Plungers

Development of vaccines for COVID-19 and its variants continues to present challenges such as accelerated timelines. Since there is not the usual time available for selection, evaluation, and qualification of the package and delivery systems, risks must be mitigated at every phase. For vaccines packaged in prefilled syringes, use of an elastomer plunger laminated with FluroTec^® film can help.

To improve the consistent evaluation of the quality and efficacy of generic drugs for injections, National Medical Products Administration of China（NMPA）published the draft guidance “Technical Requirement for Quality and Efficacy Consistency Evaluation on Chemical Generic Injections (Exposure Draft)” (15 October 2019). This indicates that the evaluation of the consistency of injections has finally begun. This Exposure Draft clarifies the specific technical requirements on reference-listed drugs, prescription technology, quality control of bulk drugs and excipient packaging, quality studies and control, stability studies, etc.

In 2015, the FDA shed light on a problematic practice within the healthcare industry involving improper, off-label use of syringes as closed container storage systems for compounded or repackaged drugs. The incidents cited revealed that interaction with rubber plungers in syringes that were not cleared for the purpose of closed container storage resulted in the loss of potency of several drugs when administration was delayed.¹

In the prefilled syringe system, the plunger is in contact with the drug product during administration and the drug storage period, which may last up to two years and can affect the long-term stability of the drug product.

Anti-VEGF therapeutics for the treatment of ophthalmic conditions such as neovascular (wet) age-related macular degeneration (AMD) and diabetic macular edema (DME) have significantly improved patient prognoses, in some cases preventing or reversing progression to blindness.  Routine injections into the eye of recombinant protein drugs such as bevacizumab, ranibizumab or aflibercept have proven to be efficacious in neutralizing the binding of over-expressed vascular endothelial growth factor (VEGF) proteins to their corresponding cellular receptors, thus interrupting the angiogenesis signaling pathway which otherwise leads to the disease states. In short, anti-VEGF injections are preventing or restoring vision loss for millions of people world-wide.

Most physicians agree - of all the services that can be performed for patients, eliminating the pain and fear of injections is at the top of the list. How can pain be minimized? One approach is to maximize syringe performance - whether the syringe is employed by a clinician, in an autoinjector, or in a wearable device. A critical element of syringe performance is the break-loose force. This is the force needed to overcome the plunger inertia in a filled syringe to initiate plunger movement and introduction of drug product. A lower, more consistent, break-loose force can provide for increased patient comfort.