# US 2014/0227361 A1 · Cross-linked hyaluronic acid and collagen and uses thereof

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- Number: US 2014/0227361 A1
- Document ID: US20140227361A1
- Status: Published application
- Kind: A1
- Application number: 14/252,458
- Filed: 2014-04-14
- Published: 2014-08-14
- Earliest claimed: 2007-10-09
- Assignees: Allergan, Inc.
- Applicants: Allergan, Inc.
- Inventors: Jacqueline A. Schroeder; Gregory S. Dapper; Kenneth C. Olson
- Web page: https://patentgrep.com/patent/US20140227361A1

## CPC

- A61L 27/44: having a macromolecular matrix
- A61L 27/26: Mixtures of macromolecular compounds
- A61L 27/48: with macromolecular fillers
- A61L 27/54: Biologically active materials, e.g. therapeutic substances {(A61L27/227 takes precedence)}
- A61P 23/02: Local anaesthetics
- A61L 2300/204: with nitrogen-containing functional groups, e.g. aminoxides, nitriles, guanidines
- A61L 2300/402: Anaestetics, analgesics, e.g. lidocaine
- A61L 2400/06: Flowable or injectable implant compositions
- A61L 2430/04: for mammary reconstruction
- A61L 2430/34: for soft tissue reconstruction
- A61M 5/002: {Packages specially adapted therefor, e.g. packages for syringes or needles or kits for diabetics}
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

The present invention discloses a cross-linked hyaluronic acid/collagen formulation which has improved composition for dermal filling and higher persistence than cross-linked collagen or HA alone. Also disclosed are methods for preparing cross-linked hyaluronic acid/collagen formulations and using such for augmenting soft tissues in mammals.

## Claims

### Claim 1

A process for preparing an injectable composition useful for correcting mammary hypoplasia, the process comprising:
(1) contacting hyaluronic acid (HA) with a cross-linker to allow cross-linking of the HA by the cross-linker, thereby forming a first composition comprising a crosslinked HA;
(2) contacting the crosslinked HA with collagen to form a second composition comprising a collagen layer crosslinked to and surrounding a crosslinked HA core;
(3) homogenizing the second composition to form an injectable composition, the composition being injectable under normal manual pressure though a 25 gauge needle, thereby preparing the injectable composition useful for correcting the mammary hypoplasia.

### Claim 2 (depends on 1)

The process of claim 1, wherein the cross-linker is 1,4-butanediol diglycidyl ether (BDDE).

### Claim 3 (depends on 1)

The process of claim 1, wherein the concentration of the HA for forming the first composition is about 30 mg/ml or higher.

### Claim 4 (depends on 1)

The process of claim 1, wherein the pH of the HA for forming the first composition is about 9-12.

### Claim 5 (depends on 1)

The process of claim 1, wherein the collagen for contacting the first composition is soluble.

### Claim 6 (depends on 1)

The process of claim 1, wherein the concentration of the collagen for contacting the first composition is about 10-50 mg/ml.

### Claim 7 (depends on 1)

The process of claim 1, wherein the concentration of the collagen for contacting the first composition is about 30 mg/ml.

### Claim 8 (depends on 1)

The process of claim 1, wherein the pH of the collagen for contacting the first composition is about 2-3.

### Claim 9 (depends on 1)

The process of claim 1, wherein the pH of the second composition is about 6-8.

### Claim 10 (depends on 1)

The process of claim 1, wherein the pH of the second composition is about 7.

### Claim 11 (depends on 1)

The process of claim 1, further comprising adding a local anesthetic agent to the second composition.

### Claim 12 (depends on 11)

The process of claim 11, wherein the local anesthetic agent is lidocaine.

### Claim 13 (depends on 1)

The process of claim 1 further comprising the step of adding soluble HA to the second composition.

### Claim 14

An injectable composition useful for correcting mammary hypoplasia in a patient, the composition made by the process of:
(1) contacting hyaluronic acid (HA) with a cross-linker to allow cross-linking of the HA by the cross-linker, thereby forming a first composition comprising a crosslinked HA;
(2) contacting the crosslinked HA with collagen to form a second composition comprising a collagen layer crosslinked to and surrounding a crosslinked HA core; and
(3) homogenizing the second composition to form an injectable composition, thereby preparing the injectable composition useful for correcting the mammary hypoplasia.

### Claim 15 (depends on 14)

The composition of claim 14, wherein the cross-linker is 1,4-butanediol diglycidyl ether (BDDE).

### Claim 16 (depends on 14)

The composition of claim 14, wherein the concentration of the HA for forming the first composition is about 30 mg/ml or higher.

### Claim 17 (depends on 14)

The composition of claim 14, wherein the pH of the HA for forming the first composition is about 9-12.

### Claim 18 (depends on 14)

The composition of claim 14, wherein the collagen for contacting the first composition is soluble.

### Claim 19 (depends on 14)

The composition of claim 14, wherein the concentration of the collagen for contacting the first composition is about 10-50 mg/ml.

### Claim 20 (depends on 14)

The composition of claim 14, wherein the concentration of the collagen for contacting the first composition is about 30 mg/ml.

### Claim 21 (depends on 14)

The composition of claim 14, wherein the process further comprises adding lidocaine to the second composition.

### Claim 22 (depends on 14)

A method for volumizing a hypoplastic breast in a patient comprising introducing the composition of claim 14 into the breast of a patient.
