WO2008050714A1

WO2008050714A1 - Packaging material

Info

Publication number: WO2008050714A1
Application number: PCT/JP2007/070539
Authority: WO
Inventors: Masaaki Takahashi; Takahiko Sato; Tatsuya Ogawa; Shin-Ichi Koizumi
Original assignee: Daiichi Sankyo Company, Limited
Priority date: 2006-10-25
Filing date: 2007-10-22
Publication date: 2008-05-02
Also published as: JP2013121535A; TWI402085B; CN101528179B; JP5546072B2; JP5241503B2; TW201332594A; JPWO2008050714A1; KR101400653B1; CN101528179A; TWI486183B; TW200824728A; KR20090074754A

Abstract

It is intended to provide a medicine pack which gives little noticeable odor when taking out the medicinal preparation therefrom. A packaging material containing an odor-adsorbent; and a press through pack or a blister pack having a medicine packaged therein.

Description

Specification

Packaging material

Technical field

[0001] 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.

Background art

[0002] Conventionally, press-through packs (PTP) 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.

[0003] In the 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. However, in general, 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. In addition, 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

Disclosure of the invention

Problems to be solved by the invention

[0004] 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 Ν, Ν'-bis ((S) -l-ethoxycarboninole) ethinole) phosphonamide] furinole} thiazole.

Means for solving the problem

[0005] As a result of intensive investigations to achieve the above object, the present inventors have found that when the packaging material contains an odor adsorbent, the packaging material is olmesartan medoxomil or 2-amino-5-isobutynol-4. -{2- [5- (Ν, Ν'-bis ((S) -l-ethoxycarboninole) ethinole) phosphonamide] furaninole} odor generated from thiazole! /, Adsorbing substances and its gas concentration As a result, it was found that the strength of the packaging can be reduced by reducing the odor when the preparation is taken out, and the discomfort can be reduced.

That is, the present invention provides:

(1) A packaging material for packaging a preparation containing olmesartan medoxomil, characterized by containing odor V, an adsorbent,

(2) The packaging material according to (1), wherein the odor adsorbent is one or more compounds selected from physical adsorbents and chemical adsorbents,

(3) The packaging material according to (1), wherein the odor adsorbent is one or more compounds selected from synthetic zeolite and activated carbon,

(4) The packaging material according to (1), wherein the odor adsorbent is synthetic zeolite 13X,

(5) The packaging material according to (1), wherein the odor adsorbent is hydrophobic zeolite.

(6) The packaging material according to (1), wherein the odor! /, The adsorbent is hydrophobic zeolite obtained by subjecting synthetic zeolite 13X to a hydrophobic treatment,

(7) The packaging material according to (1), wherein the odor adsorbent is high silica zeolite,

(8) The packaging material according to any one of (1) to (7), wherein the packaging material is a multilayer film,

(9) Multilayer film strength The packaging material according to (8), which has an adsorption layer and a base material layer containing an odorous adsorbent,

(10) The packaging material according to (9), further including an adhesive layer between the adsorption layer and the base material layer,

(11) The packaging material according to (9) or (10), further comprising a sealant layer on the side of the adsorption layer facing the base material layer,

(12) The adsorbent layer further has an outer layer on the side in contact with the base material layer. Packaging material according to

(13) 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 according to any one of (9) to (12), containing at least one compound selected from a polymer, an ethylene methyl acrylate copolymer, and an ethylene methyl methacrylate copolymer. Material,

(14) 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,

(15) The packaging material according to any one of (9) to (12), wherein the adsorption layer contains low-density polyethylene,

(16) 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)! / The packaging material described in

(17) The packaging material according to any one of (9) to (15), wherein the base material layer contains polychlorinated bur;

(18) The packaging according to any one of (10) to (17), wherein the adhesive layer contains one or more compounds selected from low-density polyethylene, linear low-density polyethylene, and polypropylene. Material,

(19) The packaging material according to any one of (10) to (17), wherein the adhesive layer contains low density polyethylene,

(20) The packaging material according to any one of (11) to (19), wherein the sealant layer contains one or more compounds selected from low-density polyethylene, linear low-density polyethylene, and polypropylene.

(21) The packaging material according to any one of (11) to (19), wherein the sealant layer contains linear low-density polyethylene.

(22) The package according to any one of (12) to (21), wherein the outer layer contains one or more compounds selected from low-density polyethylene, linear low-density polyethylene, and polypropylene. Materials,

(23) The packaging material according to any one of (12) to (21), wherein the outer layer contains linear low-density polyethylene,

(24) Press-through pack or blister pack using the packaging material according to any one of (1) to (23),

(25) A press-through pack or blister pack using the packaging material according to any one of (1) to (23) for a pocket sheet of a container,

(26) The press-through pack or blister pack according to (24) or (25), in which a preparation containing olmesartan medoxomil is packaged,

(27) Olmesartan medoxomil-containing preparation packaged with the packaging material according to any one of (1) to (23),

(28) Olmesartan medoxomil-containing preparation packaged in the press-through pack or blister pack described in (24) or (25),

(29) A method for preventing odor of a nonoresartan medoxomil-containing preparation, characterized by being packaged with the packaging material according to any one of (1) to (23),

(30) 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).

