Nanodrugs: Pharmacokinetics and safety

International Journal of Nanomedicine

Volumn 9, Issue 1, 2014, Pages 1025-1037

  Onoue, Satomi ^a   Yamada, Shizuo ^a   Chan, Hak Kim ^b  

^a UNIVERSITY OF SHIZUOKA   (Japan)

^b UNIVERSITY OF SYDNEY   (Australia)

Author keywords

Nanoparticles; Nanotechnology; Nanotoxicity; Solubilization; Targeted delivery

Indexed keywords

AMPHOTERICIN B LIPID COMPLEX; CYCLOSPORIN A; DENDRIMER; DOXORUBICIN; DRUG CARRIER; LIPOSOME; NANODRUG; PACLITAXEL; SOLID LIPID NANOPARTICLE; UNCLASSIFIED DRUG; EMULSION; MICELLE; NANOPARTICLE;

AREA UNDER THE CURVE; DRUG ABSORPTION; DRUG APPROVAL; DRUG BIOAVAILABILITY; DRUG CLEARANCE; DRUG FORMULATION; DRUG SAFETY; HUMAN; MAXIMUM PLASMA CONCENTRATION; MICELLE; NANOEMULSION; NANOENGINEERING; NONHUMAN; PARTICLE SIZE; PROCESS DEVELOPMENT; REVIEW; RISK FACTOR; TIME TO MAXIMUM PLASMA CONCENTRATION; ADVERSE EFFECTS; CHEMISTRY; DRUG DELIVERY SYSTEM; EMULSION; NANOMEDICINE; NANOTECHNOLOGY; PHARMACOKINETICS; SAFETY;

DENDRIMERS; DRUG DELIVERY SYSTEMS; EMULSIONS; HUMANS; LIPOSOMES; MICELLES; NANOMEDICINE; NANOPARTICLES; NANOTECHNOLOGY; PHARMACOKINETICS; SAFETY;

EID: 84896809223     PISSN: 11769114     EISSN: 11782013     Source Type: Journal    
DOI: 10.2147/IJN.S38378     Document Type: Review

References (90)

