CN108685877A - With the patch system for percutaneous absorbtion for minimizing skin irritatin - Google Patents
With the patch system for percutaneous absorbtion for minimizing skin irritatin Download PDFInfo
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- CN108685877A CN108685877A CN201810311417.8A CN201810311417A CN108685877A CN 108685877 A CN108685877 A CN 108685877A CN 201810311417 A CN201810311417 A CN 201810311417A CN 108685877 A CN108685877 A CN 108685877A
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- 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
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- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/02—Cosmetics or similar toiletry preparations characterised by special physical form
- A61K8/0208—Tissues; Wipes; Patches
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
- A61Q19/00—Preparations for care of the skin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2800/00—Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
- A61K2800/10—General cosmetic use
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- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
The present invention relates to a kind of patch systems for percutaneous absorbtion, include (a) external protection, (b) solvent type adhesive layer, (c) non-solvent adhesive phase, and (d) releasing layer, the releasing layer is the film being removed before use, wherein, the solvent type adhesive layer is adjacent with the external protection, and the non-solvent adhesive phase it is adjacent with the releasing layer and when in use with skin contact, and wherein, the solvent type adhesive layer and/or the non-solvent adhesive phase include one or more ingredients in the group being made of skin actives and medicinal active ingredient.The patch system effectively can absorb various active constituents via skin and reduce skin irritatin to greatest extent in the skin for being applied to human body.
Description
Technical field
The present invention relates to a kind of patch systems for percutaneous absorbtion for having and minimizing skin irritatin.More specifically, this
Invention is related to a kind of in the skin for being applied to human body, effectively can absorb various active constituents and maximum limit via skin
Degree reduces the patch system of skin irritatin.
Background technology
The needs for the various active constituents that advantageous effect is showed to human body are used by skin in response to long-time,
It has been widely used the patch using contact adhesive.
Various preparations, creme, lotion, ointment, finish, spraying, patch etc. can be used for delivering to people by skin
The method that body shows the active constituent of advantageous effect.Wherein, the creme in addition to pasting dosage formulation, lotion, ointment, finish,
Spraying etc. usually shows short run effect, and after application can due to external factor, such as water or clothing and be washed off or
It is removed in an undesired manner.In addition, the administration time of product may be temporary, and therefore, troublesome to be, product
It must one day administered several times.
On the contrary, patch dosage formulation can application to skin a very long time, such as 3 hours or longer, or if need
Sustainable 24 hours or longer are wanted, to keep required effect.Therefore, it can be said that this preparation is best suited for active constituent
It is effectively delivered to human body by skin.
The patch product of most conventional uses solvent type adhesive, and specifically, mainly use rubber adhesive,
Acrylate adhesive or silicone based adhesive.When the product using these solvent type adhesives by the contact with skin come
When using a very long time daily, they may result in skin allergy sexual stimulus.
In addition, the characteristics of solvent type adhesive of routine, is, when patch product application to skin and then stripping, they
It can lead to skin irritatin.In addition, for solvent type adhesive, when being subjected to process, it is difficult to make remaining micro- in product
Residual solvent control is measured in law allowable range.
It specifically, when in use and/or after use may be to a certain degree when conventional patch product is applied to human body
Cause skin irritatin, and therefore to using the consumer of the patch to be likely to result in serious problem.If patch product by
Serious problems are caused to consumer in this skin irritatin, then while its have single administration just can be by active constituent
This benefit of long-time application to skin, consumer can also avoid this patch product.
Accordingly, there exist the demand to novel patch product, this novel patch product is when application to skin and then tears
When there is smaller skin irritatin, and with asking caused by the less undesirable residual solvent by included in traditional patch
Topic.
Invention content
In these cases, the shortcomings that present inventor has performed extensive researchs to overcome conventional patch product, and
It was found that when solvent type adhesive layer and non-solvent adhesive phase are incorporated as specific layer structure, not only activity at
It point dermal delivery and can be also obtained without there are the degradation of effective active composition or active reductions during application
The preparation that skin irritatin present in conventional patch can be reduced to greatest extent, has thus completed the present invention.
Therefore, the present invention provides a kind of patch system for percutaneous absorbtion, and the patch system includes:
(a) external protection,
(b) solvent type adhesive layer, the solvent type adhesive layer have at least one layer,
(c) non-solvent adhesive phase, the non-solvent adhesive phase have at least one layer, and
(d) releasing layer, the releasing layer are the film being removed before use,
Wherein, the solvent type adhesive layer is adjacent with the external protection, and the non-solvent adhesive phase with
The releasing layer it is adjacent and when in use with skin contact.
According to the present invention, the non-solvent adhesive phase has the 180 degree peel strength of 0.1N/25mm~10N/25mm
And the after tack value of 0.1N/25mm~8N/25mm.
According to one embodiment, the non-solvent adhesive phase may include hotmelt.
The hotmelt may include selected from by hydrogenated styrene block copolymers and the copolymerization of non-hydrogenated styrene block
It is one or more in the group of object composition.
Preferably, the hydrogenated styrene block copolymers can be selected from by hydrogenated styrene/butadiene copolymer, hydrogenation of benzene
Ethylene/methyl styrene/indene copolymer, hydrogenation of ethylene/propylene/styrene copolymer, hydrogenation butylene/ethylene/styrene copolymerization
The group that object is formed;And the non-hydrogenated styrene block copolymers are selected from by styrene/isoprene/styrene block
Copolymer, styrene/butadiene/styrene block copolymers, styrene/isoprene/butadiene/styrene block copolymer
The group formed.
The solvent type adhesive layer may include being selected to be glued by acrylate adhesive, rubber adhesive and silicone
One or more adhesives in the group formed described in mixture.
According to one embodiment, the non-solvent adhesive phase without containing any active constituent or contain at least one
The active constituent stablized kind at a temperature of 120 DEG C~200 DEG C, and the solvent type adhesive layer contain at least one activity at
Point, wherein the active constituent is selected from the group being made of skin actives and medicinal active ingredient.
