KR20150023618A - Nonwoven materials containing chlorhexidine acetate and triclosan - Google Patents

Abstract

The present invention provides a medical article having antimicrobial efficacy and excellent barrier properties. Specifically, the medical article includes a nonwoven material, and a coating comprising chlorhexidine acetate and triclosan. The present invention relates to an article comprising a material such as a nonwoven material and a coating comprising chlorhexidine acetate and triclosan acid. The articles are preferably medical articles such as gowns, shoe covers, drapes, wraps and caps. Coatings with a combination of chlorhexidine acetate and triclosan on the same material as nonwoven materials have been found to provide effective and fast acting antimicrobial activity while minimally affecting the barrier properties of the material.

Description

[0001] NONWOVEN MATERIALS CONTAINING CHLORHEXIDINE ACETATE AND TRICLOSAN [0002]

The present invention relates to a medical article having antimicrobial efficacy and excellent barrier properties.

In the United States, hospital-acquired infections, also known as nosocomial infections, cause or contribute nearly 100,000 deaths each year. To minimize the spread of such infections, disposable medical items such as gowns, drapes, shoe covers, wraps and caps are regularly used. These articles are often worn or used for short periods of time, for example less than 10 minutes.

Many of these articles are prepared using nonwoven materials or nonwoven fabrics, such as spunbond / meltblown / spunbond (SMS) laminates of polypropylene fibers, and provide a barrier against microorganisms and / . The ability to block the penetration of fluid, such as body fluids, is important in a medical environment. Some medical articles, such as medical gowns, were developed by the Association for the Advancement of Medical Instrumentation and based on the AAMI / ANSI PB70 standard, a standard approved by the American National Standards Institute , And barrier performance. In the AAMI / ANSI PB70 standard, the core test for measuring the barrier performance of materials is the water resistance: hydrostatic test, AATCC test method 127, established by the American Association of Textile Chemists and Colorists. The hydrostatic pressure test measures the resistance of the material to penetration of water under increasing pressure. According to the AAMI / ANSI PB70 standard, there are four barrier performance levels. Materials with AAMI Level 1 grades pass the spray impact test and are effective against impact penetration. Examples of materials that typically have an AAMI level 1 rating include a base cover gown and isolation gown. Materials with AAMI Level 2 grades require a hydrostatic pressure of at least 20 cm H ₂ O to allow water to penetrate through the material. Examples of materials that typically have an AAMI level 2 rating include those articles that are often used for short periods of time, providing basic protection and relatively low exposure to fluids. Materials with AAMI Level 3 grades require hydrostatic pressure of at least 50 cm H ₂ O to allow water to penetrate through the material. Examples of materials that typically have AAMI level 3 grades include those articles that are often used when providing medium barrier fluids and providing increased barrier protection. Materials with AAMI level 4 grades are impermeable to water penetration. Surgical drapes and gowns often have AAMI level 4 grades.

Some nonwoven materials are coated with an antimicrobial material that kills the microorganisms that contact the surface of the article. Antimicrobial activity is measured by measuring the log reduction of infectious bacterial counts after exposure to an antimicrobial agent. For example, a 3-log reduction refers to a 99.9% decrease and a 4-log decrease refers to a 99.99% decrease. Although the use of an antimicrobial coating on nonwoven materials may be beneficial in reducing the amount of microorganisms present on the surface, sometimes the coating may increase the likelihood of fluid penetration by compromising the barrier properties of the nonwoven material.

There is a need in the industry for nonwoven materials having effective barrier properties and exhibiting fast-acting antimicrobial activity. Preferably, the medical article can kill a large number of microorganisms such as 3 or 4 log reduction (99.9% to 99.99%) within a short period of time such as less than 10 minutes. Since the "fast killing" of microorganisms can break the infection chain from one surface to another, such materials help to reduce the spread of hospital infection.

U.S.A. Patent No. 6,146,651 discloses halogenated phenolic biocides; A water-soluble film-forming polymer; And a non-woven fabric treated with a biocidal composition comprising at least one surfactant.

