Design control process enhances a new device’s functional performance. An innovative injector for home use not only encourages patient to take control of disease state but also improves treatment adherence. Symlin™ Pen (Pramlitide Acetate) is a subcutaneous injectable drug delivery device for type 1 and type 2 diabetes patients to control glucose excursion and lower glucose concentration. Symlin™ is supplied as sterile injection in two images: 1.5mL disposable multi-dose SymlinPen® 60 pen injector, and 2.7mL disposable multi-dose SymlinPen® 120 pen injector. Both contain 1000mcg/mL Pramlintide Acetate. SYMLIN has active ingredient of Pramlintide acetate and inactive ingredients including meta-cresol, D-mannitol, acetic acid, and sodium acetate. Symlin is a marketed product. During the entire product life cycle, design history file plays a vital role to guard the device and ensures that a safe and efficacious device product reaches patients. Many times, resin change or new indication warrant DHF review and update. Design control process for Symlin™ will be discussed.

Design control process for drug delivery injection device - Symlin™ pen for parenteral diabetes treatment

249th National Meeting (2015)

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