Effect of inhalation profile and throat geometry on predicted lung deposition of budesonide and formoterol (BF) in COPD: An in-vitro comparison of Spiromax with Turbuhaler

International Journal of Pharmaceutics

Volumn 491, Issue 1-2, 2015, Pages 268-276

  Chrystyn, Henry ^a   Safioti, Guilherme ^b   Keegstra, Johan René ^c   Gopalan, Gokul ^d,e  

^a Inhalation Consultancy Ltd   (United Kingdom)

^b Medical Affairs Department   (Sweden)

^c TEVA Pharmachemie   (Netherlands)

^d TEVA PHARMACEUTICALS   (Israel)

^e NONE   (United States)

Author keywords

Anatomical throat; Chronic obstructive pulmonary disease; Dose constancy; Dry power inhaler; Inhalation manoeuvre; Inhalation profile

Indexed keywords

BUDESONIDE; FORMOTEROL; BRONCHODILATING AGENT; FORMOTEROL FUMARATE;

ARTICLE; CHRONIC OBSTRUCTIVE LUNG DISEASE; CLINICAL ARTICLE; DEVICE COMPARISON; DRY POWDER INHALER; GEOMETRY; HUMAN; IN VITRO STUDY; LUNG; METERED DOSE INHALER; PREDICTION; PRIORITY JOURNAL; SPIROMAX; THROAT; ANATOMIC MODEL; ANATOMY AND HISTOLOGY; COMPARATIVE STUDY; INHALATIONAL DRUG ADMINISTRATION; METABOLISM; PARTICLE SIZE; PHARYNX; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE;

ADMINISTRATION, INHALATION; BRONCHODILATOR AGENTS; BUDESONIDE; DRY POWDER INHALERS; FORMOTEROL FUMARATE; HUMANS; LUNG; MODELS, ANATOMIC; PARTICLE SIZE; PHARYNX; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE;

EID: 84936818589     PISSN: 03785173     EISSN: 18733476     Source Type: Journal    
DOI: 10.1016/j.ijpharm.2015.05.076     Document Type: Article

References (43)

