US 11,890,328 B2
Fibroin-derived protein composition
Brian D. Lawrence, Plymouth, MN (US); and David W. Infanger, Plymouth, MN (US)
Assigned to Silk Technologies, Ltd., Plymouth, MN (US)
Filed by Silk Technologies, Ltd., Plymouth, MN (US)
Filed on Jun. 28, 2021, as Appl. No. 17/360,674.
Application 17/360,674 is a continuation of application No. 16/680,186, filed on Nov. 11, 2019, granted, now 11,045,524, issued on Jun. 29, 2021.
Application 16/680,186 is a continuation of application No. 15/912,295, filed on Mar. 5, 2018, granted, now 10,471,128, issued on Nov. 12, 2019.
Application 15/912,295 is a continuation of application No. 15/212,086, filed on Jul. 15, 2016, granted, now 9,907,836, issued on Mar. 6, 2018.
Application 15/212,086 is a continuation of application No. 14/831,473, filed on Aug. 20, 2015, granted, now 9,394,355, issued on Jul. 19, 2016.
Claims priority of provisional application 62/193,790, filed on Jul. 17, 2015.
Claims priority of provisional application 62/039,675, filed on Aug. 20, 2014.
Prior Publication US 2022/0054596 A1, Feb. 24, 2022
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 38/39 (2006.01); A23L 33/17 (2016.01); A23J 3/00 (2006.01); A61K 35/64 (2015.01); A23L 2/66 (2006.01); C07K 14/78 (2006.01); A61K 45/06 (2006.01)
CPC A61K 38/39 (2013.01) [A23J 3/00 (2013.01); A23L 2/66 (2013.01); A23L 33/17 (2016.08); A61K 35/64 (2013.01); A61K 45/06 (2013.01); C07K 14/78 (2013.01); A23V 2002/00 (2013.01)] 16 Claims
 
1. A method of treating dry eye syndrome in a subject comprising administering an effective amount of a protein composition to an eye of the subject, thereby treating the dry eye disease, wherein the protein composition is formulated as an ophthalmic formulation comprising water; wherein the protein composition is a fibroin-derived protein composition prepared by a process comprising heating an aqueous fibroin solution at an elevated pressure, wherein:
the aqueous fibroin solution comprises lithium bromide at a concentration of at least about 8M, and the aqueous fibroin solution is heated to at least about 105° C. (221° F.) under a pressure of about 10 PSI to about 20 PSI for at least about 20 minutes in the presence of the lithium bromide;
to provide a protein composition comprising fibroin-derived protein wherein:
the primary amino acid sequences of the fibroin-derived protein composition differ from native fibroin by at least by at least 4% with respect to the combined amino acid content of serine, glycine, and alanine, based on the combined absolute values of the differences in the content of serine, glycine, and alanine;
cysteine disulfide bonds between the fibroin heavy and fibroin light protein chains of fibroin are reduced or eliminated;
the protein composition has a serine content that is reduced by greater than 25% compared to native fibroin protein; and
wherein the average molecular weight of the fibroin-derived protein composition is less than about 100 kDa.