Połączenia glikokortykosteroidu z długo działającym β2-mimetykiem w inhalatorze ciśnieniowym dozującym – jakie, komu, kiedy? Praca przeglądowa
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Opublikowane:
wrz 29, 2021
Słowa kluczowe:
inhalator ciśnieniowy dozujący, propionian flutykazonu, salmeterol, chmura aerozolowa, astma, dzieci, dorośli
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Abstrakt
W pracy o charakterze przeglądowym przedstawiono dane dotyczące inhalatorów ciśnieniowych dozujących. Omówiono zasady działania i formulacje leków w tego typu inhalatorach. Pokazano różnice w charakterystyce chmur aerozolowych i wielkości depozycji płucnej wybranych leków inhalowanych z inhalatorów ciśnieniowych dozujących. Szczególny nacisk położono na inhalatory ciśnieniowe dozujące zawierające połączenia glikokortykosteroidu wziewnego z długo działającym β2-mimetykiem. Zwrócono uwagę na konieczność stosowania odpowiednich komór inhalacyjnych podczas inhalacji leków z inhalatora ciśnieniowego dozującego. Porównano efektywność i koszty terapii z inhalatorów ciśnieniowych dozujących vs inne urządzenia inhalacyjne (inhalatory suchego proszku, nebulizatory). Wyszczególniono sytuacje kliniczne, w których inhalator ciśnieniowy dozujący może być pierwszym wyborem spośród innych inhalatorów u chorych na astmę lub przewlekłą obturacyjną chorobę płuc.
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Emeryk, A., Janeczek , K., Sosnowski , T. R., & Emeryk-Maksymiuk , J. (2021). Połączenia glikokortykosteroidu z długo działającym β2-mimetykiem w inhalatorze ciśnieniowym dozującym – jakie, komu, kiedy?. Alergoprofil, 17(3), 19-26. https://doi.org/10.24292/01.AP.173300821
Numer
Dział
THERAPY
Utwór dostępny jest na licencji Creative Commons Uznanie autorstwa – Użycie niekomercyjne 4.0 Międzynarodowe.
Copyright: © Medical Education sp. z o.o. This is an Open Access article distributed under the terms of the Attribution-NonCommercial 4.0 International (CC BY-NC 4.0). License (https://creativecommons.org/licenses/by-nc/4.0/), allowing third parties to copy and redistribute the material in any medium or format and to remix, transform, and build upon the material, provided the original work is properly cited and states its license.
Address reprint requests to: Medical Education, Marcin Kuźma (marcin.kuzma@mededu.pl)
Bibliografia
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3. Stein SW, Charles G. Thiel ChG. The history of therapeutic aerosols: a chronological review. J Aerosol Med Pulm Drug Deliv. 2017; 30(1): 20-41.
4. Sosnowski TR. Zasada działania i konstrukcja inhalatorów medycznych. In: Sosnowski TR (ed). Aerozole wziewne i inhalatory. 2nd ed suppl. Politechnika Warszawska – Wydział Inżynierii Chemicznej i Procesowej, Warszawa 2012: 73-124.
5. Newman SP. Principles of metered-dose inhaler design. Respir Care. 2005; 50(9): 1177-90.
6. Ibiapina CC, Cruz AA, Camargos PMA [Hydrofluoroalkane as a propellant for pressurized metered-dose inhalers: history, pulmonary deposition, pharmacokinetics, efficacy and safety]. J Pediatr (Rio J). 2004; 80(6): 441-6.
7. Stein SW, Sheth P, Hodson PD et al. Advances in metered dose inhaler technology: hardware development. AAPS Pharm Sci Tech. 2014; 15(2): 326-38.
8. Emeryk A, Pirożyński M, Mazurek H et al. Polski przewodnik inhalacyjny. 2nd ed. Via Medica, Gdańsk 2021: 1-33.
9. Newman SP, Weisz AW, Talaee N et al. Improvement of drug delivery with a breath actuated pressurized aerosol for patients with poor inhaler technique. Thorax. 1991; 46(10): 712-6.
10. PRODUCT INFORMATION. QVAR (access: 18.06.2021).
11. Lechuga-Ballesteros D, Noga B, Vehring R et al. Novel cosuspension metered-dose inhalers for the combination therapy of chronic obstructive pulmonary disease and asthma. Futur Med Chem. 2011; 3: 1703-18.
