CA2278753C - Removable protective film for plaster systems, in particular self-adhesive plaster systems, containing active substances - Google Patents
Removable protective film for plaster systems, in particular self-adhesive plaster systems, containing active substances Download PDFInfo
- Publication number
- CA2278753C CA2278753C CA002278753A CA2278753A CA2278753C CA 2278753 C CA2278753 C CA 2278753C CA 002278753 A CA002278753 A CA 002278753A CA 2278753 A CA2278753 A CA 2278753A CA 2278753 C CA2278753 C CA 2278753C
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- Prior art keywords
- plaster
- plaster systems
- systems
- plaster system
- active ingredient
- Prior art date
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- Expired - Fee Related
Links
- 239000011505 plaster Substances 0.000 title claims abstract description 35
- 230000001681 protective effect Effects 0.000 title claims abstract description 16
- 239000000853 adhesive Substances 0.000 title abstract description 15
- 239000013543 active substance Substances 0.000 title abstract description 3
- 229920006267 polyester film Polymers 0.000 claims abstract description 8
- 239000004480 active ingredient Substances 0.000 claims description 18
- 229920000728 polyester Polymers 0.000 claims description 18
- -1 polyethylene terephthalate Polymers 0.000 claims description 7
- 239000011248 coating agent Substances 0.000 claims description 5
- 238000000576 coating method Methods 0.000 claims description 5
- 229920000139 polyethylene terephthalate Polymers 0.000 claims description 4
- 239000005020 polyethylene terephthalate Substances 0.000 claims description 4
- YCKRFDGAMUMZLT-UHFFFAOYSA-N Fluorine atom Chemical compound [F] YCKRFDGAMUMZLT-UHFFFAOYSA-N 0.000 claims description 2
- 229910052731 fluorine Inorganic materials 0.000 claims description 2
- 239000011737 fluorine Substances 0.000 claims description 2
- 239000004615 ingredient Substances 0.000 claims description 2
- 229920000642 polymer Polymers 0.000 claims description 2
- 229920005573 silicon-containing polymer Polymers 0.000 claims 1
- 239000010410 layer Substances 0.000 description 22
- 239000000123 paper Substances 0.000 description 18
- 230000001070 adhesive effect Effects 0.000 description 7
- LVYLCBNXHHHPSB-UHFFFAOYSA-N 2-hydroxyethyl salicylate Chemical compound OCCOC(=O)C1=CC=CC=C1O LVYLCBNXHHHPSB-UHFFFAOYSA-N 0.000 description 6
- 239000004698 Polyethylene Substances 0.000 description 4
- 229920000573 polyethylene Polymers 0.000 description 4
- 230000000699 topical effect Effects 0.000 description 4
- 229960002389 glycol salicylate Drugs 0.000 description 3
- DKYWVDODHFEZIM-UHFFFAOYSA-N ketoprofen Chemical compound OC(=O)C(C)C1=CC=CC(C(=O)C=2C=CC=CC=2)=C1 DKYWVDODHFEZIM-UHFFFAOYSA-N 0.000 description 3
- 229960000991 ketoprofen Drugs 0.000 description 3
- 239000000463 material Substances 0.000 description 3
- 239000011159 matrix material Substances 0.000 description 3
- 229920000058 polyacrylate Polymers 0.000 description 3
- HEFNNWSXXWATRW-UHFFFAOYSA-N Ibuprofen Chemical compound CC(C)CC1=CC=C(C(C)C(O)=O)C=C1 HEFNNWSXXWATRW-UHFFFAOYSA-N 0.000 description 2
- 239000000654 additive Substances 0.000 description 2
- 239000012790 adhesive layer Substances 0.000 description 2
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical group [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 description 2
- 229910052782 aluminium Inorganic materials 0.000 description 2
- 239000004411 aluminium Substances 0.000 description 2
- 235000014113 dietary fatty acids Nutrition 0.000 description 2
- 229930195729 fatty acid Natural products 0.000 description 2
- 239000000194 fatty acid Substances 0.000 description 2
- 150000004665 fatty acids Chemical class 0.000 description 2
- 229960001680 ibuprofen Drugs 0.000 description 2
- 239000007788 liquid Substances 0.000 description 2
- 239000012528 membrane Substances 0.000 description 2
- 239000004821 Contact adhesive Substances 0.000 description 1
- 230000004888 barrier function Effects 0.000 description 1
- 239000000470 constituent Substances 0.000 description 1
- 238000010276 construction Methods 0.000 description 1
- 230000001419 dependent effect Effects 0.000 description 1
- 230000008021 deposition Effects 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 230000005012 migration Effects 0.000 description 1
- 238000013508 migration Methods 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 239000011101 paper laminate Substances 0.000 description 1
- 238000013112 stability test Methods 0.000 description 1
- 238000005728 strengthening Methods 0.000 description 1
- 238000012360 testing method Methods 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
Classifications
