EP3528795A1 - Zweischichtiges topisches therapeutisches system - Google Patents
Zweischichtiges topisches therapeutisches systemInfo
- Publication number
- EP3528795A1 EP3528795A1 EP17784297.8A EP17784297A EP3528795A1 EP 3528795 A1 EP3528795 A1 EP 3528795A1 EP 17784297 A EP17784297 A EP 17784297A EP 3528795 A1 EP3528795 A1 EP 3528795A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- therapeutic system
- topical therapeutic
- adhesive
- active ingredient
- layer
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Withdrawn
Links
Classifications
-
- 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
- A61K9/7084—Transdermal patches having a drug layer or reservoir, and one or more separate drug-free skin-adhesive layers, e.g. between drug reservoir and skin, or surrounding the drug reservoir; Liquid-filled reservoir patches
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/196—Carboxylic acids, e.g. valproic acid having an amino group the amino group being directly attached to a ring, e.g. anthranilic acid, mefenamic acid, diclofenac, chlorambucil
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/20—Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids
- A61K31/201—Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids having one or two double bonds, e.g. oleic, linoleic acids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
- A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline
- A61K31/353—3,4-Dihydrobenzopyrans, e.g. chroman, catechin
- A61K31/355—Tocopherols, e.g. vitamin E
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
Definitions
- the invention relates to a topical therapeutic system or a topical active substance-containing patch, in particular with diclofenac (2- [2 - [(2,6-dichlorophenyl) amino] phenyl] acetic acid) as the active ingredient.
- the invention further relates to the use of such a system as a medicament, in particular in the therapy of pain and inflammatory conditions.
- Topical therapeutic systems are a dosage form for administering drugs in patch form. These systems have certain advantages over conventional dosage forms. Thus, by sticking the active substance-containing patch, the active ingredient is absorbed in the area of the body and at the correct dosage at the affected body site without being broken down prematurely in the gastrointestinal tract or the liver. In addition, this dosage form allows a constant release of the drug over a longer period.
- the occlusion of the patch is effected according to DE 10103860 A1, by the use of a water vapor-impermeable backing layer, such as a thin plastic film, preferably a polyethylene terephthalate (PET) film.
- a water vapor-impermeable backing layer such as a thin plastic film, preferably a polyethylene terephthalate (PET) film.
- EP 1 312 360 A1 discloses an analgesic anti-inflammatory patch ("dojin patch") for the local release of diclofenac
- the system contains N-methyl-2-pyrrolidone as a penetration enhancer and thus provides for an increased permeation of the active ingredient through the skin.
- the disadvantage of this system is the health concern of this penetration enhancer, according to ICH Guideline Q3C (from 4 February 2011) should namely a daily intake of 5.3 mg N-methyl-2-pyrrolidone should not be exceeded.
- the object of the present invention is to overcome the above-mentioned disadvantages of the prior art.
- the object of the present invention is to provide a topical therapeutic system, which causes an optimal absorption of an active ingredient via the skin and thereby manages without health-critical penetration enhancers.
- this system should have a high level of comfort and high adhesion, even on flexible body parts, such as joints.
- a topical therapeutic system which comprises a backing layer, a matrix layer containing active substance which contains at least one active substance, at least one penetration enhancer, at least one non-occlusive adhesive, at least one antioxidant and at least one crosslinking agent, and at least one adhesive, Occlusion causing layer, which is located between the active ingredient-containing matrix layer and the back layer includes.
- Occlusion here is understood to mean, at least as far as possible, covering or closing skin regions with materials impermeable to water vapor.
- the at least one penetration enhancer is a compound which stabilizes the active ingredient in dissolved form and thus ensures a relatively high and stable absorption of the active ingredient over the skin over a relatively long period of time.
- a non-occlusive adhesive is to be understood as meaning an adhesive which fixes the active substance-containing plaster as firmly as possible on the skin, but without preventing perspiration insensibilis, ie the escape of water vapor from the skin.
- the non-occlusive adhesive should take up the active ingredient in dissolved form and be able to prevent it from crystallizing out as much as possible.
- non-occlusive adhesive is a pressure sensitive adhesive.
