EP1490039A2 - Assembled unit consisting of individually separable transdermal therapeutic systems - Google Patents

Assembled unit consisting of individually separable transdermal therapeutic systems

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Publication number
EP1490039A2
EP1490039A2 EP03744842A EP03744842A EP1490039A2 EP 1490039 A2 EP1490039 A2 EP 1490039A2 EP 03744842 A EP03744842 A EP 03744842A EP 03744842 A EP03744842 A EP 03744842A EP 1490039 A2 EP1490039 A2 EP 1490039A2
Authority
EP
European Patent Office
Prior art keywords
drug
unit according
transdermal
base film
therapeutic systems
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Withdrawn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
EP03744842A
Other languages
German (de)
French (fr)
Inventor
Klaus M. Wilsmann
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.)
Gruenenthal GmbH
Original Assignee
Gruenenthal GmbH
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Filing date
Publication date
Application filed by Gruenenthal GmbH filed Critical Gruenenthal GmbH
Publication of EP1490039A2 publication Critical patent/EP1490039A2/en
Withdrawn legal-status Critical Current

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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.

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

Abstract

The invention relates to an assembled unit consisting of individually separable transdermal therapeutic systems.

Description

Zusammenhängende Einheit aus vereinzelbaren transdermalen therapeutischen Systemen Cohesive unit of singular transdermal therapeutic systems
Die Erfindung betrifft eine zusammenhängende Einheit aus vereinzelbaren, transdermalen, therapeutischen Systemen.The invention relates to a coherent unit of isolable, transdermal, therapeutic systems.
Transdermale, therapeutische Systeme zur Applikation von transdermal zu verabreichenden Wirkstoffen sind bekannt. Dabei handelt es sich um technisch spezifizierte Pflastersysteme, die kontinuierlich über einen bestimmten Zeitraum kontrolliert einen therapeutischen Wirkstoff über die Haut an einen menschlichen oder tierischen Organismus abgeben.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.
In diesen Systemen kann der Wirkstoff in einer Matrix dispergiert oder in einem Wirkstoffreservoir vorliegen. Sowohl in der Matrix als auch im Wirkstoffreservoir ist es möglich, den Wirkstoff flüssig, halbfest oder fest oder als entsprechende Wirkstofformulierung zu verwenden.In these systems, 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.
Die bekannten transdermalen, therapeutischen Systeme enthalten eine bestimmte vorgegebene Dosis des Wirkstoffs zur kontrollierten Freigabe. Problematisch dabei ist die individuelle Dosierung des Wirkstoffs gemäß den Patientenerfordernissen.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.
Nach dem Stand der Technik wird eine individuelle Dosierung auf unterschiedliche Weise erreicht.According to the prior art, an individual dosage is achieved in different ways.
Gemäß der Lehre von DE-U-295 11 878 wird dafür ein streifenförmiges, transdermales, therapeutisches System empfohlen, von dem entsprechend den Patientenerfordernissen ein Stück abgetrennt werden kann. Die Trennung erfolgt im wirkstoffhaltigen Bereich. Dadurch kann Wirkstoff zum Teil verloren gehen und kleine Trennungsungenauigkeiten bereits zu einer abweichenden Dosierung des Wirkstoffs führen. Eine exakte Dosierung ist somit nicht möglich.According to the teaching of DE-U-295 11 878, 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. As a result, 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.
In der Veröffentlichung DE 197 33 981 wird ein transdermales, therapeutisches System beschrieben, dessen wirkstoffhaltiger Bereich teilweise abgedeckt werden kann, um eine geringere Dosierung zu erzielen. Dadurch wird jedoch gegebenenfalls ein Teil des Wirkstoffs nicht genutzt. Ferner kann der Hautkontakt des wirkstoffhaltigen Bereichs beeinträchtigt werden.In the publication DE 197 33 981 a transdermal, therapeutic system is described, 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.
