Classifications

• • 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
  • A61J1/03—Containers specially adapted for medical or pharmaceutical purposes for pills or tablets
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
  • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
  • B65D75/00—Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes, or webs of flexible sheet material, e.g. in folded wrappers
  • B65D75/28—Articles or materials wholly enclosed in composite wrappers, i.e. wrappers formed by associating or interconnecting two or more sheets or blanks
  • B65D75/30—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding
  • B65D75/32—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents
• • 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
  • A61J1/03—Containers specially adapted for medical or pharmaceutical purposes for pills or tablets
  • A61J1/035—Blister-type containers
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
  • B01J20/00—Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof
  • B01J20/02—Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof comprising inorganic material
  • B01J20/10—Solid sorbent compositions or filter aid compositions; Sorbents for chromatography; Processes for preparing, regenerating or reactivating thereof comprising inorganic material comprising silica or silicate
  • B01J20/16—Alumino-silicates
  • B01J20/18—Synthetic zeolitic molecular sieves
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
  • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
  • B65D81/00—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
  • B65D81/24—Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants
  • B65D81/26—Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants with provision for draining away, or absorbing, or removing by ventilation, fluids, e.g. exuded by contents; Applications of corrosion inhibitors or desiccators
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
  • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
  • B65D81/00—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
  • B65D81/24—Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants
  • B65D81/26—Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants with provision for draining away, or absorbing, or removing by ventilation, fluids, e.g. exuded by contents; Applications of corrosion inhibitors or desiccators
  • B65D81/266—Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants with provision for draining away, or absorbing, or removing by ventilation, fluids, e.g. exuded by contents; Applications of corrosion inhibitors or desiccators for absorbing gases, e.g. oxygen absorbers or desiccants
  • B65D81/267—Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants with provision for draining away, or absorbing, or removing by ventilation, fluids, e.g. exuded by contents; Applications of corrosion inhibitors or desiccators for absorbing gases, e.g. oxygen absorbers or desiccants the absorber being in sheet form

Definitions

• the present invention relates to a packaging material containing an odor adsorbent and a press-through pack or a prestar pack in which a pharmaceutical is packaged.
• press-through packs or blister packs are widely used in the packaging of pharmaceutical products, but some pharmaceutical products have a odor peculiar to pharmaceutical preparations and handle press-through packs. Dispensing personnel at medical facilities may find the odor uncomfortable. In addition, when a user takes out a tablet from a press-through pack or a blister pack, or when taking it, the odor may feel uncomfortable. Such preparations will reduce the compliance of the user and also affect the commercial value.
• press-through pack or pre-star pack packaging form of pharmaceuticals as a method of adsorbing odors evaporating from the preparation, the press-through pack or blister pack is sealed with an aluminum laminate film having a high gas barrier property (hereinafter referred to as "pillow packaging").
• the odor adsorbent is put in it, and the press-through pack or blister pack force is adsorbed.
• press-through packs and blisters are selected from packaging materials that have a relatively high airtightness in order to ensure the hygiene and long-term stability of the formulation. It remained in the pack pocket and the effect of suppressing odor was insufficient.
• a deodorizing film material in which zeolite is homogeneously dispersed and mixed in a film material is known (Japanese Patent Laid-Open No. 11-35077), but a packaging material for packaging a preparation containing the specific drug of the present invention. Is not known about.
• Patent Document 1 Japanese Patent Laid-Open No. 11 35077
• the object of the present invention is to provide olmesartan medoxomil or 2-amino-5-isobutyl-4- ⁇ 2- [5_ ( It is an object of the present invention to provide a packaging material that adsorbs odorous substances generated from a preparation containing ⁇ , ⁇ '-bis ((S) -l-ethoxycarboninole) ethinole) phosphonamide] furinole ⁇ thiazole.
• the packaging material contains an odor adsorbent
• the packaging material is olmesartan medoxomil or 2-amino-5-isobutynol-4.
• the strength of the packaging can be reduced by reducing the odor when the preparation is taken out, and the discomfort can be reduced.
