Physicochemical characterization and aerosol dispersion performance of organic solution advanced spray-dried cyclosporine A multifunctional particles for dry powder inhalation aerosol delivery

International Journal of Nanomedicine

Volumn 8, Issue , 2013, Pages 1269-1283

  Wu, Xiao ^a   Zhang, Weifen ^a,b   Hayes, Don ^c,d   Mansour, Heidi M ^a  

^a UNIVERSITY OF KENTUCKY   (United States)

^b WEIFANG MEDICAL UNIVERSITY   (China)

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

^d OHIO STATE UNIVERSITY   (United States)

Author keywords

Calcineurin inhibitor; Dipalmitoylphosphatidylcholine (DPPC); Dipalmitoylphosphatidylglycerol (DPPG); Dry powder inhaler (DPI); Lung immunosuppression; Lung surfactant; Polypeptide drug; Targeted lung immunosuppression

Indexed keywords

CYCLOSPORIN A; DIPALMITOYLPHOSPHATIDYLCHOLINE; DIPALMITOYLPHOSPHATIDYLGLYCEROL; HYDROXYPROPYLMETHYLCELLULOSE;

AEROSOL; ARTICLE; CIRCULAR DICHROISM; DEVICE APPROVAL; DIFFERENTIAL SCANNING CALORIMETRY; DISPERSION; DRUG DELIVERY DEVICE; DRUG FORMULATION; DRY POWDER; EQUIPMENT DESIGN; FOOD AND DRUG ADMINISTRATION; GRAVIMETRY; LASER DIFFRACTION; PARTICLE SIZE; PHOSPHOLIPID BILAYER; PHYSICAL CHEMISTRY; POWDER INHALER; SCANNING ELECTRON MICROSCOPY; SOLID STATE; SPRAY DRYING; TITRIMETRY; VAPOR; X RAY DIFFRACTION;

EID: 84875514505     PISSN: 11769114     EISSN: 11782013     Source Type: Journal    
DOI: 10.2147/IJN.S40904     Document Type: Article

References (57)

