Bridgewater, NJ-based Valeritas Holdings, Inc. has introduced what it considers a game-changing insulin delivery device for patients with Type 2 diabetes. The V-Go® Wearable Insulin Delivery devicefeatures an injection-molded cartridge made of TOPAS®cyclic olefin copolymer (COC) from TOPAS Advanced Polymers.
The medical device is worn like a patch and can eliminate the need for taking multiple daily shots. The innovative V-Go Wearable Basal plus Bolus Insulin Delivery device is commercially available in the U.S., and will be shown at the upcoming MD&M West show in Anaheim, Feb. 6-8, and at Pharmapack in Paris, Feb. 7-8.
Basal insulin is long-acting, and keeps blood glucose levels consistent between meals and during sleep. Fast-acting bolus insulin is typically taken at meal times to control blood sugar.
V-Go is designed to simplify basal-bolus insulin therapy and helps make blood glucose control possible for adults. V-Go is a simple, affordable, and fully disposable device and works with no electronics, batteries, infusion sets, or programming. It is small, lightweight, and worn under clothing. The company’s website includes a video demonstrating how the device works to deliver the medication to the patient.
The decision to use TOPAS COC for the device cartridge involved thorough research and evaluation. The material was selected over competitive thermoplastics due to its purity, drug compatibility, biocompatibility, and dimensional stability, according to Geoffrey Jenkins, Executive VP of Manufacturing and Research and Development for Valeritas. TOPAS COC can also be molded with zero draft.
“TOPAS COC fills an important role in the cartridge system of the V-Go insulin delivery device,” says Jenkins. “We find it to be highly stable in contact with the drug and it has great optical clarity; moreover, it offers good injection-molding characteristics with excellent dimensional stability and minimal shrinkage.”
The tube-shaped cartridge contains 1mL of insulin. Valeritas reports that users switching from multiple daily insulin shots toV-Gosignificantly lowered their glucose levels and reduced their insulin use by as much as 44% per day.
According to the supplier, TOPAS COC offers a non-ionic, minimally reactive surface. This non-polar substrate does not promote adsorption, denaturation, aggregation, or precipitation. Glass-clear TOPAS resin has low leachables and extractables compared to glass and other medical grade polymers for drug delivery, preserving long-term drug purity and enabling better quality at high yields.
Each V-Go device individually packaged in a thermoformed tray with a Tyvek® lidstock. Trays are automatically packaged 30/outer box. Devices are available in the U.S. CE-marked. Prices are dependent on healthcare reimbursement.