12. Sukasamea N, Boonmea P, Srichanaa T. Development of budesonide suspensions for use in an HFA pressurized metered dose inhaler. Science Asia. 2011; 37: 31-7.
13. Rogueda P. Novel hydrofluoroalkane suspension formulations for respiratory drug delivery. Expert Opin Drug Deliv. 2005; 2(4): 625-38.
14. De Vries TW, Rottier BL, Gjaltema D. Comparative in vitro evaluation of four corticosteroid metered dose inhalers: consistency of delivered dose and particle size distribution. Respir Med. 2009; 103(8): 1167-73.
15. Schroeter JD, Sheth P, Hickey AJ. Effects of formulation variables on lung dosimetry of albuterol sulfate suspension and beclomethasone dipropionate solution metered dose inhalers. AAPS PharmSciTech. 2018; 19: 2335-45.
16. Emeryk A, Doniec Z, Mazurek H et al. Guidelines for inhalation chambers in children. Ped Pol. 2017; 92: 288-93.
17. Vincken W, Levy ML, Scullion J et al. Spacer devices for inhaled therapy: why use them, and how? ERJ Open Res. 2018; 4: 00065-2018.
18. GINA 2021 Report, Global Strategy for Asthma Management and Prevention (access: 25.04.2021).
19. Ammari WG, Oriquat GA, Sanders M. Comparative pharmacokinetics of salbutamol inhaled from a pressurized metered dose inhaler either alone or connected to a newly enhanced spacer design. Eur J Pharm Sci. 2020; 147: 105304.
20. Nikander K, Nicholls C, Denyer J et al. The evolution of spacers and valved holding chambers. J Aerosol Med Pulm Drug Deliv. 2014; 27(suppl 1): S4-S23.
21. Williams RO, Patel AM, Barron MK et al. Investigation of some commercially available spacer devices for the delivery of glucocorticoid steroids from a pMDI. Drug Dev Ind Pharm. 2001; 27(5): 401-12.
22. Saeed H, Abdelrahim ME, Rabea H et al. Evaluation of disposable and traditional accessory devices for use with a pressurized metered-dose inhaler. Respir Care. 2020; 65(3): 320-5.
23. Blake K, Mehta R, Spencer T et al. Bioavailability of inhaled fluticasone propionate via chambers/masks in young children. Eur Respir J. 2012; 39(1): 97-103.
24. Dissanayake S. Application of the EU Guidelines for pharmacokinetic studies of locally acting orally inhaled drug products. Respir Drug Deliv. 2010; 1: 293-304.
25. Lavorini F, Barreto C, van Boven JFM et al. Spacers and valved holding chambers – the risk of switching to different chambers. J Allergy Clin Immunol Pract. 2020; 8(5): 1569-73.
26. Dissanayake S, Suggest J. A review of the in vitro and in vivo valved holding chamber (VHC) literature with a focus on the AeroChamber Plus Flow-Vu Anti-static VHC. Ther Adv Respir Dis. 2018; 12: 1-14.
27. Martin RJ. Therapeutic significance of distal airway inflammation in asthma. J Allergy Clin Immunol. 2002; 109(2 suppl): S447-S60.
28. Zeidler M, Corren J. Hydrofluoroalkane formulations of inhaled corticosteroids for the treatment of asthma. Treat Respir Med. 2004; 3(1): 35-44.
29. Leach ChL. The CFC to HFA transition and its impact on pulmonary drug development. Respir Care. 2005; 50(9): 1201-6.
30. Emeryk A. Glikokortykosteroidy w astmie. In: Emeryk A, Bręborowicz A, Lis G et al (ed). Astma i choroby obturacyjne oskrzeli u dzieci. Elsevier Urban & Partner, Wrocław 2010: 121-44.
31. Hirst PH, Pitcairn GR, Richards JC et al. Deposition and pharmacokinetics of an HFA formulation of triamcinolone acetonide delivered by pressurized metered dose inhaler. J Aerosol Med. 2001; 14(2): 155-65.
