Packaged product

• US 8,338,375 B2
• Filed: 12/29/2009
• Issued: 12/25/2012
• Est. Priority Date: 05/23/2007
• Status: Active Grant

• Current Assignee: Allergan Incorporated (Abbvie Incorporated)
• Original Assignee: Allergan Incorporated (Abbvie Incorporated)
• Inventors: Schroeder, Jacqueline Anne, Dapper, Gregory S., Olson, Kenneth C.
• Primary Examiner(s): Robinson, Hope A.
• Application Number:
  US12/649,020
• Publication Number:
  US 20100099624A1
• Time in Patent Office: 1,092 Days
• Field of Search: None
• US Class Current: 514/12
• CPC Class Codes: A61P 17/00 Drugs for dermatological disorders
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: C07K 14/78 Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin or cold insoluble globulin [CIG]

Abstract

The present invention discloses collagen cross-linked in a micro to non-fibrillar form and at a high concentration. The cross-linked collagen gel has improved volume stability or persistence than collagen cross-linked at a neutral pH. Also disclosed are methods for preparing the inventive cross-linked collagen and using such for augmenting soft tissues in mammals.

Claims

1. A packaged product useful for dermal correction and sculpting comprising:

a syringe; and

an injectable dermal filler composition in the syringe, the composition comprising a cross-linked collagen prepared by the steps of

incubating collagen selected from a group consisting of type I collagen, type II collagen, type III collagen, type IV collagen, type V collagen, telo-containing collagen, atelo-collagen, derivatized collagen, and a combination thereof, in a suspension or solution having pH in the range of pH 2-5 or pH 9-12,

treating said collagen with a cross-linking agent selected from the group consisting of carbodiimides, polyaldehydes, polysulfones, activated PEGs, epoxides, imidazoles and diisocyanates at pH 2-5 or pH 9-12, and

isolating the cross-linked collagen to thereby obtain the composition,

wherein the cross-linked collagen is in a gel but not in a fibrous state.

2. The packaged product of claim 1, wherein the cross-linking agent is glutaraldehyde.

3. The packaged product of claim 1, wherein the cross-linked collagen locks water in the gel and does not disperse like a fibrous collagen suspension.

4. The packaged product of claim 1, wherein the fibers of the cross-linked collagen are smaller than those of fibrous collagen cross-linked at a neutral pH.

5. The packaged product of claim 1, wherein a concentration of the collagen in the composition is in the range of 3 mg/mL-150 mg/mL.

6. The packaged product of claim 1, wherein a concentration of the collagen in the composition is in the range of 38 mg/mL-52 mg/mL.

7. The packaged product of claim 1, wherein the composition further comprises a local anesthetic agent admixed with the cross-linked collagen.

8. The packaged product of claim 7, wherein the local anesthetic agent is lidocaine.

9. The packaged product of claim 1, wherein the incubating step comprises incubating the collagen in a suspension or solution of pH 4.2-5.0.

10. The packaged product of claim 1, wherein the treating step further comprises treating the collagen with the cross-linking agent at pH 6-8.

11. The packaged product of claim 1, wherein the pH of the suspension or solution containing the collagen is in the range of pH 4.2-5.0.

12. The packaged product of claim 1, wherein the process for preparing the composition further comprises washing the crosslinked collagen with an aqueous buffer solution having a pH of 6.9 to 7.4.