- the at least one antioxidant is a chemical compound which prevents or reduces unwanted oxidation of other substances, especially of the active ingredient, and thus counteracts aging of the therapeutic system.
- antioxidants are distinguished by their action as radical scavengers and by the fact that they prevent the oxidative degradation of sensitive molecules caused by atmospheric oxygen, in this case especially of the active substance contained.
- the at least one cross-linking agent is a chemical compound that ensures greater cohesiveness and higher strength of individual layers of the therapeutic system.
- the topical therapeutic system according to the invention is structured in such a way that the active substance-containing matrix layer lies on the skin. On the side of the matrix layer which does not touch the skin, there is the occlusion-causing layer and on this is the backing layer so that the occlusion-causing layer is between the active-containing matrix layer and the backing layer.
- the topical therapeutic system according to the invention is preferably characterized in that the backing layer comprises an elastic woven fabric, knitted fabric or fleece.
- This is preferably extensible in one, more preferably in two directions. This is understood to mean the extensibility or elasticity in the longitudinal and transverse direction, but not in the thickness direction, of the woven fabric, knitted fabric or fleece.
- Thickness direction based on the initial state of the material to stretch without losing the basic shape. A permanent deformation of the stretched material does not occur.
- the elasticity is evaluated by means of the elongation, which is given as a dimensionless number or multiplied by 100 as a percentage value.
- the elongation is in two different directions, preferably in the longitudinal and transverse directions, preferably 0 to 100%, more preferably 10 to 50% and most preferably 15 to 30%, based on the original
- tissue, knitted fabric or nonwoven has the advantage that the inventive topical therapeutic system or drug-containing patch, even in large versions and when adhering to flexible regions of the body, such as joints of the extremities, a high level of comfort , no mobility restriction, as well as a high Has adhesion to the skin and thus prevents unwanted detachment.
- active ingredient in the topical therapeutic system according to the invention, individual or combinations of active ingredients (s), preferably those with pain and inflammation-reducing effects may be included.
- the invention is topical
- the active ingredient comprises at least one non-steroidal anti-inflammatory drug (NSAID).
- NSAID non-steroidal anti-inflammatory drug
- Non-steroidal anti-inflammatory drugs are also known under the terms non-steroidal anti-inflammatory drugs (NSAIDs) or nonsteroidal anti-inflammatory drugs (NSAIDs).
- Anthranilic acid derivatives such as mefenamic acid (Ponstan®),
- Meclofenamic acid (Meclomen®) and niflumic acid, Cox-2 inhibitors, such as
- Celecoxib (Celebrex®), etoricoxib (Arcoxia®), acetic acid derivatives and
- Arylacetic acid derivatives such as aceclofenac (Beofenac®, D), acemetacin (Tilur®), bufexamac (Parfenac®), diclofenac, diclofenac gel (Voltaren®), etodolac
- Salicylic acid and others such as nabumetone (Balmox®) and / or nimesulide
- the topical therapeutic system according to the invention is characterized in that the at least one active ingredient comprises diclofenac or a pharmaceutically acceptable salt thereof.
- the topical therapeutic system of the invention is characterized in that the pharmaceutically acceptable salt is diclofenac sodium salt.
- the active ingredient in particular the diclofenac salt, particularly preferably the diclofenac sodium salt, is present in an amount of from 0.1 to 20% by weight, preferably from 0.5 to 15% by weight and particularly preferably from 1 to 10% by weight, based on the total weight of the active ingredient-containing matrix layer, in the active ingredient-containing matrix layer.
- the topical therapeutic system according to the invention is characterized in that it is the at least one penetration enhancer, not pyrrolidones, in particular not N-methyl-2-pyrrolidone, sulfoxides, in particular dimethyl sulfoxide (DMSO), formamides, in particular dimethylformamide (DMF ), and / or 1-dodecylazacycloheptan-2-one or laurocapran (azone) and / or derivatives thereof.
- sulfoxides in particular dimethyl sulfoxide (DMSO)
- formamides in particular dimethylformamide (DMF )
- azone 1-dodecylazacycloheptan-2-one or laurocapran
- the carrier of the topical therapeutic system according to the invention does not contain the harmful substances N-methyl-2-pyrrolidone, dimethyl sulfoxide (DMSO), dimethylformamide (DMF) and / or 1-dodecylazacycloheptan-2-one or laurocapran (Azon ) and / or their derivatives is exposed, and thus can carry the inventive topical therapeutic system over a longer period of time.
