Dry powder aerosols generated by standardized entrainment tubes from drug blends with lactose monohydrate: 1. Albuterol sulfate and disodium cromoglycate

Journal of Pharmaceutical Sciences

Volumn 99, Issue 8, 2010, Pages 3398-3414

  Xu, Zhen ^a   Mansour, Heidi M ^a,d   Mulder, Tako ^b   Mclean, Richard ^c   Langridge, John ^b   Hickey, Anthony J ^a  

^a University of North Carolina   (United States)

^b DMV Fonterra Excipients   (Germany)

^c PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United Kingdom)

^d University of Kentucky   (United States)

Author keywords

Aerosolization performance; Aerosols; Dry powder inhaler; Emitted dose; Fine particle fraction; Physical characterization; Powder aerosol deaggregation equation; Pulmonary drug delivery; Shear stress; Standardized entrainment tubes

Indexed keywords

CROMOGLYCATE DISODIUM; LACTOSE; SALBUTAMOL SULFATE; AEROSOL; ANTIASTHMATIC AGENT; DRUG CARRIER; POWDER; SALBUTAMOL;

AEROSOL; AIRFLOW; ARTICLE; DIFFERENTIAL SCANNING CALORIMETRY; DRUG RELEASE; DRY POWDER; LASER DIFFRACTION; MOLECULAR INTERACTION; PARTICLE SIZE; POWDER INHALER; SCANNING ELECTRON MICROSCOPY; SHEAR STRESS; SOLID STATE; X RAY DIFFRACTION; ADSORPTION; CHEMISTRY; CRYSTALLIZATION; DEVICES; DRUG FORMULATION; LASER; MEDICINAL CHEMISTRY; POWDER; THERMODYNAMICS;

ADSORPTION; AEROSOLS; ALBUTEROL; ANTI-ASTHMATIC AGENTS; CALORIMETRY, DIFFERENTIAL SCANNING; CHEMISTRY, PHARMACEUTICAL; CROMOLYN SODIUM; CRYSTALLIZATION; DRUG CARRIERS; DRUG COMPOUNDING; LACTOSE; LASERS; MICROSCOPY, ELECTRON, SCANNING; PARTICLE SIZE; POWDERS; THERMODYNAMICS; X-RAY DIFFRACTION;

EID: 77955116447     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.22107     Document Type: Article

References (35)

