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Updated: Jun 4, 2026

Film Extrusion of Crambe abyssinica/Wheat Gluten Blends

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Published on: January 17, 2017

Key considerations for optimization of formulation and melt-extrusion process parameters for developing

Indrajit Ghosh¹, Radha Vippagunta, Shoufeng Li

¹Novartis Pharmaceutical Corporation, PHAD-ARD, One Health Plaza, East Hanover, NJ, USA. indrajit.ghosh@novartis.com

Pharmaceutical Development and Technology

|February 3, 2011

Summary

Melt-extrusion manufacturing can cause thermal degradation of sensitive drugs. Optimizing extruder design, screw speed, temperature, and feed rate helps control drug degradation during scale-up.

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Published on: August 9, 2022

Area of Science:

Pharmaceutical Manufacturing
Process Chemistry
Drug Stability

Background:

Melt-extrusion is a continuous pharmaceutical manufacturing technology for various dosage forms, including solid dispersions.
A key challenge is the potential thermal degradation of drug substances due to heat stress and shear forces inherent in the process.

Purpose of the Study:

To investigate the impact of thermal and mechanical factors during melt-extrusion scale-up on the stability of a thermosensitive drug substance.
To correlate drug degradation profiles with extruder physical modifications and process parameters.

Main Methods:

Utilized melt-extrusion process with controlled variations in extruder design and operating parameters.
Analyzed drug substance degradation profiles in relation to process temperature, screw speed (rotations per minute), and feed rate.
Correlated degradation patterns with physical changes implemented in the extruder setup.

Main Results:

The study identified a direct correlation between the drug substance's degradation profile and physical alterations within the extruder.
Process temperature emerged as a significant factor influencing the extent of thermal degradation.
Optimization of screw assembly design and operating parameters (screw speed, temperature, feed rate) demonstrated control over degradation.

Conclusions:

The melt-extrusion process requires careful consideration of thermal and mechanical stresses to maintain drug stability.
Proper screw assembly design and precise optimization of process parameters are crucial for mitigating drug degradation during scale-up.
This research provides a framework for controlling the stability of thermosensitive drugs manufactured via melt-extrusion.