In the patch system of the present invention, the weight of the solvent type adhesive layer and the non-solvent adhesive phase
Amount is than that can be 90:10 to 10:90, preferably 80:20 to 20:80.
In the patch system of the present invention, the thickness of the solvent type adhesive layer and the non-solvent adhesive phase
Degree is than that can be 90:10 to 10:90, preferably 80:20 to 20:80.
Specifically, the thickness of the solvent type adhesive layer can be 10~200 μm, preferably 20~120 μm, more preferably
30~120 μm.The thickness of the non-solvent adhesive phase can be 10~300 μm, preferably 20~120 μm, more preferably 20
~80 μm.
Specifically, the skin actives can be one or more Cosmetic Ingredients in the group that following item forms:
Skin elasticity improver, moisturizer, lipidolysis accelerating agent, carbohydrate-modifying inhibitor for lipid, burning lipid
Matter, blood circulation improving agent, exfoliator, alleviate the reagent of skin freckle, brightening agent, the reagent for alleviating Atopic dermatitis,
Anti wrinkling agent, antidotal agent, light senescence inhibitor, hot senescence inhibitor, collagen generate accelerating agent, elastin laminin activator,
Hyaluronic acid generates reinforcing agent, free radical scavenger, cell expansion agents, keratinocyte proliferation inhibitor, harmful active oxygen
Inhibitor, cytothesis substance, skin regeneration promoter, anti-acne agents and the antioxidant of generation.
Preferably, the skin actives can be one or more in the group being made of following item:Collagen egg
In vain, retinoids, vitamin A, vitamin C, vitamin E, 'alpha '-hydroxy acids, beta-hydroxy acid, curcuminoids, resveratrol are transparent
Matter acid, ursin, niacinamide, vitamin B5, Co-Q10, adenosine, elastin laminin, chitosan, albumin, yolk, milk proem,
Capsaicine, conjugate linolenic acid, caffeine, Garcinia Cambogia (HCA), pyruvic acid and inulin propionic ester, phosphatidyl choline, l-carnitine, L-
Arginine, modified capsaicine, catechin, chromium, lipase, the extract of the following terms:Aloe, green tea, Korean ginseng, red ginseng,
Pyroligneous liquor, pine tree leaf, ginkgo leaf, propolis, mulberry leaf, silkworm, snail mucus, Ka Kaduli, Ka Muguo, A Sayi palm, spiny dogfish
Alkane, caviar, broccoli, blueberry, hamamelis, golden tail tiger, chlorella, mangosteen, guava, Fructus Corni, carrot, coffee
Beans, wood in perfume, spirulina, Salmon Roe, chamber kelp, bulk kelp, kelp, common purslane, green laver, agar, Sang Gen, cover basin
Son, wild strawberry, sargassum fusifome, sargassum, edelweiss, chamomile, lavender, peppermint, eucalyptus, lemon mint, wild marjoram, tea tree,
The form of scutellaria, cordate houttuynia, sea-buckthorn, citron and soybean and their free alkali, the form of pharmaceutically acceptable salt with
And their derivative.
Specifically, the active constituent pharmaceutically can be selected from by following item group in groups in one or more ingredients:
Steroids medicament, contraceptive, antiphlogistic medicament, dermatitis remedies, smoking cessation adjuvant, angina pectoris remedy, Treating Bronchial Asthma
Agent, hypertension therapeutic agent, antalgesic, narcotic analgesics, emesis agent, alleviates nausea at attention deficit/hyperactivity therapeutic agent
Therapeutic agent, treatment of Parkinson disease agent, the agent of anaphylaxis cystitis treatments in medicament, dementia remedies, alzheimer disease, epidemic disease
Seedling and antidepressants.
Preferably, the active constituent pharmaceutically be selected from by following item group in groups in one or more ingredients:It is female
Glycol, testosterone, estradiol/progesterone compound, estradiol/norethindrone, ethinylestradiol, ethinylestradiol/norgestrel, female two
Alcohol/Levonorgestrel, Ketoprofen, piroxicam, Triamcinolone acetonide, Flurbiprofen, naproxen, Meloxicam, Flosulide, former times cloth difficult to understand
Rather, Indomethacin, buprenorphine, capsaicine, Diclofenac, nicotine, nitroglycerin, tulobuterol, methylphenidate, clonidine,
Lidocaine, fentanyl, sufentanil, Granisetron, Tropisetron, Ramosetron, hyoscine, Rivastigmine, mostly how piperazine
Together, rotigotine, oxybutynin and selegiline and their free alkali form, their pharmaceutically acceptable salts and it
Derivative.
In the solvent type adhesive layer, the amount of the active constituent is relative to the weight of the solvent type adhesive
0.001~30wt%, preferably 0.01~20wt%.In the non-solvent adhesive phase, the active constituent (if there is
Words) amount relative to the non-solvent adhesive weight be 0.001~30wt%, preferably 0.01~20wt%.
Therefore, the purpose of the present invention is to provide one kind being used for percutaneous absorption patch system, which can be as far as possible
The skin problem occurred when reducing due to skin irritatin in patch product use and/or before and after use, while enhancing patch production
Active constituent is provided to the benefit of skin by product for a long time.
Description of the drawings
Fig. 1 is the figure for the structure for showing the patch system according to the present invention for percutaneous absorbtion.
Specific implementation mode
Hereinafter, the present invention will be described in greater detail with reference to the attached drawings.
As shown in Figure 1, the patch system according to the present invention for percutaneous absorbtion includes:External protection 1;Solvent type bonds
Oxidant layer 2;With the non-solvent adhesive phase 3 of skin contact;And releasing layer 4, the releasing layer are removed before use
Film;Wherein, the solvent type adhesive layer is adjacent with the external protection, and the non-solvent adhesive phase is when in use
With skin contact.That is, in the present invention, including the solvent type adhesive layer of independent stratum form and the non-solvent
Type adhesive phase, and they have following unique structure:They are in specific location adjacent contact, such as solvent type
Layer, contacts with external protection, and for non-solvent layer, it is adjacent to releasing layer and contacts, and is straight with skin when in use
Contact.
