Method of lyophilizing lipid nanoparticles
AssigneeArcturus Therapeutics, Inc.
InventorsAmit Sagi, Yanjie Bao, Priya Prakash Karmali
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Abstract
Methods of preparing lyophilized lipid nanoparticle-nucleic acid compositions are provided. The methods comprise preparing a suspension of lipid nanoparticles with a monosaccharide and one or more excipients selected from thiosulfate, potassium sorbate, sodium benzoate, and iodixanol. Lyophilized lipid nanoparticle-nucleic acid compositions and methods of reconstituting and administering the same are further provided.
Claims16
A pharmaceutical composition comprising a solid lyophilized composition, wherein the solid lyophilized composition comprises:
- i. lipid nanoparticles encapsulating from about 0.001 to about 1.0% w/w of a ribonucleic acid (RNA) by the weight of the lyophilized composition,
- ii. a lyoprotectant composition comprising from about 0.01% w/w to about 1.0% w/w of a poloxamer by the weight of the lyophilized composition and from about 0.5% w/w to about 5.0% w/w of potassium sorbate by the weight of the lyophilized composition, and
- iii. from about 85% w/w to about 96% w/w of a sugar by the weight of the lyophilized composition.
A pharmaceutical composition comprising a solid lyophilized composition, wherein the solid lyophilized composition comprises:
- i. lipid nanoparticles encapsulating from about 0.001 to about 1.0% w/w of an RNA by the weight of the lyophilized composition,
- ii. from about 0.01% w/w to about 1.0% w/w of a poloxamer by the weight of the lyophilized composition and from about 0.5% w/w to about 5.0% w/w of potassium sorbate by the weight of the lyophilized composition,
- iiii. from about 0.75% w/w to about 2.75% w/w of a salt by the weight of the lyophilized composition, and
- iv. from about 85% w/w to about 96% w/w of a sugar by the weight of the lyophilized composition,
- wherein upon reconstitution of the solid lyophilized composition with a liquid medium the lipid nanoparticles have a change in mean diameter less than about 15 nm as compared to a mean diameter prior to lyophilization.
Dependencies are inferred from the claim text.