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
  • A61K8/02—Cosmetics or similar toiletry preparations characterised by special physical form
  • A61K8/0208—Tissues; Wipes; Patches
• • 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
  • A61K8/72—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds
  • A61K8/73—Polysaccharides
• • 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
  • A61K8/72—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds
  • A61K8/73—Polysaccharides
  • A61K8/737—Galactomannans, e.g. guar; Derivatives 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
  • A61K8/72—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds
  • A61K8/81—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds obtained by reactions involving only carbon-to-carbon unsaturated bonds
  • A61K8/817—Compositions of homopolymers or copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and at least one being terminated by a single or double bond to nitrogen or by a heterocyclic ring containing nitrogen; Compositions or derivatives of such polymers, e.g. vinylimidazol, vinylcaprolactame, allylamines (Polyquaternium 6)
  • A61K8/8176—Homopolymers of N-vinyl-pyrrolidones. Compositions of derivatives of such polymers
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K9/00—Medicinal preparations characterised by special physical form
  • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
  • A61K9/7007—Drug-containing films, membranes or sheets
• • C—CHEMISTRY; METALLURGY
  • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
  • C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
  • C08L5/00—Compositions of polysaccharides or of their derivatives not provided for in groups C08L1/00 or C08L3/00
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K2800/00—Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
  • A61K2800/40—Chemical, physico-chemical or functional or structural properties of particular ingredients
  • A61K2800/59—Mixtures
  • A61K2800/594—Mixtures of polymers

Definitions

• the present invention relates to novel pre-formed, sheet devices and compositions thereof.
• self-adhesive devices comprising an aqueous polysaccharide mixture, which are suitable for topical application and display desirable amounts of syneresis and/or improved mechanical properties such as strength or flexibility, as well as excellent moisturisation, hydration and cooling benefits.
• the devices of the present invention are easy to handle, unobtrusive and conform to the contours of a target surface when applied.
• the desired properties are achieved by selecting the chemical composition and rheological characteristics of the polysaccharide mixture.
• EP-A-392,845 in one embodiment describes a method of preparation of a gel patch whereby the patch requires formation in-situ on the skin, making it messy to apply.
• EP-B-309,309 describes a dry patch which requires the skin to be moistened or the patch wetted so that it hydrates and adheres to the skin.
• other patches or devices may be too wet or sticky, as the gelling agents comprising the patch or device may not form a solid gel structure and as a result, the patches or devices are difficult to handle and apply to the skin.
• Some patches or devices are too dry, or are inflexible and therefore do not conform well to the contours of the surface to which they are applied.
• others may be strongly adhesive, tight and uncomfortable to wear and remove, and many patches may not provide an effective release and penetration of benefit agents.
• Polysaccharide compositions are known for use in self adhesive patches or devices.
• EP-A-682 938, WO96/25923, EP-A-750905, WO98/17263, EP-A-850649, EP- A-674913 and WO84/02466 disclose various polysaccharides which may be useful in an adhesive patch or device.
• many of the adhesive patches or devices described in the aforementioned documents optionally comprise cosmetic or therapeutic actives.
• GB 1,341,999 discloses a gelled medium suitable for treating burns comprising a liquid phase, a burn treating agent and an amount of a gel former.
• the gelled medium is described as being flexible and having an essentially dry, continuous, non-adhesive surface and plasticity so as to conform to the body.
• a preferred gel former is disclosed as a combination of xanthan and locust bean gum.
• the examples also disclose a burn treating antiseptic pad comprising agarose, water and silver nitrate. The document discusses that a slight amount of syneresis in the gelled medium is helpful in wetting the surface with the burn treating substance and for ease in removal of the medium from a mould.
• JP-B2-276 1936 discloses aqueous sheet-like pack agents comprising xanthan gum and locust bean gum in combination with a water-soluble solvent.
• the sheet-like pack agents of the invention are disclosed as having excellent shape retention properties at high temperature, providing a moist feel and having a high skin moisturising effect.
• the examples disclose that the pack agents may further comprise 0.1% of a skin beautifying component.
• EP-A-161 681 discloses gel plates comprising a polysaccharide and an aqueous solution of a polyhydric alcohol.
• Preferred polysaccharides for the gel plates described therein are a blend of carrageenan and a galactomannan, or carrageenan alone.
• the compositions optionally comprise medical components such as skin stimulants, antiphlogistics, analgesics and antibiotics.
• the gel plates are disclosed as transparent or inconspicuous, having a refreshing feeling and good adhesion, as well as being sufficiently elastic, stretchable and strong.
• WO97/17944 discloses cosmetic formulations made up of a gel material consisting of a balanced mixture of polysaccharides containing a soluble alginate (0.1-5%), agar (0.01- 0.5%), pectin (0.01-0.5%), xanthan gum (0.05-1%) with the balance consisting of water.
• the gel material is optionally enriched with water-soluble or water-dispersible active ingredients.
• the gel material may be processed to form a structured gel which is disclosed as being easy to handle and well adapted to the skin surface.
• WO90/14110 discloses pharmaceutical preparations which may take the form of a self- supporting slab, pad or wafer of a desired size, shape and thickness comprising a water insoluble alginate and suspending agents such as xanthan gum alone, or xanthan gum in combination with locust bean gum. Gellan gum is also disclosed as a further useful suspending agent. The suspending agents in the preparations may also act as gelling agents. The preparations optionally comprise anti-inflammatory agents, or the antiseptic agent, iodine.
• the slab or wafer forms of a preparation may be flexible and applied onto a plastic backing to form an integral surgical dressing, with the gel either exposed or covered with a gauze.
• the gel preparations may comprise a calcium source which in combination with the alginate acts to absorb exudate fluid from a lesion or wound on the skin.
• the preparations may also be left in-situ on the skin and replaced at a rate of up to once or twice a week.
• JP-A- 54 92618 discloses a wet compress comprising an aqueous calcium ion cross-linked alginate gel as a base, substances having an antiphlogistic and analgesic action and water.
• Example 5 discloses a wet compress comprising a mixture of locust bean gum, ko ⁇ jac powder, a 3% sodium alginate solution, a calcium monohydrate phosphate source and a styrene-butadiene copolymer latex. The document teaches that the addition of water soluble polymers increases the shape retaining power of a compress and a highly elastic gel is obtained by adding locust bean gum and konjac mannan, or carrageenan alone.
• water soluble polymers such as konjac and locust bean gum, amongst others
• the base containing gels of the wet compresses of the invention are taught as not being liable to release water.
• patches and devices from the cosmetic and medical field art provide advances in attaining desirable physical and in-use characteristics from a polysaccharide gel, they do not teach devices comprising the specific aqueous polysaccharide mixtures of the present invention which have improved mechanical properties and/or which display a desirable amount of syneresis so as to provide a patch or device which is self adhesive and which effectively releases the ingredients comprised within the polysaccharide matrices such as benefit agents and water to deliver in-use hydration, moisturisation or treatment benefits.
• an aqueous polysaccharide mixture consisting of a red seaweed polysaccharide; a mannose containing polysaccharide, or mixtures thereof; and a fermentation polysaccharide or derivatives thereof, provides a pre-formed, sheet device with excellent in-use characteristics, and improved syneresis, and/or mechanical properties.
• Devices comprising the aforementioned aqueous polysaccharide mixture form a self supporting, sheet device which has a high flexibility to conform to the contours of the skin, hair or nails, is thin, yet forms a high strength structure which is easy to handle and apply to the target surface.
• the aqueous polysaccharide mixture is selected to further provide the pre-formed, sheet device with a desirable amount of syneresis.
• the present invention relates to a pre-formed, sheet device comprising;
• a mannose containing polysaccharide selected from a galactomannan, glucomannan, and derivatives or mixtures thereof and;
• the pre-formed, sheet devices of the present invention show a desirable amount of syneresis, as well as providing excellent in-use characteristics such as unobtrusiveness, ease of handling, conformability, hydration, moisturisation and cooling benefits upon topical application. Further, the pre-formed, sheet devices of the present invention have excellent mechanical properties and form a high strength structure from a thin aqueous polysaccharide mixture which has a degree of elasticity and is flexible.
• a cosmetic method of treatment comprising applying to the skin, hair or nails a pre-formed, sheet device.
• a red seaweed polysaccharide (i) a red seaweed polysaccharide; (ii) a mannose containing polysaccharide selected from a galactomannan, glucomannan, and derivatives or mixtures thereof and;
• the pre-formed, sheet device of the present invention comprises a specified polysaccharide mixture together with water, as well as various optional ingredients as indicated below. All levels and ratios are by weight of total composition of the device unless otherwise indicated. When a substrate is used as an adjunct to the device, the total weight of the composition of the device is calculated without including the weight of the substrate.
• pre-formed means that the device so described is manufactured into a product form having a predetermined thickness, shape and size, wherein the device may be removed from the packaging and placed or draped onto the target surface by the fingers without the need to spread, rub or coat the target area with the product form.
• sheet device means that the device described is a patch or mask for cosmetic or medical application having a planar or non-planar topography, wherein the patch is a continuous, uni-, bi-, or multi- lamellar sheet, and the shape of which is pre-determined according to the specific area of skin, hair or nails to be treated and wherein the mask is a non-continuous, uni-, bi-, or multi- lamellar sheet covering the facial area with apertures for the eyes, nose or mouth.
• gel compositions form 3 -dimensional matrices which bind or encapsulate other ingredients of the composition. Syneresis is believed to involve a spontaneous separation of an initial homogeneous system into a coherent gel phase and a liquid.
