Dried nanoparticle compositions
Inventors
Reed, Steven Gregory • Khandhar, Amit Praful • Carter, Darrick Albert
Assignees
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Publication Number
US-12233160-B2
Publication Date
2025-02-25
Expiration Date
Abstract
Provided herein are dried compositions and methods for preparing such compositions for use in delivery of a nucleic acid to a subject. The dried composition may comprise a lipid carrier, wherein the lipid carrier is a nanoemulsion comprising a hydrophobic core, optionally one or more inorganic nanoparticles and one or more lipids, one or more nucleic acid, and at least one cryoprotectant. Methods of using these dried compositions for treatment are also provided.
Core Innovation
The invention relates to a dried composition that includes a lipid carrier configured as a nanoemulsion with a hydrophobic core and one or more lipids. The hydrophobic core comprises one or more inorganic nanoparticles, including magnetite (Fe3O4), maghemite (γ-Fe2O3), wüstite (FeO), hematite (α-Fe2O3), or combinations thereof. The dried composition optionally includes one or more nucleic acids and includes at least one sugar present at about 80% to about 98% by weight of the composition.
The disclosed compositions address dried nanoparticle/nucleic acid formulations that retain formulation integrity while providing an effective carrier structure with inorganic nanoparticles within a nanoemulsion lipid carrier. The material also emphasizes high sugar content to support the dried state. The dried formulations can be provided in lyophilized form.
Additional refinements disclosed in the claims specify selected oil and surfactant components, optionally iron oxide, with quantitative ranges for sugar content and optional constraints for nucleic acid amount and lipid concentration. The compositions can include lipid carrier–nucleic acid complexes and define nanoemulsion size characteristics such as z-average hydrodynamic diameter and polydispersity index.
Claims Coverage
The provided claim set includes three independent claims. Across these independent claims, the main inventive theme is a dried nanoemulsion lipid carrier containing inorganic nanoparticles, including specified iron oxide forms, together with optional nucleic acids and a high level of sugar (80–98% by weight), with additional quantitative constraints for sugar amount, nucleic acid amount, cationic lipid concentration, and, for one claim, specific hydrophobic-core excipient concentrations.
Dried nanoemulsion lipid carrier with inorganic nanoparticles, optional nucleic acids, and high sugar content
A dried composition comprising a lipid carrier as a nanoemulsion having a hydrophobic core with one or more inorganic nanoparticles comprising magnetite (Fe3O4), maghemite (γ-Fe2O3), wüstite (FeO), hematite (α-Fe2O3), or combinations thereof; optionally one or more nucleic acids; and at least one sugar present in an amount by weight of 80% to 98%.
High-sugar dried composition with nanoemulsion lipid carrier and minimum sugar amount
A dried composition comprising a lipid carrier as a nanoemulsion having a hydrophobic core and one or more lipids; optionally one or more nucleic acids; and at least one sugar present in an amount by weight of 80% to 98%, wherein the at least one sugar is present in an amount of at least about 50 mg.
Dried nanoemulsion with specified squalene, sorbitan monostearate, and polysorbate 80 hydrophobic core components
A dried composition comprising a lipid carrier as a nanoemulsion having a hydrophobic core comprising squalene, sorbitan monostearate, and polysorbate 80, and optionally iron oxide; one or more nucleic acids; and at least one sugar in an amount by weight of 80% to 98%, with further constraints on nucleic acid amount, cationic lipid concentration, and sucrose amount.
Together, the independent claims cover dried compositions where a nanoemulsion lipid carrier contains inorganic nanoparticles in a hydrophobic core, optionally carries nucleic acids, and includes high levels of sugar (80–98% by weight), with further quantitative constraints for sugar mass, nucleic acid amount, cationic lipid concentration, and specific hydrophobic-core excipient components in at least one independent claim.
Stated Advantages
Dried formulations maintain RNA integrity.
Dried formulations support functional protein expression.
Dried formulations maintain performance better than corresponding liquid storage under elevated temperatures.
Documented Applications
Vaccines and pharmaceutical compositions comprising nucleic acid delivery using the dried nanoemulsion lipid-carrier systems.
Immune response evaluation including in vivo immunogenicity.
Imaging and tracking using inorganic reporter-containing nanoparticles for monitoring.
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