• the present invention provides:
• a packaging material for packaging a preparation containing olmesartan medoxomil characterized by containing odor V, an adsorbent
• the packaging material according to (1), wherein the odor! /, The adsorbent is hydrophobic zeolite obtained by subjecting synthetic zeolite 13X to a hydrophobic treatment,
• the adsorbent layer further has an outer layer on the side in contact with the base material layer.
• Packaging material according to
• Adsorption layer is low-density polyethylene, linear low-density polyethylene, polypropylene, ionomer, ethylene acrylic acid copolymer, ethylene methacrylic acid copolymer, ethylene acetate butyl copolymer, ethylene ethylene acrylate copolymer.
• the packaging material according to any one of (9) to (12), wherein the adsorption layer contains one or more compounds selected from low-density polyethylene, linear low-density polyethylene, and polypropylene,
• the substrate layer contains one or more compounds selected from polychlorinated butyl, unstretched polypropylene, polypropylene, polyvinylidene chloride, polytrifluoroethylene chloride, and cyclic olefin copolymers ( 9) to (15)! /
• An object of the present invention is to provide a method for preventing odor of an olmesartan medoxomil-containing preparation characterized by packaging with a press-through pack or blister pack described in (24) or (25).
• the packaging material in the present invention contains an odor adsorbent. Thereby, the package using the packaging material of the present invention can adsorb the odor generated from the preparation.
• odor adsorbents examples include physical adsorbents such as synthetic zeolite, silica gel, alumina, activated carbon, and odors such as complex chemical deodorizers based on organic acids (Daimu Shu).
• a chemical adsorbent capable of chemisorbing with a substance can be mentioned, preferably synthetic zeolite, more preferably hydrophobic zeolite, particularly preferably nosilica or isilica zeolite.
• a physical adsorbent and a chemical adsorbent may be used in combination due to the adsorption rate and adsorption characteristics for odorous substances.
• Synthetic zeolite is a porous particulate material used to separate substances according to the difference in molecular size, and is a small molecule that has a uniform pore structure and enters the pore cavity. Adsorbs and acts as a kind of sieve.
• the adsorption pore diameter is preferably 0.3 nm to lnm.
• Synthetic zeolites having pore sizes of about 0.3 nm, 0.4 nm, 0.5 nm, and 1 nm are referred to as synthetic zeolite 3A, synthetic zeolite 4A, synthetic zeolite 5A, and synthetic zeolite 13X, respectively. Of these, synthetic zeolite 13X having a pore diameter of about 1 nm is particularly preferred.
• the average particle size of the synthetic zeolite is not limited as long as the object of the present invention is achieved, but for example, the average particle size is preferably around 10 m.
• the pore size is involved in the adsorption characteristics of synthetic zeolite, and in order to improve the adsorption characteristics of odor, the surface area of the pores can be substantially increased by making the synthetic zeolite powder finer. We can cope by increasing the number
• the hydrophobic zeolite is a synthetic zeolite that has been subjected to a hydrophobic treatment.
• Synthetic zeolite which has a odor adsorption and moisture absorption capacity and the odor adsorption performance declines as moisture absorption progresses, is more preferred because it has been treated with a hydrophobic treatment to suppress the moisture absorption capacity.
• Examples of the method for hydrophobic treatment of synthetic zeolite include a method for surface modification such as a method for adsorbing a surfactant on zeolite or a method for reacting a silylating agent with a hydroxyl group on the surface of the zeolite, a method for dealumination, etc. Can be mentioned.
• the high silica zeolite is a synthetic zeolite having a silica / alumina ratio (Si02 / A1203 ratio) increased by reducing aluminum atoms in the crystal skeleton of the synthetic zeolite by dealumination.
• synthetic zeolite loses its affinity for polar substances such as water, and can more strongly adsorb non-polar substances such as odorous substances.
• high silica zeolite having a silica / alumina ratio of 5 or more is preferable.
• it is possible to use commercially available products such as Union Showa's ABSCENT and Tosoh's HSZ series.
