ArticleAdvanced therapeutics2020
Stable Monomeric Insulin Formulations Enabled by Supramolecular PEGylation of Insulin Analogues.
Article in Advanced therapeutics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
17 citing papers in PubMed.
- Synthesis and Characterisation of Bioactive Fluorescent FITC-Insulin Glulisine Conjugates for Potential Use in Insulin Delivery.Pharmaceutics · 2026Article
- Traceless linkers used for reversible protein-polymer conjugations.Chemical science · 2026Review
- Hydrophilic Poly(Iminopyridinium Ylide)s: Defining a New Chemical Space for Poly(ylide)s.Macromolecular rapid communications · 2026Article
- Peptides from Animal Venoms: A Promising Frontier in Diabetes Therapy via Multi-Target Mechanisms.Pharmaceuticals (Basel, Switzerland) · 2025Review
- Programmable Host-Guest Recognition for Shape-Shifting Supramolecular Nanostructure States.ACS nano · 2025Article
- Zinc in Dermatology: Exploring Its Emerging Role in Enhancing Botulinum Toxin Formulations and Clinical Efficacy.Current issues in molecular biology · 2024Review
- Structural modulation of insulin by hydrophobic and hydrophilic molecules.RSC advances · 2023Article
- Deep Eutectic Solvents for Subcutaneous Delivery of Protein Therapeutics.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2023Article
- Formulation Excipients and Their Role in Insulin Stability and Association State in Formulation.Pharmaceutical research · 2022Article
- Poly(trehalose methacrylate) as an Excipient for Insulin Stabilization: Mechanism and Safety.ACS applied materials & interfaces · 2022Article
- Ultra-Fast Insulin-Pramlintide Co-Formulation for Improved Glucose Management in Diabetic Rats.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2021Article
- Self-Assembled, Dilution-Responsive Hydrogels for Enhanced Thermal Stability of Insulin Biopharmaceuticals.ACS biomaterials science & engineering · 2021Article
- Engineering Insulin Cold Chain Resilience to Improve Global Access.Biomacromolecules · 2021Article
- Affinity-Directed Dynamics of Host-Guest Motifs for Pharmacokinetic ModulationBiomacromolecules · 2021Article
- Engineering biopharmaceutical formulations to improve diabetes management.Science translational medicine · 2021Review
- An ultrafast insulin formulation enabled by high-throughput screening of engineered polymeric excipients.Science translational medicine · 2020Article
- A co-formulation of supramolecularly stabilized insulin and pramlintide enhances mealtime glucagon suppression in diabetic pigs.Nature biomedical engineering · 2020Article
Corrections and comments
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Authors and funding
7 authors.
Funding
Abstract
Current "fast-acting" insulin analogues contain amino acid modifications meant to inhibit dimer formation and shift the equilibrium of association states toward the monomeric state. However, the insulin monomer is highly unstable and current formulation techniques require insulin to primarily exist as hexamers to prevent aggregation into inactive and immunogenic amyloids. Insulin formulation excipients have thus been traditionally selected to promote insulin association into the hexameric form to enhance formulation stability. This study exploits a novel excipient for the supramolecular PEGylation of insulin analogues, including aspart and lispro, to enhance the stability and maximize the prevalence of insulin monomers in formulation. Using multiple techniques, it is demonstrated that judicious choice of formulation excipients (tonicity agents and parenteral preservatives) enables insulin analogue formulations with 70-80% monomer and supramolecular PEGylation imbued stability under stressed aging for over 100 h without altering the insulin association state. Comparatively, commercial "fast-acting" formulations contain less than 1% monomer and remain stable for only 10 h under the same stressed aging conditions. This simple and effective formulation approach shows promise for next-generation ultrafast insulin formulations with a short duration of action that can reduce the risk of post-prandial hypoglycemia in the treatment of diabetes.
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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.