WO1996000094A1

WO1996000094A1 - An adhesive agent and use of such agent

Info

Publication number: WO1996000094A1
Application number: PCT/DK1995/000233
Authority: WO
Inventors: Thorbjørn STRØM-HANSEN
Original assignee: Coloplast A/S
Priority date: 1994-06-24
Filing date: 1995-06-09
Publication date: 1996-01-04
Also published as: AU2785295A; DK75994A

Abstract

By use of psyllium material as hydrocolloid in a skin adhesive agent or an adhesive paste based on such dispersed in a matrix, one may obtain that the hydrocolloid after swelling forms a coherent gel which even after a breaking up of the matrix to a considerable degree will prevent washing out of the adhesive agent or the adhesive paste due to leaching body fluids. For this reason such an adhesive agent is suitable for securing of and tightening around ostomy bandages, for wound dressings, for securing of devices for collecting urine, wound-drainage bandages, orthoses and prostheses and for protecting skin areas and parts of the body against pressure, impacts and friction; the adhesive paste is suitable for use as an ostomy paste.

Description

AN ADHESIVE AGENT AND USE OF SUCH AGENT

The invention relates to an adhesive agent for application to human or animal skin, comprising a self- adhesive elastomeric matrix, hydrocolloid particles dispersed herein and optionally additives common in adhesive agents of this kind and possibly skin-treating or thera- peutically active additives. The invention also relates to an adhesive paste for application to human or animal skin, comprising a matrix, hydrocolloid particles dispersed herein and optionally additives common in adhesive pastes of this kind.

Finally, the invention relates to the use of the adhesive agent for securing of and tightening around ostomy bandages, for wound dressings, for securing of devices for collecting urine, wound-drainage bandages, orthoses and protheses and for protectiong skin areas and parts of the body against pressure, impacts and friction, and the use of the adhesive paste as an ostomy paste.

Skin adhesive agents are today a.o. used for the above mentioned purposes.

A very widespread embodiment of skin adhesive agents comprises a self-adhesive elastomeric matrix, in which water-absorbing, swelling particles, the so-called hydrocolloids, are dispersed.

The self-adhesive elastomer makes adhesion to dry skin possible and is besides responsible for the cohesive force (cohesion) of the adhesive agent. The water-absorbing properties of the hydrocolloids render the adhesive agent capable of also adhering to moist skin (wet tack). As the hydrocolloids are constantly absorbing the moist emanating from the skin under the adhesive agent, the hydrocolloids are also contributing in securing a good adherence over a longer period of time, and they prevent the skin from being macerated.

Within the fields of use mentioned above the ad hesive agents will enter into contact with body fluids of different kinds: faeces, urine, wound exudates, sweat etc. In existing skin adhesive agents it is a problem that the contact with the body fluids has an decomposing effect on the adhesive agent. That part of the adhesive agent which is exposed to the body fluids will gradually swell due to the water-absorbing properties of the hydrocolloids. This swelling will gradually become so pronounced that the elastomeric matrix will split apart causing disintegration of the adhesive agent.

Under use in ostomy bandages it is observed how the exposed part of the adhesive agent around the stoma is gradually eroded as a consequence of the disintegration. This, particularly, is a problem for ostomy patients with thin exudates (patients having an urinary or ileostomy stoma and certain colostomy patients) . The consequence is that a risk of leakage will arise, and the adhesive agent will therefore have to be changed more frequently than desirable. Frequent changes of the adhesive agent will be a strain on the skin and make the use more expensive. Besides the skin around the stoma will be exposed to the exudates which may give rise to serious skin problems due the aggressive nature of the exudates. When removing the adhesive agent, remnants of the disintegrated adhesive agent will be left on the skin. These remnants will have to be removed mechanically, which may strain the skin further, at the same time being a troublesome process which renders the bandaging difficult. If the remnants are not meticulously removed, it will become more diffi- cult to obtain a good adhesion when a new adhesive agent it to be attached.

Similar problems are encountered when using adhesive agents for wound-drainage bandages.

