EP1107742A1 - Pansement compose de trois couches et contenant un medicament - Google Patents

Pansement compose de trois couches et contenant un medicament

Info

Publication number
EP1107742A1
EP1107742A1 EP99968625A EP99968625A EP1107742A1 EP 1107742 A1 EP1107742 A1 EP 1107742A1 EP 99968625 A EP99968625 A EP 99968625A EP 99968625 A EP99968625 A EP 99968625A EP 1107742 A1 EP1107742 A1 EP 1107742A1
Authority
EP
European Patent Office
Prior art keywords
layer
plaster according
medicament
fibers
containing plaster
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Withdrawn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
EP99968625A
Other languages
German (de)
English (en)
Inventor
Michael Horstmann
Stefan Bracht
Horst Dzekan
Wolfgang Laux
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.)
Horstmann Michael
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 EP1107742A1 publication Critical patent/EP1107742A1/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Withdrawn legal-status Critical Current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
    • 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

Definitions

  • a prerequisite for transdermal therapy is the sufficient permeability of the active ingredient through the skin, which is only sufficient with some active ingredients.
  • water is also suitable as a well-tolerated substance for improving the permeation properties of the skin.
  • Medicinal plasters that contain vapor barriers that counteract this loss of water are referred to as "occlusive"; they generally have the desired increase in permeation for the active substance introduced. This is very often caused by metal foils or plastic foils which are slightly permeable to water vapor, e.g. made of polyethylene terephthalate.
  • plasters which contain non-stretch films, damage the skin through shear effects or cuts in the edge area of the plasters. Since the skin itself is stretchable due to its structure, a plaster that is stretchable to a limited extent has far more favorable wearing properties than a plaster based on non-stretchable films. Furthermore, the extensibility of soft matrices largely prevents the adhesive from escaping from the side, since the shear effect on the adhesive matrix does not occur.
  • US 4,753,231 describes a water vapor permeable, active ingredient-free plaster consisting of a mechanically flexible back layer, which is provided with an adhesive layer on the skin side and carries a wound pad on it.
  • Multilayer systems are also known in which a paper, nonwoven fabric or textile fabric is introduced between a soft plastic film and the active substance-containing adhesive layer (JP 2 212 423). In this way, an improved positive contact between the backing layer and the matrix is to be achieved.
  • the present invention is based on the object of advantageously combining the two desirable properties, occlusivity or partial occlusiveness and extensibility.
  • a drug-containing plaster with a layered structure, consisting of a) a layer composed of fibers, b) a layer limiting the water transport on the basis of a thermoplastic polymer, and c) at least one matrix layer containing the active substance.
  • the plaster can have a removable protective film.
  • the stretchable layer constructed from the fibers can be made of a textile, e.g. woven or knitted surface material, or consist of a non-textile non-woven composite.
  • the elasticity is sufficient, as is generally achieved by a geometrical arrangement of a fiber composite that is familiar to the person skilled in the art.
  • an extensibility of at least 1% of the initial dimension in length or width will suffice.
  • expansion of the extension length of at least 30 5s may be useful.
  • the elastic recovery force of such fiber composites should not exceed 1 N / cm at 5% elongation.
  • the dosage of topical plasters and transdermal therapeutic systems depends on the area applied and therefore, in the interest of a uniform and uniform dosage, the elasticity should generally also be limited. This can be achieved, for example, by the fact that the stretch restoring force at a stretch of 10% and more is clearly above 5 N / cm. In this way, possible overdosing due to overstretching during application can be largely avoided.
  • the base material of the fibers should comply without limitation with the principles of toxicological suitability for use on the skin.
  • largely inert base polymers such as polyethylene, polypropylene, polyester, e.g. PET, preferably, but also viscose, cotton, wool or silk can correspond to the purpose according to the invention.
  • the layer limiting the water transport between the fiber-containing layer and the adhesive matrix consists of a thermoplastic polymer. Polymer layers that limit or at least influence the water transport from the skin to the outside are suitable for this.
  • the layer is not necessarily a monolithic photo lie, since the occlusivity can also be limited by porosity.
  • Resins in particular rosin esters or hydrocarbon resins, and plasticizers customary in polymer technology can be used to match the thermoplastic properties of these materials.
  • the structure of the thermoplastic layer can entail that the active ingredient can diffuse into the layer containing the thermoplastic polymer shortly after production from the drug-carrying layers.
  • the active ingredient can also be added preventively to the thermoplastic polymer layer, which can result in advantageous additional reservoir properties.
  • the layer thickness of the thermoplastic film provided it is formed with a uniformly thick layer, can be, for example, between 5 and 500 ⁇ m.
  • a function according to the invention can be expected with an additional dependence on the polymer properties. Depending on the density of the polymers and additives used, this corresponds to an application weight of approx. 10 to 100 g / m 2 .
  • thermoplastic polymer A self-resetting effect of the polymer layer may be desirable, but is in no way a prerequisite for the function according to the invention.
  • the application of thermoplastic polymer will be so small that the mechanical limitation of the stretch comes from the fiber-containing layer.
  • Essential to the invention is only the control of the water vapor access through the thermoplastic polymer layer, which enables the overall composite to control the water vapor release under physiological conditions in the range from approximately 10 to 600 g / m 2 -d, preferably approximately 50 to 300 g / m 2 - d allowed. Experimentally, these values correspond to temptation conditions of 90% relative air humidity against 30% relative air humidity at 40 ° C.
  • thermoplastic polymer layer has an impregnating effect on the fiber-containing cover layer and thus mechanical immigration of the layer, which is softer as a rule, is avoided. It is particularly important that the thermoplastic layer and the third, drug-carrying layer are bonded directly. This can be achieved by choosing the base materials of the polymer layer and the active substance-containing layers.
  • the principle according to the invention can be used both in matrix systems and in reservoir / membrane systems, which are to be regarded as the third, active substance-containing layer of the patch according to the invention.
  • the manufacture of such systems is possible in a number of ways:
  • a TTS matrix produced according to known technology which is located on a film which has been provided with a adhesive layer as a later release liner, can be laminated on with a thermoplastic film and then covered with a textile or fleece-like fibrous layer using heat and / or pressure get connected.
  • the adhesive bond is often improved by flowing around the fiber texture with melting thermoplastic polymer mass.
  • the punching knife can stop in front of the release liner film and provide the central positioning of a TTS on the protective film for later easier application to the skin.
  • the composite of fiber-containing layer and thermoplastic polymer is laminated directly onto the matrix or matrix composite layer, which on the other side is already equipped with a release-coated release liner.
  • a desired geometric shape such as a circle, rounded rectangle, etc.
  • FIG. 1 a plaster according to the invention with a single layer
  • FIG. 3 a plaster according to the invention with two layers
  • FIG. 5 shows a detailed drawing of a plaster according to the invention with an overlapping anchoring between the fiber-guiding layer and the thermoplastic polymer layer.