- DMSO dimethyl sulfoxide
- DMF dimethylformamide
- Azon 1-dodecylazacycloheptan-2-one or laurocapran
- Suitable penetration enhancers are preferably non-toxic or non-hazardous compounds, preferably selected from the group of fatty acids or fatty acid esters.
- the inventive topical therapeutic system is thus preferably characterized in that the at least one penetration enhancer is selected from fatty acids and / or fatty acid esters, such as pentanoic acid, hexanoic acid, octanoic acid, nonanoic acid, decanoic acid, lauric acid, myristic acid, palmitic acid, stearic acid, arachidic acid, behenic acid, lignoceric acid , Isoic, oleoic, palmitoleic Isopropyl palmitate, isopropyl oleate (oleic acid isopropyl ester), preferably Oleic acid, lauric acid and / or myristic acid, more preferably oleic acid, and / or fatty acid esters, preferably oleic acid isopropyl ester and / or myristic isopropyl ester.
- fatty acids and / or fatty acid esters such as pentanoic acid, he
- the at least one penetration enhancer is preferably in an amount of from 1 to 50% by weight, more preferably in an amount of from 2 to 40% by weight, and most preferably in an amount of from 5 to 30% by weight, based on the total weight of the active ingredient Matrix layer, before.
- fatty acids and / or fatty acid esters as penetration enhancers, and in particular by the omission of pyrrolidones, in particular N-methyl-2-pyrrolidone, sulfoxides, in particular dimethyl sulfoxide (DMSO), formamides, in particular dimethylformamide (DMF) and / or 1- Dodecylazacycloheptan-2- ⁇ or laurocapran (Azon), and / or derivatives thereof, there is the advantage that the user of the topical therapeutic system according to the invention is not exposed to any health-critical penetration enhancer, which allows him the inventive topical therapeutic system also to apply over a longer period of time.
- pyrrolidones in particular N-methyl-2-pyrrolidone
- sulfoxides in particular dimethyl sulfoxide (DMSO)
- formamides in particular dimethylformamide (DMF) and / or 1-
- DMF dimethylformamide
- Azon Dodecylazacycloheptan-2- ⁇
- the at least one non-occlusive adhesive comprises a pressure-sensitive adhesive.
- the at least one non-occlusive adhesive preferably the at least one non-occlusive pressure-sensitive adhesive comprises an adhesive, preferably a pressure-sensitive adhesive based on an acrylate copolymer. Particularly preferred is the use of an acrylate / vinyl acetate copolymer.
- the non-occlusive adhesive preferably a pressure-sensitive adhesive based on an acrylate copolymer, preferably an acrylate / vinyl acetate copolymer, contains free hydroxyl groups which ensure optimum solubility of the at least one active ingredient, preferably diclofenac.
- the non-occlusive adhesive is a pressure sensitive adhesive, preferably based on an acrylate copolymer, more preferably an acrylate / vinyl acetate copolymer, a non-acidic adhesive, i. H. an adhesive that does not contain free carboxyl groups, causing crystallization the at least one active ingredient, preferably the diclofenac sodium salt, largely prevented.
- the non-occlusive adhesive preferably an adhesive, is preferably in an amount of from 20 to 99% by weight, more preferably from 40 to 99% by weight, most preferably from 50 to 98% by weight, and most preferably from 70 to 80 Wt .-%, based on the total weight of the active ingredient-containing matrix layer, contained in the active ingredient-containing matrix layer.
- the non-occlusive adhesive preferably a pressure-sensitive adhesive based on an acrylate / vinyl acetate copolymer
- the non-occlusive adhesive is "DuroTak 387-2287" (from Henkel, Germany).
- the topical therapeutic system according to the invention is characterized in that the at least one antioxidant is selected from alpha-tocopherol, ascorbyl palmitate and butylhydroxytoluene.
