# US 11,298,309 B2 · Topical silk compositions and methods of using

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- Number: US 11,298,309 B2
- Document ID: US11298309B2
- Status: Granted
- Kind: B2
- Application number: 16/641,606
- Filed: 2018-08-24
- Published: 2021-02-04
- Granted: 2022-04-12
- Earliest claimed: 2017-08-24
- Assignees: The Regents of the University of Colorado; University of Central Florida Research Foundation, Inc.
- Applicants: The Regents of the University of Colorado; University of Central Florida Research Foundation, Inc.
- Inventors: Ken Liechty; Sudipta Seal; Swetha Barkam
- Web page: https://patentgrep.com/patent/US11298309B2

## CPC

- A61K 8/64: Proteins; Peptides; Derivatives or degradation products thereof
- A61K 8/027: {Fibers; Fibrils}
- A61K 8/19: containing inorganic ingredients
- A61K 8/981: {of mammals or bird}
- A61K 8/987: {of species other than mammals or birds}
- A61K 9/0014: {Skin, i.e. galenical aspects of topical compositions (non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00)}
- A61K 9/08: Solutions {(composition of solutions A61K47/00)}
- A61K 9/7007: {Drug-containing films, membranes or sheets (A61K9/0041, A61K9/0043, A61K9/006, A61K9/0063 take precedence)}
- A61K 9/7015: {Drug-containing film-forming compositions, e.g. spray-on}
- A61K 33/244: Lanthanides; Compounds thereof (medicinal preparations containing radioactive lanthanides for use in therapy or testing in vivo A61K51/00)
- A61K 35/28: Bone marrow; Haematopoietic stem cells; Mesenchymal stem cells of any origin, e.g. adipose-derived stem cells
- A61K 35/64: Insects, e.g. bees, wasps or fleas
- A61K 35/646: Arachnids, e.g. spiders, scorpions, ticks or mites
- A61K 38/12: Cyclic peptides {, e.g. bacitracins; Polymyxins; Gramicidins S, C; Tyrocidins A, B or C (A61K38/043 - A61K38/046 take precedence)}
- A61K 38/1767: {from invertebrates}
- A61K 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
- A61K 47/46: Ingredients of undetermined constitution or reaction products thereof, e.g. skin, bone, milk, cotton fibre, eggshell, oxgall or plant extracts
- A61K 47/549: {Sugars, nucleosides, nucleotides or nucleic acids}
- A61K 47/6923: {the form being an inorganic particle, e.g. ceramic particles, silica particles, ferrite or synsorb}
- A61L 15/32: Proteins, polypeptides; Degradation products or derivatives thereof, e.g. albumin, collagen, fibrin, gelatin {(A61L15/225 takes precedence)}
- A61P 17/02: for treating wounds, ulcers, burns, scars, keloids, or the like
- A61Q 19/00: Preparations for care of the skin
- C12N 15/113: Non-coding nucleic acids modulating the expression of genes, e.g. antisense oligonucleotides; {Antisense DNA or RNA; Triplex- forming oligonucleotides; Catalytic nucleic acids, e.g. ribozymes; Nucleic acids used in co-suppression or gene silencing (when used in plants C12N15/8218)}
- A61K 2800/30: Characterized by the absence of a particular group of ingredients
- C12N 2310/141: MicroRNAs, miRNAs
- C12N 2310/351: Conjugate
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61Q: SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)

## Abstract

Methods of protecting skin of a mammal by application of silk-derived compositions useful for treating or preventing a wide variety of skin conditions. Silk solutions and silk mats are prepared and applied to the skin surface. The silk compositions may be self-adhesive or sutured to cover a wound or area of skin exposed to physical stresses and strains, thereby preventing a wound and/or promoting wound healing.

## Claims

### Claim 1

A method of protecting skin of a mammal comprising:
applying a solution of silk fibroin fibers to the skin of a mammal, wherein the mammal is non-diabetic and the skin is not damaged; and
applying a silk fibroin mat over the solution of silk fibroin fibers applied to the skin of the mammal;
thereby increasing the elastic modulus of the skin of the mammal.

### Claim 2 (depends on 1)

The method of claim 1, wherein the silk fibroin fibers in the solution have a diameter in a range of about 1 to about 1,000 nm.

### Claim 3 (depends on 1)

The method of claim 1, wherein the silk fibroin fibers in the solution are obtained from another solution containing a dissolved silkworm silk or a dissolved spider silk.

### Claim 4 (depends on 1)

The method of claim 1, wherein the silk fibroin fibers in the solution have a sericin content of less than 5%.

### Claim 5 (depends on 1)

The method of claim 1, wherein the silk fibroin fibers in the solution have a concentration of about 0.1 to about 25 weight percent of the solution.

### Claim 6 (depends on 1)

The method of claim 1, wherein the solution of silk fibroin fibers is an aqueous solution or an alcohol solution.

### Claim 7 (depends on 1)

The method of claim 1, wherein the solution of silk fibroin fibers further comprises a biocompatible polymer selected from the group comprising polyethylene oxide (PEO), polyethylene glycol (PEG), collagen, fibronectin, keratin, polyaspartic acid, polylysine, alginate, chitosan, chitin, hyaluronic acid, pectin, polycaprolactone, polylactic acid, polyglycolic acid, polyhydroxyalkanoates, dextrans, polyanhydrides, and combinations thereof.

### Claim 8 (depends on 1)

The method of claim 1, wherein the solution of silk fibroin fibers is applied as at least one of a spray, a liquid, a film, a foam, a suspension, a cream, an ointment, or a gel.

### Claim 9 (depends on 1)

The method of claim 1, wherein the silk fibroin mat is applied as at least one of a sheet, a gel, a hydrogel, a mesh, a non-woven mat, a fabric, a scaffold, a tube, a slab, a fiber, a particle, a powder, a sponge, and a lyophilized article.

### Claim 10 (depends on 1)

The method of claim 1, wherein the solution of silk fibroin fibers, the silk fibroin mat or both incorporates an active agent.

### Claim 11 (depends on 10)

The method of claim 10, wherein the active agent is at least one of cerium oxide nanoparticle and mesenchymal stem cells.

### Claim 12 (depends on 11)

The method of claim 11, wherein the cerium oxide nanoparticle is conjugated to a microRNA (miRNA).

### Claim 13 (depends on 12)

The method of claim 12, wherein the miRNA is miRNA-146a.