Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K31/00—Medicinal preparations containing organic active ingredients
  • A61K31/33—Heterocyclic compounds
  • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
  • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
  • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
  • A61K31/455—Nicotinic acids, e.g. niacin; Derivatives thereof, e.g. esters, amides
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K31/00—Medicinal preparations containing organic active ingredients
  • A61K31/16—Amides, e.g. hydroxamic acids
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
  • A61F7/10—Cooling bags, e.g. ice-bags
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
  • A61F7/10—Cooling bags, e.g. ice-bags
  • A61F7/106—Cooling bags, e.g. ice-bags self-cooling, e.g. using a chemical reaction
• • 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
  • A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
• • 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
  • A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
  • A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
  • A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
  • A61K9/7046—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds
  • A61K9/7053—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds obtained by reactions only involving carbon to carbon unsaturated bonds, e.g. polyvinyl, polyisobutylene, polystyrene
  • A61K9/7061—Polyacrylates
• • 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
  • A61L15/20—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing organic 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
  • A61L15/42—Use of materials characterised by their function or physical properties
  • A61L15/44—Medicaments
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P17/00—Drugs for dermatological disorders
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
  • A61F2007/0001—Body part
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
  • A61F2007/0098—Heating or cooling appliances for medical or therapeutic treatment of the human body ways of manufacturing heating or cooling devices for therapy
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F13/00—Bandages or dressings; Absorbent pads
  • A61F13/02—Adhesive bandages or dressings
  • A61F13/0276—Apparatus or processes for manufacturing adhesive dressings or bandages
  • A61F2013/0296—Apparatus or processes for manufacturing adhesive dressings or bandages for making transdermal patches (chemical processes excluded)
• • 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
  • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
  • A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
  • A61L2300/204—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials with nitrogen-containing functional groups, e.g. aminoxides, nitriles, guanidines
• • 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
  • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
  • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action

