WO2001000156A1 - Administration d"un agent benefique pour la peau sur un substrat traite - Google Patents

Administration d"un agent benefique pour la peau sur un substrat traite Download PDF

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Publication number
WO2001000156A1
WO2001000156A1 PCT/US2000/017999 US0017999W WO0100156A1 WO 2001000156 A1 WO2001000156 A1 WO 2001000156A1 US 0017999 W US0017999 W US 0017999W WO 0100156 A1 WO0100156 A1 WO 0100156A1
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WO
WIPO (PCT)
Prior art keywords
substrate
skin
benefit agent
health benefit
surfactant
Prior art date
Application number
PCT/US2000/017999
Other languages
English (en)
Inventor
David John Tyrrell
Robert Cosmo Diluccio
Ali Yahiaoui
Dennis Stein Everhart
Wade Bolton May
Original Assignee
Kimberly-Clark Worldwide, Inc.
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 Kimberly-Clark Worldwide, Inc. filed Critical Kimberly-Clark Worldwide, Inc.
Priority to AU59016/00A priority Critical patent/AU5901600A/en
Priority to MXPA01012650A priority patent/MXPA01012650A/es
Publication of WO2001000156A1 publication Critical patent/WO2001000156A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q19/00—Preparations for care of the skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/19—Cosmetics or similar toiletry preparations characterised by the composition containing inorganic ingredients
    • A61K8/23—Sulfur; Selenium; Tellurium; Compounds thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/64—Proteins; Peptides; Derivatives or degradation products thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/18—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing inorganic materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/22—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
    • A61L15/32—Proteins, polypeptides; Degradation products or derivatives thereof, e.g. albumin, collagen, fibrin, gelatin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/42—Use of materials characterised by their function or physical properties
    • A61L15/48—Surfactants

Definitions

  • This invention relates to the use of a skin health benefit agent to enhance skin health
  • a treatment combination includes a surfactant and skin health benefit agent that can be applied to a substrate such as a nonwoven web, such that the composition will impart adequate fluid handling properties to the substrate and will subsequently be transferred to the skin for enhancing skin health
  • the treatment composition may further be used as a vehicle to deliver other agents to the skin, e g proteins BACKGROUND OF THE INVENTION
  • the skin is naturally an excellent barrier to the penetration of many foreign substances From time-to-time, the natural ability of the skin to protect is compromised by external factors including abrasions, irritants and the like Attempts have been made in recent years to promote skin health through the use of various products containing additives or developing synthetic or naturally occurring polymers that mimic or complement the properties of skin in order to maintain the skin health
  • Enhancing skin health and delivering agents to the skin to promote skin health has many advantages including 1) protecting the skin and maintaining the skin in a moist state, essentially free from chapping or irritation, 2) pH buffering and barrier enhancement to maintain or enhance such base properties of skin, 3) inhibition of irritants that are suspected to promote irritant or allergic contact dermatitis, and 4) maintaining the lubricity of skin
  • the permeability of the skin to a foreign substance is influenced by a combination of physico-chemical parameters for both the object and the vehicle, if applicable, that delivers the object Maintaining health of the skin and its underlying barrier properties requires optimal physico-chemical properties of the skin
  • a treatment composition for use with a substrate that is capable of delivering a thin, tenacious, substantially continuous film of the skin health benefit agent to the skin that can prevent or reduce skin irritation, maintain pH, and maintain skin hydration and lubrication
  • the combination of the instant invention fulfills this need
  • skin wellness additives are known, other compositions have had the undesired side effect of reducing wettabihty, or the fluid intake rate, of the substrate
  • a treatment combination for application and use with a substrate that will not adversely affect fluid handling properties of the substrate, e g fast and sustainable fluid intake rate
  • the present invention relates to a combination for surface treatment of a substrate, e g a nonwoven web, used in personal care product applications
  • the surface treatment combination not only provides adequate fluid handling properties, but also provides a topical delivery system effective in depositing a thin, tenacious and substantially continuous coating of a skin health benefit agent on skin by an aqueous emulsion mediated dissolution of the agent from a substrate with subsequent transfer and deposition onto the skin Coatings of the skin health benefit agent on the skin resist removal, thereby preventing damage to the natural skin barrier and providing a protective barrier against mechanically-, chemically-, and biochemically-induced skin damage
  • a treatment combination for application and use with a substrate that will not adversely affect fluid properties of the substrate, e g fast and sustainable fluid intake rate as long as the material/product is being used
  • FIG 1 is a schematic illustration of a treating process useful for application of the treatment combination of the present invention to one or both sides of the nonwoven web
  • FIG 2 is a partially cut-away top plan view of an exemplary personal care product, in this case a diaper, which may utilize the treated substrate according to the present invention
  • FIG 3 is a 200X optical microscopy (B ⁇ ghtfield and Fluorescent Image) of a substrate treated with a treatment composition according to an aspect of the present invention
  • FIG 4 is a 200X optical microscopy (Fluorescent Image) showing the liquid mediated transfer of the treatment composition from the treated substrate and dissolving in the liquid
