Paclitaxel loaded PEG5000-DSPE micelles as pulmonary delivery platform: Formulation characterization, tissue distribution, plasma pharmacokinetics, and toxicological evaluation

European Journal of Pharmaceutics and Biopharmaceutics

Volumn 79, Issue 2, 2011, Pages 276-284

  Gill, Kanwaldeep K ^a   Nazzal, Sami ^a   Kaddoumi, Amal ^a  

^a UNIVERSITY OF LOUISIANA AT MONROE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DISTEAROYLPHOSPHATIDYLETHANOLAMINE; MACROGOL; MACROGOL 5000; PACLITAXEL; PHOSPHATIDYLETHANOLAMINE; UNCLASSIFIED DRUG;

ANIMAL EXPERIMENT; ARTICLE; CONTROLLED STUDY; DRUG DELIVERY SYSTEM; DRUG DISTRIBUTION; DRUG RELEASE; DRUG STABILITY; ENCAPSULATION; LUNG; LUNG INJURY; MALE; MICELLE; NONHUMAN; RAT; SUSTAINED RELEASE FORMULATION; TISSUE DISTRIBUTION; TOXICITY TESTING;

EID: 80054970488     PISSN: 09396411     EISSN: 18733441     Source Type: Journal    
DOI: 10.1016/j.ejpb.2011.04.017     Document Type: Article

References (52)

