Optimizing nanomedicine pharmacokinetics using physiologically based pharmacokinetics modelling

British Journal of Pharmacology

Volumn 171, Issue 17, 2014, Pages 3963-3979

  Moss, Darren Michael ^a   Siccardi, Marco ^a  

^a UNIVERSITY OF LIVERPOOL   (United Kingdom)

Author keywords

ADME; nanoformulation; nanoparticle; optimization; PBPK; pharmacokinetics

Indexed keywords

CELECOXIB; CHITOSAN; CHLORAMBUCIL; DAUNORUBICIN; DENDRIMER; DOCETAXEL; DOXORUBICIN; EFAVIRENZ; ISONIAZID; LIPOSOME; LOPINAVIR; MACROGOL; OLANZAPINE; POLYMER; PRIMAQUINE; PRODRUG; QUANTUM DOT; RILPIVIRINE; ROSUVASTATIN; SAQUINAVIR; SILVER NANOPARTICLE; SOLID LIPID NANOPARTICLE; TAMOXIFEN; TIZANIDINE; VINCRISTINE; ZIDOVUDINE; ZOLEDRONIC ACID; DRUG;

CONTROLLED DRUG RELEASE; DRUG ABSORPTION; DRUG ADMINISTRATION ROUTE; DRUG BIOAVAILABILITY; DRUG CLEARANCE; DRUG DIFFUSION; DRUG DISPOSITION; DRUG DISTRIBUTION; DRUG ELIMINATION; DRUG FORMULATION; DRUG METABOLISM; DRUG PENETRATION; DRUG TRANSPORT; HUMAN; MATHEMATICAL MODEL; NANOEMULSION; NANOENCAPSULATION; NANOFORMULATION; NANOMEDICINE; NANOPHARMACEUTICS; NONHUMAN; ORAL DRUG ADMINISTRATION; PARTICLE SIZE; PHARMACOKINETICS; PRIORITY JOURNAL; REVIEW; TISSUE DISTRIBUTION; UNSPECIFIED SIDE EFFECT; BIOLOGICAL MODEL; MEDICINAL CHEMISTRY;

CHEMISTRY, PHARMACEUTICAL; HUMANS; MODELS, BIOLOGICAL; NANOMEDICINE; PHARMACEUTICAL PREPARATIONS; PHARMACOKINETICS;

EID: 84906058875     PISSN: 00071188     EISSN: 14765381     Source Type: Journal    
DOI: 10.1111/bph.12604     Document Type: Review

References (191)

1. Abu Lila AS, Kiwada H, Ishida T, (2013). The accelerated blood clearance (ABC) phenomenon: clinical challenge and approaches to manage. J Control Release 172: 38-47.
2. Abuqayyas L, Balthasar JP, (2012). Application of PBPK modeling to predict monoclonal antibody disposition in plasma and tissues in mouse models of human colorectal cancer. J Pharmacokinet Pharmacodyn 39: 683-710.
3. Aji Alex MR, Chacko AJ, Jose S, Souto EB, (2011). Lopinavir loaded solid lipid nanoparticles (SLN) for intestinal lymphatic targeting. Eur J Pharm Sci 42: 11-18.
4. Alexis F, Pridgen E, Molnar LK, Farokhzad OC, (2008). Factors affecting the clearance and biodistribution of polymeric nanoparticles. Mol Pharm 5: 505-515.
5. Almeida JP, Chen AL, Foster A, Drezek R, (2011). In vivo biodistribution of nanoparticles. Nanomedicine (Lond) 6: 815-835.
6. Alonso MJ, Sánchez A, (2004) Biodegradable nanoparticles as new transmucosal drug carriers. In:, Svenson S, (ed.). Carrier-Based Drug Delivery-ACS Symposium Series, Chapter 20. American Chemical Society: Washington DC, pp. 283-295.
7. Assifaoui A, Bouyer F, Chambin O, Cayot P, (2013). Silica-coated calcium pectinate beads for colonic drug delivery. Acta Biomater 9: 6218-6225.
8. Bachler G, von Goetz N, Hungerbuhler K, (2013). A physiologically based pharmacokinetic model for ionic silver and silver nanoparticles. Int J Nanomedicine 8: 3365-3382.
9. Badawi AA, El-Laithy HM, El Qidra RK, El Mofty H, El dally M, (2008). Chitosan based nanocarriers for indomethacin ocular delivery. Arch Pharm Res 31: 1040-1049.
10. Baert L, van't Klooster G, Dries W, Francois M, Wouters A, Basstanie E, et-al. (2009). Development of a long-acting injectable formulation with nanoparticles of rilpivirine (TMC278) for HIV treatment. Eur J Pharm Biopharm 72: 502-508.
11. Bahadur S, Pathak K, (2012). Buffered nanoemulsion for nose to brain delivery of ziprasidone hydrochloride: preformulation and pharmacodynamic evaluation. Curr Drug Deliv 9: 596-607.
12. Bailey MM, Berkland CJ, (2009). Nanoparticle formulations in pulmonary drug delivery. Med Res Rev 29: 196-212.
13. Balakumar K, Raghavan CV, Selvan NT, Prasad RH, Abdu S, (2013). Self nanoemulsifying drug delivery system (SNEDDS) of Rosuvastatin calcium: design, formulation, bioavailability and pharmacokinetic evaluation. Colloids Surf B Biointerfaces 112C: 337-343.
14. Bali V, Ali M, Ali J, (2010). Study of surfactant combinations and development of a novel nanoemulsion for minimising variations in bioavailability of ezetimibe. Colloids Surf B Biointerfaces 76: 410-420.
15. Ballatori N, Clarkson TW, (1985). Biliary secretion of glutathione and of glutathione-metal complexes. Fundam Appl Toxicol 5: 816-831.
