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A Package of Established Analytical Tools to Investigate the Solid-State Alteration of Lipid-Based Excipients

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The study of different solid forms of Emodepside.

Julia Baronsky¹, Sabine Bongaerts, Michael Traeubel

¹Institute of Pharmaceutics and Biopharmaceutics, Heinrich-Heine-University, Duesseldorf, Germany. julia.baronsky@bayerhealthcare.com

European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V

|July 8, 2008

Summary

This summary is machine-generated.

Emodepside, a veterinary endoparasiticide, exhibits four crystal forms. Forms II-IV are non-stoichiometric hydrates, losing water upon heating but retaining crystal structure, indicating isomorphic dehydrates.

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Area of Science:

Solid-state chemistry
Veterinary pharmacology
Materials science

Background:

Emodepside is a key veterinary endoparasiticide.
Understanding its solid-state properties is crucial for drug formulation.
Polymorphism, including hydration, can significantly impact drug performance.

Purpose of the Study:

To characterize the four known crystal forms of Emodepside.
To investigate the hydration behavior of Emodepside crystal forms II-IV.
To determine if these forms are true hydrates or surface-adsorbed water.

Main Methods:

Differential scanning calorimetry (DSC) and thermogravimetric analysis (TGA).
Evolved gas analysis (FT-IR spectroscopy).
Hot-stage microscopy, FT-Raman, FT-IR, FT-NIR spectroscopy, powder X-ray diffraction, and vapour sorption analysis.

Main Results:

Forms II-IV contain significant amounts of water, easily lost upon heating without structural change.
Spectroscopic and sorption analyses confirmed forms II-IV as non-stoichiometric hydrates forming isomorphic dehydrates.
Water molecules are localized within the structure, with distinct binding environments observed via NIR spectroscopy.

Conclusions:

Emodepside exhibits complex hydration behavior in its solid forms.
The characterized hydrates are non-stoichiometric and form isomorphic dehydrates.
Detailed understanding of Emodepside hydration is essential for its pharmaceutical development.