In addition, the solvent type adhesive layer and non-solvent adhesive phase employed in the present invention can respectively include it is more
Layer, that is, 2 layers or more layers.According to specific embodiment, the solvent type adhesive layer and the non-solvent adhesive phase
1~7 layer can be respectively provided with.
In the layer structure of this patch system for percutaneous absorbtion, the external protection 1, which plays, assigns preparation machine
Tool performance and the effect for supporting preparation, and the adhesive phase containing active constituent is protected not acted on by ectocine.Outer protection
The material that can be attached to solvent type adhesive layer, the material can be used to prevent the loss of the active constituent during storage for layer, and
With the property for keeping its own shape and to skin without reactive without causing the allergic reaction to skin.Also, it is right
The material is not particularly limited.
The material that can be used as external protection is not particularly limited.As example, such material may include but be not limited to select
Freely one or more materials in the group of following item composition:Polyester, polyolefin film, polyurethane, polyvinyl acetate, poly- inclined two
Vinyl chloride, polyethylene, ethylene vinyl acetate, polyethylene terephthalate, polyacrylonitrile, polybutylene terephthalate
Ester, nylon, artificial silk, non-woven fabrics, acrylic (acryl), silk, cotton, aluminium flake, polyamide etc..External protection can be piece, film, fibre
The form of dimension, fabric, knitted fabric (knitted fabric), non-woven fabrics etc..The external protection can be permeable or can not ooze
Saturating material, such as by including perforated membrane that the material for the laminate being made of two or more above-mentioned combination of polymers is formed.
In the present invention, non-solvent adhesive phase 3 is adjacent with releasing layer 4, and is after removing releasing layer when in use
Directly with the layer of skin contact.
The non-solvent adhesive phase includes hotmelt.Hotmelt refers to such adhesive:In room temperature
Under exist with solid state, and 100% solid content is only melted by heating and is used with molten condition, without dissolving or
Dispersion is in a solvent.Hotmelt is pressure-sensitive synthetic rubber class adhesive, relative to solvent type adhesive etc., is not necessarily to drying
Process, and due to not using solvent but environment friendly material.
Hotmelt for non-solvent adhesive phase can be base resin commonly used in the prior art.These hot melts
The example of adhesive includes polyolefin-type, such as polybutadiene ene-type, polyisoprene type, polyethylene, polypropylene;Styrene
Block copolymer type;Polyindene type;Polyamide;Non-hydrogenated styrene block copolymer;Polyester-type, such as ethane-acetic acid ethyenyl
Ester type;Polyurethane-type (reactive hot-melt body);Hydrogenated styrene block copolymers etc., but it is not limited to this.
The specific example of this hotmelt includes hydrogenated styrene block copolymers, and but it is not limited to this.
In addition, hydrogenated styrene block copolymers include hydrogenated styrene/butadiene copolymer, hydrogenated styrene methyl
Styrene/indene copolymer, hydrogenation of ethylene/propylene/styrene copolymer, hydrogenation butylene/ethylene/styrene copolymer etc., but simultaneously
It is without being limited thereto.Non-hydrogenated styrene block copolymer includes styrene/isoprene/styrene block copolymer, styrene/fourth
Diene/styrene block copolymer, styrene/isoprene/butadiene/styrene block copolymer etc., but it is not limited to this.
In the specific embodiments of the present invention, it is heated using PSM154A DERMA-TAK (being purchased from Henkel) as non-solvent
Adhesive builds the patch system for percutaneous absorbtion.
In the present invention, the hotmelt used in non-solvent adhesive phase preferably has 50,000~3,000,
000 weight average molecular weight and 100~1,000,000 degree of polymerization distribution, but it is not limited to this.
Hotmelt for the non-solvent adhesive phase, which usually has at a temperature of 150 DEG C~180 DEG C, to be added
Work, this is relatively higher than the processing temperature for the adhesive for solvent type adhesive layer that will be described below.
When the present invention is for the patch system application to skin of percutaneous absorbtion and when from skin removed, non-solvent heats
Adhesive is for significantly decreasing skin irritatin.
Specifically, compared with solvent-type acrylic ester adhesive, during adhering to and detaching patch product, hot melt is viscous
Mixture can smoothly be fallen off so that traditional patch product is removed required power from skin compared to smaller power, thus reduced
Excellent physical property is shown in terms of skin irritatin.Preferably, non-solvent hot melt adhesive layer have 0.1N/25mm~
The 180 degree peel strength of 10N/25mm and the after tack value of 0.1N/25mm~8N/25mm.
Peel strength measures herein according to the method for ASTM D903, is one of the method for measuring adhesion strength, and
And it indicates to remove the testing piece after being adhered to testing piece on the uniform and glass plate of smooth surface with 180 ° of angle
Required power.The numerical value the high, means that adhesion strength is higher, demonstrates the need for higher power to remove the testing piece.In addition, sticky
(tack) refer to instantaneous adherence, and after tack (loop tack), measured herein according to the method for ASTM D6195, be
Refer to indicate testing piece particular area (in general, 1 square inch area) under constant force with constant speed and metal surface
After contact, the value of the power needed for the testing piece is removed with constant speed, and the value is higher shows that adhesion strength is higher.In the present invention
Patch system in, non-solvent hot melt adhesive layer has peel strength and after tack within the above range, and therefore,
The product only needs compared with solvent type product about 6% power just can be easily from skin removed.
Therefore, in the patch system of the present invention, when the non-solvent adhesive phase formed by hotmelt is placed on
Can be in direct contact with the skin side when, when the product application to skin long-time or when from the skin removed product
When, it can be easily peeled off the product, without skin irritatin.