- the at least one antioxidant is preferably in an amount of 0.001 to 5 wt.%, Preferably from 0.01 to 4 wt.% And particularly preferably from 0.05 to 3 wt.%, Based on the total weight of the active ingredient-containing matrix layer, in the containing active ingredient matrix layer.
- an antioxidant has the advantage that the topical therapeutic system according to the invention remains stable over a longer period of time and under a wide variety of external conditions.
- the topical therapeutic system of the invention is over a period of 36 months in all three ICH climates (25 ° C / 60% Relative Humidity (RH), 30 ° C / 65% RH, and 30 ° C / 75% RH).
- the topical therapeutic system according to the invention is preferably characterized in that the at least one crosslinking agent is selected from the group of metal chelates, preferably aluminum acetylacetonate.
- the at least one crosslinking agent which is particularly preferably aluminum acetylacetonate, in an amount of 0.01 to 25 wt.%, Preferably from 0.05 to 20 wt.% And particularly preferably from 0.1 to 10 % By weight, based on the total weight of the active ingredient-containing matrix layer.
- the crosslinking agent causes the drug-containing matrix layer to be more uniform and firmer, i. leads to an increase in the cohesion of the active ingredient-containing matrix layer.
- the active substance-containing matrix layer does not remain partially on the skin of the user, but is completely detached.
- the occlusion-inducing layer preferably comprises an adhesive.
- This is preferably a polyisobutylene adhesive, more preferably a polyisobutylene adhesive based on a low molecular weight polyisobutylene adhesive and a high molecular weight polyisobutylene adhesive.
- low molecular weight is meant here a polyisobutylene adhesive having an average molecular weight of 5000 to 490000 g / mol, by "high molecular weight” a polyisobutylene adhesive having an average molecular weight of 500000 to 5 million g / mol. The molecular weight is taken from the date of filing valid analysis certificates of each manufacturer.
- the low molecular weight polyisobutylene adhesive is "Oppanol B 10 SFN" and the high molecular weight, polyisobutylene adhesive is "Oppanol B 100" (both from BASF).
- the mixing ratio of low molecular weight polyisobutylene adhesive to high molecular weight polyisobutylene adhesive is preferably about 60 to 90 to about 40 to 10 parts by weight, more preferably about 70 to 90 to about 30 to 10 parts by weight, and most preferably about 85 to about 15 parts by weight ,
- the high molecular weight of polyisobutylene adhesive is responsible for the occlusion of the system.
- an adaptation of the occlusion can take place.
- the topical therapeutic system according to the invention is further preferably characterized in that the active substance-containing matrix layer has a basis weight of 40 to 160 g / m 2 , preferably 50 to 120 g / m 2 and more preferably 60 to 100 g / m 2 .
- the occlusion-inducing layer has a weight per unit area of 5 to 150 g / m 2 , preferably of 10 to 120 g / m 2 and particularly preferably of 20 to 100 g / m 2 .
- topical therapeutic system of the invention may optionally contain a perfume.
- the topical therapeutic system according to the invention is characterized in that the at least one active ingredient is diclofenac sodium salt which is at least one oleic acid penetration enhancer, the at least one non-occlusive adhesive is an acrylate / vinyl acetate copolymer based adhesive is, the antioxidant is selected from alpha-tocopherol and / or ascorbyl palmitate, which is at least one crosslinking agent aluminum acetylacetonate and the occlusion-causing layer comprises an adhesive based on a mixture of a low molecular weight polyisobutylene adhesive and a high molecular weight polyisobutylene adhesive.
- the at least one active ingredient is diclofenac sodium salt which is at least one oleic acid penetration enhancer
- the at least one non-occlusive adhesive is an acrylate / vinyl acetate copolymer based adhesive is
- the antioxidant is selected from alpha-tocopherol and / or ascorbyl palmitate, which is at least one crosslink
- the topical therapeutic system according to the invention is characterized in that it comprises an area of about 40 to 250 cm 2 , preferably of about 70 and about 160 cm 2 .
- the topical therapeutic system according to the invention is characterized in that it comprises a redetachable protective layer, preferably a siliconized polyethylene terephthalate film, which is adhered to the side of the active substance-containing matrix layer, which is not the occlusion-inducing layer.
