JP2017081830A - Solid preparation packages and odor removal method of solid preparations - Google Patents

Abstract

An object of the present invention is to provide means for suppressing unpleasant odor components generated from a solid preparation in a solid preparation package in which PTP-packaged solid preparations are secondary packaged. A solid preparation package according to the present invention comprises a solid preparation containing a drug having a medoxomil group, a PTP packaging material enclosing the solid preparation, a secondary packaging material enclosing the PTP packaging material, an odor adsorbent enclosed in the inner space of the secondary packaging material, and the PTP packaging material has at least a portion with a film thickness of 0.13 mm or less around the solid preparation. [Selection drawing] Fig. 1

Description

  The present invention relates to a solid preparation package in which a solid preparation packed in PTP is enclosed in a secondary packaging material together with an odor adsorbent, and a method for removing odor from the solid preparation.

  Angiotensin II receptor antagonist, which is a renin-angiotensin system inhibitor, is effective for renin-dependent hypertension, has a protective effect on cardiovascular and renal disorders, and treats hypertension or heart disease Or it is widely used as a medicine for prevention.

  (5-Methyl-2-oxo-1,3-dioxolen-4-yl) methyl 4- (1-hydroxy-1-methylethyl) -2-propyl-1- [2 ′-(1H-tetrazole-5- Yl) biphenyl-4-ylmethyl)] imidazole-5-carboxylate (hereinafter also referred to as “olmesartan medoxomil”) is an excellent angiotensin II receptor antagonist and is used for the treatment or prevention of hypertension and heart disease. It is useful as a pharmaceutical.

  Olmesartan medoxomil is sold as Olmetec (registered trademark) and contains 5 mg, 10 mg, 20 mg, or 40 mg of olmesartan medoxomil as an active ingredient, and low-substituted hydroxypropyl cellulose, hydroxypropyl cellulose, crystalline cellulose, lactose as an additive Contains water suppository, magnesium stearate.

  Olmesartan medoxomil has an ester group on the imidazole ring and thus is susceptible to hydrolysis and the like, and is hydrolyzed under acidic or basic conditions to give 4- (1-hydroxy-1-methylethyl)- Converted to 2-propyl-1- [2 ′-(1H-tetrazol-5-yl) biphenyl-4-ylmethyl] imidazole-5-carboxylic acid.

  Olmesartan medoxomil is known to produce an unpleasant odor for the user. On the other hand, it is disclosed that an unpleasant odor can be suppressed by adding cyclodextrin as an additive to a solid preparation of olmesartan medoxomil (Patent Document 1).

  In addition, it has been proposed that a packaging material for packaging a preparation containing olmesartan medoxomil contains an odor adsorbent such as synthetic zeolite or activated carbon (Patent Document 2). Moreover, a pharmaceutical package containing a pharmaceutical preparation containing a benzimidazole derivative and a desiccant such as synthetic zeolite or activated carbon has been proposed (Patent Document 3).

International Publication No. 2010/018777 International Publication No. 2008/050714 International Publication No. 2007/097451

  In the methods of Patent Documents 1 and 2, it is necessary to add an additive to a solid preparation or an odor adsorbent to a packaging material, but it is desirable to suppress unpleasant odor with a simpler method. ing.

  In the method of Patent Document 3, it is sufficient that the pharmaceutical preparation and the desiccant coexist independently in the pharmaceutical package. However, for example, in a mode in which the pharmaceutical preparation is PTP-packed and then pillow-packaged, and the desiccant is disposed in the pillow package, the desiccant is an odor released from the PTP package to the outside in the pillow package. Although the components can be removed, it is difficult to remove the odorous components in the PTP package.

  The present invention has been made in view of the above circumstances, and provides a means capable of suppressing unpleasant odor components generated from a solid preparation in a solid preparation package in which a PTP-wrapped solid preparation is secondarily packaged. There is.

  As a result of diligent research to achieve the above object, the present inventors have surprisingly been able to effectively suppress the unpleasant odor of the drug by defining the film thickness of the PTP packaging material that encapsulates the solid preparation. And the present invention was completed.

