CA2332012A1

CA2332012A1 - Laminate for application onto an acceptor

Info

Publication number: CA2332012A1
Application number: CA002332012A
Authority: CA
Inventors: Christian Von Falkenhausen
Original assignee: Individual
Current assignee: LTS Lohmann Therapie Systeme AG
Priority date: 1998-05-11
Filing date: 1999-04-29
Publication date: 1999-11-18
Also published as: HUP0101825A2; SK16952000A3; IL139510A0; DE19820999A1; ID26661A; TR200003320T2; TW431897B; JP2002514523A; NO20005731L; KR20010071242A; EP1077663A1; NO20005731D0; ZA200006492B; PL344253A1; AU4035499A; WO1999058089A1

Abstract

The invention relates to a laminate for application onto an acceptor, comprising at least one intact layer, at least one non-intact layer, at least one additional layer and a removable protective layer. The laminate is characterized in that along a cross-sectional edge of any cross section it consists in places of m layers and in places of n layers, m and n are whole numbers and m > n.

Description

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....~-02332012 2000-11-14 . ... . . . . .. .. .
Laminate for application to an acceptor-The invention relates to a laminate for application to am acceptor, comprising:
-- at least one undamaged layer, - at least one damaged sheet, - at least one further layer, and - a detachable protective layer.
The invention furthez~nore relates to a process for its production and to its; use.
The suitability of laminates for applic,~tion to an acceptor, for examp~.e to the skin, is essentially determined by the quality of a laminate contact area. Tn the case of a transdermal therapeutic system (TTS) furthermore the amount of active ingredient perfusing through the skin per unit of time is determined by the nature and quality of: the skin contact .area.
During the period of wearing, laminates of a wide variety of types for application to the skin - 'wound plasters, bandages, tapes, TTS etc. - are subject to repeated mechanical stresses owing to stretching, compression, kinking, depending on the site of application, which may lead to partial detae:hment, fraying of the edges or blistering. This problem is frequently to be observed with laminates for application to the skin and, in the case of a TTS, results in even greater disadvantages since on reduction of the TTY skin contact area there is in some cases a considerable reduction in the intended amount o:E
active ingredient perfusing. Furthermore, a laminate fo:r application to the skin loses mechanical stability through stretching and bending stresses, further assisting the detachment process. :3uch mechanical stresses have a more sustained effect on the loss of adhesion as the elasticity ~.r.~~. ...-.._..._:.-, ~. -..,-_..,...;,. ......,_-.-.~..--.. . ...,..-..~-.0~2332012,2000-11-14 ....,... ......_.._.....- . ..,_,.. ........ ..

