WO2010123103A1 - 貼付剤入り包装袋、及び貼付剤の保存方法 - Google Patents
貼付剤入り包装袋、及び貼付剤の保存方法 Download PDFInfo
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- WO2010123103A1 WO2010123103A1 PCT/JP2010/057245 JP2010057245W WO2010123103A1 WO 2010123103 A1 WO2010123103 A1 WO 2010123103A1 JP 2010057245 W JP2010057245 W JP 2010057245W WO 2010123103 A1 WO2010123103 A1 WO 2010123103A1
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- packaging bag
- patch
- sensitive adhesive
- pressure
- layer
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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
- A61K9/7076—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising ingredients of undetermined constitution or reaction products thereof, e.g. rosin or other plant resins
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
-
- 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
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
- A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
- A61K31/404—Indoles, e.g. pindolol
- A61K31/4045—Indole-alkylamines; Amides thereof, e.g. serotonin, melatonin
-
- 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
- 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
- A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
-
- 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
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
- A61P25/16—Anti-Parkinson drugs
Definitions
- the present invention relates to a packaging bag containing a ropinirole-containing patch and a method for preserving the ropinirole-containing patch.
- Ropinirole was developed as a drug that overcomes the limitations associated with L-Dopa therapy and is used in the treatment of Parkinson's disease. Then, from the viewpoint of avoiding side effects in the gastrointestinal tract and ease of removal when side effects occur, studies have been made on transdermal absorbents containing ropinirole (see Patent Documents 1 and 2).
- a packaging bag for example, a packaging bag in which a laminated sheet including a base material layer, a barrier layer, a biaxially stretched polypropylene film layer, and a sealant layer is three-side sealed or four-side sealed (see Patent Document 3). ), A packaging bag made of a laminated packaging material in which the moisture absorbing member layer is disposed between the water permeable member layer and the shielding member layer (see Patent Document 4), and a packaging bag made of at least a part of the inner surface made of polyacrylonitrile ( Patent Document 5) is known.
- the present invention provides a patch-containing packaging bag that prevents crystal precipitation during storage, suppresses coloration, and further suppresses decomposition of ropinirole and pharmaceutically acceptable salts thereof, and a method for storing the patch
- the purpose is to provide.
- the relative humidity at 4 ° C. actually includes the case where the maximum water vapor amount (kg ⁇ m ⁇ 3 : saturation humidity) that air in a constant volume at 4 ° C. can have is 100.
- the ratio (%) of the amount of water vapor (kg ⁇ m ⁇ 3 ) shall be used.
- the packaging bag has a deoxygenation means. Thereby, the decomposition prevention effect of ropinirole and the coloration prevention effect of the patch over time are further improved.
- the packaging bag is preferably composed of two or more layers, and the innermost layer of the packaging bag is preferably a sealant layer formed from one resin selected from the group consisting of polyacrylonitrile, polyethylene, and polyester. More preferably, the outermost layer of the packaging bag is an outer layer formed from one resin selected from the group consisting of polyethylene terephthalate, cellophane, and biaxially oriented polypropylene.
- the pressure-sensitive adhesive layer preferably contains at least one pressure-sensitive adhesive selected from the group consisting of acrylic pressure-sensitive adhesives, rubber-based pressure-sensitive adhesives, and silicon-based pressure-sensitive adhesives.
- FIG. 1 is a cross-sectional view showing a preferred embodiment of a packaging bag containing a patch of the present invention.
- the patch-containing packaging bag 1 has a packaging bag 8 made up of a pair of laminated packaging materials 7a and 7b arranged opposite to each other, and a patch 10 accommodated in a space inside the packaging bag 8.
- a packaging oxygen scavenger 20 as a oxygen scavenging means is further accommodated in the packaging bag 8.
- the relative humidity at 4 ° C. inside the packaging bag 8 is maintained at 35% or more.
- the packaging bag 8 for packaging the patch 10 described above is composed of a pair of substantially rectangular laminated packaging materials 7a and 7b arranged to face each other.
