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Solid-state characterization of Felodipine-Soluplus amorphous solid dispersions.

Jiannan Lu¹, Kristina Cuellar², Nathan I Hammer²

¹a Department of Pharmaceutics and Drug Delivery , School of Pharmacy, the University of Mississippi, University , MS , USA .

Drug Development and Industrial Pharmacy

|November 5, 2015

Summary

This summary is machine-generated.

Hot-melt extrusion created amorphous solid dispersions (SDs) of felodipine (FEL) using Soluplus® (SOL). This significantly improved FEL solubility and achieved a homogeneous dispersion at 10% drug loading.

Keywords:

Amorphous solid dispersion felodipine hot-melt extrusion miscibility/solubility solid-state characterization

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Area of Science:

Pharmaceutical Technology
Materials Science

Background:

Improving the solubility of poorly water-soluble drugs like felodipine (FEL) is crucial for enhancing bioavailability.
Amorphous solid dispersions (SDs) are a promising strategy to overcome solubility challenges.

Purpose of the Study:

To develop amorphous solid dispersions (SDs) of felodipine (FEL) using hot-melt extrusion (HME) technology.
To enhance the solubility and achieve molecular dispersion of FEL within an amphiphilic polymer matrix.

Main Methods:

Hot-melt extrusion (HME) was employed to prepare amorphous solid dispersions (SDs) of FEL with Soluplus® (SOL).
Solubility parameters were calculated to assess miscibility between FEL and SOL.
Techniques including Fourier Transform Infrared Spectrometry, Raman spectroscopy, and Scanning Electron Microscopy were used for characterization.

Main Results:

Amorphous SDs prepared via HME significantly increased FEL solubility.
FEL was found to be miscible with SOL, with a solubility range of 6.2-9.9% (w/w).
Molecular dispersion of FEL was achieved in the polymer matrix at 10% drug loading, with minimal crystallization observed at higher loadings.

Conclusions:

Hot-melt extrusion is an effective method for creating amorphous solid dispersions of felodipine.
The developed SDs demonstrate enhanced solubility and homogeneity, particularly at 10% drug loading.
This approach offers a viable strategy for improving the delivery of poorly soluble drugs.