of a plaster in its horizontal extent descreases. The elasticity of such systems is determined by the moduli of elasticity of individual components or layers in a system.
In the case of a TTS, this is usually an outer supporting or protective sheet forming the backing layer. It is furthermore necessary that systems intended for therapeutic uses display a number of otrier characteristics such as, for example, supportive or protective functions or compatibility with wound fluid or skin moisture. For this reason, a wide variability of use is necessary from.
case to case for laminates to be applied to the skin, arising simply from the diverse sites oi° application on the body. For example, in the case of axi antirheumatic plaster which is applied to areas of skin with smooth surfaces and with underlying smooth muscle, a laminate must meet considerably fewer demands in respect of its robustness on exposure to bending and si:retching forces than a laminate which is applied to areas of skin with underlying striped muscle, for example arm or thigh muscle, or else in the region of a joins:, for example one the knee.
As soon as a laminate of this type is not intended to display a supportive or protective funci:ion, as is the case for instance with knee-protecting bandages or tape;
for protecting the fingers for example of rock climbers, but is furthermore intended to serve al;~o for administration of a wide range of different active ingredients, a great variability is desired in this regard, for example regarding the time course of a rate which is set up for the delivery of active ingredient pear unit of time. It ought also to be possible to incorporate various active ingredlients into a laminate and, moreover, adjust the release thereof by means of ~coxatrol layers in such a way that deferred delivery onto .and/or through the .. . . .. . .. ... , ,. ~ 02332012 2000-11-14 skin a.s achieved. It ought also to be possible to incorporate a reservoir for active ingredient being consumed during the administration. Other embodiments ought to make it possible, for example, also to incorporate into a laminate precursors of active ingredients, which are delivered to the skin after conversion into the active ingredient o~aly after an intended inert period, for example under the influence of skin moisture and/or substances such as enzymes.
More specific demands. on active ingredient-containing plasters relate, fox example, to good adhesion to a substrate, low water permeability and/o:r active ingredient uptake, good protection from light and/or thermal insulation. The utilization of an occlusive effect - foi-example increasing the water content in the skin layers under a plaster - is another essential '.feature of a number of TTS and can be acraieved by specific ~u,se of water vapour impermeable sheets as backing layer.
In view of a diverse range of demands o;n laminates to be applied to various acceptors for various applications, their usual embodiments are often unable to provide satisfactory results.
The available sheets or layered materials frequently display only a few of the required properties. This may lead, for example in therapeutic applications, to corresponding systems being either elastic but permeable to water vapour, or impermeable but substantially inelastic. The freedom regarding selection of different active ingredients is also restricted or entirely absent:
from case to case.
DE 36 34 016 C2 describes a sheet-like therapeutic system for administering active ingredients onto the skin, hav:Lng active ingredient reservoirs, having active ingredient delivery areas and having a skin adhesson area arranged on the skin side and located at the same lEavel as the latter, which is characterized in that either tree skin adhesion area is distributed in an uninterrupted manner over the entire skin contact area, and the interi:uptions are formed by active ingredient delivery area sections, or the active ingredient delivery area. is distributed in an interrupted manner over the entire skin contact area, and the interruptions are formed by skin adhesion area sections, and in that the size of the active ingreadient delivery area sections is essentially independent: of the contact pressure acting on the therapeutic systeam.
DE 38 09 978 C2 describes a reservoir with a delivery area for the controlled delivery, diminishinc_~ over the period.
of use thereof, of active ingredients to solid, liquid or gaseous acceptors, characterized in that: a cross-sectional area, parallel to the delivery area, of the reservoir is smaller than the delivery area on one pT.ace on the reservoir at least.
This is intended to produce a reservoir which makes it possible for the active ingredients to iiecrease in a defined and controlled manner over a de:~ired or necessary time.
EP 0 288 734 B1 describes an active ingredient-aontainir~.g plaster for controlled administration oi: active ingredients onto the skin, having an aci:ive ingredient reservoir which is divided essentially perpendicular to the skin contact area of the plaster anti comprises one o~r more active ingredients, having a pressure sensitive adhesive arrangement on the skin side and, where appropriate, having a covering Layer which can be detached before application of the plaster, it being possible to reduce the size of the active ingredient: delivery area of the plaster by a predetermined area by removing part of the active ingredient; reservoir, which is characterized in that at least one part of the active ingredient reservoLr can be detached leaving one or more parts of the active ingredient reservoir on the skin, with the part of the active ingredient reservoir remaining o;n the skin having better adhesion to the skin than to the reverse side.
The invention is based on the object, starting from the abovementioned state of the art, of providing a laminate o~ the type mentioned earlier for application to an acceptor, which laminate causes, for ex:aznple on adhesion to the skin of a liv3,ng organism, even with great mechanical stresses, for example throug7h stretching, compression, kinking, no manifestations of detachment a=id frayed edges or blistering, and avoids ~~, reduction in ita contact area caused thereby, and which :Furthermore make..
possible a wide variability of the poss:Lbilities of use with regard to different quality demands, such as, for example, incorporation of different act:i.ve ingredients, time course of an ir.~tended rate of active ingredient delivery, low water permeability, su3.tal~ility for different active ingredients etc.
The object is achieved by the invention with a laminate for application to an. acceptor, compris:lng - at least one unda~rcaged layer, - at least one damaged sheet, - at least one further layer, and - a detachable prote~ative layer in that the laminat0 is composed along a cut edge of any suitable cross sections in places both of m layers and i,n places of n layers, in that m and n are integers, and in:
that m < n.

