Pharmaceutical preparation

Abstract

To provide a pharmaceutical preparation containing ibuprofen and vitamin B1.SOLUTION: A pharmaceutical preparation contains a solid preparation containing ibuprofen and vitamin B1 and a desiccant, where the solid preparation and the desiccant are stored in a container.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present invention relates to a pharmaceutical preparation containing ibuprofen and vitamin B1s.

Background Art

[0002] Ibuprofen is a non-steroidal anti-inflammatory drug (NSAID) classified in the propionic acid group, and inhibits cyclooxygenase (COX) to suppress the production of prostaglandins and exhibits antipyretic and analgesic effects. In addition, vitamin B1s such as thiamine nitrates are beneficial for energy production from carbohydrates and maintenance of nerve functions, and are known to have various effects on living organisms such as fatigue recovery.

[0003] Patent Document 1 addresses the stabilization of thiamines and discloses a thiamine-containing solid preparation containing ibuprofen, thiamines, and trehalose.

Prior Art Documents

Patent Documents

[0004]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0005] ]>When a solid preparation containing ibuprofen and vitamin B1s such as thiamine nitrate is stored in a container such as a bottle, an odor derived from thiamine nitrate, particularly a decomposition odor derived from thiamine nitrate, is generated. An object of the present invention is to provide a pharmaceutical preparation in which a solid preparation containing ibuprofen and vitamin B1s has reduced odor derived from vitamin B1s in the preparation.

Means for Solving the Problems

[0006] As a result of diligent research to solve the above problems, the inventors of the present invention have found that by creating a pharmaceutical formulation containing a solid preparation containing ibuprofen and vitamin B1 compounds, along with a desiccant, in a container, the odor derived from vitamin B1 compounds can be reduced, and have completed the present invention. In other words, the present invention includes the following embodiments. [1] A pharmaceutical preparation characterized by containing a solid preparation containing ibuprofen and vitamin B1, and a desiccant in a container. [2] The pharmaceutical preparation according to [1], wherein the vitamin B1 is fursultiamine, fursultiamine hydrochloride, thiamine chloride hydrochloride, or thiamine nitrate. [3] The pharmaceutical preparation according to [1] or [2], wherein the desiccant is one or more selected from the group consisting of silica gel, silica alumina gel (allophene), natural zeolite, synthetic zeolite (molecular sieve), calcium chloride, quicklime (calcium oxide), bentonite clay (montmorillonite), magnesium chloride, activated carbon, and magnesium oxide. [4] A pharmaceutical preparation described in any one of items [1] to [3], wherein the container is a glass bottle. [5] A pharmaceutical preparation described in any one of items [1] to [3], wherein the solid dosage form is packaged in PTP packaging. [6] A pharmaceutical preparation according to any one of items [1] to [5], wherein the solid dosage form is a tablet, powder, granule, fine granule, pill, or capsule. [Effects of the Invention]

[0007] According to the present invention, it is possible to provide a pharmaceutical formulation containing ibuprofen and vitamin B1, wherein the odor derived from vitamin B1 is reduced. Furthermore, it is possible to provide a pharmaceutical formulation containing ibuprofen and vitamin B1, with reduced odor derived from vitamin B1, in a simple and inexpensive manner without complex processes. [Brief explanation of the drawing]

[0008] [Figure 1]This graph shows the results of odor evaluation using an odor sensor for the pharmaceutical formulations according to Examples 3-6 and Comparative Example 2. [Modes for carrying out the invention]

[0009] The "ibuprofen" used in this invention is ibuprofen in accordance with the Japanese Pharmacopoeia, and can be manufactured by known methods or commercially available ibuprofen can be used. The ibuprofen content in the solid formulation of the present invention is not particularly limited, but is, for example, 1 to 60% by mass of the total solid formulation, preferably 5 to 50% by mass, and more preferably 10 to 40% by mass.

