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Changes in Physical Stability of Supercooled Etoricoxib after Compression
Marzena Rams-Baron1,2, Justyna Pacułt1,2, Agnieszka Jędrzejowska1,2
1Institute of Physics , University of Silesia , 75 Pulku Piechoty 1A , 41-500 Chorzow , Poland.
Molecular Pharmaceutics
|July 28, 2018
Summary
Supercooled etoricoxib (ETB) rapidly crystallizes under pressure. However, forming an amorphous solid dispersion with polyvinylpyrrolidone (PVP) effectively inhibits this pressure-induced recrystallization, offering a stable formulation strategy.
Area of Science:
- Pharmaceutical Sciences
- Materials Science
- Physical Chemistry
Background:
- Amorphous active pharmaceutical ingredients (APIs) pose a risk of pressure-induced recrystallization.
- Supercooled etoricoxib (ETB) exhibits low crystallization tendency at atmospheric pressure but crystallizes rapidly upon compression.
Purpose of the Study:
- To investigate the pressure-induced crystallization kinetics of supercooled etoricoxib (ETB).
- To explore methods for inhibiting pressure-induced recrystallization in ETB formulations.
- To analyze the molecular dynamics of ETB and its solid dispersion under elevated pressure.
Main Methods:
- Broadband dielectric spectroscopy was employed to study crystallization kinetics under varying temperature (T) and pressure (p) conditions.
- Analysis of molecular dynamics at elevated pressures was performed.
Main Results:
- Compression significantly accelerates the nucleation of supercooled ETB.
- Pressure-induced recrystallization of ETB was efficiently inhibited by creating an amorphous solid dispersion with polyvinylpyrrolidone (PVP) at 10% w/w.
- Comprehensive analysis revealed insights into the pressure sensitivity of supercooled dynamics in ETB and its solid dispersion.
Conclusions:
- Pressure-induced recrystallization of amorphous ETB is a significant technological challenge.
- Amorphous solid dispersions with PVP offer an effective strategy to stabilize ETB against pressure-induced crystallization.
- Understanding the pressure-dependent molecular dynamics is crucial for developing stable amorphous pharmaceutical formulations.
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