DOI: https://doi.org/10.2478/acph-2026-0018
Article ID: 260018 (11 pages)
Acta Pharm. 76(2) (2026)
Short communication
SEM/EDS analysis as a complementary tool for continuous improvement of cefixime granules for oral suspension
IVANA MITREVSKA, DINO KARPICAROV, ANA MIHAILOVSKA, DEJAN MIRAKOVSKI, OLIVERA PANEVA, GJORGJI PETRUSHEVSKI
Abstract
The aim of this study was to evaluate scanning electron microscopy (SEM) combined with ener-gy-dispersive X-ray spectroscopy (EDS) as complementary analytical tools for supporting continuous improvement in pharmaceutical granule manufacturing. Pilot-scale cefixime granules for oral suspension were prepared as defined process scenarios, including placebo, reference, intermediate, stress-exposed, and optimized batches. SEM was used to compare granule morphology, surface integrity, and agglomeration behavior, while EDS provided qualitative and semi-quantitative information on localized elemental composition, with emphasis on sulfur as an API-related marker and oxygen-to-sulfur trends as surface-sensitive indicators of process- or stress-related variability. Inter-mediate and stress-exposed batches showed increased surface roughness, microstructural deterioration, and higher oxygen-to-sulfur ratios, whereas reference and optimized batches showed more uniform morphology and comparable elemental profiles. The findings indicate that SEM/EDS can provide useful material-level insight into process-related variability and may support root-cause in-vestigation and process refinement. Overall, SEM/EDS is proposed as a complementary, localized, and semi-quantitative approach for supporting continuous improvement in pharmaceutical granule manufacturing.
Keywords
continuous improvement, SEM/EDS analysis, cefixime granules, pharmaceutical manufacturing, process variability
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