Definitions

• Tissue inflammation is the result of interconnected physiological events. Inflammation of the skin, which is associated with tissue damage, can result from various skin disorders such as eczema, psoriasis, seborrheic dermatitis, contact dermatitis, allergic dermatitis, etc. Inflammation is also associated with tissue damage resulting from ultraviolet or thermal burns, attack by certain microorganisms, insect bites, stings, etc. Inflammation of deeper structures, the muscles, tendons, bursa, and joints, which is associated with tissue damage, can result from physical trauma, e.g. sprains, strains, contusions, strenuous exercise, etc. Such inflammation may result in bursitis, tendinitis, and muscle soreness. Inflammation is also associated with tissue damage resulting from metabolic disorders, such as gout, or from immunologic disorders, such as rheumatoid arthritis, or from changes associated with aging, such as osteoarthritis.
• Symptoms of inflammation are erythema (redness), edema (swelling), heat, pain, and loss of function.
• the immediate consequence of tissue damage is the release of certain chemical agents which are mediators of inflammation, i.e., these materials evoke and intensify the events which result in the redness, swelling, pain and heat. Examples of these chemical agents are histamine, seratonin and the kinins.
• Topical patch preparations that contain an odorless physiological cooling agent, and methods for using the same are provided.
• the subject topical patch preparations are made up of an adhesive gel composition that is present on a support, where the adhesive gel composition includes the odorless physiological cooling agent, a water-soluble polymer gel, water and a water holding agent.
• the topical patch preparations are applied to a skin surface of a subject and maintained at the site of application for a period of time sufficient for an effective amount of the an odorless physiological cooling agent to be administered to the subject.
• the subject invention finds use in a variety of applications.
• Fig. 1 provides a cross-sectional view of a topical patch preparation according to an embodiment of the invention.
• Figs. 2 and 3 provide schematic representations of the manufacturing process for topical patch preparations according to an embodiment of the invention. DETAILED DESCRIPTION
• Topical patch preparations that contain an odorless physiological cooling agent, and methods for using the same are provided.
• the subject topical patch preparations are made up of an adhesive gel composition that is present on a support, where the adhesive gel composition includes the odorless physiological cooling agent, a water-soluble polymer gel, water and a water holding agent.
• the topical patch preparations are applied to a skin surface of a subject and maintained at the site of application for a period of time sufficient for an effective amount of the an odorless physiological cooling agent to be administered to the subject.
• the subject invention finds use in a variety of applications.
• the subject invention is directed to topical patch preparations of an odorless physiological cooling agent.
• the topical patch preparations of the subject invention are characterized by having an effective amount of the odorless physiological cooling agent present in a gel adhesive base.
• Figure 1 provides a representation of a topical patch preparation described according to the subject invention. As can be seen in Figure 1, this representative topical patch preparation 10 contains a gel adhesive base 12 present on a support 14. Each of these components is now described in greater detail.
• the gel adhesive base which serves as the retaining layer, is made up of the odorless physiological cooling agent that is present in, e.g., dissolved in or dispersed in, and adhesive gel base.
• physiological cooling agent is meant an agent that, when contacted with skin of a subject, imparts a cooling sensation or effect to the subject, in a manner analogous to the cooling effect of menthol.
• odorless is meant that the odor of the agent is less pungent than the odor of menthol.
• the cooling agent is an acyclic amide, where representative acyclic amids include compounds of the formula:
• Ri, R 2 and R 3 are each Ci -C 5 alkyl and together provide a total of at least 3,, such as from about 3-10, including from about 5-10, carbon atoms; and R 1 is Ci -C 5 alkyl, Ci -Cs hydroxyalkyl or alkylcarboxyalkyl of up to 8 carbon atoms.
• Ri is in representative embodiments, methyl, ethyl or n-propyl and one or both of R 2 and R 3 is branched in an alpha or beta position relative to the carbon atom marked (*).
• the cooling agent is N,2,3-trimethyl-w- isopropylbutamide (also known as WS-23; trimethyl isopropyl butanimide, CAS#51115-67-4).
• odorless physiological cooling agents of interest include, but are not limited to: linalool, geraniol, hydroxycitronellal, WS-3(Millennium Chemical), FlescolatMGA(Haarman & Reimer), FrescolatML(Haarmann & Reimer), PMD38(Takasago), CoolactP(Takasago) and Cooling Agent 10(Takasago); and the like.
