WO2011072097A1 - Revêtement pour articles en latex - Google Patents

Revêtement pour articles en latex Download PDF

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Publication number
WO2011072097A1
WO2011072097A1 PCT/US2010/059625 US2010059625W WO2011072097A1 WO 2011072097 A1 WO2011072097 A1 WO 2011072097A1 US 2010059625 W US2010059625 W US 2010059625W WO 2011072097 A1 WO2011072097 A1 WO 2011072097A1
Authority
WO
WIPO (PCT)
Prior art keywords
acid
surfactant
personal protection
coating
latex barrier
Prior art date
Application number
PCT/US2010/059625
Other languages
English (en)
Inventor
William Bess
Leonard Mackles
Original Assignee
Glaxosmithkline Llc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Glaxosmithkline Llc filed Critical Glaxosmithkline Llc
Priority to JP2012543274A priority Critical patent/JP2013513437A/ja
Priority to EP10836665.9A priority patent/EP2509547A4/fr
Priority to US13/513,970 priority patent/US20120240937A1/en
Publication of WO2011072097A1 publication Critical patent/WO2011072097A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F6/00—Contraceptive devices; Pessaries; Applicators therefor
    • A61F6/02—Contraceptive devices; Pessaries; Applicators therefor for use by males
    • A61F6/04—Condoms, sheaths or the like, e.g. combined with devices protecting against contagion