1. Devalapally H, Chakilam A, Amiji MM. Role of nanotechnology in pharmaceutical product development. J Pharm Sci. 2007;96(10): 2547-2565.
2. Naahidi S, Jafari M, Edalat F, Raymond K, Khademhosseini A, Chen P. Biocompatibility of engineered nanoparticles for drug delivery. J Control Release. 2013;166(2):182-194.
3. Petros RA, DeSimone JM. Strategies in the design of nanoparticles for therapeutic applications. Nat Rev Drug Discov. 2010;9(8):615-627.
4. Yang W, Peters JI, Williams RO. Inhaled nanoparticles a current review. Int J Pharm. 2008;356(1-2):239-247.
5. De Jong WH, Borm PJ. Drug delivery and nanoparticles: applications and hazards. Int J Nanomedicine. 2008;3(2):133-149.
6. Win KY, Feng SS. Effects of particle size and surface coating on cellular uptake of polymeric nanoparticles for oral delivery of anticancer drugs. Biomaterials. 2005;26(15):2713-2722.
7. Kreuter J. Nanoparticulate systems for brain delivery of drugs. Adv Drug Deliv Rev. 2001;47(1):65-81.
8. Liu W, Yang XL, Ho WS. Preparation of uniform-sized multiple emulsions and micro/nano particulates for drug delivery by membrane emulsification. J Pharm Sci. 2011;100(1):75-93.
9. Nel A, Xia T, Mädler L, Li N. Toxic potential of materials at the nanolevel. Science. 2006;311(5761):622-627.
10. Roger E, Lagarce F, Garcion E, Benoit JP. Biopharmaceutical parameters to consider in order to alter the fate of nanocarriers after oral delivery. Nanomedicine (Lond). 2010;5(2):287-306.
11. Jain A, Jain SK. In vitro and cell uptake studies for targeting of ligand anchored nanoparticles for colon tumors. Eur J Pharm Sci. 2008;35(5):404-416.
12. Francis MF, Cristea M, Winnik FM. Exploiting the vitamin B12 pathway to enhance oral drug delivery via polymeric micelles. Biomacromolecules. 2005;6(5):2462-2467.
13. Vega-Villa KR, Takemoto JK, Yáñez JA, Remsberg CM, Forrest ML, Davies NM. Clinical toxicities of nanocarrier systems. Adv Drug Deliv Rev. 2008;60(8):929-938.
14. des Rieux A, Fievez V, Garinot M, Schneider YJ, Préat V. Nanoparticles as potential oral delivery systems of proteins and vaccines: a mechanistic approach. J Control Release. 2006;116(1):1-27.
15. Mori S, Matsuura A, Rama Prasad YV, Takada K. Studies on the intestinal absorption of low molecular weight heparin using saturated fatty acids and their derivatives as an absorption enhancer in rats. Biol Pharm Bull. 2004;27(3):418-421.
16. Shahbazi MA, Santos HA. Improving oral absorption via drug-loaded nanocarriers: absorption mechanisms, intestinal models and rational fabrication. Curr Drug Metab. 2013;14(1):28-56.
17. Chuang EY, Lin KJ, Su FY, et al. Calcium depletion-mediated protease inhibition and apical-junctional-complex disassembly via an EGTA-conjugated carrier for oral insulin delivery. J Control Release. 2013;169(3):296-305.
18. Kozlowska D, Foran P, MacMahon P, Shelly MJ, Eustace S, O'Kennedy R. Molecular and magnetic resonance imaging: The value of immunoliposomes. Adv Drug Deliv Rev. 2009;61(15): 1402-1411.
19. Onoue S, Sato H, Ogawa K, et al. Inhalable dry-emulsion formulation of cyclosporine A with improved anti-inflammatory effects in experimental asthma/COPD-model rats. Eur J Pharm Biopharm. 2012;80(1):54-60.
20. Onoue S, Matsui T, Kuriyama K, et al. Inhalable sustained-release formulation of long-acting vasoactive intestinal peptide derivative alleviates acute airway inflammation. Peptides. 2012;35(2):182-189.
21. Mobley C, Hochhaus G. Methods used to assess pulmonary deposition and absorption of drugs. Drug Discov Today. 2001;6(7):367-375.
22. Bur M, Henning A, Hein S, Schneider M, Lehr CM. Inhalative nanomedicine opportunities and challenges. Inhal Toxicol. 2009; 21 Suppl 1:S137-S143.
23. Ai J, Biazar E, Jafarpour M, et al. Nanotoxicology and nanoparticle safety in biomedical designs. Int J Nanomedicine. 2011;6:1117-1127.
24. Drobne D. Nanotoxicology for safe and sustainable nanotechnology. Arh Hig Rada Toksikol. 2007;58(4):471-478.
25. Choi HS, Frangioni JV. Nanoparticles for biomedical imaging: fundamentals of clinical translation. Mol Imaging. 2010;9(6): 291-310.