• the exuded liquid is a solution whose composition depends upon that comprised in the original gel.
• polysaccharide as used herein, means a naturally occurring or synthetically produced, linear or branched polymer of monosaccharide units, which swells when dispersed in water at low dry concentrations and gels the aqueous phase.
• non-occlusive means that the pre-formed, sheet device as so described does not substantially block the passage of air and moisture through the surface of the skin, hair or nails.
• the present pre-formed, sheet devices are suitable for topical application to the skin, hair or nails.
• the devices comprise a specified polysaccharide mixture.
• the polysaccharide mixture of the present invention forms a self-adhesive, sheet device which is self-supporting.
• an occlusive or non-occlusive backing material often referred to as a "substrate” may be employed as an adjunct to the device.
• substances which act as gel strengthening agents such as mono- or multi- valent salts may be incorporated into the polysaccharide mixture.
• Suitable cations for the mono- or multi- valent salts may be selected from potassium, sodium, ammonium, zinc, aluminium, calcium and magnesium ions, or mixtures thereof.
• Suitable anions associated with the aforementioned cations may be selected from chloride, citrates, sulfate, carbonate, borate and phosphate anions, or mixtures thereof.
• polysaccharides of the mixture of the present invention may be combined together at various percentages or ratios to modify the physical characteristics of the pre-formed, sheet devices.
• the polysaccharide mixture herein provides improved syneresis, or mechanical properties, such as flexibility or strength, from the aqueous, pre-formed, sheet device.
• the polysaccharide mixture of the present invention improves the flexibility, strength, and syneresis of a pre-formed, sheet device.
• the pre-formed, sheet devices of the present invention comprise less than 10% total polysaccharide.
• the pre-formed, sheet devices of the present invention preferably comprise less than 10%, more preferably less than 5% and especially less than 3% and preferably greater than 0.5%, more preferably greater than 0.7%, by dry weight of the polysaccharide mixture.
• the polysaccharide mixture of the devices herein consists of (i) a red seaweed polysaccharide, (ii) a mannose containing polysaccharide selected from a galactomannan, glucomannan, and derivatives or mixtures thereof; and (iii) a fermentation polysaccharide, or derivatives thereof.
• Red Seaweed Polysaccharides Polysaccharides which are classified as red seaweed polysaccharides are isolated from marine plant species belonging to the class of Rhodophyceae. Red seaweed polysaccharides provide mechanical strength to an aqueous gel. Suitable red seaweed polysaccharides for use in the present invention include agar known in the industry under the (CTFA) trade designation as agar agar flake derived from various Gelidium plant species or closely related red algae commercially available as "Agar Agar 100" or "Agar Agar 150" from TIC Gums (Belcamp, MD, USA) or "Agar Agar K-100" from Gumix International Inc.
• CTFA Cosmetic Acid
• the red seaweed polysaccharide for use herein is selected from agar, agarose, kappa-carrageenan and furcellaran, or mixtures thereof. More preferably, the red seaweed polysaccharide for use herein is selected from agar and agarose, or mixtures thereof.
• carrageenan is not a chemically homogeneous product, but comprises the product group of sulfated galactans, with a proportion of the galacto- pyranose residues being present as a 3,6-anhydrogalactose residue.
• Certain fractions of carrageenans can be isolated from red algae extracts which are chemically defined with respect to their structure and are designated by Greek letters. Only lambda-, iota-, and kappa-carrageenan are of commercial importance. Their different properties are principally explicable in terms of differences in the content of anhydrogalactose and sulfate ester groups.
• the presence of the sulfate groups has the consequence that the properties of carrageenan as an anionic polysaccharide can be modified by the presence of cations in the aqueous system.
• the gelling properties of kappa- carrageenan are greatly influenced by potassium ions and those of iota-carrageenan by calcium ions.
• Kappa-carrageenan has the highest anhydrogalactose content and the lowest sulfate content among the carrageenans and as a result has the most powerful gel-forming properties.
• Galactomannans are vegetable reserve polysaccharides which occur in the endosperm cells of numerous seeds of Leguminosae.
• the collective term "galactomannan” comprises all polysaccharides which are built up of galactose and mannose residues.
• Galactomannans are mannose containing polysaccharides as they comprise a linear backbone of (l->4)-linked ⁇ -D-mannopyranosyl units. To these rings are attached as branches, isolated galactopyranose residues by cc-(l,6)-glucoside bonds.
• Galactomannans may in addition also contain minor amounts of other sugar residues.
• Suitable galactomannans for use herein are fenugreek gum; lucern; clover; locust bean gum known for example in the industry under the (CTFA) trade designation as carob bean gum, commercially available as "Seagul L” from FMC (Philadelphia, PA, USA); tara gum commercially available from Starlight Products (Rouen, France) or Bunge Foods (Atlanta, GA, USA); guar gum derived from the ground endosperms of Cyamopsis tetragonolobus, commercially available as "Burtonite V7E” from TIC Gums (Belcamp, MD, USA), “Jaguar C” from Rhone-Poulenc (Marietta, GA, USA), or “Supercol” from Aqualon (Wilmington, DE, USA); and cassia gum commercially available from Starlight Products (Rouen, France), or mixtures thereof.
• the galactomannans for use herein have on average one of every 1 to about 5 mannosyl units substituted with a (l - 6)-linked-cc- D-galactopyranosyl unit and are selected from guar gum, locust bean gum and cassia gum, or mixtures thereof.
• Glucomannans are mannose containing polysaccharides which comprise an essentially linear backbone of ⁇ (l- 4)-linked glucose and mannose residues.
• the C-6 position of a mannose or glucose residue in the polysaccharide backbone may be substituted with an acetyl group.
• the acetyl groups are generally found on one per six sugar residues to one per twenty sugar residues.
• Suitable glucomannans or derivatives thereof for use herein have a ratio of mannose to glucose of from about 0.2 to about 3.
• glucomannans for use herein include konjac mannan, which is the generic name for the flour formed from grinding the tuber root of the Amorphophallus konjac plant (elephant yam), commercially available under the trade name "Nutricol® konjac flour” from FMC (Philadelphia, PA, USA); and deacetylated konjac mannan; or mixtures thereof.
• konjac mannan is the generic name for the flour formed from grinding the tuber root of the Amorphophallus konjac plant (elephant yam), commercially available under the trade name "Nutricol® konjac flour” from FMC (Philadelphia, PA, USA); and deacetylated konjac mannan; or mixtures thereof.
• Fermentation Polysaccharides are polysaccharides which are commercially produced by the fermentation of microorganisms in a medium containing a carbon and nitrogen source, buffering agent, and trace elements.
• Suitable fermentation polysaccharides, or derivatives thereof, for use in the present invention include gellan gum known in the industry under the (CTFA) trade designation as gum gellan, a high molecular weight hetero polysaccharide gum produced by a pure-culture fermentation of a carbohydrate with Pseudomonas elodea, commercially available as "Kelcogel” from Kelco (San Diego, CA, USA); xanthan gum which is a high molecular weight hetero polysaccharide gum produced by a pure-culture fermentation of a carbohydrate with Xanthomonas campestris, known in the industry under the (CTFA) trade designation as xanthan, commercially available for example as "Keltrol CG 1000/BT/F/GM/RD/SF/T/TF", all from Calgon (Pittsburgh, PA, USA), or "Kelzan” from Kelco (San Diego, CA, USA); natto gum; pullulan; rhamsan gum
• Preferred fermentation polysaccharides, or derivatives thereof for use in the polysaccharide mixture herein are selected from xanthan gum and gellan gum, or mixtures thereof. More preferably, the fermentation polysaccharide or derivative thereof is xanthan gum.
• the fermentation polysaccharide is gellan gum
• gellan gum it has been found by the present inventors that by varying the amount of gellan gum in the polysaccharide mixture, the amount of syneresis exhibited by a sheet device of the present invention may be altered.
• the addition of gellan gum to a sheet device comprising a red seaweed polysaccharide typically reduces the amount of liquid exuded from the coherent gel phase.
• the polysaccharide mixture comprises xanthan gum as the fermentation polysaccharide
• synergistic interactions are formed between xanthan gum and the mannose containing polysaccharides.
• the synergistic interactions result in modifications to the elasticity of the aqueous gel, yet the interactions do not unduly interfere in the mechanical strength provided to the gel by the red seaweed polysaccharide.
• the ratio of xanthan gum to mannose containing polysaccharide is from about 2:1 to about 1 :4.
• the polysaccharide mixture comprises a mannose containing polysaccharide which is a mixture of a galactomannan and glucomannan or derivatives thereof.
• syneresis provides a mechanism for the delivery of a benefit agent to a target area.
• the liquid layer exuded onto the surface of the coherent gel phase is readily available for diffusion, facilitating a short wear time of the device.
• the pre-formed, sheet devices of the present invention desirably display a moderate amount of syneresis and preferably, the devices herein are moist to the touch.
• a moderate amount of syneresis is seen by the present inventors as a highly desirable property of a device comprising the polysaccharide mixture as the liquid exuded onto the surface of the gelled device facilitates its adhesion to a target surface thus obviating the need for either an additional adhesive overlaying the gelled form or an adhesive coated substrate.
• a gelled device exhibits too little syneresis, the device although wetting an area, is not likely to provide good adhesion to the target area, whilst an excessive amount of syneresis results in an ineffective and unattractive product.
• the ratio of red seaweed polysaccharide to mannose containing polysaccharide is from about 20:1 to about 1:5 and more preferably from about 7:1 to about 1:2.
