EP0986374A2 - Systeme therapeutique transdermique (tts) permettant d'introduire un principe actif dans un organisme par la peau et procede d'application sur la peau - Google Patents

Systeme therapeutique transdermique (tts) permettant d'introduire un principe actif dans un organisme par la peau et procede d'application sur la peau

Info

Publication number
EP0986374A2
EP0986374A2 EP98947418A EP98947418A EP0986374A2 EP 0986374 A2 EP0986374 A2 EP 0986374A2 EP 98947418 A EP98947418 A EP 98947418A EP 98947418 A EP98947418 A EP 98947418A EP 0986374 A2 EP0986374 A2 EP 0986374A2
Authority
EP
European Patent Office
Prior art keywords
layer
skin
active
barrier layer
matrix
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.)
Withdrawn
Application number
EP98947418A
Other languages
German (de)
English (en)
Inventor
Reinhard Von Kleinsorgen
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.)
LTS Lohmann Therapie Systeme AG
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
Publication of EP0986374A2 publication Critical patent/EP0986374A2/fr
Withdrawn legal-status Critical Current

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
    • 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

Definitions

  • Transdermal therapeutic system for the delivery of active ingredient through the skin to an organism and method for application to the skin
  • the invention relates to a transdermal therapeutic system (TTS) for delivering active substance through the skin to a human or animal organism, comprising an active substance-containing matrix with a pressure-sensitive adhesive layer facing the skin, which can be covered with a removable protective layer prior to its application, and a Matrix covering outer layer.
  • TTS transdermal therapeutic system
  • Transdermal therapeutic systems are drug forms in which the drug is made systemically available through the barrier layer of the skin in the organism.
  • single-dose units are characterized in terms of their dosage strength by the release (g / cm / t) or ( ⁇ g / cmVt), generally “amount of drug (g or ⁇ g) / area / time unit”.
  • these TTSs are difficult or impossible to divide with regard to the divisibility of the dose to be supplied.
  • divisibility is easily achieved in order to adapt the dosage to the patient's requirements by breaking notches, or in the case of foils by applying lines of weakness.
  • dividing a TTS for example by cutting along a marking line, is extremely problematic.
  • the invention is based on the object of specifying a TTS and a method for its application which allows the dosage to be adapted to specific patient requirements without cutting and, in the case of a uniform product, leads to an exactly predeterminable subsystem which, with regard to its contact capability to the skin is unproblematic and reliable.
  • the barrier layer can be made of film-forming polymers such as hydroxypropyl cellulose, hydroxypropyl methyl cellulose, polyvinyl pyrrolidone, vinyl pyrrolidone-vinyl acetate copolymer 60:40, ethyl cellulose, acrylic and.
  • This barrier layer can be designed in the form of a laminate in the layer facing the skin with pressure-sensitive adhesive, the pressure-sensitive adhesive layer optionally containing active ingredient. Suitable components in this sense are all commercially available adhesives known to the person skilled in the art, which are also used for wound care in the form of bandages and plasters, such as, for example, adhesives based on acrylates, polyisobutylene, silicones, etc.
  • the barrier layer can also not be self-adhesive on the skin side, but the self-adhesive finish additionally increases the safety of the TTS.
  • the system which has been partially inactivated for the purpose of setting a defined dose with a barrier layer before application, is distinguished from previous systems in that only one dose strength or even 2 - 3 graduated dose strengths are produced during production, which are subsequently immediately before application by standardized barrier layers, for example in the form of circular segments, with respect to the active substance flux can be further adjusted.
  • a TTS without a barrier layer could be used in an adult for the therapy of a certain disease state, while the TTS is set up for the same purpose in a child with a considerably lower body weight for a correspondingly reduced active substance flux before the application.
  • FIG. 1 is a perspective view of a TTS with an applied barrier layer
  • the transdermal therapeutic system shown in FIG. 1 for the delivery of active ingredient through the skin to a human or animal organism comprises a matrix 5 containing the active ingredient with a pressure-sensitive adhesive active layer 2 facing the skin, which can be covered with a removable protective layer 11 prior to its application, and one the matrix 5 outwardly delimiting top layer 1, which is impermeable to the active ingredient.
  • This can consist of the same material as the barrier layer 3, which is also impermeable to the active ingredient, in accordance with the preceding list of suitable film-forming polymers, such as hydroxypropyl cellulose, hydroxypropyl methyl cellulose, polyvinylpyrrolidone etc.
  • the active layer 2 of the matrix 5 is in a subarea 6 of its active ingredient delivery surface facing the skin with a layer that is impermeable to the active ingredient on a selected location of the human skin for this purpose Barrier layer 3 covered, so that an active ingredient flux into the skin from the matrix area 6 is prevented.
  • the barrier layer 3 is equipped with an adhesive layer 4 on the skin side.
  • an adhesive layer 4 on the skin side.
  • FIG. 2 shows the sectional view of a plaster or TTS according to the invention with a structure corresponding to that of FIG skin-side adhesive layer 4 is covered before application, so that an active substance flux into the skin from this sub-area 6 is prevented.
  • the barrier layer 3 can have a layer thickness between 1 ⁇ m and 40 ⁇ m, preferably between 5 ⁇ m and 30 ⁇ m and particularly preferably between 10 ⁇ m and 20 ⁇ m.
  • both the active layer 2 of the matrix 5 and the barrier layer 3 are preferably each formed with a circular surface and the diameter of the barrier layer 3 is smaller than the diameter of the active layer 2.
  • FIG. 3 further shows, the plaster according to the invention with its constituents, namely on the one hand the matrix 5 with its cover layer 1 and a removable protective layer 11 for the active layer 2, and the barrier layer 3 with the adhesive layer 4, which is initially covered with a removable protective layer 10, for example loosely assigned together in one package.
  • the patch can thus be stored separately from the barrier layer in packaging.
  • a TTS to the skin for the dosable delivery of active ingredient through the skin to an organism, comprising a matrix 5 containing the active ingredient with an active layer 2 which is pressure-sensitive adhesive on the skin and covered with a removable protective layer 11 before application, and a the matrix 5 covering the outside, impermeable to active ingredient covering layer 1,
  • the procedure is such that first the protective layer 11 is detached from the matrix 5, so that the pressure-sensitive active layer 2 is exposed, onto which the barrier layer 3 is then placed in accordance with the dash-dotted arrows and is attached in a pressure-sensitive manner by gentle pressure, after which the protective layer 10 is removed from the adhesive layer 4 thereof in accordance with the arrow 12.
  • the TTS designed according to the invention is now ready to be glued to an intended skin site of a patient.
  • the active layer 2 is then the matrix of their per unit time and active area to adjusting drug delivery rate (mg / cm 2/24 hr) inactivated 5 in accordance with a previously determinable limitation in a partial region of its operative surface by the impermeable for active ingredient barrier layer.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Dermatology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

