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Quality by Design Approach for Hot-Melt Extrusion Coupled Fused Deposition Modeling (HME-FDM) 3D Printing: A

Petra Arany¹, Ádám Papp^2,3, Dániel Nemes^1,2

¹Department of Pharmaceutical Technology, Faculty of Pharmacy, University of Debrecen, 1 Rex Ferenc Utca, H-4002 Debrecen, Hungary.

|May 27, 2026

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Hot-melt extrusion fused deposition modeling (HME-FDM) is a key 3D printing method for pharmaceuticals. A guideline for quality production is proposed, but inconsistent parameter reporting hinders robust quality by design approaches.

Area of Science:

Pharmaceutical Technology
Additive Manufacturing
Drug Delivery Systems

Background:

Fused Deposition Modeling (FDM) is a prevalent 3D printing technique for pharmaceutical applications.
Hot-Melt Extrusion (HME) filament manufacturing has emerged as a significant advancement over earlier soaking methods.
Research in HME-FDM for drug delivery has expanded, exploring diverse polymers, active ingredients, and printing parameters.

Purpose of the Study:

To synthesize Quality by Design (QbD) approaches and existing research to create a guideline for HME-FDM 3D-printed pharmaceuticals.
To establish a framework for appropriate quality production in pharmaceutical additive manufacturing.
To address the need for standardized guidelines in the rapidly evolving field of 3D-printed medicines.

Main Methods:

Keywords:

3D printing critical printing parameters fused deposition modeling hot-melt extrusion process analytical technologies quality by design

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Systematic literature review following PRISMA 2020 guidelines (2015-2025).
PubMed database search.
Inclusion of 26 articles based on parameter monitoring and methodological detail.

Main Results:

Comparison and compilation of HME, FDM, and analytical testing data from selected publications.
Analysis of pharmacopeial dosage-form tests and Process Analytical Technologies (PAT) integration.
Identified heterogeneous reporting of influential parameters, limiting QbD development.

Conclusions:

Synthesized trends from available data to create a preliminary guideline for HME-FDM pharmaceutical production.
Highlighted that inconsistent reporting of critical parameters is a major limitation for developing robust QbD strategies.
Emphasized the need for standardized reporting schemes to advance the field.