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WO2004071499A1 - Emplatre contenant du diclofenac - Google Patents

Emplatre contenant du diclofenac Download PDF

Info

Publication number
WO2004071499A1
WO2004071499A1 PCT/JP2004/001202 JP2004001202W WO2004071499A1 WO 2004071499 A1 WO2004071499 A1 WO 2004071499A1 JP 2004001202 W JP2004001202 W JP 2004001202W WO 2004071499 A1 WO2004071499 A1 WO 2004071499A1
Authority
WO
WIPO (PCT)
Prior art keywords
layer
base layer
diclofenac
drug
patch
Prior art date
Application number
PCT/JP2004/001202
Other languages
English (en)
Japanese (ja)
Inventor
Hidetatsu Takeuchi
Akira Hara
Hirohisa Okuyama
Original Assignee
Teika Pharmaceutical Co., Ltd.
Hisamitsu Medical Co., Ltd.
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 Teika Pharmaceutical Co., Ltd., Hisamitsu Medical Co., Ltd. filed Critical Teika Pharmaceutical Co., Ltd.
Priority to JP2005504952A priority Critical patent/JP4890856B2/ja
Publication of WO2004071499A1 publication Critical patent/WO2004071499A1/fr

Links

Classifications

    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/196—Carboxylic acids, e.g. valproic acid having an amino group the amino group being directly attached to a ring, e.g. anthranilic acid, mefenamic acid, diclofenac, chlorambucil
    • 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]

