Untitled

Harashima, Hideyoshi; Komatsu, Shintaro; Kojima, Soichi; Yanagi, Chieko; Morioka, Yushi; Naito, Makoto; Kojima, Hiroshi

doi:10.1023/a:1016058724452

Cited by 27 publications

(4 citation statements)

References 14 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The influences of these anatomical differences on the intrahepatic distribution and hepatobiliary clearance of nanomaterials between species has not be studied in depth. Reports on the species dependent hepatic uptake of liposomes in mice, rats, and rabbits noted that liposome uptake in rats was dependent on specific plasma opsonins whereas mice exhibited opsonin independent uptake 81, 82. Although, species specificity has also been reported in the activity of particular opsonins against liposomes too 82.…”

Section: Extrapolating Nanomaterials Pharmacokinetics From Preclinicalmentioning

confidence: 99%

“…Although, species specificity has also been reported in the activity of particular opsonins against liposomes too 82. No significant differences have been observed in the density of Kupffer cells in mouse, rat, and rabbit livers 81. More multispecies data, specifically in nonrodent species and humans, are needed in order to conclude which preclinical animal models can best recreate nanomaterial intrahepatic distribution, hepatobiliary clearance profiles, and hepatotoxicity in humans.…”

Section: Extrapolating Nanomaterials Pharmacokinetics From Preclinicalmentioning

confidence: 99%

“…PBPK-based modelling efforts for nanomaterial tumour uptake have traditionally focused on simulating anticancer drug release kinetics into the tumour interstitium or tumour cells. The approaches described so far have ranged in complexity from simple single tumour compartment representations 111, 112 to intricate tumour structures subdivided into vascular, interstitial, and cellular sub-compartments (Figure 6A) 81, 113. The advantages of complex PBPK tumour models are the mechanistic insights they can provide regarding the distribution of nanomaterials in tumours and their overall therapeutic efficacy.…”

Section: Mechanistic Modelling Of Nanomaterials Disposition and Pharmamentioning

confidence: 99%

See 2 more Smart Citations

Research tools for extrapolating the disposition and pharmacokinetics of nanomaterials from preclinical animals to humans

Valic¹,

Zheng²

2019

Theranostics

View full text Add to dashboard Cite

A critical step in the translational science of nanomaterials from preclinical animal studies to humans is the comprehensive investigation of their disposition (or ADME) and pharmacokinetic behaviours. Disposition and pharmacokinetic data are ideally collected in different animal species (rodent and nonrodent), at different dose levels, and following multiple administrations. These data are used to assess the systemic exposure and effect to nanomaterials, primary determinants of their potential toxicity and therapeutic efficacy. At toxic doses in animal models, pharmacokinetic (termed toxicokinetic) data are related to toxicologic findings that inform the design of nonclinical toxicity studies and contribute to the determination of the maximum recommended starting dose in clinical phase 1 trials. Nanomaterials present a unique challenge for disposition and pharmacokinetic investigations owing to their prolonged circulation times, nonlinear pharmacokinetic profiles, and their extensive distribution into tissues. Predictive relationships between nanomaterial physicochemical properties and behaviours in vivo are lacking and are confounded by anatomical, physiological, and immunological differences amongst preclinical animal models and humans. These challenges are poorly understood and frequently overlooked by investigators, leading to inaccurate assumptions of disposition, pharmacokinetic, and toxicokinetics profiles across species that can have profoundly detrimental impacts for nonclinical toxicity studies and clinical phase 1 trials. Herein are highlighted two research tools for analysing and interpreting disposition and pharmacokinetic data from multiple species and for extrapolating this data accurately in humans. Empirical methodologies and mechanistic mathematical modelling approaches are discussed with emphasis placed on important considerations and caveats for representing nanomaterials, such as the importance of integrating physiological variables associated with the mononuclear phagocyte system (MPS) into extrapolation methods for nanomaterials. The application of these tools will be examined in recent examples of investigational and clinically approved nanomaterials. Finally, strategies for applying these extrapolation tools in a complementary manner to perform dose predictions and in silico toxicity assessments in humans will be explained. A greater familiarity with the available tools and prior experiences of extrapolating nanomaterial disposition and pharmacokinetics from preclinical animal models to humans will hopefully result in a more straightforward roadmap for the clinical translation of promising nanomaterials.