- This removable protective layer makes the topical therapeutic system according to the invention packable and transportable.
- the term "comprising” may also mean “consisting of”.
- the topical therapeutic system according to the invention in a particularly preferred embodiment is characterized in that the at least one active ingredient diclofenac sodium salt in an amount of 1 to 10 wt .-%, the at least one penetration enhancer oleic acid in an amount of 5 to 30 wt .-%, the at least one non-occlusive adhesive based on an acrylate / vinyl acetate copolymer in an amount of 50 to 98 wt .-%, the antioxidant alpha-tocopherol in an amount of 0.05 to 3 wt %, which contains at least one crosslinking agent aluminum acetylacetonate in an amount of 0.1 to 10 wt .-%, based on the active ingredient-containing matrix layer, in the active ingredient-containing matrix layer, and the occlusion-causing layer a polyisobutylene adhesive based on a low molecular weight Polyisobutylene adhesive and a high molecular weight polyisobutylene adhesive comprises.
- the present invention also relates to a topical therapeutic system as described above as a medicament.
- the present invention relates to a topical therapeutic system as described above, for use in pain and inflammatory conditions, such as in inflammatory rheumatic diseases, such as chronic polyarthritis, fibromyalgia or osteoarthritis, acute attacks of gout, joint injuries during exercise, pain and swelling after surgery, Herniated discs, venous diseases.
- inflammatory rheumatic diseases such as chronic polyarthritis, fibromyalgia or osteoarthritis, acute attacks of gout, joint injuries during exercise, pain and swelling after surgery, Herniated discs, venous diseases.
- Topical Therapeutic Systems A, B, C, D and E with the active ingredient-containing matrix layer shown in Table 1 and a backing layer of PET, PBT woven or nonwoven or knitted fabric or a PET film (System E) were as follows:
- Topical therapeutic system disclosed in EP 1 312 360 Al containing N-methyl-2-pyrrolidones as penetration enhancers
- Example 1 polyethylene terephthalate
- the in vitro human skin permeation of the systems listed in Example 1 was measured using a Franz cell.
- the donor compartment contains the substance or formulation (eg gels, ointments, solutions, patches).
- the acceptor compartment is filled with buffer or other solutions.
- permeation of a substance through the skin over the selected period of time can be monitored.
- penetration enhancers on the permeation of a substance can be tested by this system.
- the Franz cell was obtained with human abdominal skin from operations.
- 500 ⁇ dermatomixe skin were incubated with a diffusion area of 1.165 cm 2 with the topical therapeutic system.
- Systems A, D and E are comparative examples.
- System A was based on the following constituents: Composition according to EP 1 312 360 A1 ("Dojin patch").
- System D did not use a penetration enhancer.
- the last column of Table 1 indicates how the occlusion was achieved.
- a PET film was applied to the backing layer.
- the backing layer is located directly on the active ingredient-containing matrix layer (without additional adhesive layer).
- Figure 1 and Table 2 show the in vitro human skin permeation of systems A to E.
- Systems B and C according to the invention show a permeation of the active substance in comparable quality to the known system A, but with oleic acid as penetration enhancer, instead of the harmful N-methyl 2-pyrrolidone in the comparison system.
- Comparison of Systems B and C with Comparative System E shows a comparable permeation of the drug due to a comparable occlusion, but without the use of an occlusive support material in Systems B and C.
- Table 3 below shows the water vapor permeabilities of the formulations determined in the laboratory.
- Formulation F corresponds to Formulation E, but without PET film.
- Diclofenac-Na patch formulations with values below 500 g / m 2 of water in 24 h are sufficient to achieve the permeation of diclofenac-Na through the skin in comparable orders of magnitude as in the Dojin patch.