°~Damaging°° of a layea: or "damaged" layer is meant in this connection the cutting through, of the relevant layer, with the layer not necessarily being mufti-part, as is the case for example on cutting into a sheet. The damaging moreo~;rer has for the purpose of the invention a minimal extent o:E 1 mm.
The laminate can, however, also have at least one further layer which is likewise damaged. Further embodiments provide for at least one further layer and at least one sheet forming sectians lying congruently one on top of the other. It is possible in this case for the elastic layer to be a sheet. The e~ctensibility of this layer is characterized by an increase of from 0.5% to 95% in length in the direction of stretching. In this case an increases of from 5 to 20% in 7Length can be particularly advantageous. Further. possibilities of an embodiment of the subject-matter of: the application emerge from the fact that sections of a one-part layer consist of inelastic sheet or of inert sheset or of a sheet with water impermeable propertieas.
Another embodiment oi: the laminate provides for at lease:
one of the layers being in one part and at least one other of these layers being mufti-part and consisting of sections lying side by side. 2t is possible in this case for the damaging of a layer to consist of a number of parallel cuts which alternately coincide or are arranged with an offset in their longitudinal extent side by Side.
Finally, it is also ppossible to make use of the measure of achieving the extensibility of a layer or of the sheet forming the latter either by the elastic property thereof or by compensatory pleatings between individual section:a.
It is then possible 3.n this case for at least two layer:>

to form sections lying congruently one~on top of the other.
In this case, an application of the laminate as TTS to i:he skin, the stretching of the complete system results in a displacement of the sections with respect to one another or a change in their spacings from one another, which significantly increases the comfort on wearing because t:he relevant area of skin is able to yield -as usual to mechanical stresses and is riot impeded in this by the plaster. gn addition, the individual sections lie next i:o the skin with optimal contact even on prolonged application, which keeps the total skin contact area constant aver an extended period. Furthermore the use oi:
one sheet fixing the individual segments guarantees detachment without residues whew, the plaster is removed from the skin.
7Ct is possible by use of a sheet shaped flexibly by means of compensator-like pleatings artificially between the individual segments for it to be, for ea~ample, selected from a type of sheet which is impermeable to water, because its material itself doss not have to meet the elasticity requirements. The use of a laminate structure of this type makes it: possible to combine in a technica7.ly simple manner backings layer requirements which are otherwise substantially mutually exclusive. For one form of the invention it may be advantageous for the thickne:~s of a layer between tcro sheet layers, it being possible f:or one of the two sheet layers or both sheet layers to be damaged or in one part or mufti-part, to be in the range between 1 dun and 500 ~.un, preferably between 5 utn and 150 dam, particularly preferably between 10 um and 30 Nm., One embodiment of the! invention providers for the laminate, in particular for therapeutic uses, to .comprise at least;

