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Cited by 42Nanoparticle-Based Drug DeliveryDrug Solubulity and Delivery SystemsAdvanced Drug Delivery Systems

A comparison of two biorelevant in vitro drug release methods for nanotherapeutics based on advanced physiologically-based pharmacokinetic modelling

Jung, Fabian, Nothnagel, Lisa, Gao, Fiona, Thurn, Manuela, Vogel, Vitali, Wacker, Matthias G.·2018·European Journal of Pharmaceutics and Biopharmaceutics
DOI 10.1016/j.ejpb.2018.03.010
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Abstract

As a growing number of nanotherapeutics enters the market, improved analytical techniques for measuring the drug release are required. Biorelevant release tests have become a standard in the prediction of in vivo pharmacokinetics but also in quality control of novel dosage forms. In the present study, two methods for testing the drug release from nanocarriers, namely the filtration technique and the dispersion releaser technology, have been investigated. Initially, the in vitro release rates were determined using two different biorelevant media. Additionally, the effect of each method on a simulated in vivo pharmacokinetic profile was studied using advanced PBPK modelling. The two methods resulted in slightly different release profiles. Applying the filtration method, an early plateau of 91.0 ± 5.3% was reached at the first sampling time point. In comparison, the release rate steadily increased to a maximum of 100.9 ± 4.1% when the dispersion releaser technology was used. Sensitivity analysis revealed how these differences translated into the PBPK-based simulation. A change in the total dissolution rate of 10% resulted in c max values of +1.6% and -11.0%, respectively, when using input data obtained with the dispersion releaser. Data obtained by filtration translated into c max values of ±1.8%.

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Crossref · 10.1016/j.ejpb.2018.03.010

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38 of 38 references verified0 citation errors · 0 not checkable

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  • The external medium loaded with 45 mg/l BSA remarkably increases the release of ellipticine in comparison to the same medium without the protein, confirming the strong impact of protein-drug interactions on the release profile.

    “The external medium loaded with 45 mg/l BSA remarkably increases the release of the drug in comparison to the same medium without the protein, thus confirming the strong impact of protein-drug interactions on the release profile.”

    From Polymeric micelles in drug delivery: An insight of the techniques for their characterization and assessment in biorelevant conditions (2021) · cites this paper as [127]

  • Liu et al. studied the release of ellipticine from MePEG-b-PBTMC micelles in the absence and presence of bovine serum albumin at 37°C to assess the influence of serum protein on the drug release profile.

    “For instance, Liu et al. [127] studied the release of an anticancer drug, ellipticine, from micelles composed of (polyethylene glycol)-b-poly (5-benzyloxy-trimethylene carbonate; MePEG-b-PBTMC 5000-b-4800) (MePEG-b-PBTMC) in the absence and presence of bovine serum albumin (BSA) at 37 • C to assess the influence of serum protein on the drug release profile.”

    From Polymeric micelles in drug delivery: An insight of the techniques for their characterization and assessment in biorelevant conditions (2021) · cites this paper as [127]

  • Liu et al. studied interactions between micelles and different plasma proteins using AF4 coupled with fluorescence and DLS and obtained strong indications for their stability or instability in vivo; the behavior of micelles in vivo in the bloodstream was in line with the in vitro stability.

    “Liu et al. [127] studied the interactions between micelles and different plasma proteins by using AF4 coupled with fluorescence and DLS and obtained strong indications for their stability or instability in vivo.Indeed, the behavior of micelles in vivo in the bloodstream resulted very well in line with the in vitro stability.”

    From Polymeric micelles in drug delivery: An insight of the techniques for their characterization and assessment in biorelevant conditions (2021) · cites this paper as [127]

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Authors
Jung, F., Nothnagel, L., Gao, F., Thurn, M., Vogel, V., & Wacker, M. G.
Affiliations
  • Fraunhofer Institute for Molecular Biology and Applied Ecology (DE)
  • Goethe University Frankfurt (DE)
Corresponding author
Wacker, Matthias G.
ORCID
Venue
European Journal of Pharmaceutics and Biopharmaceutics
Publisher
Elsevier BV
Published
2018-06
Volume
127
Pages
462-470
ISSN
0939-6411 (ISSN-L)
DOI
10.1016/j.ejpb.2018.03.010
OpenAlex
W2794956428
Cited by
42
References
38
Citations by year
2026: 1 · 2025: 3 · 2024: 4 · 2023: 3 · 2022: 7 · 2021: 8 · 2020: 7 · 2019: 3 · 2018: 6
FWCI
1.94
Type
journal article
Language
en
Open access
closed
Licence
Locations
  • European Journal of Pharmaceutics and Biopharmaceutics (publishedVersion)
  • PubMed (publishedVersion)
  • Publikationsdatenbank der Fraunhofer-Gesellschaft (Fraunhofer-Gesellschaft) (submittedVersion)
  • Fraunhofer-Publica (Fraunhofer-Gesellschaft) (submittedVersion)
Funders
  • Deutsche Bundesstiftung Umwelt (AZ 32725-31)
  • Bundesministerium für Bildung und Forschung (16GW0057K)
Topics
  • Physical Sciences › Materials Science › Biomaterials › Nanoparticle-Based Drug Delivery
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmaceutical Science › Drug Solubulity and Delivery Systems
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmaceutical Science › Advanced Drug Delivery Systems
Keywords
nanotherapeutics, nanocarriers, drug release testing, physiologically based pharmacokinetic modelling, in vitro-in vivo correlation, dissolution rate, sensitivity analysis
MeSH terms
Computer Simulation, Dosage Forms, Flurbiprofen, Humans, Models, Biological, Solubility, Tablets, Nanoparticles, Drug Liberation

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