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Epidemiology (AREA)
- Dermatology (AREA)
- Pain & Pain Management (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Rheumatology (AREA)
- Inorganic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
Description
Claims
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP16194418 | 2016-10-18 | ||
PCT/EP2017/076442 WO2018073227A1 (de) | 2016-10-18 | 2017-10-17 | Zweischichtiges topisches therapeutisches system |
Publications (1)
Publication Number | Publication Date |
---|---|
EP3528795A1 true EP3528795A1 (de) | 2019-08-28 |
Family
ID=57178293
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP17784297.8A Withdrawn EP3528795A1 (de) | 2016-10-18 | 2017-10-17 | Zweischichtiges topisches therapeutisches system |
Country Status (7)
Country | Link |
---|---|
US (1) | US20190240167A1 (de) |
EP (1) | EP3528795A1 (de) |
JP (1) | JP2019531355A (de) |
CN (1) | CN109862885A (de) |
BR (1) | BR112019007325A2 (de) |
CA (1) | CA3038702A1 (de) |
WO (1) | WO2018073227A1 (de) |
Families Citing this family (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP3725306A1 (de) * | 2019-04-17 | 2020-10-21 | LTS Lohmann Therapie-Systeme AG | Transdermales therapeutisches system |
US11752114B2 (en) | 2019-04-17 | 2023-09-12 | Lts Lohmann Therapie-Systeme Ag | Transdermal therapeutic system |
US20220241218A1 (en) * | 2019-04-17 | 2022-08-04 | Lts Lohmann Therapie-Systeme Ag | Transdermal therapeutic system |
DE102021128911A1 (de) * | 2021-11-05 | 2023-05-11 | Lts Lohmann Therapie-Systeme Ag. | Diclofenac enthaltendes tts mit dimethylpropylenharnstoff |
DE102021128912A1 (de) | 2021-11-05 | 2023-05-11 | Lts Lohmann Therapie-Systeme Ag. | Okklusives pflaster mit flexibler backing |
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DE4313402A1 (de) * | 1993-04-23 | 1994-10-27 | Hexal Pharma Gmbh | Transdermale Wirkstoffzubereitung |
DE19830649C2 (de) * | 1998-07-09 | 2003-04-10 | Lohmann Therapie Syst Lts | Topisches Pflaster mit nichtsteroidalen Antirheumatika mit Säuregruppe |
ATE517614T1 (de) * | 2000-04-18 | 2011-08-15 | Hisamitsu Pharmaceutical Co | Pflaster enthaltend einen anti-inflammatorischen wirkstoff |
DE10103860B4 (de) * | 2001-01-30 | 2004-12-23 | Lts Lohmann Therapie-Systeme Ag | Transdermales therapeutisches System für die Verabreichung carboxylgruppenhaltiger, nichtsteroidaler Antiphlogistika, sowie Verfahren zu seiner Herstellung |
JP4865958B2 (ja) | 2001-05-23 | 2012-02-01 | 株式会社トクホン | 鎮痛抗炎症局所作用型の貼付剤 |
JP4194277B2 (ja) * | 2002-01-25 | 2008-12-10 | 久光製薬株式会社 | 架橋ポリマーを主成分とする粘着性成形体の製造方法 |
DE102011114411A1 (de) * | 2011-09-26 | 2013-03-28 | Lts Lohmann Therapie-Systeme Ag | Pflaster mit einstellbarer Okklusion |
CA2981397C (en) * | 2015-04-08 | 2023-04-04 | Lts Lohmann Therapie-Systeme Ag | Electrically heatable plaster |
-
2017
- 2017-10-17 CN CN201780064312.0A patent/CN109862885A/zh active Pending
- 2017-10-17 EP EP17784297.8A patent/EP3528795A1/de not_active Withdrawn
- 2017-10-17 WO PCT/EP2017/076442 patent/WO2018073227A1/de unknown
- 2017-10-17 CA CA3038702A patent/CA3038702A1/en not_active Abandoned
- 2017-10-17 BR BR112019007325A patent/BR112019007325A2/pt not_active Application Discontinuation
- 2017-10-17 JP JP2019541880A patent/JP2019531355A/ja active Pending
- 2017-10-17 US US16/343,195 patent/US20190240167A1/en not_active Abandoned
Also Published As
Publication number | Publication date |
---|---|
CN109862885A (zh) | 2019-06-07 |
WO2018073227A1 (de) | 2018-04-26 |
US20190240167A1 (en) | 2019-08-08 |
BR112019007325A2 (pt) | 2019-07-02 |
JP2019531355A (ja) | 2019-10-31 |
CA3038702A1 (en) | 2018-04-26 |
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