Dry powder inhaler for pulmonary drug delivery: human respiratory system, approved products and therapeutic equivalence guideline

다국어 초록 (Multilingual Abstract)

Pulmonary drug delivery is the promising delivery route to treat not only respiratory diseases but also systemic diseases and has proven as a potential delivery route for complex drugs that cannot be delivered orally. Development of dry powder inhalation systems targets the delivery of fine drug particles to the deep lung surface by a combination of particle deposition and clearance in human respiratory tract. Various dry powder inhalers (DPIs) with their advanced technologies have been proposed and marketed to treat pulmonary diseases such as asthma, chronic obstructive pulmonary diseases, cystic fibrosis and furthermore, systemic diseases such as diabetes and schizophrenia. Bioequivalent therapeutic effects can be derived from generic products that provide additional benefits to the patients and the health care system. Currently, European Medicines Agency (EMA) have established the bioequivalent methods to develop and approve the inhaled products. This review covers the anatomical and physiological characteristics of human respiratory tract to understand the mechanism of drug deposition and clearance. Also, therapeutic areas for both local and systemic treatment, DPI products and their advanced technologies are presented. Finally, European Medicines Agency (EMA) guidelines for inhaled products are presented to demonstrate the therapeutic bioequivalence between generic and reference products.

참고문헌 (Reference)

1 Weibel ER, "Why measure lung structure?" 163 (163): 314-315, 2001

2 Lee RJ, "Vasoactive intestinal peptide regulates sinonasal mucociliary clearance and synergizes with histamine in stimulating sinonasal fluid secretion" 27 (27): 5094-5103, 2013

3 Sulis G, "Tuberculosis:epidemiology and control. Mediterr" 6 (6): 2014070-, 2014

4 Knechel NA, "Tuberculosis: pathophysiology, clinical features, and diagnosis" 29 (29): 34-43, 2009

5 Wania RLS, "Tuberculosis 2: Pathophysiology and microbiology of pulmonary tuberculosis" 6 (6): 10-12, 2013

6 VanDevanter DR, "Tobramycin administered by the TOBI® Podhaler® for persons with cystic fibrosis: a review" 4 : 179-188, 2011

7 Salvi S, "Tobacco smoking and environmental risk factors for chronic obstructive pulmonary disease" 35 (35): 17-27, 2014

8 Robinson M, "The effect of inhaled mannitol on bronchial mucus clearance in cystic fibrosis patients: a pilot study" 14 (14): 678-685, 1999

9 Postma DS, "The asthma–COPD overlap syndrome" 373 (373): 1241-1249, 2015

10 Grant AC, "The ELLIPTA ®dry powder inhaler: design, functionality, in vitro dosing performance and critical task compliance by patients and caregivers" 28 (28): 474-485, 2015

11 Pfützner A, "Technosphere™/Insulin—a new approach for effective delivery of human insulin via the pulmonary route" 4 (4): 589-594, 2002

12 Steiner S, "TechnosphereTM/Insulin-proof of concept study with a new insulin formulation for pulmonary delivery" 110 (110): 17-21, 2002

13 Kuna P, "Symbicort Turbuhaler: a new concept in asthma management" 56 (56): 797-803, 2002

14 Lavorini F, "Switching from branded to generic inhaled medications:potential impact on asthma and COPD" Taylor & Francis 2013

15 Chapman KR, "Seretide for obstructive lung disease" 3 (3): 341-350, 2002

16 Hastedt JE, "Scope and relevance of a pulmonary biopharmaceutical classification system" 2 (2): 1-, 2016

17 Antje Schuster, "Safety, efficacy and convenience of colistimethate sodium dry powder for inhalation (Colobreathe DPI) in patients with cystic fibrosis: a randomised study" BMJ 68 (68): 344-350, 2013

18 Beasley R, "Risk factors for asthma: is prevention possible?" 386 (386): 1075-1085, 2015

19 Svedsater H, "Qualitative assessment of attributes and ease of use of the ELLIPTA™dry powder inhaler for delivery of maintenance therapy for asthma and COPD" 13 (13): 72-, 2013

20 Leung AN, "Pulmonary tuberculosis: the essentials" 210 (210): 307-322, 1999

21 Pfützner A, "Pulmonary insulin delivery by means of the Technosphere™ drug carrier mechanism" 2 (2): 1097-1106, 2005

22 Verma RK, "Pulmonary drug delivery: advances and challenges" 1-18, 2015

23 Høiby N, "Pseudomonas aeruginosa biofilms in cystic fibrosis" 5 (5): 1663-1674, 2010

24 임준열, "Process cycle development of freeze drying for therapeutic proteins with stability evaluation" 한국약제학회 46 (46): 519-536, 2016