_ g _ one support layer, at; least one active_ingredient-containing layer as further layer and, if necessary, a further for example release-controlling layer and/or a pressure sensitive layer and/or a detachable protective layer, and for at least one of these layers to be mufti--part, that is to say it has a plurality of regions differing in structure in the laminate. It is moreover possible for the one-part layer to be a;n extensible or elastic sheet. Anothesr embodiment provides for the laminate to have a nLtmber of sections which each represent independent microsyst;ems of identical structure and are fixed with a highly elastic sheet as support layer to form a complete system. ~lith this structure .it is possible for the laminate to have a different number of layers and locally different active ingredients or active ingredient concentrations or active ingredient combinations or control means for different active ingredient delivery rates etc. in the individual layers.
Particularly for therapeutic uses, the .invention can in principle be used with all pharmaceutical active ingredients or ancillary substances abl~a to pass through the skin. Suitable acaive ingredients airs to be found in the active ingredient; groups of parasym;patholytics (for example scopolamine, atropine, benactyzine), of cholinergics (fox example physostigmine, nicotine), of neuroleptics (for ex~~nple chlorpromazine, haloperidol), of monoamine oxidase in'Y~ibitors (for example tranylcypromine, selegiline) , of sympa~thomimetics (for eacample ephedrine,.
D-norpseudoephedrine, salbutamol, fenfluramine), of sympatholytics and aratisympathotonics (for example propranolol, timolol, bupranolol, cloni~dine, dihydroergotamine, naphazoline), of anx.iolytics (for example diazepam, tra.azolam), of local .anaesthetics (for example lidocaine), of central analgesics (for example fentanyl, sufentanil), of antirheumatics (for example indomethacin, piroxicam, lornoxicam), o:E coronary therapeutics (for example glycerol trin:Ltrate, isosorbicle dinitrate, nitroglycerin), of oestrogen;s, gestagens and androgens, of antihistamines (for examp:Le diphenhydramine, clemastine, terfenadine), of prostaglandin derivatives, of vitamins (of vitamin E, cholecalciferol;) and of cytostatics. Furthermore, depending on ith~ arrangement of the layer properties, particular advant~~ges emerge on u~oe of light-sensitive substances, which occur in numerous organic chemical active ingredient groups, such as, for example, phenothiazines, certain peptid~ss, dihydropyridines (for example nifedipin~a), opioids and many other active ing~rec~.ient groups. In addition, other active ingredients are suitable for the process according to the invention if they have a therapeutic daily dose of less than 50 mg and a.re soluble both in water and in organic solvents.
Ethanol, prapanediol and other low molecular weight alcohols, menthol, ev,calyptol, limonene and many other terpenes, low molecular weight fatty ac:Lds such as, for example, capric acid, as well as dimeth~,rl sulphoxide ma~~
be mentioned as examples of typical add:Ltives in such preparations, which might migrate out of the preparation through the backing layer to a greater car lesser extent.
It is possible to use as ingredient in i:,he basic material of the active ingredient-containing layers in this case polymers such as polyisobutylene, ester:a of polyvinyl alcohol, polyacrylic and polymethacryli~: esters, natural.
rubber, styrene, isaprene and styrene/butadiene polymers or silicone polymers, resin. ingredients such as saturated and unsaturated hydrocarbon resins, derivatives of abiet:yl alcohol and of (3-pinene, plasticizers such as phthalic esters, triglycerides and fatty acids, ~~nd a number of other substances knornm to the skilled parson.