  (1) A solid preparation package according to the present invention includes a solid preparation containing a drug having a medoxomil group, a PTP packaging material that encloses the solid preparation, a secondary packaging material that encloses the PTP packaging material, and the above An odor adsorbent enclosed in the internal space of the secondary packaging material, and the PTP packaging material has at least a portion having a film thickness of 0.13 mm or less around the solid preparation.

  (2) Preferably, the PTP packaging material has at least a portion having a film thickness of 0.12 mm or less around the solid preparation.

  (3) Preferably, the PTP packaging material has at least a portion with a film thickness of 0.10 mm or less around the solid preparation.

  (4) Preferably, the drug is olmesartan medoxomil.

  (5) Preferably, the odor adsorbent is one or more selected from synthetic zeolite or activated carbon.

  (6) Preferably, the PTP packaging material is a polypropylene sheet in which a pocket capable of accommodating the solid preparation is formed, and the film thickness is a film thickness in the pocket.

  (7) Preferably, the solid preparation is a tablet.

  (8) Preferably, the secondary packaging material is a pillow packaging material.

  (9) The method for removing odor of a solid preparation according to the present invention includes enclosing a solid preparation containing a drug having a medoxomil group in a PTP packaging material having a thickness of at least 0.13 mm around the solid preparation. Then, the odorous component generated from the drug is removed by enclosing the PTP packaging material in a secondary packaging material and encapsulating the odor adsorbent in the internal space of the secondary packaging material.

  ADVANTAGE OF THE INVENTION According to this invention, the unpleasant odor component generate | occur | produced from a solid formulation can be suppressed in the solid formulation package body by which the solid formulation by which PTP packaging was carried out was secondary-packaged.

FIG. 1 is a cross-sectional view of a PTP packaging material 10.

  Hereinafter, embodiments of the present invention will be described with reference to the drawings as appropriate. The embodiment described below is merely an example of the present invention, and it is needless to say that the embodiment of the present invention can be changed as appropriate without departing from the gist of the present invention.

  In the present invention, the active ingredient contained in the drug may be a drug having a smell, for example, olmesartan medoxomil, 2-amino-5-isobutyl-4- {2- [5- (N, N′-bis ((S) -1-Ethoxycarbonyl) ethyl) phosphonamido] furanyl} thiazole, (5-methyl-2-oxo-1,3-dioxolen-4-yl) methyl (5R, 6S) -6-[(R ) -1-hydroxyethyl] -2-[(R) -2-tetrahydrofuryl] penem-3-carboxylate, 2-ethoxy-1-{[2 '-(5-oxo-4,5-dihydro-1 , 2,4-oxadiazol-3-yl) biphenyl-4-yl] methyl} -1H-benzimidazole-7-carboxylic acid (5-methyl-2-oxo-1,3-dioxol-4-yl) Methyl or a salt thereof (hereinafter sometimes referred to as “azirsartan medoxomil”), 2-ethoxy-1-{[2 ′-(5-oxo-2,5-dihydro-1,2,4-oxadiazole) -3-yl) biphenyl-4-yl] L} -1H-benzimidazole-7-carboxylic acid (5-methyl-2-oxo-1,3-dioxol-4-yl) methyl or a salt thereof (hereinafter sometimes referred to as “Azilsartan Camedoxomil”) 2-cyclopropyl-1-{[2 '-(5-oxo-4,5-dihydro-1,2,4-oxadiazol-3-yl) biphenyl-4-yl] methyl} -1H-benz Imidazole-7-carboxylic acid (5-methyl-2-oxo-1,3-dioxol-4-yl) methyl or a salt thereof, 2-cyclopropyl-1-{[2 '-(5-oxo-2,5 -Dihydro-1,2,4-oxadiazol-3-yl) biphenyl-4-yl] methyl} -1H-benzimidazole-7-carboxylic acid (5-methyl-2-oxo-1,3-dioxole- 4-yl) methyl or a salt thereof.

