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WO1999009960A1 - Systemes plats d'administration therapeutique cutanee et transcutanee mettant en oeuvre un emplatre adhesif comme vecteur d'information, et mode de fabrication d'un tel emplatre - Google Patents

Systemes plats d'administration therapeutique cutanee et transcutanee mettant en oeuvre un emplatre adhesif comme vecteur d'information, et mode de fabrication d'un tel emplatre Download PDF

Info

Publication number
WO1999009960A1
WO1999009960A1 PCT/EP1998/004846 EP9804846W WO9909960A1 WO 1999009960 A1 WO1999009960 A1 WO 1999009960A1 EP 9804846 W EP9804846 W EP 9804846W WO 9909960 A1 WO9909960 A1 WO 9909960A1
Authority
WO
WIPO (PCT)
Prior art keywords
coding
plaster
labeling according
information
skin
Prior art date
Application number
PCT/EP1998/004846
Other languages
German (de)
English (en)
Inventor
Volker Siemund
Frank Becher
Original Assignee
Lts Lohmann Therapie-Systeme Ag
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 Lts Lohmann Therapie-Systeme Ag filed Critical Lts Lohmann Therapie-Systeme Ag
Priority to IL13438698A priority Critical patent/IL134386A0/xx
Priority to KR1020007001802A priority patent/KR20010023176A/ko
Priority to SK232-2000A priority patent/SK2322000A3/sk
Priority to NZ502830A priority patent/NZ502830A/en
Priority to JP2000507351A priority patent/JP2001513547A/ja
Priority to AU93387/98A priority patent/AU737379B2/en
Priority to EP98946274A priority patent/EP1007016A1/fr
Priority to HU0004184A priority patent/HUP0004184A3/hu
Priority to CA002299715A priority patent/CA2299715A1/fr
Publication of WO1999009960A1 publication Critical patent/WO1999009960A1/fr
Priority to NO20000814A priority patent/NO20000814D0/no

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
    • G—PHYSICS
    • G09—EDUCATION; CRYPTOGRAPHY; DISPLAY; ADVERTISING; SEALS
    • G09F—DISPLAYING; ADVERTISING; SIGNS; LABELS OR NAME-PLATES; SEALS
    • G09F3/00—Labels, tag tickets, or similar identification or indication means; Seals; Postage or like stamps
    • G09F3/08—Fastening or securing by means not forming part of the material of the label itself
    • G09F3/10—Fastening or securing by means not forming part of the material of the label itself by an adhesive layer

