WO2003079962A2 - Unite de liaison de systemes therapeutiques transdermiques separables individuellement - Google Patents

Unite de liaison de systemes therapeutiques transdermiques separables individuellement Download PDF

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Publication number
WO2003079962A2
WO2003079962A2 PCT/EP2003/003004 EP0303004W WO03079962A2 WO 2003079962 A2 WO2003079962 A2 WO 2003079962A2 EP 0303004 W EP0303004 W EP 0303004W WO 03079962 A2 WO03079962 A2 WO 03079962A2
Authority
WO
WIPO (PCT)
Prior art keywords
drug
unit according
transdermal
base film
therapeutic systems
Prior art date
Application number
PCT/EP2003/003004
Other languages
German (de)
English (en)
Other versions
WO2003079962A3 (fr
Inventor
Klaus M. Wilsmann
Original Assignee
Grünenthal GmbH
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 Grünenthal GmbH filed Critical Grünenthal GmbH
Priority to JP2003577795A priority Critical patent/JP2005520844A/ja
Priority to EP03744842A priority patent/EP1490039A2/fr
Priority to CA002480683A priority patent/CA2480683A1/fr
Priority to AU2003226695A priority patent/AU2003226695B2/en
Publication of WO2003079962A2 publication Critical patent/WO2003079962A2/fr
Publication of WO2003079962A3 publication Critical patent/WO2003079962A3/fr
Priority to US10/950,891 priority patent/US20050118245A1/en

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
    • 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
    • A61K9/7084—Transdermal patches having a drug layer or reservoir, and one or more separate drug-free skin-adhesive layers, e.g. between drug reservoir and skin, or surrounding the drug reservoir; Liquid-filled reservoir patches
    • 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
    • A61K9/7092—Transdermal patches having multiple drug layers or reservoirs, e.g. for obtaining a specific release pattern, or for combining different drugs