When bandaging wounds, contact with the wound exudate will in a similar way effect a disintegration of the adhesive agent which means that when the bandage is changed remnants will be left in the wound, which rem nants may affect the wound-healing process. Besides during use leakage may arise which partly means reduced time of use, partly may increase the risk of contaminating the wound with bacteriae or other microorganisms .

Adhesive agents are also used for securing devices, such as uridomas, for collecting the urine from incontinent men. Disintegration of the adhesive agent due to contact with urine will again mean a risk of leakage and a reduction of the time of use.

Adhesive agents are also employed for securing orthoses and protheses (e.g. breast protheses) and for protection of skin areas or parts of the body against pressure, impacts and friction. In these cases it is primarly the secretion of sweat which may cause swelling and disintegration of the adhesive agent. When removing the adhesive agent remnants will be left on the skin, involving the inconveniences earlier mentioned.

Suitable hydrocolloids are naturally occurring hydrocolloids such as guar, locust bean gum (LBG), pectin, alginates, gelatine, xanthan or karaya, semisynthetic hydrocolloids such as cellulose derivates (e.g. salts of carboxymethylcellulose, methylcellulose and hydroxypropylmethylcellulose), sodium starch glycolate and synthetic hydrocolloids such as polyvinylpyrrolidone, poly- vinylalcohol, polyethylene glycol or polyacrylates.

Typical examples of hitherto applied skin adhesive agents of the type mentioned above and the production and use of same are described in DK patent specifications Nos 147,034 and 147,035 and in US patent specification No. 4,551,490.

The adhesive pastes are especially used for filling irregularities in the skin around an ostomy in order to obtain a plane adhesion surface for an adhesive agent and for tightening spaces between adhesive agent and ostomy. The product is of a semi-liquid consistency and is typically based on an alcoholic solution of a film forming polymer in which hydrocolloids are dispersed. There may further be added adhesion promoting agents, emulsifiers, consistency regulating and stabilizing agents and preservatives. In this connection reference is e.g. made to DK patent specification No. 155,571 and to EP patent specification No. 48,556.

There exists, however, especially for applications as described above a need for an adhesive agent and an adhesive paste which even, when strongly swelled, will retain its coherence and be resistant to leaching.

As a method for improving the adhesive integrity the use of hydrocolloids has been described which in themselves are cross-linked (e.g. cross-linked carboxy- methylcellulose (CMC), cross-linked dextrane and other water-absorbing, but insoluble hydrocolloids). They will not dissolve due to the cross-linked structure. During the swelling process the individual particles will, therefore, obtainin a gel-like structure, but no coherent gel could be formed since the macromolecules of the cross-linked hydrocolloids are locked in the gel network constituted by the individual particles. Due to the lack of a coherent, cohesive gel the cross-linked hydrocolloids will only be leached out and suspended in the body fluids and the effect on the integrity of the swelled adhesive, therefore, is limited.

Alternatively, it has been tried to increase the integrity of the swelled adhesive agent by increasing the cohesion of the elastomeric phase (as described in several of the prior art patents referred to). The elastomeric phase, therefore, will not so easily be split by the expanding hydrocolloids during the swelling process. This process, however, has a number of drawbacks:

- The water absorption velocity and thus the "wet- tack" of the adhesive agent will be reduced.

- By strenghtening the cohesion elastic properties will be added to the elastomeric matrix. When the hydrocolloids absorb water and swell, this will enhance an increase in the dimensions of the adhesive agent. Due to the elastic properties of the matrix, the tensions occurring in the adhesive agent cannot be relaxed by plastic deformation. Instead pleats may occur in the adhesive agent around the swelled area. In these pleats the adhesive agent will loose contact with the skin exposed to the body fluids, and a risk of leakage arises.

With the above purpose in mind International patent application No. WO 90/10465 describes a dressing for highly exuding wounds, said dressing comprising a vapour transmitting supporting layer, which on one side thereof is provided with a pressure sensitive adhesive with a self-adhesive elastomer comprising polyisobutylene and a hydrocolloid comprising at least two different alginates, especially a mixture of calcium and sodium alginate. Such adhesive agent is said to possess a good water absorption during gelling, but the desired resistance against leaching is not found to be supported in this application.

