US 12,280,101 B2
Compositions and methods for stabilization of active agents
David L. Kaplan, Concord, MA (US); and Fiorenzo G. Omenetto, Lexington, MA (US)
Assigned to Trustees of Tufts College, Medford, MA (US)
Filed by Trustees of Tufts College, Medford, MA (US)
Filed on Dec. 29, 2017, as Appl. No. 15/858,239.
Application 15/492,363 is a division of application No. 14/112,769, abandoned, previously published as PCT/US2012/034643, filed on Apr. 23, 2012.
Application 15/858,239 is a continuation of application No. 15/492,363, filed on Apr. 20, 2017, abandoned.
Claims priority of provisional application 61/477,737, filed on Apr. 21, 2011.
Prior Publication US 2018/0360947 A1, Dec. 20, 2018
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 39/20 (2006.01); A61K 9/00 (2006.01); A61K 9/06 (2006.01); A61K 9/14 (2006.01); A61K 9/19 (2006.01); A61K 9/50 (2006.01); A61K 9/70 (2006.01); A61K 38/00 (2006.01); A61K 39/00 (2006.01); A61K 39/02 (2006.01); A61K 39/04 (2006.01); A61K 39/08 (2006.01); A61K 39/09 (2006.01); A61K 39/095 (2006.01); A61K 39/12 (2006.01); A61K 39/165 (2006.01); A61K 47/42 (2017.01); A61K 47/46 (2006.01); B82Y 5/00 (2011.01)
CPC A61K 39/20 (2013.01) [A61K 9/0019 (2013.01); A61K 9/06 (2013.01); A61K 9/146 (2013.01); A61K 9/19 (2013.01); A61K 9/5026 (2013.01); A61K 9/5063 (2013.01); A61K 9/7007 (2013.01); A61K 39/0015 (2013.01); A61K 39/02 (2013.01); A61K 39/04 (2013.01); A61K 39/08 (2013.01); A61K 39/092 (2013.01); A61K 39/095 (2013.01); A61K 39/099 (2013.01); A61K 39/12 (2013.01); A61K 39/165 (2013.01); A61K 47/42 (2013.01); A61K 47/46 (2013.01); B82Y 5/00 (2013.01); A61K 38/00 (2013.01); A61K 2039/5252 (2013.01); A61K 2039/5254 (2013.01); A61K 2039/6031 (2013.01); A61K 2039/622 (2013.01); A61K 2039/64 (2013.01); A61K 2039/70 (2013.01); C12N 2760/18434 (2013.01); C12N 2760/18734 (2013.01); C12N 2770/36234 (2013.01); Y02A 50/30 (2018.01)] 26 Claims
 
1. 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).