Ideal solution for silicone-sensitive biotech drugs, ophthalmic drugs, and vaccines.

At present, the inner glass surface of the large majority of ready-to-use pre-fillable glass syringes delivered to the pharmaceutical industry are siliconized. Silicone oil acts as a lubricant to enable the movement of the plunger in the syringe barrel ensuring its functionality.

However, silicone oil can interact with highly sensitive molecules in biotech products.1,2,3 For this reason, it has been recognized as one of the potential causes for aggregation and particle formation in therapeutic protein formulations.

Today, more than 80% of injection drugs in the drug pipeline are biotech products4 and the demand for silicone oil-free injection systems is growing.

Nipro launches the new D2F™ Pre-fillable Glass Syringe System – Silicone Oil-Free. This new drug delivery system is a solution for drug products highly sensitive to silicone oil.    

Nipro PharmaPackaging - Glass Pre-fillable Syringes - Silicone oil-free​

The key quality attributes of the D2F™ Pre-fillable Glass Syringe System – Silicone Oil-Free have been thoroughly tested5 and the results confirm:

  • Smooth Plunger Movement Performance
    Consistent break loose and gliding forces due to plunger characteristics and hydrophilic glass surface with high surface free energy, good wettability, and good adhesiveness
  • Very Low Particle Levels6
    Amount of visible and subvisible particles significantly below the limit criteria in EP 2.9.20 and EP 2.9.19
  • Container Closure Integrity

The D2F™ Pre-fillable Glass Syringe System – Silicone Oil-Free are delivered in ENHANCE quality to meet the challenging drug product and service requirements of the pharmaceutical industry for sensitive drug products.

  • Excellent Drug-container Compatibility
  • Smooth Integration into Auto-injection Devices
  • Optimized Processability for Minimal Drug Loss
  • Extended Data Package for Fast Acceptance of Goods

 

References

  1. Latoya S. Jones, Allyn Kaufmann, C. Russel Middaugh, Silicone Oil Induced Aggregation of Proteins, Journal of Pharmaceutical sciences, vol. 94, no. 4, April 2005.​

  2. Michael Adler, Challenges in the development of pre-filled syringes for biologics from a formulation scientist´s point of view, American Pharmaceutical Review, 2012.​

  3. Tina Tölke, Jenny Rudolf, Andreas Pfuch, Bernd Grünler, Syringe Siliconization, Pharm. Ind. 81, Nr. 3, 404-409, 2019.​

  4. Globaldata – Drug Database – Analysis 27.01.2023.

  5. D2F Pre-fillable Glass Syringes – Silicone Oil Free - Nipro Product Development Report 2023.

  6. Compared to standard silicone oil syringe system

D2F™ Pre-fillable Glass Syringe System - Silicone Oil-Free

Nipro PharmaPackaging - D2F Pre-fillable Glass Syringe - Silicone oil-free
Pharmaceutical Packaging

D2F™ Pre-fillable Glass Syringe System - Silicone Oil-Free

For Biotech, Ophthalmics, and Vaccines Highly Sensitive to Silicone
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