WO2000050507A1 - Diminution de l'hypersensibilite associee au latex - Google Patents

Diminution de l'hypersensibilite associee au latex Download PDF

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Publication number
WO2000050507A1
WO2000050507A1 PCT/US2000/004002 US0004002W WO0050507A1 WO 2000050507 A1 WO2000050507 A1 WO 2000050507A1 US 0004002 W US0004002 W US 0004002W WO 0050507 A1 WO0050507 A1 WO 0050507A1
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WO
WIPO (PCT)
Prior art keywords
chitosan
latex
article
hypersensitivity
protective sheath
Prior art date
Application number
PCT/US2000/004002
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English (en)
Inventor
Hans Udo Kraechter
Rolf Wachter
Original Assignee
Cognis Corporation
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 Cognis Corporation filed Critical Cognis Corporation
Priority to AU41672/00A priority Critical patent/AU4167200A/en
Publication of WO2000050507A1 publication Critical patent/WO2000050507A1/fr

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Classifications

    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08K—Use of inorganic or non-macromolecular organic substances as compounding ingredients
    • C08K5/00—Use of organic ingredients
    • C08K5/0008—Organic ingredients according to more than one of the "one dot" groups of C08K5/01 - C08K5/59
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08J—WORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H
    • C08J7/00—Chemical treatment or coating of shaped articles made of macromolecular substances
    • C08J7/04—Coating
    • C08J7/0427—Coating with only one layer of a composition containing a polymer binder
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B42/00—Surgical gloves; Finger-stalls specially adapted for surgery; Devices for handling or treatment thereof
    • 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
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08J—WORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H
    • C08J2405/00—Characterised by the use of polysaccharides or of their derivatives not provided for in groups C08J2401/00 or C08J2403/00

