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Hexahistidine-metal assembly encapsulated fibroblast growth factor 21 for lipopolysaccharide-induced acute lung injury.

European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V2025-01-28PubMed
Total: 69.0Innovation: 8Impact: 6Rigor: 6Citation: 8

Summary

A pH-responsive hexahistidine-metal nano-assembly encapsulating FGF21 achieved high loading and stability and outperformed free FGF21 in LPS-induced ALI, decreasing edema (wet/dry ratio), BALF protein, and cell counts via both airway and intravenous delivery. This platform addresses key translational barriers for FGF21 in ARDS/ALI.

Key Findings

  • HmA@FGF21 achieved >90% entrapment efficiency and >35% loading capacity with ~130 nm size, PDI ~0.28, and +24 mV zeta potential.
  • In LPS-induced ALI, HmA@FGF21 reduced lung wet/dry ratio, BALF total protein, and total cell counts versus free FGF21.
  • Therapeutic benefit was observed with both airway and intravenous administration routes.

Clinical Implications

Preclinical only; no immediate practice change. If safety and efficacy translate, targeted FGF21 delivery could become an adjunctive therapy for ALI/ARDS.

Why It Matters

Introduces a generalizable pulmonary delivery platform that enhances efficacy of a promising biologic (FGF21) across routes, potentially enabling translational advancement in ARDS therapeutics.

Limitations

  • Preclinical LPS model only; lack of infection- or ventilation-related ARDS models.
  • No data on pharmacokinetics, immunogenicity, or long-term safety.

Future Directions

Evaluate in infectious and ventilator-induced ARDS models, perform PK/toxicity studies, dose optimization, and assess scalability and manufacturability.

Study Information

Study Type
Case-control
Research Domain
Treatment
Evidence Level
V - Preclinical animal experiment comparing treated versus control groups; no human data.
Study Design
OTHER