U.S.A. 6,626,873 and U.S. Pat. Patent No. 5,772, 640 relates to a polymeric medical article comprising chlorhexidine and its salts and triclosan. U.S.A. 6,626,873 and U.S. Pat. Patent No. 5,772,640 refers to medical articles such as catheters, wound drain tubes, arterial grafts, soft tissue patches, gloves, shunts, stents, tracheal catheters, wound dressings, sutures, guide wires and prosthetic devices.

U.S.A. Patent No. 6,503,952 discloses an antimicrobial agent such as chlorhexidine free base, chlorhexidine salt, polyhexamethylene ligand and alexidine; Quaternary ammonium compounds; And a chlorinated phenolic compound.

U.S.A. Patent Application Publication No. 2011/0150958 relates to a sterilizing detergent containing chlorhexidine acetate, a solvent such as an alcohol and / or water, and a second biocidal agent such as triclosan acid.

All references cited herein are incorporated by reference in their entirety.

SUMMARY OF THE INVENTION [

The present invention relates to an article comprising a material such as a nonwoven material and a coating comprising chlorhexidine acetate and triclosan acid. The articles are preferably medical articles such as gowns, shoe covers, drapes, wraps and caps.

It has been found that coatings with a combination of chlorhexidine acetate and triclosan on a material such as a nonwoven material provide effective and fast acting antimicrobial activity while minimally affecting the barrier properties of the material.

The present invention relates to an article comprising a material such as a nonwoven material and a coating comprising chlorhexidine acetate and triclosan acid. The article can be a medical article, such as a gown, shoe lid, drape, wrap, cap, face mask, lab coat, or any other article that can be used to prevent the propagation of fluids and / or microorganisms.

In some embodiments, the material may include a predetermined fabric or material, including nonwoven materials or nonwoven fabrics. The nonwoven fabric may be formed into individual random laid yarns using spunlaid, thermobonded, spunbonded, meltblown, or bonded carded web processes, Quot;) < / RTI > fibers, or assemblies or laminates of multiple webs. Nonwoven laminates such as spunbond / meltblown / spunbond (SMS) laminates of polypropylene fibers are one example of a typical fabric that can be used in the surgical field. Another example is a spunbond / film / spunbond (SFS) laminate. In some embodiments, a spunlace (hydroentangled) material may be used. In some embodiments, the material is from about 1 to about 1000 grams per square meter, preferably from 10 to 100 grams per square meter, and more preferably from 20 to 50 grams per square meter (gsm).

Chlorhexidine acetate, also known as chlorhexidine diacetate, is an antimicrobial agent. It has been found that chlorhexidine acetate as well as other free salts of chlorhexidine and other salts of chlorhexidine, such as chlorhexidine gluconate, are effective against gram-positive and gram-negative bacteria and have both killed bacteria and bacteriostatic activity. Surprisingly, it has been found that chlorhexidine acetate, especially in combination with triclosan, provides effective antimicrobial activity while minimizing the effect on the barrier properties of the material.

Triclosan, also known as 5-chloro-2- (2,4-dichlorophenoxy) phenol and 2,4,4'-trichloro-2'-hydroxydiphenyl ether, is an anti- It is a microbial agent.

The combination of chlorhexidine acetate and triclosan has been found to provide an effective antimicrobial coating on materials such as nonwoven materials. The combination has been found to provide a synergistic effect that provides a high degree of bacterial log reduction while minimally affecting the barrier properties (fluid permeability) of the material. In particular, the combination of chlorhexidine acetate and triclosan, as measured using a hydrostatic pressure test, is superior to that of each agent alone, and compared to other combinations such as chlorhexidine free base and triclosan and chlorhexidine gluconate and triclosan, It has been found that it provides an effective antimicrobial activity while maintaining the resistance of the material.

In some embodiments, the chlorhexidine acetate and the triclosan are preferably present in a ratio of from about 25: 1 to about 1:25, more preferably from about 10: 1 to about 1:10, even more preferably from about 5: 1 to about 1: 5, and most preferably from about 3: 1 to about 1: 3, in the presence of chlorhexidine acetate: triclosan acid. In some embodiments, the total amount (dry weight) of chlorhexidine acetate and triclosan is from about 0.1% to about 70%, preferably from 0.25% to 50%, more preferably from about 0.35% to 20% And preferably about 50% to 10%.

