FR2628326A1 - IMPROVEMENT IN OBTAINING SPARADRAPS - Google Patents

Abstract

Adhesive plaster of the type intended to be applied superficially to epidermal lesions, characterized in that it essentially comprises a self-adhesive strip 2, the adhesive side of which 1 carries an element 3 made of lyophilized heterologous collagen, previously laminated, this assembly being prophylactically active.

Description

Improvement in obtaining plasters The object of this invention

  consists in certain improvements in obtaining plasters, intended especially to be applied

  superficially on the epidermal lesions.

  The traditional methodology for treating epidermal lesions is fundamentally based on two systems or procedures, which

  are: protective plasters and antiseptic plasters.

  With regard to the distribution of drugs, it should be borne in mind that each of the systems or procedures fulfills a function

  specific by providing particular advantages and disadvantages.

  Indeed, the protective plasters meet the adequate conditions to cover the wound or lesion in defense of the damaged part against aggressions and external agents. Despite this, 'this kind of plaster has the disadvantage of requiring periodic replacement with another new plaster, causing disturbances and disturbances for the patient even if these plasters are not

  antiseptics (curative), but only protective.

  The antiseptic plasters are prepared with any ether, 70 'ethyl alcohol and pure cellulose and give, in addition to the protective function, a specifically curative function thanks to the contribution of an active pharmacological product. These plasters have the advantage, in comparison with those which are simply protective, of not making necessary their constant and compulsory renewal with the corresponding treatments. The drug delivery system is the latest and most advanced among the methodologies for treating superficial pain, especially rheumatic pain. The diffusion of the drugs is carried out by an original system of displacement through membranes of cellulose acetophthalate which considerably simplifies the treatment and implies more convenience (comfort) for the patient in order to avoid him the periodic manipulations, in spite of the diffusion of the medication does not fully meet the actual need for total healing in some cases of skin damage and therefore it is

  need to repeat treatment for long periods.

  In light of the limitations of the methodologies known and used to date for the treatment of epidermal lesions, it appears that the ideal solution consists in the use of a plaster which, in addition to the fact that it protects the wound, can contribute to the regeneration of the

  damaged part and speed up the healing process.

  For this purpose, the adhesive plaster according to the invention is of the kind for surface application on] es epidermal lesions and it is characterized in particular in that on the adhesive side of a self-adhesive strip is arranged an element. lyophilized and sterilized heterologous collagen thereby achieving an active prophylactic combination which provides

  hemostatic, keratoplastic and antiseptic actions.

  Between. collagen and the self-adhesive strip, is advantageously imposed a sheet-shaped element which is made of a suitable material, preferably non-porous and / or waterproofed and which is fixed to the strip

  self-adhesive with greater adhesion than the collagen element.

  The adhesive used between the gauze and the collagen may be of the type based on polyvinylpyrrole in isotonic solution at 6%, urea, formaldehyde and hydroxyethylcellulose or albumin, with a total dry matter content of 10%. , in addition to other ingredients useful for the purpose pursued. A particularly advantageous adhesive is based on polyvinylepyrrole, polyvinyl alcohol, lauryl alcohol, dehydrated and sterilized albumin, monomethyl or plurimethyl glycol, in its ether form, soluble collagen and a specific sedative, by incorporating in addition as active ingredients, amide wax,

  vitamins of group D and B, lipoproteins, amino acids -

  complementary, antiseptics and / or anesthetics and a local lysis inhibitor composition, such as sulfonamides, a quaternary ammonium salt or the like, except iodine, the volatile material of the compound

  adhesive as a whole representing approximately 70% by weight.

  Such an adhesive has the following characteristics: - it does not damage or gel the lyophilized collagen, - it absolutely does not alter the intrinsic functions of the latter, - it adheres perfectly to the portion of sheet as soon as it is deposited, - it detaches from the aforementioned leaf portion without dynamic effort, which is in antagonism with the hard surface coagulum of the wound, - it contains at the same time auxiliary active principles which

  will promote the installation of collagen.

  In the mass of lyophilized heterologous collagen are included optional drugs or substances, which increase the power of prevention, activation or additional treatment, such as antibiotics, sulfonamides, physiological sera as a basic vehicle, or isotonic solutions, picric solutions, antinecrotics, stable vitamins, mineral or metallic salts, plant extracts, etc. The finished assembly and conditioned in an airtight container, preferably in modified polyethylene, is subjected to radiation by gamma rays in order to sterilize it, in addition to other methods accepted by the

pharmacopoeia.

