Freeze-dried formulation of lipid nanoparticles, preparation method therefor, and use thereof
By optimizing the lyophilized formulation and using a specific combination of ionizable lipids, sucrose, and buffer solutions, the issues of nucleic acid vaccine stability and the complexity of lyophilized formulations were resolved, achieving long-term storage and efficient mRNA delivery at room temperature.
WO2026124214A1PCT designated stage Publication Date: 2026-06-18RONGCAN (SHANGHAI) BIOTECH CO LTD
Patent Information
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- RONGCAN (SHANGHAI) BIOTECH CO LTD
- Filing Date
- 2025-11-26
- Publication Date
- 2026-06-18
Smart Images
Figure PCTCN2025137724-FTAPPB-I100001 
Figure PCTCN2025137724-FTAPPB-I100002 
Figure PCTCN2025137724-FTAPPB-I100003
Abstract
The present invention relates to the technical field of drug delivery and particularly to a freeze-dried formulation of lipid nanoparticles, a preparation method therefor, and use thereof. In the present invention, suitable freeze-dried formulation formulas, including freeze-drying protectant types and concentrations, buffer types and concentrations, and lipid nanoparticle formulas, are screened to obtain a freeze-dried formulation of lipid nanoparticles that comprises 10%-20% w / v sucrose as a single-component freeze-drying protectant, a 1-20 mM Tris or HEPES buffer as a buffer system, and a specific ionizable lipid. The freeze-dried formulation is simple to prepare and still retains excellent physicochemical properties and in vivo transfection efficiency after reconstitution, demonstrating good prospects in the development and application of nucleic acid drugs.
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