L'invention concerne un système thérapeutique transdermique (TTS) permettant d'introduire un principe actif dans un organisme humain ou animal par la peau. Ce système comprend une matrice (5) contenant le principe actif et dotée d'une couche active (2) pouvant être recouverte, avant son application, d'une couche de protection (11) détachable et adhésive orientée vers la peau. Ce système comprend également une couche de revêtement (1) imperméable au principe actif et délimitant la matrice (5) vers l'extérieur. Ce système est caractérisé en ce que la couche active (2) de la matrice (5) est recouverte, au moment de l'application et dans une zone partielle (6) de sa surface de libération du principe actif, qui est tournée vers la peau, d'une couche d'arrêt (3) imperméable au principe actif.
EP98947418A 1997-08-06 1998-08-01 Systeme therapeutique transdermique (tts) permettant d'introduire un principe actif dans un organisme par la peau et procede d'application sur la peau Withdrawn EP0986374A2 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE19733981 1997-08-06
DE19733981A DE19733981A1 (de) 1997-08-06 1997-08-06 Transdermales Therapeutisches System (TTS) zur Abgabe von Wirkstoff durch die Haut an einen Organismus und Verfahren zur Applikation auf der Haut
PCT/EP1998/004824 WO1999007349A2 (fr) 1997-08-06 1998-08-01 Systeme therapeutique transdermique (tts) permettant d'introduire un principe actif dans un organisme par la peau et procede d'application sur la peau

Publications (1)

Publication Number Publication Date
EP0986374A2 true EP0986374A2 (fr) 2000-03-22

Family

ID=7838128

Family Applications (1)

Application Number Title Priority Date Filing Date
EP98947418A Withdrawn EP0986374A2 (fr) 1997-08-06 1998-08-01 Systeme therapeutique transdermique (tts) permettant d'introduire un principe actif dans un organisme par la peau et procede d'application sur la peau

