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West 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, 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 Israel 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 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,” stated Mr. Norton.
Read the full press release here
For more information about the SmartDose injector, or any of West’s technologies for integrated drug delivery, visit www.westpharma.com or www.smartdose.com.
The SmartDose patch injector is for investigational use only by our pharmaceutical and biotechnology development partners. West seeks partners for the SmartDose technology platform. This platform is intended to be used as an integrated system with drug filling and final assembly completed by the pharmaceutical company.
Daikyo Crystal Zenith® and Flurotec® are registered trademarks of Daikyo Seiko, Ltd.
Crystal Zenith technology is licensed from Daikyo Seiko, Ltd.
Polymeric container systems are not new to the pharmaceutical industry, and their benefits in terms of break resistance, cosmetic quality and dimensional precision have been recognized by many companies around the world who have chosen to use a polymer vial or syringe.
In a previous <a href="/blog/2012/may/lifecycle-planning"><span style="text-decoration: underline;">post</span></a>, my colleague Fran DeGrazio discussed lifecycle planning and the use of a single material for packaging components from development through commercialization. There has been a great deal of innovation around drug container materials. Although glass has been the traditional material of choice for drug containment, it has significant limitations including breakage, glass particulate, visual quality and functional performance.
Ever wondered what West’s cutting-edge product development facilities look like on the inside? Jeff Kyle, Sr. Director New Product Introduction, and Tom McLean, VP Delivery Systems R&D, take you behind the scenes of the Scottsdale, AZ plant.
<p style="margin: 0in 0in 0pt;"><span>West is pleased to announce new extensions of the SmartDose® drug delivery platform, including several new wearable injectors that allow for up to 10 mL of volume to be injected in easy-to-use, wearable formats. The new devices were showcased at the annual PDA Universe of Pre-filled Syringes and Injection Devices conference in Vienna, Austria, in November. </span></p>
West works by the side of our health care partners to understand patient needs and provide integrated delivery systems that optimize the effectiveness of drug delivery while enhancing the patient experience. Creative business models will ensure effective collaboration, either by leveraging West’s proprietary technologies or partnering with individual customers through the development process to apply West’s design, engineering and manufacturing skills to create customer-specific solutions.
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