In der Veröffentlichung DE 19900645 wird ein transdermales, therapeutisches System aus vereinzelbaren, wirkstoffhaltigen Matrixabschnitten beschrieben, die jeweils einzeln oder mehrere gleichzeitig mit Hilfe von Klebestreifen appliziert werden können. Die Handhabung eines Matrixsystems und getrennter Klebestreifen ist jedoch kompliziert und gewährleistet keinen optimalen Hautkontakt der wirkstoffhaltigen Matrixabschnitte.In the publication DE 19900645 a transdermal, therapeutic system of isolable, drug-containing matrix sections is described, which can be applied individually or more simultaneously with the help of adhesive strips. The handling of a matrix system and separate adhesive tape is complicated and does not ensure optimal skin contact of the drug-containing matrix sections.
Es stellte sich daher die Aufgabe, ein einfach zu handhabendes, transdermales, therapeutisches System zur Applikation von transdermal verabreichbaren Wirkstoffen zur Verfügung zu stellen, das eine exakte individuelle Dosierung der Wirkstoffe nach den Patientenerfordernissen ohne Verlust von Wirkstoff bei zuverlässigem Hautkontakt ermöglicht.It was therefore an object to provide an easy-to-use, transdermal therapeutic system for the application of transdermally administered drugs available that allows an exact individual dosage of the drugs according to the patient requirements without loss of active ingredient in reliable skin contact.
Diese Aufgabe wird erfindungsgemäß gelöst durch Bereitstellung einer zusammenhängenden Einheit aus mindestens zwei vereinzelbaren, transdermalen, therapeutischen Systemen umfassend jeweilsThis object is achieved according to the invention by providing a coherent unit comprising at least two isolable, transdermal, therapeutic systems comprising each
a) eine wirkstoffundurchlässige Basisfolie, b) eine klebefähige, die Basisfolie zumindest teilweise bedeckende und entweder ein Wirkstoffreservoir oder eine wirkstoffhaltige Matrix aufweisende Schicht, die einen wirkstofffreien, umlaufenden Randbereich hat und gegebenenfalls c) eine die klebefähige Schicht zumindest teilweise bedeckende, abziehbare Schutzfolie,a) 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,
wobei die vereinzelbaren, transdermalen, therapeutischen Systeme in ihren aneinander grenzenden wirkstofffreien Randbereichen Trennungsmöglichkeiten aufweisen. Vorzugsweise liegen linienförmige Perforationen zur Trennung der vereinzelbaren, transdermalen, therapeutischen Systeme von der zusammenhängenden, erfindungsgemäßen Einheit vor.wherein the singular, transdermal, therapeutic systems have in their contiguous drug-free border areas separation possibilities. Preferably, there are linear perforations for the separation of the singular, transdermal, therapeutic systems from the coherent unit according to the invention.
Weiter bevorzugt sind Schneidemarkierungen auf der Basisfolie und/oder der Abdeckfolie, die die Trennmöglichkeit der vereinzelbaren Systeme von der erfindungsgemäßen Einheit vorgeben. Die Trennmöglichkeiten sind jeweils vorzugsweise so angeordnet, daß sie eine Abtrennung jedes zusammenhängenden, transdermalen, therapeutischen Systems komplett von der erfindungsgemäßen Einheit ermöglichen.Further preferred are cutting marks on the base film and / or the cover, which dictate the ability to separate the separable systems of the unit according to the invention. 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.
Als Wirkstoffe eignen sich alle transdermal verabreichbaren Wirkstoffe, wie Corticosteroide, Analgetika, Sedativa, Tranquilizer, Antibiotika, Anästetika, antivirale Mittel, antimikrobielle Mittel, Fungizide, Vitamine, Antiepileptika, Sexualhormone, Nicotin, Psychopharmaka, Koronardilatatoren, Antiarthritika, Antiasthmatika, Antidepressiva, Antidiabetika, Antihistamine, Entzündungshemmende Mittel und/oder Antimigränemittel.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.
Bevorzugt eignet sich die erfindungsgemäße Einheit bzw. ein vereinzeltes System zur Bekämpfung von Schmerzen.Preferably, the unit according to the invention or an isolated system for controlling pain is suitable.