• thermoplastic resins such as thermoplastic resins, papers, fibers, metals, various paints, various adhesives and the like can be used, and thermoplastic resins are preferable.
• the thermoplastic resin is not particularly limited and can use a known one.
• poly (vinyl chloride) PVC
• unstretched polypropylene CPP
• polypropylene PP
• polyvinylidene chloride PVDC
• PCTFE poly Ethylene trifluoride chloride
• CO C polyethylene
• PE polyethylene
• PC polycarbonate
• PA polyamide
• EVA ethylene vinyl acetate copolymer
• EVA ethylene metatalate Polymers
• PS polystyrene
• PET polyacrylic acid
• PA polyacrylic acid
• polyvinylene chloride unstretched polypropylene, polypropylene, polyvinylidene chloride, polytrifluoride Chemical engineering Tylene or cyclic olefin copolymer. In the present invention, these may be used alone or in combination of two or more.
• the packaging material in the present invention is not limited to a single layer, but may be a multilayer film in which multiple layers are laminated.
• the type, amount, thickness, and number of layers of the multilayer film are not limited as long as the purpose of the present invention is achieved, and can be widely used, and are appropriately selected according to the application.
• the multilayer film 1 in the present invention contains an odor adsorbent as an inner layer. It has an adsorbing layer 2 and a base material layer (barrier layer) 3 that prevents intrusion of moisture, oxygen and the like from outside air as an outer layer.
• the resin used in the adsorption layer is not particularly limited, and can be appropriately selected by those skilled in the art. Preferably there is. If it is a high melt flow rate resin, even if the melt flow rate is lowered by adding an adsorbent, a certain degree of flow characteristics can be secured. In addition, if the melting point is low, the resin softens at a low temperature, thereby enabling low-temperature extrusion and avoiding the possibility of foaming. A resin excellent in low-temperature drawdown can be easily extruded by an extruder even if an adsorbent is added. Among them, a resin having a melt flow rate of 10 or more, a low melting point, and an excellent low-temperature drawdown property is more preferable.
• examples of the resin used for the adsorption layer include low density polyethylene (LDPE), linear low density polyethylene (LLDPE), polypropylene (PP), and various copolymers (copolymers).
• Ionomer for example, salt of ethylene acrylic acid copolymer
• EAA ethylene acrylic acid copolymer
• EAA ethylene methacrylic acid copolymer
• EAA ethylene acetate butyl copolymer
• EAA ethylene ethylene acrylate Rate copolymer
• EMMA ethylene methyl acrylate copolymer
• low density polyethylene linear low density Polyethylene and polypropylene are preferable, and low density polyethylene is more preferable. In the present invention, these can be used alone or in combination of two or more.
• pigments can be blended as necessary.
• pigments other than the above-mentioned odor adsorbents they do not particularly have moisture absorption performance or gas adsorption performance! If pigments are used, they can have various composite effects if they contain functional pigments.
• a facial material include synthetic zeolite, calcium chloride, calcium oxide, calcium carbonate, titanium oxide, zinc oxide, zirconium oxide, alumina, silica, my strength, talc, strength bonbon, and activated carbon.
• synthetic zeolite is synthetic zeolite.
• the content of the odor adsorbent is, for example, 5 to 70% by weight, and preferably 10 to 60% by weight.
• the total pigment content is, for example, 30 to 70% by weight, and preferably 45 to 65% by weight.
• the thickness of the adsorption layer is not particularly limited as long as the object of the present invention is achieved, but is, for example, 10 ⁇ m to 200 ⁇ m, preferably 30 ⁇ m to 100 ⁇ m.
• the resin used for the base material layer is not particularly limited as long as it can prevent entry of moisture, oxygen, and the like from the outside. Bull, Unstretched polypropylene, Polypropylene, Polyvinylidene chloride, Polyethylene trifluoride, Cycloolefin copolymer, Polyethylene, Polycarbonate, Polyamide, Ethylene acetate butyl copolymer, Ethylene metaacrylate copolymer, Polystyrene, Polyester, Polyacrylic acid and the like can be mentioned, and preferred are polychlorinated butyl, unstretched polypropylene, polypropylene, polyvinylidene chloride, and polyethylene terephthalate, and more preferred is polychlorinated butyl. In the present invention, these can be used alone or in combination of two or more.
