Physicochemical stability, pharmacokinetic, and biodistribution evaluation of paclitaxel solid dispersion prepared using supercritical antisolvent process

References

• Rowinsky EK, Donehower RC. (1995). Paclitaxel (Taxol). N Engl J Med 332:1004–1014.
   PubMed Web of Science ®Google Scholar
• Wall ME, Wani MC. (1995). Camptothecin and Taxol: discovery to clinic—thirteenth Bruce F. Cain Memorial Award Lecture. Cancer Res 55:753–760.
   PubMed Web of Science ®Google Scholar
• Straubinger RM, Sharma A, Sharma US, Balasubramanian SV. (1995). Taxane Anticancer Agents. Washington, DC: ACS Publications.
   Google Scholar
• Hamoudeh M, Diab R, Fessi H, Dumontet C, Cuchet D. (2008). Paclitaxel-loaded microparticles for intratumoral administration via the TMT technique: preparation, characterization, and preliminary antitumoral evaluation. Drug Dev Ind Pharm 34:698–707.
   PubMed Web of Science ®Google Scholar
• Huizing MT, Misser VH, Pieters RC, ten Bokkel Huinink WW, Veenhof CH, Vermorken JB, Pinedo HM, Beijnen JH. (1995). Taxanes: a new class of antitumor agents. Cancer Invest 13:381–404.
   PubMed Web of Science ®Google Scholar
• Kollipara S, Bende G, Movva S, Saha R. (2010). Application of rotatable central composite design in the preparation and optimization of poly(lactic-co-glycolic acid) nanoparticles for controlled delivery of paclitaxel. Drug Dev Ind Pharm 36:1377–1387.
   PubMed Web of Science ®Google Scholar
• Wu L, Tang C, Yin C. (2010). Folate-mediated solid–liquid lipid nanoparticles for paclitaxel-coated poly(ethylene glycol). Drug Dev Ind Pharm 36:439–448.
   PubMed Web of Science ®Google Scholar
• Han J, Washington C, Davis SS. (2007). Design and evaluation of an emulsion vehicle for paclitaxel. II. Suppression of the crystallization of paclitaxel by freeze-drying technique. Drug Dev Ind Pharm 33:1151–1157.
   PubMed Web of Science ®Google Scholar
• Howrie DL, Ptachcinski RJ, Griffith BP, Hardesty RJ, Rosenthal JT, Burckart GJ, Venkataramanan R. (1985). Anaphylactoid reactions associated with parenteral cyclosporine use: possible role of Cremophor EL. Drug Intell Clin Pharm 19:425–427.
   PubMedGoogle Scholar
• O’ Dwyer PJ, King SA, FortnerCL, Leyland-Jones B. (1986). Hypersensitivity reactions to teniposide (VM-26): an analysis. J Clin Oncol 4:1262–1269.
   PubMed Web of Science ®Google Scholar
• Webster’ LK, Cosson’ EJ, Stokes’KH, Millward MJ. (1996). Effect of the paclitaxel vehicle, Cremophor EL, on the pharmacokinetics of doxorubicin and doxorubicinol in mice. Brit J Cancer 73:522–524.
   PubMed Web of Science ®Google Scholar
• Ellis AG, Crinis NA, Webster LK. (1996). Inhibition of etoposide elimination in the isolated perfused rat liver by Cremophor EL and Tween 80. Cancer Chemother Pharmacol 38:81–87.
   PubMed Web of Science ®Google Scholar
• Chervinsky DS, Brecher ML, Baker RM, Hoelcle MJ, Tebbi CK. (1993). Reversal of C1300 murine neuroblastoma multidrug resistance by Cremophor EL, a solvent for cyclosporin A. Cancer Biother 8:67–75.
   PubMedGoogle Scholar
• Friche E, Jensen PB, Sehested M, Demant EJ, Nissen NN. (1990). The solvents Cremophor EL and Tween 80 modulate daunorubicin resistance in the multidrug resistant Ehrlich ascites tumor. Cancer Commun 2:297–303.
   PubMed Web of Science ®Google Scholar
• Kongshaug M, Cheng LS, Moan J, Rimington C. (1991). Interaction of Cremophor EL with human plasma. Int J Biochem 23:473–478.
   PubMedGoogle Scholar
• Sykes E, Woodburn K, Decker D, Kessel D. (1994). Effects of Cremophor EL on distribution of Taxol to serum lipoproteins. Br J Cancer 70:401–404.
   PubMed Web of Science ®Google Scholar
• Webster L, Linsenmeyer M, Millward M, Morton C, Bishop J, Woodcock D. (1993). Measurement of Cremophor EL following Taxol: plasma levels sufficient to reverse drug exclusion mediated by the multidrug-resistant phenotype. J Natl Cancer Inst 85:1685–1690.
