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Twin-Screw Extrusion Process to Produce Renewable Fiberboards

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Pellet layering: scale-up considerations using different kinds of processing equipment.

Lisa Suhrenbrock¹, Guido Radtke, Klaus Knop

¹Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.

Drug Development and Industrial Pharmacy

|March 29, 2012

Summary

The CPS rotor processor offers the fastest and most efficient method for producing hydrochlorothiazide (HCT) layered pellets, outperforming traditional fluid-bed and drum coaters in both small and pilot scales.

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Area of Science:

Pharmaceutical Technology
Process Engineering
Drug Delivery Systems

Background:

Poorly water-soluble drugs like hydrochlorothiazide (HCT) require advanced formulation techniques for optimal delivery.
Pelletization is a common method for controlled drug release, but efficiency and scalability vary with equipment.
Optimizing the layering process is crucial for achieving desired drug content and minimizing process time.

Purpose of the Study:

To compare the process efficiency, duration, and scalability of different equipment for layering HCT onto spherical cores.
To evaluate Wurster fluid-bed, CPS rotor fluid-bed, and drum coater technologies for HCT pellet production.
To determine the optimal processing conditions for high yield and layering efficiency.

Main Methods:

Aqueous suspension of HCT (30% drug content) was layered onto spherical starter cores.
Processing was conducted using Wurster fluid-bed, CPS rotor fluid-bed (cone and planar disc), and drum coaters.
Key performance indicators included process time, yield, layering efficiency (LE), and agglomerate formation.

Main Results:

Drum coater achieved >95% yield and LE but required over 202 minutes.
Wurster fluid-bed showed reduced time (41 min small scale) but increased agglomerates and longer scale-up times (114 min).
CPS rotor processor (cone disc) demonstrated superior performance: 98.4% yield, 99.3% LE (small scale), and 85 kg/h spray rate (pilot scale) with minimal agglomerates.

Conclusions:

CPS rotor technology is the most efficient and fastest method for HCT layered pellet production.
CPS rotor processing achieved significantly shorter cycle times (29 min small scale, 44 min pilot scale) compared to other equipment.
The CPS rotor processor ensures high quality, high yield, and minimal agglomerate formation, proving its scalability.