  Preferably olmesartan medoxomil, 2-amino-5-isobutyl-4- {2- [5- (N, N′-bis ((S) -1-ethoxycarbonyl) ethyl) phosphonamido] furanyl} thiazole or (5 -Methyl-2-oxo-1,3-dioxolen-4-yl) methyl (5R, 6S) -6-[(R) -1-hydroxyethyl] -2-[(R) -2-tetrahydrofuryl] penem -3-carboxylate, particularly preferably olmesartan medoxomil.

  Olmesartan medoxomil is used for hypertension or a disease derived from hypertension (more specifically, hypertension, heart disease [angina, myocardial infarction, arrhythmia, heart failure or hypertrophy), kidney disease [diabetic nephropathy, thread Spherical nephritis or nephrosclerosis] or cerebrovascular disease [cerebral infarction or cerebral hemorrhage]) is effective in the prevention or treatment, and the method described in Japanese Patent No. 2082519 (US Pat. No. 5,616,599) and the like And can be manufactured easily. 2-amino-5-isobutyl-4- {2- [5- (N, N'-bis ((S) -1-ethoxycarbonyl) ethyl) phosphonamido] furanyl} thiazole is a diabetic, hyperglycemic, It is effective for the prevention or treatment of dysfunction, obesity, diabetic complications, etc. (preferably prevention or treatment of diabetes), and can be easily produced according to the method described in International Publication No. 2001/047935 pamphlet etc. it can. In addition, (5-methyl-2-oxo-1,3-dioxolen-4-yl) methyl (5R, 6S) -6-[(R) -1-hydroxyethyl] -2-[(R) -2- Tetrahydrofuryl] penem-3-carboxylate is a penem compound expected as an antibacterial agent, and can be easily produced according to the method described in International Publication No. 1992/003442 pamphlet or the like. Furthermore, azilsartan medoxomil, azilsartan medoxomil, 2-cyclopropyl-1-{[2 '-(5-oxo-4,5-dihydro-1,2,4-oxadiazol-3-yl) biphenyl- 4-yl] methyl} -1H-benzimidazole-7-carboxylic acid (5-methyl-2-oxo-1,3-dioxol-4-yl) methyl or a salt thereof and 2-cyclopropyl-1-{[2 '-(5-oxo-2,5-dihydro-1,2,4-oxadiazol-3-yl) biphenyl-4-yl] methyl} -1H-benzimidazole-7-carboxylic acid (5-methyl- 2-Oxo-1,3-dioxol-4-yl) methyl or a salt thereof is regarded as a promising therapeutic agent for hypertension and the like, and is disclosed in WO 2005/080384 pamphlet or WO 2006/107062 pamphlet. Can be produced by the method disclosed in the above or the like, or a method analogous thereto.

  A compound having a medoxomil group in the molecule, for example, olmesartan medoxomil, which is a therapeutic agent for hypertension, is obtained by gradually cleaving the medoxomil ester into an active substance, thereby producing a low-molecular 2,3-butanedione (hereinafter referred to as “diacetyl”). ). This diacetyl itself is known as a causative substance of a unique odor, and is considered to be an odor causative substance of a pharmaceutical composition containing a medoxomil group.

  In addition, the drug in the present invention may contain other active ingredients as necessary. Other active ingredients include, for example, diuretics such as Trichloromethiazide, Hydrochlorothiazide, or Benzylhydrochlorothiazide, Azelnidipine, Amlodipine (including besylate salt), Calcium antagonists such as Benidipine, Nitrendipine, Manidipine, Nicardipine, Nifedipine, Cilnidipine, Efonidipine, Barnidipine, or felodipine (Pioglitazone), rosiglitazone (Rosiglitazone), riboglitazone (Rivoglitazone), MCC-555, NN-2344, BMS-298585, AZ-242, LY-519818, or TAK-559 insulin resistance improver, pravastatin ( Pravastatin), simvastatin, HMG-CoA reductase inhibitors such as atorvastatin, rosuvastatin, cerivastatin, pitavastatin, or fluvastatin, ACAT inhibitors such as SMP-797, or Pactimibe Etc. The amount of the active ingredient of other drugs is not particularly limited, and usually the amount used for the preparation is used.

  The drug in the present invention further contains additives such as pharmacologically acceptable excipients, lubricants, binders, disintegrants, emulsifiers, stabilizers, flavoring agents, or diluents as necessary. May be included.

