Preserved Silk Protein Fragment Compositions and Articles Manufactured Therefrom

Abstract

In some embodiments, a composition is disclosed that includes pure silk fibroin-based protein fragments that are substantially devoid of sericin, wherein the composition has an average weight average molecular weight ranging from about 17 kDa to about 38 kDa, wherein the composition has a polydispersity of between about 1.5 and about 3.0, wherein the composition is substantially homogeneous, wherein the composition between 0 ppm to about 500 ppm of inorganic residuals, and wherein the composition includes between 0 ppm to about 500 ppm of organic residuals. In some embodiments, a composition is disclosed that includes silk fibroin-based protein fragments and is suitable for use in consumer applications. In some embodiments, a preserved composition is disclosed that includes silk fibroin-based protein fragments. In some embodiments, a method of preserving a solution using silk fibroin-based protein fragments is disclosed.

1 . A composition comprising silk fibroin protein or fragments thereof, a nucleating agent, and water;
 wherein the composition is in the form of a gel;   wherein the pH of the gel is less than about 7.0;   wherein the silk fibroin protein or fragments thereof have a weight average molecular weight range of about 5 kDa to about 144 kDa; and   wherein the gel exhibits a bacterial count of less than 100 CFU/mL when stored for a period of time selected from the group consisting of 3 months, 6 months, 1 year, 2 years, and 3 years.   
     
     
         2 . The composition of  claim 1 , wherein the nucleating agent is selected from the group consisting of glycolic acid, lactic acid, ascorbyl glucoside, and ascorbic acid. 
     
     
         3 . The composition of  claim 2 , wherein the silk fibroin protein or fragments thereof have an average weight average molecular weight range selected from the group consisting of about 5 to about 10 kDa, about 6 kDa to about 16 kDa, about 17 kDa to about 38 kDa, about 39 kDa to about 80 kDa, about 60 to about 100 kDa, and about 80 kDa to about 144 kDa; and
 wherein the silk fibroin protein or fragments thereof have a polydispersity of between about 1.5 and about 3.0.   
     
     
         4 . The composition of  claim 3 , further comprising sodium anisate at a concentration of 0.1% to 5.0% w/v, wherein the gel is substantially homogenous, and wherein the gel exhibits a fungal count of less than 100 CFU/mL when stored for a period of time selected from the group consisting of 6 months, 1 year, 2 years, and 3 years. 
     
     
         5 . The composition of  claim 4 , wherein the concentration of silk fibroin protein or fragments thereof is between about 2.0% and 3.0% w/v. 
     
     
         6 . A composition comprising silk fibroin protein or fragments thereof, lemongrass essential oil, and water;
 wherein the composition is in the form of a solution;   wherein the pH of the solution is less than about 7.0;   wherein the silk fibroin protein or fragments thereof have a weight average molecular weight range of about 5 kDa to about 144 kDa; and   wherein the solution exhibits a fungal count of less than 100 CFU/mL when stored for a period of time selected from the group consisting of 3 months, 6 months, 1 year, 2 years, and 3 years.   
     
     
         7 . The composition of  claim 6 , wherein the silk fibroin protein or fragments thereof have an average weight average molecular weight range selected from the group consisting of about 5 to about 10 kDa, about 6 kDa to about 16 kDa, about 17 kDa to about 38 kDa, about 39 kDa to about 80 kDa, about 60 to about 100 kDa, and about 80 kDa to about 144 kDa; and
 wherein the silk fibroin protein or fragments thereof have a polydispersity of between about 1.5 and about 3.0.   
     
     
         8 . The composition of  claim 7 , wherein the concentration of the lemongrass essential oil is between about 0.01% to 2.0% w/v. 
     