  • FIG 5 is a 200X optical microscopy (Fluorescent Image) of skin that has been treated with a treatment composition including liquid mediated transfer of the composition to the skin, wherein the skin health benefit agent has been labeled with a fluorescent dye to show the transfer of a thin, tenacious, substantially continuous film to the skin
  • FIG 6 is a 100X optical microscopy (B ⁇ ghtfield and Fluorescent Image) of skin that has been treated in accordance with the prior art in that the treatment composition has been transferred to the skin by mechanical transfer, wherein a silk protein has been labeled with a fluorescent dye to show the transfer of a substantially discontinuous film
  • FIG 7 is a graph comparing inhibition of proteolytic activity by zinc sulfate heptahydrate in accordance with the present invention
  • FIG 8 is another graph comparing inhibition of proteolytic activity by zinc sulfate heptahydrate in accordance with the present invention
  • FIG 9 is a graph showing reduction of released ⁇ nterleuk ⁇ n-1 alpha by zinc in accordance with the present invention
  • FIG 10 is a graph showing reduction of released ⁇ nterleuk ⁇ n-1 alpha by zinc in accordance with the present invention
  • Combinations and methods are provided by the present invention for topical administration of treatment compositions to the skin of mammals, especially humans, to protect the skin by preserving and restoring the natural integrity of the skin
  • This is achieved by depositing a skin health benefit agent from a substrate that is able to control the release of the agent to the surface of the skin and that is able to provide adequate handling of body fluids
  • the skin health benefit agent acts as a protectorant that is capable of maintaining the pH of the skin, inhibit the activity of irritants to the skin, and maintain skin hydration and lubrication
  • Pancreatic digestive enzymes that are expelled by the body with feces have been implicated to induce skin inflammation (Anderson, P H , Bucher, A P , Saees, II, Lee, P C , Davis, J A , and Maibach, H I , Faecal enzymes in vivo skin irritation Contact Dermatitis 1994, 30, 152-158) When the feces, including these enzymes, contact the skin, the skin
  • the nonionic surfactant may include the condensation products of a higher alcohol (e g , an alkanol containing about 8, 9, 10, 11 , 12, 13, 14, 15, 16, 17 or 18 carbon atoms in a straight or branched chain configuration) condensed with about 5 to 30 moles of ethylene oxide
  • a higher alcohol e g , an alkanol containing about 8, 9, 10, 11 , 12, 13, 14, 15, 16, 17 or 18 carbon atoms in a straight or branched chain configuration
  • examples include lauryl or mynstyl alcohol condensed with about 16 moles of ethylene oxide (EO), t ⁇ decanol condensed with about 6 moles of EO, mynstyl alcohol condensed with about 10 moles of EO per mole of mynstyl alcohol, the condensation product of EO with a cut of coconut fatty alcohol containing a mixture of fatty alcohols with alkyl chains varying from 10, 11 , 12, 13 or 14 carbon atoms in length and wherein the conden
  • the present invention provides zinc compositions to reduce or prevent skin irritation and/or acute inflammatory reactions of the skin.
  • such agents include zinc salt, zinc sulfate monohydrate, and the like.
  • the zinc salt will be present in the composition as an aqueous emulsion.
  • These agents are useful as astringents and enzyme inhibitors, and more particularly useful in inhibiting both fecal and urine proteases.
  • Zinc can either directly interact with the catalytic site of the protease, in particular, the class of proteases known as serine proteases, to inhibit proteolytic activity. By inhibiting the proteolytic activity, the intent is to keep the skin from ever becoming irritated, rather than treating the skin once it has become irritated.
  • a further advantage of the skin health benefit agent of the present invention relates to lowering the pH.
  • the serine proteases e.g. trypsin and pancreatic elastase, which are present in, for example, feces and urine, have a pH optimum of approximately 8.0 and 8.5, respectively.
  • the skin health benefit agent of the present invention has unexpectedly been found to lower the pH, thereby decreasing the catalytic efficiency of these proteases.
  • the amount of skin health benefit agent will be introduced in the combination described above in the range of from about 0.01 % to about 10% by weight of the composition.
  • the agent will be present in the amount of about 0.25% to about 1% by weight of the composition.
  • compositions and methods are also provided by the present invention for topical administration of the skin health benefit agent concurrently with a protein that can be administered topically in a controlled manner.
  • Sericin is one of two proteins that are part of the twin fibroin silk thread spun by Bombyx mori, a domestic insect. Sericin acts as a protective envelope around the fibroin thread as it is spun, which is like spinning of fibers with soluble sizing agents to help form good quality fibers
  • the sericin can be easily separated from silk protein by hydrolysis
  • Post-spun sericin, with its unique properties, is known to have high affinity to a number of proteins When refined to a high molecular weight substance it is amenable to binding to the keratin of skin and hair, forming a resistant, moisturizing, and protective film on the skin/hair, imparting good barrier properties
  • Sericin is a silk protein obtained by controlled hydrolysis of low molecular weight silk having a specific gravity of at least about 1
  • a commercially available silk protein is available from Croda, Inc , of Parsippany, NJ, and is sold under the trade name CROSILK LIQUID (silk ammo acids), CROSILK 10,000 (hydrolyzed silk), CROSILK POWDER (powdered silk), and CROSILKQUAT (cocodimonium hydroxypropyl silk ammo acid)
  • CROSILK LIQUID sik ammo acids
  • CROSILK 10,000 hydrolyzed silk
  • CROSILK POWDER powdered silk
  • CROSILKQUAT cocodimonium hydroxypropyl silk ammo acid
  • SERICIN available from Pentapharm, LTD, a division of Kordia, bv, of the Netherlands
  • the silk protein derivatives may be chosen from one of several potential compositions Included among the silk derivatives are silk fibers and hydrolysate of silk fibers.