- the laminated packaging materials 7a and 7b are film-like laminated bodies having a substantially rectangular shape, and have a configuration in which a sealant layer 2, a barrier layer 4, and an outer layer 6 are laminated in order from the inside.
- the laminated packaging materials 7a and 7b arranged to face each other are joined at their outer edge portions, so that the periphery is closed over the entire circumference.
- stacking packaging materials 7 can be performed by heat sealing, or can be performed using an adhesive agent.
- the material of the outer layer 6 among the layers constituting the laminated packaging material 7a, 7b is not particularly limited.
- polyethylene terephthalate, cellophane, and biaxially oriented polypropylene (OPP) are preferably used.
- the outer layer 6 may be composed of a plurality of layers made of different materials.
- the outer layer 6 may be a laminate of a cellophane layer and a polyethylene layer.
- the thickness of the outer layer 6 is preferably in the range of 5 ⁇ m to 600 ⁇ m, more preferably in the range of 5 ⁇ m to 500 ⁇ m.
- the thickness of the outer layer 6 is smaller than 5 ⁇ m, the rigidity is lowered, the physical strength is lowered, and the handleability and the protective property tend to be lowered.
- the thickness of the outer layer 6 exceeds 600 ⁇ m, the rigidity is improved and the physical strength is improved, but the manufacturing yield tends to decrease and the manufacturing cost tends to increase.
- the barrier layer 4 is laminated inside the packaging bag in order to ensure the non-permeability from the outside and prevent volatilization of the filled contents, and to ensure the stability of the patch.
- the material is not particularly limited, and examples thereof include aluminum foil, ethylene vinyl alcohol copolymer (EVOH) film, and a film obtained by vapor-depositing a metal such as aluminum or a ceramic such as silicon oxide on the surface of a plastic film.
- Aluminum foil is used. By using an aluminum foil as the barrier layer 4, light, water vapor, and oxygen can be completely blocked.
- the sealant layer 2 is a resin layer for forming a packaging bag by bonding the laminated packaging material constituting the packaging bag by heat sealing, and is preferably a thermoplastic resin layer.
- the material which comprises the sealant layer 2 is not specifically limited, For example, low density polyethylene (LDPE), linear low density polyethylene (LLDPE), ethylene vinyl acetate (EVA), ethylene methacrylic acid copolymer (EMAA), polyester, ethylene acrylic acid copolymer (EAA), unstretched polypropylene (CPP), polyolefin-based ionomer resin, and polyacrylonitrile (PAN) are preferable, and polyacrylonitrile, polyethylene, and polyester are preferably used.
- LDPE low density polyethylene
- LLDPE linear low density polyethylene
- EVA ethylene vinyl acetate
- EAA ethylene methacrylic acid copolymer
- EAA ethylene acrylic acid copolymer
- CPP unstretched polypropylene
- PAN polyacrylonit
- the sealant layer 2 is made of a material having a high drug permeability, there may occur a phenomenon that the interface of the layer of the laminated packaging material is peeled off during storage of the patch (delamination).
- polyacrylonitrile, polyethylene, or polyester penetration of the patch component is prevented, so that the problem of delamination does not occur.
- the decomposition of the drug can be efficiently suppressed. That is, even when the patch containing the drug is accommodated in the packaging bag and then the patch moves inside the packaging bag, the drug can be prevented from being decomposed.
- the thickness of the sealant layer 2 may be sufficient to bond the laminated packaging materials to each other. For example, it may have a thickness of about 10 ⁇ m to 50 ⁇ m.
- the method for laminating each layer constituting the above-described laminated packaging materials 7a and 7b is not particularly limited, and extrusion lamination, dry lamination, hot melt lamination, and wet lamination are used.
- the patch 10 has a substantially rectangular support 12, a pressure-sensitive adhesive layer 14 laminated on substantially the entire surface of one side of the support 12, and a release that can be peeled off from the pressure-sensitive adhesive layer 14 that covers the pressure-sensitive adhesive layer 14. And a film 16.