  Examples of the excipient include sugar derivatives such as lactose, sucrose, sucrose, mannitol, or sorbitol, starch derivatives such as corn starch, potato starch, α-starch, or dextrin, cellulose derivatives such as crystalline cellulose, gum arabic, Organic excipients such as dextran or pullulan, light anhydrous silicic acid, synthetic aluminum silicate, calcium silicate, silicate derivatives such as magnesium metasilicate magnesium phosphate, phosphates such as calcium hydrogen phosphate, carbonates such as calcium carbonate Examples thereof include inorganic excipients such as salts and sulfates such as calcium sulfate.

  Examples of the lubricant include stearic acid, calcium stearate, magnesium stearate such as magnesium stearate, talc, colloidal silica, beeswax, wax such as gay wax, boric acid, adipic acid, sodium sulfate and the like. Silicates such as sulfate, glycol, fumaric acid, sodium stearyl fumarate, sodium benzoate, D, L-leucine, sodium lauryl sulfate, or lauryl sulfate such as magnesium lauryl sulfate, anhydrous silicic acid, or silicic acid hydrate, A starch derivative is mentioned.

  Examples of the binder include hydroxypropylcellulose, hydroxypropylmethylcellulose, polyvinylpyrrolidone, macrogol, and the same compounds as the excipients described above.

  Examples of the disintegrant include chemically modified cellulose derivatives such as low-substituted hydroxypropyl cellulose, carboxymethyl cellulose, carboxymethyl cellulose calcium, or internally crosslinked sodium carboxymethyl cellulose, crosslinked polyvinylpyrrolidone, carboxymethyl starch, or sodium carboxymethyl starch. And starch and cellulose.

  Examples of the emulsifier include colloidal clay such as bentonite or bee gum, metal hydroxide such as magnesium hydroxide or aluminum hydroxide, anionic surfactant such as sodium lauryl sulfate or calcium stearate, benzalkonium chloride And nonionic surfactants such as polyoxyethylene alkyl ether, polyoxyethylene sorbitan fatty acid ester, or sucrose fatty acid ester.

  Examples of the stabilizer include parahydroxybenzoates such as methylparaben or propylparaben, alcohols such as chlorobutanol, benzyl alcohol, or phenylethyl alcohol, phenols such as benzalkonium chloride, phenol, or cresol, Examples include thimerosal, dehydroacetic acid, and sorbic acid.

  Examples of the flavoring agents include sweeteners such as saccharin sodium and aspartame, acidulants such as citric acid, malic acid, and tartaric acid, and flavors such as menthol, lemon, and orange.

  Diluents include, for example, lactose, mannitol, glucose, sucrose, calcium sulfate, calcium phosphate, hydroxypropyl cellulose, microcrystalline cellulose, water, ethanol, polyethylene glycol, propylene glycol, glycerol, starch, polyvinyl pyrrolidone, metasilicate aluminate Magnesium or a mixture thereof can be mentioned.

  The drug in the present invention is a solid preparation, and includes, for example, tablets (including sublingual tablets and orally disintegrating tablets), capsules (including soft capsules and microcapsules), granules, fine granules, powders, pills, and chewables. Agents, lozenges and the like, preferably powders, fine granules, granules, capsules, or tablets, more preferably tablets.

  Examples of the method for producing a solid preparation in the present invention include The Theory and Practice of Industrial Pharmacy (Third Edition) (Leon Lachman et al .: LEA & FEBIGER 1986, pages 3-99, pages 293-373), and Pharmaceutical Dosage Forms: Tablets volume. General methods described in publications such as 1 (Second Edition) (Herbert A. Lieberman et al .: MARCEL DEKKER INC. 1989, pages 131-284) are used.

  Tablets can be obtained, for example, by granulating, drying, and sizing the active ingredient together with excipients, binders, disintegrants, etc., adding a lubricant, etc., mixing and tableting in a manner known per se. . Here, the granulation can be carried out by any of wet granulation, dry granulation, and heat granulation methods. Specifically, a high-speed agitation granulator, a fluidized granulator / dryer, an extrusion A granulator, a roller compactor or the like is used. In addition, after granulation, operations such as drying and sizing may be performed as necessary. A mixture of the active ingredient and excipient, binder, disintegrant, lubricant, etc. may be directly compressed. The tablet may also be provided with at least one layer of film coating.