26. Wick P, Manser P, Limbach LK, et al. The degree and kind of agglomeration affect carbon nanotube cytotoxicity. Toxicol Lett. 2007;168(2):121-131.
27. Stern ST, McNeil SE. Nanotechnology safety concerns revisited. Toxicol Sci. 2008;101(1):4-21.
28. Liu M, Fréchet JMJ. Designing dendrimers for drug delivery. Pharm Sci Technolo Today. 1999;2(10):393-401.
29. Honda M, Asai T, Oku N, Araki Y, Tanaka M, Ebihara N. Liposomes and nanotechnology in drug development: focus on ocular targets. Int J Nanomedicine. 2013;8:495-503.
30. Kaminskas LM, McLeod VM, Kelly BD, et al. A comparison of changes to doxorubicin pharmacokinetics, antitumor activity, and toxicity mediated by PEGylated dendrimer and PEGylated liposome drug delivery systems. Nanomedicine. 2012;8(1):103-111.
31. Maeda H, Sawa T, Konno T. Mechanism of tumor-targeted delivery of macromolecular drugs, including the EPR effect in solid tumor and clinical overview of the prototype polymeric drug SMANCS. J Control Release. 2001;74(1-3):47-61.
32. Asthana A, Chauhan AS, Diwan PV, Jain NK. Poly(amidoamine) (PAMAM) dendritic nanostructures for controlled site-specific delivery of acidic anti-inflammatory active ingredient. AAPS PharmSciTech. 2005;6(3):E536-E542.
33. Kaminskas LM, Kelly BD, McLeod VM, et al. Capping methotrexate α-carboxyl groups enhances systemic exposure and retains the cytotoxicity of drug conjugated PEGylated polylysine dendrimers. Mol Pharm. 2011;8(2):338-349.
34. Kurmi BD, Gajbhiye V, Kayat J, Jain NK. Lactoferrin-conjugated dendritic nanoconstructs for lung targeting of methotrexate. J Pharm Sci. 2011;100(6):2311-2320.
35. Prajapati RN, Tekade RK, Gupta U, Gajbhiye V, Jain NK. Dendimermediated solubilization, formulation development and in vitro-in vivo assessment of piroxicam. Mol Pharm. 2009;6(3):940-950.
36. Kaminskas LM, Porter CJ. Targeting the lymphatics using dendritic polymers (dendrimers). Adv Drug Deliv Rev. 2011;63(10-11):890-900.
37. Ziemba B, Matuszko G, Bryszewska M, Klajnert B. Influence of dendrimers on red blood cells. Cell Mol Biol Lett. 2012;17(1):21-35.
38. Kawabata Y, Wada K, Nakatani M, Yamada S, Onoue S. Formulation design for poorly water-soluble drugs based on biopharmaceutics classification system: basic approaches and practical applications. Int J Pharm. 2011;420(1):1-10.
39. Gao L, Liu G, Ma J, Wang X, Zhou L, Li X. Drug nanocrystals: In vivo performances. J Control Release. 2012;160(3):418-430.
40. Chan HK, Kwok PC. Production methods for nanodrug particles using the bottom-up approach. Adv Drug Deliv Rev. 2011;63(6):406-416.
41. Jia L, Wong H, Wang Y, Garza M, Weitman SD. Carbendazim: disposition, cellular permeability, metabolite identification, and pharmacokinetic comparison with its nanoparticle. J Pharm Sci. 2003;92(1):161-172.
42. Jinno J, Kamada N, Miyake M, et al. Effect of particle size reduction on dissolution and oral absorption of a poorly water-soluble drug, cilostazol, in beagle dogs. J Control Release. 2006;111(1-2):56-64.
43. Onoue S, Takahashi H, Kawabata Y, et al. Formulation design and photochemical studies on nanocrystal solid dispersion of curcumin with improved oral bioavailability. J Pharm Sci. 2010;99(4):1871-1881.
44. Wu CY, Benet LZ. Predicting drug disposition via application of BCS: transport/absorption/elimination interplay and development of a biopharmaceutics drug disposition classification system. Pharm Res. 2005;22(1):11-23.
45. Hanafy A, Spahn-Langguth H, Vergnault G, et al. Pharmacokinetic evaluation of oral fenofibrate nanosuspensions and SLN in comparison to conventional suspensions of micronized drug. Adv Drug Deliv Rev. 2007;59(6):419-426.
46. Sylvestre JP, Tang MC, Furtos A, Leclair G, Meunier M, Leroux JC. Nanonization of megestrol acetate by laser fragmentation in aqueous milieu. J Control Release. 2011;149(3):273-280.
47. Xia D, Cui F, Piao H, et al. Effect of crystal size on the in vitro dissolution and oral absorption of nitrendipine in rats. Pharm Res. 2010;27(9): 1965-1976.
