Nov. 7, 2013
West Pharmaceutical Services, Inc.
(NYSE: WST), a global leader in innovative solutions for injectable drug administration, 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.
study, entitled "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
in ten 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
, 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," stated 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.