16. Barnes PJ, (2004). Alveolar macrophages as orchestrators of COPD. COPD 1: 59-70.
17. Bazile D, Prud'homme C, Bassoullet MT, Marlard M, Spenlehauer G, Veillard M, (1995). Stealth Me.PEG-PLA nanoparticles avoid uptake by the mononuclear phagocytes system. J Pharm Sci 84: 493-498.
18. Begley DJ, (2004). Delivery of therapeutic agents to the central nervous system: the problems and the possibilities. Pharmacol Ther 104: 29-45.
19. Bessems JG, Loizou G, Krishnan K, Clewell HJ 3rd, Bernasconi C, Bois F, et-al. (2013). PBTK modelling platforms and parameter estimation tools to enable animal-free risk assessment: recommendations from a joint EPAA-EURL ECVAM ADME workshop. Regul Toxicol Pharmacol 68: 119-139.
20. Bhandari R, Kaur IP, (2013). Pharmacokinetics, tissue distribution and relative bioavailability of isoniazid-solid lipid nanoparticles. Int J Pharm 441: 202-212.
21. Biricova V, Laznickova A, (2009). Dendrimers: analytical characterization and applications. Bioorg Chem 37: 185-192.
22. Biswas SK, Mantovani A, (2010). Macrophage plasticity and interaction with lymphocyte subsets: cancer as a paradigm. Nat Immunol 11: 889-896.
23. Bravo R, Axelrod DE, (2013). A calibrated agent-based computer model of stochastic cell dynamics in normal human colon crypts useful for in silico experiments. Theor Biol Med Model 10: 66.
24. Cai S, Yang Q, Bagby TR, Forrest ML, (2011). Lymphatic drug delivery using engineered liposomes and solid lipid nanoparticles. Adv Drug Deliv Rev 63: 901-908.
25. Cappel MJ, Kreuter J, (1991). Effect of nanoparticles on transdermal drug delivery. J Microencapsul 8: 369-374.
26. Cavalli R, Zara GP, Caputo O, Bargoni A, Fundaro A, Gasco MR, (2000). Transmucosal transport of tobramycin incorporated in SLN after duodenal administration to rats. Part I-a pharmacokinetic study. Pharmacol Res 42: 541-545.
27. Chamundeeswari M, Sastry TP, Lakhsmi BS, Senthil V, Agostinelli E, (2013). Iron nanoparticles from animal blood for cellular imaging and targeted delivery for cancer treatment. Biochim Biophys Acta 1830: 3005-3010.
28. Chan HK, (2011). Nanodrug particles and nanoformulations for drug delivery. Adv Drug Deliv Rev 63: 405.
29. Chattopadhyay S, (2013). Aerosol generation using nanometer liposome suspensions for pulmonary drug delivery applications. J Liposome Res 23: 255-267.
30. Chauhan VP, Jain RK, (2013). Strategies for advancing cancer nanomedicine. Nat Mater 12: 958-962.
31. Chen Q, Xue Y, Sun J, (2013). Kupffer cell-mediated hepatic injury induced by silica nanoparticles in vitro and in vivo. Int J Nanomedicine 8: 1129-1140.
32. Chen R, Qian Y, Li R, Zhang Q, Liu D, Wang M, et-al. (2010). Methazolamide calcium phosphate nanoparticles in an ocular delivery system. Yakugaku Zasshi 130: 419-424.
33. Choi HS, Liu W, Misra P, Tanaka E, Zimmer JP, Itty Ipe B, et-al. (2007). Renal clearance of quantum dots. Nat Biotechnol 25: 1165-1170.
34. Cnop M, Welsh N, Jonas JC, Jorns A, Lenzen S, Eizirik DL, (2005). Mechanisms of pancreatic beta-cell death in type 1 and type 2 diabetes: many differences, few similarities. Diabetes 54 (Suppl. 2): S97-S107.
35. Corazziari ES, (2009). Intestinal mucus barrier in normal and inflamed colon. J Pediatr Gastroenterol Nutr 48 (Suppl. 2): S54-S55.
36. Crowe S, Zhu T, Muller WA, (2003). The contribution of monocyte infection and trafficking to viral persistence, and maintenance of the viral reservoir in HIV infection. J Leukoc Biol 74: 635-641.
37. Dilnawaz F, Singh A, Mohanty C, Sahoo SK, (2010). Dual drug loaded superparamagnetic iron oxide nanoparticles for targeted cancer therapy. Biomaterials 31: 3694-3706.
38. Dufes C, Uchegbu IF, Schatzlein AG, (2005). Dendrimers in gene delivery. Adv Drug Deliv Rev 57: 2177-2202.
39. Duwal S, Schutte C, von Kleist M, (2012). Pharmacokinetics and pharmacodynamics of the reverse transcriptase inhibitor tenofovir and prophylactic efficacy against HIV-1 infection. PLoS ONE 7: e40382.
40. Ensign LM, Schneider C, Suk JS, Cone R, Hanes J, (2012). Mucus penetrating nanoparticles: biophysical tool and method of drug and gene delivery. Adv Mater 24: 3887-3894.
41. Farah FS, Samra SA, Nuwayri-Salti N, (1975). The role of the macrophage in cutaneous leishmaniasis. Immunology 29: 755-764.
42. Fenneteau F, Poulin P, Nekka F, (2010). Physiologically based predictions of the impact of inhibition of intestinal and hepatic metabolism on human pharmacokinetics of CYP3A substrates. J Pharm Sci 99: 486-514.
43. Friedman SL, Rockey DC, McGuire RF, Maher JJ, Boyles JK, Yamasaki G, (1992). Isolated hepatic lipocytes and Kupffer cells from normal human liver: morphological and functional characteristics in primary culture. Hepatology 15: 234-243.
