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Pharmaceutical & Medical Packaging News, October/Fall 2016

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Page 23 of 35 • Pharmaceutical & Medical Packaging News Fall 2016 24 Parenteral Packaging & Drug Delivery Tapping into Quality by Design principles for drug delivery devices Use of QbD helped ensure consistency and cleanliness. By Daphne Allen Editor W ith drug delivery devices being used more and more by patients these days, they need to be designed so that profes- sional experience isn't required for safe and effective drug administration. A few years ago West Pharmaceutical Services Inc. set out to enhance the performance and reliability of syringe components with the patient in mind, and the NovaPure family of prefilled syringe components was born thanks to Quality by Design (QbD) principles. West is now expanding the brand to meet the needs of higher-volume bio- tech products. The NovaPure brand now includes a 1-3 mL plunger to suit higher- volume injectable drug delivery sys- tems. The line already includes the 1-mL long NovaPure plunger and 13-mm and 20-mm NovaPure lyo and serum stoppers, and West continues to add components, reports Karen A. Flynn, Senior Vice President & Chief Commercial Ofcer. "Traditionally, prefilled syringe delivery methods have relied on hand forces to push the plunger rod down the barrel. Any variability in the force needed to move the plunger down the syringe barrel could be easily compen- sated for by the healthcare provider, with more or less force as needed," says Flynn. As delivery systems have now evolved to include syringes with- in autoinjectors, the variability of the forces required to move the syringe plunger must be reduced in order for the system to operate efectively each and every time, she says. Autoinjectors use a spring-loaded mechanical system to overcome some variability, but Flynn says there's potential for incomplete doses or even glass breakage, especially when deliv- ering high-viscosity drug products. "Understanding and controlling the dimensions of the syringe system com- ponents and the autoinjector device is very important for appropriate func- tion of the system. West redesigned the syringe plunger, a critical component within the system, to optimize break- loose and glide force profiles," she says. West employed QbD principles to ensure dimensional control and consis- tency. "It starts with defining a target product profile, designing the plunger for optimal container closure integrity and functional performance within the syringe, and maintaining the consisten- cy of the whole manufacturing process. This is coupled with an efective control strategy based on the critical process parameters within manufacturing." West's 1-3 mL NovaPure plunger is designed for higher-volume injectable drug delivery systems.

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