Definitions

  • the present invention relates to a patch for transdermally administering a drug.
  • Diclofenac and its salts are non-steroidal anti-inflammatory analgesics that exhibit excellent anti-inflammatory and analgesic effects.
  • gastrointestinal disorders may occur. It is known to cause various side effects. Therefore, in order to reduce such side effects and make use of the excellent pharmacological activity of diclofenac, an external preparation that is absorbed transdermally without passing through the digestive tract has been studied (International Publication No. WO 9). 2/0 7 5 6 1).
  • diclofenac since the transdermal absorbability of diclofenac is generally low, an effective patch requires an increase in the amount of diclofenac per unit area or an absorption enhancer. It has to be used in large quantities, and has various drawbacks, such as being economically inefficient.
  • the present inventors have conducted intensive studies to solve the above-mentioned problems, and as a result, by adjusting the pH of each layer of a patch comprising a drug layer and a base layer, as an active ingredient, The inventors have found that the percutaneous absorption efficiency of diclopanac contained therein can be improved and the above object can be achieved, and the present invention has been accomplished.
  • the present invention relates to a patch comprising at least a drug layer, a base layer and a support, wherein the drug layer contains diclofenac or a salt thereof, and the pH of the drug layer is higher than the pH of the base layer. It is a patch characterized by having been adjusted to be as follows.
  • the pH of the drug layer and the base layer are both in the range of 4.0 to 6.5, and the pH of the drug layer is 0.1 or more larger than the pH of the base layer. It is a patch.
  • the patch of the present invention comprises at least a drug layer, a base layer and a support, One y-
  • diclofenac or a salt thereof as an essential ingredient as an active ingredient.
  • the drug layer is a layer that directly contacts the skin at the time of application
  • the base layer is a layer that mainly gives the adhesive a physical thickness to give it formability and increases the adherence to the skin. You. Further, the support holds a base layer and a drug layer thereon, imparts strength and enhances usability.
  • the drug layer and the base layer in the patch of the present invention can be prepared by conventionally known materials and methods. That is, it can be prepared according to a conventional method using a known hydrophilic polymer compound, a cross-linking agent, a dissolving agent, a plasticizer, a transdermal absorbent, a preservative, a skin irritation relieving agent, an adhesion improving agent and the like.
  • the hydrophilic polymer compound forms a gel by acting with water to form a plaster of the drug layer and the base layer.
  • the hydrophilic high molecular compound is not particularly limited as long as it forms a gel that becomes a plaster, but polyacrylic acid and / or a salt thereof, a (meth) acrylic acid (co) polymer or a salt thereof , Carboxymethylcellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose, polyvinyl alcohol, polyvinylpyrrolidone, alginic acid or a salt thereof, gelatin, starch and the like can be preferably used.
  • the cross-linking agent cross-links the gelled hydrophilic polymer to increase its strength.
  • the crosslinking agent to be used is not particularly limited, but a substance having a divalent or higher cation, such as a magnesium salt or an aluminum salt, is preferably used.
  • the dissolving agent and the plasticizer have the function of improving the solubility of the components in each layer, or enhancing the flexibility and maintaining the adhesiveness to the skin.
  • polyhydric alcohols such as glycerin
  • fats and oils such as polyethylene daricol, heart oil, and leaven oil
  • fatty acid esters are preferably used.
  • transdermal absorption enhancer is incorporated in the drug layer, and the active ingredient diclofe It promotes the transfer of nuts to the skin.
  • Fatty acid esters such as octyldodecyl
  • polyhydric alcohol fatty acid esters such as glycerin fatty acid esters
  • isostearyl alcohol is incorporated in the drug layer, and the active ingredient diclofe It promotes the transfer of nuts to the skin.
  • Higher alcohols such as 2-octyldodecanol; urea; polyethylene glycol alkyl ethers such as polyethylene glycol lauryl ether; polypropylene glycol alkyl ethers; pyrrolidone derivatives; vegetable oils;
  • alkyl paraoxybenzoate alkyl paraoxybenzoate, sorbitan, devidroacetic acid, butylhydroxytoluene (BHT), butylhydroxyanisole (BHA), etc.
  • BHT butylhydroxytoluene
  • BHA butylhydroxyanisole
  • tackifiers kaolin, talc, titania, etc. , Alumina and the like can be used.
  • the transfer of diclofenac as an active ingredient from the drug layer to the base layer is suppressed, and the diclofenac in the drug layer directly in contact with the skin is controlled.
  • a major feature of this method is that it prevents the concentration over time from decreasing and maintains its efficacy.
  • the pH of the drug layer is higher than the pH of the base layer (it is on the alkaline side). More specifically, the pH of the drug layer is at least 0.1 or more higher than the pH of the base layer. is necessary.
  • the pH of the drug layer and the base layer are both in the range of 4.0 to 6.5, and the pH of the drug layer is preferably greater than 0.1, and the pH of the drug layer is in the range of 4.5 to 6.5. More preferably, the pH of the base layer is in the range of 4.0 to 5.5, and the pH of the drug layer is more than the pH of the base layer, and the pH of the drug layer is in the range of 5. "! To 6.5. It is particularly preferred that the pH of the base layer is in the range of 4.0 to 5.0. --
  • the pH regulator used to adjust the PH of the drug layer and the base layer to a predetermined value.
  • organic acids such as malic acid and metal salts thereof; ammonium salts, alkyl ammonium salts; and inorganic acids such as boric acid and salts thereof.
  • diclofenac compounded as an active ingredient in the drug layer is a well-known anti-inflammatory analgesic, and any salt thereof can be used as long as it is pharmaceutically acceptable.