25 Fiegel J, "Preparation and in vivo evaluation of a dry powder for inhalation of capreomycin" 25 (25): 805-811, 2008

26 Pressman JJ, "Physiology of the larynx" 35 (35): 506-554, 1955

27 Sciurba FC, "Physiologic similarities and differences between COPD and asthma" 126 (126): 117S-124S, 2004

28 Dharmadhikari AS, "Phase I, single-dose, dose-escalating study of inhaled dry powder capreomycin: a new approach to therapy of drug-resistant tuberculosis" 57 (57): 2613-2619, 2013

29 Wright P, "Pharmaceutical preformulation and formulation: a practical guide from candidate drug selection to commercial dosage form" 348-, 2016

30 Broeders M, "Peak inspiratory flow rate and slope of the inhalation profiles in dry powder inhalers" 18 (18): 780-783, 2001

31 Koch C, "Pathogenesis of cystic fibrosis" 341 (341): 1065-1069, 1993

32 Hamman JH, "Oral delivery of peptide drugs" 19 (19): 165-177, 2005

33 Lumb AB, "Nunn’s applied respiratory physiology" Elsevier Health Sciences 2016

34 Island OA, "New recertification deadlines take effect for active PTCB certified pharmacy technicians" 7 (7): 1916

35 Lavorini F, "New inhaler devices-the good, the bad and the ugly" 88 (88): 3-15, 2014

36 Boucher RC, "New concepts of the pathogenesis of cystic fibrosis lung disease" 23 (23): 146-158, 2004

37 Sung JC, "Nanoparticles for drug delivery to the lungs" 25 (25): 563-570, 2007

38 Mansour HM, "Nanoparticle lung delivery and inhalation aerosols for targeted pulmonary nanomedicine" CRC Press, Taylor & Francis Group 2013

39 Corradi M, "NEXThaler, an innovative dry powder inhaler delivering an extrafine fixed combination of beclometasone and formoterol to treat large and small airways in asthma" 11 (11): 1497-1506, 2014

40 Ceglia L, "Meta-analysis: efficacy and safety of inhaled insulin therapy in adults with diabetes mellitus" 145 (145): 665-675, 2006

41 Cheng YS, "Mechanisms of pharmaceutical aerosol deposition in the respiratory tract" 15 (15): 630-640, 2014

42 Patton JS, "Mechanisms of macromolecule absorption by the lungs" 19 (19): 3-36, 1996

43 Zemanick ET, "Measuring and improving respiratory outcomes in cystic fibrosis lung disease: opportunities and challenges to therapy" 9 (9): 1-16, 2010

44 Cotes JE, "Lung function: physiology, measurement and application in medicine" Wiley 2009

45 Valdes J, "Loxapine inhalation powder (adasuve):a new and innovative formulation of an antipsychotic treatment for agitation" 39 (39): 621-, 2014

46 Nolan SJ, "Inhaled mannitol (Bronchitol) for cystic fibrosis" 18 : 52-54, 2016

47 Newhouse MT, "Inhalation of a dry powder tobramycin PulmoSphere formulation in healthy volunteers" 124 (124): 360-366, 2003

48 Carvalho TC, "Influence of particle size on regional lung deposition–what evidence is there?" 406 (406): 1-10, 2011

49 Dinh KV, "In vitro aerosol deposition in the oropharyngeal region for Staccato ® loxapine" 23 (23): 253-260, 2010

50 Rommens JM, "Identification of the cystic fibrosis gene: chromosome walking and jumping" 245 (245): 1059-1065, 1989

51 Use C. f. M. P. f. H, "Guideline on the requirements for clinical documentation for orally inhaled products (oip) including the requirements for demonstration of therapeutic equivalence between two inhaled products for use in the treatment of asthma and chronic obstructive pulm" European Medicines Agency

52 Vestbo J, "Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary" 187 (187): 347-365, 2013

53 Boe J, "European respiratory society guidelines on the use of nebulizers" 18 (18): 228-242, 2001

54 Daley-Yates PT, "Establishing bioequivalence for inhaled drugs; weighing the evidence" 8 (8): 1297-1308, 2011

55 Pittas AG, "Efficacy, safety, and patient acceptability of Technosphere inhaled insulin for people with diabetes: a systematic review and meta-analysis" 3 (3): 886-894, 2015

