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Film Extrusion of Crambe abyssinica/Wheat Gluten Blends

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Published on: January 17, 2017

Material-Sparing Feasibility Screening for Hot Melt Extrusion.

Amanda Pluntze¹, Scott Beecher¹, Maria Anderson¹

¹Global Research and Development, Small Molecules, Lonza, 64550 Research Road, Bend, OR 97703, USA.

|January 23, 2024

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This study introduces a new, material-sparing method for screening amorphous solid dispersion manufacturability using hot melt extrusion (HME). The approach predicts achievable API loadings and degradation, requiring minimal material for pharmaceutical development.

Area of Science:

Pharmaceutical Technology
Materials Science
Chemical Engineering

Background:

Hot melt extrusion (HME) is a high-throughput method for creating amorphous solid dispersions.
Existing methods for predicting API solubility in polymer melts often neglect critical kinetic and degradation factors during HME processing.

Purpose of the Study:

To develop a material-sparing approach for screening the manufacturability of pharmaceutical APIs via HME.
To predict achievable API loadings and API degradation during HME processing.

Main Methods:

A screening flowchart utilizing a custom device was developed.
Physically relevant time, temperature, and shear parameters were employed.
Piroxicam, ritonavir, and phenytoin were used as model APIs with PVP VA64 as the dispersion polymer.

Keywords:

copovidone feasibility hot melt extrusion material sparing

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Main Results:

The developed method allows rapid formulation screening.
It accurately predicts achievable API loadings and expected API degradation.
The approach showed good correlation with industry-standard micro compounder processing.

Conclusions:

This material-sparing HME screening method requires 200 mg of API or less.
It provides critical insights into API solubility, kinetics, and degradation for successful amorphous solid dispersion formulation.
The method facilitates efficient screening of pharmaceutical API manufacturability.