     
         9 . A composition comprising silk fibroin protein or fragments thereof and water;
 wherein the composition is in the form of a solution;   wherein the pH of the solution is between about 1.0 and about 4.0;   wherein the silk fibroin protein or fragments thereof have a weight average molecular weight range of about 5 kDa to about 144 kDa;   wherein the solution exhibits a fungal count of less than 100 CFU/mL when stored for a period of time selected from the group consisting of 3 months, 6 months, 1 year, 2 years, and 3 years; and   wherein the solution exhibits a bacterial count of less than 100 CFU/mL when stored for a period of time selected from the group consisting of 6 months, 1 year, 2 years, and 3 years.   
     
     
         10 . The composition of  claim 9 , wherein the silk fibroin protein or fragments thereof have an average weight average molecular weight range selected from the group consisting of about 5 to about 10 kDa, about 6 kDa to about 16 kDa, about 17 kDa to about 38 kDa, about 39 kDa to about 80 kDa, about 60 to about 100 kDa, and about 80 kDa to about 144 kDa; and
 wherein the silk fibroin protein or fragments thereof have a polydispersity of between about 1.5 and about 3.0.   
     
     
         11 . A composition comprising a first preservative, a second preservative, and water;
 wherein the first preservative is silk fibroin protein or fragments thereof;   wherein the composition is in the form of a solution;   wherein the second preservative is selected from the group consisting of Aspen bark extract, potassium sorbate, sodium anisate, magnesium salicylate, lemongrass essential oil, and any combination thereof;   wherein the silk fibroin protein or fragments thereof have a weight average molecular weight range of about 5 kDa to about 144 kDa;   wherein the solution exhibits a fungal count of less than 100 CFU/mL when stored for a period of time selected from the group consisting of 3 months, 6 months, 1 year, 2 years, and 3 years; and   wherein the solution exhibits a bacterial count of less than 100 CFU/mL when stored for a period of time selected from the group consisting of 3 months, 6 months, 1 year, 2 years, and 3 years.   
     
     
         12 . The composition of  claim 11 , wherein the pH of the solution is selected from the group consisting of between about 1.0 to about 1.5, between about 1.5 to about 2.0, between about 2.0 to about 2.5, between about 2.5 to about 3.0, between about 3.0 to about 3.5, between about 3.5 to about 4.0, between about 5.5 and about 6.0, between about 6.0 and about 6.5, and between about 6.5 and about 7.0; and
 wherein the second preservative is sodium anisate.   
     
     
         13 . The composition of  claim 11 , wherein the silk fibroin protein or fragments thereof have an average weight average molecular weight range selected from the group consisting of about 5 to about 10 kDa, about 6 kDa to about 16 kDa, about 17 kDa to about 38 kDa, about 39 kDa to about 80 kDa, about 60 to about 100 kDa, and about 80 kDa to about 144 kDa; and
 wherein the silk fibroin protein or fragments thereof have a polydispersity of between about 1.5 and about 3.0.   
     
     
         14 . The composition of  claim 13 , wherein the concentration of the second preservative is selected from the group consisting of between about 0.05% to 5% w/v, about 0.1 to about 4% w/v, and about 0.25 to 3% w/v. 
     
     
         15 . A method of preserving a composition comprising the steps of:
 (a) providing a first preservative comprising a quantity of silk fibroin protein or fragments thereof, wherein the silk fibroin protein or fragments thereof have a weight average molecular weight range of about 5 kDa to about 144 kDa;   (b) dissolving the silk fibroin protein or fragments thereof to form an aqueous solution;   (c) optionally adjusting the pH of the aqueous solution to between about 1.0 and about 4.0;   (d) optionally adding a second preservative, wherein the second preservative is selected from the group consisting of Aspen bark extract, potassium sorbate, sodium anisate, magnesium salicylate, lemongrass essential oil, and any combination thereof;   (e) storing the aqueous solution for a period of time selected from the group consisting of 6 months, 1 year, 2 years, and 3 years, wherein after the storage period, the aqueous solution exhibits a bacterial count of less than 100 CFU/mL and a fungal count of less than 100 CFU/mL.   
     
