ZA200006492B

ZA200006492B - Laminate for application onto an acceptor.

Info

Publication number: ZA200006492B
Application number: ZA200006492A
Authority: ZA
Inventors: Christian Von Falkenhausen
Original assignee: Lohmann Therapie Syst Lts
Priority date: 1998-05-11
Filing date: 2000-11-09
Publication date: 2002-10-04
Also published as: HUP0101825A2; EP1077663A1; AU4035499A; PL344253A1; IL139510A0; TR200003320T2; TW431897B; CA2332012A1; SK16952000A3; WO1999058089A1; NO20005731D0; JP2002514523A; ID26661A; KR20010071242A; NO20005731L; DE19820999A1

Description

_ . Laminate for application to an acceptor

The invention relates to a laminate for application to an acceptor, comprising: — at least one undamaged layer, — at least one damaged sheet, — at least one further layer, and — a detachable protective layer.

The invention furthermore relates to a process for its production and to its use.

The suitability of laminates for application to an acceptor, for example to the skin, is essentially determined by the quality of a laminate contact area. In \ 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 detachment, fraying of the edges or i 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 TTS skin contact area there is in some cases a considerable reduction in the intended amount of active ingredient perfusing. Furthermore, a laminate for application to the skin loses mechanical stability through stretching and bending stresses, further assisting the detachment process. Such mechanical stresses have a more sustained effect on the loss of adhesion as the elasticity

. @ a « : of a plaster in its horizontal extent decreases. 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 other 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 of application on the body. For example, in the case of an 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 stretching 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 joint, for example on the knee.

As soon as a laminate of this type is not intended to display a supportive or protective function, as is the _ case for instance with knee-protecting bandages or tapes - for protecting the fingers for example of rock climbers, but is furthermore intended to serve also 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 per unit of time. It ought also to be possible to incorporate various active ingredients into a laminate and, moreover, adjust the release thereof by means of control layers in such a way that deferred delivery onto and/or through the

.® 5 . p skin is 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 only 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, for example, to good adhesion to a substrate, low water permeability and/or active ingredient uptake, good protection from light and/or thermal insulation. The utilization of an occlusive effect - for example increasing the water content in the skin layers under a plaster - is another essential feature of a number of TTS and can be achieved by specific use of water vapour impermeable sheets as backing layer.

In view of a diverse range of demands on 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, having active ingredient reservoirs, having active ingredient

® - 4 - : delivery areas and having a skin adhesion area arranged on the skin side and located at the same level as the latter, which is characterized in that either the skin adhesion area is distributed in an uninterrupted manner over the entire skin contact area, and the interruptions 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 ingredient delivery area sections is essentially independent of the contact pressure acting on the therapeutic system.

DE 38 09 978 C2 describes a reservoir with a delivery area for the controlled delivery, diminishing 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 place on the reservoir at least.

This is intended to produce a reservoir which makes it possible for the active ingredients to decrease in a defined and controlled manner over a desired or necessary time.

EP 0 288 734 Bl describes an active ingredient-containing plaster for controlled administration of active ingredients onto the skin, having an active ingredient reservoir which is divided essentially perpendicular to the skin contact area of the plaster and comprises one or 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 oe Cs 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 reservoir 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 on 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 of the type mentioned earlier for application to an acceptor, which laminate causes, for example on adhesion to the skin of a living organism, even with great mechanical stresses, for example through stretching, compression, kinking, no manifestations of detachment and frayed edges or blistering, and avoids a reduction in its contact area caused thereby, and which furthermore makes possible a wide variability of the possibilities of use with regard to different quality demands, such as, for example, incorporation of different active ingredients, time course of an intended rate of active ingredient delivery, low water permeability, suitability for different active ingredients etc. } The object is achieved by the invention with a laminate } for application to an acceptor, comprising ~ at least one undamaged layer, - at least one damaged sheet, - at least one further layer, and : - a detachable protective layer in that the laminate is composed along a cut edge of any suitable cross sections in places both of m layers and in places of n layers, in that m and n are integers, and in that m < n.

oe Ce "Damaging" of a layer or "damaged" layer is meant in this connection the cutting through of the relevant layer, with the layer not necessarily being multi-part, as is the case for example on cutting into a sheet. The damaging moreover has for the purpose of the invention a minimal extent of 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 sections lying congruently one on top of the other. It is possible in this case for the elastic layer to be a sheet. The extensibility 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 increase of from 5 to 20% in length 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 sheet or of a sheet with water impermeable properties.

Another embodiment of the laminate provides for at least one of the layers being in one part and at least one other of these layers being multi-part and consisting of i sections lying side by side. It 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 possible 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 sections.

