title: Manufacturing and device options for the delivery of biotherapeutics.
abstract: Biotherapeutic aerosol formulations are an intense area of interest for systemic and local drug delivery. This article provides a short overview of typical factors required specifically for biotherapeutic aerosol formulation design, the processing options open for consideration, and the issue of inhalation device selection. Focusing on spray drying, four case studies are used to highlight the relevant issues, describing investigations into: (1) the mechanical stresses occurring in bacteriophage formulations during spray-dryer atomization; (2) modeling of the spray-dryer process and droplet drying kinetics, to assist process design and predictions of formulation stability; (3) a predictive approach to the design and processing of a five-component dry powder aerosol formulation; and (4) the survival of bacteriophages after pressurized metered dose inhaler atomization.
authors.affiliation: Department of Mechanical Engineering, University of Alberta , Edmonton, AB, Canada .
authors.forename: Susan
authors.initials: S
authors.lastname: Hoe
authors.forename: Mohammed A
authors.initials: MA
authors.lastname: Boraey
authors.forename: James W
authors.initials: JW
authors.lastname: Ivey
authors.forename: Warren H
authors.initials: WH
authors.lastname: Finlay
authors.forename: Reinhard
authors.initials: R
authors.lastname: Vehring
mesh_terms: D000280:Administration, Inhalation; D001691:Biological Therapy / Q000295:instrumentation* / Q000379:methods; D016503:Drug Delivery Systems / Q000295:instrumentation* / Q000379:methods; D004867:Equipment Design; D006801:Humans; D008171:Lung Diseases / Q000188:drug therapy; D008420:Manufactured Materials; D009330:Nebulizers and Vaporizers; D013314:Stress, Mechanical
keywords: bacteriophages; biotherapeutics; droplet drying kinetics; dry powder inhaler; metered dose inhaler; predictive approach; process modeling; spray drying