1. M. Zaru, S. Mourtas, P. Klepetsanis, A.M. Fadda, S.G. Antimisiaris, Liposomes for drug delivery to the lungs by nebulization, Eur. J. Pharm. Biopharm. 67 (2007) 655-666. (Pubitemid 47576612)
2. S. Jaspart, P. Bertholet, G. Piel, J.M. Dogné, L. Delattre, B. Evrard, Solid lipid microparticles as a sustained release system for pulmonary drug delivery, Eur. J. Pharm. Biopharm. 65 (2007) 47-56. (Pubitemid 44827691)
3. A. Grenha, B. Seijo, C. Remuñán-López, Microencapsulated chitosan nanoparticles for lung protein delivery, Eur. J. Pharm. Sci. 25 (2005) 427-437. (Pubitemid 40853870)
4. N.V. Koshkina, E. Golunski, L.E. Roberts, B.E. Gilbert, V. Knight, Cyclosporin A aerosol improves the anticancer effect of paclitaxel aerosol in mice, J. Aero. Med. 17 (2004) 7-14. (Pubitemid 38520668)
5. J.C. Sung, B.L. Pulliam, D.A. Edwards, Nanoparticles for drug delivery to the lungs, Trends Biotech. 12 (2007) 563-570. (Pubitemid 350138179)
6. J. Fu, J. Fiegel, E. Krauland, J. Hanes, New polymeric carriers for controlled drug delivery following inhalation or injection, Biomaterials 23 (2002) 4425-4433.
7. M.M. Bailey, C.J. Berkland, Nanoparticle formulations in pulmonary drug delivery, Med. Res. Rev. 29 (2009) 196-212.
8. H.W. Kim, I.K. Park, C.S. Cho, K.H. Lee Jr., G.R. Beck, N.H. Colburn, M.H. Cho, Aerosol delivery of glucosylated polyethylenimine/phosphatase and tensin homologue deleted on chromosome 10 complex suppresses Akt downstream pathways in the lung of K-ras null mice, Can. Res. 64 (2004) 7971-7976. (Pubitemid 39446931)
9. L.J. Zhang, B. Xing, J. Wu, B. Xu, X.L. Fang, Biodistribution in mice and severity of damage in rat lungs following pulmonary delivery of 9-nitrocamptothecin liposomes, Pulm. Pharm. Ther. 21 (2008) 239-246.
10. N.V. Koshkina, J.C. Waldrep, L.E. Roberts, E. Golunski, S. Melton, V. Knight, Paclitaxel liposome aerosol treatment induces inhibition of pulmonary metastases in murine renal carcinoma model, Clin. Can. Res. 7 (2001) 3258-3262. (Pubitemid 32963851)
11. M.I. Ugwoke, I.J. Vereyken, H. Luessen, Microparticles and liposomes as pulmonary drug delivery systems: what are the recent trends?, in: K. Bechtold-Peters, H. Luessen (Eds.), Pulmonary Drug Delivery, Basics, Applications and Opportunities for Small Molecules and Biopharmaceutics, Editio Cantor, Aulendorf, Germany, 2007, pp. 308-331.
12. J. Malo, A. Cartier, N. Merland, H. Ghezzo, A. Burek, J. Morris, B.H. Jennings, Four-times-a-day dosing frequency is better than a twice-a-day regimen in subjects requiring a high-dose inhaled steroid, budesonides to control moderate to severe asthma, Am. Rev. Respir. Dis. 140 (1989) 624-628. (Pubitemid 19234304)
13. K. Kataoka, A. Harada, Y. Nagasaki, Block copolymer micelles for drug delivery: design, characterization and biological significance, J. Controlled Release 109 (2005) 169-188.
14. R.O. Cook, R.K. Pannu, I.W. Kellaway, Novel sustained release microspheres for pulmonary drug delivery, J. Controlled Release 104 (2005) 79-90. (Pubitemid 40615237)
15. A. Grenha, C.I. Grainger, L.A. Dailey, B. Seijo, G.P. Martin, C. Remuñán-López, B. Forbes, Chitosan nanoparticles are compatible with respiratory epithelial cells in vitro, Eur. J. Pharm. Sci. 31 (2007) 73-84. (Pubitemid 46660576)
16. M. Smola, T. Vandamme, A. Sokolowski, Nanocarriers as pulmonary drug delivery systems to treat and to diagnose respiratory and non respiratory diseases, Int. J. Nanomed. 3 (2008) 1-19. (Pubitemid 351517072)
17. I.M. El-Sherbiny, H.D. Smyth, Biodegradable nano-micro carrier systems for sustained pulmonary drug delivery: (I) self-assembled nanoparticles encapsulated in respirable/swellable semi-IPN microspheres, Int. J. Pharm. 395 (2010) 132-141.
