Gore Launches 0.5 mL Silicone-Free Gore Improject Plunger for Ophthalmic Pre-Filled Syringes
W. L. Gore & Associates announced the commercial launch of the 0.5 mL silicone-free Gore Improject syringe plunger. The new offering, made within the company's PharmBIO business, is designed for prefilled syringes used in various applications, including ophthalmic intravitreal injections. The new product complements the Gore Improject 1 mLL plunger, which Gore launched in mid-2018.
According to Gore, conventional pre-filled syringe systems use silicone to provide a seal and act as a lubricant between the barrel and the plunger. However, peer reviewed literature highlights various problems with silicone including elevated subvisible particulate levels, silicone accumulation in the eye resulting in floaters, silicone-induced protein aggregation resulting in immunological responses, and ocular inflammation and increased intraocular pressure (IOP). In addition, silicone-containing syringes have been associated with particle count increases and fatty acid creation over time.
The new Gore plunger enabled syringe systems to achieve particulate levels below the limits of the USP<789> subvisible particle standard in testing performed. The plunger is capable of being terminally sterilized and has been shown to provide suitable break loose and glide force (BL/GF) and CCI performance when used in combination with appropriate syringe components and commercial fill and finish processes.
“Gore’s 0.5mL plunger, in combination with a silicone-free glass or advanced polymer syringe barrel, enables pharmaceutical companies to achieve what they’ve been asking for. To reduce risk associated with silicone by enabling its removal from the syringe plunger and barrel,” Emily Oliver, Gore Syringe Business Leader, said in a company news release.
The Gore Improject plunger may enable more challenging ophthalmic injections without the need to introduce silicone oil, cross-linked silicone, or resin enhanced silicone. With increasing needs for precise, low-volume injections in ophthalmology, gene therapy, and pediatric care, Gore’s 0.5 mL prefilled syringe plunger offers a new alternative.