solid components

Abstract

To provide solid compositions containing ibuprofen and ambroxol or salts thereof to suppress the reduction in the content of ambroxol or salt thereof and change in the formulation appearance with time.SOLUTION: Disclosed is a solid composition comprising (a) ibuprofen, (b) ambroxol or its salt, and (c) pseudoephedrine or its salt, where the ibuprofen (a) is 11 pts.mass or more to 1 pts.mass of the ambroxol (b).SELECTED DRAWING: None

Description

[Technical Field]

[0001] The present invention relates to a solid composition containing ibuprofen and ambroxol or a salt thereof. [Background technology]

[0002] Symptoms of the so-called "cold" often include fever, rhinitis, and throat inflammation, and alleviating these symptoms simultaneously will significantly improve the patient's quality of life.

[0003] Ibuprofen is a nonsteroidal anti-inflammatory drug that inhibits the production of prostaglandins, thereby exerting anti-inflammatory, antipyretic, and analgesic effects. Because it is effective in reducing fever and relieving pain in acute upper respiratory tract inflammation (colds), it is incorporated as an antipyretic and analgesic ingredient in general cold medicines (Non-Patent Document 1). Headaches caused by colds are particularly painful for patients, and prompt relief is desirable. One possible approach is to increase the amount of antipyretic and analgesic ingredients incorporated to increase blood concentrations. Currently, commercially available ibuprofen products have daily dosages of 450 mg and 600 mg. Ambroxol hydrochloride is known as an expectorant that lubricates the airways, and as a prescription drug it has the efficacy and effect of expectorating acute and chronic bronchitis, bronchial asthma, etc. (Non-Patent Document 2).

[0004] Solid preparations containing ibuprofen and ambroxol or its salts have been known to date, but it is known that when these ingredients coexist in specific amounts, the appearance of the preparation changes and the stability of ambroxol decreases. However, there is a widespread demand for the simultaneous combination of anti-inflammatory and antipyretic analgesics such as ibuprofen and expectorants such as ambroxol for the treatment and alleviation of cold symptoms. While the stability and ease of administration of combination preparations have improved with technological advances, they are still not sufficient. Furthermore, there is a demand for pharmaceuticals containing higher amounts of anti-inflammatory and antipyretic analgesic ingredients such as ibuprofen to alleviate symptoms.

[0005] Patent Document 1 discloses a method for improving the compatibility (change in appearance of the preparation) when ibuprofen and ambroxol hydrochloride are combined by adding tranexamic acid and packaging the mixture in an airtight package. Patent Document 2 discloses a method for improving the stability of ambroxol or its salts, which is reduced by adding carbocisteine ​​when ibuprofen and ambroxol or its salts are combined.

[0006] However, when a composition containing ibuprofen and ambroxol or a salt thereof simultaneously experiences changes in the appearance of the formulation and a decrease in the stability of ambroxol, no method is known that can improve both the appearance change and the stability of ambroxol.Furthermore, it cannot be said that there are sufficient methods that can improve the incompatibility of a composition containing ibuprofen and ambroxol or a salt thereof, and a further method that can easily improve the incompatibility is desired. [Prior art documents] [Non-patent literature]

[0007] [Non-Patent Document 1] Commentary on the 17th revised Japanese Pharmacopoeia, Hirokawa Publishing Co., Ltd., page C-625 [Non-patent document 2] Japanese Pharmacopoeia Non-Drug Standards 2002, page 158 [Patent documents]

[0008] [Patent Document 1] Patent Publication No. 2019-38801 [Patent Document 2] Patent 6260736 Summary of the Invention [Problem to be solved by the invention]

[0009] The present inventors have produced a solid composition containing ibuprofen, ambroxol or a salt thereof, and have found that when 11 parts by mass or more of ibuprofen are blended with 1 part by mass of ambroxol or a salt thereof, the content of ambroxol or a salt thereof decreases over time and the appearance of the formulation, particularly the color tone, changes simultaneously.

[0010] The present invention has been made in consideration of the above background and circumstances, and aims to provide an excellent solid composition containing specific amounts of ibuprofen and ambroxol or a salt thereof, in which the content of ambroxol or a salt thereof is inhibited from decreasing over time and the appearance of the composition is inhibited from changing. [Means for solving the problem]

[0011] As a result of extensive research, the present inventors have unexpectedly found that when pseudoephedrine or a salt thereof is added to a solid composition containing ibuprofen, ambroxol, or a salt thereof, both the decrease in the content of ambroxol or a salt thereof over time and the change in the appearance of the composition are suppressed, and have completed the present invention.

