Rational development of a stable liquid formulation for nanomedicine products

Tőke, Enikő R.; Lőrincz, Orsolya; Somogyi, E; Lisziewicz, Julianna

doi:10.1016/j.ijpharm.2010.03.048

Cited by 40 publications

(38 citation statements)

References 25 publications

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“…A significant difference in the bio-physical properties between such corona-covered NPs and those of the formulated pristine particle during manufacturing is observed (17,36,37,46,51,52). Ccientist and eventually regulators therefore consider (bio) molecule-coated NMs as novel materials with different properties compared to the pristine nanomaterials during production (17,36).…”

Section: Factors Influencing Nm-corona Composition -Fate and -Toxicitymentioning

confidence: 99%

The bio-corona and its impact on nanomaterial toxicity

Westmeier

Chen²,

Stauber

et al. 2015

European Journal of Nanomedicine

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Abstract:The rapidly growing application of nanosized materials and nano-scaled processes will result in increased exposure of humans and the environment. The small size of nanomaterials (NM) comparable with molecular building blocks of cells raises concerns that their toxic potential cannot be extrapolated from studies of larger particles due to their unique physico-chemical properties. These properties are also responsible that NM rapidly adsorb various (bio)molecules when introduced into complex physiological or natural environments. As the thus formed protein/biomolecule 'corona' seems to affect the NM' in situ identity, an understanding of its toxicological relevance and the biophysical forces regulating corona formation is needed but not yet achieved. This review introduces our current concept of corona formation and evolution and present analytical methods for corona profiling. We discuss toxicity mechanisms potentially affected by the biomolecule corona, including NM cellular uptake and impact on components of the blood system. Further, we comment on pending knowledge gaps and challenges, which need to be resolved by the field. We conclude by presenting a tiered systems biology-driven approach recommended to mechanistically understand the coronas' nanotoxicological relevance and predictive potential.

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Section: Factors Influencing Nm-corona Composition -Fate and -Toxicitymentioning

confidence: 99%

The bio-corona and its impact on nanomaterial toxicity

Westmeier

Chen²,

Stauber

et al. 2015

European Journal of Nanomedicine

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“…DermaVir nanomedicine composed from the pDNA core that is covered by a synthetic polymer, a mannobyosilated polyethylenimine-mannobiose (PEIm) (33,34) . DermaVir NP not only looks like as a virus but also functions as a virus: it enters cells via receptor-mediated endocytosis, escapes from endosome and delivers the pDNA to the nucleus.…”

Section: Pathogen-like Features Of Dermavir Nanomedicinementioning

confidence: 99%

“…By fi ne-tuning the ionic properties of the formulation we can control the intracellular traffi cking and biological activity of the NP: setting the optimal pH and ionic strength of the nanomedicine solution during the manufacturing processes makes us able to control the biological activity of pDNA/PEIm nanomedicines (33,34) . …”

Section: Controlling the Biological Activity Of Dermavir During The Mmentioning

confidence: 99%

HIV-specific immunotherapy with DermaVir, the first pDNA/PEIm pathogen-like nanomedicine

Lisziewicz¹,

Lőrincz²

2012

European Journal of Nanomedicine

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Eradication of HIV requires the clearance of latently infected cells that remained in the reservoirs after highly active antiretroviral therapy (HAART). DermaVir is the fi rst nanomedicine that induces long-lasting cytotoxic T cells (CTL) capable to kill these HIV-infected cells. DermaVir is a synthetic " pathogen-like " nanomedicine mimicking the size, shape, surface properties, cellular entry, endosomal escape, and antigen expression features of pathogens (e.g., viruses). We can optimize the biological activity of DermaVir during the manufacturing processes by controlling the physico-chemical properties of the nanoparticles that infl uence its structure and intracellular mode-of-action. In the clinic, targeted delivery of DermaVir to epidermal Langerhans cells is achieved with the DermaPrep medical device. Three clinical trials consistently demonstrated long-lasting CTL induced by DermaVir in HIV-infected people and killing of HIV-infected cells compared to Placebo. Since HAART and DermaVir are complementary, we envision that their combination might be suitable to achieve the cure: HAART to potent viral load suppression and DermaVir to kill latently infected cells that get activated to produce HIV.

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“…To maintain potent biological activity and achieve stability we investigated the components alone and also the system together, we found the optimum of the crucial parameters, extended their specification and developed a stable, liquid formulation with the same biological activity as the fresh control after storage of 8 weeks at 4°C and 3 weeks at 37°C. 40 Parallel the liquid formulation we were also working on a two-vial formulation stored at -20°C, where after thawing the two vials can be simply mixed together. This formulation bears 1 year stability and unlike the old one, needs no special storage (-80°C), or clinical pharmacist for preparation, a nurse can easily mix the two solutions.…”

Section: A Dermavir Nanorészecske Szerkezetementioning

confidence: 99%

“…38,39 Mind a lineáris, mind az elágazó láncú PEI képes megvédeni a pDNS-t az enzimatikus és egyéb biokémiai támadásoktól, köztük a sejtbe való bejutást követően az endoszóma alacsony pHjától. 40,41,42 A nem protonált nitrogének ugyanis képesek pufferelni a protonpumpák hatását. Ezt a tulajdonságot nevezzük proton-spongya jelenségnek.…”

Rational development of a stable liquid formulation for nanomedicine products

Cited by 40 publications

References 25 publications

The bio-corona and its impact on nanomaterial toxicity

The bio-corona and its impact on nanomaterial toxicity

HIV-specific immunotherapy with DermaVir, the first pDNA/PEIm pathogen-like nanomedicine

Plazmid DNS-alapú nanomedicína formuláció fejlesztése

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