European patent specification No. 340,945 describes, especially for use in wound dressings, an adhesive composition made from a natural or synthetic rubber as an elastomeric matrix, in which hydrocolloid particles have been dispersed. It is stated that an improved resistance against leaching caused by body fluids is obtained in this adhesive composition when the hydrocolloid encompasses particles of a polycationic hydrocolloid particles, especially chitosan salts or diethylaminoethyl (DEAE) dextran. In some instances a certain resistance against leaching of such adhesive compositions is demonstrated, but as a drawback in adhesive compositions according to this publication should be mentioned that the suggested polycationic hydrocolloids are very expensive.

It has now surprisingly been found that adhesive agents of the above stated kind can be obtained having just as good or better resistance against leaching under the influence of body fluids when the hydrocolloid material of the adhesive agent comprises the far more less expensive polyanionic hydrocolloid psyllium. In accordance herewith the adhesive agent according to the invention is characterized in that the hydrocolloid particles wholly or partly are constituted of psyllium material and that the adhesive paste according to the invention is characterized in that the hydrocolloid particles wholly or partly are constituted of psyllium material.

The essential feature of the action mechanism of psyllium is its capacity of forming a gel in situ. This may be illustrated as follows. When a psyllium containing adhesive agent enters into contact with body fluids, the water-absorbing psyllium particles will swell. In this context psyllium does not differ from the hitherto known hydrocolloids used for this purpose. As the swelling progresses, the barrier as initially constituted by the elastomeric matrix between the individual particles will split up, and the swelled psyllium particles will get into contact with each other. In this process the hydrated psyllium macromolecules will be able to cross-link with each other during formation of a coherent gel, extending over the whole swelled area. Thereby a strong increase in the integrity of the swelled adhesive agent is attained.

In this respect psyllium differs from the main part of the hitherto described hydrocolloids, the latter being unable to form a coherent gel. The majority of the hydrocolloids normally applid will gradually dissolve during the swelling process and thus be unable to keep the swelled adhesive agent together.

Psyllium is a term for a water-absorbing, mucus forming material which is produced from the seeds from plants of the genus Plantago (fleawort seed). Especially seed from Plantago Ovata, Plantago Indica (Plantago Arenaria) and Plantago Psyllium (Plantago Afra) are used in the commercial production of psyllium. Other sorts of Plantago may furthermore be used as a source for psyllium, this applies to e.g., but not only Plantago Albi cans, Plantago Lanceolata, Plantago Rugelii and Plantago Major. The terms Isphagula and more rare Isabgul are often used as synonyms for psyllium.

The water-absorbing and mucus forming properties are especially attached to the husk which may be separated from the seed by a mechanical process. Psyllium seed husk may be obtained in various degrees of purity depending on how effectively the seed husk has been separated from the remaining components of the seed. Typical com- mercially available degrees of purity are 85%, 95%, 98% and >98%.

By an extraction of the seed or the seed husk it is possible to further purify the water-absorbing and mucus forming substances. Hereby the material psyllium gum is obtained which primarily consist of a polysaccharide. This polysaccharide has been identified as being a po- lyxylane having side-chains comprising one or more of the following sugar species: galacturonic acid, galactose, arabinose, rhamnose and xylose.

Psyllium seed and seed husk in whole or pulverized form have been described in various pharmacopoeiae, among which Ph. Eur. 2. ed. part II (Psyllii Semen); USP XXII (Psyllium Husk) and BP 88 (Isphagula Husk).

Psyllium is a well-known material which is widely used as a laxative and which has also proven to possess a hypocholestrolemic effect in humans and animals.

As hydrocolloid in adhesive agents and adhesive pistes may be used either psyllium seed, seed husk or the isolated psyllium gum. Moreover a synthetically or semisynthetically produced polysaccharide of substantially the same structure and composition as the polysaccharide in psyllium gum may be applied.

