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Pharmaceutical Deformulation

The Analytical Tools Needed for Deformulation of Pharmaceutical

Imaging plays an integral role in the deformulation of any product. Separation and quantification of individual ingredients often require a suite of analytical instrumentation. The Phenom ProX desktop SEM with EDS is the ideal tool for accurately measuring pharmaceutical particle morphology, sizes and distribution and determining the elemental composition of active pharmaceutical ingredients (API) and excipients.

Energy dispersive X-ray spectroscopy can be used to quantitatively determine the elemental composition of materials with extremely high spatial resolution. While EDS does not provide direct chemical information about the bonding of the identified elements, careful inspection of the image can often be employed in conjunction with the elemental information to determine the excipient utilized. Back-scatter electron imaging can be employed to quickly and quantitatively determine the area coverage of the excipient particles. Coverage likely corresponds to the ratio of excipient to API used during the formulation of the tablet prior to compounding.

Quantifying the Chemical Composition of Surfaces and Coatings Pharmaceutical Tablets

Coatings are applied to pharmaceutical tablets to optimize an array of different features including, swallowability, product stability and the controlled release properties of the active pharmaceutical ingredient (API). Both surface finish and coating thickness are important features that must be characterized during both product research and development and tablet manufacturing. Further, energy dispersive X-ray spectroscopy can be employed to quantify the chemical composition of the coating with very high spatial resolution.

Quantitative assessment of surface roughness can be measured using the Zeta-20 3D optical profilometer. Conventional high-pass filtering techniques can be used to remove the curvature of the tablet itself without affecting the micro/nanoscale roughness of the surface. In addition to the quantitative determination of coating roughness. It is also important for pharmaceutical companies to understand both the thickness and chemical composition of tablet coatings.

The Phenom Desktop SEM is unique in its capacity to evaluate pharmaceutical tablet coatings:

  • Back-scatter electron detection allows for the unambiguous determination of elementally different materials without the need for EDS.
  • The high-brightness Cerium Hexaboride source produces unparalleled image quality while maintaining an extremely long lifetime.
  • The integrated EDS detector with mapping enables quick determination of elemental composition.
  • Integration with Quartz PCI/CFR enables imaging in compliance with FDA 21 CFR Part 11.
Generic EDS of a bulk tablet.
Elemental analysis of a generic pharmaceutical drug.

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