18. N.N. Gaber, Y. Darwis, K.K. Peh, Y.T. Tan, Characterization of PEG-lipid micelles for pulmonary delivery of beclomethasone dipropionate, J. Nanosci. Nanotech. 6 (2006) 3095-3101. (Pubitemid 44579987)
19. V.P. Torchilin, Lipid-core micelles for targeted drug delivery current drug delivery, Curr. Drug Deliv. 2 (2005) 319-327. (Pubitemid 41282750)
20. S.R. Croy, G.S. Kwon, PEG-lipid micelles for drug delivery, Curr. Pharm. Des. 12 (2006) 4669-4684.
21. R.D. Dabholkar, R.M. Sawant, D.A. Mongayt, P.V. Devarajan, V.P. Torchilin, Polyethylene glycol phosphatidylethanolamine conjugate (PEG-PE)-based mixed micelles: some properties, loading with paclitaxel, and modulation of P-glycoprotein-mediated efflux, Int. J. Pharm. 315 (2006) 148-157. (Pubitemid 43674120)
22. A.N. Lukyanov, Z. Gao, V.P. Torchilin, Micelles from polyethylene glycol/phosphatidylethanolamine conjugates for tumor drug delivery, J. Controlled Release 91 (2003) 97-110.
23. W.K. Murphy, F.V. Fossella, R.J. Winn, D.M. Shin, H.E. Hynes, H.M. Gross, E. Davilla, J. Leimert, H. Dhingra, M.N. Raber, I.H. Krakoff, W.K. Hong, Phase II study of taxol in patients with untreated advanced non-small cell lung cancer, J. Nat. Cancer Inst. (Bethesda) 85 (1993) 384-388. (Pubitemid 23073156)
24. E.K. Rowinsky, R.C. Donehower, Paclitaxel (Taxol), New Engl. J. Med. 332 (1995) 1004-1014.
25. C.P. Belani, Paclitaxel and docetaxel combinations in non-small cell lung cancer, Chest 114 (2000) 144S-151S. (Pubitemid 30225155)
26. V.P. Torchilin, Microencapsulation of poorly soluble anticancer drugs into micelles made of polyethylene glycol-phosphatidylethanolamine (PEG-PE) conjugates, in: 15th International Symposium on Microencapsulation, Parma, Italy, 2005, pp. 18-21.
27. O.R. Moss, Simulants of lung interstitial fluid, Health Phys. 36 (1979) 447-448. (Pubitemid 9218628)
28. H.C. Shin, A.W. Alani, D.A. Rao, N.C. Rockich, G.S. Kwon, Multi-drug loaded PEG-lipid micelles for simultaneous delivery of poorly soluble anticancer drugs, J. Controlled Release 140 (2009) 294-300.
29. Y. El-Malah, S. Nazzal, Hydrophilic matrices, application of Placket-Burman screening design to model the effect of POLYOX-carbopol blends on drug release, Int. J. Pharm. 309 (2006) 163-170. (Pubitemid 43129479)
30. Y. Zou, H. Fu, S. Ghosh, D. Farquhar, J. Klostergaard, Antitumor activity of hydrophilic paclitaxel copolymer prodrug using locoregional delivery in human orthotopic non-small cell lung cancer xenograft models, Clin. Cancer Res. 10 (2004) 7382-7391. (Pubitemid 39487728)
31. A. Hussain, T. Yang, A.A. Zaghloul, F. Ahsan, Pulmonary absorption of insulin mediated by tetradecyl-maltoside and dimethyl-cyclodextrin, Pharm. Res. 20 (2003) 1551-1557. (Pubitemid 37268267)
32. S. Bai, C. Thomas, F. Ahsan, Dendrimers as a carrier for pulmonary delivery of enoxaparin, a low-molecular weight heparin, J. Pharm. Sci. 96 (2007) 2090-2106. (Pubitemid 47280103)
33. S.C. Kim, J. Yu, J.W. Lee, E.S. Park, S.C. Chi, Sensitive HPLC method for quantitation of paclitaxel (Genexol®) in biological samples with application to preclinical pharmacokinetics and biodistribution, J. Pharm. Biomed. Anal. 39 (2005) 170-176. (Pubitemid 41112134)
34. B. Ashok, L. Arleth, R.P. Hjelm, I. Rubinstein, H. Onyüksel, In vitro characterization of PEGylated phospholipid micelles for improved drug solubilization: effects of PEG chain length and PC incorporation, J. Pharm. Sci. 93 (2004) 2476-2487. (Pubitemid 39319431)
35. J. Davidsen, C. Vermehren, S. Frokjaer, O.G. Mouritsen, K. Jørgensen, Drug delivery by phospholipase A2 degradable liposomes, Int. J. Pharm. 214 (2001) 67-69. (Pubitemid 32244080)