Definitions

  • the invention relates to a coherent unit of isolable, transdermal, therapeutic systems.
  • Transdermal, therapeutic systems for the application of transdermally administered drugs are known. These are technically specified plaster systems that continuously release a therapeutic agent via the skin to a human or animal organism over a certain period of time.
  • the active ingredient may be dispersed in a matrix or present in a drug reservoir. Both in the matrix and in the drug reservoir, it is possible to use the drug liquid, semi-solid or solid or as a corresponding drug formulation.
  • the known transdermal therapeutic systems contain a certain predetermined dose of controlled release drug.
  • the problem here is the individual dosage of the drug according to the patient requirements.
  • a strip-shaped, transdermal, therapeutic system is recommended for this purpose, from which a piece can be separated according to the patient's requirements.
  • the separation takes place in the active substance-containing area.
  • active ingredient can be lost in part and small separation inaccuracies already lead to a different dosage of the active ingredient. An exact dosage is therefore not possible.
  • the active ingredient-containing area can be partially covered in order to achieve a lower dosage. This will, however, if necessary a part of the active ingredient was not used. Furthermore, the skin contact of the active substance-containing area may be impaired.
  • This object is achieved according to the invention by providing a coherent unit comprising at least two isolable, transdermal, therapeutic systems comprising each
  • an active substance-impermeable base film b) an adhesive, the base film at least partially covering and either a drug reservoir or drug-containing matrix having layer having an active substance-free, peripheral edge region and optionally c) a the adhesive layer at least partially covering, peelable protective film,
  • singular, transdermal, therapeutic systems have in their contiguous drug-free border areas separation possibilities.
  • the separation options are each preferably arranged so that they allow a separation of each coherent, transdermal, therapeutic system completely from the unit according to the invention.
  • Suitable active ingredients are all transdermally administrable active substances, such as corticosteroids, analgesics, sedatives, tranquilizers, antibiotics, anesthetics, antiviral agents, antimicrobials, fungicides, vitamins, antiepileptics, sex hormones, nicotine, psychotropic drugs, coronary dilators, antiarthritics, antiasthmatics, antidepressants, antidiabetics, Antihistamines, anti-inflammatories and / or antimigraine agents.
  • active substances such as corticosteroids, analgesics, sedatives, tranquilizers, antibiotics, anesthetics, antiviral agents, antimicrobials, fungicides, vitamins, antiepileptics, sex hormones, nicotine, psychotropic drugs, coronary dilators, antiarthritics, antiasthmatics, antidepressants, antidiabetics, Antihistamines, anti-inflammatories and /
  • the unit according to the invention or an isolated system for controlling pain is suitable.
  • the individualizable, transdermal systems comprise a base film and thereon an adhesive, with a drug-containing matrix or a drug reservoir layer provided, which may optionally have a protective film.
  • the adhesive layer may consist, at least in some areas, preferably completely, of matrix material which contains an adhesive component, preferably a pressure-sensitive adhesive component, and comprises an active substance-containing region. This active substance-containing area is surrounded by a peripheral, drug-free edge area.
  • the drug-impermeable base film is preferably made of a flexible, stretchable, breathable, durable material. Particularly preferred is a textile-like fabric.
  • the base film may be colored, preferably skin-colored.
  • Substance-impermeable means that the base film, at least in the region in which a drug-containing matrix is present, the base film is drug-impermeable. If the base film itself is not impermeable to active substance, an active substance-impermeable barrier layer should be applied between the matrix layer or the active substance reservoir and the base film. This barrier layer should preferably consist of a film-forming polymer.
  • the matrix material of layer b.) May be based on lipophilic or hydrophilic polymers.
  • Hydrophilic polymer matrices may be hydrous, which are preferably gels.
  • Suitable matrix materials are crosslinkable polymers, preferably synthetic resins, silicone rubber or rubber, such as styrene-isoprene-styrene block copolymers, silicones, polyacrylates, polyurethanes, polyvinyl ethers, polyvinyl chloride, polyvinyl alcohols, polyvinylpyrrolidones, polyesters, polypropylene and / or polysaccharides , Particularly preferred are polyacrylates.
  • a skin-compatible polymeric adhesive is used, more preferably a pressure-sensitive adhesive such as hot melt.
  • the adhesive component can be mixed with the matrix materials listed above in known amounts and an active ingredient can be added to produce the active ingredient-containing matrix region.
  • the active ingredient-containing matrix region is applied to the base film in such a way that a drug-free, peripheral edge region is provided.
  • the matrix material can also be crosslinked if necessary.
  • the active substance present in the matrix or the active substances present in the matrix can be liquid, semisolid or solid in the dispersed state or can be incorporated as an appropriate formulation with the addition of customary excipients as active ingredient formulation.
  • adjuvants compounds which enhance or facilitate the transdermal transport of the active ingredients can be used. These adjuvants can mixed with the active ingredients or present in a separate layer to the active ingredient-containing matrix layer.
  • the active substances to be transdermally applied are present in a drug reservoir in the adhesive layer, this reservoir is preferably embedded in the adhesive layer.
  • Suitable adhesives for this layer are the abovementioned polymeric adhesives which are listed as an adhesive component.
  • the active substance reservoir preferably contains the active substance or the corresponding active substance formulation as a solution which can diffuse unhindered through the membrane of the active substance reservoir.
  • Suitable membrane materials are the polymers listed above, which can also be used as matrix material.
  • the transdermal system can also be designed so that only in the edge zone, which is drug-free, the adhesive component is present as a matrix component.
  • the transdermal therapeutic system according to the invention has, at least in the drug-releasing region, preferably over the entire adhesive layer, a protective film which is easily removable before application.
  • this protective film is made of paper or is a slightly adherent physiologically harmless plastic film.
  • the coherent, transdermal therapeutic system according to the invention preferably contains the same dose of active ingredient per system, whereby the individual, demand-dependent application for the patient or user is considerably facilitated. This is especially true when fluctuations in drug demand occur, for. B. in recurrent attacks of pain or when a decaying therapy with decreasing Dosage is necessary.
  • inventive, transdermal, therapeutic systems can first be treated as needed and be made by reducing the number of systems in the course of therapy, the necessary reduction of the drug dose in a simple manner by the patient.
  • the contiguous unit of isolable, transdermal, therapeutic systems according to the invention is preferably present in a packaged form, wherein sterile packaging is also possible if required.
  • FIG. 1 shows a plan view of a unit (1) according to the invention from 4 isolatable, transdermal, therapeutic systems.
  • FIG. 2 shows a plan view of a unit (1) according to the invention from 2 isolatable, transdermal, therapeutic systems.
  • Each isolatable system comprises an active substance-containing matrix region (3) or an active substance-containing reservoir (3a) which is surrounded by an active agent-free, adhesive-capable, peripheral edge region (2).
  • the base film and an optionally present protective film are not shown separately in FIGS. 1 and 2.

