# US 2019/0167849 A1 · Wetting agent formulation

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- Number: US 2019/0167849 A1
- Document ID: US20190167849A1
- Status: Published application
- Kind: A1
- Application number: 16/324,437
- Filed: 2017-08-09
- Published: 2019-06-06
- Earliest claimed: 2016-08-09
- Assignees: Teleflex Life Sciences Pte. Ltd.
- Applicants: Teleflex Life Sciences Unlimited Company
- Inventors: Denzell MCBURNEY; Ronald John KELLY; Morgan TIERNEY
- Web page: https://patentgrep.com/patent/US20190167849A1

## CPC

- A61L 29/085: {Macromolecular materials}
- A61K 39/0002: {Fungal antigens, e.g. Trichophyton, Aspergillus, Candida}
- A61L 2/081: Gamma radiation
- A61L 27/34: Macromolecular materials
- A61L 27/50: Materials characterised by their function or physical properties {, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials}
- A61L 27/505: {Stabilizers}
- A61L 27/52: Hydrogels or hydrocolloids
- A61L 29/08: Materials for coatings
- A61L 29/14: Materials characterised by their function or physical properties {, e.g. lubricating compositions}
- A61L 29/143: {Stabilizers}
- A61L 29/145: {Hydrogels or hydrocolloids}
- A61M 25/002: {Packages specially adapted therefor (combined with means for introducing catheters, e.g. dispensers, A61M25/0113); catheter kit packages (for surgical articles A61B50/30)}
- B65B 55/16: by irradiation
- C08L 1/286: {substituted with acid radicals, e.g. carboxymethyl cellulose [CMC] (C08L1/282 takes precedence)}
- A61L 2/10: Ultraviolet [UV] radiation
- A61L 2103/15: Laboratory, medical or dentistry appliances, e.g. catheters or sharps
- A61L 2202/18: Aseptic storing means
- A61L 2400/10: Materials for lubricating medical devices
- A61L 2420/02: Methods for coating medical devices
- C08J 3/03: in aqueous media
- C08K 5/06: Ethers; Acetals; Ketals; Ortho-esters
- C08K 5/1345: {Carboxylic esters of phenolcarboxylic acids}
- 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)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- 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)}
- B65B: MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING (bundling and pressing devices for cigars A24C1/44; devices for tensioning and securing binders adapted to be supported by the article or articles to be bound B25B25/00; applying closure members to bottles, jars or similar containers B67B1/00-B67B6/00; concurrent cleaning, filling and closing of bottles B67C7/00; emptying bottles, jars, cans, casks, barrels or similar containers B67C9/00)
- C08L: COMPOSITIONS OF MACROMOLECULAR COMPOUNDS (compositions based on polymerisable monomers C08F, C08G; artificial filaments or fibres D01F; textile treating compositions D06)
- C08J: WORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H (working, e.g. shaping, of plastics B29)
- C08K: Use of inorganic or non-macromolecular organic substances as compounding ingredients (paints, inks, varnishes, dyes, polishes, adhesives C09)

## Abstract

A first alternative to a composition for preventing or retarding degradation of a functional coating on a medical device includes an antioxidant selected from gallic acid or a derivative thereof. A second alternative to a composition for preventing or retarding degradation of a functional coating on a medical device includes carboxymethyl cellulose or a derivative or salt thereof. The use of the compositions for preventing or retarding degradation of a functional coating on a medical device from reactive species generated during exposure of radiation, and a wetting agent comprising the compositions, are also provided. The wetting agent prevents or retards the hydrolytic degradation of the coating during the intended shelf-life of the wetted coated product.

## Claims

### Claim 1

A composition for preventing or retarding degradation of a functional coating on a medical device, comprising:
an antioxidant selected from gallic acid or a derivative thereof.

### Claim 2 (depends on 1)

The composition of claim 1, wherein the antioxidant comprises an ester, amide or oxadiazole derivative of gallic acid.

### Claim 3 (depends on 1)

The composition of claim 1, further comprising a solution enhancer.

### Claim 4 (depends on 1)

The composition of claim 1, wherein gallic acid or a derivative thereof is present in an amount of 0.001% to 5% by weight based on a total weight of the composition.

### Claim 5

A composition for preventing or retarding degradation of a functional coating on a medical device, comprising:
carboxymethyl cellulose or a derivative or salt thereof.

### Claim 6 (depends on 5)

The composition of claim 5, comprising a sodium salt of carboxymethyl cellulose.

### Claim 7 (depends on 5)

The composition of claim 5, wherein carboxymethyl cellulose or a derivative or salt thereof is present in an amount of 0.1% to 10% by weight based on a total weight of the composition.

### Claim 8 (depends on 1)

The composition of claim 1, further comprising an aqueous or oil based base solution or a lipid media or a combination thereof.

### Claim 9 (depends on 8)

The composition of claim 8, wherein the aqueous base solution is selected from a group consisting of distilled water, deionized water, reverse osmosis water, filtered water and a saline solution.

### Claim 10 (depends on 8)

The composition of claim 8, wherein the aqueous base solution is present in an amount of from 50% to 99.99% by weight, based on a total weight of the composition.

### Claim 11 (depends on 1)

The composition of claim 1, wherein gallic acid or a derivative thereof is present as a suspension within and/or around the functional coating.

### Claim 12 (depends on 1)

The composition of claim 1, further comprising a stabilizer and/or a buffer solution.

### Claim 13 (depends on 3)

The composition of claim 3, wherein the solution enhancer is selected from ethylene glycol, diethylene glycol, propylene glycol, or glycerol, and is present in an amount of 0.1% to 49.8% by weight, based on the total weight of the composition.

### Claim 14 (depends on 5)

The composition of claim 5, further comprising gallic acid or a derivative thereof selected from an ester, amide or oxadiazole derivative of gallic acid, preferably propyl gallate.

### Claim 15 (depends on 14)

The composition of claim 14, wherein gallic acid or a derivative thereof is present in an amount of 0.001% to 1% by weight, based on the total weight of the composition.

### Claim 16 (depends on 5)

The composition of claim 5, further comprising a stabilizer, a solution enhancer and/or a buffer solution.

### Claim 17 (depends on 16)

The composition of claim 16, wherein the solution enhancer is selected from a group consisting of ethylene glycol, diethylene glycol, propylene glycol, and glycerol.

### Claim 18 (depends on 17)

The composition of claim 17, wherein the solution enhancer is present in an amount of 0.1% to 49.8% by weight, based on the total weight of the composition.

### Claim 19 (depends on 5)

The composition of claim 5, comprising:
0.1% to 5% by weight of sodium carboxymethyl cellulose;
0% to 0.5% by weight of propyl gallate; and
1% to 10% by weight of propylene glycol.

### Claim 20 (depends on 12)

The composition of claim 12, wherein the buffer solution has a pH of from 2.0 to 7.4.

### Claim 21

(canceled)

### Claim 22 (depends on 1)

A wetting agent, comprising the composition of claim 1.

### Claim 23 (depends on 5)

A wetting agent, comprising the composition of claim 5.
