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US 11,167,032 B2Granted
Methods and compositions for therapeutic agents
AssigneeVariation Biotechnologies Inc.
InventorsMarc J. Kirchmeier, David E. Anderson
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Abstract
The present disclosure provides inter alia compositions that comprise therapeutic agents (e.g., live attenuated viral antigens, therapeutic proteins, etc.) and a lipid component. The lipid component may comprise or consist of different types of lipid or lipids as described herein. In some embodiments the therapeutic agents are thermolabile. The present disclosure also provides methods for preparing compositions, including the aforementioned compositions (e.g., melt methods and spray injection methods among others).
Claims8
A method comprising:
- preparing pre-formed vesicles comprising a lipid component that comprises a non-ionic surfactant, a steroid and an ionic amphiphile;
- admixing the pre-formed vesicles with an aqueous solution that includes a thermolabile therapeutic agent, wherein pre-formed vesicles are prepared in the absence of thermolabile therapeutic agent;
- homogenizing the resulting product to form a homogenate, wherein the homogenate does not comprise thermolabile therapeutic agent entrapped within the pre-formed vesicles;
- and
- lyophilizing the homogenate to form a lyophilized homogenate,
- wherein the ionic amphiphile is dicetylphosphate (DCP) or 1,2-dipalmitoylphosphatidyl glycerol (DPPG), and
- when the ionic amphiphile is DCP, the non-ionic surfactant is 1-monopalmitoyl glycerol (MPG) and the steroid is cholesterol (CHO);
- and
- when the ionic amphiphile is DPPG, the non-ionic surfactant is MPG and the steroid is CHO and the MPG, CHO, and DPPG are present in a ratio of 5:4:1.
6 more elements
Dependencies are inferred from the claim text.