The thickness of non-solvent adhesive phase is 10 μm~300 μm, preferably 20 μm~120 μm, more preferable 20 μm~80 μm.
Further, referring back to Fig. 1, the solvent type adhesive layer 2 of patch system of the invention and external protection 1 and non-molten
Dosage form adhesive phase 3 abuts.Solvent type adhesive layer 2 includes solvent type adhesive.It is different from non-solvent adhesive, solvent type
Adhesive refers to by being dissolved or dispersed in the adhesive for becoming liquid in solvent to use.
The example of solvent type adhesive includes acryloyl class adhesive, rubber adhesive and silicone based adhesive etc., but
Be, can without restriction used in any adhesive, as long as it can serve as solvent type adhesive.
Specifically, the monomer for being used for acryloyl class adhesive can not have substituent group, it is possible to have at least one such as hydroxyl
The substituent group of base, epoxy group, carboxyl etc..The monomer of acryloyl class adhesive includes (methyl) acrylic acid, (methyl) alkyl acrylate
Base ester, wherein alkyl can have 1~12 carbon atom.
In addition, rubber adhesive can be natural rubber, synthetic rubber or graft rubber class adhesive.Preferably, rubber
Class adhesive can be selected from polyisobutene, polyisobutylene blend, neoprene, polybutadiene, polyisoprene, polysiloxanes,
Acryloyl class adhesive, vinyl acetate-binder, polyacrylate, ethylene vinyl acetate copolymer, styrene-isoamyl two
Alkene copolymer and polyurethane.
As silicone based adhesive, silicon rubber (such as polysiloxanes) or silicone resin adhesive can be used.These are molten
Dosage form adhesive shows various adhesion strengths and physical property according to the degree of polymerization, and they can be used alone or in combination.
The present invention solvent type adhesive layer used in adhesive have 50,000~3,000,000, preferably 100,000~1,000,
000 weight average molecular weight, but it is not limited to this.
The thickness of solvent type adhesive layer is 10 μm~200 μm, preferably 20 μm~120 μm, more preferable 30 μm~120 μm.
Solvent type adhesive, such as propionyl class adhesive, rubber adhesive and silicone based adhesive, depending on being used
Solvent, their processing temperature is slightly different, but the representative condition that processing is manufacturing process is carried out at 80 DEG C~120 DEG C.
However, as described above, because the hotmelt of non-solvent exists with solid block at room temperature, and in order to
Its processing is carried out, needs to be handled at a high temperature of about 150 DEG C~200 DEG C.Therefore, when including thermal sensitivity or unstable work
Property ingredient and/or when additive, it is possible that degradation occurs or the problem of stability degradation.
According to the present invention in the patch system of percutaneous absorbtion, being born when by active constituent or additive to be loaded
It is loaded onto when on solvent type adhesive layer or non-solvent adhesive phase, it is characterised in that consider these processing characteristics to load
(including) they.
Specifically, in patch system according to the present invention, even if still to thermostabilization at a temperature of 120 DEG C~200 DEG C
Active constituent and additive also can all be supported on solvent type adhesive layer or non-solvent adhesive phase.But to heat
Unstable active constituent and additive is supported on respectively with compared on the solvent type adhesive layer of low processing temperature.
That is, although when being removed from skin, hotmelt can be easily peeled off without skin irritatin, but
Be active constituent or additive unstable under 120 DEG C~200 DEG C of high processing temperature can not be applied to high plus
Method in the hotmelt of work temperature.However, in patch system according to the present invention, by opposite using having simultaneously
The solvent type adhesive layer of low processing temperature and non-solvent adhesive phase with higher processing temperature, can ask to avoid these
Topic.
In patch system according to the present invention, the stable active constituent quilt under 120 DEG C~200 DEG C of high processing temperature
It is absorbed included in the non-solvent adhesive phase with skin contact, therefore by direct contact with the skin.In addition, 120
DEG C~200 DEG C of high processing temperature under unstable active constituent be comprised in the solvent type adhesive layer with skin contact,
Therefore, the active constituent being supported on solvent type adhesive layer spreads according to concentration gradient and is moved to adjacent non-solvent and glues
In mixture layer.Therefore, it is diffused into active constituent in non-solvent adhesive phase finally and skin contact.
Therefore, solvent type adhesive layer and non-solvent adhesive phase are formed with independent layer, and under high temperature process
Unstable active constituent is not absorbed by direct contact with the skin by, and one or more non-solvents is passed through to bond
Oxidant layer and and skin contact.Therefore, because the problem of solvent type adhesive layer itself, the disadvantage is that being difficult to be moved to non-solvent
Adhesive phase or non-solvent adhesive phase are likely to become barrier layer, therefore the finally amount with the active constituent of skin contact
And its rate of release may be non-constant or insufficient.
In order to make these active constituents be enough with skin contact it is effective amount and speed release, it is molten as making to be supported on
Active constituent on dosage form adhesive phase is easily moved to the method in adjacent non-solvent adhesive phase, can be in adjacent layer
It is middle to use various concentration, or the component of active constituent that can will be completely dissolved in solvent type adhesive layer load to it is non-
In solvent type adhesive layer, to which the active constituent that induction is supported on solvent type adhesive layer is moved to non-solvent adhesive phase
It is dynamic.
In addition, according to the present invention in the patch system of percutaneous absorbtion, solvent type adhesive layer and non-solvent
Weight ratio (the solvent type adhesive layer of adhesive phase:Non-solvent adhesive phase) can be 90:10 to 10:90, preferably 80:20 to
20:80.In addition, thickness ratio (the solvent type adhesive layer of solvent type adhesive layer and non-solvent adhesive phase:Non-solvent is viscous
Mixture layer) can be 90:10 to 10:90, preferably 80:20 to 20:80.When solvent type adhesive layer and non-solvent adhesive phase have
When having weight ratio as described above and/or thickness ratio, particularly, the active constituent for being supported on solvent type adhesive layer can be appropriate
Ground is eluted and is easy to effectively be absorbed by skin by non-solvent adhesive phase.