Definitions

  • the present invention relates to methods and materials for reducing or eliminating hypersensitivity reactions such as dermatitis and allergic reactions associated with latex.
  • Latex containing products are widely used in industry and by consumers. Latex was originally isolated from plants, e.g., Havea braziliensis. Natural latex is typically made of globules of rubber hydrocarbon coated with protein and usually contains about 60% water, 35% hydrocarbon, 2% protein and relatively low percentages of sugars and inorganic salts. Compounding ingredients such as stabilizers and thickeners may be utilized in compounding latices. In addition, latex can be coagulated by treatment with electrolytes, freezing temperatures, or acid and concentrated by evaporation or centrifugation. Latex may be formed or processed into useful thin films or other configurations.
  • a vulcanized form of natural latex is available in which vulcanizing ingredients cause the solid phase deposited from latex to become cross-linked when suitable conditions such as elevated temperature are established.
  • Synthetic latexes are made by emulsion polymerization techniques from polychloroprenes, polystyrenes, polybutadienes, styrene-butadiene copolymers, acrylate resins, and polyvinyl acetate.
  • Additives include protective colloids, stabilizers, thickeners, pigments and vulcanization aids.
  • Latex is endowed with beneficial chemical and physical characteristics which promote widespread use of latex products. Such characteristics are well known and include, e.g., resistance to permeability of liquids such as water, alcohol, bodily secretions, etc., resistance to corrosion, and elasticity, i.e., the ability to return to original size and shape after compressing or stretching.
  • articles made from latex products have found use in a number of industries, e.g., medicine as, e.g., gloves, catheters, bandages and condoms.
  • Surgical gloves can be manufactured by providing hand-shaped molds or mandrels onto which a film forming latex is deposited by dipping or the like.
  • a mold-releasing powder is usually dusted first onto the mold to facilitate removal of the molded material from the mold. It is a usual practice to apply a lubricating substance onto the outside of the molded glove, so that when the finished glove is peeled from the mold and retroverted, the interior of the glove is thus coated with a layer of lubricating powder for ease in donning the glove.
  • Particles of the mold-releasing powder frequently remain on or entrapped in the exterior surface of the surgical glove and may be the cause of hypersensitivity. Sensitization may be caused by skin contact or by inhalation of glove powders, which may generally contain allergens.
  • U.S. Pat. No. 5,741,885 is directed to methods for reducing allergenicity of natural rubber latex articles and U.S. Pat. No. 4,540,407 is directed to surgical gloves and surface treatment of surgical gloves for avoiding starch peritonitis and the like. Due to the increasing incidence of hypersensitivity reactions to latex products, the need for additional techniques to reduce or eliminate such reactions is continuing.
  • An article of manufacture which includes latex and an effective latex hypersensitivity reducing amount of an anti-hypersensitivity agent selected from the group consisting of chitosan, chitosan derivative, anti-inflammatory agent and combinations thereof.
  • a protective sheath having a layer of material manufactured from latex and a coating of an anti-hypersensitivity agent selected from the group consisting of chitosan, chitosan derivative, anti-inflammatory agent and combinations thereof.
  • a method of reducing latex hypersensitivity reaction in an individual includes providing an article containing latex; coating the article with an effective amount of an anti-hypersensitivity agent selected from the group consisting of chitosan, chitosan derivative, anti-inflammatory agent and combinations thereof; and exposing the individual to the coated article.
  • a method of manufacturing a latex article having reduced hypersensitivity associated therewith which includes contacting and adhering the latex article with an anti-hypersensitivity agent selected from the group consisting of chitosan, chitosan derivative, anti-inflammatory agent and combinations thereof.
  • a method of binding water in a latex protective sheath which contacts skin which includes contacting and adhering chitosan or a chitosan derivative to a surface of the sheath which is intended to contact skin in an amount effective to absorb water.
  • the property of latex containing articles to promote hypersensitivity reactions including allergy, dermatitis or any other idiosyncratic reaction of an individual to latex or materials used to process latices or latex articles is reduced according to the present invention by treating such articles with an effective amount of an anti-hypersensitivity agent as defined herein.
  • the anti- hypersensitivity agent forms a protective film between the latex and skin or other latex contacting tissue.
  • the therapeutic action of the anti-hypersensitivity agent acts to block or reduce a sensitive individual's response to latex or materials used to process latices or latex articles.
  • the anti-hypersensitivity agent combines a protective film forming property with therapeutic action to block or reduce a sensitive individual's adverse response.
  • chitosan and/or chitosan derivatives are utilized as active ingredients for anti-hypersensitivity finishing of latices, specifically for coating of latices.
  • a protective film is created between skin or other body tissue and the potential allergens or other irritants in the latex, which if it does not completely exclude the possibility of precipitating a hypersensitivity reaction, nevertheless significantly reduces it.