  For coating, for example, a film coating apparatus is used, and examples of the film coating base include sugar coating base, water-soluble film coating base, enteric film coating base, sustained-release film coating base, and the like. .

  As the sugar coating base, sucrose is used, and one or more kinds selected from talc, precipitated calcium carbonate, calcium phosphate, calcium sulfate, gelatin, gum arabic, polyvinylpyrrolidone, pullulan and the like may be combined.

  Examples of the water-soluble film coating base include cellulose derivatives such as hydroxypropylcellulose, hydroxypropylmethylcellulose, hydroxyethylcellulose, methylhydroxyethylcellulose, or sodium carboxymethylcellulose, polyvinyl acetal diethylaminoacetate, aminoalkyl methacrylate copolymer, polyvinylpyrrolidone, and polyvinyl alcohol. Or a synthetic polymer such as a polyvinyl alcohol copolymer, a polysaccharide such as pullulan, and the like.

  Examples of enteric film coating bases include cellulose derivatives such as hydroxypropylmethylcellulose phthalate, hydroxypropylmethylcellulose acetate succinate, carboxymethylethylcellulose, or cellulose acetate phthalate, methacrylic acid copolymer L, methacrylic acid copolymer LD, or Examples include acrylic acid derivatives such as methacrylic acid copolymer S and natural products such as shellac.

Examples of the sustained-release film coating base include cellulose derivatives such as ethyl cellulose, and acrylic acid derivatives such as aminoalkyl methacrylate copolymer RS, ethyl acrylate / methyl methacrylate / copolymer emulsion, and the like.

  Two or more kinds of the above-described coating bases may be mixed and used at an appropriate ratio. If necessary, additives such as appropriate pharmacologically acceptable plasticizers, excipients, lubricants, masking agents, coloring agents, preservatives and the like may be contained.

  Examples of the PTP packaging material in the present invention include resins such as thermoplastic resins, papers, fibers, metals, various paints, various adhesives, and the like. The thermoplastic resin is not particularly limited, and known resins 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), etc., preferably polyvinyl chloride, unstretched polypropylene, polypropylene, polyvinylidene chloride, polytrifluoroethylene chloride or cyclic olefin copolymer It is. These may be used alone or in combination of two or more, and is preferably polypropylene.

  Examples of the lid for PTP packaging include aluminum foil, a laminate film of an aluminum foil and a plastic film, and the like. Production methods for PTP packaging are described in publications such as “Design, labeling, material standards, and packaging process quality assurance for pharmaceuticals and food packaging (Technical Information Association, published on September 1, 2005)” General methods are used.

  The PTP packaging material is suitable from the viewpoint of easily releasing the odor component released from the encapsulated solid preparation to have at least a portion having a film thickness of 0.13 mm or less around the solid preparation to the outside of the PTP packaging material. More preferably, it has at least a portion having a thickness of 0.12 mm or less, and particularly preferably has a portion having a thickness of 0.10 mm or less. For example, as shown in FIG. 1, the film thickness of the PTP packaging material 10 is such that the upper wall portion 12, the side wall portion 13, and the like in the pocket 11 having a cylindrical shape formed in the PTP packaging material 10 enclosing the solid preparation. Or it can measure as a film thickness in either the boundary part 14 of an upper wall and a side wall.

  The secondary packaging material is not particularly limited as long as it can encapsulate the PTP packaging material encapsulating the solid preparation and the odor adsorbent. For example, a glass bottle, a plastic bottle, a plastic bag, an aluminum bag, a metal can, a blister Examples of the packaging material include a pillow packaging material, and a pillow packaging material is preferable. Pillow packaging is a packaging form in which a PTP packaging material in which a solid preparation is enclosed is covered with a film in a bag shape and then sealed with gas. Examples of the pillow packaging material include an aluminum laminate film or a thermoplastic resin, and a packaging material in which these are combined may be used. An aluminum laminate film is preferred.

