Dose emission characteristics of placebo pulmosphere® particles are unaffected by a subject's inhalation maneuver

Journal of Aerosol Medicine and Pulmonary Drug Delivery

Volumn 26, Issue 1, 2013, Pages 56-68

  Weers, Jeffry ^a   Ung, Keith ^a   Le, John ^a   Rao, Nagaraja ^a   Ament, Brian ^a   Axford, George ^a   Maltz, David ^a   Chan, Leo ^a  

^a NOVARTIS PHARMA AG   (Switzerland)

Author keywords

breathing profiles; dose inhalation errors; flow rate independence; PulmoSphere; Simoon Inhaler

Indexed keywords

PLACEBO;

ADULT; AEROSOL; ARTICLE; ASTHMA; BLISTER; CHRONIC OBSTRUCTIVE LUNG DISEASE; FEMALE; HUMAN; IN VITRO STUDY; INHALATION DEVICE; INHALATION MANEUVER; MAJOR CLINICAL STUDY; MALE; PHOTOMETRY; POWDER INHALER; SPRAY DRYING;

ADMINISTRATION, INHALATION; ADOLESCENT; ADULT; AEROSOLS; AGED; ASTHMA; CHILD; DRUG DELIVERY SYSTEMS; DRY POWDER INHALERS; FEMALE; HUMANS; MALE; MEDICATION ADHERENCE; MEDICATION ERRORS; MIDDLE AGED; PHOTOMETRY; POROSITY; POWDERS; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; TISSUE DISTRIBUTION; YOUNG ADULT;

EID: 84873343392     PISSN: 19412711     EISSN: 19412703     Source Type: Journal    
DOI: 10.1089/jamp.2012.0973     Document Type: Article

References (57)