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B32—LAYERED PRODUCTS
- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B27/00—Layered products comprising a layer of synthetic resin
- B32B27/06—Layered products comprising a layer of synthetic resin as the main or only constituent of a layer, which is next to another layer of the same or of a different material
- B32B27/10—Layered products comprising a layer of synthetic resin as the main or only constituent of a layer, which is next to another layer of the same or of a different material of paper or cardboard
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B32—LAYERED PRODUCTS
- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B27/00—Layered products comprising a layer of synthetic resin
- B32B27/36—Layered products comprising a layer of synthetic resin comprising polyesters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
- A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
- A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
- A61K9/7046—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds
- A61K9/7053—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds obtained by reactions only involving carbon to carbon unsaturated bonds, e.g. polyvinyl, polyisobutylene, polystyrene
- A61K9/7061—Polyacrylates
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B32—LAYERED PRODUCTS
- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B7/00—Layered products characterised by the relation between layers; Layered products characterised by the relative orientation of features between layers, or by the relative values of a measurable parameter between layers, i.e. products comprising layers having different physical, chemical or physicochemical properties; Layered products characterised by the interconnection of layers
- B32B7/04—Interconnection of layers
- B32B7/06—Interconnection of layers permitting easy separation
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B32—LAYERED PRODUCTS
- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B7/00—Layered products characterised by the relation between layers; Layered products characterised by the relative orientation of features between layers, or by the relative values of a measurable parameter between layers, i.e. products comprising layers having different physical, chemical or physicochemical properties; Layered products characterised by the interconnection of layers
- B32B7/04—Interconnection of layers
- B32B7/12—Interconnection of layers using interposed adhesives or interposed materials with bonding properties
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B32—LAYERED PRODUCTS
- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B2535/00—Medical equipment, e.g. bandage, prostheses or catheter
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Dermatology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Chemical & Material Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Medicinal Preparation (AREA)
- Laminated Bodies (AREA)
- Adhesives Or Adhesive Processes (AREA)
- Manufacture Of Macromolecular Shaped Articles (AREA)
- Adhesive Tapes (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention relates to a removable protective film (3) for plaster systems, in particular self-adhesive plaster systems, containing active substances, characterized in that it consists of a laminate constituted by a paper layer (7) and an abhesively coated polyester film (8).
Description
Removat]le YrOLeCL7.ve rilm iwor klaszer SysLems, in rarilcutar Self-Adhesive Plaster Systems, Containing Active Substances Active ingredieat-coataining plaster systems delivering active inQrgdients, in particular for delivering medicinal active ixxgradiente to or through the hwaan skin are becoming increasingly important because of their therapeutic advantages. They can be divided roughly into two dlasges, namoly into the trangclermal and the topical plaster systems. in the transdermal systesas, the active ingredient in transported through the human, or anixna], skin, and this active ingredient then has a svatemic action. Yn, topical plaster systems the aim is for the active ingredient preferably to act only in the tissue below the application site.
Soth plaster systems are at ].oagt partly aelf-ad#xesive for attachrnent to the skin. Yn the simplest case, such systems (Fig. 1) consist of a backing layer, of a self-adhesive layer with active ingredient incorporated therein and of a detachable protscting layer.
Yn another oinbodiment, the systems have the form.ot a flat bag, with the rear side of the bag beitlg f.ripexmeable for the active ingredient, and the side of the bag making contact with the akin being formed by a permeabXe membrasse.