44. Gajbhiye V, Ganesh N, Barve J, Jain NK, (2013). Synthesis, characterization and targeting potential of zidovudine loaded sialic acid conjugated-mannosylated poly(propyleneimine) dendrimers. Eur J Pharm Sci 48: 668-679.
45. Ganta S, Sharma P, Paxton JW, Baguley BC, Garg S, (2010). Pharmacokinetics and pharmacodynamics of chlorambucil delivered in long-circulating nanoemulsion. J Drug Target 18: 125-133.
46. Ge C, Du J, Zhao L, Wang L, Liu Y, Li D, et-al. (2011). Binding of blood proteins to carbon nanotubes reduces cytotoxicity. Proc Natl Acad Sci U S A 108: 16968-16973.
47. Geenen S, Yates JW, Kenna JG, Bois FY, Wilson ID, Westerhoff HV, (2013). Multiscale modelling approach combining a kinetic model of glutathione metabolism with PBPK models of paracetamol and the potential glutathione-depletion biomarkers ophthalmic acid and 5-oxoproline in humans and rats. Integr Biol (Camb) 5: 877-888.
48. Gentile F, Ferrari M, Decuzzi P, (2008). The transport of nanoparticles in blood vessels: the effect of vessel permeability and blood rheology. Ann Biomed Eng 36: 254-261.
49. Georgieva JV, Kalicharan D, Couraud PO, Romero IA, Weksler B, Hoekstra D, et-al. (2011). Surface characteristics of nanoparticles determine their intracellular fate in and processing by human blood-brain barrier endothelial cells in vitro. Mol Ther 19: 318-325.
50. Gertz M, Cartwright CM, Hobbs MJ, Kenworthy KE, Rowland M, Houston JB, et-al. (2013). Cyclosporine inhibition of hepatic and intestinal CYP3A4, uptake and efflux transporters: application of PBPK modeling in the assessment of drug-drug interaction potential. Pharm Res 30: 761-780.
51. Gide PS, Gidwani SK, Kothule KU, (2013). Enhancement of transdermal penetration and bioavailability of poorly soluble acyclovir using solid lipid nanoparticles incorporated in gel cream. Indian J Pharm Sci 75: 138-142.
52. Gref R, Luck M, Quellec P, Marchand M, Dellacherie E, Harnisch S, et-al. (2000). Stealth' corona-core nanoparticles surface modified by polyethylene glycol (PEG): influences of the corona (PEG chain length and surface density) and of the core composition on phagocytic uptake and plasma protein adsorption. Colloids Surf B Biointerfaces 18: 301-313.
53. Hadinoto K, Sundaresan A, Cheow WS, (2013). Lipid-polymer hybrid nanoparticles as a new generation therapeutic delivery platform: a review. Eur J Pharm Biopharm 85: 427-443.
54. Han SF, Yao TT, Zhang XX, Gan L, Zhu C, Yu HZ, et-al. (2009). Lipid-based formulations to enhance oral bioavailability of the poorly water-soluble drug anethol trithione: effects of lipid composition and formulation. Int J Pharm 379: 18-24.
55. Harivardhan Reddy L, Sharma RK, Chuttani K, Mishra AK, Murthy RS, (2005). Influence of administration route on tumor uptake and biodistribution of etoposide loaded solid lipid nanoparticles in Dalton's lymphoma tumor bearing mice. J Control Release 105: 185-198.
56. Hashem FM, Nasr M, Khairy A, (2013). In vitro cytotoxicity and bioavailability of solid lipid nanoparticles containing tamoxifen citrate. Pharm Dev Technol 19: 824-832.
57. Hatakeyama S, Sugihara K, Shibata TK, Nakayama J, Akama TO, Tamura N, et-al. (2011). Targeted drug delivery to tumor vasculature by a carbohydrate mimetic peptide. Proc Natl Acad Sci U S A 108: 19587-19592.
58. Hathout RM, Mansour S, Mortada ND, Guinedi AS, (2007). Liposomes as an ocular delivery system for acetazolamide: in vitro and in vivo studies. AAPS PharmSciTech 8: E1-E12.
59. He B, Lin P, Jia ZR, Du WW, Qu W, Yuan L, et-al. (2013). The transport mechanisms of polymer nanoparticles in Caco-2 epithelial cells. Biomaterials 34: 6082-6098.
60. He C, Yin L, Tang C, Yin C, (2012). Size-dependent absorption mechanism of polymeric nanoparticles for oral delivery of protein drugs. Biomaterials 33: 8569-8578.
61. Heinsbroek SE, Gordon S, (2009). The role of macrophages in inflammatory bowel diseases. Expert Rev Mol Med 11: e14.
62. Hellstrand E, Lynch I, Andersson A, Drakenberg T, Dahlback B, Dawson KA, et-al. (2009). Complete high-density lipoproteins in nanoparticle corona. FEBS J 276: 3372-3381.
63. Hillaireau H, Couvreur P, (2009). Nanocarriers' entry into the cell: relevance to drug delivery. Cell Mol Life Sci 66: 2873-2896.
64. Hobbs SK, Monsky WL, Yuan F, Roberts WG, Griffith L, Torchilin VP, et-al. (1998). Regulation of transport pathways in tumor vessels: role of tumor type and microenvironment. Proc Natl Acad Sci U S A 95: 4607-4612.
65. Honda M, Asai T, Oku N, Araki Y, Tanaka M, Ebihara N, (2013). Liposomes and nanotechnology in drug development: focus on ocular targets. Int J Nanomedicine 8: 495-503.