1. Molimard M, Raherison C, Lignot S, Depont F, Abouelfath A, and Moore N: Assessment of handling of inhaler devices in real life: an observational study in 3811 patients in primary care. J Aerosol Med. 2003;16:249-254 (Pubitemid 37169635)
2. Broeders M, Molema J, Hop W, and Folgering H: Inhalation profiles in asthmatics and COPD patients: reproducibility and effect of instruction. J Aerosol Med. 2003;16:131-141 (Pubitemid 36702667)
3. Lavorini F, Magnan A, Dubus JC, Voshaar T, Corbetta L, Broeders M, Dekhuijzen R, Sanchis J, Viejo JL, Barnes P, Corrigan C, Levy M, and Crompton GK: Effect of incorrect use of dry powder inhalers on management of patients with asthma and COPD. Respir Med. 2008;102:593-604
4. Dixon J, and Simpson I: Appealing to users-designing inhalers to maximize compliance and minimize misuse. Proceedings of RDD Europe 2009. Davis Healthcare, River Grove, IL; pp. 117-127, 2009
5. Schulte M, Osseiran K, Betz R, Wencker M, Brand P, Meyer T, and Haidl P: Handling of and preferences for available dry powder inhaler systems by patients with asthma and COPD. J Aerosol Med Pulm Drug Del. 2008;21:321-328
6. Borgström L, Asking L, and Thorsson L: Idealhalers or realhalers? A comparison of Diskus and Turbuhaler. Int J Clin Pract. 2005;59:1488-1495 (Pubitemid 43922640)
7. Rootmensen GN, van Keimpema ARJ, Jansen HM, and de Haan RJ: Predictors of incorrect inhalation technique in patients with asthma or COPD: a study using a validated videotaped scoring method. J Aerosol Med Pulm Drug Deliv. 2010;23:323-328
8. Chrystyn H: The Diskus: a review of its position among dry powder inhaler devices. Int J Clin Pract. 2006;61:1022-1036 (Pubitemid 46744072)
9. Borgström L, Asking L, and Lipniunas P: An in vivo and in vitro comparison of two powder inhalers following storage at hot/humid conditions. J Aerosol Med. 2005;18:304-310 (Pubitemid 41395732)
10. Everard ML: Aerosol therapy: regimen and device compliance in daily practice. Paedeatr Respir Rev. 2006;7S:S80-S82 (Pubitemid 43906246)
11. Everard ML, Devadason SG, and Le Souef PN: Flow early in the inspiratory maneuvre affects the aerosol particle size distribution from a Turbuhaler. Respir Med. 1997;91:624-628 (Pubitemid 27453661)
12. Hannay M, Govind N, Ludzik A, Jansen R, and Fletcher I: Overcoming the challenges of developing combination products in different inhalation device platforms. Proceedings of Respiratory Drug Delivery 2008. Davis Healthcare, River Grove, IL: pp. 319-328, 2008
13. Tajber L, Corrigan OI, and Healy AM: Spray drying of budesonide, formoterol fumarate and their composites II. Statistical factorial design and in vitro deposition properties. Int J Pharm. 2009;367:86-96
14. Westmeier R, and Steckel H: Combination particles containing salmeterol xinafoate and fluticasone propionate: formulation and aerodynamic assessment. J Pharm Sci. 2008;97:2299-2310
15. Pitchayajittipong C, Shur J, and Price R: Engineering of crystalline combination inhalation particles of a long-acting b2-agonist and a corticosteroid. Pharm Res. 2009;26:2657-2666
16. Clark A, and Hollingworth A: The relationship between powder inhaler resistance and peak inspiratory conditions in healthy volunteers-implications for in-vitro testing. J Aerosol Med. 1993;6:99-110 (Pubitemid 23231366)
17. Sarinas PS, Robinson TE, Clark AR, Canfield J, Chitkara RK, and Fick RB: Inspiratory flow rate and dynamic lung function in cystic fibrosis and chronic obstructive pulmonary disease. Chest. 1998;114:988-992 (Pubitemid 28495891)
18. Chrystyn H: Effects of device design on patient compliance: comparing the same drug in different devices. Proceedings of RDD Europe 2009. Davis Healthcare International Publishing, River Grove, IL; pp. 105-116, 2009
19. DeBoer AH, Winter HMI, and Lerk CF: Inhalation characteristics and their effects on in vitro drug 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
20. De Boer AH, Gjaltema D, and Hagedoorn P: Inhalation characteristics and their effects on in vitro drug delivery from dry powder inhalers: Part 2. Effect of peak flow rate (PIFR) and inspiration time on the in vitro drug release from three different types of commercial dry powder inhalers. Int J Pharm. 1996;138:45-56 (Pubitemid 26241921)
