Development of docetaxel-loaded intravenous formulation, Nanoxel-PM™ using polymer-based delivery system

Journal of Controlled Release

Volumn 155, Issue 2, 2011, Pages 262-271

  Lee, Sa Won ^a   Yun, Min Hyuk ^a   Jeong, Seung Wei ^a   In, Chang Hoon ^a   Kim, Ji Young ^a   Seo, Min Hyo ^a   Pai, Chaul Min ^a   Kim, Sun Ok ^a  

^a Samyang Pharmaceutical RandD Center   (South Korea)

Author keywords

Bioequivalence; Docetaxel; Hypersensitivity reactions; Methoxy poly(ethylene glycol) block poly(d,l lactide) micelles; Nanoxel PM

Indexed keywords

ANTI-TUMOR EFFICACY; BEAGLE DOG; BIOEQUIVALENCE; BODY WEIGHT; BREAST CANCER CELLS; CANCER PATIENTS; D , L-LACTIDE; DELIVERY SYSTEMS; DOCETAXEL; FLUID RETENTION; HUMAN LUNG; HYPERSENSITIVITY REACTION; MEAN DIAMETER; METHOXY-POLY(ETHYLENE GLYCOL)-BLOCK-POLY(D,L-LACTIDE) MICELLES; MONODISPERSE; MOUSE MODELS; NARROW SIZE DISTRIBUTIONS; NUDE MICE; PHARMACOKINETIC PROFILES; PHARMACOKINETIC STUDIES; PRECLINICAL STUDIES; SIDE EFFECT; SINGLE-DOSE; STATISTICALLY SIGNIFICANT DIFFERENCE; TAXOTERE; TOXIC EFFECT; UNIMODAL; NANOXEL-PM;

BIOLOGICAL ORGANS; CELL CULTURE; DISEASES; ETHYLENE; GLYCOLS; MOTION PICTURE EXPERTS GROUP STANDARDS; PHARMACOKINETICS; POLYDISPERSITY; POLYETHYLENE GLYCOLS; RATS; TOXICITY;

DRUG PRODUCTS;

ANTINEOPLASTIC AGENT; DOCETAXEL; DRUG CARRIER; GENERIC DRUG; METHOXY POLY(ETHYLENEGLYCOL) BLOCK POLY(DEXTRO, LEVO LACTIDE); NANOXEL PM; UNCLASSIFIED DRUG; MACROGOL; METHOXY POLY(ETHYLENE GLYCOL)POLY(DEXTRO,LEVO LACTIDE); POLYLACTIDE;

ANTINEOPLASTIC ACTIVITY; AREA UNDER THE CURVE; BIOEQUIVALENCE; BREAST CANCER; CONFERENCE PAPER; CONTROLLED STUDY; DISPERSION; DRUG DELIVERY SYSTEM; DRUG DOSE INCREASE; DRUG EFFICACY; DRUG FECES LEVEL; DRUG FORMULATION; DRUG HYPERSENSITIVITY; DRUG MEGADOSE; DRUG METABOLISM; DRUG URINE LEVEL; HUMAN; HUMAN CELL; LUNG CANCER; MAXIMUM PLASMA CONCENTRATION; MICELLIZATION; MOUSE; NONHUMAN; OVARY CANCER; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RAT; SINGLE DRUG DOSE; TOXICITY TESTING; WEIGHT REDUCTION; ANIMAL EXPERIMENT; ANIMAL MODEL; ANIMAL TISSUE; BLOOD TOXICITY; CANCER CELL CULTURE; CANCER CHEMOTHERAPY; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG CYTOTOXICITY; DRUG DOSAGE FORM COMPARISON; DRUG DOSE COMPARISON; DRUG EXCRETION; DRUG HALF LIFE; DRUG SYNTHESIS; EXPERIMENTAL DOG; FEMALE; IC 50; LUNG NON SMALL CELL CANCER; MALE; PARTICLE SIZE; REPEATED DRUG DOSE; TIME TO MAXIMUM PLASMA CONCENTRATION; URINARY EXCRETION; WEIGHT GAIN;

ANIMALS; ANTINEOPLASTIC AGENTS; CELL LINE, TUMOR; CELL SURVIVAL; DOGS; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG CARRIERS; DRUG DESIGN; HUMANS; INJECTIONS, INTRAVENOUS; METABOLIC CLEARANCE RATE; MICE; MICE, INBRED BALB C; MICE, INBRED ICR; MICE, NUDE; MICELLES; PARTICLE SIZE; POLYESTERS; POLYETHYLENE GLYCOLS; RATS; RATS, SPRAGUE-DAWLEY; SOLUBILITY; TAXOIDS; TOXICITY TESTS; XENOGRAFT MODEL ANTITUMOR ASSAYS;

EID: 80054110603     PISSN: 01683659     EISSN: 18734995     Source Type: Journal    
DOI: 10.1016/j.jconrel.2011.06.012     Document Type: Conference Paper

References (39)

