Dermal fillers comprising silk fibroin hydrogels and uses thereof

• US 8,288,347 B2
• Filed: 10/18/2010
• Issued: 10/16/2012
• Est. Priority Date: 04/20/2009
• Status: Active Grant

• Current Assignee: Allergan, Inc. (Canada) (Abbvie Incorporated)
• Original Assignee: Allergan, Inc. (Canada) (Abbvie Incorporated)
• Inventors: Collette, Adam L., Horan, Rebecca L., Chen, Jingsong, Altman, Gregory H.
• Primary Examiner(s): Monshipouri, Maryam
• Application Number:
  US12/906,777
• Publication Number:
  US 20110129531A1
• Time in Patent Office: 729 Days
• Field of Search: 424/93.7, 424/484, 424/489, 424/497, 514/18.6, 514/18.8
• US Class Current: 514/18.6
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/16 Amides, e.g. hydroxamic acids
• CPC Class Codes: A61K 31/167 having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
• CPC Class Codes: A61K 38/17 from animals; from humans enzyme inhibitors A61K38/005
• CPC Class Codes: A61K 47/42 Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein oligopeptides having up to five amino acids A61K47/183; polyamino acids A61K47/34
• CPC Class Codes: A61K 8/64 Proteins; Peptides; Derivatives or degradation products thereof
• CPC Class Codes: A61K 9/0019 Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner non-active ingredients are additionally classified in A61K47/00
• CPC Class Codes: A61K 9/06 Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels composition of ointments, creams or gels A61K47/00
• CPC Class Codes: A61L 27/227 Other specific proteins or polypeptides not covered by A61L27/222, A61L27/225 or A61L27/24
• CPC Class Codes: A61L 27/3604 characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
• CPC Class Codes: A61L 27/3641 characterised by the site of application in the body materials for artificial blood vessels A61L27/507; materials for use in artificial skin A61L27/60
• CPC Class Codes: A61P 17/00 Drugs for dermatological disorders
• CPC Class Codes: A61P 17/02 for treating wounds, ulcers, burns, scars, keloids, or the like
• CPC Class Codes: A61Q 19/08 Anti-ageing preparations

Abstract

The present specification provides compositions useful as dermal fillers and methods using such compositions to treat a condition of skin.

Claims

1. A dermal filler composition comprising a gel phase and a carrier phase that increases the fluidity of the gel phase, the gel phase including

a) first hydrogel particles comprising a substantially sericin-depleted silk fibroin;

and

b) second hydrogel particles comprising a matrix polymer including an elastic protein;

wherein the first hydrogel particles has a protein structure that makes the hydrogel particles resist biodegradation.

2. The composition of claim 1, wherein the silk fibroin hydrogel particles comprises about 1% (w/v) to about 10% (w/v) of silk fibroin.

3. The composition of claim 1, wherein the elastic protein is an elastin.

4. The composition of claim 1, wherein the silk fibroin hydrogel particles and elastic protein hydrogel particles have a cross-sectional area from about 0.1 μ

m² to about 1000 μ

m².

5. The composition of claim 1, wherein the silk fibroin hydrogel particles further comprises an amphiphilic peptide.

6. The composition of claim 1, wherein the carrier phase is water, a saline solution, or a buffered solution.

7. The composition of claim 1, wherein the carrier phase further comprises lidocaine.

8. A method of treating a soft tissue condition in an individual in need thereof, the method comprising the step of administering a composition of claim 1 into a skin region of the individual, wherein the administration improves the condition.

9. The method of claim 8, wherein the soft tissue condition is a breast tissue condition, a facial tissue condition, a neck condition, a skin condition, an upper arm condition, a lower arm condition, a hand condition, a shoulder condition, a back condition, a torso including abdominal condition, a buttock condition, an upper leg condition, a lower leg condition including calf condition, a foot condition including plantar fat pad condition, an eye condition, a genital condition, or a condition effecting another body part, region or area.

10. The method of claim 9, wherein the breast tissue condition is a breast imperfection, a breast defect, a breast augmentation, or a breast reconstruction.

11. The method of claim 9, wherein the facial tissue condition is a facial imperfection, a facial defect, a facial augmentation, or a facial reconstruction.

12. The method of claim 9, wherein the facial tissue condition is a dermal divot, a sunken cheek, a thin lip, a nasal imperfection or defect, a retro-orbital imperfection or defect, a facial fold, a facial line, a facial wrinkle, or other size, shape or contour imperfection or defect of the face.

13. The method of claim 9, wherein the facial tissue condition is skin dehydration, a lack of skin elasticity, skin roughness, a lack of skin tautness, a skin stretch line or mark, or skin paleness.