  • the salt of diclofenac include metal salts such as sodium salt, potassium salt and calcium salt; ammonium salt; monoalkyl ammonium salt such as monomethyl ammonium salt and monoethyl ammonium salt; dimethyl ammonium salt; Dialkylammonium salts such as triethylammonium salt; trialkylammonium salts such as trimethylammonium salt and triethylammonium salt; monoethanolamine, diethanolamine, and triethanolamine salts.
  • Alkanolamine salts such as ethanolamine, monoisopropanolamine and dipropanolamine; and hydroxyethylpyrrolidine salts. Of these, sodium salts and ammonium salts are preferred, and sodium salts are particularly preferred.
  • the content of diclofenac in the drug layer may be an amount that exerts its medicinal effect, but is generally 0.1 to 20% by mass, preferably 0.2 to 10% by mass, and particularly preferably 0.2 to 10% by mass. Preferably, it is 0.5 to 2% by mass. Although a small amount of diclofenac can be contained in the base layer, it is preferable not to include it in the base layer when the purpose is to reduce the amount of drug per unit area.
  • the base layer and the drug layer thus prepared are spread and held in this order on a support, and finally, a release film is attached to form a patch.
  • the support used in the present invention is not particularly limited, and known materials such as polyethylene, polypropylene, polybutadiene, ethylene-vinyl acetate copolymer, polyester, nylon, polyurethane, paper, cloth and the like can be used. You.
  • release film that covers the drug layer side of the patch
  • known films for example, sheets of polyethylene, polypropylene, ethylene-vinyl acetate copolymer, polyester, silicon-coated paper, etc. Can be used.
  • the preparation of the patch of the present invention is not particularly limited, and a known method can be used.
  • An example thereof includes the following method. That is, a base layer may be spread and coated on the support by a known method, and then a drug layer may be spread and coated thereon, and finally, a release film may be bonded, or a drug layer may be formed on the release film. After spreading and applying the layer, and further spreading and applying the base layer, the support may be laminated. Alternatively, a product in which a drug layer is extended and applied on a release film and a material in which a base layer is extended and applied on a support may be prepared, and finally, these may be laminated.
  • the drug layer is generally in the patch of the present invention is 0.1 is 1 ⁇ 5. 0 g / 1 00 cm 2 or so, preferably, 0. 5 ⁇ 1. 5 g , 1 00 cm 2. If the thickness is too small, sufficient drug cannot be contained per unit area, so that the drug efficacy decreases. If the thickness is too large, the drug content must be increased more than necessary, which is not preferable.
  • base layer is typically a 1 ⁇ 20 g / 1 00 cm 2 approximately, preferably 5 ⁇ 1 5 8 1 00 cm 2. If it is too thin, it will not be possible to obtain good shaping properties and adhesion to the skin, and it is not necessary to make it unnecessarily thick.
  • the patch of the present invention controls the pH of the drug layer containing the active ingredient diclofenac and the pH of the base layer, thereby suppressing the transfer of diclofenac from the drug layer to the base layer. It is possible to suppress a decrease in the concentration of diclofenacs therein. Therefore, diclofenacs can be preferentially transferred to the skin from the drug layer that comes into contact with the skin, the medicinal effect can be maintained, and the amount of diclofenac used can be reduced. --
  • each component necessary for the production of the patch was prepared.
  • the amounts of each substance are parts by weight.
  • solution D After dissolving 1 part of tartaric acid and 0.2 part of sodium edetate in purified water to make the whole 100 parts, add solution A, solution B and solution C obtained above in order to make it uniform. To prepare a drug layer component (solution D). Table 1 shows the amounts of the components and the pH.
  • the preparation of the H-1 solution was carried out in the same manner as in the preparation of the H-1 solution, except that the base layer component (solution H-2) was used at 0.8 parts by weight of tartaric acid.
  • a base layer component (H-3 solution) was prepared in the same manner as described above.
  • Table 2 shows the component amounts and the pH of the base layer. As shown in Tables 1 and 2, the PH of the components obtained in this production example was 5.1 for the drug layer component (Solution D). Of the base layer components, H-1 solution and H-2 The pH of the liquid and the H-3 liquid were 5.0 4.0 and 5.1, respectively.
  • Additive component Addition amount (parts by weight)
  • D-sorbitol solution 25.0 25.0 25.0
  • Liquid D obtained in Production Example was applied to release paper to form only a drug layer, and Liquid H-1 obtained in Production Example was applied to a support to form only a base layer. Prepared and liner coated on their surface. After aging these at room temperature for 1 week, each was cut into 3.5 cm x 5.0 cm and weighed, the liner was peeled off, and the adhesive surfaces of the drug layer and the base layer were stuck together and the patch ( Invention product 1) was prepared.
  • a patch (inventive product 2) was prepared in the same manner as in Example 1, except that the H-2 solution obtained in the Production Example was used instead of the H-1 solution. After storage at 40 ° C. for one month, the bonded surfaces were peeled off, and the amount of diclofenac sodium in each layer before and after storage was measured. Table 3 shows the average results for the three samples.
  • a patch (comparative product) was prepared in the same manner as in Example 1 except that the H_3 solution obtained in Production Example was used instead of the H-1 solution. After storage at 40 ° C for one month, the bonded surfaces were peeled off, and the amount of diclofenac sodium in each layer before and after storage was measured.
  • Table 3 shows the average results for the three samples.
  • diclofenac can be contained only in the drug layer, and the migration of the substance to the base layer can be suppressed.
  • the content of oral fenac can be reduced, and the transdermal absorption efficiency can be increased.