• the thickness of the base material layer is not particularly limited as long as the object of the present invention is achieved, but is, for example, 20 m to 400 ⁇ m, and preferably 50 ⁇ m to 300 ⁇ m.
• An adhesive layer may be further provided between the adsorption layer and the base material layer.
• the adhesive layer include low density polyethylene, linear low density polyethylene, and polypropylene, and low density polyethylene is preferable. In the present invention, these may be used alone or in combination of two or more.
• extrusion lamination is a method of laminating molten resin from a T-die thinly onto a substrate and roll-bonding them.
• Dry lamination is a method of laminating a base material and a preformed thermoplastic resin film, etc.! After applying an adhesive to the base material, dry the adhesive in a heating and drying furnace. After this, the film is stacked and roll-bonded.
• Wet lamination is a method of attaching a substrate and a film without drying the adhesive, unlike dry lamination.
• Thermal lamination is a method in which a preformed thermoplastic resin film is stacked on a base material and heat-pressed through a hot roll.
• Sandra lamination means that two substrates are fed out, the molten resin is extruded from a T-die, and it flows between both substrates, rolls This is a method of bonding by pressure bonding.
• the thickness of the obtained multilayer film is not particularly limited as long as the object of the present invention is achieved, but is, for example, 30 ⁇ m to 500 ⁇ m, preferably 100 ⁇ m to 400 ⁇ m.
• the adsorption layer 2 may further include an outer layer 4 on the side of the main adsorption layer 2a in contact with the base material layer 3.
• a sealant layer 5 may be further provided on the side of the adsorption layer 2a facing the base material layer 3.
• the adsorption layer is composed of a main adsorption layer and a sub-adsorption layer
• the content of the adsorbent in the main adsorption layer is preferably larger than that of the sub-adsorption layer.
• sealant layer examples include low-density polyethylene, linear low-density polyethylene, and polypropylene, and linear low-density polyethylene is preferable. In the present invention, these can be used alone or in combination of two or more.
• Examples of the outer layer include low-density polyethylene, linear low-density polyethylene, and polypropylene, and linear low-density polyethylene is preferable. In the present invention, these can be used alone or in combination of two or more.
• the adsorption layer is formed of a resin and an adsorbent in the form of a film or a sheet by an inflation method, a T-die method, coextrusion or the like, and a multilayer film by an inflation method is particularly preferred.
• the multi-layer inflation method is a method for producing a multi-layer film by extruding a resin melted by a plurality of extruders into a tube shape, and sending the air into the tube to inflate it.
• a two-kind three-layer or a three-kind three-layer consisting of an outer layer / main adsorbing layer / sealant layer is preferable.
• the press-through pack 8 includes a multilayer film 1 (pocket sheet) having a pocket portion for storing the preparation 7 and a lid member 6 for sealing the pocket.
• the pocket sheet is provided with a plurality of concave bucket portions for storing the preparation 7, and the preparation 7 is stored in the pocket portion.
• Examples of the preparation packaged in a press-through pack or a prestar pack include tablets, capsules, powders, fine granules, granules, troches, and the like, preferably tablets.
• the sealant layer On the side of the packaging material that comes into contact with the preparation!
• the sealant layer becomes a layer that is heat-sealed with the lid material, and can also prevent direct contact between the preparation and the adsorption layer.
• cover material examples include aluminum foil, a laminate film of an aluminum foil and a plastic film, and the like.
