Inhalation of tobramycin using simulated cystic fibrosis patient profiles

Pediatric Pulmonology

Volumn 51, Issue 11, 2016, Pages 1159-1167

  Haynes, Alfred ^a   Geller, David ^b   Weers, Jeffry ^a   Ament, Brian ^a   Pavkov, Richard ^a   Malcolmson, Richard ^a   Debonnett, Laurie ^a   Mastoridis, Paul ^a   Yadao, Anthony ^a   Heuerding, Silvia ^a  

^a NOVARTIS PHARMA AG   (Switzerland)

^b FLORIDA STATE UNIVERSITY COLLEGE OF MEDICINE   (United States)

Author keywords

delivered dose; dry powder inhaler; inspiratory flow; PulmoSphere; T 326 Inhaler

Indexed keywords

TOBRAMYCIN; ANTIINFECTIVE AGENT;

ADOLESCENT; ADULT; AEROSOL; AGED; ARTICLE; CHILD; CLINICAL ARTICLE; CONTROLLED STUDY; CYSTIC FIBROSIS; DISEASE SEVERITY; DRUG DELIVERY DEVICE; DRUG FORMULATION; DRY POWDER INHALER; FEMALE; FORCED EXPIRATORY VOLUME; HUMAN; IN VITRO STUDY; IN VIVO STUDY; INFORMED CONSENT; MALE; MIDDLE AGED; PEAK INSPIRATORY FLOW; PRESCHOOL CHILD; PRIORITY JOURNAL; RESPIRATORY TRACT PARAMETERS; SCHOOL CHILD; SIMULATOR; TOTAL LUNG DOSE; YOUNG ADULT; BIOLOGICAL MODEL; COMPLICATION; INHALATIONAL DRUG ADMINISTRATION; LUNG; MICROBIOLOGY; PATHOPHYSIOLOGY; PHARYNX; PSEUDOMONAS INFECTIONS;

ADMINISTRATION, INHALATION; ADULT; ANTI-BACTERIAL AGENTS; CHILD; CYSTIC FIBROSIS; DRY POWDER INHALERS; FEMALE; HUMANS; LUNG; MALE; MODELS, BIOLOGICAL; PHARYNX; PSEUDOMONAS INFECTIONS; TOBRAMYCIN; YOUNG ADULT;

EID: 84964645536     PISSN: 87556863     EISSN: 10990496     Source Type: Journal    
DOI: 10.1002/ppul.23451     Document Type: Article

References (35)