• a further essential ingredient of a pre-formed, sheet device of the present invention is water.
• the total water content of a pre-formed, sheet device of the present invention is from about 30% to about 99.5%, preferably from about 40% to about 95%, more preferably from about 50% to about 85% by weight of the device.
• the pre-formed, sheet devices herein comprise a substrate.
• a substrate is an occlusive or non-occlusive sheet that provides additional integrity and support to the device.
• the substrate is non-occlusive.
• the liquid, aqueous polysaccharide mixture may be coated or cast onto one surface of a substrate.
• a wide variety of materials can be used as the substrate. The following characteristics are desirable: (i) sufficient wet strength for use, (ii) sufficient flexibility, (iii) sufficient loft and porosity, (iv) sufficient thickness, (v) sufficient hydrophilicity such that the polysaccharide gel mixture may diffuse and infiltrate into the substrate, (vi) sufficient compatibility with the polysaccharide mixture to prevent de-lamination, (vii) sufficient transparency or translucency, and (viii) appropriate size.
• Non-limiting examples of suitable substrates meeting the above criteria include woven and nonwoven materials; polymeric sheet materials such as apertured formed thermoplastic films, formed films, apertured plastic films, and hydroformed thermoplastic films; natural sponges; synthetic sponges; polymeric mesh sponge; paper substrates; polymeric porous foams; collagen sheets; polymeric scrims and the like.
• Preferred substrates for use herein are paper substrates, nonwoven materials and formed films especially apertured formed films since they are economical and readily available in a variety of materials.
• nonwoven a manufactured sheet, web, mat, pad or batt of directionally or randomly oriented fibers, bonded by friction, and/or cohesion and/or adhesion. These materials generally exclude products which are woven, knitted, tufted, stitch-bonded incorporating binding yarns or filaments, or felted by wet-milling, whether or not additionally needled.
• the nonwoven materials can be composed of a combination of layers of random and carded fibers.
• the fibers may be of natural or synthetic origin.
• they may be staple or continuous filaments or be formed in situ.
• Non-woven materials may be comprised of a variety of fibers both natural and synthetic.
• the conventional base starting material is usually a fibrous web comprising any of the common synthetic or natural textile-length fibers, or mixtures thereof.
• Natural fibers useful in the present invention are silk fibers, keratin fibers such as wool fibers, camel hair fibers, and the like and cellulosic fibers including wood pulp fibers, cotton fibers, hemp fibers, jute fibers, flax fibers, and mixtures thereof.
• Synthetic fibers useful in the present invention include acetate fibers, acrylic fibers, cellulose ester fibers, modacrylic fibers, polyamide fibers, polyester fibers, polyolefin fibers, polyvinyl alcohol fibers, rayon fibers, polyurethane foam, and mixtures thereof.
• nonwoven materials are well known in the art and are described generally in WO98/18444, which is incorporated herein by reference.
• the nonwoven layer can be prepared by a variety of processes including hydroentanglement, air entanglement, thermally bonding or thermo-bonding, and combinations of these processes.
• the substrates of the present invention can consist of a single layer or multiple layers.
• a multilayered substrate can include films and other nonfibrous materials.
• Nonwoven materials made from synthetic fibers useful in the present invention can also be obtained from a wide variety of commercial sources.
• suitable nonwoven layer materials useful herein are described in WO98/18444 and include HEF 40-047, an apertured hydroentangled material containing about 50% rayon and 50% polyester, and having a basis weight of about 51 grams per square metre (gsm), available from Veratec,
• Novonet R 149-616 a thermo-bonded grid patterned material containing about 100% polypropylene, and having a basis weight of about 60 gsm, available from Veratec, Inc., Walpole, MA; and HEF Nubtex R 149-801, a nubbed, apertured hydroentangled material, containing about 100% polyester, and having a basis weight of about 84 gsm, available from Veratec, Inc. Walpole, MA.
• Paper substrates made from natural materials consist of webs or sheets most commonly formed on a fine wire screen from a liquid suspension of the fibers. See C. A. Hampel et al, The Encyclopedia of Chemistry, third edition, 1973, pp. 793-795 (1973); The
• Paper substrates made from natural materials useful in the present invention can be obtained from a wide variety of commercial sources. Suitable commercially available paper substrates useful herein include "Kimwipes EX-L” available from Kimberley-Clark Corp., Roswell, GA, USA;
• Airtex R an embossed airlaid cellulosic layer having a base weight of about 85 gsm, available from James River, Green Bay, WI; and Walkisoft R , an embossed airlaid cellulosic having a base weight of about 90 gsm, available from Walkisoft U.S.A., Mount Holly, NC.
• the substrate can be a polymeric sheet material.
• Polymeric sheet materials may be prepared by methods well-described in the patent literature. For example, according to the process described in US-A-4,324,246, to Mullane and Smith, issued Apr. 13, 1982, a sample of thermoplastic material such as 0.0038 cm thick polyethylene film is heated above its softening point which is the temperature at which the thermoplastic material can be formed or moulded and is less than the melting point of the material. The heated thermoplastic material sheet form is then brought into contact with a heated forming screen.
• the forming screen is preferably an apertured wire mesh screen having the desired aperture size, pattern, and configuration.
• a vacuum is used to draw the heated film against the forming screen.
• a film is thereby formed against this screen with a desired pattern and hole size.
• a jet of hot air is passed over the film.
• the hot air jet perforates the film in pattern and size of apertures in the forming screen.
• Fluid-permeable sheets prepared in the manner of the Mullane et al patent are conveniently refe ⁇ ed to as "formed films”. These sheet materials may also be made using a similar process method using a jet of water passed over the film. These materials are commonly referred to as "hydroformed films”.
• Another formed-film substrate useful herein is an apertured formed film - a resilient, 3- dimensional web exhibiting a fiber-like appearance and tactile impression, comprising a fluid-impervious plastic material, with said web having a multiplicity of apertures, the apertures being defined by a multiplicity of intersecting fiberlike elements, as described in US-A-4,342,314, to Radel and Thompson, issued Aug. 3, 1982, incorporated herein by reference.
• the sheet materials described in US-A-4,342,314 can be prepared using hydrophobic plastics such as polyethylene, polypropylene, PVC, and the like, and are well-known for use in absorbent products such as catamenials and the like.
• hydrophobic plastics such as polyethylene, polypropylene, PVC, and the like
• An example of such a material is the formed film described in the above patent and marketed on sanitary napkins by The Procter and Gamble Company as "DRI- WEAVE”. Additionally, such materials may be surface treated to reduce their hydrophobicity.
• the substrate can be a polymeric mesh sponge as described in EP-A-702550 and WO98/18444 incorporated by reference herein in their entirety.
• the substrate may also be a polymeric porous foam as described in US-A-5,260,345, to DesMarais, et al., issued Nov. 9, 1993, and US-A-4,394,930, to Koroman, issued July 26, 1983, incorporated herein by reference.
• Polymeric foams can in general be characterized as the structures which result when a relatively monomer-free gas or relatively monomer- free liquid is dispersed as bubbles in a polymerizable monomer-containing liquid, followed by polymerization of the polymerizable monomers in the monomer-containing liquid which surrounds the bubbles.
• the resulting polymerized dispersion can be in the form of a porous solidified structure which is an aggregate of cells, the boundaries or walls of which cells comprise solid polymerized material.
• the cells themselves contain the relatively monomer-free gas or relatively monomer-free liquid which, prior to polymerization, had formed the "bubbles" in the liquid dispersion.
• soft, flexible, microporous (open or closed-cell) foam materials having surface hydrophilicity and fluid retention characteristics are particularly suitable for this application.
• polymeric foam materials are those prepared by polymerizing a particular type of water-in-oil emulsion. Such an emulsion is formed from a relatively small amount of a polymerizable monomer-containing oil phase and a relatively larger amount of a relatively monomer-free water phase.
• the relatively monomer-free, discontinuous "internal” water phase thus forms the dispersed "bubbles" surrounded by the continuous polymerizable monomer-containing oil phase.
• Subsequent polymerization of the monomers in the continuous oil phase forms the cellular foam structure.
• the aqueous liquid remaining in the foam structure formed upon polymerization can be removed by pressing and/or drying the foam.
• This type of polymerisation emulsion in general in known in the art as a high internal phase emulsion or "HIPE" foam.
• Polymeric porous foams including the foams prepared from the water-in-oil emulsions herein, may be relatively closed-celled or relatively open-celled in character, depending upon whether and/or the extent to which, the cell walls or boundaries, i.e., the cell windows, are filled or taken up with polymeric material.
• the polymeric porous foams useful in the present invention are those which are relatively open-celled in that the individual cells of the foam are for the most part not completely isolated from each other by polymeric material of the cell walls.
• the cells in such substantially open-celled foam structures have intercellular openings or "windows" which are large enough to permit ready fluid transfer from one cell to the other within the foam structure.
• the foam will generally have a reticulated character with the individual cells being defined by a plurality of mutually connected, three dimensionally branched webs.
• the strands of polymeric material which make up the branched webs of the open-cell foam structure can be referred to as "struts.”
• polymeric porous foams useful herein are hydrophilic in character.
• polymeric porous foams herein should be sufficiently hydrophilic such that the polysaccharide gel mixture may diffuse and infiltrate into the substrate and be sufficiently compatible with the polysaccharide mixture to prevent de-lamination.
• polymeric porous foams as herein before described are designed to be used in various fluid handling articles such as diapers, catamenials and incontinent devices, these types of materials are useful as a substrate in the present invention.