In addition, when various additives are mixed and are only loaded to an adhesive phase and various in terms of causing stability are asked
When topic, the active constituent of patch to be loaded to or additive are loaded to two different adhesive phases with different processing temperatures
On may be particularly useful.In addition, even other are since various active constituents or additive mix and generate steady
The generation of the chemical reactions such as the problem of qualitative aspect, or acid-base reaction, also similarly can be to avoid advantageous to provide
The advantages of.
The active constituent that can be comprised in the patch system of the present invention may include selected from by showing human body beneficial to effect
The medicinal active ingredient of fruit and to skin show advantageous effect Cosmetic Ingredient composition group in one or more ingredients, but
It is not limited to this.However, as described above, it is considered that their denaturation or stability at high temperature and with the activity that is used together
They selectively can be loaded to solvent type or non-solvent adhesive phase by the interaction etc. of ingredient.
Specifically, it may include the present invention patch system in the Cosmetic Ingredient that advantageous effect is showed to skin include
It is one or more in following item:Skin elasticity improver, moisturizer, lipidolysis accelerating agent, it is carbohydrate-modifying be fat
The inhibitor of matter, blood circulation improving agent, exfoliator, the reagent for alleviating skin freckle, brightening agent, delays burning lipid matter
Reagent, anti wrinkling agent, antidotal agent, light senescence inhibitor, hot senescence inhibitor, the collagen for solving Atopic dermatitis generate rush
Reinforcing agent, free radical scavenger, cell expansion agents, keratinocyte are generated into agent, elastin laminin activator, hyaluronic acid to increase
Grow inhibitor, the inhibitor that harmful active oxygen generates, cytothesis substance, skin regeneration promoter, anti-acne agents and anti-oxidant
Agent etc., but it is not limited specifically, as long as they show advantageous effect in application to skin.
The example of useful activity ingredient for Cosmetic Ingredient selected from by following item group in groups in it is one or more:Collagen
Albumen, retinoids (retinoid), vitamin A, vitamin C, vitamin E, 'alpha '-hydroxy acids, beta-hydroxy acid, curcuminoids, in vain
Veratryl alcohol, hyaluronic acid, ursin (arbutin), niacinamide, vitamin B5, Co-Q10, adenosine, elastin laminin, chitosan,
Albumin, yolk, milk proem, capsaicine, conjugate linolenic acid, caffeine, Garcinia Cambogia (HCA), pyruvic acid and inulin propionic ester, phosphorus
Phosphatidylcholine, l-carnitine, L-arginine, modified capsaicine, catechin, chromium, lipase, the extract of the following terms:Aloe,
Green tea, Korean ginseng, red ginseng, pyroligneous liquor (pyroligneous liquor), pine tree leaf, ginkgo leaf, propolis, mulberry leaf, silkworm, snail
Ox mucus, Ka Kaduli (kakadu plum), Ka Muguo (camu camu), A Sayi palms (acai palm), saualane,
Caviar, broccoli, blueberry, hamamelis (witch hazel), golden tail brave (acerola), chlorella (chlorella),
It is fragrant in mangosteen (mangosteen), guava, Fructus Corni (Cornus officinalis), carrot, coffee bean, wood
(hamamelis), spirulina, Salmon Roe, chamber kelp (Ecklonia cava), bulk kelp (giant kelp), kelp
(Laminaria japonica areschoung), common purslane (common purslane), green laver, agar
(Gelidium amansii), Sang Gen, raspberry, wild strawberry, sargassum fusifome (hijiki), sargassum (gulfweed), edelweiss
(edelweiss), chamomile, lavender, peppermint, eucalyptus, lemon mint (lemon balm), wild marjoram, tea tree, scutellaria
(skullcaps), cordate houttuynia (Houttuynia cordata), sea-buckthorn (sea buckthorn), citron (citron) and big
The form of beans and their free alkali, the form of pharmaceutically acceptable salt and their derivative, but be not limited to
This.
It may include showing that the example of the pharmaceutically therapeutic agent of advantageous effect may include in the patch system of the present invention
One or more active constituents pharmaceutically in the group of following item composition:Steroids medicament, contraceptive, antiphlogistic medicament, dermatitis
Therapeutic agent, smoking cessation adjuvant, angina pectoris remedy, Treating Bronchial Asthma agent, attention deficit/hyperactivity therapeutic agent, high blood
Press therapeutic agent, antalgesic, narcotic analgesics, emesis agent, the medicament for alleviating nausea, dementia remedies, alzheimer disease
In therapeutic agent, treatment of Parkinson disease agent, the agent of anaphylaxis cystitis treatments, vaccine and antidepressants, but do not limit particularly
System, as long as they show advantageous effect pharmaceutically in application to skin.
The example for use in the present invention for showing the pharmaceutically medicinal active ingredient of advantageous effect includes selected from by following
One or more medicinal active ingredients in the group that item is formed:Estradiol, testosterone, estradiol/progesterone compound, estradiol/
Norethindrone, ethinylestradiol, ethinylestradiol/norgestrel, estradiol/Levonorgestrel, Ketoprofen, piroxicam, Qu An
Nai De, Flurbiprofen, naproxen, Meloxicam, Flosulide, oxybutynin, Indomethacin, buprenorphine, capsaicine, double chlorine are fragrant
Acid, nicotine, nitroglycerin, tulobuterol, methylphenidate, clonidine, lidocaine, fentanyl, sufentanil, Granisetron,
Tropisetron, Ramosetron, hyoscine, Rivastigmine, donepezil, rotigotine, oxybutynin and selegiline, and
Their free alkali form, their pharmaceutically acceptable salts and their derivative, but be not particularly limited, as long as it
Advantageous effect pharmaceutically is shown in application to skin.
