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WO2025041654A1 - Cataplasme et son procédé de production - Google Patents

Cataplasme et son procédé de production Download PDF

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Publication number
WO2025041654A1
WO2025041654A1 PCT/JP2024/028691 JP2024028691W WO2025041654A1 WO 2025041654 A1 WO2025041654 A1 WO 2025041654A1 JP 2024028691 W JP2024028691 W JP 2024028691W WO 2025041654 A1 WO2025041654 A1 WO 2025041654A1
Authority
WO
WIPO (PCT)
Prior art keywords
adhesive layer
poultice
liner
mass
surfactant
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/JP2024/028691
Other languages
English (en)
Japanese (ja)
Inventor
将 佐藤
圭一郎 鶴島
哲治 桑原
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Hisamitsu Pharmaceutical Co Inc
Original Assignee
Hisamitsu Pharmaceutical Co Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Hisamitsu Pharmaceutical Co Inc filed Critical Hisamitsu Pharmaceutical Co Inc
Publication of WO2025041654A1 publication Critical patent/WO2025041654A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

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
    • A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • 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
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • 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

Definitions

  • the present invention relates to a poultice and a method for producing the same.
  • a poultice is a type of patch that is manufactured by spreading an adhesive layer (preferably a paste layer containing a drug) onto a support layer such as cloth.
  • the adhesive layer contains water and a water-soluble polymer, and also contains a crosslinking agent and a surfactant to ensure the adhesive layer's shape retention and cohesiveness.
  • Patent Document 1 Japanese Patent Application Laid-Open No. 6-135828
  • Patent Document 2 Japanese Patent Application Laid-Open No. 2005-314290
  • Patent Document 314290 Japanese Patent Application Laid-Open No. 2005-314290
  • Patent Document 2 describes a patch containing 0.5% of polyethylene glycol monostearate, 0.5% of synthetic aluminum silicate, and 0.3% of magnesium aluminometasilicate.
  • a cataplasm comprising a support layer, an adhesive layer and a liner layer for protecting the adhesive layer, the adhesive layer containing water, a water-soluble polymer, a crosslinking agent and a surfactant, by blending magnesium aluminometasilicate as the crosslinking agent and polyethylene glycol monostearate as the surfactant in specific proportions, a cataplasm can be obtained in which the adhesive layer has excellent adhesion to the skin, the adhesive layer is unlikely to remain when peeled off from the skin, the liner has excellent peelability and the liner is unlikely to slip off during storage.
  • a poultice comprising a support layer, an adhesive layer, and a liner layer for protecting the adhesive layer, the adhesive layer containing water, a water-soluble polymer, a crosslinking agent, and a surfactant, the crosslinking agent is magnesium aluminometasilicate, and its content is 0.25 to 2.5% by mass relative to the total mass of the pressure-sensitive adhesive layer;
  • the poultice, wherein the surfactant is polyethylene glycol monostearate, and the content thereof is 0.8 to 4.5% by mass based on the total mass of the adhesive layer.
  • a method for producing a poultice comprising a support layer, an adhesive layer, and a liner layer for protecting the adhesive layer comprising: The method includes the steps of: preparing a pressure-sensitive adhesive layer composition by mixing water, a water-soluble polymer, a crosslinking agent, and a surfactant; and spreading the pressure-sensitive adhesive layer composition to form the pressure-sensitive adhesive layer, thereby obtaining a poultice comprising the support layer, the pressure-sensitive adhesive layer, and the liner layer;
  • the crosslinking agent is magnesium aluminometasilicate, and its content is 0.25 to 2.5% by mass relative to the total mass of the pressure-sensitive adhesive layer;
  • the method for producing a poultice wherein the surfactant is polyethylene glycol monostearate, and the content thereof is 0.8 to 4.5% by mass based on the total mass of the adhesive layer.
  • the present invention makes it possible to obtain a poultice in which the adhesive layer has excellent adhesion to the skin, the adhesive layer is unlikely to remain when peeled off from the skin, the liner has excellent releasability, and the liner is unlikely to shift during storage.
  • the poultice of the present invention comprises a support layer, an adhesive layer, and a liner layer for protecting the adhesive layer, and the adhesive layer contains water, a water-soluble polymer, a crosslinking agent, and a surfactant, wherein the crosslinking agent is magnesium aluminometasilicate and its content is 0.25 to 2.5% by mass relative to the total mass of the adhesive layer, and the surfactant is polyethylene glycol monostearate and its content is 0.8 to 4.5% by mass relative to the total mass of the adhesive layer.
  • the crosslinking agent is magnesium aluminometasilicate and its content is 0.25 to 2.5% by mass relative to the total mass of the adhesive layer
  • the surfactant is polyethylene glycol monostearate and its content is 0.8 to 4.5% by mass relative to the total mass of the adhesive layer.
  • the poultice of the present invention includes a support layer.
  • the support layer is not particularly limited as long as it can support the adhesive layer described below, and any known support layer for poultices can be appropriately used.
  • the material for the support layer include polyolefins such as polyethylene and polypropylene; ethylene-vinyl acetate copolymers, vinyl acetate-vinyl chloride copolymers, polyvinyl chloride, etc.; polyamides such as nylon; polyesters such as polyethylene terephthalate (PET), polybutylene terephthalate, and polyethylene naphthalate; cellulose derivatives; synthetic resins such as polyurethane, and metals such as aluminum.
  • Examples of the form of the support layer include films, sheets, fabrics, foils, and laminates thereof. Among these, it is preferable to use fabrics made of fibers of the above materials, and it is more preferable to use woven fabrics or nonwoven fabrics obtained by processing the fibers by a method such as knitting, entanglement, heat fusion, pressure bonding, or binder adhesion.
  • a nonwoven fabric made of polyester fibers is preferably used as such a support layer, and the basis weight of the nonwoven fabric is more preferably 50 to 200 g/m 2. If the basis weight of the nonwoven fabric is less than the lower limit, problems tend to occur in terms of strength, such as the cataplasm being easily torn when peeled off, or problems tend to occur in which the components contained in the pressure-sensitive adhesive layer seep out to the back surface of the support layer, i.e., "seepage", leading to deterioration in the appearance and usability of the cataplasm. On the other hand, if the basis weight exceeds the upper limit, the support layer lacks elasticity and flexibility, and the cataplasm tends to be easily peeled off.
  • the poultice of the present invention has a liner layer (release liner) on the surface of the adhesive layer opposite to the support layer, the liner layer having the purpose of covering and protecting the surface of the adhesive layer until the poultice is used.
  • the material of the liner layer is not particularly limited, and examples thereof include polyolefins such as polyethylene and polypropylene; ethylene-vinyl acetate copolymers, vinyl acetate-vinyl chloride copolymers, polyvinyl chloride, etc.; polyamides such as nylon; polyesters such as polyethylene terephthalate; cellulose derivatives; synthetic resins such as polyurethane, aluminum, and paper.
  • the form of the release liner includes films and sheets made of the above materials, and laminates thereof.
  • the release liner is preferably one that has been subjected to a release treatment such as a silicone-containing compound coating or a fluorine-containing compound coating on the surface that comes into contact with the adhesive layer so that it can be easily peeled off from the adhesive layer.
  • a release treatment such as a silicone-containing compound coating or a fluorine-containing compound coating on the surface that comes into contact with the adhesive layer so that it can be easily peeled off from the adhesive layer.
  • films made of polyethylene terephthalate and polypropylene are preferred.
  • the thickness of such a release liner is not particularly limited, and is preferably, for example, 20 to 150 ⁇ m.
  • the poultice of the present invention has an adhesive layer on the surface (usually on one surface) of the support layer.
  • the mass per unit area (area of the application surface) of the adhesive layer is not particularly limited, but is preferably 100 to 1900 g/ m2 , more preferably 430 to 1500 g/ m2 , and even more preferably 500 to 1100 g/ m2 .
  • the area of the application surface of the adhesive layer is adjusted appropriately depending on the type and content of the drug, the purpose of the treatment, the subject of application, and the like, and is not particularly limited, but is usually preferably 1 to 280 cm2 , more preferably 2 to 140 cm2 , and even more preferably 3 to 50 cm2 .