Definitions

  • Adhesive sheet-like systems are known for the treatment of a large number of diseases and have proven themselves extremely well in many therapeutic areas of application.
  • Transdermal therapeutic systems with a systemic effect are also becoming increasingly important. Their advantage is, for example, a controlled, relatively long-term release of active ingredients through the skin.
  • TTS Transdermal therapeutic systems
  • Such a transdermal system has an impermeable and non-adhesive backing layer to protect against undesired escape of active substances and a pressure-sensitive adhesive layer for the necessary adhesion to the skin, which can at the same time contain active substances, as well as a removable, to protect loss of active substances during storage of a TTS. usually a protective layer with a non-adhesive finish.
  • a transdermal therapeutic system with a backing layer made of thermoplastic material consisting of a laminate of an outside, low-melting thermoplastic and a higher-melting thermoplastic facing the skin, consisting of a permanent, identifying coding attached to this backing layer in a locally different surface condition, surface thickness or surface roughness of this backing layer, as well as an active part containing the active ingredient.
  • the invention is that this coding of the backing layer is generated by the action of pressure, heat, ultrasound or abrasion. Limits of applicability when applying the known identifying coding result from the fact that exposure to pressure or heat can be harmful to many plasters containing active ingredients.
  • the capacity of a coding that can be produced by different surface properties of the back layer of a plaster is comparatively narrow.
  • an additional, final work step is required to manufacture them, for example on the finished system.
  • the invention is based on the object of specifying a label for both transdermal therapeutic and for non-transdermal dosage forms using a plaster as an information carrier and methods for its production which are problem-free and with a comparatively large scope provides information about properties, quantity, risks and / or side effects.
  • the task is solved by labeling, in which the patch is provided with an electronically identifiable coding.
  • Such coding has the advantage that it can be carried out or applied using known means, that it has a comparatively high storage capacity for information and with existing electronic reading means which any doctor, pharmacy, ambulance or medical center can have or carry with it , is decodable.
  • One embodiment provides that the coding is formed on the side of the patch facing away from the skin in the form of electronically readable numbers or letters or in the form of a bar code.
  • Comparatively extensive information texts can be stored on a coding field, for example the size of a standard postage stamp.
  • the coding is easily deciphered with an optical, also IR reading device.
  • the coding is designed in the form of a microchip on the side of the plaster facing away from the skin, such as is applied to insurance cards of health insurance companies, for example.
  • This has, for example, a dimension corresponding to approximately half the area of a stamp, can be produced at low cost and can be attached to a plaster.
  • the coding can also be designed on the side of the patch facing away from the skin in the form of a magnetic strip be similar to equipping a bank card with a magnetic stripe.
  • the coding can be present on the adhesive-free side of an adhesive film, which is viable on the plaster before or after its application to a patient's skin.
  • the marking according to the invention provides that the coding contains information about the type and amount of the active substance contained in the patch and, if applicable, all other materials.
  • the coding provided for labeling the dosage forms can, however, also advantageously contain further information about, for example, side effects of the therapeutic active substance, incompatibilities with other active substances and other noteworthy special features.
  • the labeling can be supplemented with great advantage, for example, in such a way that the coding contains instructions for administration of antidote in the event of recognizable occurrence of dangerous symptoms such as overdose of the active substance or acute side effects.
  • a particular advantage of labeling is that personal information about the carrier of the dermal or transdermal system can be stored in coded form. Especially for high-risk patients with an extensive medical history, information about existing allergies, drug intolerance, etc. can be included in the coding as patient-specific information content.
  • the basic structure of basic TTS types is described, for example, by YWChien: “Developmental Concepts and Practice in Transdermal Therapeutic Systems” in Transdermal Controlled Systemic Medications, ed. By YW Chien, Marcel Dekker, New York (1987), p.25-81.
  • the coding can be contained in a drug-containing or drug-free layer of the TTS.
  • a preferred embodiment contains the coding in a separate layer of a TTS located on the backing layer, consisting of backing layer and active substance-containing adhesive matrix layer.
  • a further preferred embodiment contains the coding in the back layer of a TTS, consisting of back layer and active substance-containing pressure-sensitive adhesive matrix layer.
  • Another preferred embodiment contains the coding in a separate layer of a TTS located between the backing layer and the active substance-containing adhesive matrix layer.
  • a further preferred embodiment contains the coding in a separate, on the backing layer of a TTS, consisting of backing layer, drug-containing reservoir, the rate of release of the drug-controlling membrane and a pressure-sensitive adhesive layer.
  • a further preferred embodiment contains the coding in the back layer of a TTS, consisting of back layer, reservoir containing the active substance, the speed the release of the active ingredient-controlling membrane and a pressure-sensitive adhesive layer.
  • a further preferred embodiment contains the coding in a separate layer of a TTS located under the backing layer, consisting of backing layer, reservoir containing the active ingredient, the rate of release of the active ingredient-controlling membrane and an adhesive layer.
  • a method for producing a marking of the type according to the preamble of claim 1 is characterized in that the coding is incorporated into or applied to the plaster when the plaster is being prepared.
  • the coding can advantageously be applied to the plaster in a printing process such as screen printing or pad printing or the like.
  • the coding can also be applied to the plaster using a pressure-sensitive adhesive carrier provided with the coding.
  • an advantageous method for producing a marking of the plaster provides that the coding is stored in a separate layer of a multilayer plaster, or in the layer containing the active substance or in the outer covering layer.
  • the labeling for both transdermal therapeutic and non-transdermal dosage forms using a plaster as an information carrier advantageously eliminates risk factors that cannot always be recognized quickly enough, for example of active ingredient combinations reacting to harmful side effects or in the case of a first pass effect as a result of a damaged TTS or an overdose, allergy reactions or the consequences of using an active ingredient after its expiry date.
  • the labeling according to the invention makes it possible for the doctor in such cases to remedy serious complications with targeted auxiliary measures, in particular in cases of life-threatening conditions.
  • the invention optimally achieves the object stated at the outset.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Physics & Mathematics (AREA)
  • General Physics & Mathematics (AREA)
  • Theoretical Computer Science (AREA)
  • Dermatology (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

