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Spheronization of solid self-dispersible eutectic extrudates: A small-scale feasibility study.

Peter Schlosser¹, Heike Bunjes¹

¹Technische Universität Braunschweig, Institut für Pharmazeutische Technologie und Biopharmazie, Mendelssohnstraße 1, 38106 Braunschweig, Germany; Technische Universität Braunschweig, Zentrum für Pharmaverfahrenstechnik - PVZ, Franz-Liszt-Straße 35A, 38106 Braunschweig, Germany.

International Journal of Pharmaceutics

|July 15, 2025

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Extrusion/spheronization successfully produced lipid pellets from polyethylene glycol-40-stearate and APIs like ibuprofen. Process temperature adjustments and API concentration influenced pellet quality and API particle size.

Area of Science:

Pharmaceutical Technology
Materials Science

Background:

Twin-screw extrusion is effective for creating self-dispersible eutectics.
Lipid pellets are valuable carriers for poorly soluble active pharmaceutical ingredients (APIs).
Eutectic extrudates present challenges in spheronization due to variable melting ranges.

Purpose of the Study:

To investigate the feasibility of extrusion/spheronization for lipid pellets.
To evaluate the impact of API concentration on extrudate properties and spheronization.
To assess the effect of spheronization on API particle size.

Main Methods:

Small-scale extrusion/spheronization (10 and 20g batches) of polyethylene glycol-40-stearate with fenofibrate or ibuprofen.
Investigated extrudates at, below, and above eutectic concentrations.

Keywords:

Eutectics Polyethylene glycol esters Self-dispersible Spheronization Twin-screw extrusion

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Analyzed mechanical properties and API particle size changes.

Main Results:

Successful spheronization was achieved for extrudates without API, with ibuprofen, and with fenofibrate below eutectic concentration.
Lowering process temperature was necessary as API concentration increased to prevent sticking.
Extrudates with ibuprofen showed better rounding than those with fenofibrate.
API particle size (d50) decreased by 1-3 µm during spheronization.

Conclusions:

Extrusion/spheronization is a viable method for producing lipid pellets with APIs.
API type and concentration significantly influence spheronization parameters and outcomes.
The process can reduce API particle size, potentially enhancing dissolution.