• the amount of odorless physiological cooling agent that is present in the adhesive gel base is an amount sufficient to administer to a subject an effective amount of the agent when applied to a skin surface of the subject, as described in greater detail below.
• the amount of odorless physiological cooling agent present in the adhesive gel base ranges from about 0.1 to 15.0 % (w/w) , sometimes from about 0.5 to 10.0 % (w/w), such as from about 1.0 to 8.0 % (w/w) and including from about 2.0 to 7.0 % (w/w).
• the adhesive gel base that includes the agent, as described above, is made up of a water-soluble high molecular weight substance, water and a water-retaining agent.
• the adhesive gel base may further include a cosolvent, e.g., an organic cosolvent.
• Water-soluble high molecular weight substances of interest include water- soluble polymers, where polymers of interest include, but are not limited to: gelatin, starch, agar, mannan, alginic acid, polyacrylic acid, sodium polyacrylate, dextrin, methylcellulose, sodium methylcellulose, hydroxypropylcellulose, sodium carboxymethylcellulose, cellulose gum, carboxyvinyl polymer, polyvinyl alcohol, polyvinylpyrrolidone, Arabia gum, acacia, tragacanth gum, karaya gum, and starch acrylate copolymer or other starch sodium acrylate graft copolymers.
• polymers of interest include, but are not limited to: gelatin, starch, agar, mannan, alginic acid, polyacrylic acid, sodium polyacrylate, dextrin, methylcellulose, sodium methylcellulose, hydroxypropylcellulose, sodium carboxymethylcellulose, cellulose gum, carboxyvinyl polymer, polyvinyl alcohol, poly
• Metallic salts of these, as well as the products of cross-linking these by means of organic or inorganic cross-linking agents, are also of interest.
• These water-soluble polymers can be used to bring out the properties and characteristics of the other starting materials used in the adhesive gel composition, and in practice can be used alone or in combinations of 2 or more.
• the amount of water soluble high molecular weight substance(s) present in the adhesive gel base generally ranges from about 0.5 to 20, such as from a bout 2 to 20 % (w/w).
• the water component While any convenient water may be employed as the water component, of interest are distilled water or ion-exchange water or the like, which is preferred in many embodiments of the subject invention.
• the amount of water present in the gel adhesive is sufficient to impart the desired physical properties to the gel adhesive, and to improve the swelling of the horny or keratinized layer of the skin to thereby improve the permeability or penetration of active agent(s), where the amount of water in the gel composition generally ranges from about 10 to 80%, such as from about 30 to 60% (w/w).
• the water-retaining agent or water-holding agent of the subject adhesive gel compositions is any agent that is capable of at least diminishing the volatilization of water contained in the adhesive gel base so that the water content in the adhesive gel base is maintained at least a substantially constant, if not constant, level during storage and use of the preparation.
• One or more water-retaining agents may be employed in the subject compositions, where the amount of water-retaining agent present in the adhesive gel base may range from about 1 to 70%, such as from about 10 to 60% by weight.
• suitable water-retaining or water-holding agents include, but are not limited to: 1 or more types of polyvalent or polyhydric or sugars or alcohols, such as glycerin, sorbitol, propylene glycol, diethylene glycol, 1 ,3-butylene glycol, and ethylene glycol, and the like.
• the subject gel base compositions may also include a cosolvent, where the cosolvent is generally an organic cosolvent.
• cosolvents of interest include, but are not limited to: n-methyl-2-pyrrolidone, deet, ethyl alcohol, methyl alcohol, polyethylene glycol (e.g., low molecular weight polyethylene glycol, such as PEG 600 or lower, e.g., 500, 400, 300, 200, 100 etc and blends) thereof, and isopropyl myristate, etc.
• the cosolvent may be made up of a simple component or be incombination of two or more components.
• various additives that are used in ordinary topical water-soluble patch preparations may also be suitably compounded as needed, including inorganic substances such as kaolin, bentonite, and titanium dioxide; preservatives such as paraben; anionic, cationic, and nonionic surfactants; metallic aluminum crosslinking agents such as aluminum chloride, dried aluminum hydroxide gel, and dihydroxyaluminum aminoacetate; oils such as jojoba oil and castor oil; chelating agents such as EDTA; pH regulators such as malic acid, tartaric acid, and diisopropanolamine; alcohols such as ethanol; moisture retaining agents such as hyaluronic acid, aloe extract, and urea; and other perfumes and coloring agents.
• inorganic substances such as kaolin, bentonite, and titanium dioxide
• preservatives such as paraben
• anionic, cationic, and nonionic surfactants metallic aluminum crosslinking agents such as aluminum chloride, dried aluminum hydroxide gel,