The term "substantially" means that smaller deviations in said structure and composition may occur if only the desired functional properties of psyllium gum are preserved, i.e. the capability of forming a gel in situ in an adhesive agent during swelling of the agent which even after a breaking up of the original elastomeric matrix of the adhesive agent will keep the adhesive agent together.

Also mixtures of the psyllium materials mentioned above are suited for the adhesive agent and the adhesive paste according to the invention.

In few, rare instances it has turned out that people who work with psyllium material may experience allergy problems. For the use of such people the adhesive agent and the adhesive paste according to the invention should encompass a psyllium material which has substantially been purified of proteins originating from psyllium seed. A psyllium material purified in this way is described in the International patent applications Nos WO- 92/17073, WO93/08814 and WO/93/15095.

It may be an advantage to sterilize the psyllium material in order to obtain a substantial reduction in the number of germs before it is introduced into the adhesive agent according to the invention. Methods of sterilizing are well-known to the skilled man and need not be described in detail here. As examples may be mentioned sterilizing by means of a gas, such as ethylene- oxide, sterilizing by means of vapour and sterilizing by means of radiation with β- or γ-rays, however, in the last-mentioned case care should be taken that the intensity of radiation be kept so low that a degradation of the psyllium material is. avoided.

In order to obtain a good dispersion of the hydrocolloid material in the adhesive agent according to the invention it is advantageous that seed, seed husk or psyllium gum in advance have been comminuted to a suitable particle size. The comminuted psyllium material may e.g. have an average particle size in the range of 20- 500μ.

In the adhesive agent according to the invention the hydrocolloid material will comprise 20-80% by weight, preferably 25-70% by weight, and more preferably 30-65% by weight of the sum of the weight quantities of the hydrocolloid material and of the material for the self- adhesive elastomeric matrix.

In the adhesive paste according to the invention the hydrocolloid material will comprise 25-75% by weight and preferably 50-70% by weight of the sum of the weight quantities of the hydrocolloid material and of the matrix material.

As the hydrocolloid material in the adhesive agent or the adhesive paste according to the invention psyllium may be employed alone or in combination with other hydrocolloids. In respect to the resistance capability against leaching out an adhesive agent according to the invention in which the hydrocolloid material is essentially constituted of psyllium material has proven superior to the most leaching resistant adhesive agent according to the above mentioned EP patent specification No. 340,945. However, other hydrocolloids may typically be employed to adjust the water absorption of the adhesive agent or the adhesive paste and the resistance against leaching still remains very good and in many cases comparable to said resistance of adhesive agents according to the above mentioned EP publication according to which the adhesive agents comprise very expensive polycationic hydrocolloids. Other suitable hydrocolloids may be selected from naturally occurring hydrocolloids, preferably guar, LBG, pectin, alginates, gelatine, xanthan or karaya; semisynthetic hydrocolloids, preferably cellulose derivatives, among which especially salts of carboxymethylcellulose, hydroxyethylcellulose, methylcellulose and hydroxy- propylmethylcellulose; sodium starch glycolate and synthetic hydrocolloids, preferably polyvinylpyrrolidone, polyvinylalcohol, polyethyleneglycol or polyacrylates .

Thus, the hydrocolloid material of the adhesive agent or the adhesive paste according to the invention may comprise 5-100% by weight, especially 30-100% by weight, preferably 60-100% by weight, better 80-100% by weight, far better 90-100% by weight and particularly 98- 100% by weight of comminuted psyllium material, the possible remainder being constituted by other hydrocolloids.

The self-adhesive elastomeric matrix may be compounded in various manners, which are well-known and e.g. described in US patent specification No. 4,253,460 and in DK patent specification No. 147,035. The elastomeric matrix may e.g. be based on polyisobutylene, butyl gum, styrene block copolymers, polyacrylates or acrylate copolymers, silicon gum, natural gum, polyurethane gum, poly- vinylether and mixtures thereof. With a view to adjusting the self-adhesive and coherent properties of the elastomeric phase, it may further be supplied with adhesive- promoting substances (resin) or emulsifiers (oil). Further small amounts of antioxidants may be present to protect the elastomer against decomposition. The nature and amount of these components are well-known to the skilled man and are a.o. described in US patent specification No. 4,551,490 and in DK patent specification No. 147,035.