     
         16 . The method of  claim 15 , wherein the silk fibroin protein or fragments thereof have an average weight average molecular weight range selected from the group consisting of about 5 to about 10 kDa, about 6 kDa to about 16 kDa, about 17 kDa to about 38 kDa, about 39 kDa to about 80 kDa, about 60 to about 100 kDa, and about 80 kDa to about 144 kDa;
 and wherein the silk fibroin protein or fragments thereof has a polydispersity of between about 1.5 and about 3.0.   
     
     
         17 . The method of  claim 15 , wherein the aqueous solution does not spontaneously or gradually gelate and does not visibly change in color or turbidity after the silk fibroin silk fibroin protein or fragments thereof have been dissolved for at least 10 days. 
     
     
         18 . A method of forming a preserved gel comprising the steps of:
 (a) providing a first preservative comprising a quantity of silk fibroin protein or fragments thereof, wherein the silk fibroin protein or fragments thereof have a weight average molecular weight range of about 5 kDa to about 144 kDa;   (b) dissolving the silk fibroin protein or fragments thereof to form an aqueous solution;   (c) inducing the aqueous solution to form a gel using a nucleating agent;   (d) folding a second preservative into the gel, such that the gel and the second preservative powder are substantially homogeneous;   (e) storing the gel for a period of time selected from the group consisting of 6 months, 1 year, 2 years, and 3 years, wherein after the storage period, the gel exhibits a bacterial count of less than 100 CFU/mL.   
     
     
         19 . The method of  claim 18 , wherein the silk fibroin protein or fragments thereof have an average weight average molecular weight range selected from the group consisting of about 5 to about 10 kDa, about 6 kDa to about 16 kDa, about 17 kDa to about 38 kDa, about 39 kDa to about 80 kDa, about 60 to about 100 kDa, and about 80 kDa to about 144 kDa, wherein the silk fibroin protein or fragments thereof has a polydispersity of between about 1.5 and about 3.0. 
     
     
         20 . The method of  claim 18 , wherein the second preservative is a powder, and wherein the powder is sodium anisate. 
     
     
         21 . The method of  claim 18 , wherein the second preservative is a powder, and wherein the powder is insoluble in the aqueous solution. 
     
     
         22 . A film comprising silk fibroin protein or fragments thereof, wherein the silk fibroin protein or fragments thereof have an average weight average molecular weight range selected from the group consisting of about 5 to about 10 kDa, about 6 kDa to about 16 kDa, about 17 kDa to about 38 kDa, about 39 kDa to about 80 kDa, about 60 to about 100 kDa, and about 80 kDa to about 144 kDa, wherein the silk fibroin protein or fragments thereof has a polydispersity of between about 1.5 and about 3.0, and wherein the film comprises a plurality of perforations. 
     
     
         23 . The film of  claim 22 , wherein the film is formed to conform to an anatomical portion of the human body. 
     
     
         24 . The film of  claim 23 , wherein the anatomical portion of the human body is selected from the group consisting of a neck, an elbow, a shoulder, a hip, a knee, an ankle, and a foot. 
     
     
         25 . The film of  claim 24 , wherein the film further comprises a therapeutic agent. 
     
     
         26 . The film of  claim 25 , wherein the therapeutic agent is selected from the group consisting of a chemotherapeutic agent, a pigment, an antibacterial agent, an antifungal agent, an antibiotic, an antimicrobial, an antimycotic, an antihistamine, an antiarrhythmic agent, an antihypertensive agent, a corticosteroid, an anti-viral agent, an antidepressant, an analgesic agent, an anesthetic agent, an anti-inflammatory agent, an attention-deficit hyperactivity disorder agent, an agent for the treatment of Parkinson's disease, an agent for the treatment of dementia, a smoking cessation agent, a pain relieving agent, a hormone therapy, an agent for the treatment of migraine disorders, an agent for the treatment of menopausal symptoms, an agents for contraception, an agent for chronic pain relief, an agent for angina prophylaxis, an agent for the treatment of osteoarthritis, an agent for postherpetic neuralgia, an agent for the treatment of a skin disorder, an agent for the treatment of acne, and an agent for the treatment of psoriasis.