Your challenge

Does needle clogging change the spatial distribution of injected drug in skin?

Prefilled syringes (PFS) are primary packaging materials that enable convenient and safe subcutaneous injection of parenteral drug solutions. 
However, higher drug concentrations increasingly lead to needle clogging during storage due to water evaporation and drug solidification. 
Understanding how such clogging affects the spatial distribution of injected drug in tissue is therefore pharmacokinetically important.

 

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Our solution 1

high-resolution Synchrotron X-ray CT combined with controlled injection

Our expertise in the field of Imaging enables us to visualize and analyze the spreading pattern and whereabouts of the injected liquid from a clogged needle in pig skin.

Using high-resolution Synchrotron X-ray CT combined with controlled injection, our studies on a monoclonal antibody solution show that initially fluid escapes only through a narrow channel in the blockage, generating high dynamic pressure that can alter the distribution of the fluid in the tissue and cause a long tail of fluid that reaches deep into the subcutaneous fiber network. Any clog entering the tissue dissolves rapidly.

3D Synchrotron-CT

FAQ

Answers to the most frequently asked questions

Synchrotron X-ray CT differs from histology and ultrasonography by providing a non-destructive, three-dimensional (3D) visualization of the spatial distribution and of injected drugs within tissue.
 

It offers higher spatial resolution, improved soft-tissue contrast, and faster acquisition than tube-based X-ray CT, enabling capture of rapidly dissolving drugs in tissue.
 

Yes, of course. We are here to advise you without obligation and to find out whether we can support you. Please do not hesitate to contact us.

References

Insights from customer projects

These projects show how we work with our customers to analyze complex material challenges and generate relevant insights using neutron and synchrotron techniques.

NOVARTIS

Novartis AG

 

“Visualizing how injected medications behave within tissue is a key insight for understanding the impact a clogged needle can have on the injection process. Synchrotron X-ray tomography makes this possible in a truly impressive way. The 3D images provide even more detailed information. The outstanding expertise of the entire interdisciplinary team made this achievement possible.”

Dr. Alexander Zürn, Associate Director Advanced Testing Global Device & Packaging Development,

Novartis

Discuss your challenge with us

Infrastructure

Tailor-made infrastructure for real-time investigation of prefilled syringes under varying temperature and pressure conditions using Synchrotron CT

Climatic
  • Temperature operating range from -20°C to +80°C
  • Temperature control accuracy of ±0.5°C
  • Freely programmable temperature profiles / temperature cycles
  • Pressure operating range from ambient pressure down to 1 mbar
  • Pressure control accuracy of ±1 mbar
  • Freely programmable pressure profiles / pressure cycles
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Insitu PFS
Infrastructure

Tailor-made infrastructure for the controlled injection of prefilled syringes (PFS) into tissue samples

Automation
  • Controlled injection by the needle to a predefined injection depth
  • Controlled injection with adjustable injection speed
  • Force-displacement measurement during the injection process ± 0.1 N
  • Variable load cut-off to protect the syringe
  • Injection forces up to 60 N
  • Suitable for various syringe types (length & diameter)
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Skin_Umsetzung
Infrastructure

Fully automated sample changing unit using robotic infrastructure

Automation
  • Mobile robot unit for the use on beamlines
  • Robot arm for flexible use for a wide range of samples
  • Sample racks for holding up to 80 samples
  • Simple sample exchange by means of magnetic fixation
  • Safe operation without cage possible
  • Commissioning in less than 30 minutes
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Roboterhaken

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