Advanced Chemical and Imaging Methods for Studying Structure Morphology and Excipients Solid State Transformations in...

Area of Science:

• Pharmaceutical Sciences
• Materials Science
• Analytical Chemistry

Background:

• Paediatric medicine formulation presents challenges in safe administration and taste masking.
• Multiparticulate formulations offer dose flexibility and ease of administration for paediatric use.
• Understanding the stability of these formulations under various environmental conditions is crucial for commercialization.

Purpose of the Study:

• To expand the analytical toolkit for studying multiparticulate formulations.
• To investigate the impact of temperature and humidity on the stability of multiparticulate systems.
• To provide novel methods for in-depth characterization of drug formulations.

Main Methods:

• Environmentally-controlled scanning electron microscopy (SEM) for in-situ monitoring of temperature and humidity effects.
• Raman spectroscopies, including stimulated Raman scattering microscopy, for ingredient identification and localization.
• Advanced microscopy techniques beyond traditional SEM and confocal laser scanning microscopy.

Main Results:

• Unprecedented monitoring of structural changes within multiparticulates due to aging.
• Detailed observation of ingredient distribution changes under varying environmental conditions.
• In-situ analysis of temperature- and humidity-induced alterations in particulate structure.

Conclusions:

• Advanced microscopy techniques provide valuable tools for characterizing multiparticulate formulations.
• These methods enable a deeper understanding of chemical changes during development, manufacturing, and storage.
• The findings support the advancement of future paediatric medicine formulations.