From another viewpoint of the present invention,

(31) In (1) to (23), instead of the preparation containing olmesartan medoxomil, 2-amino-5-isobutyl-4- {2- [5- (Ν, Ν'-bis ((S) -l -Packaging material to which a preparation containing -ethoxycarbonyleno) ethinole) phosphonamide] furanyl} thiazole is applied,

(32) In (24) to (26), instead of a preparation containing olmesartan medoxomil, 2-amino-5-isobutyl-4- {2- [5- (Ν, Ν'-bis ((S) -l -Ethoxycarboninole) ethinole) phosphonamide] furanyl} thiazole applied press-through pack or blister knock,

(33) In (27) or (28), instead of the preparation containing olmesartan medoxomil, 2-amino-5-isobutyl-4- {2- [5- (Ν, Ν'-bis ((S) -l-ethoxy Carbonyl) ethyl) phosphonamide] A preparation to which a preparation containing furanyl} thiazole is applied,

(34) In (29) or (30), instead of the preparation containing olmesartan medoxomil, 2-amino-5-isobutyl-4- {2- [5- (Ν, Ν'-bis ((S) -l-ethoxy Carbonyl) ethyl) phosphonamido] Furanyl} thiazole-containing preparation is provided. The invention's effect

[0008] By using the packaging material containing the odor adsorbent of the present invention, it is possible to provide a package that hardly senses odor when taking out the preparation!

BEST MODE FOR CARRYING OUT THE INVENTION

[0009] 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.

[0010] Examples of odor adsorbents that can be used in the present invention 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.

[0011] 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. In the present invention, 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.

[0012] 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. Note that 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

Yes

[0013] The hydrophobic zeolite is a synthetic zeolite that has been subjected to a hydrophobic treatment. Synthetic zeolite 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.

[0014] 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. By the dealumination treatment, synthetic zeolite loses its affinity for polar substances such as water, and can more strongly adsorb non-polar substances such as odorous substances. Among them, high silica zeolite having a silica / alumina ratio of 5 or more is preferable. As such a high silica zeolite, it is possible to use commercially available products such as Union Showa's ABSCENT and Tosoh's HSZ series.

As the packaging material in the present invention, resins such as thermoplastic resins, papers, fibers, metals, various paints, various adhesives and the like can be used, and thermoplastic resins are preferable.

[0016] The thermoplastic resin is not particularly limited and can use a known one. For example, poly (vinyl chloride) (PVC), unstretched polypropylene (CPP), polypropylene (PP), polyvinylidene chloride (PVDC), poly Ethylene trifluoride chloride (PCTFE), cyclic olefin copolymer (CO C), polyethylene (PE), polycarbonate (PC), polyamide (PA), ethylene vinyl acetate copolymer (EVA), ethylene metatalate Polymers, polystyrene (PS), polyester (PET), polyacrylic acid (PAA), etc. can be mentioned, and preferably, 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.

[0017] 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.

[0018] As shown in Fig. 1, 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.

[0019] 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.

From this point of view, 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), ethylene acrylic acid copolymer (EAA), ethylene methacrylic acid copolymer (EMAA), ethylene acetate butyl copolymer (EVA), ethylene ethylene acrylate Rate copolymer (EEA), ethylene methyl acrylate copolymer (EMA), ethylene methyl methacrylate copolymer (EMMA), etc., preferably 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.

[0021] In the adsorbing layer, other pigments can be blended as necessary. As 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. . Examples of such 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. Preferred is synthetic zeolite.

[0022] In the adsorption layer, the content of the odor adsorbent is, for example, 5 to 70% by weight, and preferably 10 to 60% by weight. When other pigments are included in addition to the odor adsorbent, the total pigment content is, for example, 30 to 70% by weight, and preferably 45 to 65% by weight. [0023] 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 µm to 200 µm, preferably 30 µm to 100 µm.

[0024] 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.

[0025] 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 µm, and preferably 50 µm to 300 µm.

[0026] An adhesive layer may be further provided between the adsorption layer and the base material layer. Examples of 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.

[0027] As a method for bonding the adsorbing layer and the base material layer, for example, extrusion lamination, dry lamination, wet lamination, thermal lamination, sand lamination, etc. can be used. Lamination or sand lamination. 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.