[0010] In this invention, "vitamin B1 compounds" include vitamin B1 and its derivatives, pharmaceutically acceptable salts thereof, and solvates of vitamin B1 and its derivatives and pharmaceutically acceptable salts thereof with water, alcohol, etc. Examples of vitamin B1 compounds include thiamine nitrate, thiamine chloride hydrochloride, fursultiamine, fursultiamine hydrochloride, dicethiamine hydrochloride hydrate, octothiamine, sicothiamine, bisibthiamine, bisbentiamine, and benfotiamine. Preferably, fursultiamine, fursultiamine hydrochloride, thiamine chloride hydrochloride, or thiamine nitrate is used, and more preferably, thiamine nitrate. Vitamin B1 compounds can be produced by known methods, or commercially available products can be used. For example, fursultiamine, fursultiamine hydrochloride, thiamine chloride hydrochloride, or thiamine nitrate conforming to the Japanese Pharmacopoeia can be used. The content of "vitamin B1" contained in the solid formulation of the present invention is not particularly limited, but for example, it is 0.05 to 20% by mass of the total solid formulation, preferably 0.1 to 15% by mass, and more preferably 0.2 to 10% by mass.

[0011] The mass ratio of vitamin B1 compounds to ibuprofen contained in the solid formulation of the present invention is not particularly limited, but for example, for 1 part by mass of vitamin B1 compounds, the amount of ibuprofen is, for example, 1 part by mass or more, preferably 3 parts by mass or more, and 200 parts by mass or less, preferably 80 parts by mass or less, with a lower limit of 1 part by mass of vitamin B1 compounds.

[0012] The solid dosage form of the present invention may contain active ingredients other than vitamin B1 and ibuprofen, as long as they do not inhibit the effects of the present invention. For example, antipyretic analgesics other than ibuprofen, antihistamines, antitussives, expectorants, bronchodilators, gastric mucosal protectants, caffeines, vitamins other than vitamin B1, hypnotics and sedatives, masticatory dissolving agents, anti-inflammatory agents, anticholinergics, herbal medicines, and traditional Chinese medicine formulations.