Country Status (16)

Country Link
EP (1) EP0986374A2 (fr)
JP (1) JP2002517379A (fr)
KR (1) KR20010022629A (fr)
AU (1) AU737115B2 (fr)
CA (1) CA2298442A1 (fr)
DE (1) DE19733981A1 (fr)
HU (1) HUP0003347A3 (fr)
ID (1) ID24195A (fr)
IL (1) IL134007A0 (fr)
NO (1) NO20000376L (fr)
NZ (1) NZ502405A (fr)
PL (1) PL338793A1 (fr)
SK (1) SK1482000A3 (fr)
TR (1) TR200000249T2 (fr)
WO (1) WO1999007349A2 (fr)
ZA (1) ZA987006B (fr)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE10027258C1 (de) * 2000-05-31 2001-10-31 Lohmann Therapie Syst Lts Transdermales therapeutisches System mit okklusiver wirkstoffhaltiger Schicht und nicht-okklusiver Rückschicht
DE10056014A1 (de) * 2000-11-11 2002-05-16 Beiersdorf Ag Mehrschichtige Trägerkonstruktion für wirkstofhaltige Pflastersyteme
CN101380258B (zh) 2001-11-23 2013-09-18 科洛普拉斯特公司 伤口敷料
DE102004020463A1 (de) * 2004-04-26 2005-11-10 Grünenthal GmbH Wirkstoffabgabesystem aus einem wirkstoffhaltigen Pflaster und mindestens einem Wirkstoffabgaberegulierungsmittel
DE202005014347U1 (de) 2005-09-09 2007-01-18 Grünenthal GmbH Applikationssystem für ein wirkstoffhaltiges Pflaster und Wirkstoffabgaberegulierungsmittel
HU0900117D0 (en) 2009-02-26 2009-04-28 Genetic Immunity Kutatasi Topical or transdermal delivery kit
DE102017125281A1 (de) 2017-10-27 2019-05-02 Dermatools Biotech Gmbh Vorrichtung zur Bereitstellung einer Haut- oder Wundauflage
DE102018216244A1 (de) 2018-09-24 2020-03-26 Lts Lohmann Therapie-Systeme Ag Transdermales therapeutisches System mit Barriereschicht

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA1340190C (fr) * 1988-08-01 1998-12-15 The Kendall Company Surface adhesive discontinue
DE3908431A1 (de) * 1989-03-15 1990-09-27 Lohmann Therapie Syst Lts Transdermales system mit gestufter wirkstoffabgabe und verwendung fuer die lokale oder systemische wirkstoffverabreichung
EP0593807A1 (fr) * 1992-10-22 1994-04-27 LTS Lohmann Therapie-Systeme GmbH & Co. KG Pansement transdermique pour l'administration de principes actifs pharmaceutiques volatiles alcalins et procédé pour sa préparation
DE19503336C2 (de) * 1995-02-02 1998-07-30 Lohmann Therapie Syst Lts Arzneiform zur Abgabe von Wirkstoffen an Wunden, Verfahren zu ihrer Herstellung und ihre Verwendung
WO1997006784A1 (fr) * 1995-08-15 1997-02-27 Universite Libre De Bruxelles Procede et installation de production de liposomes
US5840327A (en) * 1995-08-21 1998-11-24 Alza Corporation Transdermal drug delivery device having enhanced adhesion

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO9907349A2 *

Also Published As

Publication number Publication date
NO20000376D0 (no) 2000-01-25
KR20010022629A (ko) 2001-03-26
DE19733981A1 (de) 1999-02-11
WO1999007349A3 (fr) 1999-08-05
PL338793A1 (en) 2000-11-20
SK1482000A3 (en) 2000-07-11
IL134007A0 (en) 2001-04-30
NZ502405A (en) 2001-01-26
HUP0003347A3 (en) 2001-04-28
HUP0003347A2 (hu) 2001-02-28
ID24195A (id) 2000-07-13
CA2298442A1 (fr) 1999-02-18
NO20000376L (no) 2000-01-25
TR200000249T2 (tr) 2000-08-21
WO1999007349A2 (fr) 1999-02-18
JP2002517379A (ja) 2002-06-18
AU737115B2 (en) 2001-08-09
AU9434498A (en) 1999-03-01
ZA987006B (en) 1999-02-08

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