug particle size, porosity, ingredient distribution, defects, coating thickness, and surface area. With these data, we often support the construction of data packages for ANDA and NDA filings.

Upon digital reconstruction of drug product microstructures with 3D XRM, ingredient particles and porosity networks can be used for image-based simulation of mass transport phenomena. In silico assessment for dissolution, disintegration, sublimation resistance, and reconstitution can be performed directly from analyzed 3D XRM datasets.

A 3D render of a lyophilized cake, the walls of the lyo-cake are colored white, while the air void spaces inside have been colored blue to show they are formed from ice.
X-ray Microscopy

What is X-ray Microscopy?

X-ray microscopy (XRM) is a non-destructive technique which employs an X-ray source and computed tomography to collect a 3D scan of an object. Similar to a CT CAT scan, the sample sits on top of a stage which rotates after each image is collected, and these hundreds of images are then reconstructed into a 3D volume of the sample. X-ray micro-CT technologies are highly adaptable in field of view, enabling inspection of both macroscopic and microscopic features. For XRM, the contrast of material domains depends on relative X-ray attenuation, with contributions from their true density and elemental composition. XRM scan resolutions can range from 10s of nanometers to 100s of microns. We often complement our XRM studies with FIB-SEM and mosaic-SEM analysis for a more detailed investigation of structures.  

Part of the family of X-ray micro-CT technologies, XRM adds the capability of local tomography, where a specific region of a sample can be targeted at the highest resolutions, without having to cut the sample down, bring it closer to the X-ray source, or take the sample out of its original container.

A diagram revealing the simplified components of a X-ray microscopy microscope, using similar techniques to micro-CT but with the inclusion of a scintillator.
X-ray Microscopy

End-to-end X-ray microscopy analysis services

Any XRM experiment requires careful consideration around the feature sizes of interest,  the resolutions needed to resolve features, the expected contrast between material domains, and the field of view ideal to study. Through decades of experience, we’ve mastered routine collection of micro-CT datasets, ensuring high data quality and accurate inspection for the features of interest.  Our X-ray microscopy services include the whole suite of analysis, from dataset collection to image processing, structure analytics, and image-based modeling.

An XRM, x-ray microscopy, image of a lyo-cake, the lyophilized cake image reveals pores and thin walls which can be measured and quantified.
X-ray Microscopy

X-ray Microscopy

Formulations

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