Related Experiment Video
Updated: Feb 16, 2026

Design of an Open-Source, Low-Cost Bioink and Food Melt Extrusion 3D Printer
Published on: March 2, 2020
Application of hot-melt extrusion technology in immediate-release abuse-deterrent formulations
Klaus Wening1, Sebastian Schwier1, Hans-J Stahlberg1
1Director, Grünenthal GmbH, Aachen, Germany.
Objective:
Hot-melt extrusion (HME) technology has been used for manufacturing extended-release abuse-deterrent formulations (ADFs) of opioid-type analgesics with improved tamper-resistant properties. Our objective was to describe application of this technology to immediate-release (IR) ADFs.
Design:
For development of a sample IR ADF (hydrocodone 10 mg/acetaminophen 325 mg) based on HME, feasibility studies were performed using different excipients. The formulation selected for further development was evaluated via in vitro test battery. Moreover, in vivo performance of IR ADF technologies was investigated in an open-label, randomized, cross-over, phase 1, relative oral bioavailability study with another opioid (model compound).
Setting:
Single-center bioavailability trial.
Participants:
Twenty-four healthy white male subjects.
Interventions:
ADF IR formulation of an opioid and marketed IR formulation.
Main Outcome Measure(S):
For feasibility and in vitro studies, dissolution profiles, syringeability, particle size distribution after physical manipulation, and extractability were evaluated. For the phase 1 study, pharmacokinetic parameters were evaluated and compared for ADF IR and a marketed IR formulation.
Results:
After manipulation, the majority of particles from the ADF IR formulation were >500µm and, thus, not considered suitable for intranasal abuse, while the majority of particles for the reference marketed IR formulation were <500µm. The ADF IR formulation was resistant to syringing and preparation for potential intravenous injection. In healthy subjects, pharmacokinetics of an ADF and marketed IR formulation of an opioid were nearly identical.
Conclusions:
Application of HME to IR formulations led to development of products with improved mechanical resistance to manipulation for intranasal or intravenous preparation, but similar bioavailability.
More Related Videos
12:28Melt Electrospinning Writing of Three-dimensional Poly(ε-caprolactone) Scaffolds with Controllable Morphologies for Tissue Engineering Applications
Published on: December 23, 2017
06:57Study of a Dot-patterning Process on Flexible Materials using Impact Print-Type Hot Embossing Technology
Published on: April 6, 2020
Related Concept Videos
Phase Transitions: Melting and Freezing
Drug Abuse and Addiction: Pharmacological Phenomena
Hot Weather Concreting
Mitigating the heat increase in concrete can be economically achieved by shading aggregate stockpiles to prevent heating from solar radiation,...
Comparing Intermolecular Forces: Melting Point, Boiling Point, and Miscibility
Temporary attractive forces like dispersion are present in all molecules, whether they are polar or nonpolar. They...
Hybridoma Technology
Hybridoma Selection
Commonly used fusion techniques — electroporation,...
Masonry in Cold and Hot Weather Conditions
Other key practices include keeping masonry units...