  The PTP packaging material or the pillow packaging material is not limited to a single layer, and may be a multilayer film having a multilayer structure. The type, amount, thickness, and number of layers of the multilayer film are not particularly limited, and are appropriately selected depending on the intended use.

  Examples of the odor adsorbent include synthetic zeolite, activated carbon, silica gel, alumina and the like, and preferably synthetic zeolite or activated carbon. One or more of these odor adsorbents may be used. The odor adsorbent may be molded into a pellet or tablet and enclosed in a packaging container, or may be enclosed in a breathable packaging material in the form of a powder or the like. The amount of the odor adsorbent in the secondary packaging material is not particularly limited as long as it is sufficient to adsorb the odor component generated from the solid drug and suppress the odor.

  Synthetic zeolite is a porous particulate material used to separate materials according to the difference in molecular size, and has a structure with uniform pores. Synthetic zeolite has the effect of adsorbing small molecules that enter the pore cavity.

  Activated carbon is a porous carbonaceous material produced from charcoal, coconut shells, coal, and the like. Activated carbon has a large specific surface area and adsorption capacity.

  In the secondary packaging material, a desiccant or the like may be enclosed in addition to the odor adsorbent. Examples of the desiccant include activated carbon, calcium chloride, silica gel, natural or synthetic zeolite, allophane, and clay.

  Examples of the present invention will be described below. However, these are merely examples, and it goes without saying that the present invention is not limited to the following examples.

[Examples 1 and 2]
[Preparation of uncoated tablets]
Olmesartan medoxomil 45 g, lactose hydrate 367.2 g, low-substituted hydroxypropylcellulose 78.75 g and hydroxypropylcellulose 11.25 g were charged into a high-speed agitation granulator and mixed for 1 minute. Then, water was added and granulated for 3 minutes. The obtained granulated material was dried at a temperature of 80 ° C. for 3 hours. The obtained dried product was passed through a screen of 0.5 mm to obtain a sized product. To 502.2 g of the obtained sized product, 33.75 g of crystalline cellulose and 4.05 g of calcium stearate were added and mixed. The obtained mixture was tableted with a rotary tableting machine so that the weight of one tablet was 120 mg, the diameter was 7.0 mm, and the thickness was 2.4 mm.

[Packaging]
Using a polypropylene sheet (made by Fujimori Kogyo Co., Ltd.) having a thickness of 0.25 mm and an aluminum laminate film (made by Metal Color Co., Ltd.), 10 uncoated tablets are arranged in 2 × 5 on one sheet. PTP packaging. 10 sheets of uncoated tablets in PTP packaging were used as one sheet, and 10 sheets were pillow-wrapped using an aluminum / polyethylene laminate film (Fujimori Kogyo Co., Ltd.). 5 g or 3 g of synthetic zeolite (manufactured by Tokai Chemical Industry Co., Ltd.) was enclosed in a pillow package to obtain a package.

[Comparative Examples 1-4]
Using a polypropylene sheet (manufactured by Sumitomo Bakelite Co., Ltd.) having a thickness of 0.30 mm and an aluminum laminate film (manufactured by Metal Color Co., Ltd.), 10 uncoated tablets are arranged in 2 × 5 on one sheet. PTP packaging. 10 sheets of uncoated tablets in PTP packaging were used as one sheet, and 10 sheets were pillow-wrapped using an aluminum / polyethylene laminate film (Fujimori Kogyo Co., Ltd.). In a pillow package, 5 g and 1.5 g of synthetic zeolite (manufactured by Tokai Chemical Industry Co., Ltd.), 1.5 g of synthetic zeolite and 0.5 g of activated carbon (manufactured by Shin-Etsu Chemical Co., Ltd.) were sealed to obtain a package. Or it was set as the package without enclosing anything in pillow packaging.

[PTP packaging pocket film thickness]
In the PTP packaging of Example 1 and Comparative Example 1, the thickness of the upper wall of the pocket, the side wall, and the boundary portion between the upper wall and the side wall was measured. The film thickness was measured five times at each location using a Digimatic Micrometer (Mitutoyo Corporation), and the average value was taken as the film thickness. The results are shown in Table 1.