• a suitable porous substrate material can be made from forming a thin, flexible, porous collagen sheet using a freeze-drying process. This process creates a sheet of collagen material which possesses the internal structures of an open-celled porous foam. These materials are strong, flexible, highly compatible with the polysaccharide gel, and have sufficient transparency or translucency to be appropriate as a substrate in the present invention.
• collagen sheets useful herein include “Collagen Fiber Mask” available from Beaute Attica, Inc., Redmond, WA, USA; “Professional Collagen Masks” available from Luminescence, Maple Plain, MN, USA; “Pure Soluble Collagen Lifting Masque” available from Five Star Formulators, Inc., Palo Alto, CA, USA; and “Pure Collagen Masks” available from Maybrook, Inc., Lawrence, MA, USA.
• the substrate can also be a polymeric scrim (extruded netting) as described in US-A- 5,715,561, to Tuthill, Yeazell, and Girardot, issued Feb. 10, 1998, incorporated herein by reference.
• Polymeric scrims may be tubular and the properties of these polymeric scrims can be described by the physical dimensions of the resulting structure (node width, strand length, and repeat unit average weight).
• the tubular scrim material can have mesh openings shaped as a diamond, square, hexagon or other shape and can be made from a variety of strong flexible polymers such as low density polyethylene.
• a diamond mesh scrim is plastic netting made by an extrusion process using counter- rotating die heads, each of which has multiple extrusion orifices located at the edge of each die.
• the counter rotation of the die heads causes extruded filaments or strands to align in two directions at angles to the machine direction of the extruded tubing.
• the strands periodically intersect to form nodes.
• the two strand directions are typically at acute angles to each other, such that strands form diamond patterns with nodes at each corner.
• US-A-3, 957,565 to Livingston et al. describes this process in more detail.
• these polymeric scrims are designed to be used as a personal cleansing implement
• these types of scrims can be used as a substrate in the present invention.
• the substrate can be made into a wide variety of shapes and forms including flat pads, thick pads, thin sheets, and having sizes ranging from a surface area of about 0.25 cm 2 to about 1,000 cm .
• the exact size and shape will depend upon the desired use and product characteristics. Especially convenient are shapes which are designed to fit comfortably and conveniently to the users face, neck, hands, feet, and other parts of the body.
• These shapes may be square, circular, triangular, rectangular, oval, or other shapes which are composites of these such as shapes that could be described as "pickle”, “butterfly”, “moon”, “semi-circle”, “donut”, or others.
• the substrates of the present invention can comprise two or more layers, each having different textures.
• the differing textures can result from the use of different combinations of materials or from the use of different manufacturing processes or a combination thereof.
• separate layers of the substrate can be manufactured to have different colors, thereby helping the user to further distinguish the surfaces.
• the pre-formed, sheet devices herein comprise a safe and effective amount of one or more benefit agents.
• safe and effective amount means an amount of a benefit agent high enough to modify the condition to be treated or to deliver the desired skin, hair or nail benefit, but low enough to avoid serious side effects, at a reasonable benefit to risk ratio within the scope of sound medical judgement. What is a safe and effective amount of the benefit agent will vary with the specific agent, the ability of the agent to penetrate through the skin, into, or onto the hair and/or nails, the user's age, the user's health condition, and the condition of the skin, hair or nails of the user, and other like factors.
• the benefit agents include their pharmaceutically-acceptable salts and by "pharmaceutically-acceptable salts" are meant any of the commonly-used salts that are suitable for use in contact with the tissues of humans without undue toxicity, irritation, incompatibility, instability, irritation, allergic response, and the like.
• the pre-formed, sheet devices of the present invention comprise from about 0.01% to about 40%, preferably from about 0.05% to about 30% and most preferably from about 0.1% to about 20% by weight of the device of at least one benefit agent, or mixtures thereof.
• the benefit agents useful herein can be categorised by their therapeutic benefit or their postulated mode of action. However, it is to be understood that the benefit agents useful herein can in some instances provide more than one therapeutic benefit or operate via more than one mode of action. Therefore, classifications herein are made for the sake of convenience and are not intended to limit the benefit agent to that particular application or applications listed. The following benefit agents are useful in the pre-formed, sheet devices of the present invention.
• Anti-acne actives can be effective in treating and preventing acne vulgaris, a chronic disorder of the pilosebaceous follicles.
• the condition involves inflammation of the pilosebaceous apparatus thereby resulting in lesions, which may include papules, pustules, cysts, comedones, and severe scarring.
• the bacteria may include papules, pustules, cysts, comedones, and severe scarring.
• Corynebacterium acnes and Staphylococcus epidermis are usually present in the pustular contents.
• useful anti-acne actives include the keratolytics described in
• retinoids such as retinoic acid (e.g., cis and/or trans) and its derivatives (e.g., esters); retinol and its esters (e.g., retinyl propionate, retinyl acetate); abietic acid, adapalene, tazarotene, allantoin, aloe extracts, arbietic acid and its salts, ASEBIOL (available from Laboratories Serobi Listerios located in
• azaleic acid barberry extracts, bearberry extracts, belamcanda chinensis, benzoquinolinones, benzoyl peroxide, berberine, BIODERMLNE (available from Sederma located in Brooklyn, NY), bioflavonoids as a class, bisabolol, s-carboxymefhyl cysteine, carrot extracts, cassin oil, clove extracts, citral, citronellal, climazole, COMPLETECH
• MBAC-OS available from Lipo, located in Paterson, NJ
• CREMOGEN M82 available from Dragoco, located in Totowa, NJ
• cucumber extracts dehydroacetic acid and its salts, dehydroepiandrosterone and its sulfate derivative, dichlorophenyl imidazoldioxolan, d,l-valine and its esters, DMDM hydantoin, erythromycin, escinol, ethyl hexyl monoglyceryl ether, ethyl 2-hydroxy undecanoate, farnesol, farnesyl acetate, geraniol, geranyl geraniol, glabridin, gluconic acid, gluconolactone, glyceryl monocaprate, glycolic acid, grapefruit seed extract, gugu lipid, HEDERAGENTN (available from Maruzen located in Morristown, NJ), hesperitin, hinokitol, hops extract
• Non-Steroidal Anti-Inflammatory Actives examples of suitable NSATDS and their esters for use herein are described in WO98/18444, incorporated herein by reference. Further non-limiting examples of non-steroidal anti-inflammatory drugs (NSATDS) include flufenamic acid; panthenol and ether and ester derivatives thereof e.g.
• Topical Anaesthetics examples of suitable topical anaesthetic drugs for use herein are benzocaine and bupivacaine. Further suitable examples are described in WO98/18444, incorporated herein by reference.
• Artificial tanning agents can help in simulating a natural suntan by increasing melanin in the skin or by producing the appearance of increased melanin in the skin.
• Non-limiting examples of artificial tanning agents and accelerators include glucose tyrosinate and acetyl tyrosine, brazilin, caffeine, coffee extracts, DNA fragments, isobutyl methyl xanthine, methyl xanthine, PHOTOTAN (available from Laboratoires Serobiiquess located in Somerville, NJ), prostaglandins, tea extracts, theophylline, UNIPERTAN P2002 (available from Unichem, located in Chicago, IL) and UNIPERTAN P27 (available from Unichem, located in Chicago, IL); and mixtures thereof. Further useful artificial tanning agents herein are described in WO98/18444.
• Antiseptics examples include alcohols, benzoate, sorbic acid, and mixtures thereof.
• Anti-microbial and anti-fungal actives can be effective to prevent the proliferation and growth of bacteria and fungi.
• Non-limiting examples of antimicrobial and antifungal actives include ketoconazole, ciclopirox, benzoyl peroxide, tetracycline, azelaic acid and its derivatives, ethyl acetate, alantolactone, isoalantolactone, alkanet extract (alaninin), anise, arnica extract (helenalin acetate and 11, 13 dihydrohelenalin), aspidium extract (phloro, lucinol containing extract), barberry extract (berberine chloride), bay sweet extract, bayberry bark extract (myricitrin), benzalkonium chloride, benzethonium chloride, benzoic acid and its salts, benzoin, benzyl alcohol, blessed thistle, bletilla tuber, bloodroot, bois de rose oil, burdock,
• Skin soothing agents can be effective in preventing or treating inflammation of the skin.
• the soothing agent enhances the skin appearance benefits of the present invention, e.g., such agents contribute to a more uniform and acceptable skin tone or colour.
• Non-limiting examples of skin soothing agents include absinthium, acacia, aescin, alder buckthorn extract, allantoin, aloe, APT (available from Centerchem, located in Stamford, CT), arnica, astragalus, astragalus root extract, azulene, BAICALL SR 15
• PREREGEN available from Bio Botanica, located in Hauppauge, NY
• SENSrLLNE available from Silab, located in Brive, France
• SIEGESBECKIA available from Sederma, located in Brooklyn, NY
• stearyl glycyrrhetinate STLMUTEX (available from Pentapharm, located in Basel, Switzerland)
• storax sweet birch oil, sweet woodruff, tagetes, tea extract, thyme extract, tienchi ginseng, tocopherol, tocopheryl acetate, triclosan, turmeric, urimei, ursolic acid, white pine bark, witch hazel, xinyi, yarrow, yeast extract, yucca, and mixtures thereof.
• sunscreening agents examples include diethanolamine p-methoxycinnamate, dioxybenzone, ethyl dihydroxypropyl PABA, glyceryl aminobenzoate, lawsome and dihydroxyacetone, menthyl anthranilate, methyl anthranilate, octyl dimethyl PABA, red petroleum, sulisobenzone, triethanolamine salicylate, and mixtures thereof.