Several materials which are acceptable_,in particular fo~°
pharmaceutical products are suitable in principle for the layers in sheet fornn: polyvinyl alcohol, styrene/diene block copolymers, pol.yurethanes, polyvinyl chloride, polymethacn.~ylates, polyolefins, polyesters, to mention only a few examples.
It may be very worthvrhile, for safeguarding the relatively easy application of t:he transdermal therapeutic system t;o the skin, to incorparate an additional supporting layer which can be removed again after applic~sti.on and has an abherent finish to allow detachment after the system ha:o been put in place.
A process for producing a laminate of the type accordinc_~
to the invention is characterized by:
- application of sections onto a one-part layer or sheet:, - punching through the layer apart from a detachable protective sheet, - laminating on a further layer or sheet, - detaching the protective sheet.
Another process for producing a laminate of the type according to the invention is characterized by:
- making available a laminate comprisin~~ at least one sheet (2, 5), - punching through th.e layers (11) of tlse laminate apart:
from at least one layer (5), - laminating on at least one further layer (1), detaching an intermediate covering where approp.riate~
- where appropriate detaching a layer sitabilizing the layers laminated on.
Further details, features and advantages of the invention are evident from the following explanation of an example depicted diagrammatically in the drawings. These show in:
Fig. 1a a laminate in section along plane I-I in Fig. 1&>;
Fig. 1b the laminate in Fig. 1a seen from above;
Fig. 2a a laminate with a different structure in the section along plane II-II in Fig. 2b;
Fig. 2b the laminate in Fig. 2a seen from above.
Fig. 3a a laminate with a number of secvtions in the section along plane II-II in Fi~~. 4, Fig. 3b the laminate according to Fig. .3a in the section along plane I:-I in Fig. 4, Fig. 4 the laminate in Figs. 3a and 3b seen from above., Fig. 5 the laminate according to Fig. .4 with additional.
damage seen from above, Fig. 6 an example af: a mufti-part laminate with advantageous damage of at least one layer, the damage forming sections or segments, Fig. 7 an example af; a one-part laminate with advantageous damage of at least one layer, the damage formirag no sections or segments, Fig. 8 a laminate with a number of sections in the section along plane I-I in Fig. 9, Fig. 8a a laminate with alternative layer structure according to Fig. 8 with a number of sections in the section along plane I-I in ;fig. 9, Fig. 8b a laminate with alternative layer structure according to Fig. 8 with, a number of sections in the section along plane I-I in ~~ig. 9, Fig. 9 the laminate in Fig. 8, Figs. 8.a and 8b seen from above.
The cross section as shown in Figure 1a, of a laminate i:or application to an ace:eptor, for example to the skin, has a segmentation accordirag to the invention with the segmenta or sections 10a, 10b, 10c chosen by way of example. As <~
consequence of the great variability achieved according to the invention by this segmentation it is possible for the individual sections 3.0a-c to have different layerings to achieve predetermined effects. Tn this case, at least one of these layers 1 or 5 is in one part a;nd at least one other of these layers 2, 3, 4 is multi-;part, and these form individual sections 10a, 10b, 10c.
The segments 10a have the different layers 1-5, with layer 1 being in one part and representing a support layer onto which individual segments are fixed to form a complete system. It is possib~.e in this case for layer 2 to be, jEor example, an active ingredient-containing reservoir layer, whereas layer 3 is, for example, a release-controlling layer for controlling active ingredient delivery to the skin, which in turn bears a separate pressure sensitive layer 4. The latter is hermetically protected from loss of active ingredient and/or penetration in of a foreign substance between production, transport and application by the one-part protective layer 5, which is detached in a known manner before application of the 7Laminate.
Section 10b has layers 1, 2, 3 and 5, that is to say no separate pressure sensitive layer is present, but the release-controlling layer may be self-aiih,esive.
Segments 10c likewise have four layers, namely 1, 2, 4 a.nd 5, that is to say they have no release-<;ontrolling layer 3, but the matrix 2 is coated with a prE3ssure sensitive layer 4 and is not self-adhesive as such.
According to a known configuration of a self-adhesive plaster, for example a TTS, the latter might also consist of only three layers, namely of a suppo~:t layer 1, a sel,f-adhesive reservoir ~ and a detachable protective layer 5~.
The exemplary embodiment of segments 10a-10c in Fig. 1a is intended merely to provide illustrative examples of the fact that the segmentation results in a not previously achieved variety of possible embodiment: due to the individual segments or sections. In thia~ case it would be possible to produce a layer structure ojE this type in an efficient manner for example using a known printing process.
However, the segmentation also has the :Further serious advantage that, irrespective of the modulus of elasticity of the individual layers, on use of a h:i.ghly elastic support layer 1 there is production of a laminate which is able to withstand the greatest demands due to regeated mechanical stresses. After application to the skin, the high flexibility achieved for the complete laminate results in reliable avoidance of partial detachment, fraying of the edges or blistering even on repeated mechanical stress due to kinking, stretching and compression, and thus the intended perfusion of the act:i.ve ingredient through the skin contact area is achieved without problems. The use of relatively inelastic layer materials within the individual segments or sections then involves no disadvantages because, when an elastic support layer 1 is present, the individual sections are able straightforwardly to follow, by alteration of distances"
the movements of the skin during stretching or compression.
Even the unskilled person is able by looking at the arrangement of the individual sections or segments 10a-:LOc in Fig. 1b straightforwardly to recognize and understand the gain in total elasticity of the laminate according i:o the invention as a result of segmentation.
