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Monitoring Supersaturation State of Solid Dispersions of Low Solubility Compounds

Monitoring Supersaturation State of Solid Dispersions of Low Solubility Compounds

Poster

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The µDISS Profiler provided concentration-time profiles with high data density without precipitation artifacts caused by liquid sampling.
Monitoring Supersaturation State of Solid Dispersions of Low Solubility Compounds

Poster

Purpose.  To prepare and test hot melt extrudates of loratidine or piroxicam with copovidone polymers to improve the API solubility.  A bench-top Dynisco laboratory mixing extruder (LME) was used for preparation of the materials at various temperatures.  Dissolution behavior and solubility enhancement was tested using a small-volume in situ UV dissolution apparatus (μDISS Profiler) to collect concentration-time profiles in biorelevant media such as FaSSIF and FeSSIF.

Conclusions.  The supersaturation of piroxicam hot melt extrudates was quasi-stable for more than 24 hours at 3.5 times the solubility of the neat API.  Loratidine extrudates also exhibited a potential for supersaturation as well.  The µDISS Profiler provided concentration-time profiles with high data density without precipitation artifacts caused by liquid sampling.

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