WO1999009960A1 - Flat systems for cutaneous and percutaneous administration involving a sticking-plaster as an information carrier, and method for producing such a plaster - Google Patents
Flat systems for cutaneous and percutaneous administration involving a sticking-plaster as an information carrier, and method for producing such a plaster Download PDFInfo
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- 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
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- 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
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- 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.
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Abstract
Description
Kennzeichnung für klebende flächenför ige dermale und transdermale therapeutische Darreichungsformen unter Verwendung eines klebenden Pflasters als Informationsträger, sowie Verfahren zu seiner HerstellungLabeling for adhesive sheet-like dermal and transdermal therapeutic dosage forms using an adhesive plaster as an information carrier, and method for its production
Klebende flächenförmige Systeme sind für die Therapierung einer großen Anzahl von Erkrankungen bekannt und haben sich in vielen therapeutischen Anwendungsbereichen hervorragend bewährt.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.
Seit langem bekannt sind derartige Systeme als superfizi- ell wirkende Systeme zur Anwendung auf der Haut mit einer oberflächlichen (topischen) Wirkung als Rheumapflaster oder als Pflaster zur Behandlung von Rekanzerosen mit dem Wirkstoff 5-Fluor-Uracil. Zunehmende Bedeutung erhalten auch transdermale therapeutische Systeme (TTS) mit systemischer Wirkung. Ihr Vorteil besteht beispielsweise in einer kontrollierten, relativ langfristigen Abgabe von Wirkstoffen durch die Haut. Ein derartiges transdermales System besitzt zum Schutz vor unerwünschtem Austritt von Wirkstoffen nach außen eine undurchlässige und nicht klebende Rückschicht und zur erforderlichen Haftung auf der Haut eine drucksensitive Haftklebeschicht, die gleichzeitig wirkstoffhaltig sein kann, sowie zum Schutz von Wirkstoffverlust bei der Lagerung eines TTS eine ablösbare, üblicherweise dehäsiv ausgerüstete Schutzschicht.Systems of this type have long been known as superficial systems for use on the skin with a superficial (topical) action as rheumatic plasters or as plasters for the treatment of recancerous diseases with the active ingredient 5-fluoro-uracil. Transdermal therapeutic systems (TTS) 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. 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.
Als Ergebnis medizinischer und pharmakologischer Forschung und insbesondere zur Verbesserung der medizinischen Behandlungsmöglichkeiten von Patienten werden ständig neue Wirkstoffkombinationen und Darreichungsformen entwickelt und zur medizinischen Anwendung vorgeschlagen. Nach einer Studie der Universität von Ottawa und insbesondere des dortigen Herzinstitutes, dokumentiert in Mus- sivand et al., ASAIO Journal , 1995; 41: M253-M258, wird berichtet, daß jährlich 25 000 neue medizinische Artikel in den Markt eingeführt werden.As a result of medical and pharmacological research and in particular to improve the medical treatment options for patients, new combinations of active substances and dosage forms are constantly being developed and proposed for medical use. According to a study by the University of Ottawa and in particular the cardiac institute there, documented in Mus- sivand et al., ASAIO Journal, 1995; 41: M253-M258, 25,000 new medical articles are reported to be launched annually.
