KR20090074754A - Packaging material - Google Patents

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

Packing material {PACKAGING MATERIAL}

The present invention relates to a packaging material containing malodor adsorbent and a press-through pack or blister pack packed with a medicine.

Conventionally, in the packaging of pharmaceutical products, press through packs (PTPs) or blister packs are widely used. Some medicines may have odors specific to the preparations, and the person in charge of the medical facility that handles the press through packs or blister packs has the odor. You may feel unpleasant. In addition, the odor may be unpleasant when the taker takes the tablet out of the press-through pack or the blister pack or takes the tablet. Such formulations result in a lower compliance of the doser and thus affect product value.

In the form of a press-through pack or a blister pack packaging of a medicine, a press-through pack or a blister pack is sealed with an aluminum laminate film having a high gas barrier property as a method of adsorbing odors volatilized from the formulation (hereinafter referred to as "pillow packaging"). The odor adsorbent is put in it, and the method of adsorb | sucking the odor coming out slightly from a press-through pack or a blister pack is taken. However, in general, in the press-through pack or the blister pack, a relatively high airtight packaging material is selected for the purpose of securing hygiene and long-term stability of the formulation, and therefore, odorous substances remain in the pockets of the press-through pack or the blister pack. The effect of odor suppression was insufficient. Moreover, although the deodorizing film material which disperse | distributed and mixed a zeolite homogeneously to a film material is known (JP-A-11-35077), the packaging material for packaging the formulation containing the specific chemical agent of this invention is known. Not.

Patent Document 1: Japanese Patent Application Laid-Open No. 11-35077

Disclosure of Invention

Problems to be Solved by the Invention

An object of the present invention is olmesaltanmedoxomil or 2-amino-5-isobutyl-4- {2- [5- (N, N'-bis ((S) -1-ethoxycarbonyl) ethyl) phosphone It is providing the packaging material which adsorbs the malodorous substance generate | occur | produced from the formulation containing amide] furanyl} thiazole.

Means to solve the problem

MEANS TO SOLVE THE PROBLEM As a result of earnestly examining in order to achieve the said objective, when a odor adsorbent is contained in a packaging material, the packaging material is olmesaltan medoxomil or 2-amino-5-isobutyl-4- {2- [5- (N, Odor when removing the preparation from the package by adsorbing malodorous substances generated from N'-bis ((S) -1-ethoxycarbonyl) ethyl) phosphonamide] furanyl} thiazole and reducing its gas concentration The present invention has been accomplished by finding out that it can prevent or reduce the sensitization of sensitization, thereby reducing discomfort.

That is, the present invention,

(1) a packaging material for packaging a formulation containing olmesaltan medoxo mill, comprising a malodor adsorbent;

(2) the packaging material according to (1), wherein the malodor adsorbent is one or two or more kinds of compounds selected from physical adsorbents and chemical adsorbents;

(3) The packaging material according to (1), wherein the malodor adsorbent is one kind or two or more kinds of a compound selected from synthetic zeolites and activated carbon;

(4) the packaging material according to (1), wherein the malodor adsorbent is a synthetic zeolite 13X;

(5) the packaging material according to (1), wherein the malodor adsorbent is a hydrophobic zeolite,

(6) The packaging material according to (1), wherein the malodor adsorbent is a hydrophobic zeolite subjected to hydrophobic treatment to synthetic zeolite 13X,

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

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

(9) The packaging material according to (8), wherein the multilayer film has an adsorption layer and a base material layer containing a malodor adsorbent,

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

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

(12) The packaging material according to any one of (9) to (11), which further has an outer layer on the side in contact with the base layer of the adsorption layer,

(13) Adsorption layer is low density polyethylene, linear low density polyethylene, polypropylene, ionomer, ethylene acrylic acid copolymer, ethylene methacrylic acid copolymer, ethylene vinyl acetate copolymer, ethylene ethylene acrylate copolymer, ethylene methyl acrylate The packaging material in any one of (9)-(12) containing 1 type (s) or 2 or more types of a compound chosen from a copolymer and an ethylenemethyl methacrylate copolymer,

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

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

(16) The base layer contains one, two or more of the compounds selected from polyvinyl chloride, unstretched polypropylene, polypropylene, polyvinylidene chloride, poly 3 chlorochloride, cyclic olefin copolymers (9 ) The packaging material according to any one of (15),