  • the silk fibers may be used in the form of powder in preparing the emulsion or as a powder of a product obtained by washing and treating the silk fibers with an acid
  • silk fibers are used as a product obtained by hydrolysis with an acid, alkali or enzyme, as disclosed in U S Patent No 4,839,168 to Abe et al , U S Patent No 5,009,813 to Watanube et al , and U S Patent No 5,069,898 to Goldberg, each incorporated herein by reference in its entirety
  • Another silk derivative that may be employed in the composition of the present invention is protein obtained from degumming raw silk, as disclosed, for example, in U S Patent No 4,839,165 to Hoppe et al , incorporated herein by reference in its entirety
  • the principal protein obtained from the raw silk is sericin, which has an empirical formula of C 15 H 25 O 3 N 5 and a molecular weight of about 323 5
  • a preferred silk derivative is a mixture of two or more individual ammo acids, which naturally occur in silk
  • the principal silk ammo acids are glycme, alanine, serine and tyrosme
  • a silk derivative for use in the emulsion composition of the present invention is a fine powder of silk fibroin in nonfibrous or particulate form, as disclosed in U S Patent No 4,233,212 to Otoi et al , incorporated herein by reference in its entirety
  • the fine powder is produced by dissolving a degummed silk material in at least one solvent selected from, for example, an aqueous cup ⁇ ethylene diamine solution, an aqueous ammonia solution of cupnc hydroxide, an aqueous alkaline solution of cupric hydroxide and glycerol, an aqueous lithium bromide solution, an aqueous solution of the chloride, nitrate or thiocyanate of calcium, magnesium or zinc and an aqueous sodium thiocyanate solution
  • the resulting fibroin solution is then dialyzed
  • the dialyzed aqueous silk fibroin solution having a silk fibroin concentration of from about 3 to 20% by weight, is subjected to at least
  • the resulting product is a silk fibroin gel, which may be incorporated directly into a treatment composition or the same may be dehydrated and dried into a powder and then dissolved in the treatment composition
  • the silk material used to form the silk fibroin includes cocoons, raw silk, waste cocoons, raw silk waste, silk fabric waste and the like
  • the silk material is degummed or freed from sericin by a conventional procedure such as, for example, by washing in warm water containing a surfactant-active agent or an enzyme, and then dried
  • the degummed material is dissolved in the solvent and preheated to a temperature of from about 60 to 95°C, preferably of from about 70 to 85°C Further details of the process of obtaining the silk fibroin are discussed in previously referenced U S Patent No 4,233,212
  • an additional protein may be present in the amount of about 0 1 to about 4 0% by weight
  • This additional protein may be selected from the group consisting of hydrolyzed animal collagen protein obtained by an enzymatic hydrolysis, lexeme protein, vegetal protein and hydrolyzed wheat protein and mixtures thereof
  • composition of the present invention can be in the form of an oil-in-water (o/w) emulsion or after dilution with water, with the essential ingredients being water, surfactant, and/or co-surfactant
  • composition as prepared is an aqueous liquid formulation and since no particular mixing is required to form the o/w emulsion, the composition is easily prepared simply by combining all the ingredients in a suitable vessel or container
  • the order of mixing the ingredients is not particularly important and generally the various ingredients can be added sequentially or all at once or in the form of aqueous emulsions of each or all of the primary surfactants and co-surfactants can be separately prepared and combined with each other
  • emulsions of, for instance, organic acid emulsions would not be acceptable for use in the present invention, since such emulsions would be a strong skin irritant and counterproductive to the intended use of the present invention
  • the protein when present, can be added as an aqueous emulsion thereof or can be added directly It is not necessary to use elevated temperatures in the formation step and room temperature is sufficient However, higher temperatures of up to about 180°F (82 2°C), preferably 110 to 140°F (43 3 to 60°C), can also be used
  • the treatment compositions will often be sterilized or formulated to contain one or more preservatives for incorporation into pharmaceutical, cosmetic or veterinary formulations
  • These treatment compositions can be sterilized by conventional, well-known sterilization techniques, e g , boiling or pasteurization, without substantially adversely affecting the biological activity of the composition
  • the compositions may contain pharmaceutically acceptable auxiliary substances as required to approximate physiological conditions and as necessary to prepare compositions for convenient administration, such as pH adjusting and buffering agents, preservatives, and delivery vehicles
  • auxiliary substances as required to approximate physiological conditions and as necessary to prepare compositions for convenient administration, such as pH adjusting and buffering agents, preservatives, and delivery vehicles
  • Actual methods for preparing pharmaceutically administrable compounds will be known or apparent to those skilled in the art and are described in detail in, for example, Remington's Pharmaceutical Science, supra
  • Perfumes, dyes and pigments can also be incorporated into the treatment compositions of the invention
  • the peptone-copper complexes can be provided separately or may be compounded with conventional nontoxic carriers such as, for example, aloe vera gel, squalene, glycerol stearate, polyethylene glycol, cetyl alcohol, stea ⁇ c acid, and propylene glycol, among others
  • nontoxic carriers such as, for example, aloe vera gel, squalene, glycerol stearate, polyethylene glycol, cetyl alcohol, stea ⁇ c acid, and propylene glycol, among others
  • Such compositions may contain about 5-100% active ingredients, more preferably about 5-25%
  • compositions formulated for administration to the skin are administered to a wearer, such as humans, with un-compromised skin or in situations where a subject is already suffering from damaged skin (e g , peeling) due to ultraviolet or other irradiation or oxidative skin damage
  • the treatment compositions are administered in an amount sufficient to allow inhibition of further damage by topically administered irritating substances or other unknown irritating substances and are more effective than if the host were not treated
  • Amounts adequate to accomplish these effects are defined as a "therapeutically effective dose” and will vary according to the application