48. Onoue S, Nakamura T, Uchida A, et al. Physicochemical and biopharmaceutical characterization of amorphous solid dispersion of nobiletin, a citrus polymethoxylated flavone, with improved hepatoprotective effects. Eur J Pharm Sci. 2013;49(4):453-460.
49. Kawabata Y, Yamamoto K, Debari K, Onoue S, Yamada S. Novelcrystalline solid dispersion of tranilast with high photostability and improved oral bioavailability. Eur J Pharm Sci. 2010;39(4):256-262.
50. Onoue S, Aoki Y, Kawabata Y, et al. Development of inhalable nanocrystalline solid dispersion of tranilast for airway inflammatory diseases. J Pharm Sci. 2011;100(2):622-633.
51. Manvelian G, Daniels S, Gibofsky A. The pharmacokinetic parameters of a single dose of a novel nano-formulated, lower-dose oral diclofenac. Postgrad Med. 2012;124(1):117-123.
52. Manvelian G, Daniels S, Altman R. A phase I study evaluating the pharmacokinetic profile of a novel, proprietary, nano-formulated, lower-dose oral indomethacin. Postgrad Med. 2012;124(4):197-205.
53. Gibofsky A, Silberstein S, Argoff C, Daniels S, Jensen S, Young CL. Lower-dose diclofenac submicron particle capsules provide early and sustained acute patient pain relief in a phase 3 study. Postgrad Med. 2013;125(5):130-138.
54. Shegokar R, Müller RH. Nanocrystals: industrially feasible multifunctional formulation technology for poorly soluble actives. Int J Pharm. 2010;399(1-2):129-139.
55. Martins S, Sarmento B, Ferreira DC, Souto EB. Lipid-based colloidal carriers for peptide and protein delivery liposomes versus lipid nanoparticles. Int J Nanomedicine. 2007;2(4):595-607.
56. Larsen AT, Ohlsson AG, Polentarutti B, et al. Oral bioavailability of cinnarizine in dogs: relation to SNEDDS droplet size, drug solubility and in vitro precipitation. Eur J Pharm Sci. 2013;48(1-2):339-350.
57. Onoue S, Uchida A, Kuriyama K, et al. Novel solid self-emulsifying drug delivery system of coenzyme Q10 with improved photochemical and pharmacokinetic behaviors. Eur J Pharm Sci. 2012;46(5):492-499.
58. Strickley RG. Solubilizing excipients in oral and injectable formulations. Pharm Res. 2004;21(2):201-230.
59. Thomas N, Holm R, Müllertz A, Rades T. In vitro and in vivo performance of novel supersaturated self-nanoemulsifying drug delivery systems (super-SNEDDS). J Control Release. 2012;160(1):25-32.
60. Thomas N, Holm R, Garmer M, Karlsson JJ, Müllertz A, Rades T. Supersaturated self-nanoemulsifying drug delivery systems (Super SNEDDS) enhance the bioavailability of the poorly water-soluble drug simvastatin in dogs. AAPS J. 2013;15(1):219-227.
61. Teshima M, Fumoto S, Nishida K, et al. Prolonged blood concentration of prednisolone after intravenous injection of liposomal palmitoyl prednisolone. J Control Release. 2006;112(3):320-328.
62. Zhang L, Gu FX, Chan JM, Wang AZ, Langer RS, Farokhzad OC. Nanoparticles in medicine: therapeutic applications and developments. Clin Pharmacol Ther. 2008;83(5):761-769.
63. Tomii Y. Lipid formulation as a drug carrier for drug delivery. Curr Pharm Des. 2002;8(6):467-474.
64. Kawakami S, Yamamura K, Mukai T, et al. Sustained ocular delivery of tilisolol to rabbits after topical administration or intravitreal injection of lipophilic prodrug incorporated in liposomes. J Pharm Pharmacol. 2001;53(8):1157-1161.
65. Fetterly GJ, Straubinger RM. Pharmacokinetics of paclitaxel-containing liposomes in rats. AAPS PharmSci. 2003;5(4):E32.
66. Barenholz Y. Doxil® the first FDA-approved nano-drug: lessons learned. J Control Release. 2012;160(2):117-134.
67. Feldman EJ, Kolitz JE, Trang JM, et al. Pharmacokinetics of CPX-351; a nano-scale liposomal fixed molar ratio formulation of cytarabine: daunorubicin, in patients with advanced leukemia. Leuk Res. 2012;36(10):1283-1289.
68. Reddy LH, Sharma RK, Chuttani K, Mishra AK, Murthy RR. Etoposideincorporated tripalmitin nanoparticles with different surface charge: formulation, characterization, radiolabeling, and biodistribution studies. AAPS J. 2004;6(3):e23.