• Skin Barrier Repair Aids are those skin care aids which can help repair and replenish the natural moisture barrier function of the epidermis.
• Suitable examples of skin barrier repair aids include brassicasterol, caffeine, campesterol, canola derived sterols, CERAMAX (available from Quest, located in Ashford, England), CERAMIDE 2 (available from Sederma, located in Brooklyn, NY), CERAMIDE HO3TM (available from Sederma, located in Brooklyn, NY), CERAMIDE U (available from Quest, located in Ashford, England), CERAMIDE III (available from Quest, located in Ashford, England), CERAMIDE ITfB (available from Cosmoferm, located in Delft, Netherlands), CERAMIDE IS 3773 (available from Laboratories Serobi unanimouss, located in Somerville, NJ), CERAMINOL (available from Inocosm, located in Chatenay Malabry, France), CERASOL (available from Pentapharm, located in Basel, Switzerland), CEPHALIP (available from Pentapharm, located in Basel, Switzerland), cholesterol, cholesterol hydroxystearate, cholesterol isostearate, 7-dehydrocholesterol, DERMATEIN BRC (available
• Anti-wrinkle and anti-skin atrophy actives can be effective in replenishing or rejuvenating the epidermal and/or dermal layer. These actives generally provide these desirable skin care benefits by promoting or maintaining the natural process of desquamation and/or building skin matrix components (e.g., collagen and glycosaminoglycans).
• Non- limiting examples of anti-wrinkle and anti-skin atrophy actives include nicotinic acid and its esters, nicotinyl alcohol, estrogens and estrogenic compounds, or mixtures thereof. Further suitable anti-wrinkle and anti-skin atrophy actives useful herein are described in WO98/18444.
• Skin repair actives can be effective in repairing the epidermal and/or dermal layer.
• skin repair actives include actein 27 - deoxyactein cimicifugoside (cimigoside), adapalene, tazarotene, ademethionine, adenosine, aletris extract, aloe derived lectins, 3-aminopropyl dihydrogen phosphate, AMADORTNE (available from Barnet Products, located in Englewood, NJ), anise extracts, AOSTNE (available from Secma, located in Pontrieux, France), arginine amino benzoate, ASC III (available from E.
• flavonoids especially flavanones such as unsubstituted flavanone and chalcones such as unsubstituted chalcone and monohydroxy and dihydroxy chalcones
• formononetin forsythia fruit extract
• gallic acid esters gamma amino butyric acid
• GATULL E RC available from Gattlefosse, located in Saint Priest, France
• genistein genistic acid
• gentisyl alcohol gingko bilboa extracts
• ginseng extracts ginsenoside
• RO R ⁇ -i, R6 -2 ,R 6-3 , Re, RD, RE, RF, RF- 2 , R G - I , R G -2, ghico pyranosyl-1- ascorbate, glutathione and its esters, glycitein, eptyloxy 4 salicylic acid, hesperitin, hexahydro curcumin, HMG-Coenzyme A Reductase Inhibitors, hops extracts, 11 hydroxy undecanoic acid, 10 hydroxy decanoic acid, 25-hydroxycholesterol, ISOFAVONE SG 10
• O- desmethylangoiensin O- desmethylangoiensin, oleanolic acid, pantethine, phenylalanine, photoanethone, phytic acid and its salts, piperdine, placental extracts, pratensein, pregnenolone, pregnenolone acetate, pregnenolone succinate, premarin, quillaic acid, raloxifene, REPAIR FACTOR 1
• REPAIR FACTOR SPC available from Sederma, located in Brooklyn, NY
• retinal retinoates (esters of C -C 20 alcohols), retinol, retinyl acetate, retinyl glucuronate, retinyl linoleate, retinyl palmitate, retinyl propionate, REViTALLN BT (available from Pentapharm, located in Basel, Switzerland), s-carboxymethyl cysteine, salicylic acid, SEANAML E FP (available from Laboratories
• lipids examples include cetyl ricinoleate, cholesterol hydroxystearate, cholesterol isostearate, CREMEROL (available from Amerchol, located in Edison, NJ),
• ESTERS available from Croda, located in Parsippany, NJ), or mixtures thereof.
• Skin lightening agents can actually decrease the amount of melanin in the skin or provide such an effect by other mechanisms.
• Skin lightening agents suitable for use herein are described in EP-A-758,882 and EP-A-748,307, both of which are incorporated herein by reference.
• Further examples of skin lightening agents include adapalene, aloe extract, amino tyro sine, ammonium lactate, anethole derivatives, apple extract, arbutin, ascorbic acid, ascorbyl palmitate, azelaic acid, bamboo extract, bearberry extract, bletilla tuber, bupleurum falcatum extract, burnet extract, BURNET POWDER
• GATULINE WHITENING available from Gattefosse, located in Saint Priest, France
• genistic acid and its derivatives gentisyl alcohol, glabridin and its derivatives, gluco pyranosyl-1-ascorbate, gluconic acid, glucosamine, glycolic acid, glycyrrhizinic acid, green tea extract, 4-hydroxy-5-methyl-3[2h]-furanone, hydroquinine, 4-hydroxyanisole and its derivatives, 4-hydroxy benzoic acid derivatives, hydroxycaprylic acid, inositol ascorbate, kojic acid, lactic acid, lemon extract, licorice extract, LICORICE P-TH
• MELA WHITE available from Pentapharm, located in Basel, Switzerland
• morus alba extract mulberry root extract
• niacinamide nicotinic acid and its esters
• nicotinyl alcohol 5-octanoyl salicylic acid
• parsley extract parsley extract
• phellinus linteus extract placenta extract
• pyrogallol derivatives retinoic acid
• retinol, retinyl esters acetate, propionate, palmitate, linoleate
• 2,4 resorcinol derivatives 3,5 resorcinol derivatives
• rose fruit extract rucinol
• salicylic acid song-yi extract
• SOPHORA POWDER available from Barnet Products, located in Englewood, NJ
• 4-thioresorein 3, 4, 5 trihydroxybenzyl derivatives, tranexamic acid
• TYROSLAT 10,11 available from Fytokem
• Sebum inhibitors can decrease the production of sebum in the sebaceous glands.
• suitable sebum inhibitors include aluminium hydroxy chloride, ASEBIOL (available from Laboratories Serobi unanimouss, located in Somerville,
• BIODERMLNE available from Sederma, located in Brooklyn, NY
• climbazole
• Sebum stimulators can increase the production of sebum by the sebaceous glands.
• Non-limiting examples of sebum stimulators include bryonolic acid,
• Non-limiting examples of suitable skin sensates for use herein include agents which impart a cool feel such as camphor, thymol, 1 -menthol and derivatives thereof, eucalyptus, carboxamides; menthane ethers and menthane esters; and agents imparting a warm feel such as cayenne tincture, cayenne extract, cayenne powder, vanillylamide nonanoate, nicotinic acid derivatives (benzyl nicotinate, methyl nicotinate, phenyl nicotinate, etc.), capsaicin, nasturtium officinale extract, Zanthoxylum piperitum extract and ginger extract, or mixtures thereof.
• agents which impart a cool feel such as camphor, thymol, 1 -menthol and derivatives thereof, eucalyptus, carboxamides; menthane ethers and menthane esters; and agents imparting a warm feel such as cayenne
• Protease inhibitors are compounds which inhibit the process of proteolysis, that is, the splitting of proteins into smaller peptide fractions and amino acids.
• protease inhibitors examples include A E COMPLEX (available from Barnet).
• FLUID OUT COLLOID available from Vegetech located in Glendale
• HYPOTAURINE available from Sogo Pharmaceutical Co. Ltd located in Chiroda- ku Tokyo
• LN CYTE HEATHER available from Collaborative Labs Inc. located in East
• THIOTATNE available from Barnet Products located in Englewood, NJ
• Non-limiting examples of skin tightening agents include
• BIOCARE SA available from Amerchol located in Edison, NJ
• egg albumen available from Amerchol located in Edison, NJ
• FLEXAN available from Amerchol located in Edison, NJ
• PENTACARE HP available from Pentapharm AG located in Basel, Switzerland
• VEGESERYL available from Gattefosse located in Saint Priest, France
• Anti-Itch Ingredients Non-limiting examples of anti-itch ingredients include STLMU-
• ICHTHYOL available from Ikeda-Distributor, located in Tokyo, Japan
• Non-limiting examples of suitable agents for inhibiting hair growth include 17 beta estradiol, adamantyguanidines, adamantylamidines, adenylosuccinate synthase inhibitors, anti angiogenic steroids, aspartate transcarbamylase inhibitors, betamethasone valerate, bisabolol, copper ions, curcuma extract, cycloxygenase inhibitors, cysterne pathway inhibitors, dehydroacetic acid, dehydroepiandrosterone, diopyros leak extract, epidermal growth factor, epigallocatechin, essential fatty acids, evening primrose oil, gamma glutamyl transpeptidase inhibitors, ginger oil, glucose metabolism inhibitors, glutamine metabolism inhibitors, glutathione, green tea extracts, heparin, KAPILANNE (available from International Sourcing
• L 5 diaminopentanoic acid, L-aspargine synthase inhibitors, linoleic acid, lipoxygenase inhibitors, longa extract, mimosinamine dihydrochloride, mimosine, nitric oxide synthase inhibitors, non steroidal anti- inflammatories, ornithine decarboxylase inhibitors, ornthine aminotransferase inhibitors, panthenol, phorhetur, phosphodiesterase inhibitors, pleione extract, protein kinase C inhibitors, 5-alpha reductase inhibitors, sulfhydral reactive compounds, tioxolone, transforming growth factor beta 1 , urea, zinc ions, and mixtures thereof.
