In vitro considerations to support bioequivalence of locally acting drugs in dry powder inhalers for lung diseases

AAPS Journal

Volumn 11, Issue 3, 2009, Pages 414-423

  Lee, Sau Lawrence ^a   Adams, Wallace P ^a   Li, Bing V ^a   Conner, Dale P ^a   Chowdhury, Badrul A ^b   Yu, Lawrence X ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^b CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

Bioequivalence (BE); Dry powder inhaler (DPI); Locally acting drugs; Particle size distribution; Single inhalation (actuation) content

Indexed keywords

BRONCHODILATING AGENT; CORTICOSTEROID; LONG ACTING DRUG;

AEROSOL; ASTHMA; BIOEQUIVALENCE; CHRONIC OBSTRUCTIVE LUNG DISEASE; DRUG DELIVERY SYSTEM; DRUG DISTRIBUTION; DRUG FORMULATION; DRUG RELEASE; EQUIPMENT DESIGN; FLOW RATE; FLUIDIZATION; IN VITRO STUDY; LUNG DISEASE; METERED DOSE INHALER; PARTICLE SIZE; PERFORMANCE MEASUREMENT SYSTEM; POWDER INHALER; REVIEW;

ADRENAL CORTEX HORMONES; ASTHMA; BRONCHODILATOR AGENTS; HUMANS; NEBULIZERS AND VAPORIZERS; POWDERS; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; THERAPEUTIC EQUIVALENCY;

EID: 73349098178     PISSN: 15507416     EISSN: None     Source Type: Journal    
DOI: 10.1208/s12248-009-9121-4     Document Type: Review

References (35)