Somit stellt die moderne Medizin sowohl den Arzt als auch die Patientenschaft vor eine unübersichtliche Vielzahl von Medikamenten, von welchen auch noch ein vergleichsweise großer Teil (zum Beispiel Rheumapflaster, Nikotin- pflaster zur Raucherentwöhnung usw. ) rezeptfrei zu erwerben ist. Viele Patienten sind auf eine Dauermedikation z.B. zur Senkung eines Bluthochdrucks usw. angewiesen. Somit stehen sie oftmals unter der Wirkung eines oder mehrerer Arzneistoffe. Einen Nachteil der Verwendung und des oftmals unbeabsichtigten Fehlgebrauchs von zahlreichen Medikamenten besteht in möglichen Wechselwirkungen mit anderen Arzneistoffen oder Genußmitteln (z.B. Alkohol) und Zunahme von Nebenwirkungen mit der Gefahr schädlicher WirkstoffSpiegel im Körper eines Patienten. Teilweise kann hieraus ein kritisches Problem entstehen, wenn ein Patient beispielsweise aufgrund von übermäßigem Alkoholgenuß, Drogenkonsum oder einer solchen akuten Wechselwirkung in einen hilflosen, beispielsweise komatösen oder bewußtlosen Zustand verfällt und dem herbeigerufenen Notarzt keine Informationen über sämtliche Arzneistoffe bzw. Wirkstoffe, die der Patient zu sich genommen hat, zur Verfügung stehen. Solche Informationen über die Art der im Patienten wirkenden schädlichen Pharmazeutika können in einem solchen Falle nur durch eine zeitraubende und apparativ aufwendige Blutanalyse ermittelt werden, die, wenn überhaupt, in einem akuten Fall viel zu spät zur Verfügung stehen würde. Infolgedessen hat der Arzt in einem solchen Fall keine Möglichkeit, die Wirkung eines schädlichen Wirkstoffes richtig zu beurteilen und beispielsweise mit Gegenmitteln zu beenden bzw. die Zufuhr eines für den Patienten lebensnotwendigen Arzneistoffes in kontrollierter Weise zu ergänzen. Gleichermaßen kann in solchen Fällen der Arzt nicht entscheiden, ob die Beibehaltung und eventuelle Erneuerung der Medikation auch in solchen Fällen indiziert ist. Zusehends ist mit der Notwendigkeit zu rechnen, Wirkstoffpflaster im Hinblick auf Aufbau und Inhaltsstoffe präzise zu identifizieren, damit sie im Rahmen der Entsorgung sortenrein sortiert, entsprechend angemessen entsorgt oder der Rückgewinnung von Wirkstoffen zugefügt werden können.Thus, modern medicine presents both the doctor and the patient population with a confusing variety of medications, of which a comparatively large number (for example, rheumatic plasters, nicotine plasters for smoking cessation, etc.) can be obtained without a prescription. Many patients rely on long-term medication, for example to lower high blood pressure, etc. Thus, they are often under the action of one or more drugs. A disadvantage of the use and the often unintentional misuse of numerous medications is possible interactions with other drugs or stimulants (e.g. alcohol) and an increase in side effects with the risk of harmful active substance levels in the body of a patient. In some cases, this can result in a critical problem if, for example, a patient falls into a helpless, e.g. comatose or unconscious state due to excessive alcohol consumption, drug use or such an acute interaction, and the evoked emergency doctor does not have any information about all drugs or active substances that the patient is too has taken to be available. In such a case, such information about the type of harmful pharmaceuticals acting in the patient can only be determined by a time-consuming and expensive blood analysis which, if at all, would be available much too late in an acute case. As a result, in such a case, the doctor has no way of correctly assessing the effect of a harmful active ingredient and, for example, terminating it with antidotes or the supply to supplement a drug that is vital for the patient in a controlled manner. Likewise, in such cases, the doctor cannot decide whether the maintenance and possible renewal of the medication is also indicated in such cases. It is increasingly necessary to anticipate the need to precisely identify active substance patches with regard to their structure and ingredients so that they can be sorted according to type, disposed of appropriately during the disposal process or added to the recovery of active substances.
Angesichts der zunehmenden Vielzahl von unterschiedlichen Systemen, die bereits heute auf dem Markt sind - es handelt sich um über vierzig verschiedene Grundtypen von Wirkstoffmustern - ist die Notwendigkeit, jedes einzelne umfänglich identifizieren zu können, von besonderer Bedeutung, gerade dann, wenn die Informationen aus Pak- kungsbeilage und sonstigen Begleitinformationen nicht vorliegen.Given the increasing number of different systems that are already on the market today - there are over forty different basic types of drug samples - the need to be able to identify each one extensively is of particular importance, especially when the information from Pak - Supplement and other accompanying information are not available.
Aus der DE 195 19 593 Cl ist ein transdermales therapeutisches System mit Rückschicht aus thermoplastischem Material bekannt, bestehend aus einem Laminat aus einem außenseitig liegenden, niedrigschmelzenden Thermoplasten und einem zur Haut hin gewandten höherschmelzenden Thermoplasten, einer auf dieser Rückschicht angebrachten dauerhaften, identifizierenden Codierung, bestehend in einer lokal unterschiedlichen Oberflächenbeschaffenheit, Oberflächendicke oder Oberflächenrauhigkeit dieser Rückschicht, sowie einem aktiven, den Wirkstoff enthaltenden Teil . Dabei besteht die Erfindung darin, daß diese Codierung der Rückschicht durch Einwirkung von Druck, Hitze, Ultraschall oder Abrasion erzeugt wird. Grenzen der Anwendbarkeit bei der Anbringung der bekannten identifizierenden Codierung ergeben sich dadurch, daß eine Einwirkung von Druck oder Hitze für viele wirkstoffhaltige Pflaster schädlich sein kann. Darüber hinaus ist die Kapazität einer durch unterschiedliche Oberflächenbe- schaffenheit der Rückschicht eines Pflasters herstellbaren Codierung vergleichsweise eng begrenzt . Darüber hinaus bedarf es zu deren Herstellung eines zusätzlichen, abschließenden Arbeitsschrittes, beispielsweise am fertigen System.From DE 195 19 593 Cl a transdermal therapeutic system with a backing layer made of thermoplastic material is known, 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. In addition, the capacity of a coding that can be produced by different surface properties of the back layer of a plaster is comparatively narrow. In addition, an additional, final work step is required to manufacture them, for example on the finished system.