It is then possible in this case for at least two layers

: ® -7- to form sections lying congruently one on top of the other. ]

In this case, an application of the laminate as TTS to the 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 the relevant area of skin is able to yield as usual to mechanical stresses and is not impeded in this by the plaster. In addition, the individual sections lie next to the skin with optimal contact even on prolonged application, which keeps the total skin contact area constant over an extended period. Furthermore the use of one sheet fixing the individual segments guarantees detachment without residues when the plaster is removed from the skin.

It 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 example, selected from a type of sheet which is impermeable to water, because its material itself does not have to meet the elasticity requirements. The use of a laminate structure of this type makes it possible to combine in a technically simple manner backing laver requirements which are - otherwise substantially mutually exclusive. For one form of the invention it may be advantageous for the thickness of a layer between two sheet layers, it being possible for one of the two sheet layers or both sheet layers to be damaged or in one part or multi-part, to be in the range between 1 um and 500 pm, preferably between 5 um and 150 um, particularly preferably between 10 um and 30 pum.

One embodiment of the invention provides for the laminate, in particular for therapeutic uses, to comprise at least

@ os 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 multi- 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 an extensible or elastic sheet. Another embodiment provides for the laminate to have a number of sections which each represent independent microsystems of identical structure and are fixed with a highly elastic sheet as support layer to form a complete system. With 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 able to pass through the skin. Suitable active ingredients are to be found in the active ingredient groups of parasympatholytics (for example scopolamine, atropine, benactyzine), of cholinergics (for example physostigmine, nicotine), of - neuroleptics (for example chlorpromazine, haloperidol), of monoamine oxidase inhibitors (for example tranylcypromine, selegiline), of sympathomimetics (for example ephedrine,

D-norpseudoephedrine, salbutamol, fenfluramine), of sympatholytics and antisympathotonics (for example propranolol, timolol, bupranoclol, clonidine, dihydroergotamine, naphazoline), of anxiolytics (for example diazepam, triazolam), of local anaesthetics (for example lidocaine), of central analgesics (for example fentanyl, sufentanil), of antirheumatics (for example

: ® - 9 - indomethacin, piroxicam, lornoxicam), of coronary therapeutics (for example glycerol trinitrate, isosorbide dinitrate, nitroglycerin), of oestrogens, gestagens and androgens, of antihistamines (for example diphenhydramine, clemastine, terfenadine), of prostaglandin derivatives, of vitamins (of vitamin E, cholecalciferol) and of cytostatics. Furthermore, depending on the arrangement of the layer properties, particular advantages emerge on use of light-sensitive substances, which occur in numerous organic chemical active ingredient groups, such as, for example, phenothiazines, certain peptides, dihydropyridines (for example nifedipine), opioids and many other active ingredient 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 are soluble both in water and in organic solvents.

Ethanol, propanediocl and other low molecular weight alcohols, menthol, eucalyptol, limonene and many other terpenes, low molecular weight fatty acids such as, for example, capric acid, as well as dimethyl sulphoxide may be mentioned as examples of typical additives in such preparations, which might migrate out of the preparation } through the backing layer to a greater or lesser extent.

It is possible to use as ingredient in the basic material of the active ingredient-containing layers in this case polymers such as polyisobutylene, esters of polyvinyl alcohol, polyacrylic and polymethacrylic esters, natural rubber, styrene, isoprene and styrene/butadiene polymers or silicone polymers, resin ingredients such as saturated and unsaturated hydrocarbon resins, derivatives of abietyl alcohol and of B-pinene, plasticizers such as phthalic esters, triglycerides and fatty acids, and a number of other substances known to the skilled person.

@ C10

Several materials which are acceptable in particular for pharmaceutical products are suitable in principle for the layers in sheet form: polyvinyl alcohol, styrene/diene block copolymers, polyurethanes, polyvinyl chloride, polymethacrylates, polyolefins, polyesters, to mention only a few examples.

It may be very worthwhile, for safeguarding the relatively easy application of the transdermal therapeutic system to the skin, to incorporate an additional supporting layer which can be removed again after application and has an abherent finish to allow detachment after the system has been put in place.

A process for producing a laminate of the type according 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 comprising at least one sheet (2, 5), - punching through the layers (11) of the laminate apart from at least one layer (5).