66. Huang X, El-Sayed IH, Qian W, El-Sayed MA, (2006). Cancer cell imaging and photothermal therapy in the near-infrared region by using gold nanorods. J Am Chem Soc 128: 2115-2120.
67. Ichikawa H, Watanabe T, Tokumitsu H, Fukumori Y, (2007). Formulation considerations of gadolinium lipid nanoemulsion for intravenous delivery to tumors in neutron-capture therapy. Curr Drug Deliv 4: 131-140.
68. Illum L, (2007). Nanoparticulate systems for nasal delivery of drugs: a real improvement over simple systems? J Pharm Sci 96: 473-483.
69. Ishida T, Harashima H, Kiwada H, (2002). Liposome clearance. Biosci Rep 22: 197-224.
70. Ishida T, Wang X, Shimizu T, Nawata K, Kiwada H, (2007). PEGylated liposomes elicit an anti-PEG IgM response in a T cell-independent manner. J Control Release 122: 349-355.
71. Ittrich H, Peldschus K, Raabe N, Kaul M, Adam G, (2013). Superparamagnetic iron oxide nanoparticles in biomedicine: applications and developments in diagnostics and therapy. Rofo 185: 1149-1166.
72. Iyer AK, Khaled G, Fang J, Maeda H, (2006). Exploiting the enhanced permeability and retention effect for tumor targeting. Drug Discov Today 11: 812-818.
73. Jacqmin P, McFadyen L, Wade JR, (2008). A receptor theory-based semimechanistic PD model for the CCR5 noncompetitive antagonist maraviroc. Br J Clin Pharmacol 65 (Suppl. 1): 95-106.
74. Jain RK, Stylianopoulos T, (2010). Delivering nanomedicine to solid tumors. Nat Rev Clin Oncol 7: 653-664.
75. Jansch M, Stumpf P, Graf C, Ruhl E, Muller RH, (2012). Adsorption kinetics of plasma proteins on ultrasmall superparamagnetic iron oxide (USPIO) nanoparticles. Int J Pharm 428: 125-133.
76. Jiang C, Moore MJ, Zhang X, Klassen H, Langer R, Young M, (2007). Intravitreal injections of GDNF-loaded biodegradable microspheres are neuroprotective in a rat model of glaucoma. Mol Vis 13: 1783-1792.
77. Johansson ME, Ambort D, Pelaseyed T, Schutte A, Gustafsson JK, Ermund A, et-al. (2011). Composition and functional role of the mucus layers in the intestine. Cell Mol Life Sci 68: 3635-3641.
78. Joralemon MJ, McRae S, Emrick T, (2010). PEGylated polymers for medicine: from conjugation to self-assembled systems. Chem Commun (Camb) 46: 1377-1393.
79. Joshi N, Grinstaff M, (2008). Applications of dendrimers in tissue engineering. Curr Top Med Chem 8: 1225-1236.
80. Kaminskas LM, Boyd BJ, Porter CJ, (2011). Dendrimer pharmacokinetics: the effect of size, structure and surface characteristics on ADME properties. Nanomedicine (Lond) 6: 1063-1084.
81. Karlsson FH, Bouchene S, Hilgendorf C, Dolgos H, Peters SA, (2013). Utility of in vitro systems and preclinical data for the prediction of human intestinal first-pass metabolism during drug discovery and preclinical development. Drug Metab Dispos 41: 2033-2046.
82. Ke AB, Nallani SC, Zhao P, Rostami-Hodjegan A, Unadkat JD, (2012). A PBPK model to predict disposition of CYP3A-metabolized drugs in pregnant women: verification and discerning the site of CYP3A induction. CPT Pharmacometrics Syst Pharmacol 1: e3.
83. Kelly C, Jefferies C, Cryan SA, (2011). Targeted liposomal drug delivery to monocytes and macrophages. J Drug Deliv 2011: 727241.
84. Kelly KA, Bardeesy N, Anbazhagan R, Gurumurthy S, Berger J, Alencar H, et-al. (2008). Targeted nanoparticles for imaging incipient pancreatic ductal adenocarcinoma. PLoS Med 5: e85.
85. Khurana S, Jain NK, Bedi PM, (2013). Nanoemulsion based gel for transdermal delivery of meloxicam: physico-chemical, mechanistic investigation. Life Sci 92: 383-392.
86. Kim D, Lee ES, Park K, Kwon IC, Bae YH, (2008). Doxorubicin loaded pH-sensitive micelle: antitumoral efficacy against ovarian A2780/DOXR tumor. Pharm Res 25: 2074-2082.
87. van 't Klooster G, Hoeben E, Borghys H, Looszova A, Bouche MP van, Velsen F, et-al. (2010). Pharmacokinetics and disposition of rilpivirine (TMC278) nanosuspension as a long-acting injectable antiretroviral formulation. Antimicrob Agents Chemother 54: 2042-2050.
88. Kobayashi H, Brechbiel MW, (2004). Dendrimer-based nanosized MRI contrast agents. Curr Pharm Biotechnol 5: 539-549.
89. Kreuter J, (1994) Nanoparticles. In:, Swarbrick J, Boylan JC, (eds). Encyclopedia of Pharmaceutical Technology. Marcel Dekker: New York, pp. 165-190.
90. Lai F, Fadda AM, Sinico C, (2013). Liposomes for brain delivery. Expert Opin Drug Deliv 10: 1003-1022.
91. Lameijer MA, Tang J, Nahrendorf M, Beelen RH, Mulder WJ, (2013). Monocytes and macrophages as nanomedicinal targets for improved diagnosis and treatment of disease. Expert Rev Mol Diagn 13: 567-580.
92. Lankveld DP, Oomen AG, Krystek P, Neigh A, Troost-de Jong A, Noorlander CW, et-al. (2010). The kinetics of the tissue distribution of silver nanoparticles of different sizes. Biomaterials 31: 8350-8361.