  • the compositions are employed for protecting the skin from damage
  • the skin health benefit agents and/or silk proteins are administered to a host under conditions which protect the integrity of the skin, maintains physiological pH, skin hydration and lubrication
  • the precise amounts again depend on the amount of protection desired and the extent and conditions under which the skin is exposed to potentially damaging conditions, such as those caused by fecal and urine proteases, or other irritating substances They can generally range from about 0 1 mg to about 10 mg per day per square centimeter of skin
  • Single or multiple administrations of the compositions can be carried out daily or over a prolonged period of time
  • the silk proteins of the invention may be administered to the skin in relatively large amounts without serious side effects, although indiscriminate use may produce irritation of the skin
  • the dose may be adjusted to lower maintenance levels
  • the treatment composition providing skin protection and enhanced repair of the present invention, including pharmaceutical compositions may be administered alone or as combination or adjunct therapy or prophylaxis
  • the treatment compositions can be used in combination with other skin protective factors or those found to improve other aspects of protection or healing In this manner a synergistic effect may be attained that yields a clinical efficacy greater than that realized with any single factor
  • the compositions described herein stimulate a spectrum of skin protective processes, skin can differ considerably in its properties, leading one to utilize a combination of a composition described herein and another compound or factor
  • Factors with reported healing properties which can be included with the silk protein compositions for use in protective/healing formulations and methods of the present invention include, for example, epidermal growth factor, fibroblast growth factor, nerve growth factor, transforming growth factors, angiogenic growth factors, hepa ⁇ n, fibronectm, fibrin, platelet-derived growth factor, enzymatic superoxide dismutase, extracts of blood or factors from the blood, and other similar factors
  • substrate refers to a material that can be a woven fabric, knit fabric, nonwoven fabric, foam, film-like mate ⁇ ai (e g an apertured film-like material) or paper material
  • Particularly useful substrates include infant and child care products such as disposable diapers, training pants and baby wipes, feminine hygiene products such as menses absorbing devices like sanitary napkins and tampons, bandages, and incontinent products, for example
  • the substrate is often normally hydrophobic and contains a treatment composition placed so as to contact the exudate
  • Many polymers useful in the formation of nonwoven webs, e g polypropylene, are hydrophobic and highly apolar As is known to those skilled in the art, sericin is highly hydrophihc, hence it is polar There is, therefore,
  • the substrate is a nonwoven web and may be, for example, a spunbond, meltblown, coformed or bonded carded web
  • Additional substrates which can be used include foams and films that are fib ⁇ llated, apertured or otherwise treated to have fiber-like properties as well as laminates of these and/or nonwoven webs
  • the substrate may be used as a body contact liner, a distribution layer between a liner and an absorbent layer, an absorbent layer, or in more than one of these layers
  • nonwoven fabric or web means a web having a structure of individual fibers or threads, which are interlaid, but not in a regular or identifiable manner as in a knitted fabric
  • the term also includes individual filaments and strands, yarns or tows as well as foams and films that have been fib ⁇ llated, apertured, or otherwise treated to impart fab ⁇ c-hke properties
  • Nonwoven fabrics or webs have been formed from many processes such as for example, meltblowing processes, spunbond g processes, coforming processes and bonded carded web processes
  • the basis weight of nonwoven fabrics is usually expressed in ounces of material per square yard (osy) or grams per square meter (gsm) and the fiber diameters useful are usually expressed in microns (Note that to convert from osy to gsm, multiply osy by 33 91)
  • microfibers means small diameter fibers having an average diameter not greater than about 50 microns, for example, having an average diameter of from about 0 5 microns to about 50 microns, or more particularly, microfibers may have an average diameter of from about 2 microns to about 40 microns
  • denier is defined as grams per 9000 meters of a fiber and may be calculated as fiber diameter in microns squared, multiplied by the density in grams/cc, multiplied by 0 00707
  • a lower denier indicates a finer fiber and a higher denier indicates a thicker or heavier fiber
  • the diameter of a polypropylene fiber given as 15 microns may be converted to denier by squaring, multiplying the result by 0 89 g/cc and multiplying by 0 00707
  • spunbonded fibers refers to small diameter fibers which are formed by extruding molten thermoplastic material as filaments from a plurality of fine usually circular capillaries of a spinneret with the diameter of the extruded filaments then being rapidly reduced as, for example, described in U.S. Patent No. 4,340,563 to Appel et al., and U.S. Patent No. 3,692,618 to Dorschner et al., U.S. Patent No. 3,802,817 to Matsuki et al., U.S. Patent Nos. 3,338,992 and 3,341 ,394 to Kinney, U.S. Patent No. 3,502,763 to Hartmann, U.S.
  • Spunbond fibers are quenched and generally not tacky when they are deposited onto a collecting surface and usually subjected to a separate bonding step.
  • Spunbond fibers are generally continuous and have average diameters frequently larger than 7 microns, more particularly, between about 10 and 20 microns.
  • the term "meltblown fibers" means fibers formed by extruding a molten thermoplastic material through a plurality of fine, usually circular, die capillaries as molten threads or filaments into converging high velocity, usually heated, gas (e.g.
  • meltblown fibers are carried by the high velocity gas stream and are deposited on a collecting surface often while still tacky to form a web of randomly dispersed meltblown fibers.
  • meltblown fibers are microfibers which are usually continuous, but which may also be discontinuous, and are generally smaller than 10 microns in average diameter.
  • the substrate of the present invention may also include a bonded carded web.
  • bonded carded webs or “BCW” refers to nonwoven webs formed by carding processes as are known to those skilled in the art and further described, for example, in coassigned U.S. Patent No. 4,488,928 to Alikhan and Schmidt which is incorporated herein by reference in its entirety.