  With the aim of illustrating the present invention in an appropriate manner, a nonlimiting embodiment of the adhesive plaster according to the invention is described below with reference to the appended drawing in which: - Figure 1 is a schematic and simplified side view of the adhesive plaster on which the various elements that compose it appear, and - Figure 2 is a schematic and simplified perspective view

  on which appears the mutual arrangement of its components.

  The adhesive plaster is essentially composed of a self-adhesive strip 2 and of an element 3 of lyophilized heterologous collagen, the collagen 3 mentioned being first of all prepared to present a configuration in the form of a sheet of adequate thickness, without counting the sterilization preparation, preferably based on ethylene oxide, and with a content of 0.5%

merthiolate as an antiseptic.

  Between the self-adhesive strip 2 and the collagen 3, it is advantageous to have a sheet-shaped element 4 or a similar element which is

  fixed to the adhesive side 1 of the strip 2. and to the collagen 3.

  Such a leaf-shaped element 4 may consist of a

  tape of any suitable material, such as polyethylene, -

  polyester, or a sheet material known as cellophane. In all cases, such a sheet or strip-shaped element 4 is non-porous, and / or waterproofed by means of silicone emulsions, fluoride derivatives or the like, the above-mentioned waterproofing treatment being chemically corrected by adding one or more different surfactants with a high degree of oxyethylation, based on products such as coconut fatty alcohol ethers or cold-emulsified polyglycols to obtain a gelatinous hydrate. The union which is established between the adhesive side 1 of the strip 2 is stronger than the union produced by the adhesive 5 placed between the sheet-shaped element 4 and the collagen 3; consequently, when the self-adhesive strip 2 is removed from the damaged part after the advised prudent time, the leaf-shaped element 4 separates while the collagen 3 remains on the wound and continues its curative, keratoplastic and antiseptic function. The adhesive 5 used between the sheet-shaped element 4 and the collagen 3 can, for example, be prepared as follows: By way of nonlimiting example, a standard formula of the above-mentioned adhesive is indicated below used between the leaf-shaped element

and collagen.

Phase A:

double distilled water 718 g.

polyvinyl alcohol 22'g.

polyvinylepyrrole 260 g.

1000 g.

  This phase is produced in a water bath at around 52 ° C.

  continuous turbulent agitation by a propeller.

Phase B:

result of phase A 1000 g.

lauryl alcohol 21 g.

  amide wax (or sphingolipid) '19 g.

albumin 159 g.

nonylphenolpolyglycolether 3 g.

  ethylene glycol monomethyl ether 18 g.

1220 g.

  This second phase is produced in a water bath at a temperature between 38 and 40 ° C., with continuous turbulent stirring by a propeller. Phase C: result of phase B 1220.00 g collagen gel (3% sol.) 695.00 g tryptophan 1.28 g coenzyme (riboflavin) 0.62 g vitamin B6 (pyridoxine) 0.40 g vitamin package D (1, 2 and 3) 1.80 g anesthetic solution and / or antiseptic solution 80.00 g 2000.00 g This last phase is produced in a water bath at around 36C under

  slow agitation by turbo-propeller for approximately 30 minutes.

  The adhesive obtained can be fixed without difficulty on the surface of the sheet-shaped element with its hydrophobic quality or treatment, and it also binds well to the en-collagen element without affecting its

  lyophilic and highly hydrophilic characteristics.

  Its final composition gives it the property of acting like collagen itself; this means that in contact with moods, blood or other fluids produced by an injury or burn, it gels simultaneously with collagen, forming a single regenerative patch

  with the particular contribution of its active ingredients.

  The adhesive is used, for each cm2 of porous or impermeable sheet, at a rate of 0.042 to 0.043 g in total weight, which represents approximately 0.013 g of dry matter as indicated above, the proportion of volatile matter in the whole complete being approximately 70% by weight. Lyophilized heterologous collagen 3 has an absorbent sponge structure and therefore allows the inclusion of multiple additional drugs or optional substances which increase the power of prevention, activation or treatment, such as antibiotics, sulfonamides, physiological saline, isotonic solutions, picric solutions, antinecrotics, stable vitamins, mineral or metallic salts, plant extracts, etc. The assembly, once completed, is packaged in a modified polyethylene sachet, in a paraffin envelope or in another similar container, after which the product is sterilized by subjecting the assembly to irradiation with rays. gamma, or

  another useful method for the purpose.

