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Pharm Res. 2017 Feb;34(2):321-332. doi: 10.1007/s11095-016-2064-4. Epub 2016 Nov 14.

Multifractal Characterization of Pharmaceutical Hot-Melt Extrudates.

Author information

1
Institute of Pharmaceutical Technology, University of Applied Sciences and Arts Northwestern Switzerland, GrĂ¼ndenstrasse 40, 4132, Muttenz, Switzerland.
2
Institute of Pharmaceutical Technology, University of Basel, Klingelbergstrasse 50, 4056, Basel, Switzerland.
3
DSM Nutritional Products Ltd., R&D Center Formulation & Application, P.O. Box 2676, 4002, Basel, Switzerland.
4
Institute of Pharmaceutical Technology, University of Applied Sciences and Arts Northwestern Switzerland, GrĂ¼ndenstrasse 40, 4132, Muttenz, Switzerland. martin.kuentz@fhnw.ch.

Abstract

PURPOSE:

Multifractal geometry has become a powerful tool to describe complex structures in many fields. Our first aim was to combine imaging and multifractal analysis to better understand the microstructure of pharmaceutical extrudates. A second objective was to study erosion/dispersion behavior of the formulations because it would condition release of any drug.

METHODS:

Different formulations containing a lipid, a polymer and different silica based inorganic carriers were produced by hot-melt extrusion at various screw speeds. Multifractal analysis was based on scanning electron microscopy/energy dispersive X-Ray spectroscopy images. This microstructural analysis was complemented with dynamic optical imaging of formulation erosion/dispersion behavior.

RESULTS:

Multifractal analysis indicated that inorganic carrier type and concentration as well as the screw speed affected the microstructure of the extrudates. The aqueous erosion/dispersion study showed that only the type and concentration of inorganic carrier were important.

CONCLUSIONS:

The use of microstructural and dispersion analysis appeared to be complementary to better characterize and understand complex formulations obtained by hot-melt extrusion.

KEYWORDS:

dispersion; hot-melt extrusion; inorganic carrier; multifractal; scanning electron microscopy

PMID:
27844187
DOI:
10.1007/s11095-016-2064-4
[Indexed for MEDLINE]

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