1. Waldrep JC, Scherer PW, Keyhani K, and Knight V. Cyclosporin A liposome aerosol: particle size and calculated respiratory deposition. Int J Pharm. 97:205-212 (1993).
2. Matsuda S, Koyasu S. Mechanisms of action of cyclosporine. Immunopharmacology. 2000;47(2-3):119-125.
3. Underwood SL, McMillan S, Reeves R, etal. Effects of cyclosporin A administered into the airways against antigen-induced airway inflammation and hyperreactivity in the rat. Eur J Pharmacol. 2001;420(2-3): 165-173.
4. Mitruka SN, Won A, McCurry KR, et al. In the lung aerosol cyclosporine provides a regional concentration advantage over intramuscular cyclosporine. J Heart Lung Transplant. 2000;19(10):969-975.
5. Shirbacheh MV, Jones JW, Breidenbach WC, McCabe S, Barker JH, Gruber SA. The case for local immunosuppression in composite tissue allotransplantation. Transplant Proc. 1998;30(6):2739-2742.
6. Kahan BD. Cyclosporine. New Engl J Med. 1989;321(25): 1725-1738.
7. Burkart GJ, Smaldone GC, Eldon MA, et al. Lung deposition and pharmacokinetics of cyclosporine after aerosolization in lung transplant patients. Pharm Res. 2003;20(2):252-256.
8. Rohatagi S, Calic F, Harding N, et al. Pharmacokinetics, pharmacodynamics, and safety of inhaled cyclosporin A (ADI628) after single and repeated administration in healthy male and female subjects and asthmatic patients. J Clin Pharmacol. 2000;40(11):1211-1226.
9. Niven RW. Toward managing chronic rejection after lung transplant: the fate and effects of inhaled cyclosporine in a complex environment. Adv Drug Deliv Rev. 2011;63(1-2):88-109.
10. Corcoran TE, Smaldone GC, Dauber JH, et al. Preservation of post-transplant lung function with aerosol cyclosporin. Eur Respir J. 2004; 23(3):378-383.
11. Iacono AT, Corcoran TE, Griffith BP, et al. Aerosol cyclosporin therapy in lung transplant recipients with bronchiolitis obliterans. Eur Respir J. 2004;23(3):384-390.
12. Hayes D Jr, Zwischenberger JB, Mansour HM. Aerosolized tacrolimus: a case report in a lung transplant recipient. Transplant Proc. 2010; 42(9):3876-3879.
13. Behr J, Zimmermann G, Baumgartner R, et al. Lung deposition of a liposomal cyclosporine A inhalation solution in patients after lung transplantation. J Aerosol Med Pulm Drug Deliv. 2009;22(2):121-130.
14. Onoue S, Sato H, Kawabata Y, Mizumoto T, Hashimoto N, Yamada S. In vitro and in vivo characterization on amorphous solid dispersion of cyclosporine A for inhalation therapy. J Control Release. 2009; 138(1):16-23.
15. Zijlstra GS, Rijkeboer M, Jan van Drooge D, et al. Characterization of a cyclosporine solid dispersion for inhalation. AAPS J. 2007;9(2):E190-E199.
16. Yamasaki K, Kwok PC, Fukushige K, Prud'homme RK, Chan HK. Enhanced dissolution of inhalable cyclosporine nano-matrix particles with mannitol as matrix former. Int J Pharm. 2011;420(1):34-42.
17. Chen X, Young TJ, Sarkari M, Williams RO 3rd, Johnston KP. Preparation of cyclosporine A nanoparticles by evaporative precipitation into aqueous solution. Int J Pharm. 2002;242(1-2):3-14.
18. Park CW, Hayes D Jr, Mansour HM. Pulmonary inhalation aerosols for targeted antibiotics drug delivery. Eur Pharm Rev. 2011;16(1): 32-36.
19. Hickey AJ, Mansour HM. Delivery of drugs by the pulmonary route. In: Florence AT, Siepmann J, editors. Modern Pharmaceutics: Volume 2. 5th ed. New York, NY: Informa Healthcare; 2009:191-220.
20. Patton JS, Byron PR. Inhaling medicines:delivering drugs to the body through the lungs. Nat Rev Drug Discov. 2007;6(1):67-74.
21. Hayes D Jr, Mansour HM, Kirkby S, Phillips AB. Rapid acute onset of bronchiolitis obliterans syndrome in a lung transplant recipient after respiratory syncytial virus infection. Transpl Infect Dis. 2012; 14(5):548-550.
22. Hickey AJ, Mansour HM. Formulation challenges of powders for the delivery of small molecular weight molecules as aerosols. In: Rathbone MJ, Hadgraft J, Roberts MS, Lane ME, editors. Modified-Release Drug Delivery Technology: Volume 2. 2nd ed. New York, NY: Informa Healthcare; 2008:573-602.
23. Hickey AJ, Mansour HM, Telko MJ, et al. Physical characterization of component particles included in dry powder inhalers. I. Strategy review and static characteristics. J Pharm Sci. 2007;96(5):1282-1301.
24. Hickey AJ, Mansour HM, Telko MJ, et al. Physical characterization of component particles included in dry powder inhalers. II. Dynamic characteristics. J Pharm Sci. 2007;96(5):1302-1319.
25. Willis L, Hayes D Jr, Mansour HM. Therapeutic liposomal dry powder inhalation aerosols for targeted lung delivery. Lung. 2012;190(3): 251-262.
26. Wu X, Li X, Mansour HM. Surface analytical techniques in solid-state particle characterization for predicting performance in dry powder inhalers. KONA Powder Part J. 2010;28:3-19.
27. Mansour HM, Rhee YS, Wu X. Nanomedicine in pulmonary delivery. Int J Nanomedicine. 2009;4:299-319.
28. Mansour H, Wang DS, Chen CS, Zografi G. Comparison of bilayer and monolayer properties of phospholipid systems containing dipalmitoylphosphatidylglycerol and dipalmitoylphosphatidylinositol. Langmuir. 2001;17(21):6622-6632.
29. Mansour HM, Zografi G. Relationships between equilibrium spreading pressure and phase equilibria of phospholipid bilayers and monolayers at the air-water interface. Langmuir. 2007;23(7):3809-3819.