- the support 12 is not particularly limited as long as it can support the pressure-sensitive adhesive layer 14. However, it is desirable that the support 12 has excellent flexibility while maintaining good drug migration, and a stretchable or non-stretchable one is used. It is preferable that the drug can be efficiently released from the pressure-sensitive adhesive layer.
- a film, foam, woven fabric and nonwoven fabric, or paper material can be suitably used as the support.
- the release film 16 it is possible to use a resin film such as polyethylene terephthalate or polypropylene, a release-treated paper, and the like, and in particular, a film made of polyethylene terephthalate subjected to silicon treatment is preferably used.
- the pressure-sensitive adhesive layer 14 is composed of a pressure-sensitive adhesive and a pressure-sensitive adhesive composition containing a drug ropinirole or a pharmaceutically acceptable salt thereof (hereinafter collectively referred to as “ropinirole compound”). is there.
- the pressure-sensitive adhesive in the pressure-sensitive adhesive composition is not particularly limited as long as it is excellent in adhesiveness and excellent in drug release, but is not limited to natural rubber-based adhesives, synthetic rubber-based adhesives, acrylic-based adhesives, rubber-based adhesives.
- One or more selected from pressure-sensitive adhesives and silicon-based pressure-sensitive adhesives are preferably used.
- a synthetic rubber-based pressure-sensitive adhesive and / or an acrylic pressure-sensitive adhesive are preferable because they are excellent in adhesiveness and drug release properties.
- the synthetic rubber adhesive examples include styrene-isoprene-styrene block copolymer (SIS), styrene-butadiene-styrene block copolymer (SBS), styrene-ethylene-butylene-styrene block copolymer (SEBS), or styrene-ethylene-propylene.
- SIS styrene-isoprene-styrene block copolymer
- SBS styrene-butadiene-styrene block copolymer
- SEBS styrene-ethylene-butylene-styrene block copolymer
- SIS styrene-ethylene-propylene.
- SEPS styrene block copolymer
- SIS styrene-isoprene-styrene block copolymer
- At least one (meth) acrylic acid ester represented by acrylic acid, 2-ethylhexyl acrylate, methyl acrylate, butyl acrylate, hydroxyethyl acrylate, 2-ethylhexyl methacrylate or the like is used. If it is made to contain and is copolymerized, there will be no limitation in particular.
- acrylic pressure-sensitive adhesive examples include, for example, 2-ethylhexyl acrylate / vinyl acetate copolymer, 2-ethylhexyl acrylate / vinyl acetate / acrylic acid copolymer, 2-ethylhexyl acrylate / vinyl acetate / Hydroxyethyl acrylate copolymer, 2-ethylhexyl acrylate / vinyl acetate / hydroxyethyl acrylate / acrylic acid copolymer, or 2-ethylhexyl acrylate / methacrylic acid-2-ethylhexyl / dodecyl methacrylate copolymer In particular, 2-ethylhexyl acrylate / vinyl acetate copolymer and 2-ethylhexyl acrylate / vinyl acetate / acrylic acid copolymer are preferable.
- the content of the pressure-sensitive adhesive in the pressure-sensitive adhesive composition is preferably 10 to 95% by mass based on the total mass of the pressure-sensitive adhesive composition.
- the pressure-sensitive adhesive composition may contain a tackifier, a softener, and the like as necessary.
- tackifiers include alicyclic saturated hydrocarbon resins, rosin derivatives (eg, rosin, rosin glycerin ester, hydrogenated rosin, hydrogenated rosin glycerin ester or rosin pentaerythritol ester), terpene resins, petroleum resins, or males.