  Treatment using the adhesive plaster according to the invention can be defined as the placement of a contact prosthesis, since there is a real transfer of collagen to human skin by producing an active transport which is more efficient than the simple traditional function

  membrane, which acts only. by symbiosis by contact with the parties-

  of affected skin. Despite this, the membrane function for the diffusion of drugs remains possible for the element 3 in collagen when in the latter one includes the drugs or additional substances which increase

  power, already mentioned before.

  Ultimately, the adhesive plaster according to the invention can be defined as prophylactically active because it allows the transfer of collagen 3 to the damaged dermal part and its main function, in addition to certain others, lies in the fact of acting as hemostatic, keratoplastic and antiseptic, especially eliminating the need for periodic renewal, which is disadvantageously the case for most

simply protective plasters.

  It is expedient that, before the application of collagen, almost all the volatile part of the adhesive is evaporated at a controlled temperature. Ultimately, the objective pursued according to the invention lies in obtaining a plaster in which the supply of collagen does not suffer from interference due to the presence of elements foreign to the curative action of the whole. , which is achieved by using a sheet-like element which is non-porous or which has undergone a waterproofing treatment as indicated above; the originality of the invention, also resides in the development of the adhesive possibly containing active principles like auxiliary substances reinforcing the activity, its capacity of not * o10 not modifying the element in lyophilised collagen and its capacity of detaching from the leaf-shaped element mentioned above without strong opposition in its adhesion thereto, the adhesive forming a body with the repairing collagen, whatever the active elements or principles entering into

its final composition.

  It will be easy to understand, on reading the above and

  claims, that the details of embodiment of the invention described

  above can be modified without changing the essence of the invention.

Claims (8)

  1.Sparadrap of the type intended to be applied superficially   on epidermal lesions, characterized in that it comprises essential-   lie a band. self-adhesive 2, the adhesive side 1 of which carries an element 3 of lyophilized heterologous collagen, previously laminated, this assembly being prophylactically active:   2. adhesive plaster according to claim 1, characterized essentially-   in that between the collagen and the self-adhesive strip is arranged a sheet-shaped element 4 which is made of a suitable material, preferably non-porous and / or waterproofed and which is fixed to the self-adhesive strip with greater adhesion than the collagen element.   3. adhesive plaster according to claim 2, characterized essential-   in that the waterproofing treatment of the sheet-like element is carried out by means of silicone emulsions, fluoride derivatives or the like, the abovementioned treatment being corrected   chemically by adding one or more different surfactants   high oxyethylation rents, based on products such as coconut fatty alcohol ethers or cold-emulsified polyglycols for get a gelatinous hydrate.   4. Sticking plaster according to one of the preceding claims, charac-   essentially in that the adhesive 5 used between the gauze and   collagen is of the polyvinylpyrrole-based type in iso- solution   6% tonic, urea, formaldehyde and hydroxyethylcellulose or   albumin, with a total dry matter content of 10%.   5. adhesive plaster according to one of the preceding claims,   essentially characterized in that the adhesive 5 used between the   collagen and the sheet-like element, non-porous or waterproof   sé, is based on polyvinylepyrrole, polyvinyl alcohol, alcohol   lauryl, dehydrated and sterilized albumin, monomethyl glycol   that or plurimethyl, in its ether form, of soluble collagen and a specific sedative, incorporating in addition, as principles   active ingredients, amide wax, vitamins of group D and B, lipo-   proteins, complementary amino acids, antiseptics and / or anesthetics and a composition that inhibits local lysis, such as sulfonamides, a quaternary ammonium salt or the like, except   iodine, the volatile matter of the adhesive compound as a whole represents feeling about 70% by weight.   6. Sticking plaster, according to one of the preceding claims, charac-   essentially in that the adhesive is used at a weight   0.042 to 0.043 g total per cm of leaf-shaped element, not   porous or waterproofed and at a rate of approximately 0.013 gr / cm of dry matter.   7.Sparadrap according to one of the preceding claims, character-   essentially in that in the mass of lyophilized heterologous collagen are included additional drugs or substances which increase the hemostatic power, antiseptic keratoplastic and / or prevention, activation or treatment, such as antibiotics, sulfonamides, physiological saline , isotonic solutions, picric solutions, antinecrotics, stable vitamins,   mineral or metallic salts and plant extracts.   8. Sticking plaster according to one of the preceding claims, charac-   essentially in that the finished assembly and packed in an airtight container, preferably of modified polyethylene, is subjected to irradiation by range rays, one of the possible means of sterilization.