The drug that is determined in the area of the concentration and appropriate preparation that can show advantageous effect by these active constituents and
Under conditions of additive, the total amount for the active constituent that may include in patch system according to the present invention is based on solvent type adhesive
Or the weight of non-solvent adhesive can be 0.001wt%~30wt%, preferably 0.01wt%~20wt%.When active constituent
When amount is more than 30wt%, the concentration of active constituent is high in adhesive phase, and active constituent can be settled out crystal after preparation.Work as work
Property ingredient amount when being less than 0.001wt%, the concentration of active constituent is low in adhesive phase, it reduce the permeability of skin, from
And the effect of reducing the active constituent for showing effective effect.
In addition, as needed, various additives can be used for the solvent type adhesive layer of the present invention and/or non-solvent glues
Mixture layer.The example of additive includes transdermal absorption accelerator, tackifier, plasticizer, antioxidant, filler etc..
In the present invention, during adhesive phase can be penetrated to the skin containing transdermal absorption accelerator with to increase active constituent
Rate.The example of transdermal absorption accelerator includes pyrrolidinone derivatives, has C8-18Derivative of fatty acid or fatty acid alcohol
Derivative, myristic acid derivative, Tocopheryl derivatives, polyalcohol, alkylamine, surfactant or glycerol triacetate etc.,
And they can be used alone or are applied in combination.
The example of tackifier includes rosin and its derivative with 3~12 carbon atoms, alicyclic saturated hydrocarbon resin, fat
Race's hydrocarbon resin, terpene resin and maleic acid resin etc., and rosin derivative may include the glyceride of rosin, hydrogenated rosin, hydrogen
Change the pentaerythritol ester etc. of the glyceride and rosin of rosin.
The example of plasticizer includes that oil is oily (paraffinic, naphthalenes processing oil, aromatic processing oil), squalene,
Vegetable oil (olive oil, camellia oil, castor oil, tall oil, peanut oil), silicone oil, dibasic acid ester (dibutyl phthalate, neighbour
Dioctyl phthalate), liquid rubber component (polybutene, liquid isoprene rubber), (myristic acid is different for liquid fatty acid esters
Propyl ester, lauric acid hexyl ester, diethyl sebacate, diisopropyl sebacate, diethylene glycol (DEG), polyethylene glycol, salicylic acid, ethylene glycol, third
Glycol, dipropylene glycol and glyceryl triacetate etc..
The releasing layer 4 of the present invention is to be laminated to non-solvent adhesive phase 3 in the following, and in the patch using percutaneous absorbtion
Before system/and until when using the patch system of percutaneous absorbtion, protect the layer of adhesive phase.It is not special to its material or shape
Limitation, as long as these functions can be realized.
The example of material suitable for releasing layer includes such as polyester, polyvinyl acetate, polyvinylidene chloride, poly- third
Alkene, polystyrene, makrolon, ethylene vinyl acetate, polyethylene, polyethylene terephthalate, poly terephthalic acid
Butanediol ester, aluminium flake, paper and combination thereof.The releasing layer can be formed as the form of film simultaneously by one or more above materials
And silicone coated is in the side of these films.In a preferred embodiment, the thickness of releasing layer can be 20 μm~300 μm, preferably
30 μm~150 μm.
The present invention provides a kind of preparation for percutaneous absorbtion, the preparation includes external protection, solvent type adhesive
Layer, non-solvent adhesive phase and releasing layer, wherein the solvent type adhesive layer is contacted with the external protection, and are being applied
The non-solvent adhesive phase is in direct contact with the skin when with to skin.Said preparation this have the advantage that:With it is conventional percutaneous
Preparation is compared, and preparation of the invention can not only significantly decrease skin thorn in application to skin and/or when being removed from skin
Swash, is supported on to Simultaneous Stabilization active constituent or additive unstable at a temperature of high disposal, but also can be with enough amounts
Active constituent is used with rate, so as to highly useful is used as patch.
Hereinafter, composition and effect of the invention will be described in more detail by way of embodiment.However, being given
These embodiments gone out are only used for purpose of explanation, and the scope of the present invention is not limited to these embodiments.
Embodiment 1:The preparation of patch according to the present invention for percutaneous absorbtion
In order to prepare the patch system according to the present invention for percutaneous absorbtion, made according to being formed shown in the following table 1
Standby patch.
[Table 1]
| Component | It measures (weight %) |
| DuroTak 87-2196 | 60% |
| PSM 154A DERMA-TAK | 30% |
| Alpha-tocopherol acetate | 4% |
| Caffeine | 5% |
| Isopropyl myristate | 1% |
Specifically, in solvent type adhesive Duro_TAK 87-2196, equably mixed coffee is because of/alpha-tocopherol acetic acid
Ester/isopropyl myristate is to prepare solution.Thus prepared solution is coated to protectiveness film on polyester film or equivalent
On, and then so that solvent is volatilized at 80 DEG C~120 DEG C, to prepare primary applicator roll (roll).
Hotmelt (PSM 154A DERMA-TAK) is placed in fusion tank, and keeps it abundant at 180 DEG C
Fusing is subsequently coated on the polyester film of silicone coated or is equal on film to prepare secondary applicator roll.The secondary is coated with layer of rolls
It is pressed on primary applicator roll, is subsequently molded into pre-prepd shape.
Embodiment 2:The analysis of the physical property and skin irritation effect of non-solvent adhesive phase (hot melt)
For non-solvent adhesive more of the invention and typical solvent-type acrylic ester adhesive DURO-TAK
The physical property of 8027 (acrylic copolymer is produced by Henkel) carries out following experiment.