(17) The packaging material according to any one of (9) to (15), wherein the substrate layer contains polyvinyl chloride,

(18) The packaging material according to any one of (10) to (17), wherein the adhesive layer contains one kind or two or more kinds of 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 kind or two or more kinds of 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 a linear low density polyethylene,

(22) The packaging material according to any one of (12) to (21), wherein the outer layer contains one kind or two or more kinds of a compound 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 a linear low density polyethylene,

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

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

(26) The press-through pack or blister pack according to (24) or (25), which is packaged with a formulation containing olmesaltanmedoxomil,

(27) Olmesaltan medoxo mill containing formulations packaged with the packaging material according to any one of (1) to (23),

(28) Olmesaltanmedoxomil-containing formulations packaged in press-through packs or blister packs as described in (24) or (25),

(29) A method for preventing odor of an olmesartan medoxo mill-containing formulation, which is packaged with the packaging material according to any one of (1) to (23).

(30) Provided is a method for preventing odor of an olmesartan medoxo-mil-containing formulation, which is packaged in a press-through pack or a blister pack according to (24) or (25).

Moreover, from another viewpoint of this invention,

(31) The compound of (1) to (23), wherein 2-amino-5-isobutyl-4- {2- [5- (N, N'-bis ((S A packaging material to which a formulation containing) -1-ethoxycarbonyl) ethyl) phosphonamide] furanyl} thiazole is applied,

(32) To (24) to (26), 2-amino-5-isobutyl-4- {2- [5- (N, N'-bis ((S) in place of the formulation containing olmesaltanmedoxomil. Press-through pack or blister pack to which a formulation containing) -1-ethoxycarbonyl) ethyl) phosphonamide] furanyl} thiazole is applied,

(33) The compound of (27) or (28), wherein 2-amino-5-isobutyl-4- {2- [5- (N, N'-bis ((S)- 1-ethoxycarbonyl) ethyl) phosphonamide] furanyl} thiazole-containing formulation,

(34) The compound of (29) or (30), wherein 2-amino-5-isobutyl-4- {2- [5- (N, N'-bis ((S)- There is provided a odor prevention method using a 1-ethoxycarbonyl) ethyl) phosphonamide] furanyl} thiazole-containing formulation.

Effects of the Invention

By using the packaging material containing the malodor adsorbent of the present invention, it is possible to provide a package in which almost no malodor is detected when the preparation is taken out.

Best Mode for Carrying Out the Invention

The packaging material in this invention contains a malodor adsorbent. Thereby, the package using the packaging material of this invention can adsorb the bad smell which arises from a formulation.

Examples of the malodor adsorbent that can be used in the present invention include physical adsorbents such as synthetic zeolites, silica gel, alumina, activated carbon, and chemical adsorbents capable of chemical adsorption with malodorous substances such as a complex chemical deodorant (daimusshu) based on organic acids. Etc., Preferably it is synthetic zeolite, More preferably, it is hydrophobic zeolite, Especially preferably, it is high silica zeolite. Due to the adsorption rate and adsorption characteristics for the malodorous substance, a physical adsorbent and a chemical adsorbent may be used in combination.

Synthetic zeolite is a porous granular material used to separate materials by the difference in size of molecules, and has a structure having uniform pores, which adsorbs small molecules entering the cavity of the pores and performs a kind of sieve function. In the present invention, the adsorption hole diameter is preferably 0.3 nm to 1 nm. Synthetic zeolites having a pore diameter 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. Among them, synthetic zeolite 13X having a pore diameter of about 1 nm is particularly preferable.

Moreover, although the average particle diameter of a synthetic zeolite is not limited as long as the objective of this invention is achieved, it is preferable that it is about 10 micrometers, for example. In addition, the adsorption characteristics of the synthetic zeolite are related to the pore diameter, and in order to increase the adsorption characteristics of the malodor, the powder of the synthetic zeolite can be made finer, thereby substantially increasing the surface area and increasing the number of pores.

Hydrophobic zeolite refers to synthetic zeolite subjected to hydrophobic treatment. Synthetic zeolites have odor adsorption and hygroscopic capabilities, and when moisture absorption proceeds, the odor adsorption performance decreases. Therefore, synthetic zeolites having a hydrophobic treatment to suppress the hygroscopic ability are more preferable. As a method of hydrophobicly treating a synthetic zeolite, the method of surface modification like the method of making surfactant adsorb | suck to a zeolite, or the method of making a silylating agent react with the hydroxyl group on the surface of a zeolite, the method of dealumination, etc. are mentioned, for example. .

