Compositions and methods for stabilization of active agents
AssigneeTrustees of Tufts College
InventorsDavid L. Kaplan, Fiorenzo G. Omenetto
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Abstract
Provided herein are methods and compositions for stabilization of active agents. The active agents are distributed, mixed or embedded in a silk fibroin matrix, thereby retaining the bioactivity of the active agents upon storage and/or transportation. In some embodiments, the storage-stable vaccine-silk compositions are also provided herein.
Claims26
A storage-stable composition comprising a silk fibroin film, particle, or microneedle and an active agent distributed therein, wherein the active agent is a vaccine, wherein administering the composition to a subject initiates sustained release of the active agent over a period of at least 1 hour;
- and the active agent retains at least about 30% of its original bioactivity when the composition is (a) subjected to at least one freeze-thaw cycle, or (b) maintained for at least about 24 hours at a temperature above 0° C., or (c) both (a) and (b).
A storage-stable composition comprising a silk fibroin film, particle, or microneedle and an active agent distributed therein, the active agent is a vaccine having a bioactivity that is reduced upon being subjected to either at least one freeze-thaw cycle or maintenance for at least 24 hours at a temperature of above 0° C. in the absence of the silk fibroin film, particle, or microneedle, the composition having a residual moisture that is adapted to provide storage stability such that the active agent has at least about 30% greater bioactivity relative to the active agent in the absence of the silk fibroin film, particle, or microneedle when the composition or the at least one active agent in the absence of the silk fibroin film, particle, or microneedle is (a) subjected to at least one freeze-thaw cycle, or (b) maintained for at least about 24 hours at a temperature of above 0° C., or (c) both (a) and (b), and wherein administering the composition to a subject initiates sustained release of the active agent over a period of at least 1 hour.
Dependencies are inferred from the claim text.