It specifically, will using solvent ethyl acetate (76.5v/v%), isopropanol (20.5v/v%) and toluene (3v/v%)
Above-mentioned DURO-TAK 8027 (solvent type adhesive) is prepared into solution, and is subsequently coated in polyester film, dry big to prepare
The small testing piece for 25mm × 110mm.In addition, PSM 154A DERMA- of the melting as non-solvent adhesive at 180 DEG C
TAK (hydrogenation of ethylene acrylonitrile-styrol copolymer) is then coated onto in polyester film with forming solution, dry to prepare size
For the testing piece of 25mm × 110mm.
Since 180 degree peel strength is influenced by temperature and humidity, so making temperature and humidity be maintained at 23 when measuring
± 2 DEG C of normal temperature and 50% standard relative humidity.Adhesive tape to be tested is cut into the width of the length and 110mm of 25mm
Degree, and test-strips to be measured are cleaned with standard solvent.Then, after having removed releasing layer from surface to be measured,
It is set to be adhered to surface to be measured using rectangular bonding sponge.At this point, applying minimum power.From surface to be measured
Apparent surface remove releasing layer after, on it be laminated 0.023mm thickness polyester film.By using 2kg from dynamic pressure roller with
The rate of 300mm/min is moved forward and backward to be bonded, and then stands 24 hours at 23 DEG C/50% time.
The testing piece stood at room temperature is set to be fixed on tensile strength test machine (Instron Corporation) and bonding
On power test machine (Test Machines Inc.), and measure 180 degree peel strength, at the same with 180 ° of draw angle and
The rate of extension of 300mm/min removes the testing piece.
In addition, contacted with metal surface with the area of 24mm × 24mm under constant force when test-strips produced as described above and
Power when then being removed with 90 ° of constant angle, the result to measure after tack, and as shown in table 2 below.
[Table 2]The property of adhesive
As can be seen from Table 2, non-compared with typical solvent type adhesive-acrylic ester adhesive DURO-TAK8027
Solvent type (hot melt) adhesive 154A DERMA-TAK are respectively provided with 180 degree peel strength only~9% and~6% and after-tack
Property.This demonstrate paste dosage form product made of non-solvent and be in application to after skin to carry out removing required power and significantly drop
To only the level for 1/17 (~6%) for pasting dosage form product made of solvent type adhesive.Therefore, it was confirmed that, in non-solvent
In the case of adhesive (hot melt), even if after the one long time of the product application to skin, the power needed for the product is removed
About the 6% of solvent-type acrylic ester adhesive situation is only utilized, which can easily remove from skin, without producing
Raw skin irritatin.
Claims (15)
1. a kind of patch system for percutaneous absorbtion,
(a) external protection,
(b) solvent type adhesive layer,
(c) non-solvent adhesive phase, and
(d) releasing layer, the releasing layer are the film being removed before use,
Wherein, the solvent type adhesive layer is adjacent with the external protection, and the non-solvent adhesive phase with it is described
Releasing layer it is adjacent and when in use with skin contact, and
Wherein, the solvent type adhesive layer and/or the non-solvent adhesive phase include selected from by skin actives and
One or more ingredients in the group of medicinal active ingredient composition.
2. patch system according to claim 1, wherein the solvent type adhesive layer or the non-solvent adhesive
Layer includes two or more layers.
3. patch system according to claim 1, wherein the non-solvent adhesive phase includes hotmelt.
4. patch system according to claim 3, wherein the hotmelt includes selected from by hydrogenated styrene block
It is one or more in the group of copolymer and non-hydrogenated styrene block copolymers composition.
5. patch system according to claim 1, wherein the solvent type adhesive layer includes selected from by esters of acrylic acid
One or more adhesives in the group of adhesive, rubber adhesive and silicone based adhesive composition.
6. patch system according to claim 1, wherein the non-solvent adhesive phase have 0.1N/25mm~
The 180 degree peel strength of 10N/25mm and the after tack value of 0.1N/25mm~8N/25mm.
7. patch system according to claim 1, wherein the patch system include two or more skin activities at
Point, and some ingredients in described two or more skin actives are comprised in the solvent type adhesive, and
Other ingredients in described two or more skin actives are comprised in the non-solvent adhesive phase.
8. patch system according to claim 1, wherein even if the skin actives of the non-solvent adhesive exist
It is also heat stable at a temperature of 120 DEG C~200 DEG C.
9. patch system according to claim 1, wherein bonded based on the solvent type adhesive or the non-solvent
The amount of the total weight of agent, the skin actives is 0.001wt%~30wt%.
10. patch system according to claim 1, wherein the solvent type adhesive layer is bonded with the non-solvent
Weight ratio (the solvent type adhesive layer of oxidant layer:Non-solvent adhesive phase) it is 90:10~10:90.
11. patch system according to claim 1, wherein the solvent type adhesive layer is bonded with the non-solvent
Thickness ratio (the solvent type adhesive layer of oxidant layer:Non-solvent adhesive phase) it is 90:10~10:90.
12. patch system according to claim 1, wherein the skin actives are the group formed selected from following item
In one or more Cosmetic Ingredients:Skin elasticity improver moisturizer, lipidolysis accelerating agent, carbohydrate-modifying is
The inhibitor of lipid, burning lipid matter, blood circulation improving agent, exfoliator, the reagent for alleviating skin freckle, brightening agent,
Reagent, anti wrinkling agent, antidotal agent, light senescence inhibitor, hot senescence inhibitor, the collagen for alleviating Atopic dermatitis generate
Accelerating agent, elastin laminin activator, hyaluronic acid generate reinforcing agent, free radical scavenger, cell expansion agents, keratinocyte
Inhibitor, cytothesis substance, skin regeneration promoter, anti-acne agents and the antioxygen that antiblastic, harmful active oxygen generate
Agent.