The high silica zeolite refers to a synthetic zeolite in which aluminum atoms in the crystal skeleton of the synthetic zeolite are deallocated and reduced to increase the silica / alumina ratio (SiO ₂ / Al ₂ O ₃ ratio). This is because, by dealumination, the synthetic zeolite loses its affinity for polar substances such as water and can more strongly adsorb nonpolar substances such as malodorous substances. Especially, the high silica zeolite whose silica / alumina ratio is 5 or more is preferable. As such a high silica zeolite, commercially available products such as ABSCENT manufactured by Union Showa Co., Ltd. and HSZ series manufactured by Tosoh Corporation can be used.

As the packaging material in the present invention, resins such as thermoplastic resins, paper, fibers, metals, various paints, various adhesives, and the like can be used. Preferably it is a thermoplastic resin.

The thermoplastic resin is not particularly limited and known ones can be used, for example, polyvinyl chloride (PVC), unstretched polypropylene (CPP), polypropylene (PP), polyvinylidene chloride (PVDC), polytrifluoride Ethylene chloride (PCTFE), cyclic olefin copolymer (COC), polyethylene (PE), polycarbonate (PC), polyamide (PA), ethylene-vinyl acetate copolymer (EVA), ethylene-methacrylate copolymer, Polystyrene (PS), polyester (PET), polyacrylic acid (PAA) and the like, and preferably, polyvinyl chloride, unstretched polypropylene, polypropylene, polyvinylidene chloride, poly 3 ethylene chloride or cyclic Olefin copolymer. In this invention, these may be used independently and may be used in combination of 2 or more type.

The packaging material in this invention is not limited to being a single | mono layer, It is good also as a multilayer film to which a multilayer was affixed. The type, amount, thickness, and number of layers of the multilayer film are not limited as long as the object of the present invention is achieved, and can be widely used, and is appropriately selected depending on the use.

As shown in FIG. 1, in the multilayer film 1 in this invention, the adsorption layer 2 which contains a malodor adsorbent as an inner layer, and the base material layer which prevents penetration of moisture, oxygen, etc. from outside air as an outer layer (barrier) Layer 3).

Although it does not specifically limit as resin used for an adsorption layer, Although a person skilled in the art can select suitably, it is preferable that it is a resin with high melt flow rate, low melting point (low softening point), and excellent low temperature drawdown property. If it is a high melt flow rate resin, even if a melt flow rate falls by adding an adsorbent, a certain flow characteristic can be ensured. Moreover, if it is low melting | fusing point, since resin softens at low temperature, low temperature extrusion is attained and the fear of foaming can also be avoided. If the resin is excellent in low-temperature drawdown property, even if an adsorbent is added, extrusion molding by an extrusion molding machine is easy. Especially, resin with a melt flow rate of 10 or more and excellent in low melting | fusing point and low temperature drawdown property is more preferable.

As the resin used for the adsorption layer from such a viewpoint, for example, low density polyethylene (LDPE), linear low density polyethylene (LLDPE), polypropylene (PP), various copolymers (copolymers) and ionomers (for example, Salts of ethylene acrylic acid copolymer), ethylene acrylic acid copolymer (EAA), ethylene methacrylic acid copolymer (EMAA), ethylene vinyl acetate copolymer (EVA), ethylene ethylene acrylate copolymer (EEA), ethylene methyl acrylic Laterate copolymers (EMA), ethylene methyl methacrylate copolymers (EMMA), etc. are mentioned, Preferably they are low density polyethylene, a linear low density polyethylene, and a polypropylene, More preferably, they are low density polyethylene. In this invention, these may be used independently and may be used in combination of 2 or more type.

In the adsorption layer, other pigments can be blended as necessary. As pigments other than the said malodor adsorbent, the pigment which does not have a moisture absorption performance or a gas adsorption performance in particular may be used, and if it contains the pigment which has a function, various complex effects are acquired. Such pigments include, for example, synthetic zeolite, calcium chloride, calcium oxide, calcium carbonate, titanium oxide, zinc oxide, zirconium oxide, alumina, silica, mica, talc, carbon, activated carbon, and the like, preferably synthetic zeolite to be.