The active ingredient in such a syaaten- is present in the form of a-liquid or semisolid foxmuXatior, in the bag. The membrane is advmntageoue3ly provided with an adheeive layer for attachment to the skin. xt is also neceaaary with this eatbodisnaut ghown in Fig. 2. for at least the adhesive areas to be covered beft,re use with a detachable protective sheeti. For it to be possible to detach the protect.ive oheet from the system without damagiag the latter and witfsout exertion of great foxca, the sheet munt be provided, at least on the side making contact 4vith the plaster, with a special coating which, because of its abhesive property, ensures that the forces to separate the adhesive layer and - Z -tLe protective shoot are not too large for gractical t=se.
ftuta, for all ad2t sives with the exQeption of s3licone adhesives, thin a3.Yicaaa layers are usual and are appli,ed to a suitable shae,t material in a spieia7, proGaas. Speoial fluorosilicoae layerg or fluorS.ne-eaetainiag polrnexs can be used generally but are obligatoxy !er silloone adhesives. R"lerw are =wethermorc apeciaY requlrsaLentm to be met by tbe sheet awaterial for aetive ingrellieat-aontainisxg plaster 8yatamu. ginae with all these Aysterns acta.ve ita9redient-oontaining portg also Csoale into contaat vrith C3,s sheet material, this materipl apasat be inert td a1l the iMortaat i,ngredients. This appliera in partfatilar to the aotfte inUL-adfent itself, but aleo to perm.ecLtioa-iagpaoving soiastanees which are necessary in marxy casea in orger to inflvtence the barrier action of the human slsin, and to pYastiaiaern vMcla are 3.nGox orated in the adhas4ve and have an effect on the adhesiveness of tho systema on tha skia.
The a-taadard mbLterial aMloyed for tba pxotactive shaet i.s tiherefore pol,yester (pa:Lyetbyiene tarephtihaymte) for virtually all plaster aystem. po= sil3oone a~Qsives, in a tew case9 s. sheet wAd0 of iluorirai-contialuaiag polymwa ia also used, thus saving an additional abbpaiv0 coatiag.
Thegs materia].s lsava virtualiy no untake capaoity for aabsta:sa+ap aostinally cmed as an fayredienb of active iaQr*dieat-ooats,i,nirg p1s ter systemps. ltateaials such aa polyethylane, pQlypropylea$ or paper are una+ILitable in many casas bnaauss of their uptake oapacitY for such ametitiuents of the syebeat. For practicol handliner but also ior seasoas s"elsti d to manufacturi.na tae3iaique , protoctive sboets souat have a saaiatum thickness of about 50 um. This ig a disadvaatage because polyaat*r is a relatively eontly Material by aosrpariaars wfth other a,at rfals mentiosred above. zhl.s appiieg in particuiar to topical plaster systems, which may reach a size of 300 cm~
and more.
=t is therefore an object of the invention to indicate an improved protective sheet for active ingredient-containing, in particular self-adhesive plaster systems, which, while having adequate mechanical strength, is impermeable to active ingredients and ancillary substances and distinctly reduces the costs for the polyester protective sheets used hitherto.
The object is surprisingly achieved with the invention-in that the protective sheet is a laminate of a paper layer and of an abhesively coated polyester sheet. it is ensured that the two layers hold together by using suitable adhesives. it was possible to show by appropriate stability tests with active ingredient-containing plaster systems that even very thin - and therefore too thin for producing active ingredient-containing plasters and practical use thereof - polyester sheets, laminated onto paper, reliably prevent constituents of the systems from migrating into the paper, whose inertness is low. The paper layer merely serves for mechanical strengthening of the polyester sheet and, in this case, does not come into any contact with parts of the system.
=n this regard, one embodiment provides for the polyester sheet in the laminate being provided on its side which makes contact with the plaster system with a coating which is abhesive for the particular adhesive. Preferred embodiments of the invention provide for the polyester sheet having a thickness between 5 and 30 Um, preferably between 10 and 20 pm, and the weight per unit area of the paper layer being 30 to 150, preferably 60 to 120, g/m', it being necessary that the total thickness be at least 50 um.
-3a-In accordance with one aspect of the present invention, there is provided an active ingredient-containing plaster system with detachable protective sheet, characterized in that said protective sheet is a laminate of a paper layer and of an abhesively coated, 5 to 50 pm-thick polyester film.
In accordance with a further aspect of the plaster system as defined by the present invention, the abhesive coating consists of fluorine-containing polymers.