  • a film formed from chitosan or a chitosan derivitation may adhere to skin, latex, both or neither.
  • a thin chitosan film can function as a "care polymer", i.e., it provides a pleasant skin feel and improved sliding ability.
  • the effect of glove disinfection is prolonged, since bacterial growth is stopped or at least retarded during the time the gloves are worn. Through these measures, the risk of hypersensitivity for the user and the risk of infection for the patient are distinctly reduced.
  • coating of the latices can take place in any conventional manner known to those skilled in the art; preferably the semifinished products or end products are dipped into an aqueous solution of the chitosans or sprayed with this and then dried.
  • latex containing articles are manufactured according to procedures well-known to those skilled in the art.
  • a common manufacturing process well-suited for utilization herein is the dip-forming process.
  • an article forming mandrel typically coated with a coagulating pre- treatment such as water, alcohol, or acetone suspension, is coated with a latex emulsion by dipping the mandrel into a latex emulsion bath or tank followed by rinsing and drying/curing steps prior to removal of the latex article from the mandrel.
  • the dip-formed latex articles are retroverted or turned inside out to peel or remove them from the forming mandrels.
  • the production of rubber gloves and condoms commonly utilizes such a retro version step for removal so that the inner surface of the finished article is actually the opposed outer surface of the originally dip-formed product.
  • the mandrel prior to dipping or otherwise applying latex to the mandrel, the mandrel is coated with chitosan or a chitosan derivative which can be in the form of a powder, gel, emulsion, suspension or solution which evaporates to leave a chitosan or chitosan derivative residue. It is contemplated that any method known to those skilled in the art may be utilized to apply chitosan or a derivative thereof to the mandrel.
  • the coated mandrel then receives a coating of latex by dipping, spraying or by any other known suitable coating process.
  • the coated mandrel into a latex emulsion results in a film which congeals to form a glove or other shaped object which is subsequently retroverted.
  • chitosan or a derivative thereof may be applied to the outer surface of the latex film, i.e., the surface not in contact with the mandrel, by spraying, dipping, painting or any other known coating method.
  • the mandrel contacting surface has been coated with chitosan or a derivative thereof, both the interior and exterior surfaces of the article will include chitosan or a derivative thereof.
  • chitosan or a derivative thereof is not coated on the mandrel surface, only the opposing surface will be made to include chitosan or a derivative thereof.
  • chitosan or a derivative thereof can be applied in the form of a powder, gel, emulsion, suspension or solution which evaporates to deposit a chitosan or derivative thereof residue on the mold interior prior to mold injection.
  • the chitosan or derivative thereof may be applied after removal of the article from the mold by coating the surface of the molded article.
  • any suitable manner of applying chitosan or a derivative thereof to a latex article is contemplated which does not substantially compromise the integrity of the finished latex product.
  • chitosan or a derivative thereof is introduced directly into the latex, for example by joint use of the substance as a vulcanizing aid in the manufacturing of the latices.
  • a vulcanizing aid in the manufacturing of the latices.
  • "Latex” is defined herein to include natural latex and synthetic latex polymers which, for example after coagulation by freezing or by treatment with electrolytes, are precipitated from aqueous dispersions and processed into thin films.
  • the latices which for example may involve, e.g., rubber, polychloroprenes, polystyrenes, polybutadienes, or copolymers of styrene and butadiene, acrylate resins and polyvinyl acetate may be produced by emulsion polymerization and can contain as additives protective colloids, stabilizers, thickeners, pigments and vulcanization aids.
  • chitosans are used as vulcanization aids, they can be used as additives in quantities of about 0.1 to about 2, preferably about 1 to about 1.5 wt% - based on the monomer - introduced into the emulsion polymerization or subsequently introduced into the aqueous or organic latices before these are freed from liquid phase, for example rolled into films, and then processed into the salable products.
  • powdered chitosan or derivatives thereof are utilized as water-binding agents in latex gloves.
  • the chitosan or derivatives thereof are capable of absorbing glove broth which may include, e.g., perspiration, microbes and powdered materials used to process the latex into the finished article, in this way improving the wearing comfort and reducing the risk of skin irritations.
  • glove broth may include, e.g., perspiration, microbes and powdered materials used to process the latex into the finished article, in this way improving the wearing comfort and reducing the risk of skin irritations.
  • the free moisture is reduced, bacterial growth conditions are made less favorable, thus leading to a lower infection risk.
  • Such powder preparation forms can serve directly as glove powder or also in a mixture with talc and similar additives.
  • Chitosans are biopolymers and are included in the group of hydrocolloids. Chemically they involve partially deacetylated chitins of various molecular weights that contain the following - idealized - monomer building block:
