Claims for Patent: 9,327,033

Summary for Patent: 9,327,033

Title:	Degradation-stabilised, biocompatible collagen matrices
Abstract:	The present invention relates to degradation-stabilized, biocompatible collagen matrices which are distinguished in particular by the fact that they contain soluble collagen and peptide constituents, to processes for the preparation of such collagen matrices, which processes include in particular chemical crosslinking with an epoxy-functional crosslinking agent, and to the use of the collagen matrices according to the invention as a cosmetic or pharmaceutical agent, in particular for topical use, and as a wound treatment agent, as an implant or as a haemostatic agent in humans or animals, and as a scaffold for cell population in the biotechnology, basic research and tissue engineering field.
Inventor(s):	Malessa; Ralf (Essen, DE), Kassner; Anja (Munster, DE)
Assignee:	MEDSKIN SOLUTIONS DR. SUWELACK AG (Billerbeck, DE)
Application Number:	14/228,285
Patent Claims:	1. A crosslinked collagen matrix obtained by a process comprising: a) preparing an aqueous collagen suspension, b) adjusting the pH value of the collagen suspension from step a) to pH <4, c) adding an epoxy-functional crosslinking agent in an amount of not more than 50 wt. % based on the dry mass of the collagen suspension from step a), d) freezing the collagen mixture obtainable from step d), e) freeze-drying of the frozen mixture from step e) at a freeze-drying temperature <100.degree. C., f) adjusting the freeze-dried crosslinked collagen material so obtained to a moisture content from 3 to 25 wt. %, based on the end product, and g) at least one of sterilizing and processing the formed materials. 2. The crosslinked collagen matrix of claim 1, wherein the collagen suspension from step a) comprises native acid-insoluble collagen in the form of fibers and fibrils. 3. The crosslinked collagen matrix of claim 1, wherein the collagen suspension comprises acid-soluble collagen and peptide constituents and/or wherein in step c) structure-forming agents or active ingredients from the group of the matrix proteins, extracellular matrix constituents, proteinogenic active ingredients and soluble protein or peptide constituents are added. 4. The crosslinked collagen matrix of claim 1, having a wet tear strength >50 cN/mm layer thickness, measured by DIN EN ISO 3376, or >200 cN/mm layer thickness, measured by the UV8801 method. 5. The crosslinked collagen matrix according to claim 1, having a collagenase degradation rate, characterized by an amount of decomposition products after collagenase digestion in phosphate-buffered saline after 6 hours, determined by means of an UVNIS spectral photometer, of not more than 85%. 6. The crosslinked collagen matrix according to claim 1, having a hydrolytic stability of greater than or equal to 90%, determined by the formula Hydrolytic stability (%)=M.sub.tx.times.100/M.sub.t0 with M.sub.tx=mass of the dried intact/cohesive collagen matrix material M.sub.t0=mass of the dry collagen matrix material before the start of the test, within 18 days of storing the crosslinked collagen matrix in an aqueous solution, consisting of water, glycerol, 1,5-pentanediol, sodium chloride and a preservative, at 50.degree. C. 7. The crosslinked collagen matrix according to claim 1, having a rigidity, corresponding to a modulus of elasticity according to the Young's modulus E, of 0.01 to 100 kPa. 8. The crosslinked collagen matrix according to claim 1, having a liquid absorption capacity of 1 to 200 times its own weight. 9. The crosslinked collagen matrix of claim 1, wherein the epoxy-functional crosslinking agent is a diepoxide. 10. The crosslinked collagen matrix of claim 9, wherein the diepoxide is 1,4-butanediol diglycidyl ether. 11. The crosslinked collagen matrix of claim 1, wherein the process from which it is obtained further comprises converting the materials obtainable from step g) into a desired form to afford formed materials. 12. The crosslinked collagen matrix of claim 1, wherein the process from which it is obtained further comprises adding at least one of structure-forming agents, active ingredients and auxiliary substances. 13. The crosslinked collagen matrix of claim 12, wherein the at least one active ingredient is selected from the group consisting of dermal and transdermal active ingredients: for skin treatment, for the treatment of skin diseases, for wound treatment or for hemostasis, antibacterial wound treatment agents.

Details for Patent 9,327,033

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Smith & Nephew, Inc.	SANTYL	collagenase	Ointment	101995	06/04/1965		2030-12-23