56 Glover W, "Effect of particle size of dry powder mannitol on the lung deposition in healthy volunteers" 349 (349): 314-322, 2008

57 Cooper S, "Effect of mouth taping at night on asthma control–A randomised singleblind crossover study" 103 (103): 813-819, 2009

58 Buttini F, "Effect of flow rate on in vitro aerodynamic performance of NEXThaler ® in comparison with Diskus ® and Turbohaler ® Dry Powder Inhalers" 29 (29): 167-178, 2016

59 Atkins PJ, "Dry powder inhalers: an overview" 50 (50): 1304-1312, 2005

60 Onoue S, "Dry powder inhalation systems for pulmonary delivery of therapeutic peptides and proteins" 18 (18): 429-442, 2008

61 Malcolmson RJ, "Dry powder formulations for pulmonary delivery" 1 (1): 394-398, 1998

62 Fabbri LM, "Differences in airway inflammation in patients with fixed airflow obstruction due to asthma or chronic obstructive pulmonary disease" 167 (167): 418-424, 2003

63 이정옥, "Development of poly(lactic-co-glycolic acid) microparticles with pH-sensitive drug release behaviors" 한국약제학회 45 (45): 151-156, 2015

64 Geller DE, "Development of an inhaled dry-powder formulation of tobramycin using PulmoSphere ™ technology" 24 (24): 175-182, 2011

65 Heyder J, "Deposition of particles in the human respiratory tract in the size range 0.005–15 μm" 17 (17): 811-825, 1986

66 Tena AF, "Deposition of inhaled particles in the lungs" 48 (48): 240-246, 2012

67 Ratjen FA, "Cystic fibrosis: pathogenesis and future treatment strategies" 54 (54): 595-605, 2009

68 Mogayzel PJ Jr, "Cystic fibrosis pulmonary guidelines: chronic medications for maintenance of lung health" 187 (187): 680-689, 2013

69 George AM, "Cystic fibrosis infections:treatment strategies and prospects" 300 (300): 153-164, 2009

70 Beck-Broichsitter M, "Controlled pulmonary drug and gene delivery using polymeric nano-carriers" 161 (161): 214-224, 2012

71 William J. Janssen, "Control of lung defence by mucins and macrophages: ancient defence mechanisms with modern functions" European Respiratory Society (ERS) 48 (48): 1201-1214, 2016

72 Tan W, "Characteristics of COPD in never-smokers and ever-smokers in the general population: results from the CanCOLD study" 70 (70): 822-829, 2015

73 Sapakal V, "Bioequivalence of orally inhaled drug products: focus on current regulatory perspectives" 4 : 151-161, 2015

74 Clarke SW, "Anatomy and physiology of the human lung:aspects relevant to aerosols" 1 : 2015

75 Boucher RC, "An overview of the pathogenesis of cystic fibrosis lung disease" Elsevier 2002

76 Iram J Haq, "Airway surface liquid homeostasis in cystic fibrosis: pathophysiology and therapeutic targets" BMJ 71 (71): 284-287, 2016

77 Klonoff DC, "Afrezza inhaled insulin: the fastest-acting FDAapproved insulin on the market has favorable properties" SAGE Publications 2014

78 Bell KA, "Aerosol deposition in models of a human lung bifurcation" Xerox University Microfilms 1974

79 Chan JGY, "Advances in device and formulation technologies for pulmonary drug delivery" 15 (15): 882-897, 2014

80 Miller-Larsson A, "Advances in asthma and COPD treatment: combination therapy with inhaled corticosteroids and long-acting β2-agonists" 12 (12): 3261-3279, 2006

81 Taulbee DB, "A theory of aerosol deposition in the human respiratory tract" 38 (38): 77-85, 1975

82 Dunne S, "A review of the differences and similarities between generic drugs and their originator counterparts, including economic benefits associated with usage of generic medicines, using Ireland as a case study" 14 (14): 1-, 2013

83 Dalby R, "A review of the development of Respimat® Soft Mist™ Inhaler" 283 (283): 1-9, 2004

84 Yun Kirby S, "A preference study of two placebo dry powder inhalers in adults with COPD: Ellipta ® dry powder inhaler (DPI) versus DISKUS ®DPI" 13 (13): 167-175, 2016

85 Chan JGY, "A novel dry powder inhalable formulation incorporating three first-line anti-tubercular antibiotics" 83 (83): 285-292, 2013

86 García-Arieta A, "A European perspective on orally inhaled products:In vitro requirements for a biowaiver" 27 (27): 419-429, 2014