  • chitosans In contrast to most hydrocolloids, which are negatively charged in the range of biological pH values, chitosans represent cationic biopolymers under these conditions. The positively charged chitosans can interact with oppositely charged surfaces and are therefore used in cosmetic hair and body care agents as well as pharmaceutical preparations (see Ullmans's Encyclopedia of Industrial Chemistry, 5 th Ed., Vol. A6, Weinheim, Verlag Chemie, 1996, p. 231-332). Reviews on this topic have also been published by B. Gesslein et al. in HAPPI27:57 (1990), O. Skaugrud in
  • chitosans and derivatives thereof For producing chitosans and derivatives thereof, one begins from chitin, for example crustacean shell residues, which are available in large quantities as inexpensive raw materials.
  • the chitin is deproteinated in a well-known process first described by Hackmann et al., usually first through the use of bases, demineralized by addition of mineral acids, and finally deacetylated by addition of strong bases, wherein the molecular weights can be distributed over a broad spectrum.
  • chitosan or chitosan derivatives may range from about 25,000 daltons to about 5,000,000 daltons.
  • German Patent Applications DE-A1 4,442,987 and DE-A1 19, 537,001 (Henkel) and which have an average molecular weight of about 25,000 to about 500,000 or about 800,000 to about 1,200,000 dalton, a viscosity according to Brookfield (1 wt% in gly colic acid) of less than about 5,000 mPas, a deactylation degree in the range of about 80 to about 88%, and an ash content of less than about 0.3 wt%.
  • anionic and nonionic derivatized chitosans are known, for example carboxylation, succinylation, or alkoxylation products come under consideration, as described for example in German Patent DE-C2 3,713,009 (L'Oreal) as well as German Patent Application DE-A1 19,604, 180 (Henkel).
  • latex hypersensitivity is reduced or eliminated by coating a latex article with an anti-inflammatory agent.
  • an anti-inflammatory agent Any coating method known to those skilled in the art is contemplated including, e.g., the coating processes described above.
  • Anti-inflammatory agent includes substances which may have more than anti-inflammatory activity such as anti-allergy therapeutics, e.g, antihistamines and steroids.
  • any compound having anti-inflammatory activity may be utilized in accordance with the present invention.
  • substances having anti-inflammatory activity include but are not limited to steroidal and nonsteroidal anti-inflammatories such as indomethacin, ibuprofen, alpha hydroxy acids, vitamin A derivatives, vitamin E derivatives, orange peel wax, ascorbylpalmitate, lipon acid -dihydrolipon acid, bifidus-baktera, D-panthenol, jojoba, cyclo-adenosinmonophosphate, alpha tocopherol, ascorbic acid, 2,4-hexadien-l-ol, hydrocortisone, naproxen, glycosaminoglycans, dl-alpha-tocopherol nicotinate, linola-fat, aloe vera, azelaic acid, acetylsalicylic acid, phenylbutazone, alpha- bisabol
  • Et malonyl chloride 36239-09-5, ethyl, malonyl chloride (carbamoylation of, with aminopyridine), 503-38-8,, trichloromethyl chloroformate (cyclocondensation of, with anilinoniotinate), 105-53-3, diethyl malonate (cyclocondensation, of, with phenylpyridooxazinedione),51269-84-2, methyl,2-anilinonicotinate (cyclocondensation of, with trichloromethyl, chloroformate), 89109-17-lp (prepn. and addn.
  • reaction of, with isocyanates), 138305-19-8p prepn. and cyclocondensation of, with, di-et malonate and) ethoxycarbonyl)pyridylacetamide, 138305-21-2r, (prepn.
  • CAS registry numbers given above identify substances having anti-inflammatory activity which may be utilized herein.
  • Preferred anti-inflammatory compounds herein include corticosteriods, strontium salts and phytosterols.
  • the anti-inflammatory agent acts prophylactically and/or actively to prevent, reverse or reduce symptoms from an adverse reaction based on hypersensitivity to latex or materials used in processing latex.
  • the anti-inflammatory agent is absorbed topically and can be applied to the latex article in association with known pharmaceutically acceptable vehicles which facilitate transdermal delivery.
  • chitosan or a derivative thereof and an anti-inflammatory agent as defined above are coated in combination as an anti-hypersensitivity agent on a latex article.
  • the manufacturing procedures of latex containing articles described above are suitable for use in connection with this aspect of the present invention.
  • the points at which the anti-hypersensitivity agent can be applied to the latex article during the manufacturing process correspond.
  • a benefit of combining chitosan or a derivative thereof with an anti- inflammatory agent is that chitosan is known to increase effectiveness of transdermal delivery of therapeutic agents. Accordingly, the combination may be applied as a powder, a gel or as a mixture which is suspended, emulsified or in solution.
  • a powder vehicle When a powder vehicle is desired, an effective amount of a powdered anti-inflammatory agent is mixed with chitosan powder using pharmaceutically acceptable techniques such as trituration, milling and the like until a uniform mixture is obtained.
  • Liquid anti- inflammatory agents may be adsorbed onto powders such as talc prior to mixing. Pharmaceutically acceptable diluents and excipients may be incorporated if desired.
  • the powder may be applied to the mandrel, latex article, or both as described above.
  • an anti-inflammatory agent is mixed with a chitosan gel having about 1% to about 2% by weight of chitosan which is applied as a coating to either a mandrel, an external surface of a congealing latex article or to both.
  • Preferred anti-inflammatory agents for combination with chitosan or derivatives thereof include corticosteroids, strontium salts and phytosterols.