- rosin derivatives eg, rosin, rosin glycerin ester, hydrogenated rosin, hydrogenated rosin glycerin ester or rosin pentaerythritol ester
- terpene resins e.g., rosin, rosin glycerin ester, hydrogenated rosin, hydrogenated rosin glycerin ester or rosin pentaerythritol ester
- terpene resins eglycerin, rosin pentaerythritol ester
- terpene resins e.glycerin
- softener examples include petroleum oils (for example, paraffinic process oil, naphthenic process oil or aromatic process oil), squalane, squalene, vegetable oils (for example, almond oil, olive oil, camellia oil, castor oil). , Tall oil or peanut oil), olefinic acid, silicone oil, dibasic acid ester (eg dibutyl phthalate or dioctyl phthalate), liquid rubber (eg polybutene or polyisoprene), liquid fatty acid ester (isopropyl myristate, hexyl laurate, sebacine) Diethyl acetate or isopropyl sebacate), diethylene glycol, polyethylene glycol, glycol salicylate, propylene glycol, dipropylene glycol, triacetin, triethyl citrate or Tamiton and the like.
- liquid paraffin, isopropyl myristate, and diethyl sebacate are preferable because they can impart appropriate adh
- the contents thereof are preferably in the ranges shown below. That is, it is preferable that the content of the tackifier is 10 to 90% by mass and the content of the softening agent is 5 to 60% by mass based on the total mass of the adhesive composition.
- transdermal absorption accelerator a transdermal absorption accelerator, a dispersion aid, an antioxidant, a filler, a crosslinking agent, a preservative, and an ultraviolet absorber may be appropriately blended with the pressure-sensitive adhesive composition as necessary.
- transdermal absorption enhancer examples include aliphatic alcohols such as octyldodecanol and isostearyl alcohol, fatty acids such as capric acid, propylene glycol monolaurate, fatty acid derivatives such as isopropyl palmitate and isopropyl myristate, and propylene glycol. , Polyethylene glycol, and lauric acid diethanolamide.
- aliphatic alcohols such as octyldodecanol and isostearyl alcohol
- fatty acids such as capric acid, propylene glycol monolaurate, fatty acid derivatives such as isopropyl palmitate and isopropyl myristate, and propylene glycol.
- Polyethylene glycol, and lauric acid diethanolamide One of these absorption promoters may be used alone, or two or more thereof may be used in combination.
- the blending amount when blending the absorption promoter is 1 to 30% by mass based on the total mass of the pressure
- dispersion aid examples include inorganic minerals, polymer compounds, and organic acids.
- inorganic minerals kaolin, talc, bentonite, zinc oxide, titanium oxide, zinc stearate, silica compounds such as aerosil and hydrous silica, magnesium aluminate metasilicate, and dry aluminum hydroxide gel are desirable.
- the blending amount is preferably 0.5 to 50% by weight, more preferably 1 to 20% by weight, particularly based on the total weight of the pressure-sensitive adhesive composition. Preferably, it is 1 to 10% by mass.
- antioxidant tocopherol and their ester derivatives, ascorbic acid, ascorbic acid stearic acid ester, nordihuman logger ayaretic acid, dibutylhydroxytoluene (BHT), butylhydroxyanisole, sodium pyrosulfite, sodium sulfite and the like are desirable.
- BHT dibutylhydroxytoluene
- BHT is particularly preferred for use as a solubilizer in the production process.
- fillers include aluminum hydroxide, calcium carbonate, magnesium carbonate, silicate (eg, aluminum silicate, magnesium silicate), silicic acid, barium sulfate, calcium sulfate, calcium zincate, zinc oxide, titanium oxide, and the like. desirable.
- disodium edetate As preservatives, disodium edetate, tetrasodium edetate, ethyl paraoxybenzoate, propyl paraoxybenzoate, butyl paraoxybenzoate and the like are desirable.
- the ultraviolet absorber p-aminobenzoic acid derivatives, anthranilic acid derivatives, salicylic acid derivatives, coumarin derivatives, amino acid compounds, imidazoline derivatives, pyrimidine derivatives, dioxane derivatives and the like are desirable.
- Such antioxidants, fillers, preservatives, and UV absorbers are preferably blended in an amount of 10% by mass or less based on the total mass of the pressure-sensitive adhesive composition.