93. Lazzari S, Moscatelli D, Codari F, Salmona M, Morbidelli M, Diomede L, (2012). Colloidal stability of polymeric nanoparticles in biological fluids. J Nanopart Res 14: 920.
94. Lee HA, Leavens TL, Mason SE, Monteiro-Riviere NA, Riviere JE, (2009). Comparison of quantum dot biodistribution with a blood-flow-limited physiologically based pharmacokinetic model. Nano Lett 9: 794-799.
95. Lee HJ, Engelhardt B, Lesley J, Bickel U, Pardridge WM, (2000). Targeting rat anti-mouse transferrin receptor monoclonal antibodies through blood-brain barrier in mouse. J Pharmacol Exp Ther 292: 1048-1052.
96. Li M, Panagi Z, Avgoustakis K, Reineke J, (2012). Physiologically based pharmacokinetic modeling of PLGA nanoparticles with varied mPEG content. Int J Nanomedicine 7: 1345-1356.
97. Lin P, Chen JW, Chang LW, Wu JP, Redding L, Chang H, et-al. (2008). Computational and ultrastructural toxicology of a nanoparticle, Quantum Dot 705, in mice. Environ Sci Technol 42: 6264-6270.
98. Liu L, Won YJ, Cooke PH, Coffin DR, Fishman ML, Hicks KB, et-al. (2004). Pectin/poly(lactide-co-glycolide) composite matrices for biomedical applications. Biomaterials 25: 3201-3210.
99. Lobovkina T, Jacobson GB, Gonzalez-Gonzalez E, Hickerson RP, Leake D, Kaspar RL, et-al. (2011). In vivo sustained release of siRNA from solid lipid nanoparticles. ACS Nano 5: 9977-9983.
100. Lu W, Melancon MP, Xiong C, Huang Q, Elliott A, Song S, et-al. (2011). Effects of photoacoustic imaging and photothermal ablation therapy mediated by targeted hollow gold nanospheres in an orthotopic mouse xenograft model of glioma. Cancer Res 71: 6116-6121.
101. Maeda H, Wu J, Sawa T, Matsumura Y, Hori K, (2000). Tumor vascular permeability and the EPR effect in macromolecular therapeutics: a review. J Control Release 65: 271-284.
102. Mager DE, Mody V, Xu C, Forrest A, Lesniak WG, Nigavekar SS, et-al. (2012). Physiologically based pharmacokinetic model for composite nanodevices: effect of charge and size on in vivo disposition. Pharm Res 29: 2534-2542.
103. Malfatti MA, Palko HA, Kuhn EA, Turteltaub KW, (2012). Determining the pharmacokinetics and long-term biodistribution of SiO2 nanoparticles in vivo using accelerator mass spectrometry. Nano Lett 12: 5532-5538.
104. Martin P, Giardiello M, McDonald TO, Rannard SP, Owen A, (2013). Mediation of in Vitro Cytochrome P450 Activity by Common Pharmaceutical Excipients. Mol Pharm 10: 2739-2748.
105. Matsumura Y, Maeda H, (1986). A new concept for macromolecular therapeutics in cancer chemotherapy: mechanism of tumoritropic accumulation of proteins and the antitumor agent smancs. Cancer Res 46 (12 Pt 1): 6387-6392.
106. McCaskill J, Singhania R, Burgess M, Allavena R, Wu S, Blumenthal A, et-al. (2013). Efficient biodistribution and gene silencing in the lung epithelium via intravenous liposomal delivery of siRNA. Mol Ther Nucleic Acids 2: 1-10.
107. McDonald TO, Giardiello M, Martin P, Siccardi M, Liptrott NJ, Smith D, et-al. (2013). Antiretroviral solid drug nanoparticles with enhanced oral bioavailability: production, characterization, and in vitro-in vivo correlation. Adv Healthc Mater 3: 400-411.
108. Mehnert W, Mader K, (2001). Solid lipid nanoparticles: production, characterization and applications. Adv Drug Deliv Rev 47: 165-196.
109. Menon GK, Cleary GW, Lane ME, (2012). The structure and function of the stratum corneum. Int J Pharm 435: 3-9.
110. Misra R, Sahoo SK, (2010). Intracellular trafficking of nuclear localization signal conjugated nanoparticles for cancer therapy. Eur J Pharm Sci 39: 152-163.
111. Mkandawire M, Pohl A, Gubarevich T, Lapina V, Appelhans D, Rodel G, et-al. (2009). Selective targeting of green fluorescent nanodiamond conjugates to mitochondria in HeLa cells. J Biophotonics 2: 596-606.
112. Moghimi SM, (2002). Chemical camouflage of nanospheres with a poorly reactive surface: towards development of stealth and target-specific nanocarriers. Biochim Biophys Acta 1590: 131-139.
113. Mohammad AK, Reineke JJ, (2013). Quantitative detection of PLGA nanoparticle degradation in tissues following intravenous administration. Mol Pharm 10: 2183-2189.
114. Morgen M, Bloom C, Beyerinck R, Bello A, Song W, Wilkinson K, et-al. (2012). Polymeric nanoparticles for increased oral bioavailability and rapid absorption using celecoxib as a model of a low-solubility, high-permeability drug. Pharm Res 29: 427-440.
115. Murphy GF, Brody AR, Craighead JE, (1975). Monocyte Migration across pulmonary membranes in mice infected with cytomegalovirus. Exp Mol Pathol 22: 35-44.
116. Musante CJ, Schroeter JD, Rosati JA, Crowder TM, Hickey AJ, Martonen TB, (2002). Factors affecting the deposition of inhaled porous drug particles. J Pharm Sci 91: 1590-1600.