Abstract

L'invention concerne une unité de liaison réunissant des systèmes thérapeutiques transdermiques séparables individuellement.
PCT/EP2003/003004 2002-03-27 2003-03-22 Unite de liaison de systemes therapeutiques transdermiques separables individuellement WO2003079962A2 (fr)

Priority Applications (5)

Application Number Priority Date Filing Date Title
JP2003577795A JP2005520844A (ja) 2002-03-27 2003-03-22 別々に分離できる経皮治療システムからなる組立ユニット
EP03744842A EP1490039A2 (fr) 2002-03-27 2003-03-22 Unite de liaison de systemes therapeutiques transdermiques separables individuellement
CA002480683A CA2480683A1 (fr) 2002-03-27 2003-03-22 Unite de liaison de systemes therapeutiques transdermiques separables individuellement
AU2003226695A AU2003226695B2 (en) 2002-03-27 2003-03-22 Assembled unit consisting of individually separable transdermal therapeutic systems
US10/950,891 US20050118245A1 (en) 2002-03-27 2004-09-27 Assembled unit consisting of individually separable, transdermal, therapeutic systems

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE10213772.2 2002-03-27
DE10213772A DE10213772A1 (de) 2002-03-27 2002-03-27 Zusammenhängende Einheit aus vereinzelbaren transdermalen therapeutischen Systemen

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US10/950,891 Continuation US20050118245A1 (en) 2002-03-27 2004-09-27 Assembled unit consisting of individually separable, transdermal, therapeutic systems

Publications (2)

Publication Number Publication Date
WO2003079962A2 true WO2003079962A2 (fr) 2003-10-02
WO2003079962A3 WO2003079962A3 (fr) 2003-12-24

Family

ID=27816006

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2003/003004 WO2003079962A2 (fr) 2002-03-27 2003-03-22 Unite de liaison de systemes therapeutiques transdermiques separables individuellement

Country Status (9)

Country Link
EP (1) EP1490039A2 (fr)
JP (1) JP2005520844A (fr)
AR (1) AR039137A1 (fr)
AU (1) AU2003226695B2 (fr)
CA (1) CA2480683A1 (fr)
DE (1) DE10213772A1 (fr)
PE (1) PE20031015A1 (fr)
PL (1) PL370886A1 (fr)
WO (1) WO2003079962A2 (fr)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2007529502A (ja) * 2004-03-19 2007-10-25 ファイザー・ヘルス・アクティエボラーグ ニコチンの経皮投与手段
EP2769714A1 (fr) 2006-11-21 2014-08-27 LTS LOHMANN Therapie-Systeme AG Système thérapeutique transdermique pour l'administration de la substance actif buprénorphine
US9549903B2 (en) 2011-12-12 2017-01-24 Purdue Pharma L.P. Transdermal delivery system comprising buprenorphine
US11529345B2 (en) 2013-06-04 2022-12-20 Lts Lohmann Therapie-Systeme Ag Buprenorphine transdermal delivery system

