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