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  • Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Dermatology (AREA)
  • Pain & Pain Management (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Rheumatology (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)

Abstract

L'invention concerne un emplâtre comprenant au moins une couche d'agent médical, une couche de base et un support. Ledit emplâtre se caractérise en ce que la couche d'agent médical contient du diclophénac ou son sel et en ce que la couche d'agent médical présente un pH ajusté de manière à dépasser celui de la couche de base. Cet emplâtre contient un composé diclophénac comme principe actif et, même lorsque la quantité d'agent médical par zone est faible, il présente une grande efficacité en termes d'absorption percutanée, qui ne varie que légèrement avec le temps.
PCT/JP2004/001202 2003-02-12 2004-02-05 Emplatre contenant du diclofenac WO2004071499A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2005504952A JP4890856B2 (ja) 2003-02-12 2004-02-05 ジクロフェナク含有貼付剤

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2003-033249 2003-02-12
JP2003033249 2003-02-12

Publications (1)

Publication Number Publication Date
WO2004071499A1 true WO2004071499A1 (fr) 2004-08-26

Family

ID=32866220

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2004/001202 WO2004071499A1 (fr) 2003-02-12 2004-02-05 Emplatre contenant du diclofenac

Country Status (3)

Country Link
JP (1) JP4890856B2 (fr)
TW (1) TW200500100A (fr)
WO (1) WO2004071499A1 (fr)

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2005314328A (ja) * 2004-04-30 2005-11-10 Hisamitsu Pharmaceut Co Inc 消炎鎮痛外用剤
JP2006151836A (ja) * 2004-11-26 2006-06-15 Taisho Pharmaceut Co Ltd 外用消炎鎮痛剤組成物
JP2007210941A (ja) * 2006-02-09 2007-08-23 Saitama Daiichi Seiyaku Kk 透明又は半透明含水系外用貼付剤用組成物、及び、この組成物を用いた透明又は半透明外用貼付剤
WO2011049058A1 (fr) 2009-10-23 2011-04-28 帝國製薬株式会社 Diclofénac sodique à base de pâte contenant de l'eau
WO2013191158A1 (fr) * 2012-06-20 2013-12-27 久光製薬株式会社 Agent favorisant l'absorption percutanée et patch cutané en contenant
US10202605B2 (en) 2007-06-28 2019-02-12 The Trustees Of Princeton University Methods of identifying and treating poor-prognosis cancers
US10745701B2 (en) 2007-06-28 2020-08-18 The Trustees Of Princeton University Methods of identifying and treating poor-prognosis cancers

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS6226217A (ja) * 1985-07-29 1987-02-04 Dai Ichi Seiyaku Co Ltd 貼付剤
JPS62198613A (ja) * 1986-02-26 1987-09-02 Watanabe Yakuhin Kogyo Kk 貼付剤
JPH04504515A (ja) * 1989-01-11 1992-08-13 ノーヴェン ファーマシューティカルズ インコーポレイテッド 通気性バッキング
JPH11322595A (ja) * 1998-05-15 1999-11-24 Lintec Corp 経皮吸収型解熱消炎鎮痛貼付剤
JP2001348328A (ja) * 2000-04-04 2001-12-18 Nippon Junyaku Kk 皮膚貼付シート及びその積層体
JP2002524414A (ja) * 1998-09-03 2002-08-06 エルテーエス ローマン テラピー−ジステーム アーゲー ３つの機能層を有する薬物硬膏剤