Fig. 2a shows by the cross section of a laminate with a somewhat different structure that elasticity of the support layer 1 can be achieved even with comparatively rigid starting mater~.a1 for the support sheet 1 by upfoldings 6 between the individual sections 10d and 10e.
In this case, the thx-ee segments 10d have a layer structure with the support layer 1, and the layers 2', 2' ' , 4' , .4' ' , Whi.Ch =-epresent, for eXaIllple, active ingredient contents with different concentrations. The segments or sections 10e each have underneath the support layer 1 an active ingredient reservoir 2 and a water vapour-permeable layer 3 which. is activated by skin moisture and therefore initiates perfusion of active ingredient after a delay.
This layer structure in Fig. 2a also serves merely as illustrative example of the variability which can be achieved with the invention for a laminate in terms of achieving particular: desired properties and functions, this being achieved at the same time as a high total elasticity of the system.
2n the view from above in Fig. 2b, the course of the pleatings 6 of the support layer 1 is evident, from whi<:h the great adaptabil:Lty of the laminate to skin movements is evident. Stretching of the complete system results in this case in a displacement of segments 10 with respect to one another. This increases the comfort on wearing because the relevant area of skin is able to yield as usual to i:he mechanical stresses without stressing the laminate which has been stuck on. In addition, the individual segments 10 lie next to the skin even on prolonged application, which makes it possible to keep the complete system/skin/contact area constant over a comparatively longer period.
Furthermore the use of one sheet 1 fixing the individua:L
segments guarantees detachment of the individual segmeni:s without residues. It is thus possible by using a systematic backing :Layer system of this type to achieve the highest requirements in respect, for example, of desired law water permeability, because the backing layesr 1 of the basic system is not subject to any elasticity requirements in its material properties. The technicalh;~
simple combination of backing layer requirements which are otherwise substantially mutually exclusive is made possible by the segmentation according to the invention with, at the same time, great variability for the purpo:~e Of the lnvent7.On.
These advantages are also evident from Figures 3a, 3b a~zd 4. In these, Fig. 3a shows a section of a laminate according to the invention. with a highly elastic backing layer 1 and, below this, a sheet 3.1 which consists of inelastic material and which in turn ac<xuires the possibility of transverse stretching indicated by the double-headed arrow 13 through dividing cuts 12.
Underneath this is located the reservoir layer 2 which likewise has dividirag~ cuts (12) and is i:herefore transversely flexible. and which has a large number of individual sections 10 and 10a..The underside is covered with a detachable protective sheet 5 before application.
Compared with Fig. 3a., the sections 10a appear broader because of the different position of th~a plane I-I in Figure 3b. The arrarag~ement of the damaging cuts 12 is evident from the view from above in Figure 4. Even with relatively inflexible material for the ;sheet, these result in a high degree of transverse extensibility indicated x>y the arrows 13. A further embodiment of ithe invention is shown in Fig. 5 seen from above. With the same layer structure as in Fig. 4, in this case thn damaging of at least one layer is carried out in two directions 12a anc!
12b. This ensures a bidirectional stretching of the laminate with the advantages described. In addition, then invention comprises the possibility of ~~.dvantageously combining the damaging of several layers. Fig. 6 and Fic_~. -7 show in a view from above, irrespecti~v~e of the layer structure, various possibilities for damaging at least one layer. These can be carried out advantageously dependinc_t on the requirement for the given objective.
The cross section, sYaown in Figure 8, o;f a laminate for application to an acceptor, for example to~the skin, has a segmentation according to the invention of several layer°s with the segments or sections 11a-c selected by way of example, these segmer,~ts not being arranged congruently one on top of the other but being displaced with respect to one another. In analogy to the structure of the topmost layers of the skin, t;he Stratum corneum, which is composed of several layers of individual flat ce:Lls, the layers 12a-c, which may consist of inelastic m~~terial, are displaceable with respect to one another and thereby ensure elasticity of the complete system. Layer 2 may be an active ingredient-containing reservoir layer and, where appropriate, be composed as Fig. 1. or F:ig. 2 of further underlayers, for example a release-controlling layer to control active ingredient delivery to the skin and/or a pressure sensitive layer. This layer 2 may likewise be damaged or segmented by dividing cuts (.12), as shown by Fig. 8a, but this does not preclude the possibility of it being advantageous to produce this as o:ne part (Fig. 8),.
At least one of the layers 1 and 5 of t:he laminate is in one part, with layer 5 representing a o:ne-part protective layer which is detacrred in a known manner before application of the laminate, and layer 1 acting as one-part support layer to which individual segments are fixed to form a complete system (Fig. 8, Fig. 8a). It may furthermore be advantageous to dispense with layer 1, as shown by Fig. 8b. In this case, for example, the water vapour-blocking action is achieved by t'he displaced layEar structure of the system, where appropriate made of inelastic material, and the elasticity ;by the possibility of displacing the segments with respect to one another.
Fig. 9 shows the laminate of Fig. 8 seen from above.
The layer structure S.n Fig. 8 serves merely as illustrative example of the variability which can be achieved with the invention far a laminate. in respect ojE
achieving particular desired properties and functions, this being achieved at the same time as a high total elasticity of the system.