Definitions

  • This invention relates to novel articles, particularly latex barrier articles, being coated with an antimicrobial coating useful to reduce the risk of cross-contamination and/or infection by harmful pathogenic microorganisms.
  • This invention also relates to a process for depositing such coatings, and to compositions for use in such processes.
  • Pathogenic microbes in humans including viruses, enter the system of the host predominantly through mucous membranes and the respiratory tract.
  • the first step in any infection is attachment or colonization with subsequent invasion and dissemination of the infectious microbe. Inactivation of potential pathogenic microbes at the site of entry could prevent many infectious diseases.
  • Barrier articles such as prophylactic devices, wound dressings and medical gloves all serve a role in preventing pathogenic microbes from penetrating the skin and entering the host.
  • Prophylactic devices in particular, are widely used for birth control and disease prevention.
  • Microbicidal and spermicidal compositions have been used in creams, foams and suppositories by themselves or in combination with prophylactic devices primarily for the purpose of contraception.
  • Prophylactic devices for the prevention of sexual disease are most often made of natural rubber latex material in very thin wall thicknesses.
  • natural rubber material in such thin wall membranes, does not provide a continuous, impermeable barrier to the passage of micro- size pathogens, such as the virus causing Human immunodeficiency virus (“HIV”) or Herpes simplex virus (“HSV”).
  • HIV Human immunodeficiency virus
  • HSV Herpes simplex virus
  • Such viruses are known to be as small as 0.1
  • the natural rubber membrane is comprised of a polymer matrix characterized by myriads of randomly distributed microsize openings or pores formed among the polymer chains.
  • Thin polymer films are used in the manufacture of a variety of barrier articles such as condoms, wound dressings, and medical gloves.
  • the application of such a coating to barrier articles should not reduce the ability of such articles to be a primary barrier.
  • the coating should also strongly adhere to the underlying substrate and must be able to be applied to a variety of substrate materials, without degrading the intrinsic properties of the substrate material. In addition, the coating must be able to operate over a physiologically broad spectrum of pH and physiological temperatures.
  • U.S. Patent 5,700,679 uses a composition containing a lipid vesicle having an outer bilayer formed of a non-ionic amphiphile, a surfactant having anti-viral and/or spermicidal activity, an oil and a sterol, to coat condoms.
  • U.S. Patent 6,732,735 uses a reticulated coating on various barrier articles to enhance the lubricity with respect to both dry and damp products.
  • U.S. Patent 6,892,732 relates to a condom coated with a genetically modified or natural lactic acid bacteria-containing composition for disease prevention.
  • a coating composition comprising a certain polyol, including propylene glycol and glycerine, or a polymer such as poly(ethylene glycol), a surfactant and an acid, provide antiviral activity in a wide variety of applications, and at least in part provide a solution to the problem of combating viral infection.
  • this invention is directed to a personal protection barrier article comprising a barrier layer which is substantially impermeable to water and/or air, and which is adapted to provide a physical barrier between a human body and an undesirable contact, the barrier layer having on its surface a coating composition having activity to deactivate pathogenic microorganisms, the coating comprising a polyol, including propylene glycol and/or glycerine, or a polymer such as poly(ethylene glycol), a surfactant and an acid.
  • the invention is directed to a process for making such a personal protection barrier article, in which process the surface of the material of the barrier layer is contacted with the composition comprising the polyol, including propylene glycol and/or glycerine, or a polymer such as poly(ethylene glycol), the surfactant and the acid, thereby depositing the coating composition.
  • the barrier article has multiple layers, including the barrier layer, such a process may be performed either prior to or after incorporating the barrier layer into the barrier article.
  • this invention is directed to a coating composition having activity to de-activate pathogenic microorganisms, the coating comprising a polyol, including propylene glycol and/or glycerine, or a polymer such as poly(ethylene glycol), a surfactant and an acid.
  • a polyol including propylene glycol and/or glycerine
  • a polymer such as poly(ethylene glycol)
  • surfactant and an acid
  • this invention is directed to a method for preventing the transfer of a pathogen from one individual to another by wearing a latex barrier article coated with a composition comprising a polyol, including propylene glycol and/or glycerine, or a polymer such as poly(ethylene glycol), a surfactant and an acid.
  • Examples of materials from which such a barrier layer can be made include soft plastics materials, elastomers such as synthetic and natural rubbers, for example, latex, and fabric, either woven or non-woven, natural or synthetic.
  • barrier articles include condoms, wound dressings, human body clothing such as impermeable clothing e.g., for healthcare workers or military personnel and gloves such as rubber gloves.
  • fabrics from which such an article of clothing can be made include cotton, rayon, nylon, polyester and fabrics conventionally used for clothing, and such fabrics may be permeable to air, or both air and water, or may be permeable to air but not water.
  • fabrics from which such an article of clothing can be made include cotton, rayon, nylon, polyester and fabrics conventionally used for clothing, and such fabrics may be permeable to air, or both air and water, or may be permeable to air but not water.
  • clothing include healthcare workers', e.g., physicians', nurses' uniforms and other clothing.
  • Advantageously such clothing may comprise conventional commercially available clothing upon which the coating composition is deposited, and being visually indistinguishable from conventional clothing.
  • the fabric may comprise the outer layer of such clothing.
  • the outer layer of clothing is normally the layer with which initial contact of the wearer with a
  • the coatings of this invention may be effective against the viruses that cause HIV and HSV, and mutated serotypes of these.
  • polyol means an alcohol containing multiple hydroxyl groups, including propylene glycol, glycerine (used interchangeably with glycerol), and the like.
  • the coating and impregnation compositions of this invention include one or more surfactant.
  • a surfactant can facilitate wetting of the articles of the invention, and the contact between the coating composition and the article itself.
  • Pathogens such as virus are known to be carried in small droplets of water, and consequently enhanced wetting of the article can enhance the effective contact between the pathogen and the active materials on the article.