Aus dem vorgenannten Artikel des Herzinstitutes der Universität von Ottawa ist ein transkutanes Energie- und Informationssystem bekannt, mit dem Implantate, Reantifi- brillatoren, Kreislauf-Stabilisatoren, Biosensoren etc. einerseits mit einem ferngesteuerten VerbindungsSystem mit Energie versorgt und hinsichtlich der von diesen Implantaten erzeugten Informationen überwacht werden können. Der Anwendungsbereich derartiger Vorrichtungen und Verfahren beschränkt sich jedoch auf stationäre Einrichtungen und ist wegen des hohen apparativen sowie gesamttechnischen Aufwandes für die Kennzeichnung von transdermalen therapeutischen Systemen nicht geeignet.From the aforementioned article by the Heart Institute of the University of Ottawa, a transcutaneous energy and information system is known, with which implants, reantifibrillators, circulatory stabilizers, biosensors, etc. are supplied with energy on the one hand with a remote-controlled connection system and with regard to the information generated by these implants can be monitored. The field of application of such devices and methods is, however, limited to stationary facilities and is not suitable for the identification of transdermal therapeutic systems due to the high expenditure on equipment and the overall technical requirements.
Der Erfindung liegt, ausgehend vom vorgenannten Stand der Technik, die Aufgabe zugrunde, eine Kennzeichnung für sowohl transdermale therapeutische, als auch für nicht- transdermale Darreichungsformen unter Verwendung eines Pflasters als Informationsträger sowie Verfahren zu seiner Herstellung anzugeben, die problemlos und mit einem vergleichsweise großen Umfang an Informationen Auskunft über Eigenschaften, Menge, Risiken und/oder Nebenwirkungen gibt . Die Aufgabe wird durch eine Kennzeichnung gelöst, bei der das Pflaster mit einer elektronisch identifizierbaren Codierung versehen ist.Starting from the aforementioned prior art, 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.
Eine derartige Codierung hat den Vorteil, daß sie mit bekannten Mitteln durchführbar oder aufbringbar ist, daß sie eine vergleichsweise hohe Speicherkapazität für Informationen aufweist und mit vorhandenen elektronischen Lesemitteln, die jeder Arzt, jede Apotheke, jeder Krankenwagen oder jede Krankenstation besitzen oder mit sich führen kann, decodierbar ist.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.
Eine Ausgestaltung sieht vor, daß die Codierung an der der Haut abgewandten Seite des Pflasters in Form von elektronisch lesbaren Ziffern oder Buchstaben oder in Form eines Bar-Codes ausgebildet ist.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.
Auf einem Codierungsfeld, beispielsweise von der Größe einer üblichen Briefmarke, lassen sich vergleichsweise umfangreiche Informationstexte speichern. Mit einem optischen, auch IR-Lesegerät wird die Codierung problemlos entziffert.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.
Es kann mit Vorteil aber auch von der Maßnahme Gebrauch gemacht sein, daß die Codierung an der hautabgewandten Seite des Pflasters in Form eines Mikro-Chips ausgebildet ist, wie ein solcher beispielsweise auf Versicherten- Karten der Gesundheitskassen angebracht wird. Dieser hat beispielsweise eine Dimension entsprechend etwa der halben Fläche einer Briefmarke, ist mit geringen Kosten herstellbar und auf einem Pflaster anbringbar.However, it can also be used to advantage that 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.
Die Codierung kann aber auch an der hautabgewandten Seite des Pflasters in Form eines Magnetstreifens ausgebildet sein, ähnlich der Ausrüstung einer Bankcard mit einem Magnetstreifen.However, 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.
Schließlich kann die Codierung auf der klebstofffreien Seite einer Klebefolie vorhanden sein, die auf das Pflaster vor oder nach dessen Applikation auf der Haut eines Patienten auf lebbar ist .Finally, 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.