- the method for producing the patch 10 is not particularly limited.
- a pressure-sensitive adhesive composition containing a drug (ropinirole compound), a pressure-sensitive adhesive, a softening agent, and the like is melted and uniformly mixed, and applied to a release film.
- the adhesive patch 10 can be produced by sticking it to the support.
- a solvent such as toluene, hexane, heptane or ethyl acetate
- spreading it on a release film removing the solvent by drying, forming a pressure-sensitive adhesive layer, and then bonding it to the support
- the patch 10 can also be produced.
- the packaging oxygen absorber 20 as a deoxidizing means is accommodated in the packaging bag 8 together with the patch 10.
- the packaging oxygen absorber 20 includes an oxygen absorber packaging bag 24 and an oxygen absorber 22 accommodated in the packaging bag 24.
- Examples of the packaging oxygen absorber 20 include AGELESS (Mitsubishi Gas Chemical), StabilOx (Multisorb), Wellpack (Taisei), Everfresh (Toryu Sangyo), Oxiter (Ueno Pharmaceutical), Keypit (Drainy), Kepron (Kepron) ), Sansocut (Iris Fine Products), Sansoles (Hiroyo), Secur (Nisso Resin), Tamotsu (Oe Chemical Industry), Vitalon (Tokiwa Industry), Modulan (Nippon Kayaku Food Techno), Wonder Keep (Powdertech)
- the freshness-retaining agent C (letter printing) can be suitably used as it is or after being appropriately packaged.
- a layer constituting the packaging bag for example, a sealant layer, such as aluminum, zinc, manganese, copper, iron, hydrosulfite, activated carbon, etc.
- a sealant layer such as aluminum, zinc, manganese, copper, iron, hydrosulfite, activated carbon, etc.
- the relative humidity of the space in the packaging bag is maintained at 35% or more, preferably 41% or more, more preferably 41% to 70%.
- the humidity in the packaging bag is less than 35%, crystals of the ropinirole compound in the patch are not preferable.
- the relative humidity of the space in the packaging bag is adjusted to be included in the above range by adjusting the manufacturing environment to a predetermined temperature and humidity during the manufacturing process, adjusting the humidity with moisture in the oxygen scavenger, or the like. be able to.
- Example 1 (Production of packaging bag A) Two multilayer films A in which low density polyethylene (LDPE), aluminum foil (Al), polyethylene (PE), and cellophane (PT) were laminated in this order were prepared. Next, the two multilayer films A are arranged so that the layers made of LDPE are opposed to each other, the three sides of the peripheral part are bonded by thermal fusion, and one side is opened for accommodating the patch, and the rectangular packaging bag A is opened. Got.
- LDPE low density polyethylene
- Al aluminum foil
- PE polyethylene
- PT cellophane
- Example 2 Packing bag A contains a deoxidation pack (Mitsubishi Gas Chemical Co., Ltd., deoxygenation capacity 15 cm 3 , dimensions 11 cm x 7.5 cm) containing patch B and iron-based oxygen scavenger in an environment of 23 ° C and relative humidity 38% In the same manner as in Example 1, it was stored at 4 ° C. for 30 days, and the humidity in the bag was measured.
- a deoxidation pack Mitsubishi Gas Chemical Co., Ltd., deoxygenation capacity 15 cm 3 , dimensions 11 cm x 7.5 cm
- Example 3 (Production of packaging bag B) Two multilayer films A in which polyacrylonitrile (PAN), aluminum foil (Al), polyethylene (PE), and cellophane (PT) were laminated in this order were prepared. Subsequently, the two multilayer films A were arranged so that the layers made of PAN face each other, and a packaging bag B was obtained in the same manner as in Example 1.