1. A.J. Ten Tije, J. Verweij, W.J. Loos, and A. Sparreboom Pharmacological effects of formulation vehicles: implications for cancer chemotherapy Clin. Pharmacokinet. 42 2003 665 685 (Pubitemid 36936530)
2. H. Gelderblom, J. Verweij, K. Nooter, and A. Sparreboom Cremophor EL: the drawbacks and advantages of vehicle selection for drug formulation Eur. J. Cancer 37 2001 1590 1598 (Pubitemid 32778603)
3. F.K. Engels, R.A. Mathot, and J. Verwij Alternative drug formulations of docetaxel: a review Anticancer Drugs 18 2007 95 103 (Pubitemid 44967420)
4. A. Safavy Recent developments in taxane drug delivery Curr. Drug Deliv. 5 2008 42 54 (Pubitemid 351225633)
5. F. Esmaeili, R. Dinarvand, M.H. Ghahremani, M. Amini, H. Rouhani, N. Sepehri, S.N. Ostad, and F. Atyabi Docetaxel-albumin conjugates: preparation, in vitro evaluation and biodistribution studies J. Pharm. Sci. 98 2009 2718 2730
6. M.L. Immordino, P. Brusa, S. Arpicco, B. Stella, F. Dosio, and L. Cattel Preparation, characterization, cytotoxicity and pharmacokinetics of liposomes containing docetaxel J. Control. Release 91 2003 417 429 (Pubitemid 36980659)
7. J.M. Chan, L. Zhang, K.P. Yuet, G. Liao, J.W. Rhee, R. Langer, and O.C. Farokhzad PLGA lecithin-PEG core-shell nanoparticles for controlled drug delivery Biomaterials 30 2009 1627 1634
8. H.Y. Hwang, I.S. Kim, I.C. Kwon, and Y.H. Kim Tumor targetability and antitumor effect of docetaxel-loaded hydrophobically modified glycol chitosan nanoparticles J. Control. Release 128 2008 23 31
9. B. Liu, M. Yang, R. Li, Y. Ding, X. Qian, and L. Yu The antitumor effect of novel docetaxel-loaded thermosensitive micells Eur. J. Pharm. Biopharm. 69 2008 527 534
10. L. Huynh, J.C. Leroux, and C. Allen Enhancement of docetaxel solubility via conjugation of formulation-compatible moieties Org. Biomol. Chem. 7 2009 3437 3446
11. K. Kataoka Design of nanoscopic vehicles for drug targeting based on micellization of amphiphilic block copolymers JMS-Pure Appl. Chem. A31 1994 1759 1769
12. R. Savic, T. Azzam, A. Eisenberg, and D. Maysinger Assessment of the integrity of poly (caprolactone)-b-poly(ethylene oxide) micelles under biological conditions: a fluorogenic-based approach Langmuir 8 2006 3570 3578 (Pubitemid 43672524)
13. M.T. Peracchia, R. Gref, Y. Minamitake, A. Domb, N. Lotan, and R. Langer PEG coated nanospheres from amphilic diblock and multiblock copolymers; investigation of their drug encapsulation and release characteristics J. Control. Release 46 1997 223 231 (Pubitemid 27132846)
14. D. Bazile, C. Prudhomme, M.T. Bassouller, M. Marlard, G. Spenlenhauer, and M. Veillard Stealth Me-PEG-PLA nanoparticles avoid uptake by mononuclear phagocyte system J. Pharm. Sci. 84 1995 493 498
15. R. Gref, Y. Minamitake, M.T. Perachia, V. Trubetskoy, V. Torchilin, and R. Langer Biodegradable long circulating polymeric nanospheres Science 263 1994 1600 1603 (Pubitemid 24128361)
16. M.E. Davis, Z.G. Chen, and D.M. Shin Nanoparticle therapeutics: an emerging treatment modality for cancer Nat. Rev. Drug Discov. 9 2008 771 782
17. S.C. Kim, D.W. Kim, Y.H. Shim, Y.J. Bang, H.S. Oh, S.W. Kim, and M.H. Seo In vivo evaluation of polymeric micellar paclitaxel formulation: toxicity and efficacy J. Control. Release 72 2001 191 202 (Pubitemid 32522357)
18. W.T. Lim, E.H. Tan, C.K. Toh, S.W. Hee, S.S. Leong, P.C.S. Ang, N.S. Wong, and B. Chowbay Phase I pharmacokinetic study of a weekly liposomal paclitaxel formulation (Genexol-PM) in patients with solid tumors Ann. Oncol. 21 2010 382 388
19. T.Y. Kim, D.W. Kim, J.Y. Chung, S.G. Shin, S.C. Kim, D.S. Heo, N.K. Kim, and Y.J. Bang Phase I and pharmacokinetic study of Genexol-PM, a Cremophor-free, polymeric micelle-formulated paclitaxel, in patients with advanced malignancies, Clinical Cancer Res. 10 2004 3708 3716 (Pubitemid 38697604)
20. D.W. Kim, S.Y. Kim, H.K. Kim, S.W. Kim, S.W. Shin, J.S. Kim, K. Park, M.Y. Lee, and D.S. Heo Multicenter phase II trial of Genexol-PM, a novel Cremophor-free, polymeric micelle formulation of paclitaxel, with cisplatin in patients with advanced non-small-cell lung cancer Ann. Oncol. 18 2007 2009 2014 (Pubitemid 350286241)