21. Chodosh S, Flanders JS, Kesten S, Serby CW, Hochrainer D, and Witek TJ: Effective delivery of particles with the Handihaler dry powder inhalation system over a range of chronic obstructive pulmonary disease severity. J Aerosol Med. 2001;14:309-315 (Pubitemid 32802033)
22. Pavkov R, Singh D, and Reitveld I: Concept 1 (a new single dose dry powder inhaler) peak inspiratory flow rate study with COPD patients. Proceedings of Respiratory Drug Delivery 2008. Davis Healthcare International Publishing, River Grove, IL; pp. 683-686, 2008
23. Snyder HE, and Lechuga-Ballesteros D: Spray-drying: theory and pharmaceutical applications. In: LL Augsburger, and SW Hoag (eds). Pharmaceutical Dosage Forms: Tablets, Volume 1: Unit Operations and Mechanical Properties. Informa Healthcare, New York, NY; pp. 227-260, 2008
24. Dellamary LA, Tarara TE, Smith DJ, Woelk CH, Adractas A, Costello M, Gill H, and Weers JG: Hollow porous particles in metered dose inhalers. Pharm Res. 2000;17:168-174 (Pubitemid 30158365)
25. Tarara TE, Weers JG, and Dellamary LA: Engineered powders for inhalation. Proceedings of Respiratory Drug Delivery VII. Serentec Press, Raleigh, NC; pp. 413-416, 2000
26. Duddu SP, Sisk SA, Walter YH, Tarara TE, Trimble K, Clark AR, Eldon M, Elton RC, Pickford M, Hirst PH, Newman SP, and Weers JG: Improved lung delivery from a passive dry powder inhaler using an engineered PulmoSphere powder. Pharm Res. 2002;19:689-695 (Pubitemid 34553679)
27. Geller D, Weers J, and Heuerding S: Development of a dry powder formulation of tobramycin using PulmoSphere technology. J Aerosol Med Pulm Drug Deliv. 2011;24: 175-182
28. Maltz D, Glusker M, Axford G, Postich M, Rao N, and Ung K: A novel passive dry powder inhaler for unit dose delivery to the deep lung. Proceedings of Respiratory Drug Delivery 2008. Davis Healthcare, River Grove, IL; pp. 669-673, 2008
29. Grgic B, Finlay WH, Burnell PKP, and Heenan AF: In vitro intersubject and intrasubject deposition measurements in realistic mouth-throat geometries. Aerosol Sci. 2004;35:1025-1040 (Pubitemid 38993745)
30. DeHaan WH, and Finlay WH: Predicting extrathoracic deposition from dry powder inhalers. J Aerosol Sci. 2004;35: 309-331 (Pubitemid 38294375)
31. DeHaan WH, and Finlay WH: In vitro monodisperse aerosol deposition in the mouth and throat with six different inhalation devices. J Aerosol Med. 2001;14:361-367 (Pubitemid 32802039)
32. Matida EA, Finlay WH, Lange CF, and Grgic B: Improved numerical simulation of aerosol deposition in an idealized mouth-throat geometry. J Aerosol Sci. 2004;35:1-19 (Pubitemid 37476251)
33. Stapleton KW, Guentsch E, Hoskinson MK, and Finlay WH: On the suitability of k-e turbulence modeling for aerosol deposition in the mouth and throat: a comparison with experiment. J Aerosol Sci. 2000;31:739-749 (Pubitemid 30173204)
34. Grgic B, Finlay WH, Matida EA, and Pollard A: Regional aerosol deposition and flow measurements in the idealized mouth and throat. J Aerosol Sci. 2004;35:21-32 (Pubitemid 37476252)
35. Dinh KV, Myers DJ, Noymer PD, and Cassella JV: In vitro aerosol deposition in the oropharyngeal region of Staccato loxapine. J Aerosol Med Pulm Drug Deliv. 2010;23:253-260
36. Bisgaard H, Klug B, Sumby BS, and Burnell PKP: Fine particle mass from the Diskus inhaler and Turbuhaler inhaler in children with asthma. Eur Resp J. 1998;11:1111-1115 (Pubitemid 28281031)
37. Standaert TA, Speirs RJ, Rao N, Ung K, Tep V, Lin T-C, Rourke AM, and Challoner P: Young cystic fibrosis patients can effectively use a novel high payload capsule-based dry powder inhaler with tobramycin powder for inhalation (TPI). Pediatr Pulmonol. 2004;38(S27):284
38. University of Alberta: The ARLA Respiratory Deposition Calculator. Available at: http://www.mece.ualberta.ca/ arla/aerosoldepositioncalculator- adult.html. Accessed December 2, 2011