Die vereinzelbaren, transdermalen Systeme umfassen eine Basisfolie und darauf eine klebefähige, mit einer wirkstoffhaltigen Matrix oder einem Wirkstoffreservoir versehene Schicht, die gegebenenfalls eine Schutzfolie aufweisen kann.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.
Die klebefähige Schicht kann zumindest in Teilbereichen, vorzugsweise komplett, aus Matrixmaterial bestehen, das eine klebefähige Komponente, vorzugsweise eine drucksensitive Klebekomponente enthält und einen wirkstoffhaltigen Bereich umfaßt. Dieser wirkstoffhaltige Bereich ist von einem umlaufenden, wirkstofffreien Randbereich umgeben.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.
Die wirkstoffundurchlässige Basisfolie besteht vorzugsweise aus einem flexiblen, dehnbaren, atmungsaktiven, strapazierfähigen Material. Besonders bevorzugt ist ein textilartiges Gewebe. Die Basisfolie kann gefärbt, vorzugsweise hautfarben sein. Wirkstoffundurchlässig bedeutet, daß die Basisfolie zumindest in dem Bereich, in dem eine wirkstoffhaltige Matrix vorliegt, die Basisfolie wirkstoffundurchlässig ist. Ist die Basisfolie selbst nicht wirkstoffundurchlässig, sollte zwischen der Matrixschicht bzw. dem Wirkstoffreservoir und der Basisfolie eine wirkstoffundurchlässige Sperrschicht angebracht werden. Diese Sperrschicht sollte vorzugsweise aus einem filmbildenden Polymer bestehen.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.
Das Matrixmaterial der Schicht b.) kann auf lipophilen oder hydrophilen Polymeren basieren. Hydrophile Polymermatrices können wasserhaltig sein, wobei es sich vorzugsweise um Gele handelt. Als Matrixmaterialien kommen vernetzbare Polymere, vorzugsweise synthetische Harze, Silicon-Gummi oder Gummi in Frage, wie Styrol-Isopren-Styrol-Blockcopolymere, Silicone, Polyacrylate, Polyurethane, Polyvinylether, Polyvinylchlorid, Polyvinylalkohole, Polyvinylpyrrolidone, Polyester, Polypropylen und/ oder Polysaccharide in Betracht. Besonders bevorzugt sind Polyacrylate.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.
Als klebefähige Komponente zur Herstellung der klebefähigen Schicht wird vorzugsweise ein hautverträglicher polymerer Klebstoff verwendet, besonders bevorzugt ein drucksensitiver Klebstoff wie hot melt.As adhesive component for the preparation of the adhesive layer preferably a skin-compatible polymeric adhesive is used, more preferably a pressure-sensitive adhesive such as hot melt.
Zur Herstellung der klebefähigen Schicht kann die klebefähige Komponente mit den vorstehend aufgeführten Matrixmaterialien in bekannten Mengen gemischt werden und zur Herstellung des wirkstoffhaltigen Matrixbereichs ein Wirkstoff hinzugefügt werden. Der wirkstoffhaltige Matrixbereich wird auf die Basisfolie so aufgetragen, daß ein wirkstofffreier, umlaufender Randbereich gegeben ist. Nach dem Auftrag kann das Matrixmaterial, wenn nötig, auch noch vernetzt werden. Der in der Matrix vorliegende Wirkstoff oder die in der Matrix vorliegenden Wirkstoffe können flüssig, halbfest oder fest im dispergierten Zustand vorliegen oder als entsprechende Formulierung unter Hinzufügung von üblichen Hilfsstoffen als Wirkstofformulierung eingearbeitet sein.To prepare the adhesive layer, 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. After application, 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.
Als übliche Hilfsstoffe können Verbindungen, die den transdermalen Transport der Wirkstoffe verstärken bzw. erleichtern, eingesetzt werden. Diese Hilfsstoffe können mit den Wirkstoffen gemischt oder in einer separaten Schicht zur wirkstoffhaltigen Matrixschicht vorliegen.As usual 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.
Sofern die transdermal zu applizierenden Wirkstoffe in einem Wirkstoffreservoir in der klebefähigen Schicht vorliegen, ist dieses Reservoir vorzugsweise in der klebefähigen Schicht eingebettet. Als Klebestoffe für diese Schicht eignen sich die vorstehend angegebenen polymeren Klebstoffe, die als klebefähige Komponente aufgeführt sind. Das Wirkstoffreservoir enthält den Wirkstoff bzw. die entsprechende Wirkstofformulierung vorzugsweise als Lösung, die durch die Membran des Wirkstoffreservoirs ungehindert diffundieren kann. Als Membranmaterialien sind die vorstehend aufgeführten Polymeren geeignet, die auch als Matrixmaterial zum Einsatz kommen können.If 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.