  • carding processes involve starting with a blend of, for example, staple fibers with bonding fibers or other bonding components in a bulky batt that is combed or otherwise treated to provide a generally uniform basis weight. This web is heated or otherwise treated to activate the adhesive component resulting in an integrated, usually lofty nonwoven material
  • nonwoven webs may be formed from different types of polymers, which may be extruded as monocomponent fibers, biconstituent fibers and/or conjugate fibers (multi- and bicomponent fibers) filaments
  • Biconstituent fibers are sometimes also referred to as multiconstituent fibers
  • Fibers of this general type are discussed in, for example, U S Patent No 5,108,827 to Gessner Bicomponent and biconstituent fibers are also discussed in the textbook Polymer Blends and Composites by John A Manson and Leslie H Sperling, copyright 1976 by Plenum Press, a division of Plenum Publishing Corporation of New York, IBSN 0-306-30831-2, at pages 273 through 277
  • Conjugate fibers are taught in U S Patent No 5,108,820 to Kaneko et al , U S Patent No 5,336,552 to Strack et al , and U S Patent No 5,382,400 to Pike et al
  • additives may be added for color, anti-static properties, lubrication, hydrophilicity, antibacterial, antimold, deodorizing effect, and the like
  • additives e g titanium dioxide for color and chitosan as an antibacterial, are generally present in an amount less than 5 weight percent and more typically about 2 weight percent
  • personal care product includes diapers, training pants, swim pants, absorbent underpants, adult incontinence products, sanitary wipes, feminine hygiene products such as sanitary napkins and tampons, wound dressings and bandages
  • hydrophobic means that the polymeric material has a surface free energy such that the polymeric material is wettable by an aqueous medium, i e a liquid medium of which water is a major component
  • hydrophobic includes those materials that are not hydrophihc as defined Hydrophobic materials may be treated internally or externally with surfactants and the like to render them hydrophihc
  • the substrate of the present invention may be a multilayer laminate
  • a multilayer laminate is an embodiment wherein some of the layers are spunbond and some meltblown such as a spunbond/meltblown/spunbond (SMS) laminate as disclosed in U S Patent No 4,041 ,203 to Brock et al , U S Patent No 5,169,706 to Collier, et al, and U S Patent No 4,374,888 to Bornsiaeger
  • SMS spunbond/meltblown/spunbond
  • Such substrates usually have a basis weight of from about 0 1 to 12 osy (6 to 400 gsm), or more particularly from about 0 75 to about 3 osy
  • Spunbond nonwoven fabrics are generally bonded in some manner as they are produced in order to give them sufficient structural integrity to withstand the rigors of further processing into a finished product Bonding can be accomplished in a number of ways such as hydroentanglement, needling, ultrasonic bonding, adhesive bonding, stitchbonding, through-air bonding and thermal bonding such as calendering
  • the addition of the treatment composition to the substrate may be accomplished by conventional means such as spraying, coating, dipping and the like although the use of high solids spray is advantageous in cases where drying and/or compression is desired to be minimized
  • the amount of the treatment composition used will depend on the particular end use as well as factors such as basis weight and porosity of the substrate Referring to FIG 1 , an exemplary process will be described for application to one or both sides of a traveling substrate It will be appreciated by those skilled in the art that the invention is equally applicable to inline treatment or a separate, offline treatment step
  • Substrate 12 for example a spunbond or meltblown nonwoven web is directed over support rolls 15,17 to a treating station including rotary spray heads 22 for application to one side 14 of web 12
  • An optional treating station (shown in phantom) which may include rotary spray heads 18 can also be used to apply to opposite side 23 of substrate 12
  • Each treatment station receives a supply of treatment composition 30 from a reservoir (not shown)
  • the treated substrate may then be dried if needed by passing
  • FIG 2 An exemplary article 80, in this case a diaper, is shown in FIG 2
  • most such personal care absorbent articles 80 include a liquid permeable top sheet or liner 82, a barrier back sheet or outercover 84 and an absorbent core 86 disposed between and contained by the top sheet 82 and back sheet 84
  • Articles 80, such as diapers may also include some type of fastening means 88 such as adhesive fastening tapes or mechanical hook and loop type fasteners to maintain the garment in place on the wearer
  • the substrate 12 may be used to form various portions of the article including, but not limited to the top sheet or liner 82
  • compositions of the present invention were formed by creating an emulsion of a skin health benefit agent and water as the carrier liquid
  • Aqueous emulsions of zinc salt as the skin health benefit agent, AHCOVEL, as the surfactant system, and, in some instances, SERICIN and CROSILK as the silk protein were prepared
  • the stable emulsions were diluted to about a 5% by weight emulsion and applied to the surface of a polyolefm nonwoven liner fabric at 3 and 6% by weight via a saturation dip and squeeze process as described in more detail below
  • the fabrics were then tested for fluid intake rate, softness, skin transfer, skin barrier, anti-inflammatory, and the like, as describe in more detail below
  • Fluid Intake Rate This test is identified as Fluid Stnkethrough EDANA 150 1-90 and measures the time taken for a known volume of liquid (simulated urine) applied to the surface of a nonwoven test sample in contact with an underlying absorbent pad to pass through the nonwoven
  • a 50 ml burette is positioned on a ring stand with the tip inside a funnel
