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Solubility advantage from amorphous etoricoxib solid dispersions.

Prateek Dani¹, Vibha Puri, A K Bansal

¹Department of Pharmaceutical Technology (Formulations) and.

Drug Development and Industrial Pharmacy

|January 11, 2013

Summary

Polyvinyl pyrrolidone (PVP) enhanced etoricoxib amorphous solid dispersions (ASDs) solubility the most. Understanding polymer interactions with drug solid-state changes is key for effective ASD stabilization and dissolution.

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Area of Science:

Pharmaceutical Sciences
Materials Science

Background:

Amorphous solid dispersions (ASDs) are crucial for enhancing the solubility and bioavailability of poorly soluble drugs.
The selection of appropriate polymers is critical for the stability and performance of ASDs.

Purpose of the Study:

To evaluate the kinetic solubility advantage of etoricoxib amorphous solid dispersions (ASDs) prepared with three different water-soluble polymers: polyvinyl alcohol (PVA), polyvinyl pyrrolidone (PVP), and hydroxyethyl cellulose (HEC).
To correlate the solubility enhancement with the solid-state properties and the ability of these polymers to stabilize supersaturated drug solutions.

Main Methods:

Etoricoxib ASDs were prepared at a 70:30 w/w ratio with PVA, PVP, and HEC.
Characterization included glass transition temperature (Tg), miscibility, and intermolecular interactions.
Kinetic solubility, solid-state stability (enthalpy relaxation), and recrystallization behavior of supersaturated solutions were assessed.

Main Results:

Amorphous etoricoxib showed a limited 1.5-fold solubility advantage due to rapid solid-to-solid transition.
Etoricoxib-PVP ASDs exhibited the highest solubility enhancement (2-fold peak, 1.8-fold plateau).
Etoricoxib-PVA ASDs sustained the initial peak solubility, while etoricoxib-HEC ASDs showed no advantage. The stabilization trend was amorphous etoricoxib < HEC < PVA < PVP.

Conclusions:

The dissolution behavior of ASDs is significantly influenced by concurrent solid-phase transformations.
Independent assessment of drug-polymer interactions and solid-state changes is essential.
Understanding these processes allows for predicting drug crystallization and polymer-mediated stabilization in ASDs.