- Deoxygenation pack Mitsubishi Gas Chemical Co., Ltd., deoxygenation capacity: 15 cm 3 , dimensions: 7.3 cm ⁇ 5 cm) containing patch B and iron-based oxygen scavenger in packaging bag B at 23 ° C. and relative humidity of 38% The bottom was sealed, stored at 4 ° C. for 30 days, and the humidity in the bag was measured.
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Abstract
Description
シーラント層2が薬剤浸透性の高い材料からなるものである場合は、貼付剤保管中に積層包材の層の界面が剥離する現象(層間剥離)が生じることがあるが、内面となる層をポリアクリロニトリル、ポリエチレン又はポリエステルとすることによって貼付剤成分の浸透が防止されるため、層間剥離の問題が生じない。特に、内面の層を全てポリアクリロニトリル、ポリエチレン又はポリエステルとすると、薬物の分解を効率よく抑制できる。すなわち、薬物を含む貼付剤が、包装袋の内部に収容された後、貼付剤が包装袋の内部で動いた場合等であっても薬物の分解を防止できる。
吸収促進剤を配合する場合の配合量は、製剤としての組織への有効成分の充分な透過性及び局所刺激牲等を考慮して、粘着剤組成物の全質量を基準として1~30質量%であることが好ましく、さらに好ましくは3~20質量%であり、特に好ましくは5~15質量%である。
充填剤としては、水酸化アルミニウム、炭酸カルシウム、炭酸マグネシウム、ケイ酸塩(例えば、ケイ酸アルミニウム、ケイ酸マグネシウム)、ケイ酸、硫酸バリウム、硫酸カルシウム、亜鉛酸カルシウム、酸化亜鉛、酸化チタン等が望ましい。
保存剤としては、エデト酸二ナトリウム、エデト酸四ナトリウム、パラオキシ安息香酸エチル、パラオキシ安息香酸プロピル、パラオキシ安息香酸ブチル等が望ましい。
紫外線吸収剤としては、p-アミノ安息香酸誘導体、アントラニル酸誘導体、サリチル酸誘導体、クマリン誘導体、アミノ酸系化合物、イミダゾリン誘導体、ピリミジン誘導体、ジオキサン誘導体等が望ましい。
また、粘着剤組成物をトルエン、ヘキサン、ヘプタン又は酢酸エチル等の溶媒に溶解させ、剥離フィルムに展延して、溶媒を乾燥除去し、粘着剤層を形成後、支持体と貼り合わせることにより貼付剤10を製造することもできる。
(実施例1)
(包装袋Aの作製)
低密度ポリエチレン(LDPE)、アルミニウム箔(Al)、ポリエチレン(PE)、セロハン(PT)をこの順で積層した多層フィルムAを2枚準備した。次いで、2枚の多層フィルムAをLDPEからなる層が対向するように配置し、周縁部の3辺を熱融着によって接着し、1辺が貼付剤収容のために開口した方形の包装袋Aを得た。
(貼付剤Bの製造)
混合機を用いて、表1に記載の配合率にて、塩酸ロピニロール、水酸化ナトリウム、流動パラフィン及びメタノール(溶剤)を混合した後、SIS、脂環族炭化水素樹脂及びトルエンの混合溶液を添加・混合し、粘着剤溶液を得た。この粘着剤溶液をフィルム上に展延し、溶剤を乾燥除去して粘着剤層を形成した。この粘着剤層上に支持体としてポリエチレンテレフタレートフィルムを積層し、貼付剤Bを得た。得られた貼付剤Bは6.25平方cm(正方形)に裁断した。なお、貼付剤Bの粘着剤層の厚さは100μmであった。
(貼付剤の包装袋への封入)
包装袋Aに貼付剤B及び鉄系脱酸素剤を含有する脱酸素パック(三菱ガス化学製、脱酸素能:15cm3、寸法:7.3cm×5cm)を、23℃、相対湿度38%の環境下封入し、4℃で30日間保管し、袋内の湿度を測定した。
包装袋Aに貼付剤B及び鉄系脱酸素剤を含有する脱酸素パック(三菱ガス化学製、脱酸素能15cm3、寸法11cm×7.5cm)を23℃、相対湿度38%の環境下封入し、実施例1と同様に、4℃で30日間保管し、袋内の湿度を測定した。
(包装袋Bの作製)
