Graham Reynolds

VP & GM, Global Biologics

May 25, 2012

Lifecycle-Planning-for-Phamaceutical-Delivery-Systems

In a previous post, 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.
Glass syringe systems require siliconization to enable mechanical performance when used in a delivery system, and this material can interact with certain drug products, causing aggregation.

Recent developments around the use of polymeric materials for drug containment have allowed delivery system companies to work closely with drug manufacturers to develop novel systems designed specifically to meet patient needs. The design and manufacturing flexibility of a polymeric drug container, combined with the ability to create patient-friendly devices designed with human factors engineering, enables the design of more innovative overall delivery systems that may aid in patient compliance through ease of use and enhanced technology. Cyclic olefin polymers such as the Daikyo Crystal Zenith® polymer provide a transparent, break-resistant alternative to glass.

 
Pharmaceutical and biotech companies are working closely with drug delivery device manufacturers at an early stage to ensure that there is efficient development of an overall system. The use of the same material for primary containment throughout a drug product’s lifecycle aids in cost-effective drug delivery by reducing testing required by any change in materials that are in contact with the drug product.
 
West has a long history of expertise in primary container closure and delivery components and systems. In the last few years we have developed our own proprietary technology platforms. The first is the ConfiDose® auto-injector platform technology, which is designed for a standard 1 mL long syringe system with a fixed needle and is compatible with glass and plastic syringes – including the Daikyo Crystal Zenith® insert needle syringe. Larger syringes can be used for increased dose volume, within a system customized for the drug product and designed to optimize the patient’s injection experience.
 
West also offers a technology platform for delivery of higher volumes of drug through an electronic patch injector system, the West SmartDose® platform technology. This technology is based on a Daikyo Crystal Zenith container that enables customers to develop a unique system that enables delivery of larger volumes (potentially up to 10mL) over a longer period of time.
 
For more information about these technology platforms, visit www.westpharma.com
Daikyo Crystal Zenith® is a registered trademark of Daikyo Seiko, Ltd.
Daikyo Crystal Zenith® technology is licensed from Daikyo Seiko, Ltd.
ConfiDose® is a registered trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.
SmartDose® is a registered trademark of Medimop Medical Projects Ltd., a subsidiary of West Pharmaceutical Services, Inc.

West markets SmartDose® and ConfiDose® as integrated systems with drug filling and final assembly performed  by the pharmaceutical customer.