• the pH of the gel base composition typically is one that lies in a physiologically acceptable range, where the pH typically may range from about 4.0 to 7.0, such as from about 4.0 to 6.0.
• the adhesive gel composition containing the one or more active ingredients is typically present on a support or backing.
• the support is generally made of a flexible material which is capable of fitting in the movement of human body and includes, for example, various non-woven fabrics, woven fabrics, spandex, flannel, or a laminate of these materials with polyethylene film, polyethylene glycol terephthalate film, polyvinyl chloride film, ethylene-vinyl acetate copolymer film, polyurethane film, and the like.
• the subject topical patches may also include a release film 16 on the surface of the gel layer opposite the backing that provides for protection of the gel layer from the environment.
• the release film may be any convenient material, where representative release films include polyesters, such as PET or PP, and the like.
• the patch is present in a sealed package.
• the sealed package is fabricated from a packaging material that includes a layer made out of a material capable of preventing passage of moisture, oxygen and other agents, i.e., the package includes in a moisture/oxygen barrier material.
• Any suitable barrier material may be employed, where barrier materials of interest include metallic layers, e.g., aluminum, where in many embodiments, the barrier layer is an aluminum layer.
• This barrier layer has a thickness sufficient to provide for the barrier function, where the thickness typically ranges from about 5 to 15, usually from about 6 to 10 ⁇ m.
• the package is a laminate of the barrier layer in combination with one or more additional layers, e.g., polymeric layers, paper layers, etc.
• a representative aluminum containing package that may be used with the subject patch preparations is sold by Dainippon Printing Co., Ltd. (Kyoto, Japan).
• the topical patch preparations may be fabricated using any convenient protocol.
• One convenient protocol for fabrication of the subject patches includes preparing a gel adhesive paste through the uniform mixing of the aforementioned ingredients and then coating the paste onto the support, followed by cutting of the resultant product to the specified size to obtain the desired topical patch preparation.
• the resultant topical patch preparation is then heat-sealed, typically several sheets to a package, using a packaging material containing an aluminum layer, as described supra, to obtain the sealed topical patch.
• U.S. Patent No. 5,827,529 See U.S. Patent No. 5,827,529; the disclosure of which is herein incorporated by reference.
• the base used in the present invention is produced by using a mixer to uniformly blend the aforementioned ingredients by means of any convenient protocol into a paste, which is then spread by means of a spreader onto a backing or support material.
• the support material may be, for example, paper, or a woven or nonwoven cloth made of PET or PP or some other polyester fiber.
• the surface thereof is then covered with a release film of a polyester such as PET or PP.
• the hydrogel patch compositions are self-adhesive, i.e., inherently adhesive, and thus may be fixed in a position over the skin wound, i.e., removably bonded to and/or about a given skin wound, without the use of additional adhesives or other means to hold the patch in place over the formulation.
• the hydrogel composition matrix may itself be adhesive.
• the hydrogel compositions are adhesive, as determined using the Japanese Industrial Standards (JIS) Z-0237 adhesive strength measurement protocol (see e.g., U.S. Application Serial No.
• a given hydrogel composition is considered to be adhesive if it stops at least a No. 3 size ball, such as at least about a No. 4 size ball, including at least a bout a No. 5 size ball, in this protocol.
• the composition is sufficiently adhesive to stop a No. 6 ball or greater, e.g., No. 7 ball or greater, e.g., No. 8 ball or greater, e.g., No. 9 ball or greater.
• the subject compositions are differentially adhesive, in that they show greater adhesiveness to non-living, as opposed to living matter.
• a subject hydrogel patch composition may be held in a fixed position about a skin wound using a separate adhesive such as an adhesive backing or the like or a combination of inherent adhesiveness and an additional separate adhesion means may be employed.
• hydrogel patch compositions may be adapted and employed for use with the subject invention.
• Representative hydrogel patch compositions that may be adapted for use with the subject invention include, but are not limited to those described in PCT International Publication Nos.: WO 02/078757 and WO 02/078756 and U.S. Patent Nos.: 5,120,544; 5,160,328; 5,270,358; 5,423,737; 5,476,443; 5,489,262; 5,501 ,661 ; 5,827,529; 6,039,940; 6,096,333; 6,214,374; 6,296,869; 6,348,212; 6,455,065; the disclosures of which are herein incorporated by reference.
• the resulting product is then cut to the specified size to obtain the desired topical patch preparation composition.