  • surfactants are known to be effective in disrupting the membranes of virus and bacteria.
  • non-ionic surfactant examples are those selected from the TweenTM or PolysorbateTM family (i.e., based on TweenTM or PolysorbateTM family (i.e., based on TweenTM or PolysorbateTM family (i.e., based on TweenTM or PolysorbateTM family (i.e., based on TweenTM or PolysorbateTM family (i.e., based on TweenTM or PolysorbateTM family (i.e., based on TweenTM or PolysorbateTM family (i.e., based on TweenTM or PolysorbateTM family (i.e., based on TweenTM or PolysorbateTM family (i.e., based on TweenTM or PolysorbateTM family (i.e., based on TweenTM or PolysorbateTM family (i.e., based on TweenTM or PolysorbateTM family (i.e., based on TweenTM or PolysorbateTM family (i.
  • polyoxyethylene sorbitan fatty acid esters such as the monolaurate
  • Preferred non-ionic surfactants include Polysorbate 20TM.
  • an ionic, e.g., anionic surfactant may be used.
  • Such surfactants are compounds having a hydrophilic anionic group and an associated cation.
  • Such a cation may be metallic, such as alkali metal, or non-metallic such as ammonium or quaternary ammonium.
  • anionic surfactants comprise the hydrophilic anionic group and the cation in the form of a salt.
  • the anionic surfactant comprises a sodium salt of an organic hydrophilic anionic group.
  • the organic hydrophilic anionic group may be a sulphonic acid or carboxylic acid group.
  • a preferred such anionic surfactant compound has the formula (I):
  • n 8 to 20, preferably 10 to 15, Z is S0 3 or S0 4 , and M is sodium or potassium.
  • anionic surfactants which may be suitable are those of the formula (II):
  • n + m are 8 to 20, X is -O- or -CO.O-, Z is S0 3 or S0 4 , and M is sodium or potassium.
  • Another anionic surfactant of formula (II) is sodium laureth sulphate.
  • anionic surfactants which may be suitable are those of the formula (III):
  • n and m are each 1 or more, n + m are 8 to 20 R is Ci -3 alkyl, Z is CO.O, S0 3 or S0 4 , and M is sodium or potassium.
  • anionic surfactants are olefin sulphonates such as alpha-olefin such as the commercial material BiotergeTM As-40, being the sodium salt of Ci 4 - i 6 sulphonates.
  • anionic surfactants which may be suitable include sodium methyl lauroyl taurate, sodium methyl stearoyl taurate and sodium methyl palmitoyl taurate (and their analogues of different alkyl chain length), ammonium lauryl sulphate, ammonium laureth sulphate, sodium cocoyl sarcosinate, triethanolamine lauryl sulphate, triethanolamine laureth sulphate, disodium oleamide sulfosuccinate, disodium laureth sulfosuccinate, disodium dioctyl sulfosuccinate.
  • anionic surfactants which may be suitable include the alkaryl sulphonates, alkyi succinates, alkyi sulphosuccinates, N-alkoyl sarcosonates, alkyi phosphates, alkyi ether phosphates, and acyl methyl taurates, especially the sodium, magnesium, ammonium and mono-, di- and tri- ethanolamine salts.
  • Alkyi groups in the preceding may contain 8 to 20 carbon atoms.
  • Alkyi ether sulphates and alkyi ether phosphates may contain 1 to 10 ethylene oxide or propylene oxide units per molecule.
  • the coating and impregnation compositions of the invention include one or more acid.
  • the one or more acid may be selected from organic carboxylic acids, preferably a solid such acid.
  • solid carboxylic acids include: citric, salicylic, fumaric, benzoic, glutaric, lactic, malonic, acetic, glycolic, malic, adipic, succinic, aspartic, phthalic, tartaric, glutamic, pyroglutamic, gluconic acid, sorbic acid and mixtures of two or more thereof.
  • the acid for example citric acid
  • the range is 0.25 % w/w to 15% w/w. In one embodiment, the range is 1 % w/w to 12% w/w. In another embodiment, the range is 5% w/w to 10% w/w.
  • a preferred combination of polyol, surfactant and acid in the coating and impregnation compositions of this invention is propylene glycol; the non-ionic surfactant Polysorbate 20 (polyoxyethylene sorbitan monolaurate); and the acid citric acid.
  • the coating and impregnation compositions of this invention may also incorporate one or more antimicrobial compound.
  • antimicrobial compound examples include sorbic acid, benzoic acid, thymol, antimicrobial oils, quaternary ammonium compounds (e.g., benzalkonium chloride, cetrimide), phenolic compounds (e.g., triclosan, salicylic acid) biguanides (e.g., chlorhexidine, alexidine) and mixtures thereof.
  • compositions of this invention are suitably anhydrous, which compositions are not tacky, but provide a desired amount of lubrication and antimicrobial activity.
  • the ingredients of the coating form a liquid composition, which is applied to the article e.g., by dipping, spraying or other conventional means.
  • the instant composition dries quickly so there is no need for a prolonged drying process, or subsequent drying using heat.
  • Coated condoms were prepared by dipping the first 3-4 inches of the condom into the solution according to Composition 1 and Composition 2, below.
  • the resulting coating averaged about 400mg, which produced a citric acid content of about 40mg.
  • compositions containing citric acid dissolved in either polyethylene glycol (PEG) or propylene glycol (PG) have been successfully applied to latex condoms.
  • PEG polyethylene glycol
  • PG propylene glycol
  • Polyethylene Glycol 400 (PEG 400) 80.00
  • HSV-2 Herpes Simplex Virus type 2
  • Strain G obtained from ATCC (VR-734)
  • HV-1 Human Immunodeficiency Virus type 1
  • HSV-2 Herpes Simplex Virus type 2
  • HSV-1 Human Immunodeficiency Virus type 1
  • MEM Minimum Essential Medium
  • HSV-1 Human Immunodeficiency Virus type 1
  • Stock suspensions of HIV-1 were prepared to 4-8 log 10 TCID 50 /mL in RPMI-1640 containing 10% fetal bovine serum).
  • a suspension of either HIV-1 or HSV-2 was incubated to a 1 :10 dilution of each test substance for a 1 minute exposure time. Aliquots were then removed, neutralized by serial dilution, and assayed for the presence of virus by infecting susceptible host cells. Three replicates were performed for each test substance. The positive virus control, cytotoxicity controls, and neutralization controls were assayed in parallel.
  • the Spearman- Karber formula was used to calculate viral loads as TCID 50 . Antiviral efficacy was calculated from the difference between the geometric mean loads of virus in the solutions versus the original inoculation. The viral loads applied to the compositions in these experiments ranged from 5-5 to 6.25 log 10 TCID 50 for HSV-2, and 6.25 log 10 TCID 50 for HIV-1.
  • the average viral load of the solutions after a 1 minute exposure time ranged from below the limits of detection ( ⁇ 1 -5 log-io TCID 50 ) to 1.75 log-io TCID 50 . Therefore, the relative antiviral efficacy ranged from 4.25 to >_4. 50 log-io .
  • compositions were designed to be applied full strength as a condom lubricant, so the fact that a 1 :10 dilution is effective implies that likely lower levers of citric acid (e.g., at approx 1 % levels) may also be effective.
  • PG Composition 3; Composition 4
  • PEG Composition 5

