... and hopefully everything is nicely homogeneously distributed

In the field of pharmaceutical and medical technology research and development, there are many areas that require the use of surface analytical methods. Examples are residues in ampuls, particles and discolorations of blister packs, residues of cleaning agents in needles, drug distributions on stents and implants and many more. The following example describes analyses on the localization of an active pharmaceutical ingredient (API) in a tablet cross-section.

Tabletten mit Wirkstoff

Distribution of the active pharmaceutical ingredient in tablets

Imaging of the distribution of ingredients

In addition to the pharmaceutically active substances, tablets often also contain a number of excipients. The distribution of the drug and the additives in the tablet is critical to its effectiveness. The analysis of tablet cross-sections is an excellent way to study this distribution.

In the present case, an ibuprofen-containing tablet was embedded in epoxy resin and cut with a microtome. The cross-section was then analyzed for its chemical composition. The results show that in addition to the active ingredient, various other ingredients could be detected. The sugar component 1 forms a matrix for these constituents. The ibuprofen is embedded in agglomerates with sizes between 50 and 100 microns. The second sugar component agglomerates into particles with sizes between 50 and 75 μm. The detected fatty acid conjugates are distributed relatively homogeneously on the cross-sectional area. The fine distribution of Si-containing material indicates the use of an adjuvant to improve the flow properties.







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