[0028] 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 µm to 500 µm, preferably 100 µm to 400 µm.

As shown in FIG. 2, in another multilayer film 1 according to the present invention, 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. Moreover, you may have the subadsorption layer which assists adsorption | suction of odor so that the main adsorption | suction layer mainly responsible for adsorption of odor may be pinched | interposed. When 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. Thereby, the efficiency of adsorption | suction is improved more.

[0030] Examples of the sealant 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.

[0031] 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.

[0032] 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. As the structure of the adsorbing layer, a two-kind three-layer or a three-kind three-layer consisting of an outer layer / main adsorbing layer / sealant layer is preferable.

[0033] By using the packaging material of the present invention, a press-through pack or a blister pack can be produced and the preparation can be packaged. As shown in FIG. 3, the press-through pack 8 according to the present invention 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. [0034] 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.

[0035] In the press-through pack or blister pack, it is preferable to have a sealant layer on the side of the packaging material that comes into contact with the preparation! By having the sealant layer as the innermost layer of the multilayer film, 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.

[0036] Examples of the cover material include aluminum foil, a laminate film of an aluminum foil and a plastic film, and the like.

[0037] 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

[0038] In the present invention, 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- (Ν, Ν'-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 hydrochloride, tolperisone hydrochloride, trimetasdione hydrochloride, Pyridine, Flurbipro Examples thereof include drugs having a specific odor such as hen, traditional Chinese medicine, herbal medicine, and preferably olmesartan medoxomil or 2-amino-5-isobutyl-4- {2- [5- (N, Ν'-bis ((S) -l-ethoxycarbonyl) ethinole) phosphonamido] furanyl} thiazole. 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. In addition, 2-amino-5-isobutyl-4- {2- [5- (Ν, Ν'-bis ((S) -l-ethoxycarboninole) ethyl) phosphonamide] furanyl} thiazole is It can be easily manufactured according to the method described in 01/47935 pamphlet.

[0039] The preparation of the present invention may contain other active ingredients as necessary. Examples of 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 (Cerivastatin) ), HMG-CoA reductase inhibitors such as pitavastatin and fluvastatin; SMP-797, ACAT inhibitors such as Pactimibe, etc. The amount of these active ingredients is not particularly limited, and may be the amount normally used for pharmaceutical preparations.

Example

[0040] Hereinafter, the present invention will be described in more detail by way of examples and the like, but the present invention is not limited thereto.

[0041]

(Example 1)

(1) Preparation of master batch containing odor adsorbent

As a master batch (MB1), 50 parts by weight of high-silica zeolite (trade name: ABSCEN TS3000 manufactured by Union Showa Co., Ltd.) was mixed with 50 parts by weight of LDPE to prepare pellet-shaped resin. [0042]

(2) Preparation of adsorption layer

The following two types of three-layer films were produced by the multilayer inflation method. As a resin adsorption layer, the LDPE of MB1 and base resin 2: used by Blend so the adsorbent content to 20 weight ^_0/0 3, with LLDPE only in the outer layer and the sealant layer, the layers Two types and three layers of adsorption layers were prepared so that the outer layer / main adsorption layer / sealant layer = 10 H m / 6011 m / 10 μm.

[0043]

(3) Production of multilayer film

The outer layer side of the adsorbing film and a 200,1 m-thick polychlorinated bule (manufactured by Sumitomo Bakelite Co., Ltd.) were laminated using the sand laminating method with the adhesive layer as LDPE to produce a multilayer film for a press-through pack.

[0044]

(4) Production of 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).

[0045]

(Comparative Example 1)

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.

[0046]

(Test Example 1) Functional test with odometer

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. Using this dedicated chamber and odometer (manufactured by Portable Odor Meter FPO-1 Futaba Electronics Co., Ltd.), 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.

[0047]

From the results shown in Fig. 4, in the press-through pack using the packaging material of the present invention, the odor and strength when taking out the tablets are significantly reduced!

[0048]

(Test Example 2) Sensory test

Place the press-through pack in the thermostatic bath at 40 ° C and 25 ° C with the press-through pack or without the pillow package (open), and open the pillow package after 6 months. The odor evaluation when the tablets were taken out from the test was performed by a sensory test. The results are shown in Table 1.

[0049]

(Sensory evaluation criteria)

Evaluation method 0: odorless, 0.5: very slight, 1: slightly, 2: weak, 3: strong

Evaluation value = total value of panelers / number of panelists (5)

(table 1) 1 ~~ ratio ji conduct ji

Open: 2. 2 0

Pi π ^: Packaging

2. 2 0

No desiccant

Pillow package:

L I; 0

¾ With desiccant

Phi parcel: Cloth.