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Inorganic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Preparation (AREA)

Abstract

L'invention concerne un cataplasme comprenant une couche de support, une couche adhésive et une couche de revêtement pour protéger la couche adhésive, la couche adhésive contenant de l'eau, un polymère soluble dans l'eau, un agent de réticulation et un tensioactif. Dans le cataplasme, l'agent de réticulation est l'aluminométasilicate de magnésium et sa teneur est de 0,25 à 2,5 % en masse par rapport à la masse totale de la couche adhésive, et le tensioactif est le monostéarate de polyéthylène glycol et sa teneur est de 0,8 à 4,5 % en masse par rapport à la masse totale de la couche adhésive.
PCT/JP2024/028691 2023-08-24 2024-08-09 Cataplasme et son procédé de production Pending WO2025041654A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2023136506 2023-08-24
JP2023-136506 2023-08-24

Publications (1)

Publication Number Publication Date
WO2025041654A1 true WO2025041654A1 (fr) 2025-02-27

Family

ID=94732144

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2024/028691 Pending WO2025041654A1 (fr) 2023-08-24 2024-08-09 Cataplasme et son procédé de production

Country Status (2)

Country Link
TW (1) TW202508636A (fr)
WO (1) WO2025041654A1 (fr)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS5517354A (en) * 1978-07-26 1980-02-06 Horiuchi Itarou Shoten:Kk Hydrophilic cataplasma
JP2005179312A (ja) * 2003-12-24 2005-07-07 Hisamitsu Pharmaceut Co Inc 新規な消炎鎮痛用パップ剤
JP2009263298A (ja) * 2008-04-28 2009-11-12 Ss Pharmaceut Co Ltd 不快な味を隠ぺいした経口組成物
WO2012105622A1 (fr) * 2011-02-02 2012-08-09 日東電工株式会社 Préparation de timbre transdermique
WO2016104227A1 (fr) * 2014-12-22 2016-06-30 久光製薬株式会社 Cataplasme

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS5517354A (en) * 1978-07-26 1980-02-06 Horiuchi Itarou Shoten:Kk Hydrophilic cataplasma
JP2005179312A (ja) * 2003-12-24 2005-07-07 Hisamitsu Pharmaceut Co Inc 新規な消炎鎮痛用パップ剤
JP2009263298A (ja) * 2008-04-28 2009-11-12 Ss Pharmaceut Co Ltd 不快な味を隠ぺいした経口組成物
WO2012105622A1 (fr) * 2011-02-02 2012-08-09 日東電工株式会社 Préparation de timbre transdermique
WO2016104227A1 (fr) * 2014-12-22 2016-06-30 久光製薬株式会社 Cataplasme

Also Published As

Publication number Publication date
TW202508636A (zh) 2025-03-01

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