West Completes Study Evaluating SmartDose Electronic Patch Injector Platform & Introduces Westar Cartridge Components for Self-Injection

West Pharmaceutical Services, Inc. has completed a preliminary study of its SmartDose technology platform, which incorporates a Daikyo Crystal Zenith (CZ) cartridge. The study evaluated multiple attributes of the technology and subjects’ experience with the self-application process.

The June 2013 study, First-in-Man, Single Center, Open, Two Periods, Self-Application Clinical Study to Evaluate the Safety, Performance and Tolerability of SmartDose 2.5 Using Saline in Healthy Subjects at Two Delivery Rates, was conducted in Israel in 10 healthy male study subjects.

“We believe our efforts to develop the SmartDose technology platform system are important, because we see an unmet need for high-volume subcutaneous delivery of viscous or sensitive drug products, which may require longer injection times,” said Paul Norton, Vice President of Self-Injection Systems at West.

“Daikyo Crystal Zenith has a long history of use as a primary drug container, and many of our customers find Daikyo Crystal Zenith an attractive option based on quality, stability, and performance considerations. The flexibility of CZ allows it to be optimized for use with the SmartDose platform and makes it possible to utilize these technologies for the next generation of self-administered protein-based drugs.

“This is an important step as we seek to develop a complete drug delivery system incorporating the benefits of Daikyo CZ as an alternative to glass for biotech products,” added Mr. Norton.

In May, West announced the first customer-sponsored clinical trial for the SmartDose system incorporating the Daikyo CZ cartridge. West is also working closely with several pharmaceutical companies that have expressed interest in the SmartDose system and are currently performing drug stability studies in the Daikyo CZ cartridge.

“The SmartDose system with Daikyo CZ cartridge is an excellent example of West’s partnership with biotech companies to offer fully integrated drug delivery systems designed around the importance of understanding patient needs, protein drug requirements, the primary container, and an effective delivery system,” said Mr. Norton.

The Daikyo CZ cartridge with the Flurotec film-coated piston and seal comprise a container system specifically designed for the needs of most modern biologic medications. West and its partner Daikyo Seiko, Ltd. have developed CZ primary container systems to reduce interaction with biologics, and to realize the added benefits of break resistance, higher standards of quality, dimensional tolerance, and functionality that are associated with polymer systems. West believes that the study results will be useful to its pharmaceutical and biotechnology customers as they partner with West on the SmartDose technology.

For more information about the SmartDose injector, or any of West’s technologies for integrated drug delivery, visit www.westpharma.comor www.smartdose.com.

West also announced the introduction of Westar RU (ready-to-use) components for cartridge-based injection device applications. Westar-lined seals and plungers are manufactured to meet FDA and global regulatory requirements for drug packaging components and can help drug manufacturers meet increasing demand for safe, effective self-injection delivery devices. This new product line allows companies to simplify their drug development strategy, streamline manufacturing and help ensure patient safety by selecting cartridge plungers and lined seals in ready-to-use format.

Growth in both biologics and diabetes markets is driving demand for self-injection drug formats, such as pens, that ease administration and ensure patient safety. More pharmaceutical and biotechnology manufacturers are turning to injection devices with prefilled cartridge container closures systems to help patients with chronic conditions that require self-administration of therapeutics to manage their conditions at home. West cartridge components incorporate high-quality lined seals and plungers to reduce the risk of variability and the potential effects on drug quality, safety, and efficacy. In addition, cartridge components are available in Westar RS (ready-to-sterilize) format.

“With new challenges in administration and stricter regulatory guidelines, pharmaceutical manufacturers need to be confident drug packaging won’t compromise drug product integrity, efficacy, or patient safety,” said Tibor Hlobik, Director, Global Marketing for Prefillable Syringe Technologies, West. “The Westar brand is recognized worldwide for consistent high-quality components, with industry leading particle specifications. Westar components offer superior functional performance for injectable drug delivery systems and are designed to meet the highest standards of sterility, cleanliness, and purity, making sure a patient’s medication is delivered safely and effectively, every time.”

Westar RU components streamline manufacturing operations for pharmaceutical and biotechnology customers. The consistent and predictable quality of steam-sterilized Westar components ensures there will be minimal processing variation during filling and assembly, which can lead to increased throughput in fill-finish lines and less risk of line interventions. Additionally, Westar RU seals, lined seals, and plungers have low bioburden, endotoxin, and particulate levels and may help minimize the risk of recalls due to particulates or sterility assurance issues

Westar cartridge components fit several sizes of cartridges including 1.5 mL, 1.8 mL, and 3 mL and are available for customers worldwide. For more information about Westar products, visit: www.westpharma.com/en/products/Pages/CartridgeComponents.aspx.