Evaluation of the Dual-Chamber Pen Design for the Injection of Exenatide Once Weekly for the Treatment of Type 2 Diabetes

Journal of Diabetes Science and Technology
Susan LaRue, Jaret Malloy

Abstract

Exenatide once weekly, an injectable glucagon-like peptide-1 receptor agonist, has been shown to reduce A1C, fasting glucose, and body weight in patients with type 2 diabetes. Exenatide 2.0 mg is dispersed in poly-(D,L-lactide-co-glycolide) polymer microspheres, which require resuspension in aqueous diluent before subcutaneous injection. A single-use, dual-chamber pen was developed to improve the convenience of exenatide once weekly delivery and tested following Food and Drug Administration (FDA) guidance. Design development goals were established, and validation tests (dose accuracy, torque/force requirements, usability, and ease-of-use) were performed. Dose accuracy was tested under a variety of conditions. After 10 exploratory studies in 329 patients, the final design's usability and ease-of-use were tested in untrained health care practitioners (HCPs; n = 16) and untrained/trained patients (n = 30/17). Usability testing evaluated completion of multiple setup, dose preparation, and injection steps. Ease-of-use impression was assessed using a scale of 1-7 (1 = very difficult, 7 = very easy). The dual-chamber pen successfully met development goals and delivered target volume (650 µL ± 10%) under tested conditions (mean 644.7-6...Continue Reading

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Citations

Feb 24, 2016·Drug Development and Industrial Pharmacy·Curie Javiya, Sriramakamal Jonnalagadda
Sep 17, 2016·Expert Opinion on Drug Delivery·Fabien JeannerotJoan Schertz
Jan 14, 2017·Expert Opinion on Pharmacotherapy·Filip K KnopTina Vilsbøll
Sep 6, 2017·Daru : Journal of Faculty of Pharmacy, Tehran University of Medical Sciences·Cuiwei ChenXuanshen Wang
Feb 8, 2019·Expert Opinion on Pharmacotherapy·Sebastian M HeimbürgerFilip K Knop
Feb 15, 2019·Advanced Healthcare Materials·Anastasia K Varanko, Ashutosh Chilkoti
Dec 12, 2017·Expert Opinion on Drug Delivery·Andreas E Schneider, Jakob Lange
Feb 5, 2021·International Journal of Pharmaceutics·Rahul G Ingle, Wei-Jie Fang

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