1. Inhalation of tobramycin using simulated cystic fibrosis patient profiles.
- Author
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Haynes A, Geller D, Weers J, Ament B, Pavkov R, Malcolmson R, Debonnett L, Mastoridis P, Yadao A, and Heuerding S
- Subjects
- Administration, Inhalation, Adult, Anti-Bacterial Agents administration & dosage, Child, Cystic Fibrosis physiopathology, Dry Powder Inhalers, Female, Humans, Lung physiopathology, Male, Pseudomonas Infections complications, Pseudomonas Infections physiopathology, Tobramycin administration & dosage, Young Adult, Anti-Bacterial Agents therapeutic use, Cystic Fibrosis microbiology, Lung microbiology, Models, Biological, Pharynx, Pseudomonas Infections drug therapy, Tobramycin therapeutic use
- Abstract
Introduction: TOBI
® Podhaler™ is a capsule-based drug-device combination (tobramycin inhalation powder [TIP] 28 mg capsules via unit-dose dry powder T-326 Inhaler [Podhaler™]) developed for treatment of Pseudomonas aeruginosa infection in cystic fibrosis (CF). We explored how inspiratory flow profiles and mouth-throat geometries affect drug delivery with the T-326 Inhaler., Methods: Inspiratory flow profiles were recorded from 38 subjects aged 6-71 who had CF and varying degrees of lung function impairment. Ten of the inspiratory flow profiles were simulated in the laboratory using a custom breath simulator to determine delivered dose (DD) from the T-326 Inhaler. In vitro total lung dose (TLDin vitro ) was measured using four anatomical throat models, ranging from a child to a large adult., Results: Aerosol performance was assessed across a range of inspiratory flow profiles. Mean DD ranged from 88.8% to 97.0% of declared capsule content. TLDin vitro ranged from 54.8% to 72.4% of capsule content between the flow profile/throat options tested, and the mean TLDin vitro across the range of flow profiles and anatomical throats tested was 63 ± 5%., Conclusions: Our findings indicate that the T-326 Inhaler provides reliable drug delivery at flow rates likely to be achieved by a broad spectrum of patients with CF. Importantly, forceful inhalation was not required to achieve a robust TLDin vitro . Pediatr Pulmonol. 2016;51:1159-1167. © 2016 Wiley Periodicals, Inc., (© 2016 Wiley Periodicals, Inc.)- Published
- 2016
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