2 6 0

40; ° C / 75% RH without desiccant

Pillow pack g:

0 · 3: 0

From the results shown in Table 1, it was confirmed that the press-through pack using the packaging material of the present invention maintained the odor adsorbing function for a long period of time without any odor at the time of taking out the preparation in any storage state.

Industrial applicability

[0050] According to the present invention, it is possible to provide a pharmaceutical package that hardly senses odor when a preparation is taken out.

Brief Description of Drawings

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.

[Fig. 4] (Test Example 1) Functional test results using an odometer.

Explanation of symbols

[0052] 1 Multi-layer film

2 Adsorption layer

2a Main adsorption layer

3 Base material layer (barrier layer)

4 outer layer

5 Sealant layer

6 Lid

7 Formulation

CS0.0 / .00Zdf / X3d 9 i M.0S0 / 800Z OAV

Claims

The scope of the claims

[I] A packaging material for packaging a preparation containing olmesartan medoxomil, which contains an odor adsorbent.

[2] The packaging material according to claim 1, wherein the odor adsorbent is one or more compounds selected from a physical adsorbent and a chemical adsorbent.

[3] The packaging material according to claim 1, wherein the odor adsorbent is one or more compounds selected from synthetic zeolite and activated carbon.

[4] The packaging material according to claim 1, wherein the odor adsorbent is synthetic zeolite 13X.

[5] The packaging material according to claim 1, wherein the odor! / And the adsorbent is hydrophobic zeolite.

[6] The packaging material according to claim 1, wherein the odor adsorbent is a hydrophobic zeolite obtained by subjecting synthetic zeolite 13X to a hydrophobic treatment.

7. The packaging material according to claim 1, wherein the odor adsorbent is high silica zeolite.

8. The packaging material according to any one of claims 1 to 7, wherein the packaging material is a multilayer film.

[9] The packaging material according to claim 8, wherein the multilayer film has an adsorption layer and a base material layer containing an odorous adsorbent.

10. The packaging material according to claim 9, further comprising an adhesive layer between the adsorption layer and the base material layer.

[I I] The packaging material according to claim 9 or 10, further comprising a sealant layer on the side of the adsorption layer facing the base material layer.

[12] The packaging material according to any one of [9] to [11], further comprising an outer layer on the side of the adsorbing layer in contact with the base material layer.

[13] 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 claims 9 to 12, comprising one or more compounds selected from a coalesced polymer, an ethylene methyl acrylate copolymer, and an ethylene methyl methacrylate copolymer.

14. The packaging material according to any one of claims 9 to 12, wherein the adsorption layer contains one or more compounds selected from low density polyethylene, linear low density polyethylene, and polypropylene.

[15] The packaging material according to any one of [9] to [12], wherein the adsorption layer contains low-density polyethylene.

[16] The claim wherein the base material layer contains one or more compounds selected from polychlorinated butyl, unstretched polypropylene, polypropylene, polyvinylidene chloride, polytrifluoroethylene chloride, and cyclic olefin copolymers. Item 15. A packaging material according to any one of Items 9 to 15.

[17] The packaging material according to any one of [9] to [15], wherein the base material layer contains polychlorinated butyl.

[18] The packaging material according to any one of [10] to [17], wherein the adhesive layer contains one or more compounds selected from low-density polyethylene, linear low-density polyethylene, and polypropylene.

[19] The packaging material according to any one of [10] to [17], wherein the adhesive layer contains low-density polyethylene.

[20] The packaging material according to any one of [11] to [19], wherein the sealant layer contains one or more compounds selected from low density polyethylene, linear low density polyethylene, and polypropylene.

[21] The packaging material according to any one of [11] to [19], wherein the sealant layer contains linear low-density polyethylene.

[22] The packaging material according to any one of [12] to [21], wherein the outer layer contains one or more compounds selected from low-density polyethylene, linear low-density polyethylene, and polypropylene.

[23] The packaging material according to any one of [12] to [21], wherein the outer layer contains linear low-density polyethylene.

[24] A press-through pack or a blister pack using the packaging material according to any one of claims 1 to 23.

[25] A press-through pack or blister pack using the packaging material according to any one of claims 1 to 23 for a pocket sheet of a container.

[26] The press-through pack or blister pack according to claim 24 or 25, which is packaged with a preparation containing olmesartan medoxomil.

[27] An olmesartan medoxomil-containing preparation packaged with the packaging material according to any one of claims 1 to 23.

[28] An olmesartan medoxomil-containing preparation packaged in a press-through pack or blister pack according to claim 24 or 25.

[29] A method for preventing odor wrinkles of an onoremesartan medoxomil-containing preparation, which is packaged with the packaging material according to any one of claims 1 to 23.

[30] A method for preventing odor of an olmesartan medoxomil-containing preparation, characterized by being packaged in the press-through pack or blister pack according to claim 24 or 25.