Characterization and aerosol dispersion performance of advanced spray-dried chemotherapeutic PEGylated phospholipid particles for dry powder inhalation delivery in lung cancer

European Journal of Pharmaceutical Sciences

Volumn 49, Issue 4, 2013, Pages 699-711

  Meenach, Samantha A ^a,b   Anderson, Kimberly W ^b,c   Zach Hilt, J ^b,c   McGarry, Ronald C ^d   Mansour, Heidi M ^a,c,e  

^a University of Kentucky   (United States)

^b UNIVERSITY OF KENTUCKY   (United States)

^c UNIVERSITY OF KENTUCKY   (United States)

^d UNIVERSITY OF KENTUCKY   (United States)

^e UNIVERSITY OF ARIZONA   (United States)

Author keywords

Biocompatible biodegradable lipopolymers; Dry powder inhaler (DPI); Lung surfactant; Nanomedicine; Nanotechnology; Respiratory drug delivery

Indexed keywords

PACLITAXEL; PHOSPHOLIPID;

AEROSOL; ARTICLE; CONTROLLED STUDY; DIFFERENTIAL SCANNING CALORIMETRY; DISPERSION; DRUG DELIVERY SYSTEM; DRY POWDER; DRY POWDER INHALER; GLASS TRANSITION TEMPERATURE; IN VITRO STUDY; LIMIT OF DETECTION; LUNG CANCER; PARTICLE SIZE; PHASE TRANSITION; PHOSPHOLIPID BILAYER; PRIORITY JOURNAL; SOLID STATE; SPRAY DRYING; TITRIMETRY; WATER CONTENT; X RAY POWDER DIFFRACTION;

EID: 84879470777     PISSN: 09280987     EISSN: 18790720     Source Type: Journal    
DOI: 10.1016/j.ejps.2013.05.012     Document Type: Article

References (58)