   PubMed Web of Science ®Google Scholar
• Woodcock DM, Jefferson S, Linsenmeyer ME, Crowther PJ, Chojnowski GM, Williams B, Bertoncello I. (1990). Reversal of the multidrug resistance phenotype with Cremophor EL, a common vehicle for water-insoluble vitamins and drugs. Cancer Res 50:4199–4203.
   PubMed Web of Science ®Google Scholar
• Dye D, Watkins J. (1980). Suspected anaphylactic reaction to Cremophor EL. Br Med J 280:1353.
   PubMed Web of Science ®Google Scholar
• Lorenz W, Reimann HJ, Schmal A, Dormann P, Schwarz B, Neugebauer E, Doenicke A. (1977). Histamine release in dogs by Cremophor E1 and its derivatives: oxethylated oleic acid is the most effective constituent. Agents Actions 7:63–67.
   PubMedGoogle Scholar
• Panchagnula R. (1998). Pharmaceutical aspects of paclitaxel. Int J Pharm 172:1–5.
   Web of Science ®Google Scholar
• Simamora P, Dannenfelser RM, Tabibi SE, Yalkowsky SH. (1998). Emulsion formulations for intravenous administration of paclitaxel. PDA J Pharm Sci Technol 52:170–172.
   PubMedGoogle Scholar
• Alkan-Onyuksel H, Ramakrishnan S, Chai HB, Pezzuto JM. (1994). A mixed micellar formulation suitable for the parenteral administration of Taxol. Pharm Res 11:206–212.
   PubMed Web of Science ®Google Scholar
• Shieh MF, Chu IM, Lee CJ, Kan P, Hau DM, Shieh JJ. (1997). Liposomal delivery system for Taxol. J Ferment Bioeng 83:12–15.
   Google Scholar
• Bilensoy E, Gürkaynak O, Dogan AL, Hincal AA. (2008). Safety and efficacy of amphiphilic beta-cyclodextrin nanoparticles for paclitaxel delivery. Int J Pharm 347:163–170.
   PubMed Web of Science ®Google Scholar
• Dordunoo SK, Jackson JK, Arsenault LA, Oktaba AM, Hunter WL, Burt HM. (1995). Taxol encapsulation in poly(epsilon-caprolactone) microspheres. Cancer Chemother Pharmacol 36:279–282.
   PubMed Web of Science ®Google Scholar
• Tarr BD, Sambandan TG, Yalkowsky SH. (1987). A new parenteral emulsion for the administration of Taxol. Pharm Res 4:162–165.
   PubMed Web of Science ®Google Scholar
• Kang Y, Yin G, Ouyang P, Huang Z, Yao Y, Liao X, Chen A, Pu X. (2008). Preparation of PLLA/PLGA microparticles using solution enhanced dispersion by supercritical fluids (SEDS). J Colloid Interface Sci 322:87–94.
   PubMed Web of Science ®Google Scholar
• Lee MK, Lim SJ, Kim CK. (2007). Preparation, characterization and in vitro cytotoxicity of paclitaxel-loaded sterically stabilized solid lipid nanoparticles. Biomaterials 28:2137–2146.
   PubMed Web of Science ®Google Scholar
• Lee LY, Wang CH, Smith KA. (2008). Supercritical antisolvent production of biodegradable micro- and nanoparticles for controlled delivery of paclitaxel. J Control Release 125:96–106.
   PubMed Web of Science ®Google Scholar
• Silva TD, Arantes VT, Resende JA, Speziali NL, de Oliveira RB, Vianna-Soares CD. (2010). Preparation and characterization of solid dispersion of simvastatin. Drug Dev Ind Pharm 36:1348–1355.
   PubMed Web of Science ®Google Scholar
• Khattab IS, Nada A, Zaghloul AA. (2010). Physicochemical characterization of gliclazide–macrogol solid dispersion and tablets based on optimized dispersion. Drug Dev Ind Pharm 36:893–902.
   PubMed Web of Science ®Google Scholar
• Seetapan N, Bejrapha P, Srinuanchai W, Puttipipatkhachorn S, Ruktanonchai U. (2010). Nondestructive rheological measurement of aqueous dispersions of solid lipid nanoparticles: effects of lipid types and concentrations on dispersion consistency. Drug Dev Ind Pharm 36:1005–1015.
   PubMed Web of Science ®Google Scholar
• Maghsoodi M, Sadeghpoor F. (2010). Preparation and evaluation of solid dispersions of Piroxicam and Eudragit S100 by spherical crystallization technique. Drug Dev Ind Pharm 36:917–925.
   PubMed Web of Science ®Google Scholar
• Taylor LS, Zografi G. (1997). Spectroscopic characterization of interactions between PVP and indomethacin in amorphous molecular dispersions. Pharm Res 14:1691–1698.