32. Pickering H, Pitcairn GR, Hirst PH et al. Regional lung deposition of a technetium 99m-labeled formulation of mometasone furoate administered by hydrofluoroalkane 227 metered-dose inhaler. Clin Ther. 2001; 22(12): 1483-93.
33. Frazer PA. Assessment of aerodynamic particle size distribution of BDP BAI and QVAR MDI. Data on file (R&D Investigation Report). Teva Respiratory, LLC. 2017 (access: 16.06.2021).
34. Vanden Burgt JA, Busse WW, Martin RJ et al. Efficacy and safety overview of a new inhaled corticosteroid, QVAR (hydrofluoroalkane- beclomethasone extrafine inhalation aerosol) in asthma. J Allergy Clin Immunol. 2000; 106: 1209-26.
35. Cloutier MM, Baptist AP, Blake KV et al; NAEPPCC Expert Panel Working Group. 2020 Focused Updates to the Asthma Management Guidelines: A Report from the National Asthma Education and Prevention Program Coordinating Committee Expert Panel Working Group. JACI. 2020; 146(6): 1217-70.
36. 2021 GOLD Reports. Global Strategy for Prevention, Diagnosis and Management of COPD (access: 15.06.2021).
37. Charakterystyka produktu leczniczego Fostex (access: 15.06.2021).
38. Charakterystyka produktu leczniczego Comboterol (access: 15.06.2021).
39. Budezonid + formoterol. Opis (access: 15.06.2021).
40. Charakterystyka produktu leczniczego Seretide (access: 15.06.2021).
41. Zhang S, King D, Rosen VM et al. Impact of single combination inhaler versus multiple inhalers to deliver the same medications for patients with asthma or COPD: a systematic literature review. Inter J COPD. 2020; 15: 417-38.
42. Bosnic-Anticevich S, Chrystyn H, Costello RW et al. The use of multiple respiratory inhalers requiring different inhalation techniques has an adverse effect on COPD outcomes. Int J Chron Obstruct Pulmon Dis. 2017; 12: 59-71.
43. Price D, Chrystyn H, Kaplan A et al. Effectiveness of same versus mixed asthma inhaler devices: a retrospective observational study in primary care. Allergy Asthma Immunol Res. 2012; 49(4): 184-91.
44. Usmani OS, Hickey AJ, Guranlioglu F et al. The impact of inhaler device regimen in patients with asthma or COPD. J Allergy Clin Immunol Pract. 2021; S2213-2198(21)00464-5.
45. Masayuki Hojo M, Shirai T, Hirashima J. Comparison of the clinical effects of combined salmeterol/fluticasone delivered by dry powder or pressurized metered dose inhaler. Pulm Pharmacol Ther. 2016; 37: 43-8.
46. Morice AH, Hochmuth L, Ekelund J et al. Comparable longterm safety and efficacy of a novel budesonide/formoterol pressurized metered-dose inhaler versus budesonide/formoterol Turbuhaler in adolescents and adults with asthma. Pulm Pharmacol Ther. 2008; 21(1): 32-9.
47. Kemp L, Haughney J, Barnes N et al. Cost-effectiveness analysis of corticosteroid inhaler devices in primary care asthma management: A real world observational study. Clinicoecon Outcomes Res. 2010; 2: 75-85.
48. Ninane V, Vandevoorde J, Cataldo D et al. New developments in inhaler devices within pharmaceutical companies: a systematic review of the impact on clinical outcomes and patient preferences. Respir Med. 2015; 109(11): 1430-8.
49. Wittbrodt ET, Millette LA, Evans KA et al. Differences in health care outcomes between postdischarge COPD patients treated with inhaled corticosteroid/long-acting β2-agonist via dry-powder inhalers and pressurized metered dose inhalers. Inter J Chron Obstruct Pulmon Dis. 2019; 14: 101-14.
50. Emeryk A, Janeczek K, Emeryk-Maksymiuk J. Leki z inhalatora ciśnieniowego dozującego z użyciem komory inhalacyjnej czy z nebulizatora? Co jest efektywniejsze, bezpieczniejsze i tańsze w terapii astmy u dzieci? Terapia. 2020; 4(387): 93-99.