1. R.A. Al-Showair, W.Y. Tarsin, K.H. Assi, S.B. Pearson, and H. Chrystyn Can all patients with COPD use the correct inhalation flow with all inhalers and does training help Respir. Med. 101 2007 2395 2401
2. Arp, J., Goller, M., Keegstra, H., 2013. Uniformity of delivered dose from the first to last dose of the BF Spiromax inhaler in the laboratory and under ′real-world′ conditions. Abstract #66 presented at Drug delivery to the lung.
3. P.J. Atkins Dry powder inhalers: an overview Respir. Care 50 2005 1304 1312
4. ® (T) dry powder inhalers (DPI) in healthy adults (HA) and in patients with asthma (A) or COPD. Eur. Respir. J. 42 (Suppl 57), P711.
5. W. Azouz, P. Chetcuti, H.S. Hosker, D. Saralaya, J. Stephenson, and H. Chrystyn The inhalation characteristics of patients when they use different dry powder inhalers J. Aerosol Med. Pulm. Drug. Deliv. 28 2015 35 42
6. R. Barrons, A. Pegram, and A. Borries Inhaler device selection: special considerations in elderly patients with chronic obstructive pulmonary disease Am. J. Health Syst. Pharm. 68 2011 1221 1232
7. M.E. Broeders, J. Molema, W.C. Hop, N.A. Vermue, and H.T. Folgering The course of inhalation profiles during an exacerbation of obstructive lung disease Respir. Med. 98 2004 1173 1179
8. H. Chrystyn Methods to determine lung distribution of inhaled drugs-could gamma scintigraphy be the gold standard? Br. J. Clin. Pharmacol. 49 2000 525 528
9. H. Chrystyn Is inhalation rate important for a dry powder inhaler? Using the In-Check Dial to identify these rates Respir. Med. 97 2003 181 187
10. Council of Europe, 2014. European Pharmacopoeia, 8th ed. https://www.edqm.eu/en/european-pharmacopoeia-8th-edition-1563. html.
11. A.H. de Boer, G.K. Bolhuis, D. Gjaltema, and P. Hagedoorn Inhalation characteristics and their effects on in-vitro drug delivery from dry powder inhalers: Part 3: the effect of flow increase rate (FIR) on the in-vitro drug release from the Pulmicort 200 Turbuhaler Int. J. Pharm. 153 1997 67 77
12. M.B. Dolovich, and R. Dhand Aerosol drug delivery: developments in device design and clinical use Lancet 377 2011 1032 1045
13. EU Clinical Trials Register, 2013. A 12-week, randomized, open-label, parallel group study to evaluate the mastery of inhaler technique for budesonide formoterol (BF) Spiromax(160/4.5 and 320/9 mcg) as compared to SYMBICORT® TURBOHALER® (200/6 and 400/12 mcg) as treatment for adult patients with asthma (the Easy Low Instruction Over Time [ELIOT] Study). https://www.clinicaltrialsregister.eu/ctr-search/trial/2013-004630-14/GB.
14. European Medicines Agency -Committee for Medicinal Products for Human Use (CHMP), 2006. Guideline on the pharmaceutical quality of inhalation and nasal products http://www.ema.europa.eu/docs/en-GB/document-library/Scientific-guideline/2009/09/WC500003568.pdf
15. A. Fernandez Tena, and P. Casan Clara Deposition of inhaled particles in the lungs Arch. Bronconeumol. 48 2012 240 246
16. J.C. Virchow, G. Gopalan, R. Rodriguez-Roisin, and Y. Shu P227 Efficacy And Safety Of Budesonide-formoterol (BF) Spiromax® In Adults And Adolescents With Asthma: Randomised Comparison With BF Turbuhaler® Thorax 69 2014 A176
17. D.R. Hess Aerosol delivery devices in the treatment of asthma Respir. Care 53 2008 699 723 discussion 723-725
18. International Society for Aerosols in Medicine, 2012. Science http://www.isam.org/index.php?option=com-content&view=article&id=46&Itemid=183.
19. K. Kanabuchi, T. Kondo, T. Tanigaki, S. Tajiri, N. Hayama, Y. Takahari, and K. Iwao Minimal inspiratory flow from dry powder inhalers according to a biphasic model of pressure vs flow relationship Tokai J. Exp. Clin. Med. 36 2011 1 4
20. G.M. Keating, and D. Faulds Airmax: a multi-dose dry powder inhaler Drugs 62 2002 1887 1895 discussion 1896-1897
21. N.R. Labiris, and M.B. Dolovich Pulmonary drug delivery. Part I: physiological factors affecting therapeutic effectiveness of aerosolized medications Br. J. Clin. Pharmacol. 56 2003 588 599
22. S.C. Lareau, and B.P. Yawn Improving adherence with inhaler therapy in COPD Int. J. Chron. Obstruct. Pulmon. Dis. 5 2010 401 406
23. B.L. Laube, H.M. Janssens, F.H. de Jongh, S.G. Devadason, R. Dhand, and P. Diot What the pulmonary specialist should know about the new inhalation therapies Eur. Respir. J. 37 2011 1308 1331
24. F. Lavorini, A. Magnan, J.C. Dubus, T. Voshaar, L. Corbetta, and M. Broeders Effect of incorrect use of dry powder inhalers on management of patients with asthma and COPD Respir. Med. 102 2008 593 604
25. L.P. Malmberg, P. Rytila, P. Happonen, and T. Haahtela Inspiratory flows through dry powder inhaler in chronic obstructive pulmonary disease: age and gender rather than severity matters Int. J. Chron. Obstruct. Pulmon. Dis. 5 2010 257 262
26. M. Molimard How to achieve good compliance and adherence with inhalation therapy Curr. Med. Res. Opin. 21 Suppl. (4) 2005 S33 S37
27. D.K. Nadarassan, K.H. Assi, and H. Chrystyn Aerodynamic characteristics of a dry powder inhaler at low inhalation flows using a mixing inlet with an Andersen Cascade Impactor Eur. J. Pharm. Sci. 39 2010 348 354
28. B. Olsson, L. Borgstrom, H. Lundback, and M. Svensson 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. 26 2013 355 369
29. ®. Clin. Drug Invest 20 2000 25 33
30. R. Pauwels, S. Newman, and L. Borgstrom Airway deposition and airway effects of antiasthma drugs delivered from metered-dose inhalers Eur. Respir. J. 10 1997 2127 2138
31. S.E. Pritchard, and D.W. McRobbie Studies of the human oropharyngeal airspaces using magnetic resonance imaging. II. The use of three-dimensional gated MRI to determine the influence of mouthpiece diameter and resistance of inhalation devices on the oropharyngeal airspace geometry J. Aerosol Med. 17 2004 310 324
32. C.S. Rand Patient adherence with COPD therapy Eur. Respir. Rev. 14 2005 97 101
33. J.L. Rau Practical problems with aerosol therapy in COPD Respir. Care 51 2006 158 172
34. N. Roche, H. Chrystyn, F. Lavorini, A. Agusti, J.C. Virchow, P.R. Dekhuijzen, and D. Price Effectiveness of inhaler devices in adult asthma and COPD EMJ Respir. 1 2013 64 71
35. W. Tarsin, K.H. Assi, and H. Chrystyn In-vitro intra- and inter-inhaler flow rate-dependent dosage emission from a combination of budesonide and eformoterol in a dry powder inhaler J. Aerosol Med. 17 2004 25 32
36. Teva Pharma BV, 2014. DuoResp Spiromax Summary of Product Characteristics. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002348/human-med-001749. jsp&mid=WC0b01ac058001d124
37. M. Thomas, and A.E. Williams Are outcomes the same with all dry powder inhalers Int. J. Clin. Pract. 2005 33 35 Suppl. (149)
38. United States Pharmacopeia. USP 38-NF 33, 2014.
39. O.S. Usmani, M.F. Biddiscombe, and P.J. Barnes Regional lung deposition and bronchodilator response as a function of beta2-agonist particle size Am. J. Respir. Crit. Care Med. 172 2005 1497 1504
40. J.C. Virchow, G.K. Crompton, R. Dal Negro, S. Pedersen, A. Magnan, J. Seidenberg, and P.J. Barnes Importance of inhaler devices in the management of airway disease Respir. Med. 102 2008 10 19
41. Weisfeld, L., Gopalan, G., Shu, Y., Baconnet, B., Shah, T., 2013. Pharmacokinetics (PK) and safety of budesonide plus formoterol (BF) (160/4.5mcg) Spiromax® and BF (200/6mcg) Turbuhaler® following two inhalations (+/-charcoal [char] block) in healthy volunteers (HV). Eur. Respir. J. 42 (suppl. 57), Abstract #712.
42. Weisfeld, L., Gopalan, G., Shu, Y., Baconnet, B., Shah, T., 2013. Pharmacokinetics (PK) and safety of budesonide plus formoterol (BF) (320/9mcg) Spiromax® and BF (400/12mcg) Turbuhaler® following two inhalations (+/-charcoal [char] block) in healthy volunteers (HV). Eur. Respir. J. 42 (suppl. 57), Abstract #4630.
43. Y. Zhou, J. Sun, and Y.S. Cheng Comparison of deposition in the USP and physical mouth-throat models with solid and liquid particles J. Aerosol Med. Pulm. Drug Deliv. 24 2011 277 284