117. Muthiah M, Park IK, Cho CS, (2013). Surface modification of iron oxide nanoparticles by biocompatible polymers for tissue imaging and targeting. Biotechnol Adv 31: 1224-1236.
118. Negi JS, Chattopadhyay P, Sharma AK, Ram V, (2013). Development of solid lipid nanoparticles (SLNs) of lopinavir using hot self nano-emulsification (SNE) technique. Eur J Pharm Sci 48: 231-239.
119. Nkansah MK, Tzeng SY, Holdt AM, Lavik EB, (2008). Poly(lactic-co-glycolic acid) nanospheres and microspheres for short- and long-term delivery of bioactive ciliary neurotrophic factor. Biotechnol Bioeng 100: 1010-1019.
120. O'Brien MER, Wigler N, Inbar M, Rosso R, Grischke E, Santoro A, et-al. (2004). Reduced cardiotoxicity and comparable efficacy in a phase III trial of pegylated liposomal doxorubicin HCl (CAELYX (TM)/Doxil (R)) versus conventional doxorubicin for first-line treatment of metastatic breast cancer. Ann Oncol 15: 440-449.
121. Oh P, Li Y, Yu J, Durr E, Krasinska KM, Carver LA, et-al. (2004). Subtractive proteomic mapping of the endothelial surface in lung and solid tumours for tissue-specific therapy. Nature 429: 629-635.
122. Ong C, Lim JZ, Ng CT, Li JJ, Yung LY, Bay BH, (2013). Silver nanoparticles in cancer: therapeutic efficacy and toxicity. Curr Med Chem 20: 772-781.
123. Owens DE 3rd, Peppas NA, (2006). Opsonization, biodistribution, and pharmacokinetics of polymeric nanoparticles. Int J Pharm 307: 93-102.
124. Paliwal R, Rai S, Vaidya B, Khatri K, Goyal AK, Mishra N, et-al. (2009). Effect of lipid core material on characteristics of solid lipid nanoparticles designed for oral lymphatic delivery. Nanomedicine 5: 184-191.
125. Pascal J, Ashley CE, Wang Z, Brocato TA, Butner JD, Carnes EC, et-al. (2013). Mechanistic modeling identifies drug-uptake history as predictor of tumor drug resistance and nano-carrier-mediated response. ACS Nano 7: 11174-11182.
126. Patel D, Naik S, Misra A, (2012). Improved transnasal transport and brain uptake of tizanidine HCl-loaded thiolated chitosan nanoparticles for alleviation of pain. J Pharm Sci 101: 690-706.
127. Patel K, Batty KT, Moore BR, Gibbons PL, Bulitta JB, Kirkpatrick CM, (2013). Mechanism-based model of parasite growth and dihydroartemisinin pharmacodynamics in murine malaria. Antimicrob Agents Chemother 57: 508-516.
128. Patton JS, Byron PR, (2007). Inhaling medicines: delivering drugs to the body through the lungs. Nat Rev Drug Discov 6: 67-74.
129. Paula AJ, Araujo Junior RT, Martinez DS, Paredes-Gamero EJ, Nader HB, Duran N, et-al. (2013). Influence of protein corona on the transport of molecules into cells by mesoporous silica nanoparticles. ACS Appl Mater Interfaces 5: 8387-8393.
130. Pelley JL, Daar AS, Saner MA, (2009). State of academic knowledge on toxicity and biological fate of quantum dots. Toxicol Sci 112: 276-296.
131. Peng Q, Zhang S, Yang Q, Zhang T, Wei XQ, Jiang L, et-al. (2013). Preformed albumin corona, a protective coating for nanoparticles based drug delivery system. Biomaterials 34: 8521-8530.
132. Pery AR, Brochot C, Hoet PH, Nemmar A, Bois FY, (2009). Development of a physiologically based kinetic model for 99m-technetium-labelled carbon nanoparticles inhaled by humans. Inhal Toxicol 21: 1099-1107.
133. Philips JA, Ernst JD, (2012). Tuberculosis pathogenesis and immunity. Annu Rev Pathol 7: 353-384.
134. Pierre MB, Dos Santos Miranda Costa I, (2011). Liposomal systems as drug delivery vehicles for dermal and transdermal applications. Arch Dermatol Res 303: 607-621.
135. Poulin P, Theil FP, (2002). Prediction of pharmacokinetics prior to in vivo studies. 1. Mechanism-based prediction of volume of distribution. J Pharm Sci 91: 129-156.
136. Radwan SH, Azzazy HM, (2009). Gold nanoparticles for molecular diagnostics. Expert Rev Mol Diagn 9: 511-524.
137. Rehman K, Zulfakar MH, (2013). Recent advances in gel technologies for topical and transdermal drug delivery. Drug Dev Ind Pharm 40: 433-440.
138. Ruoslahti E, (2012). Peptides as targeting elements and tissue penetration devices for nanoparticles. Adv Mater 24: 3747-3756.
139. Ryan GM, Kaminskas LM, Kelly BD, Owen DJ, McIntosh MP, Porter CJ, (2013). Pulmonary administration of PEGylated polylysine dendrimers: absorption from the lung versus retention within the lung is highly size-dependent. Mol Pharm 10: 2986-2995.
140. Sadauskas E, Wallin H, Stoltenberg M, Vogel U, Doering P, Larsen A, et-al. (2007). Kupffer cells are central in the removal of nanoparticles from the organism. Part Fibre Toxicol 4: 10.
141. de Salamanca AE, Diebold Y, Calonge M, Garcia-Vazquez C, Callejo S, Vila A, et-al. (2006). Chitosan nanoparticles as a potential drug delivery system for the ocular surface: toxicity, uptake mechanism and in vivo tolerance. Invest Ophthalmol Vis Sci 47: 1416-1425.