1. Aerosols, 2006. 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. The United States Pharmacopeial Convention, Inc., Rockville, MD, pp. 2617-2636.
2. Alves, G.P., Santana, M.H.A., 2004. Phospholipid dry powders produced by spray drying processing: structural, thermodynamic and physical properties. Powder Technol. 145, 139-148. (Pubitemid 39208838)
3. Arnold, M.M., Gonnan, E.M., Schieber, L.J., Munson, E.J., Berkland, C., 2007. NanoCipro encapsulation in monodisperse large porous PLGA microparticles. J. Controlled Release 121, 100-109. (Pubitemid 47126070)
4. Bosquillon, C., Lombry, C., Preat, V., Vanbever, R., 2001. Influence of formulation excipients and physical characteristics of inhalation dry powders on their aerosolization performance. J. Controlled Release 70, 329-339. (Pubitemid 32155456)
5. Cartiera, M.S., Ferreira, E.C., Caputo, C., Egan, M.E., Caplan, M.J., Saltzman, W.M., 2010. Partial correction of cystic fibrosis defects with PLGA nanoparticles encapsulating curcumin. Mol. Pharm. 7, 86-93.
6. Carvalho, T.C., Carbalho, S.R., McConville, J.T., 2011. Formulations for pulmonary administration of anticancer agents to treat lung malignancies. J. Aerosol Med. Pulm. Drug Del. 24, 61-80.
7. Chow, A.H.L., Tong, H.H.Y., Chattopadhyay, P., Shekunov, B.Y., 2007. Particle engineering for pulmonary drug delivery. Pharm. Res. 24, 411-437. (Pubitemid 46295160)
8. Coates, A.L., O'Callaghan, C., 2006. Drug Administration by Aerosol in Children. Saunders-Elsevier, Philadelphia, PA.
9. Dunbar, C.A., Hickey, A.J., Holzner, P., 1998. Dispersion and characterization of pharmaceutical dry powder aerosols. KONA Powder Part. J. 16, 7-45.
10. Edwards, D.A., 1995. The macrotransport of aerosol particles in the lung: aerosol deposition phenomena. J. Aerosol Sci. 26, 293-317.
11. Edwards, D.A., Ben-Jebria, A., Langer, R., 1998. Recent advances in pulmonary drug delivery using large, porous inhaled particles. J. Appl. Physiol. 85, 379-385. (Pubitemid 28365799)
12. Eldar-Boock, A., Miller, K., Sanchis, J., Lupu, R., Vicent, M.J., Satchi-Fainaro, R., 2011. Integrin-assisted drug delivery of nano-scaled polymer therapeutics bearing paclitaxel. Biomaterials 32, 3862-3874.
13. Finlay, W., 2008. The ARLA Respiratory Deposition Calculator.
14. Gagnadoux, F., Hureaux, J., Vecellio, L., Urban, T., Le Pape, A., Valo, I., Montharu, J., Leblond, V., Boisdron-Celle, M., Lerondel, S., Majoral, C., Diot, P., Racineux, J.L., Lemarie, E., 2008. Aerosolized chemotherapy. J. Aerosol Med. Pulm. Drug Del. 21, 61-69.
15. Ganguly, S., Moolchandani, V., Roche, J.A., Shapiro, P.S., Somaraju, S., Eddington, N.D., Dalby, R.N., 2008. Phospholipid-induced in vivo particle migration to enhance pulmonary deposition. J. Aerosol Med. Pulm. Drug Del. 23, 181-187.
16. Gill, S., Lobenberg, R., Ku, T., Azarmi, S., Roa, W.H., Prenner, E.J., 2007. Nanoparticles: characteristics, mechanisms of action, and toxicity in pulmonary drug delivery - a review. J. Biomed. Nanotechnol. 3, 107-119. (Pubitemid 351877160)
17. Gill, K.K., Nazzal, S., Kaddoumi, A., 2011. Paclitaxel-loaded PEG5000-DSPE micelles as pulmonary delivery platform: formulation characterizaton, tissue distribution, plasma pharmacokinetics and toxicological evaluation. Eur. J. Pharm. Biopharm. 79, 276-284.
18. Hickey, A.J., Mansour, H.M., 2008. Formulation challenges of powders for the delivery of small molecular weight molecules as aerosoles. In: Rathbone, M.J., Roberts, M.S., Lane, M.E. (Eds.), Modified-Release Drug Delivery Technology Informa Healthcare, New York, pp. 573-602.
19. Hickey, A.J., Mansour, H.M., 2009. Delivery of drugs by the pulmonary route. In: Florence, A.T., Siepmann, J. (Eds.), Modern Pharmaceutics, 5th ed. Taylor and Francis, New York, pp. 191-219.
