Design, characterization, and aerosol dispersion performance modeling of advanced spray-dried microparticulate/nanoparticulate mannitol powders for targeted pulmonary delivery as dry Powder inhalers

Journal of Aerosol Medicine and Pulmonary Drug Delivery

Volumn 27, Issue 2, 2014, Pages 81-93

  Li, Xiaojian ^a   Vogt, Frederick G ^b   Hayes, Don ^c   Mansour, Heidi M ^d  

^a UNIVERSITY OF KENTUCKY   (United States)

^b GLAXOSMITHKLINE   (United States)

^c THE OHIO STATE UNIVERSITY COLLEGE OF MEDICINE   (United States)

^d UNIVERSITY OF ARIZONA   (United States)

Author keywords

Aerosol performance modeling; Confocal Raman chemical imaging; cystic fibrosis; DPI; Lung; Osmotic agent; Particle engineering design; Respiratory; Solid state

Indexed keywords

MANNITOL; MUCOLYTIC AGENT; AEROSOL; DRUG CARRIER; EXPECTORANT AGENT; NANOPARTICLE; POWDER; WATER;

AEROSOL; ARTICLE; CRYSTALLIZATION; CYSTIC FIBROSIS; DISPERSION; DRUG DESIGN; DRUG INDICATION; DRY POWDER INHALER; MORPHOLOGY; NANOPHARMACEUTICS; PARTICLE SIZE; PARTICULATE MATTER; PHYSICAL CHEMISTRY; SOLID STATE; SPRAY DRYING; SURFACE PROPERTY; WATER CONTENT; CHEMISTRY; CONFOCAL MICROSCOPY; DEVICES; DIFFERENTIAL SCANNING CALORIMETRY; DRUG DELIVERY SYSTEM; EQUIPMENT DESIGN; INFRARED SPECTROSCOPY; INHALATIONAL DRUG ADMINISTRATION; MEDICINAL CHEMISTRY; NANOTECHNOLOGY; PHARMACEUTICS; POWDER; POWDER DIFFRACTION; PROCEDURES; RAMAN SPECTROMETRY; SCANNING ELECTRON MICROSCOPY; STATISTICAL MODEL; X RAY CRYSTALLOGRAPHY;

ADMINISTRATION, INHALATION; AEROSOLS; CALORIMETRY, DIFFERENTIAL SCANNING; CHEMISTRY, PHARMACEUTICAL; CRYSTALLIZATION; CRYSTALLOGRAPHY, X-RAY; DRUG CARRIERS; DRUG DELIVERY SYSTEMS; DRY POWDER INHALERS; EQUIPMENT DESIGN; EXPECTORANTS; LINEAR MODELS; MANNITOL; MICROSCOPY, CONFOCAL; MICROSCOPY, ELECTRON, SCANNING; NANOPARTICLES; NANOTECHNOLOGY; PARTICLE SIZE; POWDER DIFFRACTION; POWDERS; SPECTROSCOPY, FOURIER TRANSFORM INFRARED; SPECTRUM ANALYSIS, RAMAN; SURFACE PROPERTIES; TECHNOLOGY, PHARMACEUTICAL; WATER;

EID: 84897106239     PISSN: 19412711     EISSN: 19412703     Source Type: Journal    
DOI: 10.1089/jamp.2013.1078     Document Type: Article

References (51)