• Non-limiting examples of 5-alpha reductase inhibitors include CLOVE 55 (available from Barnet Products Distributor located in Englewood, NJ), ethynylestradiol, geisseine, genistine, Licochalcone LR-15, saw palmetto extracts, SOPHORA EXTRACT (available from Maruzen located in Morristown, NJ), ZINCIDONE (available from UCIB, located in Clifton, NJ), and mixtures thereof.
• Desquamation Enzyme Enhancers These agents enhance the activity of endogenous desquamating enzymes.
• Non-limiting examples of desquamation enzyme enhancers include, N-methyl serine, serine, trimethyl glycine, and mixtures thereof
• Anti Glycation Agents Anti-glycation agents prevent the sugar induced cross-linking of collagen.
• a suitable example of an anti-glycation agent includes AMADORINE (available from Barnet Products Distributor located in Englewood, NJ).
• benefit agents useful herein include those selected from the group consisting of salicylic acid, niacinamide, panthenol, tocopheryl nicotinate, benzoyl peroxide, 3-hydroxy benzoic acid, flavonoids (e.g., flavanone, chalcone), farnesol, phytantriol, glycolic acid, lactic acid, 4-hydroxy benzoic acid, acetyl salicylic acid, 2- hydroxybutanoic acid, 2-hydroxypentanoic acid, 2-hydroxyhexanoic acid, cis-retinoic acid, trans-retinoic acid, retinol, retinyl esters (e.g., retinyl propionate), phytic acid, N- acetyl-L-cysteine, lipoic acid, tocopherol and its esters (e.g., tocopheryl acetate), azelaic acid, arachidonic acid, tetracycline, ibu
• niacinamide panthenol
• glycolic acid lactic acid
• salicylic acid acetyl salicylic acid
• 2- hydroxybutanoic acid 2-hydroxypentanoic acid
• 2-hydroxyhexanoic acid 2-hydroxyhexanoic acid
• retinol and its esters tocopherol and its esters, and mixtures thereof.
• the benefit agent is preferably selected from anti-wrinkle and anti-skin atrophy actives, anti-acne actives, artificial tanning agents and accelerators, skin repair actives, skin barrier repair aids, skin lightening agents, skin sensates, skin soothing agents, lipids, sebum inhibitors, sebum stimulators, sunscreening agents, protease inhibitors, skin tightening agents, anti-itch ingredients, and desquamation enzyme enhancers, or mixtures thereof.
• Humectants selected from anti-wrinkle and anti-skin atrophy actives, anti-acne actives, artificial tanning agents and accelerators, skin repair actives, skin barrier repair aids, skin lightening agents, skin sensates, skin soothing agents, lipids, sebum inhibitors, sebum stimulators, sunscreening agents, protease inhibitors, skin tightening agents, anti-itch ingredients, and desquamation enzyme enhancers, or mixtures thereof.
• Preferred pre-formed, sheet devices comprise at least one humectant.
• Humectants can be added to achieve a plasticising effect and to increase the moisturising characteristics of the pre-formed, sheet device when applied to the target surface.
• Certain humectants such as hexylene glycol may also contribute to the antibacterial properties and characteristics of a pre-formed, sheet device of the present invention.
• incorporating humectants into the preformed, sheet devices of the present invention increases the stability of the devices such that they are less likely to undergo decomposition under extreme temperature conditions.
• the pre-formed, sheet devices of the present invention comprise from about 1.0% to about 45%, preferably from about 5% to about 40%, more preferably from about 10% to about 30% by weight of a humectant.
• Suitable humectants for use in the present invention are described in WO98/22085, WO98/18444 and WO97/01326, all of which are incoporated herein by reference.
• Further suitable humectants include amino acids and derivatives thereof such as proline and arginine aspartate, 1,3-butylene glycol, propylene glycol and water and codium tomentosum extract, collagen amino acids or peptides, creatinine, diglycerol, biosaccharide gum-1, glucamine salts, glucuronic acid salts, glutamic acid salts, polyethylene glycol ethers of glycerin (e.g.
• glycereth 20 glycerin, glycerol monopropoxylate, glycogen, hexylene glycol, honey, and extracts or derivatives thereof, hydrogenated starch hydrolysates, hydrolyzed mucopolysaccharides, inositol, keratin amino acids, LAREX A-200 (available from Larex), glycosaminoglycans, methoxy PEG 10, methyl gluceth-10 and -20 (both commercially available from Amerchol located in Edison, NJ), methyl glucose, 3-methyl-l,3-butandiol, N-acetyl glucosamine salts, panthenol, polyethylene glycol and derivatives thereof (such as PEG 15 butanediol, PEG 4, PEG 5 pentaerythitol, PEG 6, PEG 8, PEG 9), pentaerythitol, 1,2 pentanediol, PPG-1 glyceryl ether, PPG-9, 2-pyrrol
• the humectants for use herein are selected from glycerine, butylene glycol, hexylene glycol, panthenol and polyethylene glycol and derivatives thereof, or mixtures thereof.
• Emulsifiers/Surfactants are selected from glycerine, butylene glycol, hexylene glycol, panthenol and polyethylene glycol and derivatives thereof, or mixtures thereof.
• the pre-formed, sheet devices of the present invention can also optionally comprise one or more surfactants and/or emulsifiers.
• Emulsifiers and/or surfactants generally help to disperse and suspend the discontinuous phase within the continuous phase.
• a surfactant may also be useful if the product is intended for skin cleansing.
• emulsifiers will be referred to under the term 'surfactants', thus 'surfactant(s)' will be used to refer to surface active agents whether used as emulsifiers or for other surfactant purposes such as skin cleansing.
• Known or conventional surfactants can be used in the composition, provided that the selected agent is chemically and physically compatible with essential components of the composition, and provides the desired characteristics. Suitable surfactants include silicone materials, non-silicone materials, and mixtures thereof.
• compositions of the present invention preferably comprise from about 0.01% to about 15% of a surfactant or mixture of surfactants.
• a surfactant or surfactant mixture chosen will depend upon the pH of the composition and the other components present.
• Preferred surfactants are nonionic.
• the nonionic surfactants that are useful herein are the condensation products of alkylene oxides with fatty acids (i.e. alkylene oxide esters of fatty acids). These materials have the general formula RCO(X) n OH wherein R is a Ci 0-30 alkyl group, X is -OCH2CH2- (i.e. derived from ethylene glycol or oxide) or -OCTLCHCH3- (i.e. derived from propylene glycol or oxide), and n is an integer from about 6 to about 200.
• Other nonionic surfactants are the condensation products of alkylene oxides with 2 moles of fatty acids (i.e. alkylene oxide diesters of fatty acids).
• RCO(X) n OOCR wherein R is a Ci Q-30 alkyl group, X is -OCH2CH2-(i.e. derived from ethylene glycol or oxide) or -OCH2CHCH3-
• n is an integer from about 6 to about
• nonionic surfactants are the condensation products of alkylene oxides with fatty alcohols (i.e. alkylene oxide ethers of fatty alcohols). These materials have the general formula R(X) n OR' wherein R is a C1 Q-30 aliphatic group, X is -OCH2CH2-(i.e. derived from ethylene glycol or oxide) or (i.e.
• n is an integer from about 6 to about 100 and R' is H or a C 10-30 aliphatic group, examples of which include PEG 40 hydrogenated castor oil, available under the trade name "Cremophor RH 40" from BASF (Parsippany, NJ, USA); PEG 60 hydrogenated castor oil, available under the trade name “Cremophor RH 60” from BASF (Parsippany, NJ, USA); isoceteth-20, available under the trade name "Arlasolve 200" from ICI (Wilmington, MA, USA); and oleth-20, available under the trade name "Volpo
• Nonionic surfactants are the condensation products of alkylene oxides with both fatty acids and fatty alcohols [i.e. wherein the polyalkylene oxide portion is esterified on one end with a fatty acid and etherified (i.e. connected via an ether linkage) on the other end with a fatty alcohol].
• These materials have the general formula RCO(X) n OR' wherein R and R' are Ci Q-30 alkyl groups, X is -OCH2CH2 (i.e.
• n is an integer from about 6 to about 100, examples of which include ceteth-6, ceteth-10, ceteth-12, ceteareth-6, ceteareth-10, ceteareth-12, steareth-6, steareth-10,steareth-12, PEG-6 stearate, PEG- 10 stearate, PEG- 100 stearate, PEG- 12 stearate, PEG-20 glyceryl stearate, PEG-80 glyceryl tallowate, PEG-10 glyceryl stearate, PEG-30 glyceryl cocoate, PEG-80 glyceryl cocoate, PEG-200 glyceryl tallowate, PEG-8 dilaurate, PEG-10 distearate, and mixtures thereof.
• nonionic surfactants that are useful herein are alkyl glucosides and alkyl polyglucosides which are described in more detail in WO98/18444, incorporated herein by reference.
• Still other useful nonionic surfactants include polyhydroxy fatty acid amide surfactants, which are described in more detail in WO98/04241.
