WEBINAR ON DEMAND - Heat Without Harm: The Reality of Hot Melt Extrusion Webinar
In a 2025 industry survey (1), 76% of respondents selected ‘risk of thermal degradation’ as a source of hesitation to pursue hot melt extrusion (HME). Concerns about heat-sensitive APIs frequently lead development teams to rule out HME early — often before conducting a thorough scientific evaluation of their formulation options.
But thermal risk is frequently overstated. In this on-demand webinar, Stefanie Hauck, Senior Director PDS&T Pharm. Tech. at AbbVie Contract Manufacturing, explains why many compounds initially considered unsuitable for HME can be successfully processed with the right expertise.
The Growing Challenge
Modern APIs are increasingly difficult to formulate. Increasing molecular complexity often contributes to poor solubility, which impacts bioavailability and dosing. Traditional formulation approaches are often insufficient to address these challenges.
Amorphous solid dispersions (ASDs) are a leading solution. HME is one of the most promising approaches to producing ASDs — a continuous process that combines API, polymer and excipients under controlled heat and shear to produce a solid intermediate for downstream processing into tablets, capsules or other finished dosage forms.
Reframing Thermal Risk
The webinar challenges a fundamental misconception: that degradation is driven by temperature alone. In reality, multiple factors contribute to degradation risk.
How AbbVie Approaches HME
As an industry leader in HME technology, AbbVie Contract Manufacturing approaches thermal risk as a formulation and process engineering opportunity rather than a limitation.
AbbVie’s HME track record:
- 30+ years of HME experience
- 100+ drug candidates developed with HME
- 10 commercial products manufactured using HME
Instead of ruling out HME when an API is perceived to be heat-sensitive, AbbVie applies deep technical knowledge and extensive development capabilities to design processes that minimize degradation risk while preserving the advantages of extrusion.
A Smarter Feasibility Framework
When determining the suitability of HME for an API, drug developers and formulation scientists should assess:
- API characteristics: Must remain chemically stable during short exposure to elevated temperatures and shear inside the extruder
- Polymer/excipient characteristics: Should effectively inhibit API crystallization, impact solubility/miscibility during molten polymer phase, lower process temperature to reduce thermal risk and achieve high drug loading without reducing dissolution rate
- Process conditions: Parameters such as temperature profile, screw configuration, screw speed and feed rate determine shear and residence time, impacting thermal and mechanical stress applied to the formulation
Conducting feasibility assessments early in development is essential to identifying risk, taking appropriate action and avoiding unexpected late-stage issues.
Watch the Webinar
Companies often eliminate hot melt extrusion as a potential manufacturing approach before conducting a thorough scientific evaluation. With the right expertise, thermal risk is frequently manageable through informed formulation design and careful process engineering.
If you thought HME was not a feasible option for your program, it may be time to learn more.
Complete the form to access the on-demand webinar and learn how AbbVie Contract Manufacturing can help you assess whether HME is right for your molecule.
Contact us to discuss your HME project with an AbbVie expert.
References:
1. Hammeke K, Baldwin A. Industry Standard Research Report: Hot Melt Extrusion vs Spray Drying Technologies. ISR. 2025 Oct 17.
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