In an adsorption layer, the content rate of a malodor adsorbent is 5-70 weight%, for example, Preferably it is 10-60 weight%. When it contains another pigment other than a malodor adsorbent, the content rate of a total pigment is 30 to 70 weight%, for example, Preferably it is 45 to 65 weight%.

Although the film thickness of an adsorption layer is not specifically limited as long as the objective of this invention is achieved, For example, they are 10 micrometers-200 micrometers, Preferably they are 30 micrometers-100 micrometers.

The resin used for the base material layer is not particularly limited as long as it can prevent the ingress of moisture or oxygen from the outside, and known ones can be used, for example, polyvinyl chloride, unstretched polypropylene, polypropylene, Polyvinylidene chloride, polytrifluoroethylene, cyclic olefin copolymer, polyethylene, polycarbonate, polyamide, ethylene-vinyl acetate copolymer, ethylene-methacrylate copolymer, polystyrene, polyester, polyacrylic acid, etc. Polyvinyl chloride, unstretched polypropylene, polypropylene, polyvinylidene chloride, polyethylene terephthalate, and more preferably polyvinyl chloride. In this invention, these may be used independently and may be used in combination of 2 or more type.

Although the thickness of a base material layer is not specifically limited as long as the objective of this invention is achieved, For example, they are 20 micrometers-400 micrometers, Preferably they are 50 micrometers-300 micrometers.

You may further have an adhesive layer between an adsorption layer and a base material layer. As an adhesive layer, low density polyethylene, a linear low density polyethylene, a polypropylene, etc. are mentioned, for example. Preferably low density polyethylene. In this invention, these may be used independently and may be used in combination of 2 or more type.

As a method of adhering an adsorption layer and a base material layer, extrusion lamination, dry lamination, wet lamination, thermal lamination, sand lamination, etc. are mentioned, Preferably, it is dry lamination or sand lamination. Extrusion lamination is a method of thinly casting a molten resin from a T die on a substrate, and rolling and pressing the laminate. Dry lamination is a method of bonding a substrate to a preformed thermoplastic resin film or the like, after applying the adhesive to the substrate, drying the adhesive in a heat drying furnace, and then laminating and compressing the film with the film. Unlike dry lamination, wet lamination is a method of adhering a substrate and a film without drying the adhesive. Thermal lamination is a method of laminating | stacking the thermoplastic resin film previously shape | molded on the base material, and passing it between hot rolls, and heat-pressing. Sand lamination is a method of extracting two base materials, extruding molten resin from a T die, casting | flow_spread between both base materials, and carrying out roll compression and bonding.

Although the film thickness of the obtained multilayer film is not specifically limited as long as the objective of this invention is achieved, For example, they are 30 micrometers-500 micrometers, Preferably they are 100 micrometers-400 micrometers.

As shown in FIG. 2, in the other multilayer film 1 in this invention, the adsorption layer 2 has the outer layer 4 in the side which contact | connects the base material layer 3 of the main adsorption layer 2a further. It may be present and may further have the sealant layer 5 in the side which opposes the base material layer 3 of the main adsorption layer 2a. Moreover, you may have the sub adsorption layer which adsorbs malodors auxiliaryly so that the main adsorption layer mainly responsible for adsorption of malodors may be interposed. When an adsorption layer consists of a main adsorption layer and a sub adsorption layer, it is preferable that content of the adsorbent of a main adsorption layer is larger than content of a sub adsorption layer. As a result, the efficiency of adsorption is further improved.

As a sealant layer, low density polyethylene, a linear low density polyethylene, a polypropylene, etc. are mentioned, for example, Preferably it is a linear low density polyethylene. In this invention, these may be used independently and may be used in combination of 2 or more type.

As an outer layer, low density polyethylene, a linear low density polyethylene, a polypropylene, etc. are mentioned, for example, Preferably it is a linear low density polyethylene. In this invention, these may be used independently and may be used in combination of 2 or more type.

The adsorption layer is formed of a resin or an adsorbent in the form of a film or a sheet by inflation method, T-die method, co-extrusion, or the like, and a multilayer film by inflation method is particularly preferable. In addition, the multilayer inflation method is a method of extruding the resin melt | dissolved by the some extruder to the tube form, sending air in it, and inflating to manufacture a multilayer film. As a structure of an adsorption layer, 2 type 3 layers or 3 type 3 layers which consist of an outer layer / main adsorption layer / sealant layer are preferable.