ポリアクリロニトリル(PAN)、アルミニウム箔(Al)、ポリエチレン(PE)、セロハン(PT)をこの順で積層した多層フィルムAを2枚準備した。次いで、2枚の多層フィルムAをPANからなる層が対向するように配置し、実施例1と同様にして包装袋Bを得た。
(貼付剤の包装袋への封入)
包装袋Bに貼付剤B及び鉄系脱酸素剤を含有する脱酸素パック(三菱ガス化学製、脱酸素能:15cm3、寸法:7.3cm×5cm)を23℃、相対湿度38%の環境下封入し、4℃で30日間保管し、袋内の湿度を測定した。
(貼付剤の包装袋への封入)
包装袋Aに貼付剤Bを23℃、相対湿度38%の環境下封入し、4℃で30日間保管し、袋内の湿度を測定した。
(貼付剤の包装袋への封入)
包装袋Aに貼付剤B及び乾燥機能付き脱酸素パック(商品名;ファーマキープ KC-20、三菱ガス化学製)を23℃、相対湿度38%の環境下封入し、4℃で30日間保管し、袋内の湿度を測定した。
(貼付剤の包装袋への封入)
包装袋Aに貼付剤B及び市販乾燥剤パック(Sud Chemie)を23℃、相対湿度38%の環境下封入し、4℃で30日間保管し、袋内の湿度を測定した。
(貼付剤の包装袋への封入)
包装袋Aに貼付剤Bを窒素置換して封入し、4℃で約7日間保管し、袋内の湿度を測定した。
各実施例及び比較例の貼付剤入り包装袋について、袋内の湿度の測定は、貼付剤とともに包装中に小型の湿度測定器(DICKSON TK500)を封入して測定を行った。なお、当該機器は、測定環境の相対湿度を測定して電子的に記録することができ、測定終了後にこの記録された湿度データを読み取って解析することができる。
各実施例1~2、比較例1~3の貼付剤入り包装袋について袋内の相対湿度を測定した結果、図2に示すように、実施例1~2の貼付剤入り包装袋では袋内の相対湿度が41%以上に保たれたのに対し、比較例1~3の貼付剤入り包装袋はそれに満たない相対湿度で推移した。
各実施例、比較例の貼付剤入り包装袋について以下の方法により、経時着色、結晶析出、分解物の生成を評価した。
実施例及び比較例の貼付剤入り包装袋を表3に示す保存条件下にて保存した後、貼付剤を包装袋から取り出して、粘着剤層の着色を目視により以下の基準で評価した。その結果を表3に示す。
A:初期からの色の変化なし
B:わずかに着色したが実用上問題なし
C:明らかに着色しており、実用上問題あり
実施例及び比較例の貼付剤入り包装袋を4℃で30日間保管し、上述の方法で湿度を測定し、目視もしくは顕微鏡観察により貼付剤の一部もしくは全面に放射状の針状結晶が析出した場合を結晶析出「あり」とし、変化のないものを結晶析出「なし」と評価した。その結果を表4に示す。
実施例及び比較例の貼付剤入り包装袋を表5に示す保存条件下にて保存した後、貼付剤を包装袋から取り出した。この貼付剤に含まれる成分をテトラヒドロフラン10mL、水/メタノール混合溶液40mLで抽出して検液とし、高性能液体クロマトグラフィー(ODSカラム、UV検出器)にてロピニロール及び各未確認化合物を検索した。
各未確認化合物の量は、ロピニロールの理論量を100として、各化合物のクロマトグラフィーの吸収面積から算出した。なお、未確認化合物が検出されなかった場合は「-」で示した。
Claims (7)
- 包装袋と、該包装袋の内部に収容された貼付剤と、を備える貼付剤入り包装袋であって、
前記貼付剤は、支持体と、該支持体の少なくとも一方の面に積層され、ロピニロール及び/又はその薬学的に許容される塩を含有する粘着剤層と、該粘着剤層を被覆する剥離フィルムと、を有し、
前記包装袋の内部は、4℃における相対湿度が35%以上に維持されていることを特徴とする、貼付剤入り包装袋。 - 前記包装袋は脱酸素手段を有することを特徴とする、請求項1に記載の貼付剤入り包装袋。
- 前記包装袋は2以上の層から構成され、前記包装袋の最も内側の層が、ポリアクリロニトリル、ポリエチレン、ポリエステルからなる群より選択される1種の樹脂から形成されたシーラント層であることを特徴とする、請求項1又は2に記載の貼付剤入り包装袋。
- 前記包装袋の最も外側の層が、ポリエチレンテレフタレート、セロハン、二軸延伸ポリプロピレンからなる群より選択される1種の樹脂から形成された外層であることを特徴とする、請求項3に記載の貼付剤入り包装袋。
- 前記包装袋は、前記シーラント層と前記外層との間に、アルミニウムから形成されたバリア層をさらに有することを特徴とする、請求項4に記載の貼付剤入り包装袋。