In the adhesive agent may further be incorporated ingredients having a skin-strengthening and skin-caring function or active substances having skin-healing properties.

Psyllium will, when used according to the invention in adhesive agents, effect a strongly increased resistance against disintegration of the adhesive agent by contact with body fluids. This manifests itself therein that such part of the adhesive agent which swells by contact with the body fluids will form a coherent gel.

This is contrary to those hydrocolloids which are traditionally used in adhesive agents, such as those "other hydrocolloids" described above. They are either dissolved or suspended in the body fluids and are thus unable to keep the adhesive agent together after the swelling. Psyllium deviates herefrom by during the swelling process being capable if forming a gel in situ and thereby resist the disintegration of the adhesive agent. Besides, the gel formed will act as a barrier against the leaching body fluids and thereby delays a radial swelling of the adhesive agent.

By use of psyllium in adhesive agents for ostomy bandages the advantage is obtained that the exposed parts of the adhesive agent around the stoma will not erode but will be transformed into a protective gel substance. Thereby the risk of leakage is diminished, and a better protection of the skin around the stoma is obtained. This offers the possibility of prolonging the period of use and thus makes the use more economical to the ostomate. Besides, when removed the adhesive agent will leave fewer remnants on the skin which also adds to protecting the skin and to making the bandaging easier for the ostomate.

By use of psyllium in adhesive agents for wound treatment it is in the same way attained that the swelled adhesive agent will not leave remnants in the wound during change of bandage, and there will be a smaller risk of leakage.

In accordance with the above the invention finally relates to the use of an adhesive agent according to the invention for securing of and tightening around ostomy bandages, for wound dressings, for securing of devices for collecting urine, wound-drainage bandages, orthoses and protheses and for protecting skin areas and parts of the body against pressure, impacts and friction as well as the use of an adhesive paste according to the invention as an ostomy paste.

In principle, the adhesive agent and the adhesive paste according to the invention may be produced in the same way as known adhesive agents and adhesive pastes if in such processes the hydrocolloid employed is wholly or partly replaced by psyllium.

The invention will now be explained in further detail with reference to the following production examples and test examples and with reference to the drawing, showing the leaching out of a psyllium adhesive agent according to the invention compared to the leaching out of a known product in 7 urostomates. Example 1

An adhesive agent according to the invention was prepared comprising 40% by weight of polyisobutylene (Vistanex LM-MH) and 60% by weight of psyllium (200 mesh, 98% purity).

The adhesive agent was prepared in a Z-blade mixer. Before the mixing the mixing chamber was heated to 80°C by means of an oil heater. Vistanex LM-MH and hydrocolloid were weighed out separately (in cases where several hydrocolloids are used, they are pre-mixed manually). Firstly half the amount of hydrocolloid and then the whole amount of Vistanex are placed in the mixing chamber. The heat supply is turned off. Mixing takes place for 1-2 minutes after which the remaining amount of hydrocolloid is added. Then mixing continues in vacuo (100- 200 mbar) until a total mixing time of 30 minutes. The adhesive agent is removed from the mixer and is pressed into 1 mm thin plates between two sheets of silicon paper in a hydraulic press at 90°C.

This adhesive agent is designated adhesive agent No. 1.

Example of Comparison

In a similar manner adhesive agents Nos 2-8 were manufactured, the compositions of which are given in Scheme 1. The adhesive agents Nos. 2-5 are according, to WO 90/10465, the adhesive agents Nos 6-7 are according to EP-B-340 935, and adhesive agent No. 8 is based on a standard recipe for an ostomy adhesive agent. Leaching Test (Test A)

1. Background

For assessing the resistance of an adhesive agent against leaching a special test method is employed in the laboratory according to which conditions of use of the adhesive agent are simulated.