   PubMed Web of Science ®Google Scholar
• Matsumoto T, Zografi G. (1999). Physical properties of solid molecular dispersions of indomethacin with poly(vinylpyrrolidone) and poly(vinylpyrrolidone-co-vinyl-acetate) in relation to indomethacin crystallization. Pharm Res 16:1722–1728.
   PubMed Web of Science ®Google Scholar
• Pignatello R, Ferro M, De Guidi G, Salemi G, Vandelli MA, Guccione S, Geppi M, Forte C, Puglisi G. (2001). Preparation, characterisation and photosensitivity studies of solid dispersions of diflunisal and Eudragit RS100 and RL100. Int J Pharm 218:27–42.
   PubMed Web of Science ®Google Scholar
• Aceves JM, Cruz R, Hernandez E. (2000). Preparation and characterization of Furosemide–Eudragit controlled release systems. Int J Pharm 195:45–53.
   PubMed Web of Science ®Google Scholar
• Oth MP, Moes AJ. (1989). Sustained release solid dispersions of indomethacin with Eudragit RS and RL. Int J Pharm 55:157–174.
   Web of Science ®Google Scholar
• Kompella UB, Koushik K. (2001). Preparation of drug delivery systems using supercritical fluid technology. Crit Rev Ther Drug Carrier Syst 18:173–199.
   PubMed Web of Science ®Google Scholar
• Jung J, Perrut M. (2001). Particle design using supercritical fluids: literature and patent survey. J Supercrit Fluids 20:179–219.
   Web of Science ®Google Scholar
• Park JH, ChiSC, Woo JS. (2008). Preparation and evaluation of paclitaxel solid dispersion by supercritical antisolvent process. J Kor Pharm Sci 38:241–247.
   Google Scholar
• Park JH, Chi SC, Lee WS, Lee WM, Koo YB, Yong CS, Choi HG, Woo JS. (2009). Toxicity studies of Cremophor-free paclitaxel solid dispersion formulated by a supercritical antisolvent process. Arch Pharm Res 32:139–148.
   PubMed Web of Science ®Google Scholar
• U.S. Pharmacopeia. USP 29–NF 24. General Chapters: Osmolality and Osmolarity. Measurement of Osmolarity, p. 2718.
   Google Scholar
• Nornoo AO, Osborne DW, Chow DS. (2008). Cremophor-free intravenous microemulsions for paclitaxel I: formulation, cytotoxicity and hemolysis. Int J Pharm 349:108–116.
   PubMed Web of Science ®Google Scholar
• Karavas E, Georgarakis E, Bikiaris D, Thomas T, Katsos V, Xenakis A. (2001). Hydrophilic matrices as carriers in felodipine solid dispersion systems. Progr Colloid Polym Sci 118:149–152.
   Google Scholar
• Weuts I, Kempen D, Verreck G, Decorte A, Heymans K, Peeters J, Brewster M, Van den Mooter G. (2005). Study of the physicochemical properties and stability of solid dispersions of loperamide and PEG6000 prepared by spray drying. Eur J Pharm Biopharm 59:119–126.
   PubMed Web of Science ®Google Scholar
• Leuner C, Dressman J. (2000). Improving drug solubility for oral delivery using solid dispersions. Eur J Pharm Biopharm 50:47–60.
   PubMed Web of Science ®Google Scholar
• Won DH, Kim MS, Lee S, Park JS, Hwang SJ. (2005). Improved physicochemical characteristics of felodipine solid dispersion particles by supercritical anti-solvent precipitation process. Int J Pharm 301:199–208.
   PubMed Web of Science ®Google Scholar
• Hirasawa N, Ishise S, Miyata H, Danjo K. (2004). Application of nilvadipine solid dispersion to tablet formulation and manufacturing using crospovidone and methylcellulose as dispersion carriers. Chem Pharm Bull 52:244–247.
   PubMed Web of Science ®Google Scholar
• Shamblin SL, Zografi G. (1998). Enthalpy relaxation in binary amorphous mixtures containing sucrose. Pharm Res 15:1828–1834.
   PubMed Web of Science ®Google Scholar
• Yoshioka M, Hancock BC, Zografi G. (1995). Inhibition of indomethacin crystallization in poly(vinylpyrrolidone) coprecipitates. J Pharm Sci 84:983–986.
   PubMed Web of Science ®Google Scholar
• Mura P, Faucci MT, Manderioli A, Bramanti G, Parrini P. (1999). Thermal behavior and dissolution properties of naproxen from binary and ternary solid dispersions. Drug Dev Ind Pharm 25:257–264.