51. Janeczek K, Emeryk A, Bodajko-Grochowska A et al. A comparison of the costs of bronchodilator delivery methods in children with asthma exacerbations treated in hospital. The first Polish study in children. Adv Dermatol Allergol. 2020; 37: 1-6.
52. Self TH, Ellingson S. New treatment option for chronic obstructive pulmonary disease: two long-acting bronchodilators in a single metered-dose inhaler. Am J Med. 2017; 130(11): 1251-4.
53. Haidl P, Heindl S, Siemon K. Inhalation device requirements for patients’ inhalation maneuvers. Respir Med. 2016; 118: 65-75.
54. Usmani OS. Choosing the right inhaler for your asthma or COPD patient. Ther Clin Risk Manag. 2019; 15: 461-72.
55. Mahler DA. The role of inspiratory flow in selection and use of inhaled therapy for patients with chronic obstructive pulmonary disease. Respir Med. 2020; 161: 105857.
56. Fuglo-Mortensen R, Lange P, Mortensen J. [Inhalers and inhalation techniques in the treatment of asthma and chronic obstructive pulmonary disease]. Ugeskr Laeger. 2019; 181(33): 5-9.
57. Rogliani P, Calzetta L, Coppola A et al. Optimizing drug delivery in COPD: the role of inhaler devices. Respir Med. 2017; 124: 6-14.
2. Sanders M. Inhalation therapy: a historical review. Prim Care Respir J. 2007; 16(2): 71-81.
3. Stein SW, Charles G. Thiel ChG. The history of therapeutic aerosols: a chronological review. J Aerosol Med Pulm Drug Deliv. 2017; 30(1): 20-41.
4. Sosnowski TR. Zasada działania i konstrukcja inhalatorów medycznych. In: Sosnowski TR (ed). Aerozole wziewne i inhalatory. 2nd ed suppl. Politechnika Warszawska – Wydział Inżynierii Chemicznej i Procesowej, Warszawa 2012: 73-124.
5. Newman SP. Principles of metered-dose inhaler design. Respir Care. 2005; 50(9): 1177-90.
6. Ibiapina CC, Cruz AA, Camargos PMA [Hydrofluoroalkane as a propellant for pressurized metered-dose inhalers: history, pulmonary deposition, pharmacokinetics, efficacy and safety]. J Pediatr (Rio J). 2004; 80(6): 441-6.
7. Stein SW, Sheth P, Hodson PD et al. Advances in metered dose inhaler technology: hardware development. AAPS Pharm Sci Tech. 2014; 15(2): 326-38.
8. Emeryk A, Pirożyński M, Mazurek H et al. Polski przewodnik inhalacyjny. 2nd ed. Via Medica, Gdańsk 2021: 1-33.
9. Newman SP, Weisz AW, Talaee N et al. Improvement of drug delivery with a breath actuated pressurized aerosol for patients with poor inhaler technique. Thorax. 1991; 46(10): 712-6.
10. PRODUCT INFORMATION. QVAR (access: 18.06.2021).
11. Lechuga-Ballesteros D, Noga B, Vehring R et al. Novel cosuspension metered-dose inhalers for the combination therapy of chronic obstructive pulmonary disease and asthma. Futur Med Chem. 2011; 3: 1703-18.
12. Sukasamea N, Boonmea P, Srichanaa T. Development of budesonide suspensions for use in an HFA pressurized metered dose inhaler. Science Asia. 2011; 37: 31-7.
13. Rogueda P. Novel hydrofluoroalkane suspension formulations for respiratory drug delivery. Expert Opin Drug Deliv. 2005; 2(4): 625-38.
14. De Vries TW, Rottier BL, Gjaltema D. Comparative in vitro evaluation of four corticosteroid metered dose inhalers: consistency of delivered dose and particle size distribution. Respir Med. 2009; 103(8): 1167-73.
15. Schroeter JD, Sheth P, Hickey AJ. Effects of formulation variables on lung dosimetry of albuterol sulfate suspension and beclomethasone dipropionate solution metered dose inhalers. AAPS PharmSciTech. 2018; 19: 2335-45.
16. Emeryk A, Doniec Z, Mazurek H et al. Guidelines for inhalation chambers in children. Ped Pol. 2017; 92: 288-93.
17. Vincken W, Levy ML, Scullion J et al. Spacer devices for inhaled therapy: why use them, and how? ERJ Open Res. 2018; 4: 00065-2018.