20. Hickey, A.J., Mansour, H.M., Martin, J.T., Xu, Z., Smyth, H.D.C., 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)
21. Ishihara, K., Nomura, H., Mihara, T., Kurita, K., Iwasaki, Y., Nakabayashi, N., 1998. Why do phospholipid polymers reduce protein adsorption? J. Biomed. Mater. Res. 39, 323-330. (Pubitemid 28060367)
22. Kang, E., Robinson, J., Park, K., Cheng, J.-X., 2007. Paclitaxel distribution in poly(ethylene glycol)/poly(lactide-co-glycolic acid) blends and its release visualized by coherent anti-Stokes Raman scattering microscopy. J. Controlled Release 122, 261-268. (Pubitemid 47404671)
23. Kikuchi, H., Yamauchi, H., Hirota, S., 1991. A spray-drying method for mass production of liposomes. Chem. Pharm. Bull. 36, 1522-1527.
24. Labiris, N.R., Dolovich, M.B., 2003a. Pulmonary drug delivery. Part I: Physiological factors affecting therapeutic effectiveness of aerosolized medications. J. Clin. Pharmacol. 56, 588-599. (Pubitemid 37491710)
25. Labiris, N.R., Dolovich, M.B., 2003b. Pulmonary drug delivery. Part II: The role of inhalant delivery devices and drug formulation in therapeutic effectiveness of aerosolized medications. Br. J. Clin. Pharmacol. 56, 600-612. (Pubitemid 37491711)
26. Lai, S.K., Wang, Y.-Y., Hanes, J., 2009a. Mucus-penetrating nanoparticles for drug and gene delivery to mucosal tissues. Adv. Drug Deliv. Rev. 61, 158-171.
27. Lai, S.K., Wang, Y.-Y., Wirtz, D., Hanes, J., 2009b. Micro- and macrorheology of mucus. Adv. Drug Deliv. Rev. 61, 86-100.
28. Lee, J.H., Gi, U.-S., Kim, J.-H., Kim, Y., Kim, S.-H., Oh, H., Min, B., 2001. Preparation and characterization of solvent induced dihydrated, anhydrous, and amorphous paclitaxel. Bull. Korean Chem. Soc. 22, 925-928. (Pubitemid 33330999)
29. Li, X.J., Mansour, H.M., 2011. 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 12, 1420-1430.
30. Li, X., Hayes, D., Mansour, H.M., 2011. Targeted lung delivery by inhalable multifunctional microparticulate/nanoparticulate aerosols for cystic fibrosis combination drug/mucolytic treatment. Pediatr. Pulmonol., 346.
31. Liggins, R.T., Hunter, W.L., Burt, H.M., 1997. Solid-state characterization of paclitaxel. J. Pharm. Sci. 86, 1459-1463.
32. Mansour, H.M., Zografi, G., 2007a. The relationship between water vapor absorption and desorption by phospholipids and bilayer phase transitions. J. Pharm. Sci. 96, 377-396. (Pubitemid 46363568)
33. Mansour, H.M., Zografi, G., 2007b. Relationships between equilibrium spreading pressure and phase equilibria of phospholipid bilayers and monolayers at the air-water interface. Langmuir 23, 3809-3819. (Pubitemid 46581908)
34. Mansour, H., Wang, D.S., Chen, C.S., Zografi, G., 2001. Comparison of bilayer and monolayer properties of phospholipid systems containing dipalmitoylphosphatidylglycerol and dipalmitoylphosphatidylinositol. Langmuir 17, 6622-6632. (Pubitemid 35330647)
35. Mansour, H.M., Rhee, Y.-S., Wu, X., 2009. Nanomedicine in pulmonary delivery. Int. J. Nanomed. 4, 299-319.
36. Mansour, H.M., Sohn, M., Al-Ghananeem, A., DeLuca, P.P., 2010. Materials for pharmaceutical dosage forms: molecular pharmaceutics and controlled release drug delivery aspects. Int. J. Mol. Sci. 11, 3298-3322.
37. Mansour, H.M., Rhee, Y.S., Park, C.W., DeLuca, P.P., 2011. Lipid nanoparticulate drug delivery and nanomedicine. In: Moghis, A. (Ed.), Lipids in Nanotechnology. American Oil Chemists Society (AOCS) Press, Urbana, Illinois, pp. 221-268.
38. Marupudi, N.I., Han, J.E., Li, K.W., Renard, V.M., Tyler, B.M., Brem, H., 2007. Paclitaxel: a review of adverse toxicities and novel delivery strategies. Expert Opin. Drug Safe. 6, 609-621. (Pubitemid 351308218)