The packaging material of the present invention can be used to produce a press-through pack or a blister pack to package the formulation. As shown in FIG. 3, in the press-through pack 8 in this invention, the multilayer film 1 (pocket sheet) which has a pocket part which accommodates the formulation 7, and the lid material 6 for sealing a pocket It consists of. The pocket sheet is provided with a plurality of concave pocket portions for storing the formulation 7, and the formulation 7 is housed in the pocket portion.

As a formulation packaged by a press-through pack or a blister pack, a tablet, a capsule, a powder, a granule, a granule, a troche, etc. are mentioned, for example, Preferably it is a tablet.

In the press-through pack or the blister pack, it is preferable to have a sealant layer on the side in contact with the formulation of the packaging material. By having a sealant layer in the innermost layer of a multilayer film, a sealant layer becomes a layer heat-sealed with a lid | cover material, and can also prevent direct contact of a formulation and an adsorption layer.

As a lid | cover material, aluminum foil, the laminated film of aluminum foil, and a plastic film etc. are mentioned, for example.

The production method of the press-through pack or the blister pack in the present invention is as follows: "Securing the quality of design, labeling, material specification, and packaging process in pharmaceuticals and food packaging (Technical Information Association, published September 1, 2005) It is good to manufacture using the general method described in the publication, "and there is no special limitation.

In the present invention, the active ingredient included in the formulation is not limited by its structure, degree, etc., as long as it has a malodorous drug, but olmesaltanmedoxomil, 2-amino-5-isobutyl-4- {2- [5 -(N, N'-bis ((S) -1-ethoxycarbonyl) ethyl) phosphonamide] furanyl} thiazole, L-cysteine, DL-methionine, bushamine, methylthioninesulfonium chloride, hydrochloric acid Sulfur-containing compounds such as ethyl cysteine, baccampillin hydrochloride, ceproxaxetyl, tosylate sulfacillin, diclofenamide, ranitidine hydrochloride, pamotidine hydrochloride, nizatidine, olmesaltan medoxomil, pindolol, and valproic acid Drugs having specific odors, such as sodium, todralazine hydrochloride, tolperizone hydrochloride, trimetadione, salazulfopyridine, flurubiprofen, herbal medicines, herbal medicines, and the like, preferably olmesaltanmedoxomil or 2-amino-5-isobutyl-4- {2- [5- (N, N'-bis ((S) -1-ethoxycarbonyl) ethyl) phosphone Mid] furanyl} thiazole boil down. Olmesaltan medoxyl wheat is a disease derived from hypertension or hypertension (more specifically, hypertension, heart disease [angina, myocardial infarction, arrhythmia, heart failure or cardiac hypertrophy], kidney disease [diabetic nephropathy, glomerulonephritis or kidney sclerosis]). Or it is effective for the prevention or treatment of cerebrovascular disease [cerebral infarction or cerebral hemorrhage], and can be easily manufactured according to the method described in Unexamined-Japanese-Patent No. 2012519 (US Pat. No. 5,616,599). In addition, 2-amino-5-isobutyl-4- {2- [5- (N, N'-bis ((S) -1-ethoxycarbonyl) ethyl) phosphonamide] furanyl} thiazole It can manufacture easily according to the method of international publication 01/47935 pamphlet etc.

Moreover, the formulation in this invention may contain another active ingredient as needed. The active ingredient includes, for example, diuretics such as Trichloromethiazide, Hydrochlorothiazide, Benzylhydrochlorothiazide, Azelnidipine, Amlodipine, Benidipine, Nitrendipine, Manidipine, Manicpine, Nicardipine, Nifedipine, Cilnidipine, Efonidipine, Barnidipine, Calcium Antagonists such as Felodipine; Pioglitazone, Rosiglitazone, Riboglitazone, MCC-555, NN-2344, BMS-298585, AZ-242, LY-519818, TAK- Insulin resistance improvers such as 559; Pravastatin, Simvastatin, Atorvastatin, Rosuvastatin, Cerivastatin, Pitavastatin tin), HMG-CoA reductase inhibitors such as fluvastatin; ACAT inhibitors such as SMP-797, Pactimibe, and the like, but are not limited thereto. The quantity of these active ingredients is not specifically limited, What is necessary is just to use the quantity normally used for a formulation.