18. GINA 2021 Report, Global Strategy for Asthma Management and Prevention (access: 25.04.2021).
19. Ammari WG, Oriquat GA, Sanders M. Comparative pharmacokinetics of salbutamol inhaled from a pressurized metered dose inhaler either alone or connected to a newly enhanced spacer design. Eur J Pharm Sci. 2020; 147: 105304.
20. Nikander K, Nicholls C, Denyer J et al. The evolution of spacers and valved holding chambers. J Aerosol Med Pulm Drug Deliv. 2014; 27(suppl 1): S4-S23.
21. Williams RO, Patel AM, Barron MK et al. Investigation of some commercially available spacer devices for the delivery of glucocorticoid steroids from a pMDI. Drug Dev Ind Pharm. 2001; 27(5): 401-12.
22. Saeed H, Abdelrahim ME, Rabea H et al. Evaluation of disposable and traditional accessory devices for use with a pressurized metered-dose inhaler. Respir Care. 2020; 65(3): 320-5.
23. Blake K, Mehta R, Spencer T et al. Bioavailability of inhaled fluticasone propionate via chambers/masks in young children. Eur Respir J. 2012; 39(1): 97-103.
24. Dissanayake S. Application of the EU Guidelines for pharmacokinetic studies of locally acting orally inhaled drug products. Respir Drug Deliv. 2010; 1: 293-304.
25. Lavorini F, Barreto C, van Boven JFM et al. Spacers and valved holding chambers – the risk of switching to different chambers. J Allergy Clin Immunol Pract. 2020; 8(5): 1569-73.
26. Dissanayake S, Suggest J. A review of the in vitro and in vivo valved holding chamber (VHC) literature with a focus on the AeroChamber Plus Flow-Vu Anti-static VHC. Ther Adv Respir Dis. 2018; 12: 1-14.
27. Martin RJ. Therapeutic significance of distal airway inflammation in asthma. J Allergy Clin Immunol. 2002; 109(2 suppl): S447-S60.
28. Zeidler M, Corren J. Hydrofluoroalkane formulations of inhaled corticosteroids for the treatment of asthma. Treat Respir Med. 2004; 3(1): 35-44.
29. Leach ChL. The CFC to HFA transition and its impact on pulmonary drug development. Respir Care. 2005; 50(9): 1201-6.
30. Emeryk A. Glikokortykosteroidy w astmie. In: Emeryk A, Bręborowicz A, Lis G et al (ed). Astma i choroby obturacyjne oskrzeli u dzieci. Elsevier Urban & Partner, Wrocław 2010: 121-44.
31. Hirst PH, Pitcairn GR, Richards JC et al. Deposition and pharmacokinetics of an HFA formulation of triamcinolone acetonide delivered by pressurized metered dose inhaler. J Aerosol Med. 2001; 14(2): 155-65.
32. Pickering H, Pitcairn GR, Hirst PH et al. Regional lung deposition of a technetium 99m-labeled formulation of mometasone furoate administered by hydrofluoroalkane 227 metered-dose inhaler. Clin Ther. 2001; 22(12): 1483-93.
33. Frazer PA. Assessment of aerodynamic particle size distribution of BDP BAI and QVAR MDI. Data on file (R&D Investigation Report). Teva Respiratory, LLC. 2017 (access: 16.06.2021).
34. Vanden Burgt JA, Busse WW, Martin RJ et al. Efficacy and safety overview of a new inhaled corticosteroid, QVAR (hydrofluoroalkane- beclomethasone extrafine inhalation aerosol) in asthma. J Allergy Clin Immunol. 2000; 106: 1209-26.
35. Cloutier MM, Baptist AP, Blake KV et al; NAEPPCC Expert Panel Working Group. 2020 Focused Updates to the Asthma Management Guidelines: A Report from the National Asthma Education and Prevention Program Coordinating Committee Expert Panel Working Group. JACI. 2020; 146(6): 1217-70.
36. 2021 GOLD Reports. Global Strategy for Prevention, Diagnosis and Management of COPD (access: 15.06.2021).