142. Saptarshi SR, Duschl A, Lopata AL, (2013). Interaction of nanoparticles with proteins: relation to bio-reactivity of the nanoparticle. J Nanobiotechnology 11: 26.
143. Saraceno R, Chiricozzi A, Gabellini M, Chimenti S, (2013). Emerging applications of nanomedicine in dermatology. Skin Res Technol.
144. Sareen S, Mathew G, Joseph L, (2012). Improvement in solubility of poor water-soluble drugs by solid dispersion. Int J Pharm Investig 2: 12-17.
145. Schell RF, Sidone BJ, Caron WP, Walsh MD, Zamboni BA, Ramanathan RK, et-al. (2013). Meta-analysis of inter-patient pharmacokinetic variability of liposomal and non-liposomal anticancer agents. Nanomedicine 10: 109-117.
146. Schrade A, Mailander V, Ritz S, Landfester K, Ziener U, (2012). Surface roughness and charge influence the uptake of nanoparticles: fluorescently labeled pickering-type versus surfactant-stabilized nanoparticles. Macromol Biosci 12: 1459-1471.
147. Shmeeda H, Amitay Y, Tzemach D, Gorin J, Gabizon A, (2013). Liposome encapsulation of zoledronic acid results in major changes in tissue distribution and increase in toxicity. J Control Release 167: 265-275.
148. Siccardi M, Almond L, Schipani A, Csajka C, Marzolini C, Wyen C, et-al. (2012). Pharmacokinetic and pharmacodynamic analysis of efavirenz dose reduction using an in vitro-in vivo extrapolation model. Clin Pharmacol Ther 92: 494-502.
149. Siccardi M, Rajoli RKR, Curley P, Olagunju A, Moss D, Owen A, (2013). Physiologically based pharmacokinetic models for the optimization of antiretroviral therapy: recent progress and future perspective. Future Virol 8: 871-890.
150. Sikarra D, Shukla VAA, Kharia AA, Chatterjee DP, (2012). Techniques for solubility enhancement of poorly soluble drugs: an overview. JMPAS 1: 1-22.
151. Singh KK, Vingkar SK, (2008). Formulation, antimalarial activity and biodistribution of oral lipid nanoemulsion of primaquine. Int J Pharm 347: 136-143.
152. Sitharaman B, Zakharian TY, Saraf A, Misra P, Ashcroft J, Pan S, et-al. (2008). Water-soluble fullerene (C60) derivatives as nonviral gene-delivery vectors. Mol Pharm 5: 567-578.
153. Smith PJ, Giroud M, Wiggins HL, Gower F, Thorley JA, Stolpe B, et-al. (2012). Cellular entry of nanoparticles via serum sensitive clathrin-mediated endocytosis, and plasma membrane permeabilization. Int J Nanomedicine 7: 2045-2055.
154. Sood S, Jawahar N, Jain K, Gowthamarajan K, Meyyanathan SN, (2013). Olanzapine loaded cationic solid lipid nanoparticles for improved oral bioavailability. Curr Nanosci 9: 26-34.
155. Sun HW, Liu KY, Liu W, Wang WX, Guo CL, Tang B, et-al. (2012). Development and characterization of a novel nanoemulsion drug-delivery system for potential application in oral delivery of protein drugs. Int J Nanomedicine 7: 5529-5543.
156. Suzuki T, Ichihara M, Hyodo K, Yamamoto E, Ishida T, Kiwada H, et-al. (2012). Accelerated blood clearance of PEGylated liposomes containing doxorubicin upon repeated administration to dogs. Int J Pharm 436: 636-643.
157. Svenson S, (2009). Dendrimers as versatile platform in drug delivery applications. Eur J Pharm Biopharm 71: 445-462.
158. Szekanecz Z, Koch AE, (2007). Macrophages and their products in rheumatoid arthritis. Curr Opin Rheumatol 19: 289-295.
159. Tanaka Y, Inkyo M, Yumoto R, Nagai J, Takano M, Nagata S, (2012). Nanoparticulation of probucol, a poorly water-soluble drug, using a novel wet-milling process to improve in vitro dissolution and in vivo oral absorption. Drug Dev Ind Pharm 38: 1015-1023.
160. Teesalu T, Sugahara KN, Kotamraju VR, Ruoslahti E, (2009). C-end rule peptides mediate neuropilin-1-dependent cell, vascular, and tissue penetration. Proc Natl Acad Sci U S A 106: 16157-16162.
161. Tenzer S, Docter D, Kuharev J, Musyanovych A, Fetz V, Hecht R, et-al. (2013). Rapid formation of plasma protein corona critically affects nanoparticle pathophysiology. Nat Nanotechnol 8: 772-781.
162. Thakor AS, Jokerst J, Zavaleta C, Massoud TF, Gambhir SS, (2011). Gold nanoparticles: a revival in precious metal administration to patients. Nano Lett 11: 4029-4036.
163. Thomas S, (2009). Physiologically-based simulation modelling for the reduction of animal use in the discovery of novel pharmaceuticals. Altern Lab Anim 37: 497-511.
164. Tuma P, Hubbard AL, (2003). Transcytosis: crossing cellular barriers. Physiol Rev 83: 871-932.
165. Varatharajan L, Thomas SA, (2009). The transport of anti-HIV drugs across blood-CNS interfaces: summary of current knowledge and recommendations for further research. Antiviral Res 82: A99-A109.
166. Videira M, Almeida AJ, Fabra A, (2012). Preclinical evaluation of a pulmonary delivered paclitaxel-loaded lipid nanocarrier antitumor effect. Nanomedicine 8: 1208-1215.