• the shape of the patch may vary, where representative shapes include square, rectangle, oval, circle, etc.
• the size of the patch may also vary, where in many embodiments the size ranges from about 1 to 200 cm 2 , and in many embodiments from about 10 to 180 cm 2 , usually from about 100 to 150 cm 2 , e.g., 140 cm 2 .
• the weight of the base in the final topical patch may be from about 300 to about 1500 g/m 2 , such as from about 600 to about 1200 g/m 2 .
• This water-soluble topical patch preparation is then packaged by means of a heat seal in a packaging material that includes a layer of aluminum to obtain the final product, as shown in Figure 3.
• the subject patch preparations find use in applications of topically delivering a cooling agent to a subject, particularly the skin of a subject.
• the patch may be administered to any convenient topical site.
• Topical sites of interest include, but are not limited to: arms, leg, torso, head, etc.
• the surface area that is covered by the topical patch preparation following application must be sufficient to provide for the desired amount of agent administration, and in many embodiments ranges from about 1 to 200 cm 2 , and in many embodiments from about 10 to 180 cm 2 , usually from about 100 to 150 cm 2 , e.g., 140 cm 2 .
• the period of time required to deliver the desired amount of agent is generally not exceeding about 48 hours, usually not exceeding about 24 hours. However, the period of time during which the preparation is maintained at the application site is, in many embodiments, at least about 30 minutes, usually at least about 1 hour.
• a topical patch may be applied a single time or a plurality of times over a given time period, e.g., the course of the disease condition being treated, where the dosing schedule when a plurality of patches are administered over a given time period may be daily, weekly, biweekly, monthly, etc.
• the topical application the cooling agent according to the subject methods as described herein is effective for treating inflammation, aches, etc., including the maladies reviewed in the introduction section of this application.
• subjects are "mammals” or “mammalian,” where these terms are used broadly to describe organisms which are within the class mammalia, including the orders carnivore (e.g., dogs and cats), rodentia (e.g., mice, guinea pigs, and rats), and primates (e.g., humans, chimpanzees, and monkeys).
• the hosts will be humans.
• the subject methods find use in the treatment of a disease condition.
• treatment is meant at least an amelioration of the symptoms associated with the pathological condition afflicting the host, where amelioration is used in a broad sense to refer to at least a reduction in the magnitude of a parameter, e.g. symptom, associated with the pathological condition being treated, side effects associated therewith.
• treatment also includes situations where the pathological condition, or at least symptoms associated therewith, are completely inhibited, e.g. prevented from happening, or stopped, e.g. terminated, such that the host no longer suffers from the pathological condition, or at least the symptoms that characterize the pathological condition.
• treatment includes both curing and managing a disease condition.
• kits where the subject kits at least include one or more topical patch preparations, as described above.
• the subject topical patch preparations in the kits may be present in a package, as described supra.
• the topical patches of the kits are typically present in individual pouches or analogous containers, to preserve the composition of the patches until use.
• the subject kits also generally include instructions for how to use the patches, where the instructions typically include information about where to apply the patch, dosing schedules etc.
• the instructions are generally recorded on a suitable recording medium.
• the instructions may be printed on a substrate, such as paper or plastic, etc.
• the instructions may be present in the kits as a package insert, in the labeling of the container of the kit or components thereof (i.e. associated with the packaging or subpackaging) etc.
• the instructions are present as an electronic storage data file present on a suitable computer readable storage medium, e.g. CD-ROM, diskette, etc.
• Stability Data Stability data on the WS-23 content and patch adhesive strength in the practical example 01. The experiment was conducted in an environment of 4O 0 C and 75% humidity. The results are shown in a comparison with the initial value, which was taken to be 100% and are provided in Table 2. Table 2.
• the WS-23 topical patch preparation of the practical example 01 was applied to patient volunteers who suffer from stiff shoulder, back pain, muscle fatigue pain and carpal tunnel syndrome(CTS) to investigate its efficacy.
• the WS-23 topical patch preparation of practical example 01 was applied to the affected area of 4 volunteers for 12 hours
• the pain level prior to application and 30 minutes post application was measured for each subject.