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102004045599A1 (de) * 2004-09-17 2006-03-23 Grünenthal GmbH System zur sequentiellen, transdermalen Verabreichung von systemisch wirksamen Substanzen
JP4782438B2 (ja) * 2005-02-17 2011-09-28 日東電工株式会社 貼付製剤
DE202005014347U1 (de) * 2005-09-09 2007-01-18 Grünenthal GmbH Applikationssystem für ein wirkstoffhaltiges Pflaster und Wirkstoffabgaberegulierungsmittel
DE102006011340A1 (de) * 2006-03-09 2007-09-20 Grünenthal GmbH Wirkstoffhaltige Pflaster mit verbesserter Handhabung
EP2394617B1 (fr) * 2010-06-10 2013-12-11 MedSkin Solutions Dr. Suwelack AG Biomatrices perforées en forme de couches
US8936825B2 (en) 2010-09-23 2015-01-20 Monosol Rx, Llc Method and system for forming a pharmaceutical product directly onto a packaging surface
EP3458306B1 (fr) 2016-05-18 2020-12-16 Shanghai Yanfeng Jinqiao Automotive Trim Systems Co., Ltd. Ensemble console pour intérieur de véhicule
US11572723B2 (en) 2019-02-27 2023-02-07 Shanghai Yanfeng Jinqiao Automotive Triim Systems Co. Ltd. Vehicle interior component
CN111359441B (zh) * 2020-03-25 2022-02-15 青岛科技大学 一种碱性pH响应聚合物纳米容器填充耐氯反渗透膜的制备方法

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EP0559411A1 (fr) * 1992-03-04 1993-09-08 Eli Lilly And Company Système et méthode pour l'administration réglable de substances thérapeutiques par pansement transdermique
DE19900645A1 (de) * 1999-01-11 2000-07-13 Deotexis Inc Transdermales therapeutisches System
US6221384B1 (en) * 1999-11-05 2001-04-24 Anthony C. Pagedas Segmented transdermal dosage unit
WO2002041878A2 (fr) * 2000-11-16 2002-05-30 Euro-Celtique, S.A. Systeme d'administration transdermique de doses titrables

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EP0252459A1 (fr) * 1986-07-07 1988-01-13 Schering Corporation Système d'apport compartimenté agissant à travers la peau
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Publication number Priority date Publication date Assignee Title
EP0559411A1 (fr) * 1992-03-04 1993-09-08 Eli Lilly And Company Système et méthode pour l'administration réglable de substances thérapeutiques par pansement transdermique
DE19900645A1 (de) * 1999-01-11 2000-07-13 Deotexis Inc Transdermales therapeutisches System
US6221384B1 (en) * 1999-11-05 2001-04-24 Anthony C. Pagedas Segmented transdermal dosage unit
WO2002041878A2 (fr) * 2000-11-16 2002-05-30 Euro-Celtique, S.A. Systeme d'administration transdermique de doses titrables

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2007529502A (ja) * 2004-03-19 2007-10-25 ファイザー・ヘルス・アクティエボラーグ ニコチンの経皮投与手段
JP4851441B2 (ja) * 2004-03-19 2012-01-11 マクニール・アクチェボラーグ ニコチンの経皮投与手段
EP2769714A1 (fr) 2006-11-21 2014-08-27 LTS LOHMANN Therapie-Systeme AG Système thérapeutique transdermique pour l'administration de la substance actif buprénorphine
US9308202B2 (en) 2006-11-21 2016-04-12 Purdue Pharma L.P. Transdermal therapeutic system for administering the active substance buprenorphine
US9549903B2 (en) 2011-12-12 2017-01-24 Purdue Pharma L.P. Transdermal delivery system comprising buprenorphine
EP2790685B1 (fr) 2011-12-12 2017-08-16 LTS LOHMANN Therapie-Systeme AG Système d'administration transdermique comprenant de la buprénorphine
US11529345B2 (en) 2013-06-04 2022-12-20 Lts Lohmann Therapie-Systeme Ag Buprenorphine transdermal delivery system

Also Published As

Publication number Publication date
PE20031015A1 (es) 2004-01-17
JP2005520844A (ja) 2005-07-14
CA2480683A1 (fr) 2003-10-02
AU2003226695B2 (en) 2008-10-02
PL370886A1 (en) 2005-05-30
AU2003226695A1 (en) 2003-10-08
DE10213772A1 (de) 2003-10-09
AR039137A1 (es) 2005-02-09
WO2003079962A3 (fr) 2003-12-24
EP1490039A2 (fr) 2004-12-29

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