13. patch system according to claim 1, wherein the skin actives following item selected from being made of
It is one or more in group:Collagen, retinoids, vitamin A, vitamin C, vitamin E, 'alpha '-hydroxy acids, beta-hydroxy acid,
Curcuminoids, resveratrol, hyaluronic acid, ursin, niacinamide, vitamin B5, retinol, Co-Q10, adenosine, elastic egg
In vain, chitosan, aloe, green tea, Korean ginseng, red ginseng, pyroligneous liquor, pine tree leaf, ginkgo leaf, propolis, mulberry leaf, silkworm, snail mucus,
Ka Kaduli, Ka Muguo, A Sayi palm, saualane, caviar, broccoli, blueberry, hamamelis, golden tail tiger, bead
Algae, mangosteen, guava, Fructus Corni Cornus officinalis, carrot, caffeine, wood in perfume hamamelis, spirulina,
Salmon Roe, chamber kelp Ecklonia cava, bulk kelp, kelp Laminaria japonica areschoung, common dent
Amaranth, green laver, agar Gelidium amansii, Sang Gen, raspberry, wild strawberry, sargassum fusifome, sargassum, edelweiss, ocean are sweet
Chrysanthemum, lavender, peppermint, eucalyptus Eucalyptus, lemon mint, wild marjoram, tea tree, scutellaria, cordate houttuynia Houttuynia
Cordata, sea-buckthorn, citron, albumin, yolk, milk proem, capsaicine, conjugate linolenic acid, caffeine, Garcinia Cambogia (HCA), third
It is ketone acid and inulin propionic ester, phosphatidyl choline, l-carnitine, L-arginine, the capsaicine of modification, catechin, chromium, lipase, big
The form of beans and their free alkali, the form of pharmaceutically acceptable salt, their extract and their derivative
Object.
14. patch system according to claim 1, wherein the active constituent pharmaceutically is selected from by following item group
One or more ingredients in groups:Steroids medicament, contraceptive, antiphlogistic medicament, dermatitis remedies, smoking cessation adjuvant, the heart twist
Pain therapeutic agent, Treating Bronchial Asthma agent, attention deficit/hyperactivity therapeutic agent, hypertension therapeutic agent, antalgesic, anesthesia town
Pain medicine, emesis agent, the medicament for alleviating nausea, dementia remedies, the therapeutic agent in alzheimer disease, treatment of Parkinson disease
Agent, the agent of anaphylaxis cystitis treatments, vaccine and antidepressants.
15. patch system according to claim 1, wherein the active constituent pharmaceutically is selected from by following item group
One or more ingredients in groups:Estradiol, testosterone, estradiol/progesterone compound, estradiol/norethindrone, acetylene female two
Alcohol, ethinylestradiol/norgestrel, estradiol/Levonorgestrel, Ketoprofen, piroxicam, Triamcinolone acetonide, Flurbiprofen, naphthalene
General life, Meloxicam, Flosulide, oxybutynin, Indomethacin, buprenorphine, capsaicine, Diclofenac, nicotine, nitric acid are sweet
Oil, tulobuterol, methylphenidate, clonidine, lidocaine, fentanyl, sufentanil, Granisetron, Tropisetron, Lei Mosi
Fine jade, hyoscine, Rivastigmine, donepezil, rotigotine, oxybutynin and selegiline and their free alkali shape
Formula, their pharmaceutically acceptable salts and their derivative.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| KR10-2017-0045510 | 2017-04-07 | ||
| KR1020170045510A KR101892270B1 (en) | 2017-04-07 | 2017-04-07 | Patch system for transdermal absorption with minimized skin irritation |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN108685877A true CN108685877A (en) | 2018-10-23 |
| CN108685877B CN108685877B (en) | 2022-10-04 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201810311417.8A Active CN108685877B (en) | 2017-04-07 | 2018-04-09 | Patch system for percutaneous absorption with minimized skin irritation |
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| Country | Link |
|---|---|
| KR (1) | KR101892270B1 (en) |
| CN (1) | CN108685877B (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112823793A (en) * | 2019-11-20 | 2021-05-21 | 成都康弘药业集团股份有限公司 | Transdermal patch containing donepezil and preparation method thereof |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5662926A (en) * | 1992-04-01 | 1997-09-02 | Bertek, Inc. | Transdermal patch incorporating a polymer film incorporated with an active agent |
| US20040101551A1 (en) * | 2000-08-30 | 2004-05-27 | Thorsten Selzer | Transdermal therapeutic system for releasing venlafaxine |
| CN103313705A (en) * | 2010-12-24 | 2013-09-18 | 株式会社三养生物制药 | Percutaneous absorption preparation containing rivastigmine |
Family Cites Families (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE3910543A1 (en) * | 1989-04-01 | 1990-10-11 | Lohmann Therapie Syst Lts | TRANSDERMAL THERAPEUTIC SYSTEM WITH INCREASED ACTIVE FLUID AND METHOD FOR THE PRODUCTION THEREOF |
| US8906413B2 (en) * | 2003-05-12 | 2014-12-09 | Supernus Pharmaceuticals, Inc. | Drug formulations having reduced abuse potential |
-
2017
- 2017-04-07 KR KR1020170045510A patent/KR101892270B1/en active IP Right Grant
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2018
- 2018-04-09 CN CN201810311417.8A patent/CN108685877B/en active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5662926A (en) * | 1992-04-01 | 1997-09-02 | Bertek, Inc. | Transdermal patch incorporating a polymer film incorporated with an active agent |
| US20040101551A1 (en) * | 2000-08-30 | 2004-05-27 | Thorsten Selzer | Transdermal therapeutic system for releasing venlafaxine |
| CN103313705A (en) * | 2010-12-24 | 2013-09-18 | 株式会社三养生物制药 | Percutaneous absorption preparation containing rivastigmine |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112823793A (en) * | 2019-11-20 | 2021-05-21 | 成都康弘药业集团股份有限公司 | Transdermal patch containing donepezil and preparation method thereof |
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| Publication number | Publication date |
|---|---|
| KR101892270B1 (en) | 2018-08-27 |
| CN108685877B (en) | 2022-10-04 |
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