  • a standard absorbent pad of 5 plies of specified filter paper (482% absorbency) is placed on an acrylic glass base plate below the funnel, and a nonwoven sample is placed on top of the absorbent
  • An acrylic glass strike-through plate 25 mm thick and weighing 500 g is placed over the sample with the cavity centered 5 mm below the funnel
  • the burette is filled with liquid, keeping the funnel closed, and a quantity of the liquid (e g , 5 ml or 10 ml) is run into the funnel
  • the 5 ml or 10 ml is allowed to discharge starting a timer which stops when the liquid has penetrated into the pad and fallen below a set of electrodes
  • Sericin was labeled with the fluorescent dye, Texas Red (TR), according to the procedure suggested by Molecular Probes, Inc , Eugene OR (Texas Red protein labeling kit F-6162) A 4 5 wt % emulsion of sericin, 200uL, was reacted with 100uL of a 5mg/mL solution of Texas Red succinimide in dimethylsulfoxide for 1 hour The thus labeled protein was isolated via gel chromatography with centrifugation for 3 minutes at 1100 x g Emulsions of Ahcovel containing a mixture of TR labeled and unlabelled sericin was used to treat a substrate of 0 6 osy polypropylene spunbond nonwoven web, prepared as a diaper liner according to the procedure described Fluorescent microscopy using a high pressure Hg lamp with excitation and emission bandpass filters of 595nM and 615nM, respectively, confirmed the presence of the labeled protein on the substrate
  • FIG 3 is a 200X optical microscopy (TR
  • FIG 4 is a 200X optical microscopy (Fluorescent Image) showing this liquid mediated transfer of the treatment composition from the treated substrate and dissolving in the liquid
  • FIG 5 shows the thin, tenacious, substantially continuous film of silk protein that was applied to the skin by means of the present invention
  • the morphology of the resulting protein coating was consistent with a thin, tenacious, substantially continuous film of the sericin protein on the corneocytes of the forearm
  • FIG 6, shows the variability of application of
  • the fabrics were then tested for topical delivery of the zinc salt using excised skins in modified FRANZ diffusion cells
  • the amount of zinc accumulating and penetrating the skin was determined over a 36 hour period
  • the accumulation of zinc was determined to be 1311 ⁇ g/g dry weight of skin, while the penetration was measured to be 3 2 ⁇ g/cnr/hr
  • Anti-inflammatory The effect of skin health benefit agent to inhibit the hydrolysis of a model protein substrate by urine and a fecal extract was determined In addition, the ability of the skin health benefit agent to reduce a fecal extract-elicited pro-inflammatory response in EpiDermTM was measured A silk protein applied to a material was also placed on the EpiDermTM sample, both before and after application of the fecal irritant and evaluated for its ability to reduce a fecal-extract pro-inflammatory response The release of a pro-inflammatory signaling molecule lnterleuk ⁇ n-1 alpha, was compared to that of the control not containing the skin health benefit agent
  • a fecal extract sample was prepared from feces obtained from an infant on antibiotics (Sulfat ⁇ m) who had diaper rash
  • the feces was suspended in water and vigorously vortexed After vortexmg, the sample was held on ice prior to centrifugation at 15,000 times the force of gravity for 20 minutes
  • the fecal extract (7.1 mg/ml in water) was diluted in water to 2 ⁇ g/ml.
  • the zinc sulfate heptahydrate (Aldrich Chemicals, WI) solutions (20 ⁇ L) having a molecular weight of 287.5 were added to wells of a 96 white plate (Dynex, Chantilly, VA) containing 100 ⁇ L of a fecal extract and allowed to incubate for 15 minutes at room temperature.
  • the reaction was initiated with the addition of 80 ⁇ L of 12.5 ⁇ g/ml solution of a fluorescent dye-labeled casein substrate (EnzChek Protease Assay Kit (E-6639), Molecular Probes, Eugene, OR) in 20 mM Tris-HCI, pH 8.0. Reaction of the fecal extract with the casein substrate cleaves the fluorescent dye from the substrate.
  • Relative fluorescence units were collected using the Fluoroskan Ascent System (Labsystems, Incorporated, Needham Heights, MA) with excitation and emission filters of 485 and 538 nm, respectively. Data were collected each minute for 15 minutes and rates (RFU/min) were calculated. Using the uninhibited wells as 100% protease activity, percent of fecal proteolytic activity remaining was determined for each concentration of zinc inhibitor (Inhibited Rate/Uninhibited rate * 100).
  • FIG. 7 is a graph showing how the proteolytic activity of fecal extract was reduced as the zinc sulfate heptahydrate concentration was increased.
  • FIG 8 is a graph showing how the proteolytic activity of infant urine was reduced as the zinc sulfate heptahydrate concentration was increased
  • FIG 9 is a graph showing that the addition of the zinc sulfate heptahydrate (FE + zinc) reduced the amount of ⁇ nterleuk ⁇ n-1 alpha released into the underlying media relative to the application of the substrate treated with uninhibited fecal extract (FE + water)
  • FE + zinc zinc
  • the asterisk over the error bars in FIG 9 represent a Student t-test 95% confidence interval Re-running the same experiment with varied concentrations of zinc sulfate heptahydrate (0, 25, 50, 125, and 250 mM) in the 2 6 ⁇ L aliquot added to the 10 4 ⁇ L sample of fecal extract, demonstrated that zinc sulfate heptahydrate effectively inhibits the proteolytic activity of fecal extract in a dose-dependent manner
  • a plot of the data, shown in FIG 10, shows that the proteolytic activity of fecal extract is reduced as the zinc sulfate heptahydrate concentration is increased Effect of Zin
  • the pH of the samples was measured using pH Test Strips 4.5-10.0 (P-4536, Lot 067H1346, Sigma Chemical Co., St. Louis, MO).
  • the pH of the infant urine samples were reduced by 1.5-2.0 pH units and the pH of the fecal extract sample was reduced by 1 pH unit.