In accordance with another aspect of the plaster system as defined by the present invention, the polyester film is based on polyethylene terephthalate.
In accordance with still a further aspect of the present invention, there is provided a detachable protective sheet for active ingredient-containing plaster systems with diffusible ingredients, formed by a laminate according to any one of claims 1 to 7 of a paper layer and an abhesively coated 5 to 50 pm thick polyester film based on polyethylene terephthalate.
Further embodiments of the protective sheet are provided according to the dependent claims.
Examples of embodiments of plaster systems are depicted in Figures 1-3, which show:
Fig. 1: a section through a multilayer plaster system with a detachable protecting layer Fig. 2: a section through another multilayer plaster system with a detachable protecting layer Fig. 3: a section through the design according to the invention of the detachable protecting layer.
The plaster system shown in Fig. 1 comprises an active ingredient-impermeable backing layer (1), underneath which there is.a self-adhesive, active ingredient-containing matrix layer.(2) which.is covered on the skin side with a detachable protecting layer (3).
Fig. 2 shows a plaster system with a different type of construction. This has, underneath a backing layer (1) which is impermeable for active ingredient and ancillary substances, an active ingredient-containing liquid reservoir (4) with a control membrane (5), to which a skin contact adhesive layer (6) is assigned and which is covered by a detachable protecting layer (3).
Fig. 3 shows the design according to the invention of the protecting layer (3) in the form of a laminate which consists of an abhesively coated polyester sheet (8) and of a paper sheet (7).
The two sheets (7) and (8) are held together by using suitable adhesives.
Concerning the mechanical properties of the laminate (3), no disadvantages by comparison with considerably thicker polyester sheets emerged in corresponding production tests.
The polyester sheet (8) used may additionally be aluminized on one or both sides in addition to the abhesive finish.
This aluminization takes place by vapour deposition of the aluminium in vacuo and has the advantage that the abhesive finish or the adhesive which bonds the polyester sheet (8) to the paper layer (7) adheres better to aluminium than to polyester itself. The thickness of the polyester sheet (8) can be between 5 and 50 um. The thickness of the paper layer (7) necessarily depends on the particular circumstances. Tables 1, 2 and 3 show the results of stability studies with two different topical systems with the active ingredients ketoprofen, ibuprofen and ethylene glycol monosalicylate. The values in Table 1 and 2 prove that the contents of the plaster have remained unchanged over at least two years. Table 3 shows the amounts of ethylene glycol monosalicylate found after storage of the plasters for two years in a protective sheet according to the invention and compares them with the amounts which had migrated under the same storage conditions into a commercially available protective sheet based on a laminate of paper and siliconized polyethylene.
The results of the stability studies prove that the laminate (3), on which the invention is based, made of paper (7) and polyester sheet (8) meets all stability requirements and is superior to the commercially available laminate made of paper and polyethylene sheet. it combines in an advantageous manner the superiority of the polyester in respect of its inertness with the economic advantages of paper sheets. with regard to its mechanical processability, there are no restrictions whatsoever by comparison with pure polyester sheets.
Table 1 Stability of the ketoprofen content in a fatty acid-containing self-adhesive polyacrylate matrix Storage time Storage temperature Ketoprofen content [months] [ C] [mQ/cm']
0 / 0.663 25 0.651 40 0.657 25 0.674 40 0.644 12 25 0.629 18 25 0.659 24 25 0.663 Table 2 Stability of the ibuprofen content in a fatty acid-containing self-adhesive polyacrylate matrix StoraQe time Storage temperature =buprofen content [months] [ C] [mQ/cm']
0 / 0.62 25 0.63 40 0.61 25 0.63 40 0.61 12 25 0.60 18 25 0.61 Table 3 Migration of ethylene glycol monosalicylate out of a self-adhesive polyacrylate formulation into a siliconized polyethylene/paper laminate and a laminate of 23 pm siliconized polyester and 80 g paper at 250C.
Storage time Paper/polyethylene Paper/polyester [months]
6 0.11 mg/cle 0.001 mg/cle 9 0.14 mg/cm' 0.002 mg/cie 12 0.27 mg/cie 0.002 mg/ciO
Soth plaster systems are at ].oagt partly aelf-ad#xesive for attachrnent to the skin. Yn the simplest case, such systems (Fig. 1) consist of a backing layer, of a self-adhesive layer with active ingredient incorporated therein and of a detachable protscting layer.