Chlorhexidine acetate and triclosan can be applied to the material separately or together. For example, in some embodiments, chlorhexidine acetate may be applied first, followed by triclosan. In some embodiments, the combination of chlorhexidine acetate and triclosan is first combined into a single formulation, then the combination formulation is applied to the material. In some embodiments, a liquid formulation comprising an antimicrobial agent is prepared and applied to the material. The liquid formulation may comprise one or more solvents such as alcohols and / or water. Examples of the solvent include, but are not limited to, water, ethanol, hexanol, acetone, isopropanol, benzyl alcohol, propylene glycol, glycerol and polyethylene glycol. In some preferred embodiments, the liquid formulation comprises chlorhexidine acetate and triclosan in water and alcohol solution; Preferred alcohols include ethanol, hexanol or octanol. An example of a liquid formulation includes chlorhexidine acetate (0.3% w / w, 0.6% w / w or 0.75% w / w), triclosan (0.60% w / w) and ethanol (70% w / w).

The coating of chlorhexidine acetate and triclosan can be applied to the material in any way. Preferably, the coating solution containing chlorhexidine acetate and triclosan is sprayed or kiss gravure coated onto a material such as a nonwoven material. The coating may be applied directly to the fibers prior to bonding. In a preferred embodiment, the coating is applied after the nonwoven web is formed and bonded. Other additives may be added to the coating solution, including, but not limited to, antistatic agents and coating aids for lowering the solution surface tension. In another embodiment, the fabric may be dip-coated or may be coated using an immersion and compression padding process using a formulation of chlorhexidine acetate and triclosan.

After application of the coating, the coated material may be dried by air drying or using a drying apparatus. For example, air-impact and suspended drying equipment may be used. The coated material may be dried by introducing a heated gas, such as air, through the material while holding the material on a porous surface such as a drum or belt.

In some embodiments, the article of the present invention has an antimicrobial efficacy of at least 2 log reduction in bacterial, preferably at least 3 log reduction, more preferably at least 4 log reduction. In some embodiments, the antimicrobial effect is achieved in less than about 60 minutes, preferably less than about 30 minutes, more preferably less than about 10 minutes, most preferably less than about 5 minutes.

In some embodiments, the article of the present invention comprising a coated material has similar barrier properties when compared to the same material in an uncoated form. For example, in some embodiments, the application of chlorhexidine acetate and triclosan to SMS nonwovens results in an hydrostatic resistance value of the SMS nonwoven (uncoated form) of about 50% or less, preferably about 40% or less, more preferably about 30% or less, more preferably about 0 to 10% or less.

In some embodiments, the hydrostatic pressure of the coated material (e.g., as determined by hydrostatic pressure test, AATCC test method 127) is preferably at least 20 cm H ₂ O, more preferably at least 30 cm H ₂ O to be. In some embodiments, for example when the coating material is used for surgical gowns, the hydrostatic pressure of the coating material may be at least preferably 50 cmH ₂ O.

[ Example ]

Experiments were performed to compare the effects of chlorhexidine acetate (CHA) and triclosan combinations with (1) chlorhexidine free base (CH), chlorhexidine acetate, chlorhexidine gluconate (CHG), polyhexamethylenebiguanide (PHMB ) And triclosan alone, (2) CH and triclosan, CHG and triclosan, and a combination of PHMB and triclosan, respectively. The following coating formulations were prepared using deionized water and then sprayed onto a 8 x 8 inch fabric sample of 34 gsm spunbond / meltblown / spunbond (SMS) nonwoven material using a disposable micro passive sprayer.

