“The West SmartDose® electronic wearable injector, designed for patient convenience, incorporates a Daikyo Crystal Zenith® cartridge and can deliver a dose of up to 3.5mL, which may allow for viscous biologics that are sensitive to glass, metal ions and/or silicone oil to be administered over longer periods of time” By Dr. Nicolas Brandes, West Pharmaceutical Servces, Inc.
Some biologic drug products do not react well with glass, requiring drug manufacturers to look at other options for containment and delivery. For example, modern biologic formulations sensitive to silicone oil or tungsten may require alternative packaging. Silicone oil, used as a lubricant in glass containers to obtain plunger gliding functionality, has been strongly connected to protein aggregation as well as the presence of subvisible particles in the suspension. Other undesirable effects in combination with glass primary packaging include potential breakage, delamination, heavy metal release, low dimension control and lack of design flexibility.
Challenges with glass, as well as a sharpened focus on safety since patients with chronic diseases are treating themselves at home more frequently, drives pharmaceutical companies’ demand for increased quality from drug containment and delivery system manufacturers. While glass remains the standard for injectable drug containment for the prefilled syringe market, the material’s higher dimensional variability in manufacturing could be a concern when evaluating the functionality of the syringe or cartridge in conjunction with the delivery system.
High-quality polymers, such as cyclic olefin polymers (COP), help maintain the quality of sensitive biologics through enhanced cleanliness and decreased interaction with the drug product. Primary containers made from materials such as the Daikyo Crystal® Zenith (CZ) COP can help contain higher dose volumes or provide delivery options for viscous drug products. Cartridges and syringes molded from the CZ® polymer are free of silicone oil und tungsten, and exhibit break resistance as well as consistent and predictable gliding forces. The rubber components that are used in the CZ systems are laminated with Flurotec® film, which functions as an effective barrier against extractables and provides lubrication at the same time.
SMARTDOSE® ELECTRONIC WEARABLE INJECTOR: DESIGNED FOR HOME USE
Some patients either do not want to inject themselves with medications in prefilled syringes, or their conditions make it difficult. Some drugs, including biologics, might require large volumes of viscous solutions, making a single-dose option either difficult or impossible.
While there are numerous auto-injector devices on the market, pharmaceutical companies need innovative and responsive packaging partners that can keep up with the requirements these biologics create. Some glass-sensitive biologics must be housed in polymers because of potential breakage or protein aggregation with glass. Others are more suited to injectors that can control the delivery of large doses over time when the drug is too much for a single injection. An example is the West SmartDose® electronic wearable injector system, which incorporates a CZ polymer-based drug container and is designed to enhance the experience of patients required to self-inject a larger volume biologic drug at home.
Choosing the correct packaging and delivery system can not only make medication adherence easier on the patients, but also can encourage brand preference among patients and practitioners. By making the right choices early on in the development process, packaging and pharmaceutical manufacturing can mitigate risk and deliver a high-quality product to patients.
SmartDose® is a registered trademark of Medimop Medical Projects Ltd., a subsidiary of West Pharmaceutical Services, Inc.
West and the diamond logo and By your side for a healthier world™ are registered trademarks or trademarks of West Pharmaceutical Services, Inc.
Daikyo Crystal Zenith® is a registered trademark of Daikyo Seiko, Ltd. Crystal Zenith and FluroTec® technologies are licensed from Daikyo Seiko, Ltd.