[0013] Examples of antipyretic analgesics other than ibuprofen include aspirin (acetylsalicylic acid), aluminum aspirin, acetaminophen, salicylamide, sodium salicylate, ethenzamide, sazapyrine, lactylphenetidine, ketoprofen, isopropylantipyrine, and loxoprofen sodium. Examples of medications for rhinitis include pseudoephedrine hydrochloride, dl-chlorpheniramine maleate, d-chlorpheniramine maleate, belladonna total alkaloids, isopropamide iodide, and dipotassium glycyrrhizinate. Examples of antihistamines include diphenhydramine hydrochloride, diphenhydramine salicylate, diphenhydramine tannate, alimazine tartrate, isotipendyl hydrochloride, promethazine methylene disalicylate, diphenylpyraline hydrochloride, diphenylpyraline theoclate, difeterol hydrochloride, difeterol phosphate, triprolidine hydrochloride hydrate, triperenamine hydrochloride, tondiamine hydrochloride, phenetazine hydrochloride, methodilazine hydrochloride, diphenyldisulfonic acid carbinoxamine, mebhydroline napadisylate, carbinoxamine maleate, iproheptine hydrochloride, promethazine hydrochloride, alimazine tartrate, phenetazine tannate, clemastine fumarate, and mequitazine. Examples of narcotic antitussives include codeine phosphate hydrate and dihydrocodeine phosphate. Examples of non-narcotic antitussives include alloclamide, isoaminyl, eprazinon, oxerazine, clofedanol, clobutinol, cloperastine, dibnate, dimemorphan, tipepidine, dextromethorphan, noscapine, hydrocotarnin, pentoxyverine, benproperine, and hominoben, as well as their salts and hydrates. Examples of their salts and hydrates include alloclamide hydrochloride, cloperastine hydrochloride, cloperastine fendizoate, dibnate sodium, dimemorphan phosphate, tipepidine hibenzate, tipepidine citrate, dextromethorphan hydrobromide, dextromethorphan phenolphthalein salt, pentoxyverine citrate, and their hydrates. Examples of expectorants include potassium guaiacolsulfonate, bromhexine hydrochloride, guaifenesin, tipepidine citrate, L-carbocysteine, ammonium chloride, l-menthol, ammonia / fennel extract, potassium cresolsulfonate, and ambroxol hydrochloride. Examples of bronchodilators include dl-methyl ephedrine hydrochloride, dl-methyl ephedrine saccharin salt, trimethoquinol hydrochloride, phenylpropanolamine hydrochloride, methoxyphenamine hydrochloride, l-methyl ephedrine hydrochloride, pseudoephedrine hydrochloride, aminophylline, diprophylline, theophylline, and proxyphylline. Examples of gastric mucosal protective agents include glycine, aminoacetic acid, magnesium silicate, synthetic aluminum silicate, synthetic hydrotalcite, magnesium oxide, dihydroxyaluminum aminoacetate, aluminum hydroxide gel, dried aluminum hydroxide gel, mixed dried gel of aluminum hydroxide and magnesium carbonate, coprecipitation products of aluminum hydroxide and sodium bicarbonate, coprecipitation products of aluminum hydroxide, calcium carbonate and magnesium carbonate, coprecipitation products of magnesium hydroxide and aluminum potassium sulfate, and magnesium carbonate. Examples of the caffeine compounds include, for example, sodium caffeine benzoate, caffeine hydrate, anhydrous caffeine and the like. Examples of the vitamins other than the vitamin B1 compounds include, for example, vitamin B2 compounds or derivatives thereof or salts thereof, such as riboflavin, vitamin C compounds or derivatives thereof or salts thereof, such as ascorbic acid, vitamin P (hesperidin) or derivatives thereof or salts thereof and the like. Examples of the hypnotics and sedatives include, for example, allylisopropylacetylurea, bromvalerylurea and the like. Examples of the mucolytic agents include, for example, lysozyme chloride, L-ethylcysteine hydrochloride, methylcysteine hydrochloride and the like. Examples of the anti-inflammatory agents include, for example, lysozyme chloride, serrapeptase, glycyrrhizic acid and salts thereof, tranexamic acid and salts thereof and the like. Examples of the anticholinergic agents include, for example, belladonna total alkaloids, isopropamide iodide and the like. Examples of the crude drugs include, for example, Coptis chinensis, Nandina domestica, Cinnamomum cassia, Angelica acutiloba, Glycyrrhiza glabra, Platycodon grandiflorus, Bupleurum falcatum, Bupleurum scorzonerifolium, Saxifraga stolonifera, Senega canadensis, Bryonia alba, Wikstroemia indica, Paeonia lactiflora, Allium sativum, Gastrodia elata, Matricaria recutita, Cinnamomum cassia, Gentiana scabra, Alisma orientale, bear bile (including fel tauri), Bupleurum chinense, Zingiber officinale, Sophora flavescens, Cinnamomum camphora, Dioscorea nipponica, Aralia cordata, carrot and the like. Examples of the Kampo formulas include, for example, Gegen Decoction, Gegen Decoction plus Platycodon grandiflorus, Cinnamon Twig Decoction, Aroma-Suplifting Powder, Bupleurum-Cinnamon Twig Decoction, Minor Bupleurum Decoction, Minor Bluegreen Dragon Decoction, Ophiopogon Decoction, Pinellia-Stalked Magnolia Decoction, Ephedra Decoction and the like.

[0014] In addition to the above active ingredients, the solid preparation in the present invention may further contain a pharmaceutically acceptable carrier or additive commonly used in the pharmaceutical technology field as long as the effects of the present invention are not inhibited. Examples of the carrier or additive include, for example, excipients, disintegrants, binders, fluidizing agents, lubricants, colorants, pH adjusters, surfactants, stabilizers, flavoring agents, fragrances and the like. These carriers or additives are used in amounts commonly used in the pharmaceutical technology field.