Yn another oinbodiment, the systems have the form.ot a flat bag, with the rear side of the bag beitlg f.ripexmeable for the active ingredient, and the side of the bag making contact with the akin being formed by a permeabXe membrasse.
The active ingredient in such a syaaten- is present in the form of a-liquid or semisolid foxmuXatior, in the bag. The membrane is advmntageoue3ly provided with an adheeive layer for attachment to the skin. xt is also neceaaary with this eatbodisnaut ghown in Fig. 2. for at least the adhesive areas to be covered beft,re use with a detachable protective sheeti. For it to be possible to detach the protect.ive oheet from the system without damagiag the latter and witfsout exertion of great foxca, the sheet munt be provided, at least on the side making contact 4vith the plaster, with a special coating which, because of its abhesive property, ensures that the forces to separate the adhesive layer and - Z -tLe protective shoot are not too large for gractical t=se.
ftuta, for all ad2t sives with the exQeption of s3licone adhesives, thin a3.Yicaaa layers are usual and are appli,ed to a suitable shae,t material in a spieia7, proGaas. Speoial fluorosilicoae layerg or fluorS.ne-eaetainiag polrnexs can be used generally but are obligatoxy !er silloone adhesives. R"lerw are =wethermorc apeciaY requlrsaLentm to be met by tbe sheet awaterial for aetive ingrellieat-aontainisxg plaster 8yatamu. ginae with all these Aysterns acta.ve ita9redient-oontaining portg also Csoale into contaat vrith C3,s sheet material, this materipl apasat be inert td a1l the iMortaat i,ngredients. This appliera in partfatilar to the aotfte inUL-adfent itself, but aleo to perm.ecLtioa-iagpaoving soiastanees which are necessary in marxy casea in orger to inflvtence the barrier action of the human slsin, and to pYastiaiaern vMcla are 3.nGox orated in the adhas4ve and have an effect on the adhesiveness of tho systema on tha skia.
The a-taadard mbLterial aMloyed for tba pxotactive shaet i.s tiherefore pol,yester (pa:Lyetbyiene tarephtihaymte) for virtually all plaster aystem. po= sil3oone a~Qsives, in a tew case9 s. sheet wAd0 of iluorirai-contialuaiag polymwa ia also used, thus saving an additional abbpaiv0 coatiag.
Thegs materia].s lsava virtualiy no untake capaoity for aabsta:sa+ap aostinally cmed as an fayredienb of active iaQr*dieat-ooats,i,nirg p1s ter systemps. ltateaials such aa polyethylane, pQlypropylea$ or paper are una+ILitable in many casas bnaauss of their uptake oapacitY for such ametitiuents of the syebeat. For practicol handliner but also ior seasoas s"elsti d to manufacturi.na tae3iaique , protoctive sboets souat have a saaiatum thickness of about 50 um. This ig a disadvaatage because polyaat*r is a relatively eontly Material by aosrpariaars wfth other a,at rfals mentiosred above. zhl.s appiieg in particuiar to topical plaster systems, which may reach a size of 300 cm~
and more.
=t is therefore an object of the invention to indicate an improved protective sheet for active ingredient-containing, in particular self-adhesive plaster systems, which, while having adequate mechanical strength, is impermeable to active ingredients and ancillary substances and distinctly reduces the costs for the polyester protective sheets used hitherto.
The object is surprisingly achieved with the invention-in that the protective sheet is a laminate of a paper layer and of an abhesively coated polyester sheet. it is ensured that the two layers hold together by using suitable adhesives. it was possible to show by appropriate stability tests with active ingredient-containing plaster systems that even very thin - and therefore too thin for producing active ingredient-containing plasters and practical use thereof - polyester sheets, laminated onto paper, reliably prevent constituents of the systems from migrating into the paper, whose inertness is low. The paper layer merely serves for mechanical strengthening of the polyester sheet and, in this case, does not come into any contact with parts of the system.
=n this regard, one embodiment provides for the polyester sheet in the laminate being provided on its side which makes contact with the plaster system with a coating which is abhesive for the particular adhesive. Preferred embodiments of the invention provide for the polyester sheet having a thickness between 5 and 30 Um, preferably between 10 and 20 pm, and the weight per unit area of the paper layer being 30 to 150, preferably 60 to 120, g/m', it being necessary that the total thickness be at least 50 um.