Hereinafter, although an Example etc. demonstrate this invention further in detail, this invention is not limited to this.

(Example 1)

(1) Adjustment of master batch containing odor adsorbent

As a masterbatch (MB1), 50 weight part of high silica zeolites (brand name: ABSCENTS3000 Union Showa Co., Ltd. make) kneaded LDPE 50 weight part, and the pellet-form resin was prepared.

(2) Preparation of the adsorption layer

By the multilayer inflation method, the following two 3-layer films were produced. MB1 and LDPE as the base resin were blended in an amount of 2: 3 so that the adsorbent content was 20% by weight, and only LLDPE was used as the outer layer and the sealant layer, and the film thickness of each layer was determined as the outer layer / main adsorbing layer. The adsorption layer of 2 types 3 layers was produced so that it might become / sealant layer = 10 micrometer / 60 micrometer / 10 micrometer.

(3) Production of a multilayer film

The outer layer side of the said adsorption film and the polyvinyl chloride (made by Sumitomo Bakelite Co., Ltd.) of thickness 200micrometer were laminated | stacked using the sand lamination method using the adhesive layer as LDPE, and the multilayer film for pressthrough packs was produced.

(4) production of press-through packs

The press-through pack was produced using the M2 type manufactured by CKD. The material of the press-through pack is made of aluminum foil (manufactured by Toyo Aluminum) having a thickness of 17 mu m and the lid member having an odor adsorption function, and the filling is 10-definition olmesaltanmedoxomill (olmetech Registered trademark) 20 mg tablets).

(Comparative Example 1)

Press-through packs made of unstretched polypropylene were produced using the M2 type manufactured by CKD. The material of the press-through pack is made of unstretched polypropylene (manufactured by Sumitomo Bakelite Co., Ltd.) having a thickness of 250 µm and a lid member having an aluminum foil (manufactured by Toyo Aluminum) having a thickness of 17 µm. It was set as the formulation containing 20-mg tablet of olmetec (trademark) containing saltan methoxomile.

Test Example 1 Functional Test with Odo Meter

The measurement of the odometer was carried out by producing a dedicated chamber having an internal volume of 72 ml having a structure that can be measured after temporarily enclosing the malodor when taking out the tablet. Odor intensity | strength at the time of taking out the formulation containing olmesaltan metoxomil from the press-through pack using this exclusive chamber and Odo meter (Portable Odor Meter FPO-1 Futaba Electronics Co., Ltd. product) was measured. Fig. 4 shows the odor when the pillow packaging of the press-through pack and the non-opening (open) are put in a thermostatic bath at 25 ° C., and the pillow packaging is opened one month later, and the tablets are taken out from the press-through pack 10 times in a batch. This is the result of measuring by the odometer.

The results of FIG. 4 show that in the press-through pack using the packaging material of the present invention, the odor intensity at the time of taking out tablets is significantly reduced.

Test Example 2 Sensory Test

The press-through pack was placed in a thermostatic bath (open) at 40 ° C. and 25 ° C. without the pillow packing or the pillow packing (open), and the pillow packing was opened 6 months later, and the odor evaluation when the tablet was taken out of the press through pack was sensual. It was carried out by the test. The results are shown in Table 1.

(Sensory evaluation criteria)

Evaluation method 0: odorless, 0.5: extremely low, 1: low, 2: weak, 3: strong

Valuation = total panelists / panelists (5)

Comparative Example 1 Example 1 25 ℃ / 60% RH open 2.2 0 Pillow Packing Desiccant Radish 2.2 0 Pillow Packaging Desiccant Oil 1.1 0 40 ℃ / 75% RH Pillow Packing Desiccant Radish 2.6 0 Pillow Packaging Desiccant Oil 0.3 0

From the results of Table 1, it was confirmed that the press-through pack using the packaging material of the present invention had no odor when taking out the formulation in any storage state, and the odor adsorption function was maintained for a long time.

According to the present invention, it is possible to provide a pharmaceutical package in which an odor is hardly detected when the preparation is taken out.

1 is a schematic cross-sectional view of a multilayer film in the present invention.

It is another schematic sectional drawing of the multilayer film in this invention.

3 is a schematic cross-sectional view of a press through pack in the present invention.

4 (Test Example 1) is a functional test result obtained by an odometer.

