KR20010023176A - Flat systems for cutaneous and percutaneous administration involving a sticking-plaster as an information carrier, and method for producing such a plaster - Google Patents

Abstract

The present invention provides an identifier of a sheet adhesive system using a plaster as an information carrier, i.e., an identifier of the skin treatment and transdermal treatment dosage form, with the coding electronically identifiable by the plaster.

Description

Flat systems for cutaneous and percutaneous administration involving a sticking-plaster as an information carrier, and method for producing such a plaster}

Adhesive sheet-like systems are known for the treatment of numerous diseases and have been known to be very successful in numerous therapeutic applications.

This type of system has long been known as a surface acting system for skin using surface (topical) action as a plaster or antirheumatic plaster for treating precancerous conditions using the active ingredient 5-fluorouracil. Systemic transdermal therapeutic systems (TTS) are also of increasing importance. These advantages are that, for example, the skin can control the amount of active ingredient released over a relatively long time. This type of transdermal system has an impermeable and non-adhesive backing layer that prevents unwanted release of the active material to the outside and the required adhesion to the skin, while at the same time the pressure-sensitive adhesive layer and TTS containing the active material A detachable protective layer, usually with an adhesive finish, is provided to prevent loss of the active material upon storage.

Medical and pharmacological studies have shown that new active ingredient combinations and dosage forms are constantly being developed and proposed for medicinal use, particularly in order to improve the likelihood of drug treatment in patients. A study by the University of Ottawa, in particular the Heart Institute (Mussivand et al., ASAIO Journal 1995; 41: M253-M258), reports that 25,000 new drugs are on the market every year.

Therefore, modern medicine has enormous drug loads on doctors and patients and can be obtained relatively largely without a prescription (eg, antirheumatic plaster, non-smoking nicotine plaster, etc.). Many patients rely on prolonged medication for example to lower high blood pressure and the like. As a result, patients often encounter one or more drug responses. One disadvantage of the use of numerous drugs and often inadvertent misuse includes the possible interaction with other drugs or certain consumables (eg alcohols) and increased side effects due to the risk of harmful levels of active ingredients in the patient's body. In some cases, this may lead to an urgent problem, for example, if the patient is weakened, for example, with lethargy, unconsciousness due to excessive alcohol consumption, drug use or severe interaction thereof, There is no information available to the attending physician in case of emergency for all medications or active ingredients taken by the patient. Information about such harmful medicinal properties in the patient's body can only be obtained by blood analysis in this case, which takes time, requires sophisticated equipment, and in severe cases can be obtained too late. As a result, in this case, the physician cannot accurately assess, for example, measure the effects of the harmful active ingredient with the antidote or supplement the inhalation of the drug which is absolutely necessary for the patient in a controlled manner. At the same time, the physician cannot determine whether maintenance and possible renewal of the medication appear in this case. With regard to the composition and the constituents, it is clearly contemplated that accurate identification of the active ingredient plaster is necessary, so that for processing, they may be graded pure and correspondingly processed or passed for recovery of the active ingredient.

In view of the increasing number of different systems already on the market, with more than 40 different basic forms of active ingredient patterns, each is clearly identifiable especially when information from pack inserts and other accompanying information is not available. What you can do is a very important requirement.

DE 195 19 593 C1 contains a thermoplastic material consisting of a laminate of externally molten thermoplastic and a high melting thermoplastic facing the skin, used for a backing layer and locally varying surface properties, surface thickness or surface roughness of the backing layer. A transdermal therapeutic system having a permanent identification coding consisting of a backing layer consisting of an active part containing an active ingredient is disclosed. In this case, this invention involves producing said coding of the backing layer by pressure, heat, ultrasonic or polishing action.

The limit of use for the application of known identification coding is evident from the fact that pressure or thermal action is detrimental to the active ingredient containing plaster. In addition, there is a relatively narrow limit to the amount of coding that can be calculated by changing the surface properties of the backing layer of the plaster. This calculation requires, for example, an additional final operation on the production system.

In the above paper (University of Ottawa Heart Institute), implants, defibrillators, circulatory stabilizers, biosensing devices, etc. can be supplied with energy using a remotely controlled connection system, which monitors the information generated by these implants. A transdermal energy and information system can be disclosed. However, the scope of application of such devices and methods is limited to fixed installations and is inadequate because of the large complexity of devices and comprehensive techniques for identifying transdermal therapeutic systems.

The present invention relates to a sheet-like adhesive system using plaster as an information carrier, i.e. identifiers of skin and transdermal therapeutic dosage forms and methods of making the same.

The present invention is based on the object of the above-described state of the art showing the identifiers of transdermal and non-dermal therapeutic dosage forms using plaster as information carriers and methods for their preparation, and which are readily characterized by a relatively large range of information, characteristics, quantities Information on risks and / or side effects.

This object is achieved by an identifier with coding that the plaster can identify electronically.

Such coding can be carried out or applied by known means, has the advantage of having a relatively large information storage capacity, and is deciphered by an available electronic reader that can be carried by or carried by any physician, pharmacy, ambulance or ward. Can be.

One embodiment of the present invention provides coding designed in the form of an electronically readable number or letter or in the form of a barcode on the side of the plaster opposite the skin. It can store a relatively extensive text of information on a coding field, for example, usually stamp size. Coding is easily decrypted using an optical IR reader.

