Injectable cross-linked collagen implant material

A - Human Necessities – 61 – K

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167/103.9

A61K 37/12 (1985.01)

Patent

CA 1255589

Abstract of the Disclosure Cross-linked atelopeptide collagen that is substantially free of residual cross-linking agent is prepared by reconstituting atelopeptide collagen from solution by neutralizing the solution at a reduced temperature and a hypotonic ionic strength, cross- linking the reconstituted fibers in an aqueous medium at a concentration of 0.1 to 10 mg/ml with a cross- linking agent at a concentration of about 0.001% to about 0.05% by weight that forms covalent bonds with the collagen under conditions sufficient to produce a fibrous cross-linked collagen that has greater than about 15 free lysine residues per 1000 amino acid residues and that when in suspension in physiological saline at a concentration of 35 mg/ml exhibits a shear viscosity whose log varies linearly with the log of the shear rate and is approximated by the formula: log ? ?-0.96 log ? + 2.3 where ? is the shear rate in sec-1, log ? is in the range of -6 to +2 and ? is the viscosity of the suspension in Pascal-sec, optionally quenching the cross-linking re- action with an amino acid, and separating the cross-linked atelopeptide collagen from the reaction mixture. This collagen is dispersed in an isotonic aqueous medium for use in soft tissue dermal augmentation and is injectable and forms implants that have excellent persistence.

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