Die Kennzeichnung nach der Erfindung sieht vor, daß die Codierung Informationen über Art und Menge des im Pflaster enthaltenen Wirkstoffs und gegebenenfalls sämtlicher anderer Materialien aufweist.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.
Die zur Kennzeichnung der Darreichungsformen vorgesehene Codierung kann aber auch mit Vorteil weitere Informationen über beispielsweise Nebenwirkungen des therapeutischen Wirkstoffs, Unverträglichkeiten mit anderen Wirkstoffen und sonstige beachtenswerte Besonderheiten enthalten.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.
Schließlich können auch Informationen aufgebracht werden, die für die Entsorgung - Sortieren, Aufbereitung, Deponie beziehungsweise thermische Behandlung -benötigt werden. Mit großem Vorteil kann die Kennzeichnung beispielsweise dahingehend ergänzt sein, daß die Codierung Anweisungen für eine Gabe von Antidot bei erkennbarem Auftreten gefährlicher Symptome wie Uberdosierung des Wirkstoffs oder akuter Nebenwirkungen enthält .Finally, information can also be applied that is required for disposal - sorting, processing, landfill or thermal treatment. 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.
Ein besonderer Vorteil der Kennzeichung besteht darin, daß persönliche Angaben über den Träger des dermalen oder transdermalen Systems in codierter Form gespeichert werden können. Gerade bei Risikopatienten mit umfangreicher Krankengeschichte können Angaben über bestehende Allergien, Medikamentenunverträglichkeiten etc. als patienten- spezifischer Informationsgehalt in die Codierung aufgenommen werden. Der prinzipielle Aufbau grundlegender TTS-Typen ist z.B. bei Y.W.Chien: "Developmental Concepts and Practice in Transdermal Therapeutic Systems" in Transdermal Controlled Systemic Medications, ed. by Y.W. Chien, Marcel Dekker, New York (1987), p.25-81 beschrieben. Die Codierung kann in einer wirkstoffhaltigen oder wirkstofffreien Schicht des TTS enthalten sein.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.
Eine bevorzugte Ausführungsform enthält die Codierung in einer separaten, auf der Rückschicht befindlichen Schicht eines TTS, bestehend aus Rückschicht und wirkstoffhaltiger haftklebender Matrixschicht.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.
Eine weitere bevorzugte Ausführungsform enthält die Codierung in der Rückschicht eines TTS, bestehend aus Rückschicht und wirkstoffhaltiger haftklebender Matrixschicht.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.
Eine weitere bevorzugte Ausführungsform enthält die Codierung in einer separaten, zwischen der Rückschicht und der wirkstoffhaltigen haftklebenden Matrixschicht befindlichen Schicht eines TTS.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.
Eine weitere bevorzugte Ausführungsform enthält die Codierung in einer separaten, auf der Rückschicht befindlichen Schicht eines TTS, bestehend aus Rückschicht, wirkstoffhaltigem Reservoir, die Geschwindigkeit der Freisetzung des Wirkstoffs kontrollierender Membran und einer haftklebenden Schicht .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.
Eine weitere bevorzugte Ausführungsform enthält die Codierung in der Rückschicht eines TTS, bestehend aus Rückschicht, wirkstoffhaltigem Reservoir, die Geschwindigkeit der Freisetzung des Wirkstoffs kontrollierender Membran und einer haftklebenden Schicht.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.
Eine weitere bevorzugte Ausführungsform enthält die Codierung in einer separaten, unter der Rückschicht befindlichen Schicht eines TTS, bestehend aus Rückschicht, wirkstoffhaltigem Reservoir, die Geschwindigkeit der Freisetzung des Wirkstoffs kontrollierender Membran und einer haftklebenden Schicht .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.
Ein Verfahren zur Herstellung einer Kennzeichnung der gemäß Oberbegriff von Anspruch 1 gattungsgemäßen Art ist dadurch gekennzeichnet, daß die Codierung bei der Zubereitung des Pflasters in dieses eingearbeitet oder auf dieses aufgebracht wird. Mit Vorteil kann beispielsweise die Codierung auf das Pflaster in einem Druckverfahren wie Siebdruck oder Tampondruck oder dergleichen aufgebracht werden. Auch kann die Codierung auf das Pflaster unter Verwendung eines mit der Codierung versehenen haftklebenden Trägers aufgebracht werden.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. For example, 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.