30. Mansour HM, Damodaran S, Zografi G. Characterization of the in situ structural and interfacial properties of the cationic hydrophobic heteropolypeptide, KL4, in lung surfactant bilayer and monolayer models at the air-water interface: implications for pulmonary surfactant delivery. Mol Pharm. 2008;5(5):681-695.
31. Morrow MR, Temple S, Stewart J, Keough KM. Comparison of DPPC and DPPG environments in pulmonary surfactant models. Biophys J. 2007;93(1):164-175.
32. Goerke J. Pulmonary surfactant: functions and molecular composition. Biochim Biophys Acta. 1998;1408(2-3):79-89.
33. Veldhuizen R, Nag K, Orgeig S, Possmayer F. The role of lipids in pulmonary surfactant. Biochim Biophys Acta. 1998;1408(2-3):90-108.
34. Postle AD, Heeley EL, Wilton DC. A comparison of the molecular species compositions of mammalian lung surfactant phospholipids. Comp Biochem Physiol A Mol Integr Physiol. 2001;129(1):65-73.
35. Mansour HM, Rhee YS, Park CW, DeLuca PP. Lipid nanoparticulate drug delivery and nanomedicine. In: Moghis A, editor. Lipids in Nanotechnology, 1st ed. Urbana, IL: AOCS Press; 2011:221-268.
36. Mansour HM, Park CW, Hayes D Jr. Nanoparticle lung delivery and inhalation aerosols for targeted pulmonary nanomedicine. In: Kumar A, Mansour HM, Friedman A, Blough E, editors. Nanomedicine in Drug Delivery: First edition. London: CRC Press/Taylor & Francis; 2013. In press.
37. Rhee YS, Mansour HM. Nanopharmaceuticals I: nanocarrier systems in drug delivery. Int J Nanotechnol. 2011;8(1/2):84-114.
38. Wu X, Mansour HM. Nanopharmaceuticals II: application of nanoparticles and nanocarrier systems in pharmaceutics and nanomedicine. Int J Nanotechnol. 2011;8(1/2):115-145.
39. Ganguly S, Moolchandani V, Roche JA, et al. Phospholipid-induced in vivo particle migration to enhance pulmonary deposition. J Aerosol Med Pulm Drug Deliv. 2008;21(4):343-350.
40. Meenach SA, Vogt FG, Anderson KW, Hilt JZ, McGarry RC, Mansour HM. Design, physicochemical characterization, and optimization of organic solution advanced spray-dried inhalable dipalmitoylphosphatidylcholine (DPPC) and dipalmitoylphosphatidylethanolamine poly(ethylene glycol) (DPPE-PEG) microparticles and nanoparticles for targeted respiratory nanomedicine delivery as dry powder inhalation aerosols. Int J Nanomedicine. 2013;8:275-293.
41. Wu X, Hayes D Jr, Zwischenberger JB, Kuhn RJ, Mansour HM. Design and physicochemical characterization of advanced spray-dried tacrolimus multifunctional particles for inhalation. Drug Des Dev Ther. 2013;7:59-72.
42. Li X, Mansour HM. Physicochemical characterization and water vapor sorption of organic solution advanced spray-dried trehalose microparticles and nanoparticles for targeted dry powder pulmonary inhalation delivery. AAPS Pharm Sci Tech. 2011;12(4):1420-1430.
43. Xu Z, Mansour HM, Mulder T, McLean R, Langridge J, Hickey AJ. Dry powder aerosols generated by standardized entrainment tubes from drug blends with lactose monohydrate: 2. Ipratropium bromide monohydrate and fluticasone propionate. J Pharm Sci. 2010;99(8):3415-3429.
44. Xu Z, Mansour HM, Mulder T, McLean R, Langridge J, Hickey AJ. Dry powder aerosols generated by standardized entrainment tubes from drug blends with lactose monohydrate: 1. albuterol sulfate and disodium cromoglycate. J Pharm Sci. 2010;99(8):3398-3414.
45. Mansour HM, Xu Z, Hickey AJ. Dry powder aerosols generated by standardized entrainment tubes from alternative sugar blends: 3. Trehalose dihydrate and D-mannitol carriers. J Pharm Sci. 2010;99(8): 3430-3441.
46. Mansour HM, Zografi G. The relationship between water vapor absorption and desorption by phospholipids and bilayer phase transitions. J Pharm Sci. 2007;96(2):377-396.
47. Aerosols, nasal sprays, metered-dose inhalers, and dry powder inhalers monograph. In: USP 29-NF 24: The United States Pharmacopeia and The National Formulary: The Official Compendia of Standards: Volume 29/24. Rockville, MD: The United States Pharmacopeial Convention; 2006:2617-2636.
48. Holt, J. (2009). The MMAD Calculator. Available from http://www.mmadcalculator.com/. Accessed September 20, 2012.
49. Tam JM, McConville JT, Williams RO 3rd, Johnston KP. Amorphous cyclosporin nanodispersions for enhanced pulmonary deposition and dissolution. J Pharm Sci. 2008;97(11):4915-4933.
50. Tandya A, Dehghani F, Foster NR. Micronization of cyclosporine using dense gas techniques. J Supercrit Fluids. 2006;37(3):272-278.
51. Katakai R, Iizuka Y. Conformation of oligopeptides with L-leucyl-L-leucyl-L-alanyl and L-methionyl-L-methionyl-L-leucyl repeating units. Biopolymers. 1984;23(7):1411-1422.
52. Piovesan Alves G, Santana MH. Phospholipid dry powders produced by spray drying processing: structural, thermodynamic and physical properties. Powder Technol. 2004;145(2):139-148.
53. Suarez S, Hickey AJ. Drug properties affecting aerosol behavior. Respir Care. 2000;45(6):652-666.
54. Dolovich M. Lung dose, distribution, and clinical response to therapeutic aerosols. Aerosol Sci Technol. 1993;18:230-240.
55. Andya JD, Maa YF, Costantino HR, et al. The effect of formulation excipients on protein stability and aerosol performance of spray-dried powders of a recombinant humanized anti-IgE monoclonal antibody. Pharm Res. 1999;16(3):350-358.
56. Sollohub K, Cal K. Spray drying technique: II. Current applications in pharmaceutical technology. J Pharm Sci. 2010;99(2):587-597.
57. Masters K. Spray Drying Handbook, 5th ed. New York, NY: John Wiley & Sons; 1991.