2. Description of the Leaching Test

The adhesive agent is tested in the form of a circular test sample having a hole in the middle thereof, the periphery of the sample being covered with a water- impermeable tape. Thus, it is only the adhesive agent around the central hole which has not been covered (in the same way as in the situation of use) . The mounted test sample is set up in a support and is submerged in a vessel containing a 0.9% sodium chloride solution at 37°C. The sample is mechanically agitated by a rotating arm. In this way the situation of use is simulated, in which situation the adhesive agent will be acted on by liquid simultaneous with a mechanical deformation due to the movements of the skin of the abdomen.

The test sample is removed from the vessel and is photographed after 2, 4 and 6 hours. The leaching out of the adhesive agent is evaluated on the basis of these photos and is quantified by means of picture analysis.

3. Test of an adhesive agent according to the invention and of reference adhesive agents.

In the leaching test described above the adhesive agents No. 1 (according to the invention), Nos 2-8 (reference) and as adhesive agent No. 9 the widely used adhesive agent Stomahesive (ConvaTec), the composition of which is thought to be substantially the same as in the adhesive agent No. 8, were examined.

The test results appear from the following Scheme No. 1. .

It will be seen that a leaching out of the adhesive agent according to the invention had not yet commenced after a test period of 6 hours, that the adhesive agents containing two alginates according to WO 90/10465 were completely leached out at this time, that the standard adhesive agents were leached out to a high degree, whereas the adhesive agents No. 6 and particularly No. 7 according to EP-B-340 945 were still resistant against leaching out.

After the 6 hours' test a visual inspection of the gels formed was carried out, and the gel from the adhesive agent No. 7, which had hardly not leached out, was found to be considerably more loose and disintegrating than was the gel from the adhesive agent No. 1 which had not leached out.

In order to better grade between the qualities of these two adhesive agents they were subjected to a prolonged test (12 hours) . The results hereof will be seen in Scheme 2, and herefrom it appears that the adhesive agent of comparison had totally leached out whereas a beginning leaching out could be observed in adhesive agent 1.

Thus, the leaching test shows that the psyllium- containing adhesive agent according to the invention as regards leaching out possesses superior properties in relation to standard adhesive agents and to adhesive agents according to the closest prior art.

Test B

In vivo test of psyllium adhesive agents in test persons operated for urostomy.

1. Background

As a consequence of a series of promising laboratory tests with adhesive agents produced using the hydrocolloid psyllium, an evaluation of the functioning in vivo of a psyllium-containing adhesive agent was desired.

2. Test Design

7 urostomy patients participated in the test. They were each given 3 test products containing a psyllium adhesive agent (cf. paragraph 3).

In order to make a comparison between the test products and the products normally used by the patients, they were asked first to use their normal products.

The test and normal products were each to be used for 3 days and nights (72 hours).

Immediately after removal the test as well as the normal products were photographed. When the testing of the normal products and the 3 test products was terminated, the patient was requested to evaluate the test product in relation to the normal product.

Based on the pictures the area leached out was quantified by means of picture analysis equipment.

3. Test Products

The adhesive agent on the test products was adhesive agent No. 1 referred to above:

The normal products were "Assura Wearlife" (Coloplast) and "Combihesive Flexible" (ConvaTech). 4. Results

4.1. Leaching out

In the scheme belov; the values of leaching cut and time of use are given for the individual test and normal products

The data in brackets are excluded from the calculations of the average due to deviations from the stipulated time of use. However, as regards user 365 deviations from the time of use of the normal product have been allowed, since the user did not find to be able to use the normal products for 72 hours. Besides, for user 658 only data for 48 hcurs are given for the test products. 4.2 Evaluation of the Product

Out of the 7 test persons 6 reported that the psyllium adhesive agent according to the invention left fewer remnants on the skin than their normally used adhesive agent, and a single test person observed no changes in this respect. All of the test persons hereafter expected to obtain a longer period of use with the product containing psyllium adhesive agent seen in relation to the normal product.