Schließlich sieht ein vorteilhaftes Verfahren zur Herstellung einer Kennzeichnung des Pflasters vor, daß die Codierung in einer separaten Schicht eines mehrschichtigen Pflasters, oder in der wirkstoffhaltigen Schicht bzw. in der äußeren Abdeckschicht gespeichert wird.Finally, 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.
Die Kennzeichnung für sowohl transdermale therapeutische, als auch nicht-transdermale Darreichungsformen unter Verwendung eines Pflasters als Informationsträger beseitigt mit großem Vorteil nicht immer schnell genug erkennbare Risikofaktoren beispielsweise von miteinander zu schädlichen Nebenwirkungen reagierenden Wirkstoffkombinationen oder bei einem First-Pass-Effekt in Folge eines beschä- digten TTS bzw. einer Überdosierung, weiterhin von Allergiereaktionen oder Folgen einer Anwendung eines Wirkstoffs nach dessen Verfallsdatum. Die erfindungsgemäße Kennzeichnung ermöglicht es, in solchen Fällen dem Arzt, schwerwiegenden Komplikationen mit gezielten Hilfsmaßnahmen, insbesondere in Fällen von lebensbedrohlichen Zuständen abzuhelfen.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.
Insofern löst die Erfindung in optimaler Weise die eingangs gestellte Aufgabe. In this respect, the invention optimally achieves the object stated at the outset.
Claims
Priority Applications (10)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| KR1020007001802A KR20010023176A (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 (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 |
| 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 |
| EP98946274A EP1007016A1 (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 |
| 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 |
| 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 |
| 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 (en) | 1997-08-22 | 1998-08-04 | Flat system for skin and transdermal administration with adhesive plaster as information carrier and method of manufacturing the plaster |
| IL13438698A IL134386A0 (en) | 1997-08-22 | 1998-08-04 | Adhesive plaster with electronically readable code, identification based thereon and processes for the production thereof |
| NO20000814A NO20000814L (en) | 1997-08-22 | 2000-02-18 | Identification of adhesive surface-shaped dermal and transdermal therapeutic dosage forms using an adhesive patch as an information carrier, as well as methods of their preparation |
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE19736520A DE19736520A1 (en) | 1997-08-22 | 1997-08-22 | New adhesive plaster containing electronic information |
| DE19736520.5 | 1997-08-22 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| WO1999009960A1 true WO1999009960A1 (en) | 1999-03-04 |
Family
ID=7839806
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/EP1998/004846 Ceased WO1999009960A1 (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 |
Country Status (16)
| Country | Link |
|---|---|
| EP (1) | EP1007016A1 (en) |
| JP (1) | JP2001513547A (en) |
| KR (1) | KR20010023176A (en) |
| AU (1) | AU737379B2 (en) |
| CA (1) | CA2299715A1 (en) |
| DE (1) | DE19736520A1 (en) |
| HU (1) | HUP0004184A3 (en) |
| ID (1) | ID24885A (en) |
| IL (1) | IL134386A0 (en) |
| NO (1) | NO20000814L (en) |
| NZ (1) | NZ502830A (en) |
| PL (1) | PL338736A1 (en) |
| SK (1) | SK2322000A3 (en) |
| TR (1) | TR200000408T2 (en) |
| WO (1) | WO1999009960A1 (en) |
| ZA (1) | ZA987580B (en) |
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2001039748A3 (en) * | 1999-12-03 | 2002-01-03 | Qinetiq Ltd | Orally administrable pharmaceutical product and method of fabrication therefor |
| WO2001041736A3 (en) * | 1999-12-10 | 2002-01-31 | Massachusetts Inst Technology | Microchip devices for delivery of molecules and methods of fabrication thereof |
| 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 (en) * | 1999-12-10 | 2009-10-07 | Massachussetts Institute of Technology | Microchip devices for delivery of molecules and methods of fabrication thereof |
| WO2017167728A1 (en) * | 2016-03-31 | 2017-10-05 | Amw Gmbh | Transdermal application system with information layer |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE10141836A1 (en) * | 2001-08-27 | 2003-03-27 | Hartmann Paul Ag | Medical kit for use in the supply of probe or catheter exit sites |