  • Treatment compositions Treatment compositions containing water, AHCOVEL, SERICIN, CROSILK, and zinc sulfate monohydrate were prepared according to Table 2 below. For comparison purposes, a control composition was prepared containing only water and AHCOVEL. Table 2 - Composition Concentrations (wt.%)
  • Skins (dermatomed human cadaver skins, female abdominal, and EpiDermTM) were mounted between the donor and receptor compartments in the Franz diffusion cells and clamped Skins were first allowed to equilibrate for 1 hr before experimentation Then, any air bubbles remaining in the receptor cells were removed At that point, 500 mg of the aqueous emulsion was placed on each skin All donor cells were occluded with Parafilm® Receptor samples (1 5 ml) were taken after 36 hours and frozen at -70°C prior to Ion Coupled Spectroscopy (ICP) analysis to determine the zinc flux through the skins After 36 hours, the skins were removed from the cells and washed briefly in water
  • the zinc flux and skin content was determined after 36 hr and are shown in Table 3 The results are expressed as means ⁇ standard deviation The number of analyzed samples is 3-4 per experiment. All of the examples retained significant quantities of zinc.
  • EpiDermTM was more permeable and retained more zinc compared to human cadaver skin.
  • Treated Substrate Untreated polypropylene spunbond materials (basis weight of about 0.5 ounces per square yard) were used as a substrate for the treatment compositions.
  • the compositions were applied to the substrates by a low-solids batch treatment process.
  • An 8 in. x 12 in. (20.32 x 30.48 cm) example of the substrate was first dipped in an aqueous treatment bath of known composition illustrated in Table 4 below.
  • %WPU wet pick-up
  • %WPU [ ⁇ Ww - Wd)/Wd] ⁇ 100 , where:
  • Ww wet weight of the nipped fabric
  • Wd dry weight of the treated fabric
  • the treated spunbond materials were tested to assess their capacity to inhibit the reaction of fecal extract with synthetic skin
  • the fecal extract was prepared from feces obtained from an infant on antibiotics (Sulfat ⁇ m) who had diaper rash
  • the feces were suspended in water and vigorously vortexed After vortexmg, the samples were held on ice prior to centrifugation at 15,000 times the force of gravity for 20 minutes
  • the synthetic skin, EpiDermTM 201 contains keratmocytes that release ⁇ nterleuk ⁇ n-1 alpha (IL-1 alpha) when subjected to proteases such as trypsm and pancreatic elastase When the IL-1 alpha is released, it diffuses from the skin into the fluid below the EpiDermTM. Samples of this fluid are taken and analyzed for the presence of the IL-1 alpha. Higher levels of IL-1 alpha are indicative of greater skin irritation.
  • IL-1 alpha ⁇ nterleuk ⁇ n-1 alpha

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Abstract

La présente invention concerne une combinaison destinée au traitement de surface d"un substrat, notamment une bande non tissée, utilisé dans des applications du type produits d"hygiène personnelle. Outre ses propriétés satisfaisantes de gestion des fluides, cette combinaison de traitement de surface constitue un système d"administration topique efficace en termes de dépôt sur la peau d"un revêtement fin, tenace et sensiblement continu d"un agent bénéfique pour la peau, ledit agent étant dissous du substrat par émulsion aqueuse avant d"être transféré et déposé sur la peau. Les revêtements de cet agent bénéfique pour la peau sur la peau résistent à toute tentative d"élimination, ce qui permet d"une part, d"éviter les lésions de la barrière cutanée naturelle et d"autre part, de constituer une barrière de protection contre les lésions cutanées d"origine chimique et biochimique.
PCT/US2000/017999 1999-06-30 2000-06-29 Administration d"un agent benefique pour la peau sur un substrat traite WO2001000156A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
AU59016/00A AU5901600A (en) 1999-06-30 2000-06-29 Delivery of a skin health benefit agent to a treated substrate for transfer to skin
MXPA01012650A MXPA01012650A (es) 1999-06-30 2000-06-29 Distribucion de un agente benefico para la salud de la piel a un substrato tratado para transferencia a la piel.