39. Burnell PK, Asking L, Borgström L, Nichols SC, Olsson B, Prime D, and Shrubb I: Studies of the human oropharyngeal airspaces using magnetic resonance imaging IV-the oropharyngeal retention effect of four inhalation delivery systems. J Aerosol Med. 2007;20:269-281 (Pubitemid 47463183)
40. Clark AR, Chambers CB, Muir D, Newhouse MT, Paboojian S, and Schuler C: The effect of biphasic inhalation profiles on the deposition and clearance of coarse (6.5 lm) bolus aerosols. J Aerosol Med. 2007;20:75-82 (Pubitemid 46542938)
41. Newman SP, Hollingworth A, and Clark AR: Effect of different modes of inhalation on drug delivery from a dry powder inhaler. Int J Pharm. 1994;102:127-132 (Pubitemid 24042986)
42. Newhouse MT, Hirst PH, Duddu SP, Walter YH, Tarara TE, Clark AR, and Weers JG: Inhalation of a dry powder tobramycin PulmoSphere formulation in healthy volunteers. Chest. 2003;124:360-366 (Pubitemid 36851374)
43. Leach CL, Davidson PJ, Hasselquist BE, and Boudreau RJ: Influence of particle size and patient dosing technique on lung deposition of HFA-beclomethasone from a metered dose inhaler. J Aerosol Med. 2005;18:379-385 (Pubitemid 43038404)
44. Broeders MEAC, Molema J, Vermue NA, and Folgering HTM: Peak inspiratory flow rate and slope of the inhalation profiles in dry powder inhalers. Eur Resp J. 2001;18:780-783 (Pubitemid 33076919)
45. Weers JG, Bell J, Chan H-K, Cipolla D, Dunbar C, Hickey AJ, and Smith IJ: Pulmonary formulations: what remains to be done? J Aerosol Med Pulm Drug Del. 2010;23 (Suppl 2):S5-S23
46. Borgström L, Bondesson E, Morén F, Trofast E, and Newman SP: Lung deposition of budesonide inhaled via Turbuhaler: a comparison with terbutaline sulphate in normal subjects. Eur Resp J. 1994;7:69-73 (Pubitemid 24075127)
47. Dunbar CA, Hickey AJ, and Holzner P: Dispersion and characterization of pharmaceutical dry powder aerosols. KONA. 1998;16:7-45
48. Hill M, Vaughn L, and Dolovich M: Dose targeting of dry powder inhalers. Proceedings of Respiratory Drug Delivery V, Vol. 1; pp. 197-208, 1996
49. Dunbar C: Porous particles for inhalation: the science behind their improved dispersibility. Proceedings of Respiratory Drug Delivery 2006. Davis Healthcare, River Grove, IL; pp. 307-313, 2006
50. Dunbar C, Scheuch G, Sommerer K, DeLong M, Verma A, and Batycky R: In vitro and in vivo dose delivery characteristics of large porous particles for inhalation. Int J Pharm. 2002;245:179-189 (Pubitemid 35299903)
51. DeLong M, Wright J, Dawson M, Meyer T, Sommerer K, and Dunbar C: Dose delivery characteristics of the AIR pulmonary delivery system over a range of inspiratory flow rates. J Aerosol Med. 2005;18:452-459 (Pubitemid 43038410)
52. Delvadia RR, Longest PW, and Byron PR: In vitro tests for aerosol deposition. 1: scaling a physical model of the upper airways to predict drug deposition variation in normal humans. J Aerosol Med Pulm Drug Deliv. 2012;25:32-40
53. Olsson B, Borgström L, Svensson M, and Lundback H: Modeling oropharyngeal cast deposition to predict lung delivery from powder inhalers. In: RN Dalby, PR Byron, J Peart, JD Suman, SJ Farr, and PM Young (eds). Proceedings of Respiratory Drug Delivery 2008, Vol. I. Davis Healthcare International Publishing: River Grove, IL; pp. 197-206, 2008
54. Ung KT, Axford G, Chan L, Glusker M, Le J, Maltz D, Rao N, and Weers JG: Effect of powder release kinetics on the performance of a dry powder inhaler. In: RN Dalby, PR Byron, J Peart, JD Suman, SJ Farr, and PM Young (eds). Proceedings of Respiratory Drug Delivery 2012 (in press)
55. Borgström L, Olsson B, and Thorsson L: Degree of throat deposition can explain the variability in lung deposition of inhaled drugs. J Aerosol Med. 2006;19:473-483 (Pubitemid 46067766)
56. Weers JG, Tarara TE, and Clark AR: Design of fine particles for pulmonary drug delivery. Expert Opin Drug Deliv. 2007; 4:297-313 (Pubitemid 46772848)
57. Weers JG, Ung K, Chan L, Glusker M, Ament B, Le J, Rao N, Axford G, and Maltz DS: Minimizing human factors effects through improved inhaler design. In: RN Dalby, PR Byron, J Peart, JD Suman, SJ Farr, and PM Young (eds). Proceedings of Respiratory Drug Delivery 2012 (in press).