[0015] Examples of excipients include starches such as corn starch, potato starch, wheat starch, rice starch, partially pregelatinized starch, pregelatinized starch, and porous starch; sugars or sugar alcohols such as lactose hydrate, refined sugar, fructose, glucose, mannitol, sorbitol, erythritol, xylitol, trehalose, maltitol, powdered reduced maltose syrup, and lactitol; anhydrous calcium hydrogen phosphate, crystalline cellulose, powdered cellulose, precipitated calcium carbonate, calcium carbonate, etc. Examples of disintegrants include carmellose, calcium carmellose, sodium carboxymethyl starch, carboxymethyl cellulose, calcium carboxymethyl cellulose, croscarmellose sodium, crospovidone, low-substituted hydroxypropyl cellulose (L-HPC), hydroxypropyl starch, etc. Preferably, croscarmellose sodium and L-HPC are used. Examples of binders include hydroxypropyl cellulose, hydroxypropyl methyl cellulose (hypromellose), polyvinylpyrrolidone, copovidone, powdered gum arabic, methyl cellulose, low-substituted hydroxypropyl cellulose, sodium carmellose, dextrin, partially pregelatinized starch, pullulan, gum arabic, agar, gelatin, tragacanth, sodium alginate, partially saponified polyvinyl alcohol, etc. Preferably, hydroxypropyl cellulose and hydroxypropyl methyl cellulose are used. Examples of fluidizing agents include light anhydrous silicic acid, hydrated silicon dioxide, calcium silicate, magnesium silicate, magnesium metasilicate aluminate, talc, etc. Preferably, light anhydrous silicic acid and magnesium metasilicate aluminate are used. Examples of lubricants include stearic acid, magnesium stearate, calcium stearate, sodium stearyl fumarate, talc, sucrose fatty acid ester, etc. Examples of colorants include yellow iron(III) oxide, iron(III) oxide, food blue No. 1, food blue No. 2, food yellow No. 4, food yellow No. 5, food green No. 3, food red No. 2, food red No. 3, food red No. 102, food red No. 104, food red No. 105, food red No. 106, food lake pigment, riboflavin, sodium riboflavin phosphate, and titanium dioxide. Examples of pH adjusting agents include citric acid, phosphoric acid, carbonic acid, tartaric acid, fumaric acid, acetic acid, amino acids, and their salts. Examples of surfactants include sodium lauryl sulfate, polysorbate 80, and polyoxyethylene (160) polyoxypropylene (30) glycol. Examples of stabilizers include tocopherol, tetrasodium edetate, nicotinamide, and cyclodextrins. Examples of flavoring agents include ascorbic acid, citric acid, tartaric acid, malic acid, sucralose, and stevia extract. Examples of fragrances include L-menthol, peppermint oil, lemon oil, and vanillin.

[0016] The solid dosage form in the present invention is, for example, a tablet (including uncoated tablets, coated tablets, film-coated tablets, sugar-coated tablets, thin-layer sugar-coated tablets, orally disintegrating tablets, chewable tablets, etc.), a powder, a granule, a fine granule, a pill, or a capsule, and is preferably a tablet. For example, if the solid dosage form in the present invention is a tablet, the solid dosage form may be a multilayer tablet or a core tablet, for example, a two-layer tablet.

[0017] In the present invention, a multilayer tablet is a tablet formed from two or more layers having different compositions, a two-layer tablet is a tablet formed from two layers having different compositions, and a core tablet is a tablet formed by having one layer as a core and the other layer encompassing at least a part of the core.

[0018] In the solid formulation of the present invention, ibuprofen and vitamin B1 derivatives may be granules containing other active ingredients and additives as needed. For example, ibuprofen and vitamin B1 derivatives may be contained in the same granule or in separate granules.

[0019] The solid dosage forms of the present invention can be manufactured using conventional methods, such as those described in publications like the Granulation Handbook (edited by the Japan Powder Technology Association, Ohmsha), Formulation Design for Orally Administered Formulations (edited by Professor Mitsuru Hashida, Graduate School of Pharmaceutical Sciences, Kyoto University, Yakugyo Jihosha), Compression Molding Technology of Powders (edited by the Powder Engineering, Formulation and Particle Design Subcommittee, Nikkan Kogyo Shimbun), and the Handbook of Pharmaceutical Machinery Technology (2nd edition, edited by the Pharmaceutical Machinery Technology Research Association 20th Anniversary Publication Editorial Committee, Pharmaceutical Machinery Technology Research Association).