• nonionic surfactants suitable for use herein include sugar esters and polyesters, alkoxylated sugar esters and polyesters, C1 -C30 fatty acid esters of C1 -C30 fatty alcohols, alkoxylated derivatives of C1 -C30 fatty acid esters of C1 -C30 fatty alcohols, alkoxylated ethers of C1-C30 fatty alcohols, polyglyceryl esters of C1 -C30 fatty acids, C1 -C30 esters of polyols, C1 -C30 ethers of polyols, alkyl phosphates, polyoxyalkylene fatty ether phosphates, fatty acid amides, acyl lactylates, and mixtures thereof.
• non-silicon-containing surfactants examples include: polysorbate 20, polyethylene glycol 5 soya sterol, steareth-20, ceteareth-20, PPG-2 methyl glucose ether distearate, polysorbate 80; polysorbate 60, available under the trade name "Tween 60" from ICI (Wilmington, MA, USA); glyceryl stearate, sorbitan monolaurate, polyoxyethylene 4 lauryl ether sodium stearate, polyglyceryl-4 isostearate, hexyl laurate, PPG-2 methyl glucose ether distearate, and mixtures thereof.
• nonionic surfactants are those selected from the group consisting of ceteareth-12, sucrose cocoate, steareth-100, polysorbate 60, PEG-60 hydrogenated castor oil, isoceteth-20, oleth-20, PEG- 100 stearate, and mixtures thereof.
• suitable emulsifiers for use herein are polyoxypropylene, polyoxyethylene ethers of fatty alcohols.
• R has the general formula R(CH2CHCH3 ⁇ ) x - (CH2CH2 ⁇ )y-H, wherein R is an OC10-C30 alkyl group or C10-C30 alkyl group, x has an average value from 1 to 20 and y has an average value from 1 to 30, examples of which include PPG-6-Decyltetradeceth-30, available under the trade name "Pen 4630" from Nikko Chemicals Co. Ltd. (Tokyo, Japan); PPG-6-Decyltetradeceth-20, available under the trade name "Pen 4620” from Nikko Chemicals Co. Ltd. (Tokyo, Japan); and PPG-5- Ceteth-20, available under the trade name "Procetyl AWS” from Croda Chemicals Ltd. (Goole, North Humberside, England).
• emulsifier useful herein are fatty acid ester blends based on a mixture of sorbitan or sorbitol fatty acid ester and sucrose fatty acid ester, as described in more detail in WO98/22085, incorporated by reference herein.
• hydrophilic surfactants useful herein can alternatively or additionally include any of a wide variety of cationic, anionic, zwitterionic, and amphoteric surfactants such as are known in the art. See, e.g., McCutcheon's, Detergents and Emulsifiers, North American Edition (1986), published by Allured Publishing Corporation; US-A-5,011,681 to Ciotti et al, issued April 30, 1991; US-A-4,421,769 to Dixon et al., issued December 20, 1983; and US-A-3,755,560 to Dickert et al, issued August 28, 1973; these four references are incorporated herein by reference in their entirety.
• cationic surfactants are useful herein. Suitable cationic surfactants for use herein are disclosed in WO98/18444.
• anionic surfactants are also useful herein. See, e.g., US-A-3,929,678, to Laughlin et al., issued December 30, 1975, which is incorporated herein by reference in its entirety.
• exemplary anionic surfactants include the alkoyl isethionates (e.g., C12 -
• alkyl and alkyl ether sulfates and salts thereof alkyl and alkyl ether phosphates and salts thereof, alkyl methyl taurates (e.g., C12 - C30), and soaps (e.g., alkali metal salts, e.g., sodium or potassium salts) of fatty acids.
• amphoteric and zwitterionic surfactants are also useful herein.
• amphoteric and zwitterionic surfactants which can be used in the compositions of the present invention are those which are broadly described as derivatives of aliphatic secondary and tertiary amines in which the aliphatic radical can be straight or branched chain and wherein one of the aliphatic substituents contains from about 8 to about 22 carbon atoms (preferably Cg - Cjg) and one contains an anionic water solubilising group, e.g., carboxy, sulfonate, sulfate, phosphate, or phosphonate.
• amphoteric and zwitterionic surfactants are those selected from the group consisting of betaines, sultaines, hydroxysultaines, alkyl sarcosinates (e.g., C12 - C30), and alkanoyl sarcosinates.
• the pre-formed, sheet devices of the present invention may optionally contain a silicone containing emulsifier or surfactant.
• a silicone containing emulsifier or surfactant may optionally contain a silicone containing emulsifier or surfactant.
• silicone emulsifiers are useful herein. These silicone emulsifiers are typically organically modified organopolysiloxanes, also known to those skilled in the art as silicone surfactants.
• Useful silicone emulsifiers include dimethicone copolyols. These materials are polydimethyl siloxanes which have been modified to include polyether side chains such as polyethylene oxide chains, polypropylene oxide chains, mixtures of these chains, and polyether chains containing moieties derived from both ethylene oxide and propylene oxide.
• dimethicone copolyols examples include alkyl-modified dimethicone copolyols, i.e., compounds which contain C2-C30 pendant side chains.
• Still other useful dimethicone copolyols include materials having various cationic, anionic, amphoteric, and zwitterionic pendant moieties.
• the present invention can also optionally comprise oil soluble conditioning agents.
• conditioning agents useful as oil soluble conditioning agents include mineral oil, petrolatum, C7-C40 branched chain hydrocarbons, C1-C30 alcohol esters of C1-C30 carboxylic acids, C1-C30 alcohol esters of C2-C30 dicarboxylic acids, monoglycerides of C1-C30 carboxylic acids, diglycerides of C1-C30 carboxylic acids, triglycerides of Cl- C30 carboxylic acids, ethylene glycol monoesters of C1-C30 carboxylic acids, ethylene glycol diesters of C1-C30 carboxylic acids, propylene glycol monoesters of C1-C30 carboxylic acids, propylene glycol diesters of C1-C30 carboxylic acids, C1-C30 carboxylic acid monoesters and polyesters of sugars, polydialkylsiloxanes, polydiarylsiloxanes, polyalkarylsiloxa
• dimethiconol dimethiconol, cyclo- methicones having 3 to 9 silicon atoms, vegetable oils, hydrogenated vegetable oils, polypropylene glycol C4-C20 alkyl ethers, di C8-C30 alkyl ethers, and mixtures thereof.
• the pre-formed, sheet devices of the present invention can also comprise thickening polymers, preferably from about 0.01% to about 5%, more preferably from about 0.05 to about 3%, and most preferably from about 0.1% to about 2%, by weight of a thickening polymer.
• Thickening polymers may be combined with the polysaccharide mixture described herein to modify the properties of said gels.
• the thickening polymers may be chemically or physically cross-linked or employed in the polysaccharide mixture per se.
• Suitable thickening polymers useful herein include polyvinyl pyrrolidones, poly-2-ethyl- 2-oxazoline, polyvinyl alcohol, polyethylene oxide, polyvinyl ethers, copolymers of polyvinylethers and polyvinylpyrrolidone and derivatives thereof, methyl vinyl ether and maleic anhydride, copolymers of ethylene and maleic anhydride; acrylic acid based polymers or derivatives thereof such as polyacrylic acids; polyethylene glycol monomethacrylate, polydimethyl acrylamide, salts of polyacrylic acid such as ammonium polyacrylate and sodium polyacrylate; and copolymers of acrylamide and N ⁇ -methylene bisacrylamide and polyacrylamide; and polyacrylamide.
• the pre-formed, sheet devices of the present invention can also comprise additional polysaccharides.
• the sheet device of the present invention contains less than 10% total polysaccharide (by dry weight).
• the additional polysaccharides, if present, contribute to the total dry weight of the polysaccharides comprising the device.
• Suitable additional polysaccharides include brown seaweed polysaccharides such as algin, alginic acid, alginate salts such as (calcium, potassium, aluminium, or sodium) and propylene glycol alginate; extracts of marine invertebrates such as chitosan and hydroxypropyl chitosan and derivatives; starch or derivatives thereof; natural fruit extracts such as pectin and arabian; natural plant exudates such as karaya gum, tragacanth gum, arabic gum, tamarind gum, and ghatty gum; and resinous gums such as shellac gum, damar gum, copal gum and rosin gum; or mixtures thereof.
• brown seaweed polysaccharides such as algin, alginic acid, alginate salts such as (calcium, potassium, aluminium, or sodium) and propylene glycol alginate
• extracts of marine invertebrates such as chitosan and hydroxypropyl chi
• polysaccharides useful herein are cellulose and derivatives thereof as described in WO97/28785, incorporated herein by reference.
• the devices of the present invention can also comprise matting or light scattering agents, particularly organic or organosiloxane parti culates such as nylon- 12 powder, silicone elastomer powders (e.g. dimethicone / vinyl dimethicone cross-polymer), and polyalkyl- silsesquioxane powders (such as Tospearl® 145 A from GE Silicones).
• matting or light scattering agents particularly organic or organosiloxane parti culates such as nylon- 12 powder, silicone elastomer powders (e.g. dimethicone / vinyl dimethicone cross-polymer), and polyalkyl- silsesquioxane powders (such as Tospearl® 145 A from GE Silicones).
• organic or organosiloxane parti culates such as nylon- 12 powder, silicone elastomer powders (e.g. dimethicone / vinyl dimethicone cross-poly
• compositions of the present invention can comprise a wide range of other optional components. These additional components should be pharmaceutically acceptable.