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US14178899P 1999-06-30 1999-06-30
US60/141,788 1999-06-30
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Cited By (13)

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US6503525B1 (en) 1999-08-23 2003-01-07 Kimberly-Clark Worldwide, Inc. Absorbent article which maintains or improves skin health
WO2003041751A2 (fr) * 2001-11-09 2003-05-22 Kimberly-Clark Worldwide, Inc. Article absorbant comportant un fluide de traitement
US6649099B2 (en) 1998-10-30 2003-11-18 Kimberly-Clark Worldwide, Inc. Method of incorporating fluid treatment agents into absorbent composites
US6787490B2 (en) 2001-12-26 2004-09-07 Kimberly-Clark Worldwide, Inc. Glove donning delivery system
US6812169B2 (en) 1998-10-30 2004-11-02 Kimberly-Clark Worldwide, Inc. Absorbent article with fluid treatment agent
US6867344B2 (en) 1998-10-30 2005-03-15 Kimberly-Clark Worldwide, Inc. Absorbent article with fluid treatment agent
US6919015B2 (en) 2002-12-16 2005-07-19 3M Innovative Properties Company Process for manufacturing fluoroolefins
US7449613B2 (en) 2001-07-03 2008-11-11 The Procter & Gamble Company Film-forming compositions for protecting skin from body fluids and articles made therefrom
US7851668B2 (en) 1994-11-28 2010-12-14 The Procter & Gamble Company Absorbent article and method for maintaining or improving skin health
US8044256B2 (en) 1999-05-21 2011-10-25 The Procter And Gamble Company Absorbent article having a stable skin care composition
US8795716B2 (en) 2001-10-01 2014-08-05 The Procter & Gamble Company Skin care compositions on a thin sanitary napkin
US9035123B2 (en) 2002-10-01 2015-05-19 The Procter & Gamble Company Absorbent article having a lotioned topsheet
CN112064199A (zh) * 2020-09-07 2020-12-11 杭州恒邦实业有限公司 一种热轧无纺布制备工艺

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US4973473A (en) * 1989-06-23 1990-11-27 Revlon, Inc. Skin care preparation
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US5091193A (en) * 1989-08-23 1992-02-25 Roussel Uclaf Diaper rash treatment and compositions
WO1996016681A1 (fr) * 1994-11-28 1996-06-06 The Procter & Gamble Company Couche presentant une feuille de garniture enduite de lotion contenant un emolliant a base de polysiloxane
EP0750903A1 (fr) * 1995-06-28 1997-01-02 Coöperatie Cosun U.A. Composition désodorisante
EP0761867A2 (fr) * 1995-07-21 1997-03-12 Seiren Co., Ltd. Produits fibreux fonctionnels et procédé pour leur préparation
EP0875233A1 (fr) * 1997-04-24 1998-11-04 Fort James Corporation Substrat traité avec une lotion

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WO1984002845A1 (fr) * 1983-01-21 1984-08-02 Advanced Drug Tech Onguent pour les soins de la peau contenant des vitamines
US4973473A (en) * 1989-06-23 1990-11-27 Revlon, Inc. Skin care preparation
WO1991002538A1 (fr) * 1989-08-18 1991-03-07 John Morris Co., Inc. Compositions inodores et stabilisees pour traiter les tissus keratineux, des etats pathologiques de la peau et favoriser la cicatrisation de blessures
US5091193A (en) * 1989-08-23 1992-02-25 Roussel Uclaf Diaper rash treatment and compositions
WO1996016681A1 (fr) * 1994-11-28 1996-06-06 The Procter & Gamble Company Couche presentant une feuille de garniture enduite de lotion contenant un emolliant a base de polysiloxane
EP0750903A1 (fr) * 1995-06-28 1997-01-02 Coöperatie Cosun U.A. Composition désodorisante
EP0761867A2 (fr) * 1995-07-21 1997-03-12 Seiren Co., Ltd. Produits fibreux fonctionnels et procédé pour leur préparation
EP0875233A1 (fr) * 1997-04-24 1998-11-04 Fort James Corporation Substrat traité avec une lotion

Cited By (21)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8138388B2 (en) 1994-11-28 2012-03-20 The Procter & Gamble Company Absorbent article and method for maintaining or improving skin health
US7851668B2 (en) 1994-11-28 2010-12-14 The Procter & Gamble Company Absorbent article and method for maintaining or improving skin health
US8420883B2 (en) 1994-11-28 2013-04-16 The Procter & Gamble Company Absorbent article and method for maintaining or improving skin health
US6812169B2 (en) 1998-10-30 2004-11-02 Kimberly-Clark Worldwide, Inc. Absorbent article with fluid treatment agent
US6649099B2 (en) 1998-10-30 2003-11-18 Kimberly-Clark Worldwide, Inc. Method of incorporating fluid treatment agents into absorbent composites
US6867344B2 (en) 1998-10-30 2005-03-15 Kimberly-Clark Worldwide, Inc. Absorbent article with fluid treatment agent
US8044256B2 (en) 1999-05-21 2011-10-25 The Procter And Gamble Company Absorbent article having a stable skin care composition
US6503525B1 (en) 1999-08-23 2003-01-07 Kimberly-Clark Worldwide, Inc. Absorbent article which maintains or improves skin health
US7449613B2 (en) 2001-07-03 2008-11-11 The Procter & Gamble Company Film-forming compositions for protecting skin from body fluids and articles made therefrom
US8795716B2 (en) 2001-10-01 2014-08-05 The Procter & Gamble Company Skin care compositions on a thin sanitary napkin
GB2398016A (en) * 2001-11-09 2004-08-11 Kimberly Clark Co Absorbent article with fluid treatment agent
GB2398016B (en) * 2001-11-09 2005-09-28 Kimberly Clark Co Absorbent article with fluid treatment agent
WO2003041751A3 (fr) * 2001-11-09 2003-11-06 Kimberly Clark Co Article absorbant comportant un fluide de traitement
WO2003041751A2 (fr) * 2001-11-09 2003-05-22 Kimberly-Clark Worldwide, Inc. Article absorbant comportant un fluide de traitement
US6787490B2 (en) 2001-12-26 2004-09-07 Kimberly-Clark Worldwide, Inc. Glove donning delivery system
US9035123B2 (en) 2002-10-01 2015-05-19 The Procter & Gamble Company Absorbent article having a lotioned topsheet
US9737446B2 (en) 2002-10-01 2017-08-22 The Procter & Gamble Company Absorbent article having a lotioned topsheet
US10687991B2 (en) 2002-10-01 2020-06-23 The Procter & Gamble Company Absorbent article having a lotioned topsheet
US7250540B2 (en) 2002-12-16 2007-07-31 3M Innovative Properties Company Process for manufacturing fluoroolefins
US6919015B2 (en) 2002-12-16 2005-07-19 3M Innovative Properties Company Process for manufacturing fluoroolefins
CN112064199A (zh) * 2020-09-07 2020-12-11 杭州恒邦实业有限公司 一种热轧无纺布制备工艺

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AU5901600A (en) 2001-01-31

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