21. E.K. Rowinsky The development and clinical utility of the taxane class of antimicrotubule chemotherapy agents Annu. Rev. Med. 48 2009 353 374
22. S. Drori, G.D. Eytan, and Y.G. Assaraf Potentiation of anticancer-drug cytotoxicity by multidrug-resistance chemosensitizers involves alteration in membrane fluidity leading to increased membrane permeability Eur. J. Biochem. 228 1995 1020 1029
23. L. Ostacolo, M. Marra, F. Ungaro, S. Zappavigna, G. Maglio, F. Quaglia, A. Abbruzzese, and M. Caraglia In vitro anticancer activity of docetaxel-loaded micelles based on poly(ethylene oxide)-poly(epsilon-caprolactone) block copolymers: do nanocarrier properties have a role? J. Control. Release 148 2010 255 263
24. K. Gao, J. Sun, K. Liu, X. Liu, and Z. He Preparation and characterization of a submicron lipid emulsion of docetaxel: submicron lipid emulsion of docetaxel Drug Dev. Ind. Pharm. 34 2008 1227 1237
25. T. Musumeci, C.A. Ventura, I. Giannone, B. Ruozi, L. Montenegro, and R. Pignatello LA/PLGA nanoparticles for sustained release of docetaxel Int. J. Pharm. 325 2006 172 179 (Pubitemid 44573694)
26. K.J. Zhu, L. Xiangzhou, and Y. Shilin Preparation, characterization and properties of polylactide(PLA)-poly(ethylene glycol) (PEG) copolymers: a potential drug carrier J. Appl. Polym. Sci. 39 1990 1 9 (Pubitemid 20624179)
27. B. Jeong, Y.H. Bae, D.S. Lee, and S.W. Kim Biodegradable block copolymers as injectable drug delivery systems Nature 388 1997 860 862 (Pubitemid 27377054)
28. Olaf van Tellingen, J.H. Beijnen, J. Verweij, E.J. Scherrenburg, W.J. Nooijen, and A. Sparreboom Rapid esterase-sensitive breakdown of polysorbate 80 and its impact on the plasma pharmacokinetics of docetaxel and metabolites in mice Clin. Cancer Res. 5 1999 2918 2924 (Pubitemid 29493971)
29. M.C. Bissery, G. Nohynek, G.J. Sanderink, and F. Lavelle Docetaxel (Taxotere®): a review of preclinical and clinical experience. Part I: preclinical experience Anticancer Drugs 6 1995 339 368
30. A. Riva, D. Hille, A. Lebecq, and L. Thomas Pharmacokinetic and pharmacodynamic properties of docetaxel: results of phase I and phase II trials Am. J. Health Syst. Pharm. 54 Suppl. 2 1997 16 19
31. F. Lavelle, M.C. Bissery, C. Combeau, J.F. Riou, P. Vrignaud, and S. Andre Preclinical evaluation of docetaxel(Taxotere®) Semin. Oncol. 22 1995 3 16
32. I.D. Gonzáles, R.S. Saez, and E.M. Rodilla Hypersensitivity reactions to chemotherapy drugs Alergol. Immunol. Clin. 15 2000 161 181
33. A.M. Feldweg, C.W. Lee, and U.A. Matulonis Rapid desensitization for hypersensitivity reactions to paclitaxel and docetaxel: a new standard protocol used in 77 successful treatments Gynecol. Oncol. 96 2005 824 829 (Pubitemid 40255508)
34. A. Ardavanis, D. Tryfonopoulos, and I. Yiotis Non-allergic nature of docetaxel-induced acute hypersensitivity reactions Anticancer Drugs 15 2004 581 585 (Pubitemid 38932325)
35. E.R. Gomes, and P. Demoly Epidemiology of hypersensitivity drug reactions Curr. Opin. Allergy Clin. Immunol. 5 2005 309 316 (Pubitemid 41017644)
36. J. Szebeni, F.M. Muggia, and C.R. Alving Complement activation by Cremophor EL as a possible contributor to hypersensitivity to paclitaxel: an in vitro study J. Natl. Cancer Inst. 90 1998 300 306 (Pubitemid 28182386)
37. K.M. Zanotti, and M. Markman Prevention and management of antineoplastic-induced hypersensitivity reactions Drug Saf. 24 2001 767 779 (Pubitemid 32848355)
38. W. Lorenz, A. Schmal, H. Schult, S. Lang, C. Ohmann, and D. Weber Histamine release and hypotensive reactions in dogs by solubilizing agents and fatty acids: analysis of various components in Cremophor EL and development of a compound with reduced toxicity Agents Actions 12 1982 64 80 (Pubitemid 12076385)
39. M. Bergh, K. Magnusson, J.L. Nilsson, and A.T. Karlberg Contact allergenic activity of Tween 80 before and after air exposure Contact Dermatitis 37 1997 9 18 (Pubitemid 27322990)