36. A.N. Lukyanov, V.P. Torchilin, Micelles from lipid derivatives of water-soluble polymers as delivery systems for poorly soluble drugs, Adv. Drug Deliv. Rev. 56 (2004) 1273-1289. (Pubitemid 38510474)
37. G. Gaucher, M.H. Dufresne, V.P. Sant, N. Kang, D. Maysinger, J.C. Leroux, Block copolymer micelles: preparation, characterization and application in drug delivery, J. Controlled Release 109 (2005) 169-188. (Pubitemid 41742123)
38. W. Yang, J.I. Peters, R.O. Williams, Inhaled nanoparticles-a current review, Int. J. Pharm. 356 (2008) 239-247.
39. O.N.M. McCallion, K.M.G. Taylor, M. Thomas, A.J. Taylor, Nebulisation of monodisperse latex sphere suspensions in air-jet and ultrasonic nebulisers, Int. J. Pharm. 133 (1996) 203-214. (Pubitemid 26160846)
40. C.S. Kim, P.A. Jaques, Analysis of total respiratory deposition of inhaled ultrafine particles in adult subjects as various breathing patterns, Aerosol Sci. Technol. 38 (2004) 525-540. (Pubitemid 39045232)
41. G. Oberdorster, Pulmonary effects of inhaled ultrafine particles, Int. Arch. Occup. Environ. Health 74 (2001) 1-8. (Pubitemid 32123735)
42. L.J. Krenis, B. Strauss, Effect of size and concentration of latex particles on respiration of human blood leucocytes, Proc. Soc. Exp. Biol. (NY) 107 (1961) 748-750.
43. I.J. Fidler, A. Raz, W.E. Fogler, R. Kirsh, P. Bugelski, G. Poste, Design of liposomes to improve delivery of macrophage-augmenting agents to alveolar macrophages, Cancer Res. 40 (1980) 4460-4466. (Pubitemid 11199705)
44. L. Mu, S.S. Feng, Fabrication, characterization and in vitro release of paclitaxel (Taxol) loaded poly (lactic-co-glycolic acid) microspheres prepared by spray drying technique with lipid/cholesterol emulsifiers, J. Controlled Release 76 (2001) 239-254. (Pubitemid 32913433)
45. S. Alipour, H. Montaseri, M. Tafaghodi, Preparation and characterization of biodegradable paclitaxel loaded alginate microparticles for pulmonary delivery, Coll. Surf. B: Biol. 81 (2010) 521-529.
46. R.T. Liggins, W.L. Hunter, H.M. Burt, Solid-state characterization of paclitaxel, J. Pharm. Sci. 86 (1997) 1458-1463. (Pubitemid 28018330)
47. X. Huang, C.S. Brazel, On the importance and mechanisms of burst release in matrix-controlled drug delivery systems, J. Controlled Release 73 (2001) 121-136. (Pubitemid 32539245)
48. H. Lee, P.L. Soo, J. Liu, M. Butler, C. Allen, Polymeric micelles for formulation of anticancer drugs, in: M.M. Amiji (Ed.), Nanotechnology for Cancer Therapy, CRC Press, Tyler & Francis Group LLC, Boca Raton, FL, 2006, pp. 317-356.
49. C. Zhang, G. Qu, Y. Sun, X. Wu, Z. Yao, Q. Guo, Q. Ding, S. Yuan, Z. Shen, Q. Ping, H. Zhou, Pharmacokinetics, biodistribution, efficacy and safety of N-octyl-Osulfate chitosan micelles loaded with paclitaxel, Biomaterials 29 (2008) 1233-1241.
50. G. Kaul, M. Amiji, Biodistribution and targeting potential of poly(ethylene glycol) modified gelatin nanoparticles in subcutaneous murine tumor model, J. Drug Target. 2 (2004) 585-591. (Pubitemid 40100706)
51. C.M. Sayes, K.L. Reed, D.B. Warheit, Assessing toxicity of fine and nanoparticles: comparing in vitro measurements to in vivo pulmonary toxicity profiles, Toxicol. Sci. 7 (2007) 163-180. (Pubitemid 47072165)
52. M. Nassimi, C. Schleh, H.D. Lauenstein, R. Hussein, H.G. Hoymann, W. Koch, G. Pohlmann, N. Krug, K. Sewald, S. Rittinghausen, A. Braun, C. Müller-Goymann, A toxicological evaluation of inhaled solid lipid nanoparticles used as a potential drug delivery system for the lung, Eur. J. Pharm. Biopharm. 75 (2010) 107-116.