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Published on: June 15, 2016
Development of starch-based pellets via extrusion/spheronisation
Aleksandra Dukić1, Raoul Mens, Peter Adriaensens
1Laboratory of Pharmaceutical Technology, Ghent University, Ghent, Belgium.
Summary
Modified starch shows promise as a pharmaceutical excipient for extrusion/spheronisation pellet production. This resistant starch offers good pellet quality, yield, and drug release, serving as a viable alternative to microcrystalline cellulose.
Area of Science:
- Pharmaceutical Technology
- Materials Science
- Polymer Chemistry
Background:
- Microcrystalline cellulose is a common excipient for pellet formulations.
- Developing alternative excipients is crucial for pharmaceutical innovation and supply chain resilience.
- Modified starches offer unique properties for drug delivery systems.
Purpose of the Study:
- To evaluate a modified starch (high-amylose, crystalline, resistant starch) as an alternative excipient to microcrystalline cellulose.
- To optimize the extrusion/spheronisation process for pellets containing the modified starch and theophylline anhydrous.
- To assess the impact of formulation and process variables on pellet characteristics and drug release.
Main Methods:
- Extrusion/spheronisation technique was employed to prepare pellets.
- A surface response design was used to optimize formulation (binder, sorbitol, water) and process (spheronisation speed) variables.
- Pellet quality was assessed by measuring yield, sphericity (aspect ratio, shape factor), size (mean Feret diameter), friability, and disintegration time.
- Mixer torque rheometry and solid-state Nuclear Magnetic Resonance (NMR) were used to analyze material properties.
Main Results:
- A binder was necessary for acceptable pellet yield.
- Sorbitol addition improved pellet surface properties and significantly influenced wet mass consistency.
- Optimized formulations achieved high pellet yield (>90%), acceptable sphericity (AR<1.2), low friability (<0.01%), and fast disintegration (<10 min).
- Complete theophylline release was observed in under 20 minutes for all tested formulations.
Conclusions:
- The modified starch is a suitable alternative excipient for extrusion/spheronisation pellet formulations.
- The study successfully optimized the process, demonstrating the potential of modified starch in pharmaceutical pellet production.
- This resistant starch facilitates efficient drug release and meets key quality attributes for oral dosage forms.