However, it can also be advantageously confirmed that the coding of the plaster side opposite the skin is designed in the form of a microchip, for example as used for a card given to a card endorsed by a health insurance company. The microchip form has dimensions corresponding to, for example, about 1/2 of the stamp area, can be manufactured at low cost, and can be used in plaster.

However, the coding can also be designed on the side of the plaster facing the skin in the form of a magnetic strip, similar to the magnetic strip provided on a bank card. Finally, the coding may be present on the non-adhesive side of the adhesive film that can be adhered to the plaster before or after use on the patient's skin.

The identifier of the present invention provides a coding comprising information on the nature and amount of the active ingredient present in the plaster and all other other materials. However, the coding provided to identify the dosage form may advantageously include additional information, for example, about side effects of the therapeutically active ingredient, incompatibility with other active ingredients, and other salient properties. Finally, the information required for treatment—grading, processing, embedding or heat treatment—may be used. Identifiers can be very advantageously supplemented by coding, including instructions for administering antidote, for example when dangerous symptoms such as overdose or serious side effects of the active ingredient are apparent. A special advantage of the identifier is that personal data about the user of the skin or transdermal system can be stored in code form. In particular, for patients at risk with extensive medical history, data on patient specific information of the coding may include data on existing allergies, drug intolerance, and the like.

General structures of the basic TTS forms are described, for example, in 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. Coding may be present in the active ingredient containing layer or non-containing layer of TTS.

Preferred embodiments include coding in a separation layer located in the backing layer of the TTS consisting of a backing layer and an active ingredient-containing self-adhesive matrix layer.

Another preferred embodiment includes coding in a backing layer of TTS composed of a backing layer and an active ingredient-containing self-adhesive matrix layer.

Another preferred embodiment includes coding in a separation layer located between the backing layer of the TTS and the self-adhesive matrix layer containing the active ingredient.

Another preferred embodiment includes coding in a separation layer located in the backing layer of the TTS consisting of a backing layer, an active ingredient containing reservoir, a release rate controlling film of the active ingredient and a self adhesive layer.

Preferred embodiments include coding in the backing layer of the TTS consisting of a backing layer, an active ingredient containing reservoir, a release rate control film of the active ingredient and a self adhesive layer.

Another preferred embodiment includes coding in a separation layer located below the backing layer of the TTS consisting of a backing layer, an active ingredient containing reservoir, a release rate controlling film of the active ingredient and a self adhesive layer.

A method for producing an identifier of the general form according to the feature preamble of claim 1 of the claims is characterized in that the coding is incorporated into or applied to the plaster at the time of manufacture. For example, coding may be applied to the plaster during a printing process such as screen printing or tampon printing. Coding may also be applied to the plaster using a self adhesive carrier with coding.

Finally, an advantageous method for preparing the identifier of the plaster provides for storing the coding in a separate layer or active ingredient containing layer or outer cover layer of the multilayer plaster.

Identifiers of transdermal therapeutic dosage forms and non-dermal therapeutic dosage forms using plaster as information carriers, for example, may react together to produce a harmful side effect, or to bind an active ingredient associated with a drug first pass effect due to impaired TTS or overdose. From water, the risk factors are removed in a very advantageous way that are not necessarily fast enough to be recognizable from the results of the use of the active ingredient after an allergic reaction or termination. In such cases, the identifier of the present invention allows the physician to treat serious complications with special treatment procedures, particularly in life-threatening conditions.

The present invention can attain the above-described object in the best way.

Claims (13)

A sheet-like adhesive system using a plaster as an information carrier, i.e., an identifier of a skin treatment and a transdermal therapeutic dosage form, wherein the plaster has an electronically identifiable coding identifier. The identifier of claim 1, wherein the coding is designed in the form of a bar code on the side of the plaster facing the skin. The identifier of claim 1, wherein the coding is designed in the form of a microchip on the side of the plaster facing the skin. The identifier of claim 1, wherein the coding is designed in the form of a magnetic strip on the side of the plaster facing the skin. The identifier of claim 1, wherein the coding is on a non-adhesive side of the adhesive film that can be adhered to the plaster before or after use on the patient's skin. 6. The identifier of claim 1, wherein the coding comprises information about the nature and amount of the active ingredient present in the plaster. 7. The sheet-like adhesion according to any one of claims 1 to 6, wherein the coding comprises additional information on, for example, side effects of transdermal active ingredients, incompatibility with other active ingredients and other salient properties. Identifier of the system. 8. An identifier according to any one of the preceding claims, wherein the coding comprises instructions for administering the antidote when a dangerous symptom manifests clearly. 6. The identifier according to claim 1, wherein the coding comprises information on dosing maintenance justification. 7. 6. The identifier according to claim 1, wherein the coding comprises information on composition and composition with respect to processing, in particular with regard to grading, component recovery and final breakdown. 7. 6. The identifier of claim 1, wherein the coding comprises information with patient specific data such as, for example, existing allergies, drug intolerance, and the like. 7. A method for producing an identifier of a sheet-like adhesive system, wherein the coding is applied to the plaster using a self-adhesive carrier with a coding. A method for producing an identifier of a sheet-like adhesive system, wherein the coding is introduced into a separation layer or an active ingredient-containing layer or an outer cover layer of the multilayer plaster.