1. Sawicki GS, Sellers DE, Robinson WM. High treatment burden in adults with cystic fibrosis: challenges to disease self-management. J Cyst Fibros 2009; 8:91–96.
2. Sawicki GS, Ren CL, Konstan MW, Millar SJ, Pasta DJ, Quittner AL. Treatment complexity in cystic fibrosis: trends over time and associations with site-specific outcomes. J Cyst Fibros 2013; 12:461–467.
3. Briesacher BA, Quittner AL, Saiman L, Sacco P, Fouayzi H, Quittell LM. Adherence with tobramycin inhaled solution and health care utilization. BMC Pulm Med 2011; 11:5.
4. Sawicki GS, Tiddens H. Managing treatment complexity in cystic fibrosis: challenges and opportunities. Pediatr Pulmonol 2012; 47:523–533.
5. Geller DE, Weers J, Heuerding S. Development of an inhaled dry-powder formulation of tobramycin using PulmoSphere™ technology. J Aerosol Med Pulm Drug Deliv 2011; 24:175–182.
6. Harrison MJ, McCarthy M, Fleming C, Hickey C, Shortt C, Eustace JA, Murphy DM, Plant BJ. Inhaled versus nebulised tobramycin: a real world comparison in adult cystic fibrosis (CF). J Cyst Fibros 2014; 13:692–698.
7. Konstan MW, Flume PA, Kappler M, Chiron R, Higgins M, Brockhaus F, Zhang J, Angyalosi G, He E, Geller DE. Safety, efficacy and convenience of tobramycin inhalation powder in cystic fibrosis patients: the EAGER trial. J Cyst Fibros 2011; 10:54–61.
8. Weers J, Tarara T. The PulmoSphere™ platform for pulmonary drug delivery. Ther Deliv 2014; 5:277–295.
9. Pavkov R, Mueller S, Fiebich K, Singh D, Stowasser F, Pignatelli G, Walter B, Ziegler D, Dalvi M, Dederichs J, Rietveld I. Characteristics of a capsule based dry powder inhaler for the delivery of indacaterol. Curr Med Res Opin 2010; 26:2527–2533.
10. Janssens W, VandenBrande P, Hardeman E, De Langhe E, Philps T, Troosters T, Decramer M. Inspiratory flow rates at different levels of resistance in elderly COPD patients. Eur Respir J 2008; 31:78–83.
11. Laube BL, Janssens HM, de Jongh FH, Devadason SG, Dhand R, Diot P, Everard ML, Horvath I, Navalesi P, Voshaar T, Chrystyn H. What the pulmonary specialist should know about the new inhalation therapies. Eur Respir J 2011; 37:1308–1331.
12. Wang X, Dockery DW, Wypij D, Fay ME, Ferris BG, Jr., Pulmonary function between 6 and 18 years of age. Pediatr Pulmonol 1993; 15:75–88.
13. Hankinson JL, Odencrantz JR, Fedan KB. Spirometric reference values from a sample of the general U.S. population. Am J Respir Crit Care Med 1999; 159:179–187.
14. DeHaan WH, Finlay WH. Predicting extrathoracic deposition from dry powder inhalers. J Aerosol Sci 2004; 35:309–331.
15. Finlay WH, Golshahi L, Noga M, Flores-Mir C. Choosing 3-D mouth-throat dimensions: a rational merging of medical imaging and aerodynamics. Respir Drug Deliv 2010; 1:185–194.
16. Ruzycki CA, Golshahi L, Vehring R, Finlay WH. Comparison of in vitro deposition of pharmaceutical aerosols in an idealized child throat with in vivo deposition in the upper respiratory tract of children. Pharm Res 2014; 31:1525–1535.
17. Olsson B, Borgström L, Lundbäck H, Svensson M. Validation of a general In vitro approach for prediction of total lung deposition in healthy adults for pharmaceutical inhalation products. J Aerosol Med Pulm Drug Deliv 2013; 26:355–369.
18. Delvadia R, Hindle M, Longest PW, Byron PR. In vitro tests for aerosol deposition II: IVIVCs for different dry powder inhalers in normal adults. J Aerosol Med Pulm Drug Deliv 2013; 26:138–144.
19. ®. J Aerosol Med Pulm Drug Deliv 2015; 28:268–280.
20. Dunnink MA, Doeleman WR, Trappenburg JC, de Vries WR. Respiratory muscle strength in stable adolescent and adult patients with cystic fibrosis. J Cyst Fibros 2009; 8:31–36.
21. Pinet C, Cassart M, Scillia P, Lamotte M, Knoop C, Casimir G, Mélot C, Estenne M. Function and bulk of respiratory and limb muscles in patients with cystic fibrosis. Am J Respir Crit Care Med 2003; 168:989–994.
22. Barry SC, Gallagher CG. Corticosteroids and skeletal muscle function in cystic fibrosis. J Appl Physiol 2003; 95:1379–1384.
23. Sarinas PS, Robinson TE, Clark AR, Canfield J, Jr., Chitkara RK, Fick RB, Jr., Inspiratory flow rate and dynamic lung function in cystic fibrosis and chronic obstructive lung diseases. Chest 1998; 114:988–992.
24. DeBoer AH, Winter HM, Lerk CF. Inhalation characteristics and their effects on in vitro delivery from dry powder inhalers: part 1. Inhalation characteristics, work of breathing, and volunteer's preference in dependence of the inhaler resistance. Int J Pharm 1996; 130:231–244.
25. Elkins MR, Robinson P, Anderson SD, Perry CP, Daviskas E, Charlton B. Inspiratory flows and volumes in subjects with cystic fibrosis using a new dry powder inhaler device. Open Respir Med J 2014; 8:1–7.
26. Tiddens HA, Geller DE, Challoner P, Speirs RJ, Kesser KC, Overbeek SE, Humble D, Shrewsbury SB, Standaert TA. Effect of dry powder inhaler resistance on the inspiratory flow rates and volumes of cystic fibrosis patients of six years and older. J Aerosol Med 2006; 19:456–465.
27. Newman SP, Hollingworth AM, Clark AR. Effect of different modes on inhalation on drug delivery from a dry powder inhaler. Int J Pharm 1994; 102:127–132.
28. Newhouse MT, Hirst PH, Duddu SP, Walter YH, Tarara TE, Clark AR, Weers JG. Inhalation of a dry powder tobramycin PulmoSphere formulation in healthy volunteers. Chest 2003; 124:360–366.
29. Duddu SP, Sisk SA, Walter YH, Tarara TE, Trimble KR, Clark AR, Eldon MA, Elton RC, Pickford M, Hirst PH, Newman SP, Weers JG. Improved lung delivery from a passive dry powder inhaler using an Engineered PulmoSphere powder. Pharm Res 2002; 19:689–695.
30. Lenney W, Edenborough F, Kho P, Kovarik JM. Lung deposition of inhaled tobramycin with eFlow Rapid/LC Plus jet nebulizer in healthy and cystic fibrosis subjects. J Cyst Fibros 2011; 10:9–14.
31. Coates AL, Dinh L, MacNeish CF, Rollin T, Gagnon S, Ho SL, Lands LC. Accounting for radioactivity before and after nebulization of tobramycin to insure accuracy of quantification of lung deposition. J Aerosol Med 2000; 13:169–78.
32. Weers JG, Bell J, Chan HK, Cipolla D, Dunbar C, Hickey AJ, Smith IJ. Pulmonary formulations: what remains to be done? J Aerosol Med Pulm Drug Deliv 2010; 23:S5–S23.
33. ® in children with cystic fibrosis. Eur Respir J 1997; 10:2023–2028.
34. Jaques A, Daviskas E, Turton JA, McKay K, Cooper P, Stirling RG, Robertson CF, Bye PT, Lesouëf PN, Shadbolt B, Anderson SD, Charlton B. Inhaled mannitol improves lung function in cystic fibrosis. Chest 2008; 133:1388–1396.
35. Tiddens HA, Bos AC, Mouton JW, Devadason S, Janssens HM. Inhaled antibiotics: dry or wet? Eur Respir J 2014; 44:1308–1318.