La présente invention porte sur des systèmes adhésifs plats - formes d'administration thérapeutique cutanée et transcutanée - mettant en oeuvre un emplâtre adhésif comme vecteur d'information, caractérisés en ce que l'emplâtre est doté d'un codage identifiable électroniquement.
PCT/EP1998/004846 1997-08-22 1998-08-04 Systemes plats d'administration therapeutique cutanee et transcutanee mettant en oeuvre un emplatre adhesif comme vecteur d'information, et mode de fabrication d'un tel emplatre WO1999009960A1 (fr)

Priority Applications (10)

Application Number Priority Date Filing Date Title
IL13438698A IL134386A0 (en) 1997-08-22 1998-08-04 Adhesive plaster with electronically readable code, identification based thereon and processes for the production thereof
KR1020007001802A KR20010023176A (ko) 1997-08-22 1998-08-04 정보 캐리어로서 접착 플라스터를 사용한 접착 시트형피부 및 경피 치료 투여 형태의 식별자 및 이의 제조방법
SK232-2000A SK2322000A3 (en) 1997-08-22 1998-08-04 Flat systems for cutaneous and percutaneous administration involving a sticking-plaster as an information carrier, and method for producing such a plaster
NZ502830A NZ502830A (en) 1997-08-22 1998-08-04 Flat systems for cutaneous and percutaneous administration involving a sticking-plaster as an information carrier relating to therapy, and method for producing such a plaster
JP2000507351A JP2001513547A (ja) 1997-08-22 1998-08-04 情報担体として接着プラスターを備えた皮膚及び経皮投与のためのフラットシステム、及びそのプラスターの製造方法
AU93387/98A AU737379B2 (en) 1997-08-22 1998-08-04 Identification for adhesive sheet-like dermal and trans- dermal therapeutic administration forms using an adhesive plaster as information carrier, and process for its production
EP98946274A EP1007016A1 (fr) 1997-08-22 1998-08-04 Systemes plats d'administration therapeutique cutanee et transcutanee mettant en oeuvre un emplatre adhesif comme vecteur d'information, et mode de fabrication d'un tel emplatre
HU0004184A HUP0004184A3 (en) 1997-08-22 1998-08-04 Flat systems for cutaneous and percutaneous administration involving a sticking-plaster as an information carrier, and method for producing such a plaster
CA002299715A CA2299715A1 (fr) 1997-08-22 1998-08-04 Systemes plats d'administration therapeutique cutanee et transcutanee mettant en oeuvre un emplatre adhesif comme vecteur d'information, et mode de fabrication d'un tel emplatre
NO20000814A NO20000814D0 (no) 1997-08-22 2000-02-18 Identifikasjon for klebende flateformede dermale og transdermale terapeutiske administrasjonsformer under anvendelse av et klebende plaster som informasjonsbærer, såvel som fremgangsmåte for deres fremstilling

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE19736520.5 1997-08-22
DE19736520A DE19736520A1 (de) 1997-08-22 1997-08-22 Kennzeichnung für klebende flächenförmige dermale und transdermale therapeutische Darreichungsformen unter Verwendung eines klebenden Plfasters als Informationsträger, sowie Verfahren zu seiner Herstellung

Publications (1)

Publication Number Publication Date
WO1999009960A1 true WO1999009960A1 (fr) 1999-03-04

