ArticleThe AAPS journal2017
Comparison of NMR and Dynamic Light Scattering for Measuring Diffusion Coefficients of Formulated Insulin: Implications for Particle Size Distribution Measurements in Drug Products.
Article in The AAPS journal, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
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Who cites it
31 citing papers in PubMed, 61 citations in OpenAlex.
- Mechanics of small intestine motility for oral macromolecular delivery: modelling segmentation versus peristalsis.Drug delivery · 2026Article
- Insulin Encapsulation in a Chitosan-Alginate Matrix and In Vitro Release.Bioengineering (Basel, Switzerland) · 2026Article
- Simple Hydrodynamic Molecular Weight Model for Rapid Assessment of Therapeutic Protein Oligomerization States in Formulation.The AAPS journal · 2026Article
- Methyl Proton Spin Relaxation (Analytical chemistry · 2026Article
- The C-terminal Domain of SARS-CoV-2 nsp8 is a Molten Globule in the Absence of Binding Partners.Journal of molecular biology · 2025Article
- Impact of structure and formulation changes on the function of insulin products.Frontiers in endocrinology · 2025Review
- Higher Order Structure Differences Among Insulin Crystalline Drugs Revealed by 2D heteronuclear NMR.ChemMedChem · 2024Article
- Intact NMR Approach Quickly Reveals Synchronized Microstructural Changes in Oil-in-Water Nanoemulsion Formulations.The AAPS journal · 2024Article
- Advancements in Characterization Techniques for Microemulsions: From Molecular Insights to Macroscopic Phenomena.Molecules (Basel, Switzerland) · 2024Review
- Review
- Detection of insulin oligomeric forms by a novel surface plasmon resonance-diffusion coefficient based approach.Protein science : a publication of the Protein Society · 2024Article
- Conjugated Polymer Composite Nanoparticles Augmenting Photosynthesis-Based Light-Triggered Hydrogel Promotes Chronic Wound Healing.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2024Article
- Direct Assessment of Oligomerization of Chemically Modified Peptides and Proteins in Formulations using DLS and DOSY-NMR.Pharmaceutical research · 2023Article
- Best Practices for Submission of NMR Data to Support Higher Order Structure Assessment of Generic Peptide Drugs.The AAPS journal · 2023Article
- Discrete, Chiral Polymer-Insulin Conjugates.Journal of the American Chemical Society · 2022Article
- Analytical Similarity Assessment of Biosimilars: Global Regulatory Landscape, Recent Studies and Major Advancements in Orthogonal Platforms.Frontiers in bioengineering and biotechnology · 2022Review
- A fluorescence sandwich immunoassay for the real-time continuous detection of glucose and insulin in live animals.Nature biomedical engineering · 2021Article
- Sedimentation Velocity Analytical Ultracentrifugation Analysis of Marketed Rituximab Drug Product Size Distribution.Pharmaceutical research · 2020Article
- An ultrafast insulin formulation enabled by high-throughput screening of engineered polymeric excipients.Science translational medicine · 2020Article
- An NMR-Based Similarity Metric for Higher Order Structure Quality Assessment Among U.S. Marketed Insulin Therapeutics.Journal of pharmaceutical sciences · 2020Article
Corrections and comments
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Authors and funding
3 authors at 1 institution in 1 country.
Funding
Abstract
Particle size distribution, a measurable physicochemical quantity, is a critical quality attribute of drug products that needs to be controlled in drug manufacturing. The non-invasive methods of dynamic light scattering (DLS) and Diffusion Ordered SpectroscopY (DOSY) NMR can be used to measure diffusion coefficient and derive the corresponding hydrodynamic radius. However, little is known about their use and sensitivity as analytical tools for particle size measurement of formulated protein therapeutics. Here, DLS and DOSY-NMR methods are shown to be orthogonal and yield identical diffusion coefficient results for a homogenous monomeric protein standard, ribonuclease A. However, different diffusion coefficients were observed for five insulin drug products measured using the two methods. DOSY-NMR yielded an averaged diffusion coefficient among fast exchanging insulin oligomers, ranging between dimer and hexamer in size. By contrast, DLS showed several distinct species, including dimer, hexamer, dodecamer and other aggregates. The heterogeneity or polydisperse nature of insulin oligomers in formulation caused DOSY-NMR and DLS results to differ from each other. DLS measurements provided more quality attributes and higher sensitivity to larger aggregates than DOSY-NMR. Nevertheless, each method was sensitive to a different range of particle sizes and complemented each other. The application of both methods increases the assurance of complex drug quality in this similarity comparison.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.