   PubMed Web of Science ®Google Scholar
• Karavas E, Georgarakis E, Sigalas MP, Avgoustakis K, Bikiaris D. (2007). Investigation of the release mechanism of a sparingly water-soluble drug from solid dispersions in hydrophilic carriers based on physical state of drug, particle size distribution and drug–polymer interactions. Eur J Pharm Biopharm 66:334–347.
   PubMed Web of Science ®Google Scholar
• Karavas E, Georgarakis E, Bikiaris D. (2006). Felodipine nanodispersions as active core for predictable pulsatile chronotherapeutics using PVP/HPMC blends as coating layer. Int J Pharm 313:189–197.
   PubMed Web of Science ®Google Scholar
• Stability Testing for New Dosage Forms, Q1C second revision. ICH Guidelines, 1996.
   Google Scholar
• Alhneck C, Zografi G. (1990). The molecular basis of moisture effects on the physical and chemical stability of drugs in the solid state. Int J Pharm 62:87–95.
   Google Scholar
• Fitzpatrick S, McCabe JF, Petts CR, Booth SW. (2002). Effect of moisture on polyvinylpyrrolidone in accelerated stability testing. Int J Pharm 246:143–151.
   PubMed Web of Science ®Google Scholar
• Ghebremeskel AN, Vemavarapu C, Lodaya M. (2006). Use of surfactants as plasticizers in preparing solid dispersions of poorly soluble API: stability testing of selected solid dispersions. Pharm Res 23:1928–1936.
   PubMed Web of Science ®Google Scholar
• Papageorgiou GZ, Papadimitriou S, Karavas E, Georgarakis E, Docoslis A, Bikiaris D. (2009). Improvement in chemical and physical stability of fluvastatin drug through hydrogen bonding interactions with different polymer matrices. Curr Drug Deliv 6:101–112.
   PubMedGoogle Scholar
• Brown T, Havlin K, Weiss G, Cagnola J, Koeller J, Kuhn J, Rizzo J, Craig J, Phillips J, Von Hoff D. (1991). A phase I trial of Taxol given by a 6-hour intravenous infusion. J Clin Oncol 9:1261–1267.
   PubMed Web of Science ®Google Scholar
• Sparreboom A, van Tellingen O, Nooijen WJ, Beijnen JH. (1996). Tissue distribution, metabolism and excretion of paclitaxel in mice. Anticancer Drugs 7:78–86.
   PubMed Web of Science ®Google Scholar
• Rowinsky EK, Donehower RC. (1993). The clinical pharmacology of paclitaxel (Taxol). Semin Oncol 20:16–25.
   PubMed Web of Science ®Google Scholar
• van Tellingen O, Huizing MT, Panday VR, Schellens JH, Nooijen WJ, Beijnen JH. (1999). Cremophor EL causes (pseudo-) non-linear pharmacokinetics of paclitaxel in patients. Br J Cancer 81:330–335.
   PubMed Web of Science ®Google Scholar
• Sonnichsen DS, Hurwitz CA, Pratt CB, Shuster JJ, Relling MV. (1994). Saturable pharmacokinetics and paclitaxel pharmacodynamics in children with solid tumors. J Clin Oncol 12:532–538.
   PubMed Web of Science ®Google Scholar
• Walle T, Walle UK, Kumar GN, Bhalla KN. (1995). Taxol metabolism and disposition in cancer patients. Drug Metab Dispos 23:506–512.
   PubMed Web of Science ®Google Scholar
• Gianni L, Kearns CM, Giani A, Capri G, Viganó L, Lacatelli A, Bonadonna G, Egorin MJ. (1995). Nonlinear pharmacokinetics and metabolism of paclitaxel and its pharmacokinetic/pharmacodynamic relationships in humans. J Clin Oncol 13:180–190.
   PubMed Web of Science ®Google Scholar
• Gallo JM, Li S, Guo P, Reed K, Ma J. (2003). The effect of P-glycoprotein on paclitaxel brain and brain tumor distribution in mice. Cancer Res 63:5114–5117.
   PubMed Web of Science ®Google Scholar
• Stewart DJ. (1994). A critique of the role of the blood–brain barrier in the chemotherapy of human brain tumors. J Neurooncol 20:121–139.
   PubMed Web of Science ®Google Scholar
• Heimans JJ, Vermorken JB, Wolbers JG, Eeltink CM, Meijer OW, Taphoorn MJ, Beijnen JH. (1994). Paclitaxel (Taxol) concentrations in brain tumor tissue. Ann Oncol 5:951–953.
   PubMed Web of Science ®Google Scholar
• Glantz MJ, Choy H, Kearns CM, Mills PC, Wahlberg LU, Zuhowski EG, Calabresi P, Egorin MJ. (1995). Paclitaxel disposition in plasma and central nervous systems of humans and rats with brain tumors. J Natl Cancer Inst 87:1077–1081.
   PubMed Web of Science ®Google Scholar