Family

ID=7839806

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP1998/004846 WO1999009960A1 (fr) 1997-08-22 1998-08-04 Systemes plats d'administration therapeutique cutanee et transcutanee mettant en oeuvre un emplatre adhesif comme vecteur d'information, et mode de fabrication d'un tel emplatre

Country Status (16)

Country Link
EP (1) EP1007016A1 (fr)
JP (1) JP2001513547A (fr)
KR (1) KR20010023176A (fr)
AU (1) AU737379B2 (fr)
CA (1) CA2299715A1 (fr)
DE (1) DE19736520A1 (fr)
HU (1) HUP0004184A3 (fr)
ID (1) ID24885A (fr)
IL (1) IL134386A0 (fr)
NO (1) NO20000814D0 (fr)
NZ (1) NZ502830A (fr)
PL (1) PL338736A1 (fr)
SK (1) SK2322000A3 (fr)
TR (1) TR200000408T2 (fr)
WO (1) WO1999009960A1 (fr)
ZA (1) ZA987580B (fr)

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001039748A3 (fr) * 1999-12-03 2002-01-03 Qinetiq Ltd Produit pharmaceutique administrable oralement et procede de fabrication correspondant
WO2001041736A3 (fr) * 1999-12-10 2002-01-31 Massachusetts Inst Technology Dispositifs a puces pour l'administration de molecules et procedes de fabrication correspondants
US6730072B2 (en) 2000-05-30 2004-05-04 Massachusetts Institute Of Technology Methods and devices for sealing microchip reservoir devices
US7445766B2 (en) 2000-03-02 2008-11-04 Microchips, Inc. Medical device and method for diagnostic sensing
EP1688132A3 (fr) * 1999-12-10 2009-10-07 Massachussetts Institute of Technology dispositifs à puces pour l'administration de molécules et procédés de fabrication correspondants
WO2017167728A1 (fr) * 2016-03-31 2017-10-05 Amw Gmbh Système d'application transdermique comportant une couche d'information

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE10141836A1 (de) * 2001-08-27 2003-03-27 Hartmann Paul Ag Medizinisches Set für die Verwendung zur Versorgung von Sonden- oder Katheteraustrittsstellen
WO2000004480A1 (fr) 1998-07-20 2000-01-27 Noven Pharmaceuticals, Inc. Procede de suivi individuel et d'identification de dispositif d'administration de medicament
DE19950295A1 (de) * 1999-10-19 2001-04-26 Beiersdorf Ag Verbandmaterial auf Folienbasis mit Aufdruck
DE10015930A1 (de) * 2000-03-30 2001-10-18 Dieter Hafner Träger für ein Arzneimittel
DE102006011340A1 (de) * 2006-03-09 2007-09-20 Grünenthal GmbH Wirkstoffhaltige Pflaster mit verbesserter Handhabung
JP2020525196A (ja) * 2017-06-27 2020-08-27 エルテーエス ローマン テラピー−ジステーメ アーゲー 自己通知パッチ

Citations (4)

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Publication number Priority date Publication date Assignee Title
EP0114125A2 (fr) * 1983-01-20 1984-07-25 Almedco, Inc. Dispositif d'administration d'un médicament
JPH08712A (ja) * 1994-06-27 1996-01-09 Olympus Optical Co Ltd 二次元データコード付薬剤
DE19519593C1 (de) * 1995-05-29 1996-08-29 Horstmann Michael Transdermales Therapeutisches System mit druckfarbenfreier Identifikation und Verfahren zu seiner Herstellung
US5700998A (en) * 1995-10-31 1997-12-23 Palti; Yoram Drug coding and delivery system

