Silicone oil is commonly used as a lubricant coating in prefilled syringes (PFS) and is becoming one of the most highly discussed topics in the PFS market, particularly for developers of highly sensitive biotech drugs. In specific biological drug cases, unexpected drug-container interactions have been reported that were potentially attributed to or potentially associated with sub-visible particles generated from the lubricating silicone layer. These could lead to “solution inspection” concerns or even compatibility concern. Sebastien Jouffray is Core Team leader in the R&D Product Development Group at BD Medical – Pharmaceutical Systems. He leads a team working on an innovative immobilised silicone coating, (XSi™). BD XSi™ significantly reduces sub-visible particles (SbVPs) while retaining lubrication performance. BD XSi™ does not introduce any new materials, enabling rapid implementation in PFS for both legacy as well as pipeline drugs.
Detection of SbVPs, defined as particles that cannot be reliably detected by visual inspection with unaided human eye, is continuously being improved by emerging analytical techniques. In particular, the extension of the SbVP size detection limit below 10 μm, potentially into the sub-micron range, and the ability to differentiate the nature of those particles will greatly enhance the potential to monitor and report this critical attribute. Such analytical techniques can be used to understand better the contribution of silicone lubricant in prefilled syringes, to the overall pool of detected SbVPs. This knowledge will be critical to monitor, control and, if a specific need arises, reduce this contribution.
This need led Jouffray to add new techniques to his arsenal of characterization tools. He used Nanoparticle Tracking Analysis from NanoSight to clearly show that their new coating, BD XSi™, radically reduced the presence of particles compared with traditional baked silicone and conventional sprayed-silicone prefilled syringes. This data, reported in a focus on injectable drug delivery by ONdrugDELIVERY, clearly demonstrated that BD XSi™ provides a true reduction in particles in both micron and sub-micron ranges and not just a shift in counts from one range to another.
Noting the benefits of using NanoSight’s NTA instrumentation in complement to other characterization techniques, Jouffray said “NanoSight allows for the counting of nano-sized particles in small sample volumes in parallel with other techniques. This gives us cost effective routine characterization technique verifying the quality of BD Neopak XSi™ and for pharmaceutical companies a new technology to count SbVPs in nano range scale”