1. Weibel ER. Morphometry of the human lung. Berlin: Springer; 1963.
2. Hickey AJ, Thompson DC. Physiology of the airways. In: Hickey AJ, editor. Pharmaceutical inhalation aerosol technology. 2nd ed. New York: Marcel Dekker; 2004. p. 1-29.
3. JR Carstairs AJ Nimmo PJ Barnes 1985 Autoradiographic visualization of beta-adrenoceptor subtypes in human lung Am Rev Respir Dis 132 541 547 2864008 1:STN:280:DyaL2MzgsFWnsQ%3D%3D
4. OS Usmani MF Biddiscombe PJ Barnes 2005 Regional lung deposition and bronchodilator response as a function of β2-agonist particle size Am J Respir Crit Care Med 172 1497 1504 16192448 10.1164/rccm.200410-1414OC (Pubitemid 43076536)
5. JC Mak PJ Barnes 1990 Autoradiographic visualization of muscarinic receptor subtypes in human and guinea pig lung Am Rev Respir Dis 141 1559 1568 2350099 1:CAS:528:DyaK3cXkvFWktrY%3D
6. M Kraft R Djukanovic S Wilson ST Holgate RJ Martin 1996 Alveolar tissue inflammation in asthma Am J Respir Crit Care Med 154 1505 1510 8912772 1:STN:280:DyaK2s%2FmvFOqsA%3D%3D
7. N Carroll C Cooke A James 1997 The distribution of eosinophils and lymphocytes in the large and small airways of asthmatics Eur Respir J 10 292 300 9042623 10.1183/09031936.97.10020292 1:STN:280:DyaK2s7psFaitA%3D%3D (Pubitemid 27063842)
8. Sbirlea-Apiou G, Katz I, Caillibotte G, Martonen T, Yang Y. Deposition mechanics of pharmaceutical particles in human airways. In: Hickey AJ, editor. Inhalation aerosols: physical and biological basis for therapy. 2nd ed. New York: Informia Healthcare; 2007. p. 1-30.
9. P Zanen LT Go JW Lammers 1996 Optimal particle size for beta 2 agonist and anticholinergic aerosols in patients with severe airflow obstruction Thorax 51 977 980 8977595 10.1136/thx.51.10.977 1:STN:280:DyaK2s7jt1Wguw%3D%3D
10. S Sangwan JM Agosti LA Bauer BA Otulana RJ Morishige DC Cipolla JD Blanchard GC Smaldone 2001 Aerosolized protein delivery in asthma: gamma camera analysis of regional deposition and perfusion J Aerosol Med 14 185 195 11681650 10.1089/08942680152484117 1:CAS:528:DC%2BD3MXmsVyitb8%3D
11. Newman SP, Hirst PH, Pitcairn GR, Clark AR. Understanding regional lung deposition data in gamma scintigraphy. In: Dalby RN, Byron PR, Farr SJ, editors. Respiratory drug delivery VI. Buffalo Grove: Interpharm; 1998. p. 9-16.
12. JE Esposito-Festen P Zanen HA Tiddens JW Lammers 2007 Pharmacokinetics of inhaled monodisperse beclomethasone as a function of particle size Br J Clin Pharmacol 64 328 334 17439539 10.1111/j.1365-2125.2007.02894.x 1:CAS:528:DC%2BD2sXhtFKis7zN (Pubitemid 47283862)
13. 2-agonists in chronic obstructive pulmonary disease. A thesis submitted to the University of Nottingham for the degree of Doctor of Medicine, November 2007. http://etheses.nottingham.ac.uk/647/1/CHRIS-WHALE-DM-THESIS.pdf. Accessed 30 Mar 2009.
14. P Zanen LT Go JW Lammers 1994 The optimal particle-size for betaadrenergic aerosols in mild asthmatics Int J Pharm 107 211 217 10.1016/0378-5173(94)90436-7 1:CAS:528:DyaK2cXksValsro%3D (Pubitemid 24182106)
15. P Zanen LT Go JW Lammers 1995 The optimal particle-size for parasympathicolytic aerosols in mild asthmatics Int J Pharm 114 111 115 10.1016/0378-5173(94)00224-S 1:CAS:528:DyaK2MXivVKrtrY%3D (Pubitemid 24377035)
16. OS Usmani MF Biddiscombe JA Nightingale SR Underwood PJ Barnes 2003 Effects of bronchodilator particle size in asthmatic patients using monodisperse aerosols J Appl Physiol 95 2106 2112 12897033
17. Weda M. The clinical impact of changing the fine particle mass data obtained with albuterol DPIs. In: Dalby RN, Byron PR, Peart J, Suman JD, Farr SJ, Young PM, editors. Respiratory drug delivery 2008: Book I. River Grove, IL: Davis Healthcare International; 2008. p. 85-92.
18. KA Fults IF Miller AJ Hickey 1997 Effect of particle morphology on emitted dose of fatty acid-treated disodium cromoglycate powder aerosols Pharm Dev Technol 2 67 79 9552432 10.3109/10837459709022610 1:CAS:528: DyaK2sXhsl2ktbg%3D
19. CA Dunbar AJ Hickey P Holzner 1998 Dispersion and characterization of pharmaceutical dry powder aerosols Kona 16 7 24 1:CAS:528:DC%2BD3MXjtlKjtLg%3D
20. Gonda I. Targeting by deposition. In: Hickey AJ, editor. Pharmaceutical inhalation aerosol technology. 2nd ed. New York: Marcel Dekker; 2004. p. 65-88.
21. MJ Telko AJ Hickey 2005 Dry powder inhaler formulation Respir Care 50 1209 1227 16122404
22. D Ganderton MN Kassem 1992 Dry powder inhalers Adv Pharm Sci 6 165 191 1:CAS:528:DyaK38XisVWkur0%3D
23. H Schreier WC Mobley N Concessio AJ Hickey RW Niven 1994 Formulation and in vitro performance of liposome powder aerosols STP Pharma Sci 4 38 44 1:CAS:528:DyaK2cXktFOqsbY%3D
24. JN Staniforth JE Rees FK Lai JA Hersey 1982 Interparticle forces in binary and ternary ordered powder mixes J Pharm Pharmacol 34 141 145 6121889 1:STN:280:DyaL387mvFyluw%3D%3D
25. N Islam P Stewart I Larson P Hartley 2004 Effect of carrier size on the dispersion of salmeterol xinafoate from interactive mixtures J Pharm Sci 93 1030 1038 14999738 10.1002/jps.10583 1:CAS:528:DC%2BD2cXivF2ltrk%3D (Pubitemid 38420412)
26. MD Louey PJ Stewart 2002 Particle interactions involved in aerosol dispersion of ternary interactive mixtures Pharm Res 19 1524 1531 12425471 10.1023/A:1020464801786 1:CAS:528:DC%2BD38XnsFSgtr8%3D (Pubitemid 35266558)
27. AH de Boer D Gjaltema P Hagedoorn 1996 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 in Int J Pharm 138 45 56 10.1016/0378-5173(96)04526-7 (Pubitemid 26241921)
28. PA Carter G Rowley EJ Fletcher V Stylianopoulos 1998 Measurement of electrostatic charge decay in pharmaceutical powders and polymer materials used in dry powder inhaler devices Drug Dev Ind Pharm 24 1083 1088 9876564 10.3109/03639049809089953 1:CAS:528:DyaK1cXmsVams7k%3D
29. Dalby RN, Tiano SL, Hickey AJ. Medical devices for the delivery of therapeutic aerosols to the lungs. In: Hickey AJ, editor. Inhalation aerosols: physical and biological basis for therapy. 2nd ed. New York: Informa Healthcare; 2007. p. 417-44.
30. TM: a review of its position among dry powder inhaler devices Int J Clin Pract 61 1022 1036 17504364 10.1111/j.1742-1241.2007.01382.x 1:STN:280:DC%2BD2s3ptlKisw%3D%3D (Pubitemid 46744072)
31. M Molimard C Raherison S Lignot F Depont A Abouelfath N Moore 2003 Assessment of handling of inhaler devices in real life: an observational study in 3811 patients in primary care J Aerosol Med 16 249 254 14572322 10.1089/089426803769017613 1:STN:280:DC%2BD3svps1KgsA%3D%3D (Pubitemid 37169635)
32. M Hindle PR Byron 1995 Dose emissions from marketed dry powder inhalers Int J Pharm 116 169 177 10.1016/0378-5173(94)00287-F 1:CAS:528: DyaK2MXjs1Gisrw%3D
33. JP Mitchell MW Nagel 2003 Cascade impactors for the size characterization of aerosols from medical inhalers: their uses and limitations J Aerosol Med 16 341 377 14977427 10.1089/089426803772455622 1:CAS:528:DC%2BD2cXltFagtw%3D%3D (Pubitemid 38120942)
34. BJ Meakin JM Cainey PM Woodcock 1995 Drug delivery characteristics of Bricanyl Turbohaler™ dry powder inhalers Int J Pharm 119 91 102 10.1016/0378-5173(94)00387-K 1:CAS:528:DyaK2MXkvFGqtL8%3D
35. SP Newman H-K Chan 2008 in vitro/in vivo comparisons in pulmonary drug delivery J Aerosol Med Pul Drug Delivery 21 77 84 10.1089/jamp.2007.0643 1:CAS:528:DC%2BD1cXjvFehs70%3D