Compositions and methods for nanoparticle lyophile forms
AssigneeNitto Denko Corporation
InventorsRoger Adami, Yuwei Wang, Haiqing Yin, Liping Wang, Dong Liu, Wenbin Ying
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Abstract
This invention provides compositions for making a solid lyophile of one or more nucleic acid active agents, which can be reconstituted as a drug product. The composition can include an aqueous suspension of lipid nanoparticles in a pharmaceutically acceptable solution, wherein the lipid nanoparticles encapsulate one or more nucleic acid active agents, a dextrin compound, and a saccharide compound. The nucleic acid active agents can be RNAi molecules capable of mediating RNA interference, as well as other RNAs and oligonucleotides.
Claims29
A composition for making a solid lyophile of lipid nanoparticles comprising one or more nucleic acid active agents, the composition comprising:
- an aqueous suspension of the lipid nanoparticles in a pharmaceutically acceptable solution, wherein the lipid nanoparticles encapsulate the one or more nucleic acid active agents;
- a dextrin compound;
- a saccharide sugar compound;
- wherein the total amount of the dextrin and sugar compounds is from 2% to 20% (w/v) of the composition;
- wherein the dextrin compound is from 40% to 70% (w/v) of the total amount of the dextrin and sugar compounds;
- and
- wherein upon lyophilization and reconstitution of the composition without filtering, the average size of the nanoparticles is within 5% of their size in the original composition with PDI less than or equal to 0.15.
Dependencies are inferred from the claim text.