Formulation A: CHA (0.6% w / w), triclosan (0.60% w / w) and ethanol (70%

Formulation B: CHA (0.3% w / w), triclosan (0.60% w / w) and ethanol (70%

Formulation C: CHA (0.75% w / w), triclosan (0.60% w / w) and ethanol (70%

- Formulation D: Control without coating

- Formulation E: Ethanol (70%)

Formulation F: CH (0.30% w / w) and ethanol (70%)

Formulation G: CH (0.60% w / w) and ethanol (70%)

Formulation H: CH (1.20% w / w) and ethanol (70%)

Formulation I: CHA (0.30% w / w) and ethanol (70%)

Formulation J: CHA (0.30% w / w) and ethanol (70%)

Formulation K: CHG (1.0% w / w) and hexanol (0.6%)

Formulation L: CHG (1.0% w / w) and hexanol (0.6%)

Formulation M: PHMB (1.0% w / w) and ethanol (70%)

Formulation N: PHMB (1.0% w / w) and hexanol (0.6%)

Formulation O: Triclosan (0.3% w / w) and ethanol (70%)

Formulation P: Triclosan (0.6% w / w) and ethanol (70%)

Formulation Q: CH (0.30% w / w), triclosan (0.6% w / w) and ethanol (70%

- Preparation R: CH (0.60% w / w), triclosan (0.6% w / w) and ethanol (70%

Formulation S: CHG (0.35% w / w), triclosan (0.6% w / w) and ethanol (70%

Formulation T: PHMB (0.15% w / w), triclosan (0.6% w / w) and ethanol (70%

Formulation U: PHMB (0.45% w / w), triclosan (0.6% w / w) and ethanol (70%

Formulation V: PHMB (0.75% w / w), triclosan (0.6% w / w) and ethanol (70%).

The formulations were sprayed onto the fabric samples until the samples were uniformly saturated. The saturation point was determined visually when the coating formulation infiltrated the fabric sample and became translucent as it was fully saturated. Next, the specimen was placed horizontally on a wire rack and air dried in a fume hood. In some cases, the samples were placed in an oven for drying.

Gram negative . Coli (E. coli) ATCC # 11229, and Gram-positive S. Samples were tested for antimicrobial efficacy using the AATCC Test Method 100 using S. aureus , MRSA , ATCC # 43300. After 5 minutes, this. The log reduction of coli and MRSA was measured. Water resistance: Using the hydrostatic pressure test, AATCC Test Method 127, the barrier properties of the sample were also tested. Two hydrostatic reading values were collected and the values were averaged. The results are listed in the table below.

The results show that the combination of chlorhexidine acetate and triclosan on the SMS nonwoven material shows an effective antimicrobial activity . Coli < / RTI > and MRSA, respectively. In addition, the barrier properties of coated SMS nonwoven materials were maintained at high values when measured by hydrostatic testing. On the other hand, the samples coated with the individual antimicrobial agents alone or in combination with other antimicrobial agents exhibit excellent antimicrobial activity but exhibit poor barrier properties, exhibit excellent barrier properties, exhibit poor antimicrobial activity, or exhibit poor antimicrobial activity Indicating both active and poor barrier properties. For example, in the case of a sample coated only with triclosan, the barrier properties of the fabric were high, but the antimicrobial activity was very low. In the case of samples coated with chlorhexidine free base alone, the antimicrobial efficacy was high but the barrier properties were poor. In addition, samples coated with chlorhexidine acetate alone exhibited poor barrier properties and poor antimicrobial activity against MRSA .

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Claims (6)

An article comprising a nonwoven material, and a coating comprising chlorhexidine acetate and triclosan. The article of claim 1, wherein the nonwoven material comprises a spunbond meltblown spunbond polypropylene. The article of claim 1, wherein the coating comprises chlorhexidine acetate and triclosan in a ratio of about 25: 1 to about 1: 25. The article of claim 1, wherein the coating comprises chlorhexidine acetate and triclosan in a ratio of about 5: 1 to about 1: 5. The article of claim 1, wherein the coating comprises chlorhexidine acetate and triclosan in a ratio of about 3: 1 to about 1: 3. The article of claim 1, wherein the article is a medical article selected from the group consisting of a gown, a shoe lid, a drape, a lap, a cap, a lab coat, and a facial mask.