[Measurement of diacetyl concentration]
The packaging bodies of Examples 1 and 2 and Comparative Examples 1 to 4 were stored at 60 ° C. and 75% RH for 1 week. Thereafter, one uncoated tablet was cut from one sheet of the PTP package of each package, put into a gas chromatography vial (about 20 mL), and sealed. The tablet was removed from the PTP package using a needle, and the gas in the pocket of the PTP package was uniformly diffused into the vial. Thereafter, the headspace gas was injected into the gas chromatography, and the concentration of the detected gas component (diacetyl) was calculated. The measurement conditions for gas chromatography are as follows. The measurement results are shown in Table 2.

[Measurement conditions for gas chromatography]
Apparatus: Gas chromatograph Shimadzu GC-2010 (Shimadzu Corporation)
Detector: Hydrogen flame ionization detector (Shimadzu Corporation)
Analysis column: DB-WAX (Agilent Technology Co., Ltd., 0.53 mm id × 30 m, film thickness: 1.00 μm)
Column temperature: 50 ° C
Carrier gas: Helium Flow rate: 5.0 mL / min
Inlet temperature: 200 ° C
Injection volume: 1.0 mL

[sensory evaluation]
In the packaging bodies of Examples 1 and 2 and Comparative Examples 1 to 4, the degree of odor when the PTP packaging was opened was evaluated by 6 subjects. The evaluation criteria are as follows. The evaluation results are shown in Table 3.
<Evaluation: Content>
0: Does not smell 1: Smells slightly 2: Smells 3: Smells quite

  As shown in Table 2, diacetyl was not detected in Examples 1 and 2, or the detected diacetyl concentration was 0.1 ng / mL, whereas it was detected in Comparative Examples 1 to 4. The diacetyl concentration was 0.9 ng / mL or more. As shown in Table 3, in Examples 1 and 2, the total score of the sensory evaluation of 6 persons was 2 or 3, whereas in Comparative Examples 1 to 4, the total score was 4 or more. . Thus, in Examples 1 and 2, it was confirmed that diacetyl was effectively absorbed by the odor absorbent.

DESCRIPTION OF SYMBOLS 10 ... PTP packaging material 11 ... Pocket 12 ... Upper wall part 13 ... Side wall part 14 ... Boundary part 14 of an upper wall and a side wall

Claims (9)

A solid preparation containing a drug having a medoxomil group;
A PTP packaging material enclosing the solid preparation;
A secondary packaging material enclosing the PTP packaging material;
An odor adsorbent enclosed in the internal space of the secondary packaging material,
The PTP packaging material is a solid preparation package having at least a portion having a film thickness of 0.13 mm or less around the solid preparation.   The solid preparation package according to claim 1, wherein the PTP packaging material has at least a portion having a film thickness of 0.12 mm or less around the solid preparation.   The solid preparation package according to claim 2, wherein the PTP packaging material has at least a portion having a film thickness of 0.10 mm or less around the solid preparation.   The solid preparation package according to any one of claims 1 to 3, wherein the drug is olmesartan medoxomil.   The solid preparation package according to any one of claims 1 to 4, wherein the odor adsorbent is one or more selected from synthetic zeolite or activated carbon.   6. The solid according to claim 1, wherein the PTP packaging material is a polypropylene sheet in which a pocket capable of accommodating the solid preparation is formed, and the film thickness is a film thickness in the pocket. Formulation package.   The solid preparation package according to any one of claims 1 to 6, wherein the solid preparation is a tablet.   The solid preparation package according to any one of claims 1 to 7, wherein the secondary packaging material is a pillow packaging material. A solid preparation containing a drug having a medoxomil group is enclosed in a PTP packaging material having at least a portion having a film thickness of 0.13 mm or less around the solid preparation, the PTP packaging material is enclosed in a secondary packaging material, An odor removal method for a solid preparation, wherein an odorous adsorbent generated from the drug is removed by enclosing an odor adsorbent in the internal space of the secondary packaging material.

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