1. Hickey AJ. 1996. Inhalation aerosols. In: Hickey AJ, editor. Inhalation aerosols. editors. NY: Marcel Dekker, Inc. pp. 241-260.
2. Cullum VA, Farmer JB, Jack D, Levy GP. 1969. Salbutamol: A new, selective beta-adrenoceptive receptor stimulant. Br J Pharmacol 35:141-151.
3. Hickey AJ, Mansour HM, Telko MJ, Xu Z, Smyth HD, Mulder T, McLean R, Langridge J, Papadopoulos D. 2007. Physical characterization of component particles included in dry powder inhalers. II. Dynamic characteristics. J Pharm Sci 96:1302-1319. (Pubitemid 46804583)
4. Cox JS. 1967. Disodium cromoglycate (FPL 670) ('Intal'): A specific inhibitor of reaginic antibody-antigen mechanisms. Nature 216:1328-1329.
5. Chen LR, Young VG, Jr., Lechuga-Ballesteros D, Grant DJ. 1999. Solid-state behavior of cromolyn sodium hydrates. J Pharm Sci 88:1191-1200.
6. Cox JS, Woodard GD, McCrone WC. 1971. Solid-state chemistry of cromolyn sodium (disodium cromoglycate). J Pharm Sci 60:1458-1465.
7. Smyth H, Hickey AJ. 2005. Carriers in dry powder delivery: Implications for inhalation system design. Am J Drug Deliv 3:117-132.
8. Hickey AJ. 2004. Pharmaceutical inhalation aerosol technology. 2nd edition. New York: Marcel Dekkar. p. 603.
9. Melchor R, Biddiscombe MF, Mak VH, Short MD, Spiro SG. 1993. Lung deposition patterns of directly labelled salbutamol in normal subjects and in patients with reversible airflow obstruction. Thorax 48:506-511.
10. Dunbar CA, Hickey AJ, Holzner P. 1998. Dispersion and characterization of pharmaceutical dry powder aerosols. Kona 16: 7-45.
11. Chan HK. 2006. Dry powder aerosol delivery systems: Current and future research directions. J Aerosol Med 19:21-27.
12. Newman SP. 2004. Dry powder inhalers for optimal drug delivery. Expert Opin Biol Ther 4:23-33.
13. Islam N, Gladki E. 2008. Dry powder inhalers (DPIs) - A review of device reliability and innovation. Int J Pharm 360:1-11.
14. Crowder TM, Louey MD, Sethuraman VV, Smyth HDC, Hickey AJ. 2001. An odyssey in inhaler formulations and design. Pharm Tech 25:99-113.
15. Louey MD, VanOort M, Hickey AJ. 2006. Standardized entrainment tubes for the evaluation of pharmaceutical dry powder dispersion. J Aerosol Sci 37:1520-1533.
16. Xu Z, Mansour HM, Mulder T, McLean R, Langridge J, Hickey AJ. Submitted. Heterogenous particle deaggregation and its implications for therapeutic aerosol performance. J Pharm Sci.
17. Hickey AJ, Mansour HM, Telko MJ, Xu Z, Smyth HD, Mulder T, McLean R, Langridge J, Papadopoulos D. 2007. Physical characterization of component particles included in dry powder inhalers. I. Strategy review and static characteristics. J Pharm Sci 96:1282-1301. (Pubitemid 46804582)
18. Braun MA, Oschmann R, Schmidt PC, 1996. Influence of excipients and storage humidity on the deposition of disodium cromoglycate (DSCG) in the twin impinger. Int J Pharm 135: 53-62.
19. Steckel H, Muller BW. 1997. In vitro evaluation of dry powder inhalers II: Influence of carrier particle size and concentration on in vitro deposition. Int J Pharm 154:31-37.
20. Raula J, Thielmann F, Kansikas J, Hietala S, Annala M, Seppala J, Lahde A, Kauppinen EI. 2008. Investigations on the humidity-induced transformations of salbutamol sulphate particles coated with L-leucine. Pharmaceut Res 25:2250-2261.
21. Larhrib H, Martin GP, Marriott C, Prime D. 2003. The influence of carrier and drug morphology on drug delivery from dry powder formulations. Int J Pharm 257:283-296.
22. Ross KD. 1978. Effects of methanol on physical properties of alpha- and beta-lactose. J Dairy Sci 61:152-158.
23. Ahlneck C, Zografi G. 1990. The molecular basis of moisture effects on the physical and chemical stability of drugs in the solid state. Int J Pharm 62:87-95. (Pubitemid 20261777)
24. Traini D, Young PM, Thielmann F, Acharya M. 2008. The influence of lactose pseudopolymorphic form on salbutamol sulfate-lactose interactions in DPI formulations. Drug Dev Ind Pharm 34:992-1001.
25. Young PM, Tobyn MJ, Price R, Buttrum M, Dey F. 2006. The use of colloid probe microscopy to predict aerosolization performance in dry powder inhalers: AFM and in vitro correlation. J Pharm Sci 95:1800-1809.
26. Attwood D, Agarwal SP. 1984. Self-association of disodium cromoglycate in dilute aqueous solution. Int J Pharm 22:25-30.
27. Ding X, Stringfellow TC, Robinson JR. 2004. Self-association of cromolyn sodium in aqueous solution characterized by nuclear magnetic resonance spectroscopy. J Pharm Sci 93:1351-1358.
28. Xu Z, Mansour HM, Mulder T, McLean R, Langridge J, Hickey AJ. 2008. Comparative dispersion study of dry powder aerosols of albuterol sulfate/lactose monohydrate and disodium cromoglycate/lactose monohydrate delivered by standardized entrainment tubes. Respiratory Drug Delivery 3:897-900.
29. Jones MD, Price R. 2006. The influence of fine excipient particles on the performance of carrier-based dry powder inhalation formulations. Pharmaceut Res 23:1665-1674.
30. Adi H, Larson I, Chiou H, Young P, Traini D, Stewart P. 2008. Role of agglomeration in the dispersion of salmeterol xinafoate from mixtures for inhalation with differing drug to fine lactose ratios. J Pharm Sci 97:3140-3152.
31. Louey MD, Stewart PJ. 2002. Particle interactions involved in aerosol dispersion of ternary interactive mixtures. Pharmaceut Res 19:1524-1531.
32. Zeng XM, Martin GP, Marriott C. 2001. Particulate interactions in dry powder formulations for inhalation. 1st edition. NY: Taylor & Francis Inc. pp 103-132.
33. de Boer AH, Hagedoorn P, Gjaltema D, Goede J, Frijlink HW. 2003. Air classifier technology (ACT) in dry powder inhalation. Part 1. Introduction of a novel force distribution concept (FDC) explaining the performance of a basic air classifier on adhesive mixtures. Int J Pharm 260:187-200.
34. Nichols SC, Wynn E. 2008. New approaches to optimizing dispersion in dry powder inhalers-dispersion force mapping and adhesion measurements. Respiratory Drug Delivery 1:175-184.
35. Do DD. 1998. Adsorption analysis: Equilibria and kinetics. 1st edition. London: Imperial College Press.