US20250281418
2025-09-11
Human necessities
A61K9/5123
Lipid nanoparticle formulations encapsulating nucleic acids have been developed to improve the delivery of messenger RNA (mRNA) for pharmaceutical applications. These formulations address issues like instability, immune response activation, and degradation, which hinder the effectiveness of mRNA therapies. The invention provides methods to synthesize these lipid nanoparticles (LNPs) with enhanced stability and efficacy.
The lipid nanoparticle composition includes a mix of lipids such as PEG-lipids, ionizable lipids, phospholipids, and structural lipids. Specifically, the method involves mixing a lipid solution with an aqueous buffer to form a precursor nanoparticle, followed by the addition of a lipid nanoparticle modifier. This process allows for the encapsulation of nucleic acids like mRNA within the LNPs.
The synthesis method involves varying the concentration of PEG-lipids and other components in multiple steps to achieve desired properties. The process may include turbulent, vortex, or microfluidic mixing techniques. The resulting nanoparticles demonstrate improved biophysical properties and stability at various temperatures, including room temperature.
The lipid solution comprises specific molar percentages of PEG-lipids and other lipids, such as DSPC and cholesterol. Different compounds are utilized as ionizable lipids, each contributing to the nanoparticle's structure and function. The formulations ensure that the encapsulated nucleic acids remain stable over extended periods.
These advanced LNP formulations hold potential for various pharmaceutical applications, including therapeutics and vaccines. By enhancing the delivery and stability of mRNA, these nanoparticles could improve treatment outcomes for diseases that require precise genetic interventions.