show abstract

Section: Extrapolating Nanomaterials Pharmacokinetics From Preclinicalmentioning

confidence: 99%

Section: Extrapolating Nanomaterials Pharmacokinetics From Preclinicalmentioning

confidence: 99%

Section: Mechanistic Modelling Of Nanomaterials Disposition and Pharmamentioning

confidence: 99%

See 1 more Smart Citation

Research tools for extrapolating the disposition and pharmacokinetics of nanomaterials from preclinical animals to humans

Valic¹,

Zheng²

2019

Theranostics

View full text Add to dashboard Cite

show abstract

“…The half-lives (T 1/2 s) of the NIRF signals were 3.25 h and 4.73 h when the ICG-CNPs were injected into the mice and rabbits, respectively ( Figure 3 a,b). This is because smaller animals have faster clearance per body weight [ 42 ]. Compared to the NIRF signals at 1 min, further 11.2% and 25.8% increases in the NIRF signals were observed in the mouse and rabbit sera at 96 h post injection, respectively.…”

Section: Resultsmentioning

confidence: 99%

Tumor-Targeting Glycol Chitosan Nanoparticles for Image-Guided Surgery of Rabbit Orthotopic VX2 Lung Cancer

Rho

Yoon

et al. 2020

Pharmaceutics

View full text Add to dashboard Cite

Theranostic nanoparticles can deliver therapeutic agents as well as diverse imaging agents to tumors. The enhanced permeation and retention (EPR) effect is regarded as a crucial mechanism for the tumor-targeted delivery of nanoparticles. Although a large number of studies of the EPR effect of theranostic nanoparticles have been performed, the effect of the change in the body size of the host on the EPR effect is not fully understood. In this regard, comparative research is needed on the behavior of nanoparticles in large animals for developing the nanoparticles to the clinical stage. In this study, we prepared fluorophore (indocyanine green (ICG) or cyanine 5.5 (Cy5.5))–conjugated glycol chitosan nanoparticles (CNPs) for comparing the tumor-targeting efficacy in VX2 tumor-bearing mouse and rabbit models. As expected, the CNPs formed nano-sized spherical nanoparticles and were stable for 8 days under aqueous conditions. The CNPs also exhibited dose-dependent cellular uptake into VX2 tumor cells without cytotoxicity. The half-life of the near-infrared fluorescence (NIRF) signals in the blood were 3.25 h and 4.73 h when the CNPs were injected into mice and rabbits, respectively. Importantly, the CNPs showed excellent tumor accumulation and prolonged biodistribution profiles in both the VX2 tumor-bearing mouse and rabbit models, wherein the tumor accumulation was maximized at 48 h and 72 h, respectively. Based on the excellent tumor accumulation of the CNPs, finally, the CNPs were used in the image-guided surgery of the rabbit orthotopic VX2 lung tumor model. The lung tumor tissue was successfully removed based on the NIRF signal from the CNPs in the tumor tissue. This study shows that CNPs can be potentially used for tumor theragnosis in small animals and large animals.

show abstract

Pharmacokinetics of CPX-351 (Cytarabine/Daunorubicin HCl) Liposome injection in the mouse

Bayne¹,

Mayer

Swenson³

2009

Journal of Pharmaceutical Sciences

View full text Add to dashboard Cite

Untitled

Abstract: These quantitative and qualitative information on the species difference of liposome disposition will provide an useful information for constructing a drug delivery system using liposomes.

Cited by 27 publications

References 14 publications

Research tools for extrapolating the disposition and pharmacokinetics of nanomaterials from preclinical animals to humans

Research tools for extrapolating the disposition and pharmacokinetics of nanomaterials from preclinical animals to humans

Tumor-Targeting Glycol Chitosan Nanoparticles for Image-Guided Surgery of Rabbit Orthotopic VX2 Lung Cancer

Pharmacokinetics of CPX-351 (Cytarabine/Daunorubicin HCl) Liposome injection in the mouse

Contact Info

Product

Resources

About