-3a-In accordance with one aspect of the present invention, there is provided an active ingredient-containing plaster system with detachable protective sheet, characterized in that said protective sheet is a laminate of a paper layer and of an abhesively coated, 5 to 50 pm-thick polyester film.
In accordance with a further aspect of the plaster system as defined by the present invention, the abhesive coating consists of fluorine-containing polymers.
In accordance with another aspect of the plaster system as defined by the present invention, the polyester film is based on polyethylene terephthalate.
In accordance with still a further aspect of the present invention, there is provided a detachable protective sheet for active ingredient-containing plaster systems with diffusible ingredients, formed by a laminate according to any one of claims 1 to 7 of a paper layer and an abhesively coated 5 to 50 pm thick polyester film based on polyethylene terephthalate.
Further embodiments of the protective sheet are provided according to the dependent claims.
Examples of embodiments of plaster systems are depicted in Figures 1-3, which show:
Fig. 1: a section through a multilayer plaster system with a detachable protecting layer Fig. 2: a section through another multilayer plaster system with a detachable protecting layer Fig. 3: a section through the design according to the invention of the detachable protecting layer.
The plaster system shown in Fig. 1 comprises an active ingredient-impermeable backing layer (1), underneath which there is.a self-adhesive, active ingredient-containing matrix layer.(2) which.is covered on the skin side with a detachable protecting layer (3).
Fig. 2 shows a plaster system with a different type of construction. This has, underneath a backing layer (1) which is impermeable for active ingredient and ancillary substances, an active ingredient-containing liquid reservoir (4) with a control membrane (5), to which a skin contact adhesive layer (6) is assigned and which is covered by a detachable protecting layer (3).
Fig. 3 shows the design according to the invention of the protecting layer (3) in the form of a laminate which consists of an abhesively coated polyester sheet (8) and of a paper sheet (7).
The two sheets (7) and (8) are held together by using suitable adhesives.
Concerning the mechanical properties of the laminate (3), no disadvantages by comparison with considerably thicker polyester sheets emerged in corresponding production tests.
The polyester sheet (8) used may additionally be aluminized on one or both sides in addition to the abhesive finish.
This aluminization takes place by vapour deposition of the aluminium in vacuo and has the advantage that the abhesive finish or the adhesive which bonds the polyester sheet (8) to the paper layer (7) adheres better to aluminium than to polyester itself. The thickness of the polyester sheet (8) can be between 5 and 50 um. The thickness of the paper layer (7) necessarily depends on the particular circumstances. Tables 1, 2 and 3 show the results of stability studies with two different topical systems with the active ingredients ketoprofen, ibuprofen and ethylene glycol monosalicylate. The values in Table 1 and 2 prove that the contents of the plaster have remained unchanged over at least two years. Table 3 shows the amounts of ethylene glycol monosalicylate found after storage of the plasters for two years in a protective sheet according to the invention and compares them with the amounts which had migrated under the same storage conditions into a commercially available protective sheet based on a laminate of paper and siliconized polyethylene.
The results of the stability studies prove that the laminate (3), on which the invention is based, made of paper (7) and polyester sheet (8) meets all stability requirements and is superior to the commercially available laminate made of paper and polyethylene sheet. it combines in an advantageous manner the superiority of the polyester in respect of its inertness with the economic advantages of paper sheets. with regard to its mechanical processability, there are no restrictions whatsoever by comparison with pure polyester sheets.
Table 1 Stability of the ketoprofen content in a fatty acid-containing self-adhesive polyacrylate matrix Storage time Storage temperature Ketoprofen content [months] [ C] [mQ/cm']
0 / 0.663 25 0.651 40 0.657 25 0.674 40 0.644 12 25 0.629 18 25 0.659 24 25 0.663 Table 2 Stability of the ibuprofen content in a fatty acid-containing self-adhesive polyacrylate matrix StoraQe time Storage temperature =buprofen content [months] [ C] [mQ/cm']
0 / 0.62 25 0.63 40 0.61 25 0.63 40 0.61 12 25 0.60 18 25 0.61 Table 3 Migration of ethylene glycol monosalicylate out of a self-adhesive polyacrylate formulation into a siliconized polyethylene/paper laminate and a laminate of 23 pm siliconized polyester and 80 g paper at 250C.