1. Gibson RL, Burns JL, and Ramsey BW: Pathophysiology and management of pulmonary infections in cystic fibrosis. Am J Respir Crit Care Med. 2003168:918-951.
2. Elphick H, and Southern K: Antifungal therapies for allergic bronchopulmonary aspergillosis in people with cystic fibrosis. Cochrane Database Syst Rev. 2000(4):CD002204.
3. Hickey AJ, and Mansour HM: Delivery of drugs by the pulmonary route. In: AT Florence, and J Siepmann, (eds). Modern Pharmaceutics. Taylor & Francis, New York pp. 191-219, 2009.
4. Hickey AJ, and Mansour HM: Formulation challenges of powders for the delivery of small molecular weight molecules as aerosols. In: MJ Rathbone, (ed). Modified-Release Drug Delivery Technology. Informa Healthcare, New York pp. 573-602, 2008.
5. Hickey AJ, Mansour HM, Telko MJ, Xu Z, Smyth HD, Mulder T, McLean R, Langridge J, and Papadopoulos D: Physical characterization of component particles included in dry powder inhalers. I. Strategy review and static characteristics. J Pharm Sci. 200796:1282-1301.
6. Hickey AJ, Mansour HM, Telko MJ, Xu Z, Smyth HD, Mulder T, McLean R, Langridge J, and Papadopoulos D: Physical characterization of component particles included in dry powder inhalers. II. Dynamic characteristics. J Pharm Sci. 200796:1302-1319.
7. Suarez S, and Hickey AJ: Drug properties affecting aerosol behavior. Respir Care. 200045:652-666.
8. Wu X, Li X, and Mansour HM: Surface analytical techniques in solid-state particle characterization: implications for predicting performance in dry powder inhalers. KONA Powder Particle J. 20103-19.
9. Xu Z, Mansour HM, and Hickey AJ: Particle interactions in dry powder inhaler unit processes. J Adhes Sci Technol: Special Issue on Adhesion Aspects in Pharmaceutical Sciences. 201125:451-482.
10. Xu Z, Mansour HM, Mulder T, McLean R, Langridge J, and Hickey AJ: Heterogeneous particle deaggregation and its implication for therapeutic aerosol performance. J Pharm Sci. 201099:3442-3461.
11. Adi H, Traini D, Chan HK, and Young PM: The influence of drug morphology on aerosolisation efficiency of dry powder inhaler formulations. J Pharm Sci. 200897:2780- 2788.
12. Mansour HM, Rhee YS, and Wu X: Nanomedicine in pulmonary delivery. Int J Nanomedicine. 20094:299-319.
13. Taylor RF, Morgan DW, Nicholson PS, Mackay IS, Hodson ME, and Pitt TL: Extrapulmonary sites of Pseudomonas aeruginosa in adults with cystic fibrosis. Thorax. 199247:426-428.
14. Tiddens HA: Detecting early structural lung damage in cystic fibrosis. Pediatr Pulmonol. 200234:228-231.
15. Worlitzsch D, Tarran R, Ulrich M, Schwab U, Cekici A, Meyer KC, Birrer P, Bellon G, Berger J, Weiss T, Botzenhart K, Yankaskas JR, Randell S, Boucher RC, and Doring G: Effects of reduced mucus oxygen concentration in airway Pseudomonas infections of cystic fibrosis patients. J Clin Invest. 2002109:317-325.
16. Usmani OS, Biddiscombe MF, and Barnes PJ: Regional lung deposition and bronchodilator response as a function of b2-agonist particle size. Am J Respir Crit Care Med. 2005172:1497-1504.
17. Stahlhofen W, Gebhart J, and Heyder J: Experimental determination of the regional deposition of aerosol particles in the human respiratory tract. Am Ind Hyg Assoc J. 198041:385-398a.
18. Murray JF, and Nadel JA: Textbook of Respiratory Medicine. Saunders, Philadelphia 1988.
19. Raabe OG: Comparison of the criteria for sampling 'inhalablé and 'respirablé aerosols. Ann Occup Hyg. 198226:33-45.
20. Suarez S, and Hickey AJ: Drug properties affecting aerosol behavior. Respir Care. 200045:652-666.
21. Mizoe T, Ozeki T, and Okada H: Preparation of drug nanoparticle- containing microparticles using a 4-fluid nozzle spray drier for oral, pulmonary, and injection dosage forms. J Control Release. 2007122:10-15.
22. Wu X, Zhang W, Hayes DJ, and Mansour HM: Physicochemical characterization and aerosol dispersion performance of organic solution advanced spray-dried cyclosporine A multifunctional particles for dry powder inhalation aerosol delivery. Int J Nanomedicine. 20138:1-15.
23. Wu X, Hayes D Jr, Zwischenberger JB, Kuhn RJ, and Mansour HM: Design and physicochemical characterization of advanced spray-dried tacrolimus multifunctional particles for inhalation. Drug Des Devel Ther. 20137:59-72.
24. Meenach SA, Vogt FG, Anderson KW, Hilt JZ, McGarry RC, and Mansour HM: Design, physicochemical characterization, and optimization of organic solution advanced spray-dried inhalable DPPC and DPPC:DPPE-PEG microparticles and nanoparticles for targeted respiratory nanomedicine delivery as dry powder inhalation aerosols. Int J Nanomedicine. 20138:275-293.
