Preparation and/or formulation of proteins cross-linked with polysaccharides

Patent metadata

Field	Value
Publication number	US-11065365-B2
Application number	US-202016856031-A
Country	US
Kind code	B2
Filing date	Apr 23, 2020
Priority date	Nov 23, 2010
Publication date	Jul 20, 2021
Grant date	Jul 20, 2021

Abstract

Therapeutic compositions and/or formulations are provided, comprising: at least one cross-linked protein matrix, wherein the at least one cross-linked protein matrix comprises at least one protein residue and at least one saccharide-containing residue, and methods of producing the same. The cross-linked protein matrix may be derived from cross-linking a full length or substantially full length protein, such as tropoelastin, elastin, albumin, collagen, collagen monomers, immunoglobulins, insulin, and/or derivatives or combinations thereof, with a saccharide containing cross-linking agent, such as a polysaccharide cross-linking agent derived from, for example, hyaluronic acid or a cellulose derivative. The therapeutic compositions may be administered topically or by injection. The present disclosure also provides methods, systems, and/or kits for the preparation and/or formulation of the compositions disclosed herein.

First claim

What is claimed is:

1. A kit comprising:
(a) a prefilled syringe, wherein the prefilled syringe is filled with a tissue compatible composition comprising a protein selected from the group consisting of tropoelastin and albumin; a hyaluronic acid cross-linking molecule comprising one or more carboxyl groups; and at least one intermolecular cross-linkage comprising an amide bond between an amine of the protein and a carboxyl group of the hyaluronic acid cross-linking molecule; and
(b) instructions for use.

2. The kit of claim 1 , further comprising an assortment of appropriate sized needles.

3. The kit of claim 2 , wherein the assortment of appropriately sized needles comprise fine gauge needles.

4. The kit of claim 3 , wherein the needles range from about 25 gauge to about 31 gauge.

5. The kit of claim 2 , wherein the needles range from about 18 gauge to about 31 gauge.

6. The kit of claim 1 , further comprising a needle delivery system.

7. The kit of claim 6 , wherein the needle delivery system is selected from a needle roller ball type system, an automatic injection pen type system, and a mesotherapy injection gun type system.

8. The kit of claim 4 , wherein the needle delivery system is an automatic injection pen type system.

9. The kit of claim 1 , wherein the protein is tropoelastin.

10. The kit of claim 1 , wherein the composition retains a coherent structure and is sufficiently cross-linked to slow the composition's resorption in vivo.

11. The kit of claim 1 , wherein the composition is one or more of bioavailable, biodegradable, bioabsorbable, or bioresorbable.

12. The kit of claim 1 , wherein the composition is useful in bulking tissue, augmenting tissue, or combinations thereof.

13. The kit of claim 1 , wherein the composition is used in a dermatological or cosmetological application.

14. The kit of claim 1 , wherein the composition is used in one or more of restorative surgery, dermatological surgery, eye surgery, plastic surgery, vascular surgery, reconstructive surgery, orthopedic surgery, tissue augmentation, supplementation of a body cavity or a deficit, and restoring volume effused during surgery.

15. A kit comprising:
(a) a prefilled syringe, wherein the prefilled syringe is filled with a tissue compatible composition comprising tropoelastin; a hyaluronic acid cross-linking molecule comprising one or more carboxyl groups; and at least one intermolecular cross-linkage comprising an amide bond between an amine of the protein and a carboxyl group of the hyaluronic acid cross-linking molecule;
(b) one or more needles of a size selected from 25 gauge, 26 gauge, 27 gauge, 28 gauge, 29 gauge, 30 gauge and 31 gauge; and
(c) instructions for use.

16. A kit comprising:
(a) a syringe;
(b) at least one separate container, wherein the separate container is filled with a tissue compatible composition comprising a protein selected from the group consisting of tropoelastin and albumin; a hyaluronic acid cross-linking molecule comprising one or more carboxyl groups; and at least one intermolecular cross-linkage comprising an amide bond between an amine of the protein and a carboxyl group of the hyaluronic acid cross-linking molecule;
(c) a needle delivery system; and
(d) instructions for use.

17. The kit of claim 16 , wherein the needle delivery system is a selected from a needle, a needle roller ball type system, an automatic injection pen type system, and a mesotherapy injection gun type system.

18. The kit of claim 17 , wherein the needle delivery system is a needle with a size range from about 25 gauge to about 31 gauge.

19. The kit of claim 17 , wherein the needle delivery system is an automatic injection pen type system.

20. The kit of claim 16 , wherein the protein is tropoelastin.

21. The kit of claim 16 , wherein the composition retains a coherent structure and is sufficiently cross-linked to slow the composition's resorption in vivo.

22. The kit of claim 16 , wherein the composition is one or more of bioavailable, biodegradable, bioabsorbable, or bioresorbable.

23. The kit of claim 16 , wherein the composition is useful in bulking tissue, augmenting tissue, or combinations thereof.

24. The kit of claim 16 , wherein the composition is used in a dermatological or cosmetological application.

25. The kit of claim 16 , wherein the composition is used in one or more of restorative surgery, dermatological surgery, eye surgery, plastic surgery, vascular surgery, reconstructive surgery, orthopedic surgery, tissue augmentation, supplementation of a body cavity or a deficit, and restoring volume effused during surgery.

Assignees

• Allergan Pharmaceuticals Int Ltd

Inventors

• Sommer-Knudsen Jens

Classifications

• A61K8/64 Primary

  Proteins; Peptides; Derivatives or degradation products thereof · CPC title

• A61L27/50

  Materials characterised by their function or physical properties {, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials} · CPC title

• C08L1/286

  substituted with acid radicals, e.g. carboxymethyl cellulose [CMC] (C08L1/282 takes precedence) · CPC title

• C08B11/12

  substituted with carboxylic radicals {, e.g. carboxymethylcellulose [CMC]} · CPC title

• C08B37/0069

  Chondroitin-4-sulfate, i.e. chondroitin sulfate A; Dermatan sulfate, i.e. chondroitin sulfate B or beta-heparin; Chondroitin-6-sulfate, i.e. chondroitin sulfate C; Derivatives thereof · CPC title