[0020] For example, when formulating the solid dosage form of the present invention into tablets, the active ingredient can be mixed with a conventionally pharmaceutically acceptable carrier or additive, granulated as necessary, and then compressed into tablets using various tablet presses commonly used in pharmaceutical formulation (e.g., rotary tablet presses). Alternatively, when formulating the solid dosage form of the present invention into capsules, the active ingredient can be mixed with a conventionally pharmaceutically acceptable carrier or additive, granulated as necessary, and then filled into capsules to form capsules. The granulation method is not particularly limited, and any known method (extrusion granulation, rolling granulation, agitation granulation, fluid bed granulation, spray drying granulation, crushing granulation, melt granulation, etc.) may be used.

[0021] The solid dosage form in this invention may be coated by a conventional method using a commonly formulated coating base. For example, a tablet may be coated with a coating base to form a film-coated tablet. Examples of coating bases include water-soluble bases such as hydroxypropyl methylcellulose (hypromellose), hydroxypropyl cellulose, methylcellulose, povidone, copolividone, partially saponified polyvinyl alcohol, polyvinyl alcohol copolymer, and macrogol; water-insoluble bases such as ethylcellulose; enteric-coated bases such as hydroxypropyl methylcellulose phthalate, hydroxypropyl methylcellulose acetate succinate, carboxymethyl ethylcellulose, cellulose acetate phthalate, methacrylic acid copolymer, acrylic acid copolymer, and carboxyvinyl polymer; gastric-soluble bases such as polyvinyl acetal diethylaminoacetate, aminoalkyl methacrylate copolymer, and polyvinyl acetate diethylaminoacetate; and gum arabic, pullulan, carnauba wax, shellac, macrogols, glycerin fatty acid esters, and magnesium stearate. Furthermore, in the present invention, the coating base may be one type or two or more types. Furthermore, coating additives may be used in the coating. Examples of coating additives include light-shielding agents, fluidizing agents, colorants, and plasticizers. Examples of plasticizers include copolyvidone, polyethylene glycol, triethyl citrate, castor oil, and polysorbate.

[0022] The desiccant in this invention is not particularly limited as long as it can reduce the odor derived from vitamin B1 when stored together with ibuprofen and vitamin B1. Its shape is also not limited; for example, it may be in the form of a plate or bag-like sheet, or molded into a cylindrical shape (tablet-like), and it may also be cylindrical with paper wrapping or film coating.

[0023] Examples of desiccants include silica gel, silica alumina gel (allophene), natural zeolite, synthetic zeolite (molecular sieve), calcium chloride, quicklime (calcium oxide), bentonite clay (montmorillonite), magnesium chloride, activated carbon, and magnesium oxide. The desiccant may be one type or two or more types. Preferably, the desiccant is one or more selected from silica gel, silica alumina gel (allophene), synthetic zeolite (molecular sieve), calcium chloride, and activated carbon, and more preferably silica gel or silica alumina gel (allophene). The moisture absorption rate of the desiccant is, for example, 20.0% or more at a relative humidity of 90%, preferably 30.0% or more.

[0024] Various desiccants are commercially available, including, for example, Shibulets, MS-Tablets, MS-Ceram W, Tokai Gel, Desikite 25, and Alp Sheet from Tokai Chemical Industry Co., Ltd.; Dry Yarn® sachets, Dry Yarn® tablets, and Dry Yarn® sheets from Yamajin Pharmaceutical Co., Ltd.; Secard, Aro Sheet, and Zeo Sheet from Shinagawa Chemical Co., Ltd.; OZO from OZO Chemical Technology Co., Ltd.; and ID Sheet and ID Packing Desiccants from ID Co., Ltd.

[0025] The amount of desiccant contained in the pharmaceutical formulation of the present invention is not particularly limited, but for example, it is 0.05 to 100 parts by mass, preferably 0.15 to 50 parts by mass, per 1 part by mass of vitamin B1. Furthermore, the amount of ibuprofen and vitamin B1 is, for example, 0.001 to 5 parts by mass, preferably 0.001 to 3 parts by mass, and more preferably 0.002 to 2 parts by mass, relative to 1 part by mass of a solid preparation containing ibuprofen and vitamin B1.