Landscapes

• Health & Medical Sciences (AREA)
• Engineering & Computer Science (AREA)
• Life Sciences & Earth Sciences (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Animal Behavior & Ethology (AREA)
• Chemical & Material Sciences (AREA)
• Epidemiology (AREA)
• Bioinformatics & Cheminformatics (AREA)
• Medicinal Chemistry (AREA)
• Pharmacology & Pharmacy (AREA)
• Dermatology (AREA)
• Physics & Mathematics (AREA)
• Biomedical Technology (AREA)
• Vascular Medicine (AREA)
• General Chemical & Material Sciences (AREA)
• Chemical Kinetics & Catalysis (AREA)
• Hematology (AREA)
• Materials Engineering (AREA)
• Heart & Thoracic Surgery (AREA)
• Thermal Sciences (AREA)
• Organic Chemistry (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• Pain & Pain Management (AREA)
• Rheumatology (AREA)
• Medicinal Preparation (AREA)
• Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
• Thermotherapy And Cooling Therapy Devices (AREA)

Priority Applications (14)

Applications Claiming Priority (2)

Publications (1)

Family

ID=36647805

Family Applications (1)

Country Status (20)

Cited By (3)

Families Citing this family (24)

Citations (3)

Family Cites Families (70)

• 2005
  • 2005-12-16 MX MX2007008154A patent/MX2007008154A/es active IP Right Grant
  • 2005-12-16 ES ES05854530T patent/ES2377134T3/es not_active Expired - Lifetime
  • 2005-12-16 RU RU2007124791/15A patent/RU2375049C2/ru not_active IP Right Cessation
  • 2005-12-16 PL PL05854530T patent/PL1833443T3/pl unknown
  • 2005-12-16 PT PT05854530T patent/PT1833443E/pt unknown
  • 2005-12-16 CN CN2012101152892A patent/CN102670350A/zh active Pending
  • 2005-12-16 EP EP05854530A patent/EP1833443B1/en not_active Revoked
  • 2005-12-16 WO PCT/US2005/045835 patent/WO2006073767A1/en not_active Ceased
  • 2005-12-16 KR KR1020117006926A patent/KR101158711B1/ko not_active Expired - Fee Related
  • 2005-12-16 CN CN2005800458165A patent/CN101094630B/zh not_active Expired - Fee Related
  • 2005-12-16 JP JP2007549451A patent/JP5117196B2/ja not_active Expired - Fee Related
  • 2005-12-16 AT AT05854530T patent/ATE534357T1/de active
  • 2005-12-16 AU AU2005323206A patent/AU2005323206C1/en not_active Ceased
  • 2005-12-16 BR BRPI0519748-1A patent/BRPI0519748A2/pt not_active IP Right Cessation
  • 2005-12-16 KR KR1020097025251A patent/KR20100017599A/ko not_active Ceased
  • 2005-12-16 DK DK05854530.2T patent/DK1833443T3/da active
  • 2005-12-16 KR KR1020077014775A patent/KR20070102674A/ko not_active Ceased
  • 2005-12-16 SI SI200531465T patent/SI1833443T1/sl unknown
  • 2005-12-16 US US11/305,307 patent/US8105624B2/en not_active Expired - Fee Related
  • 2005-12-16 NZ NZ556202A patent/NZ556202A/en not_active IP Right Cessation
  • 2005-12-16 CA CA2591867A patent/CA2591867C/en not_active Expired - Fee Related
• 2006
  • 2006-01-02 AR ARP060100008A patent/AR055552A1/es not_active Application Discontinuation
  • 2006-01-03 TW TW095100121A patent/TWI428122B/zh not_active IP Right Cessation
  • 2006-01-03 TW TW101143367A patent/TW201313208A/zh unknown
• 2011
  • 2011-12-06 US US13/312,744 patent/US8475836B2/en not_active Expired - Fee Related
• 2012
  • 2012-06-13 JP JP2012133659A patent/JP5600141B2/ja not_active Expired - Fee Related
• 2013
  • 2013-06-04 US US13/909,804 patent/US20130337032A1/en not_active Abandoned

Patent Citations (3)

Also Published As

Similar Documents

Legal Events