※ Explanation of sign

1 multilayer film

2 adsorption layer

2a main adsorption layer

3 base material layer (barrier layer)

4 outer layers

5 sealant layer

6 lid

7 formulation

8 press through pack

Claims (30)

A packaging material for packaging a formulation containing olmesaltan medoxomil, comprising a malodor adsorbent. The method of claim 1, A packaging material in which the malodor adsorbent is one or two or more of the compounds selected from physical adsorbents and chemical adsorbents. The method of claim 1, The packaging material whose odor adsorbent is 1 type, or 2 or more types of the compound chosen from a synthetic zeolite and activated carbon. The method of claim 1, Packaging material in which the malodor adsorbent is synthetic zeolite 13X. The method of claim 1, A packaging material in which the malodor adsorbent is a hydrophobic zeolite. The method of claim 1, The packaging material whose odor adsorbent is hydrophobic zeolite which gave hydrophobic treatment to synthetic zeolite 13X. The method of claim 1, A packaging material in which the malodor adsorbent is a high silica zeolite. The method according to any one of claims 1 to 7, A packaging material wherein the packaging material is a multilayer film. The method of claim 8, The packaging material in which a multilayer film has an adsorption layer and a base material layer containing a malodor adsorbent. The method of claim 9, A packaging material further having an adhesive layer between the adsorption layer and the base layer. The method according to claim 9 or 10, The packaging material which further has a sealant layer in the side which opposes the base material layer of an adsorption layer. The method according to any one of claims 9 to 11, The packaging material which has an outer layer further in the side which contact | connects the base material layer of an adsorption layer. The method according to any one of claims 9 to 12, The adsorption layer is low density polyethylene, linear low density polyethylene, polypropylene, ionomer, ethylene acrylic acid copolymer, ethylene methacrylic acid copolymer, ethylene vinyl acetate copolymer, ethylene ethylene acrylate copolymer, ethylene methyl acrylate copolymer, The packaging material containing 1 type, or 2 or more types of compound chosen from an ethylene methyl methacrylate copolymer. The method according to any one of claims 9 to 12, The packaging material in which an adsorption layer contains 1 type (s) or 2 or more types of compounds chosen from a low density polyethylene, a linear low density polyethylene, and a polypropylene. The method according to any one of claims 9 to 12, A packaging material in which the adsorption layer contains low density polyethylene. The method according to any one of claims 9 to 15, The packaging material in which a base material layer contains 1 type (s) or 2 or more types of compounds chosen from a polyvinyl chloride, an unstretched polypropylene, a polypropylene, polyvinylidene chloride, a poly 3 ethylene fluorochloride, and a cyclic olefin copolymer. The method according to any one of claims 9 to 15, The packaging material in which a base material layer contains polyvinyl chloride. The method according to any one of claims 10 to 17, The packaging material in which an adhesive layer contains 1 type (s) or 2 or more types of compounds chosen from a low density polyethylene, a linear low density polyethylene, and a polypropylene. The method according to any one of claims 10 to 17, A packaging material in which the adhesive layer contains low density polyethylene. The method according to any one of claims 11 to 19, The packaging material in which the sealant layer contains 1 type (s) or 2 or more types of compounds chosen from a low density polyethylene, a linear low density polyethylene, and a polypropylene. The method according to any one of claims 11 to 19, A packaging material in which the sealant layer contains linear low density polyethylene. The method according to any one of claims 12 to 21, The packaging material in which an outer layer contains 1 type (s) or 2 or more types of compounds chosen from a low density polyethylene, a linear low density polyethylene, and a polypropylene. The method according to any one of claims 12 to 21, A packaging material in which the outer layer contains a linear low density polyethylene. A press-through pack or a blister pack using the packaging material according to any one of claims 1 to 23. A press-through pack or blister pack using the packaging material according to any one of claims 1 to 23 as a pocket sheet of a container. The method of claim 24 or 25, Press-through packs or blister packs packed with formulations containing olmesaltanmedoxomil. Olmesaltanmedoxomil containing formulation packaged with the packaging material of any one of Claims 1-23. An olmesaltane medoxo mill-containing formulation packaged in the press-through pack or blister pack according to claim 24. It is packaged with the packaging material in any one of Claims 1-23, The odor preventing method of the olmesaltane medoxo mill containing formulation. A method for preventing odor of an olmesaltan metoxomil-containing formulation, which is packaged in a press-through pack or a blister pack according to claim 24 or 25.

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