[0026] The container in this invention is not particularly limited as long as it can seal, airtight, or airtightly seal the solid dosage form, and is preferably an airtight container. For example, a container having a shape known in the art and made from a material known in the art can be used. Examples of containers include bottles, cans, boxes, bottles, pillow packaging, stick packaging, PTP (press-through pack) packaging and SP (strip) packaging, CF (cold foam) packaging, etc., and bottles, pillow packaging, stick packaging, PTP packaging, and SP packaging are preferred. The solid dosage form of this invention may be packaged in one type of container, or in combination of two or more types of containers.

[0027] The material of the container is not particularly limited, but may include, for example, glass, metal, paper, or plastic, and one or more of these materials may be used in appropriate combinations to form a composite or multilayer structure. Furthermore, it is preferable that moisture-permeable components such as paper are treated to prevent moisture permeability. The container may be transparent, translucent, or opaque.

[0028] The method for housing the solid preparation containing ibuprofen and vitamin B1, and the desiccant in a container is not particularly limited and can be achieved by placing the solid preparation inside the container by appropriate means such as adding the solid preparation and desiccant to the container.

[0029] In one embodiment of the present invention, the container is a bottle. When the container is a bottle, the solid preparation and a desiccant (preferably cylindrical (tablet-shaped)) may be placed inside the bottle, the bottle may be sealed with a stopper if necessary, and then sealed with a suitable lid, or the solid preparation may be placed inside the bottle and the bottle may be sealed with a lid that has a desiccant stored on the underside of the lid (inner cap).

[0030] When pillow packaging is used for the container, the solid formulation and desiccant (preferably in the form of a plate or bag-shaped sheet) can be sealed inside the pillow packaging.

[0031] In another embodiment of the present invention, the solid dosage form is packaged in stick form, PTP form, or SP form. When the solid dosage form is packaged in stick form, PTP form, or SP form, the primary packaged solid dosage form and desiccant may be sealed in a container such as a pillow pack. Furthermore, the secondary packaged solid dosage form in a container such as a pillow pack may be placed in a box for tertiary packaging. [Examples]

[0032] The present invention will be described in more detail below with reference to examples, but the present invention is not limited to these examples.

[0033] (Example 1) The components were mixed and granulated according to the formulations shown in Category A of Table 1 below to obtain Group 1 granules, Group 2 granules, and Group 3 granules, respectively. The obtained Group 1 granules, Group 2 granules, and Group 3 granules were mixed with the components according to the formulations shown in Category B. The resulting mixtures were put into a tablet press to obtain uncoated tablets. The obtained uncoated tablets were coated according to the formulations shown in Category C to obtain coated tablets. Thirty of the obtained coated tablets and 0.8 g of silica alumina gel (Siburet, manufactured by Tokai Chemical Industry Co., Ltd.) as a desiccant were placed in a glass bottle, sealed, and a pharmaceutical preparation was obtained. (Example 2) The components were mixed and granulated according to the formulation shown in Category A of Table 1 below to obtain the first layer granules and the second layer granules, respectively. The obtained first layer granules and second layer granules were mixed with the components according to the formulation shown in Category B to obtain the first layer mixture and the second layer mixture, respectively. The obtained first layer mixture and second layer mixture were placed in a tablet press and compressed into stacked tablets to obtain uncoated tablets. The obtained uncoated tablets were coated according to the formulation shown in Category C to obtain coated tablets. Thirty of the obtained coated tablets and 0.8 g of silica alumina gel (Siburet, manufactured by Tokai Chemical Industry Co., Ltd.) as a desiccant were placed in a glass bottle, sealed, and a pharmaceutical preparation was obtained. (Comparative Example 1) The components were mixed and granulated according to the formulations shown in Category A of Table 1 below to obtain Group 1 granules, Group 2 granules, and Group 3 granules, respectively. The obtained Group 1 granules, Group 2 granules, and Group 3 granules were mixed with the components according to the formulations shown in Category B. The resulting mixtures were put into a tablet press to obtain uncoated tablets. The obtained uncoated tablets were coated according to the formulations shown in Category C to obtain coated tablets. Thirty of the obtained coated tablets were placed in a glass bottle and sealed to obtain a pharmaceutical preparation. [Table 1]