Claims

claims

1. Multi-layer laminate comprising at least one undamaged layer and at least one damaged sheet, characterized in that a) the at least one undamaged layer is extensible or elastic, and b) the at least one damaged sheet is inextensible and/or inert and/or has water vapour-blocking properties.

2. Laminate according to Claim 1, characterized in that in particular for therapeutic uses it comprises at least one support layer (1), at least one active ingredient-containing layer (2) as further layer and, if necessary, a further for example release-controlling layer (3) and/or a pressure sensitive layer (4) and/or a detachable protective layer (5), in that at least one of these layers (1-5) is damaged or multi-part, and in that it has a plurality of regions differing in structure.

3. Laminate according to either of Claims 1 and 2, characterized in that the one-part support layer (1) is an extensible or elastic sheet.

4. Laminate according to any of Claims 1 to 3, characterized in that it has a number of sections (10) which each represent independent microsystems of identical structure and are fixed with a highly elastic sheet as support layer (1) to form a complete system.

5. Laminate according to one or more of Claims 1 to 4, characterized in that at least one undamaged layer is extensible or elastic, with an increase of from 0.5 to 95%
in length in the direction of stretching being beneficial and an increase of from 5 to 20% in length in the direction of stretching being particularly advantageous.

6. Laminate according to one or more o~ Claims 1 to 5, characterized in that the damaged sheet is inextensible and/or inert and/or has water vapour-impermeable properties.

7. Laminate according to one or more of Claims 1 to 6, characterized in that at least one further layer is likewise damaged.

8. Laminate according to one or more of Claims 1 to 7, characterized in that at least one further layer and at least one sheet form sections lying congruently one on top of the other.

9. Laminate according to one or more of Claims 1 to 8, characterized in that at least one further layer and at least one sheet form sections which do not lie congruently one on top of the other.

10. Laminate according to one or more of Claims 1 to 9, characterized in that the elastic layer is a sheet.

11. Laminate according to one or more of Claims 2 to 10, characterized in that segments (10) of a multi-part layer consist of inextensible and/or inert and/or water vapour-impermeable sheet.

12. Laminate according to one or more of Claims 1 to 21, characterized in that at least one of the layers (1-5) is in one part and at least one other of the layers (1-5) is multi-part and consists of sections (10) lying side by side.

13. Laminate according to one or more o~ Claims 1 to 12, characterized in that the damaging of a layer (11) consists of a number of incisions, with the layer remaining in one part.

14. Laminate according to one or more of Claims 1 to 13, characterized in that the damaging of a layer (11) consists of a number of cuts (12) distributed or aligned in any suitable way.

15. Laminate according to one or more of Claims 1 to 14, characterized in that the damaging of a layer (11) consists of a number of parallel cuts (12) which alternately coincide or are arranged with an offset in their longitudinal extent side by side.

16. Laminate according to one or more of Claims 1 to 15, characterized in that the extensibility of a layer (1) or of the sheet forming the latter is achieved either by the elastic property thereof or by compensator-like pleatings (6) between individual sections (10).

17. Laminate according to one or more of Claims 1 to 16, characterized in that at least two layers (2, 3) form sections (10) lying congruently one on top of the other.

18. Laminate according to one or more of Claims 1 to 17, characterized in that the thickness of a layer between two sheet layers, it being possible for one of the two sheet layers to be damaged or in one part or multi-part, is in the range between 1 µm and 500 µm, preferably between 5 µm and 150 µm, particularly preferably between 10 µm and 30 µm.

19. Laminate according to one or more of Claims 1 to 18, characterized in that the damaging of a damaged layer has an extent of at least 1 mm.

20. Process for producing a laminate of the type according to the invention, characterized by:
- making available a laminate comprising at least one sheet (2, 5), - punching through the layers (11) apart from at least one layer (5), - laminating on at least one further layer (1), detaching an intermediate covering where appropriate, - where appropriate detaching a layer stabilizing the layers laminated on.

21. Process for producing a laminate of the type according to the invention, characterized by:
- application of sections (10) onto a one-part layer or sheet (11), - punching through the layer (11) apart from a detachable protective sheet (5), - laminating on a further layer or sheet (1), - detaching the protective sheet (5).

22. Use of the laminate according to the invention for detachment-resistant stretching over an acceptor with complex surface geometry, which excludes the use of inextensible or only insufficiently extensible laminates.