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  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Medicinal Chemistry (AREA)
  • Polymers & Plastics (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)

Abstract

Selon l'invention, on diminue ou élimine l'hypersensibilité aux produits contenant du latex en revêtant de tels produits au moyen d'un agent de lutte contre l'hypersensibilité, ou en les combinant à un tel agent, lequel comprend du chitosane, des dérivés de chitosane, des agents anti-inflammatoires ou des combinaisons de ceux-ci.
PCT/US2000/004002 1999-02-24 2000-02-16 Diminution de l'hypersensibilite associee au latex WO2000050507A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU41672/00A AU4167200A (en) 1999-02-24 2000-02-16 Reduction of latex associated hypersensitivity

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US12148699P 1999-02-24 1999-02-24
US60/121,486 1999-02-24

Publications (1)

Publication Number Publication Date
WO2000050507A1 true WO2000050507A1 (fr) 2000-08-31

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PCT/US2000/004002 WO2000050507A1 (fr) 1999-02-24 2000-02-16 Diminution de l'hypersensibilite associee au latex

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WO (1) WO2000050507A1 (fr)

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003103732A3 (fr) * 2001-11-06 2004-04-22 Du Pont Articles a base de polyolefine ayant des proprietes antimicrobiennes et leurs procedes de preparation
WO2005107660A1 (fr) * 2004-04-28 2005-11-17 Bruecker Achim Preservatif pourvu d'un revetement et composition
WO2006108333A1 (fr) * 2005-04-15 2006-10-19 Zhengming Zhou Produit en latex ou pvc antiallergique et méthode pour le former
CN1301294C (zh) * 2004-03-10 2007-02-21 阴法义 医用复合壳聚糖液体成膜手套
FR2910015A1 (fr) * 2006-12-18 2008-06-20 Jean Loic Baratoux "composition a base d'un melange polymere utilisee comme revetement de substrats solides"
CN101870778A (zh) * 2010-07-09 2010-10-27 中国热带农业科学院农产品加工研究所 一种预硫化天然胶乳/壳聚糖共混膜材料及其制备方法
ITMI20102327A1 (it) * 2010-12-20 2012-06-21 Monciardini Leonardo Dispositivo monouso di protezione di coppia per aumentare le dimensioni del pene
CN110330702A (zh) * 2019-08-02 2019-10-15 唐卫兵 一种内衣用天然抗菌乳胶衬垫的制备方法

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1995017453A1 (fr) * 1993-12-23 1995-06-29 Hutchinson Film d'elastomere, son procede de preparation et ses applications
DE19742318A1 (de) * 1997-09-25 1999-04-01 Henkel Kgaa Verwendung von Chitosan und/oder Chitosanderivaten zur antiallergischen Ausrüstung von Latices
US5985955A (en) * 1994-07-21 1999-11-16 Witco Corporation Hypoallergenic coating composition for latex rubber gloves

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1995017453A1 (fr) * 1993-12-23 1995-06-29 Hutchinson Film d'elastomere, son procede de preparation et ses applications
US5985955A (en) * 1994-07-21 1999-11-16 Witco Corporation Hypoallergenic coating composition for latex rubber gloves
DE19742318A1 (de) * 1997-09-25 1999-04-01 Henkel Kgaa Verwendung von Chitosan und/oder Chitosanderivaten zur antiallergischen Ausrüstung von Latices

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003103732A3 (fr) * 2001-11-06 2004-04-22 Du Pont Articles a base de polyolefine ayant des proprietes antimicrobiennes et leurs procedes de preparation
CN1301294C (zh) * 2004-03-10 2007-02-21 阴法义 医用复合壳聚糖液体成膜手套
WO2005107660A1 (fr) * 2004-04-28 2005-11-17 Bruecker Achim Preservatif pourvu d'un revetement et composition
WO2006108333A1 (fr) * 2005-04-15 2006-10-19 Zhengming Zhou Produit en latex ou pvc antiallergique et méthode pour le former
JP2008532717A (ja) * 2005-04-15 2008-08-21 政明 周 抗アレルギー性のラテックス又はｐｖｃ製品及びその製造方法
FR2910015A1 (fr) * 2006-12-18 2008-06-20 Jean Loic Baratoux "composition a base d'un melange polymere utilisee comme revetement de substrats solides"
CN101870778A (zh) * 2010-07-09 2010-10-27 中国热带农业科学院农产品加工研究所 一种预硫化天然胶乳/壳聚糖共混膜材料及其制备方法
ITMI20102327A1 (it) * 2010-12-20 2012-06-21 Monciardini Leonardo Dispositivo monouso di protezione di coppia per aumentare le dimensioni del pene
CN110330702A (zh) * 2019-08-02 2019-10-15 唐卫兵 一种内衣用天然抗菌乳胶衬垫的制备方法

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Publication number Publication date
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