• abrasives examples include: abrasives, absorbents, antibiotics, anticaking agents, anti- dandruff agents, anti-perspirant agents, antioxidants, vitamins, biological additives, bleach, bleach activators, brighteners, builders, buffering agents, chelating agents, chemical additives, colorants, cosmetics, cleansers, cosmetic astringents, cosmetic biocides, denaturants, dental treatments, deodorants, desquamation actives, depilatories, drug astringents, dyes, dye transfer agents, enzymes, external analgesics, flavors, film formers, fragrance components, insect repellants, mildewcides, opacifying agents, oxidative dyes, oxidising agents, pest control ingredients, pH adjusters, pH buffers, pharmaceutical actives, plasticizers, preservatives, radical scavengers, skin, hair or nail bleaching agents, skin, hair or nail conditioners, skin, hair or nail penetration enhancers, stabilisers, surface conditioners, reducing agents
• aesthetic components such as colorings, essential oils, and skin healing agents.
• pigments include pigments.
• Pigments suitable for use in the compositions of the present invention can be organic and/or inorganic. Also included within the term pigment are materials having a low colour or lustre such as matte finishing agents, and also light scattering agents. Examples of suitable pigments are iron oxides, acyglutamate iron oxides, titanium dioxide, ultramarine blue, D&C dyes, carmine, and mixtures thereof. Depending upon the type of composition, a mixture of pigments will normally be used.
• the pH of the sheet devices herein is preferably from about 3 to about 9, more preferably from about 4 to about 8.
• the pre-formed, sheet devices of the present invention are patches or masks having a size and shape adapted to conform to the desired target area. The exact size and shape will depend upon the intended use and product characteristics.
• the pre-formed, sheet devices herein are suitable for topical application to the nails or cuticles, the hair or scalp, a human face or part thereof, legs, hands, arms, feet, or human torso.
• the devices herein may be for example, square, circular, rectangular, oval, or other shapes which are composites of these such as shapes that could be described as "semi-circle", "donut", or others.
• the surface area for devices shaped to fit the face have a surface area ranging from
• the devices herein have a thickness of from about 0.5 mm to about 20 mm, preferably from about 1 mm to about 5 mm.
• the pre-formed, sheet devices of the present invention may also be made and used in the form of handwear, footwear, or a body wrap.
• the handwear will comprise a glove for the hand or any portion thereof, and the footwear will comprise a sock for the foot or any portion thereof.
• the term "glove” is meant to be inclusive of "mitten.”
• the handwear comprises a glove body comprising a middle section, from one to four finger receptacles connected with the middle section, a thumb receptacle connected with the middle section, a palm side and an opposite back side.
• the footwear comprises a sock body forming a tubular foot portion having a closed end and an open end.
• the inventive devices may also be made or used in the form of a body wrap.
• the body wrap is wrapped radially around any body part having a longitudinal axis. Its ends may communicate with each other, or its length may be shortened so as to only wrap partially around. In either case, the wraps should exhibit excellent conformity to the shape of the body part.
• body parts will include the user's back, upper arm, lower arm, upper leg, lower leg, neck, and torso.
• the device may be left on the target area for about 3 hours, preferably about 1 hour, more preferably less than 15 minutes.
• the pre-formed, sheet device can then be removed all in one piece.
• the pre-formed, sheet devices of the present invention may have at least one of the following uses; hydrating the skin, hair or nails; smoothing fine lines and wrinkles; cosmetically treating acne; firming the skin; strengthening; softening; exfoliating; improving and/or evening skin tone and/or texture; skin, hair or nail lightening; conditioning the skin or hair; tanning; reducing the appearance of pores; absorbing or controlling secretions; protecting and/or soothing the skin, hair or nails, muscles, aches or pains; reducing puffmess, and/or dark circles; stimulating wound healing; warming, refreshing or cooling the skin; relieving inflammation; brightening the complexion; decongesting; reducing swelling; treating dermatological conditions; cushioning; purifying; fragrancing; reducing bacterial or micro-organism growth; healing; repelling insects; removing unwanted hair, dirt, or make-up; and colouring or bleaching the target area to which the device is applied.
• the amount of syneresis from a pre-formed, sheet device of the present invention is measured on the polysaccharide gel mixture comprising the device via an exudate release test.
• a gel formulation of interest is prepared as described below. While still a hot liquid (>80°C), nine grams (+/- 0.1 g) is poured into a 91 mm diameter shallow receptacle, e.g. the lid of a Falcon-1029 Petri dish. This receptacle is hermetically sealed to reduce evaporative losses. The gel is allowed to solidify undisturbed with cooling to room temperature. The gel is stored at room temperature overnight before readings are taken. The covering is removed and the receptacle with sample tared (+/- 0.005g). Three pieces of filter paper (9.0 cm Whatman- 114 Wet Strengthened) are stacked on the flat gel surface.
• a 9.0 cm diameter flat-bottomed weight of 200 g is placed on the filter paper to ensure close contact with the gel surface. After one minute the weight is removed and filter paper gently peeled away from the gel. The paper should impart a clearly visible matte surface to the gel, which confirms good contact by the filter paper. The sample is reweighed and mass loss calculated by difference. This is reported as grams of exudate released for the 9cm diameter gel disc described above.
• the mechanical properties of the pre-formed, sheet devices of the present invention are measured via compressive failure testing of the gel.
• the parameters of interest are the gel strength (measured via the compressive force required to rupture a moulded cylinder of gel) and the gel flexibility (measured via the extent of gel compression at the point of rupture).
• Compressive failure testing is performed using a Stable Micro Systems (SMS) Texture Analyser (TA), model TA-XT2i available from Stable Micro Systems Ltd (Godalming, Surrey, UK).
• SMS Texture Analyser
• TA-XT2i available from Stable Micro Systems Ltd (Godalming, Surrey, UK).
• the system is controlled through SMS's Texture Expert Exceed software (version 2.03) running within Windows-98.
• a 100 mm diameter Aluminum compression plate (P-100 probe) is attached to a 50 Kg load cell. This is mounted within the TA Probe Carrier, the extended arm whose vertical travel is under computer control.
• a gel formulation of interest is prepared as described below.
• Gel discs of a precise cylindrical-solid shape (26 mm diameter by 12 mm depth) are formed in moulds.
• the moulds with sample are hermetically sealed against evaporation during storage. These gel discs are stored at ambient temperature overnight.
• Each gel disc is removed from its mould just prior to testing and visually inspected for defects. Any gel discs with defects (e.g. trapped air bubbles) are discarded as these defects may impact the measured mechanical properties.
• the non-defective gel disc is then centered under the P- 100 compression plate.
• the Texture Expert Exceed software is set-up in Force / Compressive mode.
• the compression plate is pre-set to a starting height of 12.0 mm. Its rate of descent is set to 0.8 mm/second and total travel distance set to 10.8 mm (i.e. measurement stops when the gel disc is compressed by 90% of its original height). Data is automatically collected on force and position of the compression plate at the rate of 200 pps (points per second).
• the software is pre-set to mark compression plate position at the maximum force achieved. This maximum force is the rupture strength, that is, the force required to rupture the gel disc.
• the distance travelled by the plate from its original starting height to the point of gel rupture represents the extent of deformation of the gel. The maximum force at the point of rupture is averaged across samples (typically 5 replicates) and reported in Newtons.
• the uni-axial deformation (compression) at the gel's point of rupture is expressed as a percent of its original moulded height, i.e.
• KelgumTM is a 1 :1 mixture of xanthan gum and locust bean gum supplied by Kelco, San Diego, CA, USA.
• the polysaccharide gums are mixed with water to form an uniform dispersion (this can be facilitated by pre-dispersing the polysaccharides in a non-solvent e.g. polyhydric alcohol) and any additional components are added.
• the mixture is heated with stirring to a first temperature above the gel point of the mixture (ca. 90°C) to fully hydrate the polysaccharide gums.
• the liquid gel is then dispensed into a suitably shaped mould.
• the liquid gel is dispensed via injection moulding. This eliminates any defects which may be introduced by cutting the gel and so improves the robustness of the device. Injection moulding also allows device to be readily formed with varying regions of thickness and other structural features.
• the liquid gel may be cast into a sheet.
• the liquid gel is then cooled to a second temperature cooler than the first temperature at or below the gel point of the mixture (e.g. ambient temperature) to set up the gel structure.
• the device may then be removed from the mould or appropriately shaped patches may be cut from the gel sheet.
• the devices herein are then packaged into materials which have low water vapour permeability to minimise drying out of the device during storage. Suitable packaging for devices herein include sachets or sealed trays. If the device is packaged in a sachet, it is preferably protected prior to use. This protection can be provided by a release liner such as a plastic film, which provides easy release for the device.
• a substrate is to be used, (Examples 1 , 4, and 6) this may be placed in the suitably shaped mould prior to dispensing the gel or it may be placed on the surface of the liquid gel during the cooling stage.
• metal ions e.g. Ca 2+ , K +
• the metal ions may be included in the formulation (Examples 3 and 4) to increase the gel strength of the device.
• the metal ions are added in the form of an aqueous solution and are stirred into the hydrated liquid gel as the final addition to the mixture.
• the above method may be modified as necessary depending on the nature of any additional components.
• the liquid gel may be homogenised immediately prior to moulding or casting to ensure dispersion of the non-aqueous components.
• the formulation should be cooled to an appropriate temperature (dependent on the ingredient) after the gum hydration step and the heat sensitive ingredient added at this stage.
• the liquid gel may be de-gassed, e.g. by vacuum, to remove air bubbles dispersed within the liquid. This de-gassing step, if followed, would be the final step immediately prior to dispensing the liquid gel.
• the pre-formed, sheet devices have a desirable amount of syneresis, strength or flexibility.

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