How to Build Tiny Lipid Capsules to Deliver Genetic Medicines
A precise method for creating small, stable lipid bubbles that safely carry genetic material like siRNA into cells for medical treatment.
Patent Number
US 10155945
Status
Active
Filing Date
February 10, 2017
Grant Date
December 18, 2018
Expiration
February 10, 2037
Claims
24
Assignee
Nitto Denko Corp
Inventors
Richard P. Witte, Priya Karmali, Violetta Akopian, Victor Knopov, Robin Lee, David Webb
Citations
10 forward · 37 backward
What it covers
This patent describes a batch-processing method for creating lipid nanoparticles (LNPs) that act as microscopic delivery vehicles for genetic drugs. The process involves mixing an organic solvent containing specific lipids—including cationic lipids, helper lipids, and PEG lipids—with an aqueous solution containing the therapeutic nucleic acid. By carefully controlling the injection, dilution, and solvent removal steps, the method ensures the resulting particles are uniform in size (50-150 nm) and stable. This is critical because if the particles are too large or clump together, they cannot effectively enter cells to deliver their genetic payload.
What it doesn't cover
- —Does not cover continuous-flow manufacturing processes, as the claim specifically requires batchwise production.
- —Does not cover the synthesis of the specific lipid molecules themselves, only the method of assembling them into nanoparticles.
- —Does not cover non-lipid delivery vehicles, such as viral vectors or polymer-only nanoparticles.
- —Does not cover particles that fall outside the specified 50 to 150 nm size range or those with a polydispersity index of 0.2 or higher.
The clever bit
The process uses a specific sequence of solvent dilution and stirring to prevent the lipids from aggregating, ensuring the final particles remain small and uniform without needing complex microfluidic hardware.
Why it matters
Lipid nanoparticles are the backbone of modern mRNA and siRNA therapies. This patent provides a specific recipe for ensuring these particles are consistent and stable, which is a major hurdle in pharmaceutical manufacturing. Reliable production methods are essential for moving genetic medicines from the lab to large-scale clinical use.
Real-world examples
- 1.siRNA drug delivery systems
- 2.mRNA-based therapeutic formulations
- 3.Targeted gene therapy carriers
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US 10155945 · 2026