• the method for producing a press-through pack or blister pack according to the present invention is as follows. There are no special restrictions as long as they are manufactured using the general methods described in publications such as
• the active ingredient contained in the preparation is not limited by its structure, degree, etc., as long as it has a smell, but olmesartan medoxomil, 2-amino-5-isobutyl-4 - ⁇ 2- [5- ( ⁇ , ⁇ '-bis ((S) -l-ethoxycarbonyl) ethinole) phosphonamide] furaninole ⁇ thiazole, L-cystine, DL-methionine, bucillamine, methylthiodisulfonium chloride , Ethylcystine hydrochloride, bacampicillin hydrochloride, cefuroxime axetil, sultamicillin tosylate, diclofenamide, lanitidine hydrochloride, famotidine, nizatidine, and other sulfur-containing compounds, olmesartan medoxomil, pindolol, sodium valproate, todralazine hydrochlor
• Olmesartan medoxomil is used to treat hypertension or diseases derived from hypertension (more specifically, hypertension, heart disease [angina, myocardial infarction, arrhythmia, heart failure or hypertrophy), kidney disease [diabetic nephropathy] , Glomerulonephritis or nephrosclerosis] or cerebrovascular disease [cerebral infarction or cerebral hemorrhage]), which is effective in the prevention or treatment of patent No. 2082519 According to the method described in the report (US Pat. No. 5,616,599), it can be easily produced.
• 2-amino-5-isobutyl-4- ⁇ 2- [5- ( ⁇ , ⁇ '-bis ((S) -l-ethoxycarboninole) ethyl) phosphonamide] furanyl ⁇ thiazole is It can be easily manufactured according to the method described in 01/47935 pamphlet.
• the preparation of the present invention may contain other active ingredients as necessary.
• the active ingredient include diuretics such as trichloromethiazide (Hydrothia thiazide); azelnidipine, amlodipine, benidipine, nitrendipine, manidipine, two strengths Calcium antagonists such as nocardipine, niifedipine, cilnidipine, efonidipine, barnidipine, and felodipine; pioglitazone, gliglitazone, rogliglitazone , Riboglitazone, MCC_555, NN-2344, BMS_298585, AZ_242, LY_519818, insulin resistance improvers such as TAK-559; pravastatin (Pravastatin ⁇ simvastatin), atorenostatin (Atorvastatin), rosnostatin (Rosuvastatin), Serinostatin (
• the following two types of three-layer films were produced by the multilayer inflation method.
• the outer layer side of the adsorbing film and a 200,1 m-thick polychlorinated bule were laminated using the sand laminating method with the adhesive layer as LDPE to produce a multilayer film for a press-through pack.
• the press-through pack was produced using CKD M2 type.
• the material of the press-through pack is a 17-m thick aluminum foil (made by Toyo Aluminum) with the above-mentioned multilayer film and lid material that have an odor adsorbing function. (Trademark) 20 mg tablet).
• a press-through pack made of unstretched polypropylene was prepared using CKD M2 type.
• the material of the press-through pack is 250 m thick unstretched polypropylene (Sumitomo Bakelite Co., Ltd.) and the lid material is 17 m thick aluminum foil (Toyo Aluminum).
• the filling is 10 tablets olmesartan per sheet.
• a preparation containing medoxomil (Olmetec (registered trademark) 20 mg tablet) was prepared.
• the odometer can be measured after the odor at the time of taking out the tablet is temporarily contained.
• a special chamber with a capacity of 72 mL was prepared.
• the odor and / or strength when taking a preparation containing olmesartan medoxomil from the press-through pack was measured.
• Fig. 4 shows whether the press-through pack is packed in a pillow or not (open) in a thermostatic bath at 25 ° C. After one month, the pillow package is opened, and 10 tablets from the press-through pack are packed together in a dedicated chamber. This is the result of measuring the odor when taken out with an odometer.
• Evaluation value total value of panelers / number of panelists (5)
• FIG. 1 is a schematic cross-sectional view of a multilayer film in the present invention.
• FIG. 2 is another schematic cross-sectional view of the multilayer film in the present invention.
• FIG. 3 is a schematic sectional view of a press-through pack according to the present invention.

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• 2007
  • 2007-10-22 CN CN2007800395199A patent/CN101528179B/zh active Active
  • 2007-10-22 WO PCT/JP2007/070539 patent/WO2008050714A1/ja active Application Filing
  • 2007-10-22 KR KR1020097006803A patent/KR101400653B1/ko active IP Right Grant
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