Sofern der wirkstoffhaltige Matrixbereich der Schicht b) keine klebefähige Komponente in Ausnahmefällen enthält, kann das transdermale System auch so gestaltet werden, daß nur in der Randzone, die wirkstofffrei ist, die klebefähige Komponente als Matrixkomponente vorliegt.If the active substance-containing matrix region of the layer b) contains no adhesive component in exceptional cases, 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.
Sämtliche Materialien, die zum Aufbau der transdermalen Systeme verwendet werden, insbesondere aber diejenigen Materialien, die mit der Haut in Berührung kommen, müssen hautverträglich und physiologisch unbedenklich sein.All materials that are used to build the transdermal systems, but especially those materials that come into contact with the skin must be skin-friendly and physiologically safe.
Üblicherweise weist das erfindungsgemäße transdermale therapeutische System zumindest im Wirkstoff abgebenden Bereich, vorzugsweise über die gesamte klebefähige Schicht eine Schutzfolie auf, die vor der Applikation leicht abziehbar ist. Vorzugsweise besteht diese Schutzfolie aus Papier oder ist eine leicht haftende physiologisch unbedenkliche Kunststoffolie.Usually, 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. Preferably, this protective film is made of paper or is a slightly adherent physiologically harmless plastic film.
Die erfindungsgemäße, zusammenhängende Einheit aus vereinzelbaren, transdermalen therapeutischen Systemen, enthält vorzugsweise je System dieselbe Wirkstoffdosis, wodurch die individuelle, bedarfsabhängige Applikation für den Patienten bzw. Benutzer erheblich erleichtert wird. Dies gilt insbesondere dann, wenn Schwankungen des Wirkstoffbedarfs auftreten, z. B. bei wiederholt auftretenden Schmerzanfällen oder wenn eine ausklingende Therapie mit abnehmender Dosierung notwendig ist. Hierfür kann durch Anbringen mehrerer erfindungsgemäßer, transdermaler, therapeutischer Systeme zunächst bedarfsgerecht therapiert werden und durch Reduzierung der Zahl der Systeme im weiteren Verlauf der Therapie die notwendige Reduzierung der Wirkstoffdosis in einfacher Art und Weise durch den Patienten selbst vorgenommen werden.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. For this purpose, by attaching a plurality of 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.
Die erfindungsgemäße, zusammenhängende Einheit aus vereinzelbaren, transdermalen, therapeutischen Systemen liegt vorzugsweise verpackt vor, wobei nach Bedarfsfall auch eine sterile Verpackung möglich ist.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.
Figur 1 zeigt eine Draufsicht auf eine erfindungsgemäße Einheit (1) aus 4 vereinzelbaren, transdermalen, therapeutischen Systemen.FIG. 1 shows a plan view of a unit (1) according to the invention from 4 isolatable, transdermal, therapeutic systems.
Figur 2 zeigt eine Draufsicht auf eine erfindungsgemäße Einheit (1) aus 2 vereinzelbaren, transdermalen, therapeutischen Systemen.FIG. 2 shows a plan view of a unit (1) according to the invention from 2 isolatable, transdermal, therapeutic systems.
Sowohl in Figur 1 als auch in Figur 2 deuten die Pfeile in Richtung der Trennungslinien (4), hier Perforationen, des jeweils vereinzelbaren, transdermalen Systems von der übrigen Einheit (1). Jedes vereinzelbares System umfaßt einen wirkstoffhaltige Matrixbereich (3) bzw. ein wirkstoffhaltiges Reservoir (3a), der bzw. das von einem wirkstofffreien, klebefähigen, umlaufenden Randbereich (2) umgeben ist. Die Basisfolie und eine gegebenenfalls vorhandene Schutzfolie sind in den Figuren 1 und 2 nicht extra dargestellt. Both in FIG. 1 and in FIG. 2, the arrows in the direction of the dividing lines (4), in this case perforations, of the respectively separable, transdermal system are indicated by the remaining unit (1). 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.

