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Hot-stage microscopy for determination of API fragmentation: comparison with other methods

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While the fragmentation of the active pharmaceutical ingredient (API) is acknowledged in various literature sources, there is currently a lack of suitable analytical tools for its investigation. In this study, we employed the hot-stage microscopy method, as introduced in our prior work, to examine the actual fragmentation of tadalafil particles in model tablets prepared under different compaction pressures. The analysis included studying morphology, spectral imaging, and evaluating plastic and elastic energies to complement the hot-stage method. The tadalafil and excipient blend were compacted under various forces ranging from 5 to 35 kN to elucidate the fragmentation trend. The hot-stage microscopic method accurately revealed the fragmentation of tadalafil with increased compaction pressure, aligning well with plastic and elastic energies. In contrast, spectral imaging, utilized for this analysis, was deemed an inaccurate methodology, mainly measuring agglomerates instead of individual particles. The availability of the hot-stage microscopic method provides pharmaceutical scientists with a more reliable in vitro assessment technique to determine API fragmentation in finished tablets and understand particle behavior during compaction.
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