Landscapes

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

Abstract

L'invention concerne un pansement contenant un médicament et permettant de délivrer des principes actifs et/ou des agents auxiliaires pharmaceutiques à l'organisme humain par voie cutanée. Ce pansement a une structure en couches. Il comprend une couche réalisée en fibres, une couche à base d'un polymère thermoplastique et destinée à limiter le transport d'eau et au moins une couche matrice contenant le principe actif.
EP99968625A 1998-09-03 1999-08-28 Pansement compose de trois couches et contenant un medicament Withdrawn EP1107742A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE19840191A DE19840191A1 (de) 1998-09-03 1998-09-03 Arzneistoffhaltiges Pflaster mit drei funktionalen Schichten
DE19840191 1998-09-03
PCT/EP1999/006346 WO2000013679A1 (fr) 1998-09-03 1999-08-28 Pansement compose de trois couches et contenant un medicament

Publications (1)

Publication Number Publication Date
EP1107742A1 true EP1107742A1 (fr) 2001-06-20

Family

ID=7879697

Family Applications (1)

Application Number Title Priority Date Filing Date
EP99968625A Withdrawn EP1107742A1 (fr) 1998-09-03 1999-08-28 Pansement compose de trois couches et contenant un medicament

Country Status (10)

Country Link
EP (1) EP1107742A1 (fr)
JP (1) JP2002524414A (fr)
KR (1) KR20010073008A (fr)
CN (1) CN1320033A (fr)
AR (1) AR024201A1 (fr)
AU (1) AU5971699A (fr)
BR (1) BR9913609A (fr)
CA (1) CA2341643A1 (fr)
DE (1) DE19840191A1 (fr)
WO (1) WO2000013679A1 (fr)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR100407406B1 (ko) * 2001-10-06 2003-12-01 한웅코텍 주식회사 보형성이 있는 적층 시트
WO2004071499A1 (fr) * 2003-02-12 2004-08-26 Teika Pharmaceutical Co., Ltd. Emplatre contenant du diclofenac
DE102007006244B4 (de) 2007-02-08 2012-03-15 Lts Lohmann Therapie-Systeme Ag Transdermales Therapeutisches System zur Verabreichung wasserlöslicher Wirkstoffe

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3409079A1 (de) * 1984-03-13 1985-09-19 Bayer Ag, 5090 Leverkusen Medizinische pflaster
US4725439A (en) * 1984-06-29 1988-02-16 Alza Corporation Transdermal drug delivery device
JPS61293911A (ja) * 1985-06-24 1986-12-24 Teisan Seiyaku Kk 徐放化製剤
US4784653A (en) * 1987-06-22 1988-11-15 Johnson & Johnson Patient Care, Inc. Absorbent adhesive dressing
US5286490A (en) * 1990-05-04 1994-02-15 Colgate-Palmolive Company Transdermal fluoride medication
US5246705A (en) * 1992-04-08 1993-09-21 Cygnus Therapeutic System Occlusive, elastomeric backing materials in transdermal drug delivery systems, and associated methods of manufacture and use
JP3081858B2 (ja) * 1992-05-12 2000-08-28 日東電工株式会社 貼付剤および貼付製剤
US5702720A (en) * 1995-12-22 1997-12-30 Minnesota Mining And Manufacturing Company Transdermal device for the delivery of flurbiprofen
JP4008532B2 (ja) * 1997-05-12 2007-11-14 帝國製薬株式会社 経皮吸収貼付製剤
DE19804774A1 (de) * 1998-02-06 1999-08-12 Beiersdorf Ag Trägermaterial für medizinische Zwecke

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO0013679A1 *

Also Published As

Publication number Publication date
WO2000013679A1 (fr) 2000-03-16
BR9913609A (pt) 2001-10-09
AR024201A1 (es) 2002-09-25
AU5971699A (en) 2000-03-27
KR20010073008A (ko) 2001-07-31
CA2341643A1 (fr) 2000-03-16
JP2002524414A (ja) 2002-08-06
CN1320033A (zh) 2001-10-31
DE19840191A1 (de) 2000-03-09

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