Silk-based product formulations and methods of use
Embodiments of the present disclosure include formulations of silk-based product (SBP) formulations and related methods of preparation and use in a variety of applications in the fields of human therapeutics, veterinary medicine, agriculture, and material science.
1. A silk-based product (SBP) for ocular lubrication comprising processed silk fibroin, and optionally at least one ocular therapeutic agent,
wherein the processed silk fibroin has been degummed, dissolved in 5-13 M lithium bromide, and stressed by heating the silk fibroin to 60° C. or autoclaving the silk fibroin,
wherein a 0.05 to 5% w/v solution of the processed silk fibroin has a surface tension of between about 30 mN/m and 60 mN/n, and
wherein a 0.05 to 5% w/v solution of the processed silk fibroin has a viscosity of between 30-400 cP.
2. The SBP of claim 1 , wherein the SBP comprises from about 1% to about 5% (w/v) of silk fibroin.
3. The SBP of claim 1 , wherein the SBP comprises one or more excipients.
4. The SBP of claim 3 , wherein one or more of the excipients is selected from the group consisting of phosphate buffer, phosphate buffered saline, and sucrose.
5. The SBP of claim 1 , wherein the at least one ocular therapeutic agent is a nonsteroidal anti-inflammatory drug (NSAID) or a protein.
6. The SBP of claim 5 , wherein the SBP is formulated for ocular administration.
7. A method of treating an ocular indication of a subject comprising administering to the subject the SBP in claim 1 .
8. The method of claim 7 , wherein the ocular indication is dry eye disease.
9. The method of claim 8 , wherein the SBP is administered to the eye.
10. The method of claim 9 , wherein the SBP is administered via topical administration and wherein the topical administration of SBP is as drops or sprays.
11. The SBP formulation of claim 6 , wherein the silk fibroin is present at a concentration between 0.5% and 5%.
12. The SBP formulation of claim 11 , wherein the silk fibroin is in a solution selected from the group consisting of phosphate buffer, borate buffer, and phosphate buffered saline.
13. The SBP formulation of claim 12 , wherein the solution further comprises propylene glycol.
14. The SBP formulation of claim 13 , wherein the solution comprises propylene glycol at a concentration of 1%.
15. The SBP formulation of claim 12 , wherein the solution further comprises sucrose.
16. The SBP formulation of claim 15 , wherein the solution comprises sucrose at a concentration selected from the group consisting of 10 mM, 50 mM, 100 mM and 150 mM.
17. The SBP formulation of claim 12 , wherein the solution further comprises trehalose.
18. The SBP formulation of claim 17 , wherein the solution comprises trehalose at a concentration selected from the group consisting of 10 mM, 50 mM, 100 mM and 150 mM.