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Publication number Priority date Publication date Assignee Title
JPS5738713A (en) * 1980-08-20 1982-03-03 Nitto Electric Ind Co Ltd Therapeutic material
JPH04193826A (ja) * 1990-11-27 1992-07-13 Shirogane Seiyaku Kk ジクロフェナクナトリウム含有の経皮吸収型消炎・鎮痛貼布剤

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS6226217A (ja) * 1985-07-29 1987-02-04 Dai Ichi Seiyaku Co Ltd 貼付剤
JPS62198613A (ja) * 1986-02-26 1987-09-02 Watanabe Yakuhin Kogyo Kk 貼付剤
JPH04504515A (ja) * 1989-01-11 1992-08-13 ノーヴェン ファーマシューティカルズ インコーポレイテッド 通気性バッキング
JPH11322595A (ja) * 1998-05-15 1999-11-24 Lintec Corp 経皮吸収型解熱消炎鎮痛貼付剤
JP2002524414A (ja) * 1998-09-03 2002-08-06 エルテーエス ローマン テラピー−ジステーム アーゲー ３つの機能層を有する薬物硬膏剤
JP2001348328A (ja) * 2000-04-04 2001-12-18 Nippon Junyaku Kk 皮膚貼付シート及びその積層体

Cited By (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP4584620B2 (ja) * 2004-04-30 2010-11-24 久光製薬株式会社 消炎鎮痛外用剤
JP2005314328A (ja) * 2004-04-30 2005-11-10 Hisamitsu Pharmaceut Co Inc 消炎鎮痛外用剤
JP2006151836A (ja) * 2004-11-26 2006-06-15 Taisho Pharmaceut Co Ltd 外用消炎鎮痛剤組成物
JP2007210941A (ja) * 2006-02-09 2007-08-23 Saitama Daiichi Seiyaku Kk 透明又は半透明含水系外用貼付剤用組成物、及び、この組成物を用いた透明又は半透明外用貼付剤
US10745701B2 (en) 2007-06-28 2020-08-18 The Trustees Of Princeton University Methods of identifying and treating poor-prognosis cancers
US10202605B2 (en) 2007-06-28 2019-02-12 The Trustees Of Princeton University Methods of identifying and treating poor-prognosis cancers
US9168235B2 (en) 2009-10-23 2015-10-27 Teikoku Seiyaku Co., Ltd. Aqueous patches containing diclofenac sodium
WO2011049058A1 (fr) 2009-10-23 2011-04-28 帝國製薬株式会社 Diclofénac sodique à base de pâte contenant de l'eau
JP5584379B2 (ja) * 2012-06-20 2014-09-03 久光製薬株式会社 経皮吸収促進剤、及びそれを含む貼付剤
JPWO2013191158A1 (ja) * 2012-06-20 2016-05-26 久光製薬株式会社 経皮吸収促進剤、及びそれを含む貼付剤
CN104394858B (zh) * 2012-06-20 2017-03-22 久光制药株式会社 经皮吸收促进剂及含有其的贴附剂
CN104394858A (zh) * 2012-06-20 2015-03-04 久光制药株式会社 经皮吸收促进剂及含有其的贴附剂
WO2013191158A1 (fr) * 2012-06-20 2013-12-27 久光製薬株式会社 Agent favorisant l'absorption percutanée et patch cutané en contenant

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Publication number Publication date
TW200500100A (en) 2005-01-01
JPWO2004071499A1 (ja) 2006-06-01
JP4890856B2 (ja) 2012-03-07

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