- 前記粘着剤層は、アクリル系粘着剤、ゴム系粘着剤、シリコン系粘着剤からなる群より選択される少なくとも1種の粘着剤を含むことを特徴とする、請求項1~5に記載の貼付剤入り包装袋。
- 支持体と、該支持体の少なくとも一方の面に積層され、ロピニロール及び/又はその薬学的に許容される塩を含有する粘着剤層と、該粘着剤層を被覆する剥離フィルムと、を有する貼付剤を包装袋に収容し、該包装袋の内部の4℃における相対湿度が35%以上となるように維持することを特徴とする、貼付剤の保存方法。
Priority Applications (5)
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EP10767158.8A EP2431034B1 (en) | 2009-04-24 | 2010-04-23 | Adhesive patch-containing package bag and method for storing adhesive patch |
US13/265,418 US20120090275A1 (en) | 2009-04-24 | 2010-04-23 | Adhesive patch-containing package bag and method for storing adhesive patch |
ES10767158.8T ES2589008T3 (es) | 2009-04-24 | 2010-04-23 | Bolsa de envase que contiene parche adhesivo y método para almacenar parche adhesivo |
CN2010800132392A CN102361639A (zh) | 2009-04-24 | 2010-04-23 | 内包贴附剂的包装袋、及贴附剂的保存方法 |
JP2011510375A JP5933974B2 (ja) | 2009-04-24 | 2010-04-23 | 貼付剤入り包装袋、及び貼付剤の保存方法 |
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EP (1) | EP2431034B1 (ja) |
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JP5415645B1 (ja) * | 2013-06-28 | 2014-02-12 | 久光製薬株式会社 | 貼付剤の製造方法、貼付剤及び包装体 |
US9320728B2 (en) | 2013-06-28 | 2016-04-26 | Hisamitsu Pharmaceutical Co., Inc. | Method for producing patch, patch and package |
WO2017170933A1 (ja) * | 2016-03-31 | 2017-10-05 | ニチバン株式会社 | 貼付剤製品 |
CN110539924A (zh) * | 2019-07-18 | 2019-12-06 | 中山市马里奥机械科技有限公司 | 一种硅酮胶的全自动生产*** |
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KR20120024562A (ko) | 2012-03-14 |
EP2431034A1 (en) | 2012-03-21 |
ES2589008T3 (es) | 2016-11-08 |
JP5933974B2 (ja) | 2016-06-15 |
EP2431034A4 (en) | 2013-09-11 |
JP2016083421A (ja) | 2016-05-19 |
US20120090275A1 (en) | 2012-04-19 |
CN102361639A (zh) | 2012-02-22 |
JPWO2010123103A1 (ja) | 2012-10-25 |
EP2431034B1 (en) | 2016-08-10 |
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