| AU5104399A (en) | 1998-07-20 | 2000-02-07 | William Neil Jones | A method of individually tracking and identifying a drug delivery device |
| DE19950295A1 (en) * | 1999-10-19 | 2001-04-26 | Beiersdorf Ag | Foil-based dressing material with imprint |
| DE10015930A1 (en) * | 2000-03-30 | 2001-10-18 | Dieter Hafner | Carrier for chemical, pharmaceutical or cosmetic substances is provided with at least one section with encoded information which is readable by a code reading device |
| DE102006011340A1 (en) * | 2006-03-09 | 2007-09-20 | Grünenthal GmbH | Active substance-containing patches with improved handling |
| CA3068458A1 (en) * | 2017-06-27 | 2019-01-03 | Lts Lohmann Therapie-Systeme Ag | Self-reminding patch |
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| JPH08712A (en) * | 1994-06-27 | 1996-01-09 | Olympus Optical Co Ltd | Medicament with two dimensional data code |
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| DE3630603A1 (en) * | 1986-09-09 | 1988-03-10 | Desitin Arzneimittel Gmbh | PHARMACEUTICAL AND DOSAGE FORM FOR MEDICINAL ACTIVE SUBSTANCES, REAGENTS OR THE LIKE, AND METHOD FOR THE PRODUCTION THEREOF |
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- 1998-08-04 ID IDW20000282A patent/ID24885A/en unknown
- 1998-08-04 WO PCT/EP1998/004846 patent/WO1999009960A1/en not_active Ceased
- 1998-08-04 AU AU93387/98A patent/AU737379B2/en not_active Ceased
- 1998-08-04 KR KR1020007001802A patent/KR20010023176A/en not_active Withdrawn
- 1998-08-04 HU HU0004184A patent/HUP0004184A3/en unknown
- 1998-08-04 TR TR2000/00408T patent/TR200000408T2/en unknown
- 1998-08-04 EP EP98946274A patent/EP1007016A1/en not_active Withdrawn
- 1998-08-04 IL IL13438698A patent/IL134386A0/en unknown
- 1998-08-04 SK SK232-2000A patent/SK2322000A3/en unknown
- 1998-08-04 CA CA002299715A patent/CA2299715A1/en not_active Abandoned
- 1998-08-04 PL PL98338736A patent/PL338736A1/en unknown
- 1998-08-04 JP JP2000507351A patent/JP2001513547A/en active Pending
- 1998-08-21 ZA ZA987580A patent/ZA987580B/en unknown
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2000
- 2000-02-18 NO NO20000814A patent/NO20000814L/en not_active Application Discontinuation
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| JPH08712A (en) * | 1994-06-27 | 1996-01-09 | Olympus Optical Co Ltd | Medicament with two dimensional data code |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2001039748A3 (en) * | 1999-12-03 | 2002-01-03 | Qinetiq Ltd | Orally administrable pharmaceutical product and method of fabrication therefor |
| AU769952B2 (en) * | 1999-12-03 | 2004-02-12 | Psimedica Limited | Orally administrable pharmaceutical product and method of fabrication therefor |
| WO2001041736A3 (en) * | 1999-12-10 | 2002-01-31 | Massachusetts Inst Technology | Microchip devices for delivery of molecules and methods of fabrication thereof |
| US6808522B2 (en) | 1999-12-10 | 2004-10-26 | Massachusetts Institute Of Technology | Microchip devices for delivery of molecules and methods of fabrication thereof |
| EP1688132A3 (en) * | 1999-12-10 | 2009-10-07 | Massachussetts Institute of Technology | Microchip devices for delivery of molecules and methods of fabrication thereof |
| 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 (en) * | 2016-03-31 | 2017-10-05 | Amw Gmbh | Transdermal application system with information layer |
Also Published As
| Publication number | Publication date |
|---|---|
| CA2299715A1 (en) | 1999-03-04 |
| PL338736A1 (en) | 2000-11-20 |
| HUP0004184A3 (en) | 2001-08-28 |
| NO20000814D0 (en) | 2000-02-18 |
| IL134386A0 (en) | 2001-04-30 |
| NO20000814L (en) | 2000-02-18 |
| DE19736520A1 (en) | 1999-02-25 |
| SK2322000A3 (en) | 2000-07-11 |
| TR200000408T2 (en) | 2000-09-21 |
| AU9338798A (en) | 1999-03-16 |
| ID24885A (en) | 2000-08-31 |
| NZ502830A (en) | 2001-08-31 |
| KR20010023176A (en) | 2001-03-26 |
| JP2001513547A (en) | 2001-09-04 |
| HUP0004184A2 (en) | 2001-04-28 |
| AU737379B2 (en) | 2001-08-16 |
| ZA987580B (en) | 1999-02-23 |
| EP1007016A1 (en) | 2000-06-14 |
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