Abstract

La présente invention concerne de nouveaux articles, et en particulier des articles isolants en latex, recouverts d'un revêtement antimicrobien utile pour la réduction du risque de contamination croisée et/ou d'infection par des microorganismes pathogènes nuisibles.
PCT/US2010/059625 2009-12-09 2010-12-09 Revêtement pour articles en latex WO2011072097A1 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
JP2012543274A JP2013513437A (ja) 2009-12-09 2010-12-09 ラテックス製品のためのコーティング
EP10836665.9A EP2509547A4 (fr) 2009-12-09 2010-12-09 Revêtement pour articles en latex
US13/513,970 US20120240937A1 (en) 2009-12-09 2010-12-09 Coating for Latex Articles

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US28502409P 2009-12-09 2009-12-09
US61/285,024 2009-12-09

Publications (1)

Publication Number Publication Date
WO2011072097A1 true WO2011072097A1 (fr) 2011-06-16

Family

ID=44145909

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2010/059625 WO2011072097A1 (fr) 2009-12-09 2010-12-09 Revêtement pour articles en latex

Country Status (4)

Country Link
US (1) US20120240937A1 (fr)
EP (1) EP2509547A4 (fr)
JP (1) JP2013513437A (fr)
WO (1) WO2011072097A1 (fr)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2017217194A1 (fr) * 2016-06-14 2017-12-21 株式会社トクヤマ Matériau protecteur destiné à un corps de bétail, kit de formation de film protecteur destiné à un corps de bétail et procédé de protection de zone malade/blessée de bétail
CN110467741A (zh) 2018-04-20 2019-11-19 中科艾玛科技成都有限公司 一种亲水超滑的避孕套

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5512289A (en) * 1993-07-28 1996-04-30 Johnson & Johnson Consumer Products, Inc. Spermicidal anti-viral lubricant composition and method of using same
US6321750B1 (en) * 1993-05-03 2001-11-27 Patrick D. Kelly Condom lubricants with zinc salts as anti-viral additives
US20040102429A1 (en) * 2002-02-07 2004-05-27 Modak Shanta M. Zinc salt compositions for the prevention of dermal and mucosal irritation
US20060189493A1 (en) * 2005-02-23 2006-08-24 Ansell Healthcare Products Llc Thickened spreadable warming lubricant
US20080145390A1 (en) * 2006-06-05 2008-06-19 The Dial Corporation Methods and articles having a high antiviral and antibacterial efficacy
US20090107513A1 (en) * 2007-10-26 2009-04-30 Ansell Healthcare Products Llc Condom With Multifunctional Coating

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060188528A1 (en) * 2005-02-23 2006-08-24 Ansell Healthcare Products Llc Spreadable warming lubricant

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6321750B1 (en) * 1993-05-03 2001-11-27 Patrick D. Kelly Condom lubricants with zinc salts as anti-viral additives
US5512289A (en) * 1993-07-28 1996-04-30 Johnson & Johnson Consumer Products, Inc. Spermicidal anti-viral lubricant composition and method of using same
US20040102429A1 (en) * 2002-02-07 2004-05-27 Modak Shanta M. Zinc salt compositions for the prevention of dermal and mucosal irritation
US20060189493A1 (en) * 2005-02-23 2006-08-24 Ansell Healthcare Products Llc Thickened spreadable warming lubricant
US20080145390A1 (en) * 2006-06-05 2008-06-19 The Dial Corporation Methods and articles having a high antiviral and antibacterial efficacy
US20090107513A1 (en) * 2007-10-26 2009-04-30 Ansell Healthcare Products Llc Condom With Multifunctional Coating

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of EP2509547A4 *

Also Published As

Publication number Publication date
JP2013513437A (ja) 2013-04-22
US20120240937A1 (en) 2012-09-27
EP2509547A1 (fr) 2012-10-17
EP2509547A4 (fr) 2013-07-17

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