title: The design and performance of the exubera pulmonary insulin delivery system.
abstract: The Exubera system (Pfizer, New York, NY/Nektar Therapeutics, San Carlos, CA) is an integration of five major new technologies: protein formulation, powder processing, powder filling, drug packaging, and delivery device. The product provides a simple interface, where the patient interacts only with the delivery device and powder packaging. These components were designed together to assure repeatable dosing when used by a wide range of patients under real-world life-style and handling conditions. The device design is purely mechanical, using patient-generated compressed air as the energy source. Upon actuation, a sonic discharge of air through the novel release unit reproducibly extracts, de-agglomerates, and disperses the inhalation powder into a respirable aerosol. A clear holding chamber allows for patient feedback via dose visualization and separates aerosol cloud generation from the inspiratory effort. The Exubera product was tested under a wide range of typical use conditions and potential misuse scenarios and following long-term usage in clinical trials. These comprehensive characterization programs demonstrated robust aerosol and mechanical performance, confirming the design intent of the inhaler. These studies provide assurance of consistent and reliable dose delivery in a real-world use of the product.
authors.affiliation: Pfizer Global R&D, Groton, Connecticut 06340, USA. nancy.j.harper@pfizer.com
authors.forename: Nancy J
authors.initials: NJ
authors.lastname: Harper
authors.forename: Steven
authors.initials: S
authors.lastname: Gray
authors.forename: Jennifer
authors.initials: J
authors.lastname: De Groot
authors.forename: Joann M
authors.initials: JM
authors.lastname: Parker
authors.forename: Negar
authors.initials: N
authors.lastname: Sadrzadeh
authors.forename: Carlos
authors.initials: C
authors.lastname: Schuler
authors.forename: Jacqueline D
authors.initials: JD
authors.lastname: Schumacher
authors.forename: Sangita
authors.initials: S
authors.lastname: Seshadri
authors.forename: Adrian E
authors.initials: AE
authors.lastname: Smith
authors.forename: Gregory S
authors.initials: GS
authors.lastname: Steeno
authors.forename: Cynthia L
authors.initials: CL
authors.lastname: Stevenson
authors.forename: Romain
authors.initials: R
authors.lastname: Taniere
authors.forename: May
authors.initials: M
authors.lastname: Wang
authors.forename: David B
authors.initials: DB
authors.lastname: Bennett
mesh_terms: D000280:Administration, Inhalation; D000336:Aerosols; D004867:Equipment Design; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000627:therapeutic use; D007328:Insulin / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000627:therapeutic use*; D008168:Lung / Q000502:physiology*; D013816:Thermodynamics; D016896:Treatment Outcome
chemical_list: D000336:Aerosols; C473734:Exubera; D007004:Hypoglycemic Agents; D007328:Insulin