Storage time Paper/polyethylene Paper/polyester [months]
6 0.11 mg/cle 0.001 mg/cle 9 0.14 mg/cm' 0.002 mg/cie 12 0.27 mg/cie 0.002 mg/ciO
Claims (9)
1. Active ingredient-containing plaster system with detachable protective sheet, characterized in that said protective sheet is a laminate of a paper layer and of an abhesively coated, 5 to 50 pm-thick polyester film.
2. Plaster system containing according to claim 1, characterized in that the polyester film has a thickness between 10 and 30 pm.
3. Plaster system according to claim 1 or 2, characterized in that the weight per unit area of the paper layer is 30 to 150 g/m2.
4. Plaster system according to claim 1 or 2, characterized in that the weight per unit area of the paper layer is 60 to 120g/m2.
5. Plaster system according to claim 1, characterized in that the polyester is aluminized on at least one side.
6. Plaster system according to claim 1, characterized in that the abhesive coating consists of silicone polymers.
7. Plaster system according to claim 1, characterized in that the abhesive coating consists of fluorine-containing polymers.
8. Plaster system according to claim 1, characterized by a polyester film based on polyethylene terephthalate.
9. Detachable protective sheet for active ingredient-containing plaster systems with diffusible ingredients, formed by a laminate according to any one of claims 1 to 7 of a paper layer and an abhesively coated 5 to 50 pm thick polyester film based on polyethylene terephthalate.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE19702314.2 | 1997-01-23 | ||
DE19702314A DE19702314C2 (en) | 1997-01-23 | 1997-01-23 | Removable protective film for active substance-containing, in particular self-adhesive, plaster systems |
PCT/EP1998/000012 WO1998032604A1 (en) | 1997-01-23 | 1998-01-03 | Removable protective film for plaster systems, in particular self-adhesive plaster systems, containing active substances |
Publications (2)
Publication Number | Publication Date |
---|---|
CA2278753A1 CA2278753A1 (en) | 1998-07-30 |
CA2278753C true CA2278753C (en) | 2007-10-30 |
Family
ID=7818152
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CA002278753A Expired - Fee Related CA2278753C (en) | 1997-01-23 | 1998-01-03 | Removable protective film for plaster systems, in particular self-adhesive plaster systems, containing active substances |
Country Status (12)
Country | Link |
---|---|
EP (1) | EP0954440B1 (en) |
JP (1) | JP4063332B2 (en) |
KR (1) | KR100466815B1 (en) |
AT (1) | ATE252453T1 (en) |
AU (1) | AU744139B2 (en) |
CA (1) | CA2278753C (en) |
DE (2) | DE19702314C2 (en) |
DK (1) | DK0954440T3 (en) |
ES (1) | ES2212259T3 (en) |
NO (1) | NO993384D0 (en) |
PT (1) | PT954440E (en) |
WO (1) | WO1998032604A1 (en) |
Families Citing this family (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE19943317C1 (en) * | 1999-09-10 | 2001-03-15 | Lohmann Therapie Syst Lts | Plastic films, in particular for use in a dermal or transdermal therapeutic system and process for their manufacture |
DE10056014A1 (en) * | 2000-11-11 | 2002-05-16 | Beiersdorf Ag | Laminated plaster with active substance, used as transdermal therapeutic system, has impermeable barrier layer on side away from skin and separable carrier layer with adhesive on side towards skin |
DE10056012A1 (en) * | 2000-11-11 | 2002-05-16 | Beiersdorf Ag | Carrier material for medical applications, preferably for transdermal therapeutic system, has aluminum film between carrier and self-adhesive coating |
US7955677B2 (en) | 2005-12-07 | 2011-06-07 | Mylan Technologies, Inc. | Two-sided non-stick release film |