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EP0283474A1 (fr) * 1985-10-09 1988-09-28 Desitin Arzneimittel GmbH Procede de fabrication d'une forme d'administration ou de dosage de substances actives medicamenteuses, de reactifs ou d'autres substances actives
DE3630603A1 (de) * 1986-09-09 1988-03-10 Desitin Arzneimittel Gmbh Darreichungs- und dosierungsform fuer arzneimittelwirkstoffe, reagentien oder dergleichen sowie verfahren zu deren herstellung
DE4223004A1 (de) * 1992-07-13 1994-01-20 Liedtke Pharmed Gmbh Einzeldosierte halbfeste topische Arzneiform zur Transdermaltherapie
DE9409784U1 (de) * 1994-06-10 1994-08-11 Effner Biomet Gmbh, 12247 Berlin Vorrichtung zur transdermalen Applikation von Wirkstoffen
DE19524083C2 (de) * 1995-07-01 2000-07-06 Lohmann Therapie Syst Lts Verfahren zur Entsorgung von Transdermalapplikations-Sondermüll
DE19708674C2 (de) * 1996-03-25 2002-02-07 Lohmann Therapie Syst Lts Transdermales therapeutisches System mit einer wirkstoffhaltigen Filmschicht und einer löslichen Trennschicht, sowie ein Verfahren zu dessen Herstellung
US5797898A (en) * 1996-07-02 1998-08-25 Massachusetts Institute Of Technology Microchip drug delivery devices

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0114125A2 (fr) * 1983-01-20 1984-07-25 Almedco, Inc. Dispositif d'administration d'un médicament
JPH08712A (ja) * 1994-06-27 1996-01-09 Olympus Optical Co Ltd 二次元データコード付薬剤
DE19519593C1 (de) * 1995-05-29 1996-08-29 Horstmann Michael Transdermales Therapeutisches System mit druckfarbenfreier Identifikation und Verfahren zu seiner Herstellung
US5700998A (en) * 1995-10-31 1997-12-23 Palti; Yoram Drug coding and delivery system

Non-Patent Citations (1)

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Title
PATENT ABSTRACTS OF JAPAN vol. 096, no. 005 31 May 1996 (1996-05-31) *

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001039748A3 (fr) * 1999-12-03 2002-01-03 Qinetiq Ltd Produit pharmaceutique administrable oralement et procede de fabrication correspondant
AU769952B2 (en) * 1999-12-03 2004-02-12 Psimedica Limited Orally administrable pharmaceutical product and method of fabrication therefor
WO2001041736A3 (fr) * 1999-12-10 2002-01-31 Massachusetts Inst Technology Dispositifs a puces pour l'administration de molecules et procedes de fabrication correspondants
US6808522B2 (en) 1999-12-10 2004-10-26 Massachusetts Institute Of Technology Microchip devices for delivery of molecules and methods of fabrication thereof
EP1688132A3 (fr) * 1999-12-10 2009-10-07 Massachussetts Institute of Technology dispositifs à puces pour l'administration de molécules et procédés de fabrication correspondants
US7445766B2 (en) 2000-03-02 2008-11-04 Microchips, Inc. Medical device and method for diagnostic sensing
US7985386B2 (en) 2000-03-02 2011-07-26 Microchips, Inc. Implantable medical device for diagnostic sensing
US6730072B2 (en) 2000-05-30 2004-05-04 Massachusetts Institute Of Technology Methods and devices for sealing microchip reservoir devices
WO2017167728A1 (fr) * 2016-03-31 2017-10-05 Amw Gmbh Système d'application transdermique comportant une couche d'information

Also Published As

Publication number Publication date
TR200000408T2 (tr) 2000-09-21
IL134386A0 (en) 2001-04-30
NO20000814L (no) 2000-02-18
AU737379B2 (en) 2001-08-16
AU9338798A (en) 1999-03-16
ZA987580B (en) 1999-02-23
KR20010023176A (ko) 2001-03-26
ID24885A (id) 2000-08-31
NO20000814D0 (no) 2000-02-18
HUP0004184A2 (hu) 2001-04-28
NZ502830A (en) 2001-08-31
CA2299715A1 (fr) 1999-03-04
JP2001513547A (ja) 2001-09-04
HUP0004184A3 (en) 2001-08-28
PL338736A1 (en) 2000-11-20
DE19736520A1 (de) 1999-02-25
EP1007016A1 (fr) 2000-06-14
SK2322000A3 (en) 2000-07-11

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