25. Li X, and Mansour HM: Physicochemical characterization and water vapor sorption of organic solution advanced spray-dried inhalable trehalose microparticles and nanoparticles for targeted dry powder pulmonary inhalation delivery. AAPS PharmSciTech. 201112:1420-1430.
26. Dunbar CA, Hickey AJ, and Holzner P: Dispersion and characterization of pharmaceutical dry powder aerosols. KONA Powder Particle J. 199816:7-45.
27. Teper A, Jaques A, and Charlton B: Inhaled mannitol in patients with cystic fibrosis: a randomised open-label dose response trial. J Cyst Fibros. 201110:1-8.
28. Mansour HM, Xu Z, and Hickey AJ: Dry powder aerosols generated by standardized entrainment tubes from alternative sugar blends: 3. Trehalose dihydrate and D-mannitol carriers. J Pharm Sci. 201099:3430-3441.
29. Daviskas E, Anderson SD, Eberl S, Chan HK, and Young IH: The 24-h effect of mannitol on the clearance of mucus in patients with bronchiectasis. Chest. 2001119: 414-421.
30. Wills PJ, and Cole PJ: Mucolytic and mucokinetic therapy. Pulm Pharmacol. 19969:197-204.
31. Brannan JD, Gulliksson M, Anderson SD, Chew N, and Kumlin M: Evidence of mast cell activation and leukotriene release after mannitol inhalation. Eur Respir J. 200322: 491-496.
32. King M, and Rubin BK: Pharmacological approaches to discovery and development of new mucolytic agents. Adv Drug Deliv Rev. 200254:1475-1490.
33. Daviskas E, and Anderson SD: Hyperosmolar agents and clearance of mucus in the diseased airway. J Aerosol Med. 200619:100-109.
34. Jaques A, Daviskas E, Turton JA, McKay K, Cooper P, Stirling RG, Robertson CF, Bye PT, Lesouëf PN, Shadbolt B, Anderson SD, and Charlton B: Inhaled mannitol improves lung function in cystic fibrosis. Chest. 2008133: 1388-1396.
35. Burger A, Henck JO, Hetz S, Rollinger JM, Weissnicht AA, and Stottner H: Energy/temperature diagram and compression behavior of the polymorphs of D-mannitol. J Pharm Sci. 200089:457-468.
36. Takada A, Nail SL, and Yonese M: Influence of ethanol on physical state of freeze-dried mannitol. Pharm Res. 2009 26:1112-1120.
37. Mansour HM, and Zografi G: The relationship between water vapor absorption and desorption by phospholipids and bilayer phase transitions. J Pharm Sci. 200796: 377-396.
38. Mansour HM, and Hickey AJ: Raman characterization and chemical imaging of biocolloidal self-assemblies, drug delivery systems, and pulmonary inhalation aerosols. A review. AAPS PharmSciTech. 20078:E01-E16.
39. Park CW, Rhee YS, Vogt F, Hayes DJ, Zwischenberger JB, DeLuca PP, and Mansour HM: Advances in microscopy and complementary imaging techniques to assess the fate of drugs ex-vivo in respiratory drug delivery. Invited paper. Adv Drug Deliv Rev. 201264:344-356.
40. < 601 > Aerosols, Nasal Sprays, Metered-Dose Inhalers, and Dry Powder Inhalers Monograph. USP 29-NF 24 The United States Pharmacopoeia and The National Formulary: The Official Compendia of Standards. Vol. 29/24. The United States Pharmacopeial Convention, Inc., Rockville, MD pp. 2617-2636, 2006.
41. Finlay WH: The ARLA respiratory deposition calculator. 2008. Available at: www.mece.ualberta.ca/arla/impactormmadcalculator.html. Accessed January 17, 2013.
42. Nunes C, Suryanarayanan R, Botez CE, and Stephens PW: Characterization and crystal structure of D-mannitol hemihydrate. J Pharm Sci. 200493:2800-2809.
43. Mitchell H: Sweeteners and Sugar Alternatives in Food Technology.Blackwell Publishers,Oxford,Ames, Iowa 2006.
44. Ye P, and Byron T: Characterization of D-mannitol by thermal analysis, FTIR, and Raman spectroscopy. Am Lab. 200840:24-27.
45. Tang P, Chan HK, Chiou H, Ogawa K, Jones MD, Adi H, Buckton G, Prud'homme RK, and Raper JA: Characterisation and aerosolisation of mannitol particles produced via confined liquid impinging jets. Int J Pharm. 2009367:51-57.
46. Kumon M, Kwok PC, Adi H, Heng D, and Chan HK: Can low-dose combination products for inhalation be formulated in single crystalline particles? Eur J Pharm Sci. 201040:16-24.
47. Chan HK, Clark AR, Feeley JC, Kuo MC, Lehrman SR, Pikal-Cleland K, Miller DP, Vehring R, and Lechuga- Ballesteros D: Physical stability of salmon calcitonin spraydried powders for inhalation. J Pharm Sci. 200493: 792-804.
48. Tong P, and Zografi G: Effects of water vapor absorption on the physical and chemical stability of amorphous sodium indomethacin. AAPS PharmSciTech. 20045:e26.
49. Yoshinari T, Forbes RT, York P, and Kawashima Y: Moisture induced polymorphic transition of mannitol and its morphological transformation. Int J Pharm. 2002247: 69-77.
50. Donovan MJ, Kim SH, Raman V, and Smyth HD: Dry powder inhaler device influence on carrier particle performance. J Pharm Sci. 2011101:1097-1107.
51. Hickey AJ: Inhalation Aerosols: Physical and Biological Basis for Therapy, 2nd ed. Informa Healthcare, New York 2007.