37. Charakterystyka produktu leczniczego Fostex (access: 15.06.2021).
38. Charakterystyka produktu leczniczego Comboterol (access: 15.06.2021).
39. Budezonid + formoterol. Opis (access: 15.06.2021).
40. Charakterystyka produktu leczniczego Seretide (access: 15.06.2021).
41. Zhang S, King D, Rosen VM et al. Impact of single combination inhaler versus multiple inhalers to deliver the same medications for patients with asthma or COPD: a systematic literature review. Inter J COPD. 2020; 15: 417-38.
42. Bosnic-Anticevich S, Chrystyn H, Costello RW et al. The use of multiple respiratory inhalers requiring different inhalation techniques has an adverse effect on COPD outcomes. Int J Chron Obstruct Pulmon Dis. 2017; 12: 59-71.
43. Price D, Chrystyn H, Kaplan A et al. Effectiveness of same versus mixed asthma inhaler devices: a retrospective observational study in primary care. Allergy Asthma Immunol Res. 2012; 49(4): 184-91.
44. Usmani OS, Hickey AJ, Guranlioglu F et al. The impact of inhaler device regimen in patients with asthma or COPD. J Allergy Clin Immunol Pract. 2021; S2213-2198(21)00464-5.
45. Masayuki Hojo M, Shirai T, Hirashima J. Comparison of the clinical effects of combined salmeterol/fluticasone delivered by dry powder or pressurized metered dose inhaler. Pulm Pharmacol Ther. 2016; 37: 43-8.
46. Morice AH, Hochmuth L, Ekelund J et al. Comparable longterm safety and efficacy of a novel budesonide/formoterol pressurized metered-dose inhaler versus budesonide/formoterol Turbuhaler in adolescents and adults with asthma. Pulm Pharmacol Ther. 2008; 21(1): 32-9.
47. Kemp L, Haughney J, Barnes N et al. Cost-effectiveness analysis of corticosteroid inhaler devices in primary care asthma management: A real world observational study. Clinicoecon Outcomes Res. 2010; 2: 75-85.
48. Ninane V, Vandevoorde J, Cataldo D et al. New developments in inhaler devices within pharmaceutical companies: a systematic review of the impact on clinical outcomes and patient preferences. Respir Med. 2015; 109(11): 1430-8.
49. Wittbrodt ET, Millette LA, Evans KA et al. Differences in health care outcomes between postdischarge COPD patients treated with inhaled corticosteroid/long-acting β2-agonist via dry-powder inhalers and pressurized metered dose inhalers. Inter J Chron Obstruct Pulmon Dis. 2019; 14: 101-14.
50. Emeryk A, Janeczek K, Emeryk-Maksymiuk J. Leki z inhalatora ciśnieniowego dozującego z użyciem komory inhalacyjnej czy z nebulizatora? Co jest efektywniejsze, bezpieczniejsze i tańsze w terapii astmy u dzieci? Terapia. 2020; 4(387): 93-99.
51. Janeczek K, Emeryk A, Bodajko-Grochowska A et al. A comparison of the costs of bronchodilator delivery methods in children with asthma exacerbations treated in hospital. The first Polish study in children. Adv Dermatol Allergol. 2020; 37: 1-6.
52. Self TH, Ellingson S. New treatment option for chronic obstructive pulmonary disease: two long-acting bronchodilators in a single metered-dose inhaler. Am J Med. 2017; 130(11): 1251-4.
53. Haidl P, Heindl S, Siemon K. Inhalation device requirements for patients’ inhalation maneuvers. Respir Med. 2016; 118: 65-75.
54. Usmani OS. Choosing the right inhaler for your asthma or COPD patient. Ther Clin Risk Manag. 2019; 15: 461-72.
55. Mahler DA. The role of inspiratory flow in selection and use of inhaled therapy for patients with chronic obstructive pulmonary disease. Respir Med. 2020; 161: 105857.
56. Fuglo-Mortensen R, Lange P, Mortensen J. [Inhalers and inhalation techniques in the treatment of asthma and chronic obstructive pulmonary disease]. Ugeskr Laeger. 2019; 181(33): 5-9.
57. Rogliani P, Calzetta L, Coppola A et al. Optimizing drug delivery in COPD: the role of inhaler devices. Respir Med. 2017; 124: 6-14.