® Ca - laminating on at least one further layer (1), detaching an intermediate covering where appropriate, - where appropriate detaching a layer stabilizing 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. la a laminate in section along plane I-I in Fig. 1b;

Fig. 1b the laminate in Fig. la 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 sections in the section along plane II-IX in Fig. 4,

Fig. 3b the laminate according to Fig. 3a in the section along plane I-I in Fig. 4,

N 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 of a multi-part laminate with advantageous damage of at least one layer, the damage forming sections or segments,

@ 1a

Fig. 7 an example of a one-part laminate with advantageous damage of at least one layer, the damage forming 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 Fig. 9,

Fig. 9 the laminate in Fig. 8, Figs. 8a and 8b seen from above.

The cross section as shown in Figure la, of a laminate for application to an acceptor, for example to the skin, has a segmentation according to the invention with the segments or sections 10a, 10b, 10c chosen by way of example. As a consequence of the great variability achieved according to the invention by this segmentation it is possible for the —~ individual sections l1l0a-¢ to have different laverings to _ achieve predetermined effects. In this case, at least one of these layers 1 or 5 is in one part and at least one other of these layers 2, 3, 4 is multi-part, and these form individual sections 10a, 10b, 10c. :

The segments l1l0a 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 possible in this case for layer 2 to be, for 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 laminate.

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-adhesive.

Segments 10c likewise have four layers, namely 1, 2, 4 and 5, that is to say they have no release-controlling layer 3, but the matrix 2 is coated with a pressure 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 support layer 1, a self- adhesive reservoir 2 and a detachable protective layer 5.

The exemplary embodiment of segments 10a-10c in Fig. la is intended merely to provide illustrative examples of the fact that the segmentation results in a not previously } achieved variety of possible embodiments due to the } individual segments or sections. In this case it would be - possible to produce a layer structure of 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 highly elastic support layer 1 there is production of a laminate which is able to withstand the greatest demands due to repeated mechanical stresses. After appiication to the skin, the

: ® - 14 - 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 active 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-10c in Fig. 1b straightforwardly to recognize and understand the gain in total elasticity of the laminate according to 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 material for the support sheet 1 by upfoldings 6 between the individual sections 104 and 10e. . In this case, the three segments 104 have a layer - structure with the support layer 1, and the layers 2’, 2’, 4’, 4'’, which represent, for example, active ingredient contents with different concentrations. The segments or sections l1l0e 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 a) Cs 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.

In the view from above in Fig. 2b, the course of the pPleatings 6 of the support layer 1 is evident, from which the great adaptability 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 the 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 individual segments guarantees detachment of the individual segments 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 low water permeability, because the backing layer 1 of the basic system is not subject to any elasticity requirements in its material properties. The technically _ 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 purpose of the invention.

These advantages are also evident from Figures 3a, 3b and 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 11 which consists of

] inelastic material and which in turn acquires 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 dividing cuts (12) and is therefore 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 the plane I-I in

Figure 3b. The arrangement 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 by the arrows 13. A further embodiment of the invention is shown in Fig. 5 seen from above. With the same layer structure as in Fig. 4, in this case the damaging of at least one layer is carried out in two directions 12a and 12b. This ensures a bidirectional stretching of the laminate with the advantages described. In addition, the invention comprises the possibility of advantageously combining the damaging of several layers. Fig. 6 and Fig. 7 show in a view from above, irrespective of the layer structure, various possibilities for damaging at least one layer. These can be carried out advantageously depending So —

E on the requirement for the given objective.

The cross section, shown in Figure 8, of a laminate for application to an acceptor, for example to the skin, has a segmentation according to the invention of several layers with the segments or sections lla-c selected by way of example, these segments 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, the Stratum corneum, which is composed

® 17 - of several layers of individual flat cells, the layers lla-c, which may consist of inelastic material, 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 Fig. 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 one part (Fig. 8).

At least one of the layers 1 and 5 of the laminate is in one part, with layer 5 representing a one-part protective layer which is detached 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 the displaced layer 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 in Fig. 8 serves merely as illustrative example of the variability which can be achieved with the invention for a laminate in respect of achieving particular desired properties and functions, this being achieved at the same time as a high total elasticity of the system.

Claims

oe PP Patent claims

1. Multi-layer laminate comprising at least one undamaged layer and at least one damaged sheet, charac- terized 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, B } 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

® - 19 - 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 of 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. } oo

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

11. Laminate according to one or more of Claims 1 to 10, characterized in that segments (10) of a multi-part layer consist of inextensible and/or inert and/or water vapour- inpermeable sheet.

12. Laminate according to one or more of Claims 1 to 11, 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 eo Cao multi-part and consists of sections (10) lying side by side. )

13. Laminate according to one or more of 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 To 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

® - 21 - sheet layers, it being possible for one of the two sheet layers to be damaged or in ome part or multi-part, is in the range between 1 um and 500 um, preferably between 5 um and 150 um, particularly preferably between 10 pm and mum.

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.