EP3575086B1 (en) * | 2018-05-29 | 2020-08-26 | Papierfabriek Doetinchem BV | Protective cover film, protective cover film roll and method of manufacturing the protective cover film |
Family Cites Families (10)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
FR2498986A1 (en) * | 1981-02-05 | 1982-08-06 | Le T | Multilayer material for drawing and graphic works - comprise ethylene! terephthalate support, paper layer, acrylate! copolymer adhesive layer and anti-adhesive layer |
US4904247A (en) * | 1984-08-31 | 1990-02-27 | Kendall Company | Pressure-sensitive hydrophilic laminate structures for use in wound dressing, transdermal and topical drug delivery |
JPH07368B2 (en) * | 1987-11-04 | 1995-01-11 | 三菱製紙株式会社 | Method for manufacturing release sheet |
DE3844247A1 (en) * | 1988-12-29 | 1990-07-12 | Minnesota Mining & Mfg | DEVICE, IN PARTICULAR PLASTER FOR TRANSDERMAL ADMINISTRATION OF A MEDICINAL PRODUCT |
CA2097182C (en) * | 1990-11-28 | 1999-04-27 | James N. Kenealy | Method and device for treating tobacco addiction |
DE4110027C2 (en) * | 1991-03-27 | 1996-08-29 | Lohmann Therapie Syst Lts | Process for packaging transdermal therapeutic patches |
CA2079647A1 (en) * | 1991-10-11 | 1993-04-12 | Grover L. Farrar | In-line silicone coated polyester film and a process for coating the film |
DE4309830C1 (en) * | 1993-03-26 | 1994-05-05 | Lohmann Therapie Syst Lts | Transdermal patches for oestradiol admin. - contg. isopropylidene mono- or di-glycerol as penetration enhancer |
CA2128347C (en) * | 1993-07-28 | 1998-12-08 | Akihiko Takano | Biodegradable adhesive tape and biodegradable adhesive label |
IL113034A (en) * | 1994-04-05 | 2000-02-17 | Astra Ab | Topical dressing |
-
1997
- 1997-01-23 DE DE19702314A patent/DE19702314C2/en not_active Expired - Fee Related
-
1998
- 1998-01-03 AT AT98901336T patent/ATE252453T1/en active
- 1998-01-03 CA CA002278753A patent/CA2278753C/en not_active Expired - Fee Related
- 1998-01-03 EP EP98901336A patent/EP0954440B1/en not_active Expired - Lifetime
- 1998-01-03 ES ES98901336T patent/ES2212259T3/en not_active Expired - Lifetime
- 1998-01-03 PT PT98901336T patent/PT954440E/en unknown
- 1998-01-03 WO PCT/EP1998/000012 patent/WO1998032604A1/en active IP Right Grant
- 1998-01-03 KR KR10-1999-7006670A patent/KR100466815B1/en not_active IP Right Cessation
- 1998-01-03 DE DE59809968T patent/DE59809968D1/en not_active Expired - Lifetime
- 1998-01-03 DK DK98901336T patent/DK0954440T3/en active
- 1998-01-03 JP JP53152298A patent/JP4063332B2/en not_active Expired - Fee Related
- 1998-01-03 AU AU57653/98A patent/AU744139B2/en not_active Ceased
-
1999
- 1999-07-08 NO NO993384A patent/NO993384D0/en not_active Application Discontinuation
Also Published As
Publication number | Publication date |
---|---|
PT954440E (en) | 2004-03-31 |
KR20000070435A (en) | 2000-11-25 |
ES2212259T3 (en) | 2004-07-16 |
WO1998032604A1 (en) | 1998-07-30 |
AU5765398A (en) | 1998-08-18 |
NO993384L (en) | 1999-07-08 |
AU744139B2 (en) | 2002-02-14 |
DE19702314A1 (en) | 1998-07-30 |
DE19702314C2 (en) | 2000-12-21 |
NO993384D0 (en) | 1999-07-08 |
EP0954440B1 (en) | 2003-10-22 |
KR100466815B1 (en) | 2005-01-17 |
JP4063332B2 (en) | 2008-03-19 |
DK0954440T3 (en) | 2004-02-16 |
EP0954440A1 (en) | 1999-11-10 |
ATE252453T1 (en) | 2003-11-15 |
CA2278753A1 (en) | 1998-07-30 |
DE59809968D1 (en) | 2003-11-27 |
JP2001508451A (en) | 2001-06-26 |
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Legal Events
Date | Code | Title | Description |
---|---|---|---|
EEER | Examination request | ||
MKLA | Lapsed |
Effective date: 20140103 |