69. Manjunath K, Venkateswarlu V. Pharmacokinetics, tissue distribution and bioavailability of clozapine solid lipid nanoparticles after intravenous and intraduodenal administration. J Control Release. 2005;107(2):215-228.
70. Piao H, Kamiya N, Hirata A, Fujii T, Goto M. A novel solid-in-oil nanosuspension for transdermal delivery of diclofenac sodium. Pharm Res. 2008;25(4):896-901.
71. Zhang N, Ping Q, Huang G, Xu W, Cheng Y, Han X. Lectin-modified solid lipid nanoparticles as carriers for oral administration of insulin. Int J Pharm. 2006;327(1-2):153-159.
72. Pathak P, Nagarsenker M. Formulation and evaluation of lidocaine lipid nanosystems for dermal delivery. AAPS Pharm SciTech. 2009; 10(3):985-992.
73. Watanabe M, Kawano K, Yokoyama M, Opanasopit P, Okano T, Maitani Y. Preparation of camptothecin-loaded polymeric micelles and evaluation of their incorporation and circulation stability. Int J Pharm. 2006;308(1-2):183-189.
74. Matsumura Y, Hamaguchi T, Ura T, et al. Phase I clinical trial and pharmacokinetic evaluation of NK911, a micelle-encapsulated doxorubicin. Br J Cancer. 2004;91(10):1775-1781.
75. Kato K, Chin K, Yoshikawa T, et al. Phase II study of NK105, a paclitaxelincorporating micellar nanoparticle, for previously treated advanced or recurrent gastric cancer. Invest New Drugs. 2012;30(4):1621-1627.
76. Pepić I, Jalsenjak N, Jalsenjak I. Micellar solutions of triblock copolymer surfactants with pilocarpine. Int J Pharm. 2004;272(1-2):57-64.
77. Onoue S, Kojo Y, Suzuki H, et al. Development of novel solid dispersion of tranilast using amphiphilic block copolymer for improved oral bioavailability. Int J Pharm. 2013;452(1-2):220-226.
78. Kabanov AV, Alakhov VY. Pluronic block copolymers in drug delivery: from micellar nanocontainers to biological response modifiers. Crit Rev Ther Drug Carrier Syst. 2002;19(1):1-72.
79. Fanciullino R, Ciccolini J, Milano G. Challenges, expectations and limits for nanoparticles-based therapeutics in cancer: A focus on nano-albumin-bound drugs. Crit Rev Oncol Hematol. 2013;88(3): 504-513.
80. Mora-Huertas CE, Fessi H, Elaissari A. Polymer-based nanocapsules for drug delivery. Int J Pharm. 2010;385(1-2):113-142.
81. Morgen M, Bloom C, Beyerinck R, et al. Polymeric nanoparticles for increased oral bioavailability and rapid absorption using celecoxib as a model of a low-solubility, high-permeability drug. Pharm Res. 2012;29(2):427-440.
82. Zhang J, He C, Tang C, Yin C. Ternary polymeric nanoparticles for oral siRNA delivery. Pharm Res. 2013;30(5):1228-1239.
83. Chaturvedi K, Ganguly K, Nadagouda MN, Aminabhavi TM. Polymeric hydrogels for oral insulin delivery. J Control Release. 2013;165(2):129-138.
84. Hrkach J, Von Hoff D, Mukkaram Ali M, et al. Preclinical development and clinical translation of a PSMA-targeted docetaxel nanoparticle with a differentiated pharmacological profile. Sci Transl Med. 2012;4(128):128ra39.
85. Pandey R, Ahmad Z, Sharma S, Khuller GK. Nano-encapsulation of azole antifungals: potential applications to improve oral drug delivery. Int J Pharm. 2005;301(1-2):268-276.
86. Reddy LH, Murthy RS. Pharmacokinetics and biodistribution studies of Doxorubicin loaded poly(butyl cyanoacrylate) nanoparticles synthesized by two different techniques. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2004;148(2):161-166.
87. Onoue S, Kuriyama K, Uchida A, Mizumoto T, Yamada S. Inhalable sustained-release formulation of glucagon: in vitro amyloidogenic and inhalation properties, and in vivo absorption and bioactivity. Pharm Res. 2011;28(5):1157-1166.
88. Sharma A, Sharma S, Khuller GK. Lectin-functionalized poly (lactide-co-glycolide) nanoparticles as oral/aerosolized antitubercular drug carriers for treatment of tuberculosis. J Antimicrob Chemother. 2004;54(4):761-766.
89. Wilczewska AZ, Niemirowicz K, Markiewicz KH, Car H. Nanoparticles as drug delivery systems. Pharmacol Rep. 2012;64(5):1020-1037.
90. Uchegbu IF, Siew A. Nanomedicines and nanodiagnostics come of age. J Pharm Sci. 2013;102(2):305-310.