[0034] (Test Example 1) The pharmaceutical formulations obtained above were stored at 40°C for 3 months. After storage, the formulations were subjected to sensory evaluation by six testers, and their odor was assessed. The evaluation was on a 10-point scale, with the initial odor being set at 5. A value greater than 5 indicated a stronger odor than the initial level, and a value less than 5 indicated a weaker odor. The results are shown in Table 2. [Table 2]

[0035] As shown in Table 2, the odor was enhanced without a desiccant (Comparative Example 1), but with a desiccant (Examples 1 and 2), the initial state was maintained and the change in odor was suppressed.

[0036] (Examples 3-6) Each component was mixed and granulated according to the formulation shown in Category A of Table 3 below to obtain Group 1 granules, Group 2 granules, and Group 3 granules, respectively. The obtained Group 1 granules, Group 2 granules, and Group 3 granules were mixed with each component according to the formulation shown in Category B. The obtained mixture was put into a tablet press to obtain uncoated tablets. The obtained uncoated tablets were coated according to the formulation shown in Category C to obtain coated tablets. Nine of the obtained coated tablets were placed in a glass bottle with 0.8 g of silica alumina gel (Sibulet, manufactured by Tokai Chemical Industry Co., Ltd.) (Example 3), 1.0 g of Type A silica gel (Silica APP1G, manufactured by Tokai Chemical Industry Co., Ltd.) (Example 4), 1.0 g of Type B silica gel (Silica BPP1G, manufactured by Tokai Chemical Industry Co., Ltd.) (Example 5), or 1.0 g of zeolite (Dried Zeolite Bag 4A1G, manufactured by Tokai Chemical Industry Co., Ltd.) (Example 6) as a desiccant, and sealed to obtain a pharmaceutical preparation (Examples 3-6). On the other hand, nine coated tablets obtained as Comparative Example 2 were placed in a glass bottle and sealed to obtain a pharmaceutical formulation (Comparative Example 2). [Table 3]

[0037] (Test Example 2) The pharmaceutical formulations of Examples 3-6 and Comparative Example 2 were stored at 50°C for 8 weeks. The odor of the stored formulations was evaluated using an odor sensor (αPrometheus, manufactured by αM.OS). The results are shown in Figure 1.

[0038] As shown in Figure 1, the odor of the formulation stored at 50°C for 8 weeks with the addition of a desiccant was closer to the initial odor level compared to the formulation without the desiccant, indicating that the change in odor was suppressed. [Industrial applicability]

[0039] In a solid preparation containing ibuprofen and vitamin B1, by incorporating the solid preparation into a container along with a desiccant, it is possible to reduce the odor derived from vitamin B1 during storage and provide a pharmaceutical preparation in which changes in odor are suppressed.

Claims

1. A pharmaceutical preparation, characterized by containing a solid preparation containing ibuprofen and vitamin B1s and a desiccant in a container.

2. The pharmaceutical preparation according to Claim 1, wherein the vitamin B1s are fursultiamine, fursultiamine hydrochloride, thiamine chloride hydrochloride or thiamine nitrite.

3. The pharmaceutical preparation according to Claim 1, wherein the desiccant is at least one selected from the group consisting of silica gel, silica alumina gel (aluminosilicate), natural zeolite, synthetic zeolite (molecular sieve), calcium chloride, quicklime (calcium oxide), bentonite clay (montmorillonite), magnesium chloride, activated carbon, and magnesium oxide.

4. The pharmaceutical preparation according to any one of Claims 1 to 3, wherein the container is a bottle.

5. The pharmaceutical preparation according to any one of Claims 1 to 3, wherein the solid preparation is PTP-packaged.

6. The pharmaceutical preparation according to any one of Claims 1 to 3, wherein the solid preparation is a tablet, powder, granule, fine granule, pill or capsule.

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