5. Comments

It is observed that 6 out of 7 urostomy patients obtain a reduction in the leaching out in relation to the normal products and that the reduction is especially remarkable if the leaching out is already considerable. Test person (585) used convexx) in the normal product, but for practical reasons not in the psyllium product, and this person is the only one with an observed higher leaching out. Also the fact that the psyllium adhesive agent to a high degree left fewer remnants on the skin should be noticed.

x)

Hereby the area around the center of the adhesive plate is depressed in relation to the periphery thereof, whereby the stoma is pressed out when the adhesive agent is applied. It is well-known that such design of the adhesive agent in itself is capable of reducing the leaching out and effect a longer period of use, this advantage being independent on the nature of the adhesive agent.

Claims

C L A I M S

1. An adhesive agent for application to human or animal skin, comprising a self-adhesive elastomeric matrix, hydrocolloid particles dispersed herein and optionally additives common in adhesive agents of this kind and possibly skin-treating or therapeutically active additives, c h a r a c t e r i z e d in that the hydrocolloid particles wholly or partly are constituted of psyllium material.

2. An adhesive paste for application to human or animal skin, comprising a matrix, hydrocolloid particles dispersed herein and optionally additives common in adhesive pastes, c h a r a c t e r i z e d in that the hydrocolloid particles wholly or partly are constituted of psyllium material.

3. An adhesive agent or an adhesive paste according to claim 1 or 2, c h a r a c t e r i z e d in that the psyllium material is comminuted and is composed of pulverized psyllium seed or psyllium seed husk, a synthetically or semi-synthetically prepared polysaccharide of substantially the same structure and composition as the polysaccharide in psyllium gum, or mixtures of these materials.

4. An adhesive agent or an adhestive paste according to claims 1-3, c h a r a c t e r i z e d in that the psyllium material is substantially purified of proteins originating from psyllium seed.

5. An adhesive agent or an adhesive paste according to claims 1-4, c h a r a c t e r i z e d in that the comminuted psyllium material has been sterilized before being introduced into the adhesive agent or the adhesive paste.

6. An adhesive agent according to claims 1 or 3-5, c h a r a c t e r i z e d in that it, based on the sum of the weight quantities of the materials making up the self-adhesive, elastomeric matrix and of the hydrocolloid material, comprises 20-80% by weight, preferably 25-70% by weight, and more preferably 30-65% by weight of the hydrocolloid material.

7. An adhesive paste according to claims 2-5, c h a r a c t e r i z e d in that it, based on the sum of the weight quantities of the matrix material and of the hydrocolloid material, comprises 25-75% by weight, preferably 50-70% by weight of the hydrocolloid material.

8. An adhesive agent or an adhesive paste according to claim 1 or 2, c h a r a c t e r i z e d in that the hydrocolloid material comprises 5-100% by weight, especially 30-100% by weight, preferably 60-100% by weight, better 80-100% by weight, far better 90-100% by weight and particularly 98-100% by weight of comminuted psyllium material, the possible remainder being constituted by other hydrocolloids.

9. An adhesive agent or an adhesive paste according to claim 8, c h a r a c t e r i z e d in that the other hydrocolloids have been chosen among naturally occurring hydrocolloids, preferably guar, LBG, pectin, alginates, gelatine, xanthan or karaya; semi-synthetic hydrocolloids, preferably cellulose derivatives, among which especially salts of carboxymethylcellulose, hydroxyethyl- cellulose, methylcellulose and hydroxypropylmethylcellulose; sodium starch glycolate and synthetic hydrocolloids, preferably polyvinylpyrrolidone, polyvinylalcohol, polyethylene glycol or polyacrylates .

10. The use of an adhesive agent according to claims 1, 3-6 or 8-9 for securing of and tightening around ostomy bandages, for wound dressings, for securing of devices for collecting urine, wound-drainage bandages, orthoses and protheses and for protecting skin areas and parts of the body against pressure, impacts and friction.

11. The use of an adhesive paste according to claims 2- 5 or 7-9 as an ostomy paste.