Claims

Patentansprüche claims
1. Zusammenhängende Einheit aus mindestens zwei vereinzelbaren, transdermalen, therapeutischen Systemen umfassend jeweils1. Contiguous unit comprising at least two separate, transdermal, therapeutic systems each comprising
a) eine wirkstoffundurchlässige Basisfolie b) eine klebefähige, die Basisfolie zumindest teilweise bedeckende und entweder ein Wirkstoffreservoir oder eine wirkstoffhaltige Matrix aufweisende Schicht, die einen wirkstofffreien, umlaufenden Randbereich hat und gegebenenfalls c) eine die klebefähige Schicht zumindest teilweise bedeckende, abziehbare Schutzfolie,a) 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,
wobei die vereinzel baren, transdermalen, therapeutischen Systeme in ihren aneinander grenzenden wirkstofffreien Randbereichen Trennungsmöglichkeiten aufweisen.wherein the sporadic, transdermal, therapeutic systems have separation capabilities in their contiguous drug-free border areas.
2. Einheit gemäß Anspruch 1 , dadurch gekennzeichnet, daß die Trennungsmöglichkeit eine Perforation ist.2. Unit according to claim 1, characterized in that the possibility of separation is a perforation.
3. Einheit gemäß Anspruch 1 , dadurch gekennzeichnet, daß die Trennmöglichkeit durch eine Schneidemarkierung vorgegeben ist.3. Unit according to claim 1, characterized in that the separation possibility is predetermined by a cutting mark.
4. Einheit gemäß einem der Ansprüche 1 bis 3, dadurch gekennzeichnet, daß die Basisfolie aus Gewebe, vorzugsweise textilartigem Gewebe, besteht.4. Unit according to one of claims 1 to 3, characterized in that the base film made of tissue, preferably textile-like fabric consists.
5. Einheit gemäß einem der Ansprüche 1 bis 4, dadurch gekennzeichnet, daß wenigstens ein therapeutischer Wirkstoff in einer Matrix dispergiert oder in dem Wirkstoffreservoir vorliegt.5. Unit according to one of claims 1 to 4, characterized in that at least one therapeutic agent is dispersed in a matrix or present in the drug reservoir.
6. Einheit gemäß einem der Ansprüche 1 bis 5, dadurch gekennzeichnet, daß der Wirkstoff in dem Wirkstoffreservoir als Lösung vorliegt, die von einer wirkstoffdurchlässigen Membran umgeben ist. 6. Unit according to one of claims 1 to 5, characterized in that the active ingredient is present in the drug reservoir as a solution which is surrounded by a drug-permeable membrane.
7. Einheit gemäß einem der Ansprüche 1 bis 6, dadurch gekennzeichnet, daß jedes vereinzelbare, transdermale System dieselbe Wirkstoffdosis enthält.7. Unit according to one of claims 1 to 6, characterized in that each isolatable, transdermal system contains the same dose of active ingredient.
8. Einheit gemäß einem der Ansprüche 1 bis 7, dadurch gekennzeichnet, daß sie von einer Verpackung umhüllt ist. 8. Unit according to one of claims 1 to 7, characterized in that it is enveloped by a packaging.
EP03744842A 2002-03-27 2003-03-22 Assembled unit consisting of individually separable transdermal therapeutic systems Withdrawn EP1490039A2 (en)

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DE10213772 2002-03-27
DE10213772A DE10213772A1 (en) 2002-03-27 2002-03-27 Cohesive unit of singular transdermal therapeutic systems
PCT/EP2003/003004 WO2003079962A2 (en) 2002-03-27 2003-03-22 Assembled unit consisting of individually separable transdermal therapeutic systems

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WO2003079962A2 (en) 2003-10-02
JP2005520844A (en) 2005-07-14
CA2480683A1 (en) 2003-10-02
PL370886A1 (en) 2005-05-30
DE10213772A1 (en) 2003-10-09
AU2003226695B2 (en) 2008-10-02
WO2003079962A3 (en) 2003-12-24
AR039137A1 (en) 2005-02-09
PE20031015A1 (en) 2004-01-17

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