167. Vyas SP, Malaiya A, (1989). In vivo characterization of indomethacin magnetic polymethyl methacrylate nanoparticles. J Microencapsul 6: 493-499.
168. Vyas TK, Shahiwala A, Amiji MM, (2008). Improved oral bioavailability and brain transport of Saquinavir upon administration in novel nanoemulsion formulations. Int J Pharm 347: 93-101.
169. Waalkes MP, (2000). Cadmium carcinogenesis in review. J Inorg Biochem 79: 241-244.
170. Wacker M, (2013). Nanocarriers for intravenous injection-The long hard road to the market. Int J Pharm 457: 50-62.
171. Wallace SJ, Li J, Nation RL, Boyd BJ, (2012). Drug release from nanomedicines: selection of appropriate encapsulation and release methodology. Drug Deliv Transl Res 2: 284-292.
172. Wang H, Zhao P, Su W, Wang S, Liao Z, Niu R, et-al. (2010). PLGA/polymeric liposome for targeted drug and gene co-delivery. Biomaterials 31: 8741-8748.
173. Wang X, Ishida T, Kiwada H, (2007). Anti-PEG IgM elicited by injection of liposomes is involved in the enhanced blood clearance of a subsequent dose of PEGylated liposomes. J Control Release 119: 236-244.
174. Wilkins JJ, Dubar M, Sebastien B, Laveille C, (2013). A drug and disease model for lixisenatide, a GLP-1 receptor agonist in type 2 diabetes. J Clin Pharmacol 54: 267-278.
175. Willmann S, Thelen K, Becker C, Dressman JB, Lippert J, (2010). Mechanism-based prediction of particle size-dependent dissolution and absorption: cilostazol pharmacokinetics in dogs. Eur J Pharm Biopharm 76: 83-94.
176. Wischke C, Schwendeman SP, (2008). Principles of encapsulating hydrophobic drugs in PLA/PLGA microparticles. Int J Pharm 364: 298-327.
177. Wong H, Theil FP, Cui Y, Marsters JC Jr, Khojasteh SC, Vernillet L, et-al. (2010). Interplay of dissolution, solubility, and nonsink permeation determines the oral absorption of the Hedgehog pathway inhibitor GDC-0449 in dogs: an investigation using preclinical studies and physiologically based pharmacokinetic modeling. Drug Metab Dispos 38: 1029-1038.
178. Wu X, Wu M, Zhao JX, (2013). Recent development of silica nanoparticles as delivery vectors for cancer imaging and therapy. Nanomedicine 10: 297-312.
179. Yamashita F, Sasa Y, Yoshida S, Hisaka A, Asai Y, Kitano H, et-al. (2013). modeling of rifampicin-Induced CYP3A4 activation dynamics for the prediction of clinical drug-drug interactions from in vitro data. PLoS ONE 8: e70330.
180. Yan Z, Zhu ZL, Qian ZZ, Hu G, Wang HQ, Liu WH, et-al. (2012). Pharmacokinetic characteristics of vincristine sulfate liposomes in patients with advanced solid tumors. Acta Pharmacol Sin 33: 852-858.
181. Yang X, Doerge DR, Fisher JW, (2013). Prediction and evaluation of route dependent dosimetry of BPA in rats at different life stages using a physiologically based pharmacokinetic model. Toxicol Appl Pharmacol 270: 45-59.
182. Ying X, Wen H, Yao HJ, Zhang Y, Tian W, Zhang L, et-al. (2011). Pharmacokinetics and tissue distribution of dual-targeting daunorubicin liposomes in mice. Pharmacology 87: 105-114.
183. Yu YH, Kim E, Park DE, Shim G, Lee S, Kim YB, et-al. (2012). Cationic solid lipid nanoparticles for co-delivery of paclitaxel and siRNA. Eur J Pharm Biopharm 80: 268-273.
184. Zara GP, Bargoni A, Cavalli R, Fundaro A, Vighetto D, Gasco MR, (2002). Pharmacokinetics and tissue distribution of idarubicin-loaded solid lipid nanoparticles after duodenal administration to rats. J Pharm Sci 91: 1324-1333.
185. Zhang H, Li RY, Lu X, Mou ZZ, Lin GM, (2012). Docetaxel-loaded liposomes: preparation, pH sensitivity, pharmacokinetics, and tissue distribution. J Zhejiang Univ Sci B 13: 981-989.
186. Zhang J, Wu L, Chan HK, Watanabe W, (2011). Formation, characterization, and fate of inhaled drug nanoparticles. Adv Drug Deliv Rev 63: 441-455.
187. Zhang X, Do MD, Dean K, Hoobin P, Burgar IM, (2007). Wheat-gluten-based natural polymer nanoparticle composites. Biomacromolecules 8: 345-353.
188. Zhang Y, Zhang Y, Hong G, He W, Zhou K, Yang K, et-al. (2013). Biodistribution, pharmacokinetics and toxicology of Ag2S near-infrared quantum dots in mice. Biomaterials 34: 3639-3646.
189. Zhao Y, Wang C, Wang L, Yang Q, Tang W, She Z, et-al. (2012a). A frustrating problem: accelerated blood clearance of PEGylated solid lipid nanoparticles following subcutaneous injection in rats. Eur J Pharm Biopharm 81: 506-513.
190. Zhao Y, Wang L, Yan M, Ma Y, Zang G, She Z, et-al. (2012b). Repeated injection of PEGylated solid lipid nanoparticles induces accelerated blood clearance in mice and beagles. Int J Nanomedicine 7: 2891-2900.
191. Zheng CH, Gao JQ, Zhang YP, Liang WQ, (2004). A protein delivery system: biodegradable alginate-chitosan-poly(lactic-co-glycolic acid) composite microspheres. Biochem Biophys Res Commun 323: 1321-1327.