39. Meenach, S.A., Kim, Y.J., Kauffman, K.J., Kanthamneni, N., Bachelder, E.M., Ainslie, K.M., 2012. Synthesis, optimization, and characterization of camptothecinloaded acetalated dextran porous microparticles for pulmonary delivery. Mol. Pharm. 9, 290-298.
40. Meenach, S.A., Vogt, F.G., Anderson, K.W., Hilt, J.Z., McGarry, R.C., Mansour, H.M., 2013. 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. Nanomed. 8, 275-293.
41. Pappalardo, M., Milardi, D., Grasso, D., La Rosa, C., 2005. Phase behaviour of polymer-grafted DPPC membranes for drug delivery systems design. J. Therm. Anal. Calorim. 80, 413-418. (Pubitemid 40626516)
42. Patton, J.S., Byron, P.R., 2007. Inhaling medicines: delivering drugs to the body through the lungs. Nat. Rev. Drug Discovery 6, 67-74. (Pubitemid 46020287)
43. Rhee, Y.S., Mansour, H.M., 2011. Nanopharmaceuticals I: nanocarrier systems in drug delivery. Int. J. Nanotechnol. 8, 84-114.
44. Sharma, S., White, D., Imondi, A., Placke, M.E., Vail, D.M., Kris, M.G., 2001. Development of inhalation agents for oncologic use. J. Clin. Oncol. 19, 1839-1847. (Pubitemid 32230887)
45. Suarez, S., Hickey, A.J., 2000. Drug properties affecting aerosol behavior. Resp. Care 45, 652-666. (Pubitemid 30484805)
46. Sung, J.C., Pulliam, B.L., Edwards, D.A., 2007. Nanoparticles for drug delivery to the lungs. Trends Biotechnol. 25, 563-570. (Pubitemid 350138179)
47. Tang, B.C., Fu, J., Watkins, D.N., Hanes, J., 2010. Enhanced efficacy of local etoposide delivery by poly(ether-anhydride) particles against small cell lung cancer in vivo. Biomaterials 31, 339-344.
48. Tomoda, K., Ohkoshi, T., Hirota, K., Sonavane, G.S., Nakajima, T., Terada, H., Komuro, M., Kitazato, K., Makino, K., 2009. Preparation and properties of inhalable nanocomposite particles for treatment of lung cancer. Colloids Surf. B 71, 177-182.
49. Tong, H.H.Y., Chow, A.H.L., 2006. Control of physical forms of drug particles for pulmonary delivery by spray drying and supercritical fluid processing. KONA Powder Part. J. 24, 27-40.
50. Törmälä, P., 1974. Determination of glass transition temperature of poly(ethylene glycol) by spin probe technique. Eur. Polymer J. 10, 519-521.
51. Vaughn, J.M., McConville, J.T., Burgess, D., Peters, J.I., Johnston, K.P., Talbert, R.L., Williams, R.O., 2006. Sing dose and multiple dose studies of itraconazole nanoparticles. Eur. J. Pharm. Biopharm. 63, 95-102. (Pubitemid 43776206)
52. Vehring, R., Foss, W.R., Lechuga-Ballesteros, D., 2007. Particle formation in spray drying. J. Aerosol Sci. 38, 728-746. (Pubitemid 47087809)
53. Watts, A.B., McConville, J.T., Williams, R.O., 2008. Advancements in dry powder delivery to the lung. Drug Dev. Ind. Pharm. 34, 948-959.
54. Wu, X.A., Mansour, H.M., 2011. Nanopharmaceuticals II: application of nanoparticles and nanocarrier systems in pharmaceutics and nanomedicine. Int. J. Nanotechnol. 8, 115-145.
55. Wu, X., Hayes, D.J., Zwischenberger, J.B., Kuhn, R.J., Mansour, H.M., 2013a. Design and physicochemical characterization of advanced spray-dried tacrolimus multifunctional particles for inhalation. Drug Des., Dev., Ther. 7, 59-72.
56. Wu, X., Zhang, W., Hayes, D.J., Mansour, H.M., 2013b. Physicochemical characterization and aerosol dispersion performance of organic solution advanced spray-dried cyclosporine a multifunctional particles for dry powder inhalation aerosol delivery. Int. J. Nanomed. 8, 1269-1283.
57. Yang, T., Choi, M.-K., Cui, F.-D., Kim, J.S., Suk-Jae, C., Shim, C.-K., Kim, D.-D., 2007. Preparation and evaluation of paclitaxel-loaded PEGylated immunoliposome. J. Controlled Release 120, 169-177. (Pubitemid 47061489)
58. Yang, Y., Bajaj, N., Xu, P., Ohn, K., Tsifansky, M.D., Yeo, Y., 2009. Development of highly porous large PLGA microparticles for pulmonary drug delivery. Biomaterials 30, 1947-1953.