[0012] That is, the present invention (1) A solid composition comprising (a) ibuprofen, (b) ambroxol or a salt thereof, and (c) pseudoephedrine or a salt thereof, wherein the amount of (a) ibuprofen is 11 parts by mass or more per part by mass of (b) ambroxol or a salt thereof. (2) The solid composition according to (1), further comprising at least one selected from (d1) dihydrocodeine or a salt thereof, (d2) dextromethorphan or a salt thereof, and (d3) carbocisteine. (3) (b) The solid composition according to (1) or (2), wherein ambroxol or a salt thereof is ambroxol hydrochloride. (4) (c) The solid composition according to any one of (1) to (3), wherein pseudoephedrine or a salt thereof is pseudoephedrine hydrochloride. (5) The solid composition according to any one of (1) to (4), which is a tablet, a powder, fine granules, granules, pills, or capsules. (6) A method for suppressing a decrease in the content of (b) ambroxol or a salt thereof and a change in appearance of a solid composition containing (a) ibuprofen and (b) ambroxol or a salt thereof, the solid composition comprising (c) pseudoephedrine or a salt thereof. (7) A method for suppressing a decrease in the content of (b) ambroxol or a salt thereof and a change in appearance of a solid composition containing (a) ibuprofen and (b) ambroxol or a salt thereof, the solid composition comprising (c) pseudoephedrine or a salt thereof, and at least one selected from (d1) dihydrocodeine or a salt thereof, (d2) dextromethorphan or a salt thereof, and (d3) carbocisteine. (8) Use of (c) pseudoephedrine or a salt thereof for producing a solid composition containing (a) ibuprofen and (b) ambroxol or a salt thereof, in which (b) ambroxol or a salt thereof is stabilized and change in the appearance of the composition is suppressed. (9) Use of (c) pseudoephedrine or a salt thereof in a solid composition containing (a) ibuprofen and (b) ambroxol or a salt thereof for stabilizing (b) ambroxol or a salt thereof and suppressing changes in the appearance of the composition. is. [Effects of the Invention]

[0013] According to the present invention, it is possible to provide a solid composition containing ibuprofen and ambroxol or a salt thereof, in which the stability of ambroxol or a salt thereof is excellent and change in the color of the composition is suppressed. DETAILED DESCRIPTION OF THE INVENTION

[0014] The ibuprofen used in the present invention has the chemical formula C 13 H 18The compound is represented by the formula O2 and is not particularly limited as long as it is pharmaceutically acceptable. Ibuprofen can be produced by known methods, or commercially available products can be used.

[0015] The content of ibuprofen in the solid composition of the present invention is not particularly limited as long as it is an amount that exhibits its medicinal efficacy, but is usually 1 to 90% by mass, preferably 5 to 80% by mass, and more preferably 10 to 70% by mass. From the viewpoint of fully exerting the antipyretic and analgesic effect, the amount per day is not particularly limited, but is usually 100 mg or more, preferably 300 mg or more, more preferably 500 mg or more, and particularly preferably 600 mg or more.

[0016] Ambroxol or a salt thereof used in the present invention is represented by the chemical formula C 13 H 18 Br2N2O or a salt thereof, and one of these may be used alone or in combination of two or more. Such ambroxol or a salt thereof can be produced by known methods, or commercially available products can be used. Furthermore, ambroxol or a salt thereof is not particularly limited as long as it is pharmaceutically acceptable, and examples of the salt include salts of inorganic acids such as hydrochloride, hydrobromide, and phosphate, and salts of organic acids such as acetate, oxalate, malonate, succinate, fumarate, maleate, lactate, malate, citrate, tartrate, and carbonate, and the like, with hydrochloride being particularly preferred.

[0017] The content of ambroxol or a salt thereof in the solid composition of the present invention (when two or more of ambroxol or a salt thereof are contained, the total content thereof; the same applies hereinafter) is not particularly limited as long as it is an amount that exhibits its medicinal effect, but is usually 0.01 to 50% by mass, preferably 0.1 to 30% by mass, and more preferably 0.5 to 10% by mass.

[0018] The pseudoephedrine or salt thereof used in the present invention has the chemical formula C 10 H 15The pseudoephedrine or its salt is a compound represented by the formula NO or a salt thereof, and one of these may be used alone or two or more may be used in combination. Such pseudoephedrine or its salt can be produced by known methods, or commercially available products can be used. Furthermore, pseudoephedrine or its salt is not particularly limited as long as it is pharmaceutically acceptable. Examples of the salt include salts of inorganic acids such as hydrochloride, hydrobromide, and phosphate, and salts of organic acids such as acetate, oxalate, malonate, succinate, fumarate, maleate, lactate, malate, citrate, tartrate, and carbonate, with hydrochloride being particularly preferred.

[0019] The content of pseudoephedrine or a salt thereof in the solid composition of the present invention (when two or more types of pseudoephedrine or a salt thereof are contained, the total content thereof; the same applies hereinafter) is not particularly limited as long as it is an amount that exhibits its medicinal effect, but is usually 0.01 to 50% by mass, preferably 0.1 to 30% by mass, and more preferably 1 to 20% by mass.

[0020] Dihydrocodeine or a salt thereof used in the present invention is represented by the chemical formula C 18 H 23 The dihydrocodeine or its salt is a compound represented by the formula (I) NO3 or a salt thereof, and one of these may be used alone or two or more may be used in combination. Such dihydrocodeine or its salt can be produced by known methods, or commercially available products can be used. The dihydrocodeine or its salt is not particularly limited as long as it is pharmaceutically acceptable. Examples of the salt include salts of inorganic acids such as hydrochloride, hydrobromide, and phosphate, and salts of organic acids such as acetate, oxalate, malonate, succinate, fumarate, maleate, lactate, malate, citrate, tartrate, and carbonate, with phosphate being particularly preferred.

[0021] The content of dihydrocodeine or a salt thereof in the solid composition of the present invention (when two or more of dihydrocodeine or a salt thereof are contained, the total content thereof; the same applies hereinafter) is not particularly limited as long as it is an amount that exhibits its medicinal effect, but is usually 0.001 to 30% by mass, preferably 0.005 to 20% by mass, and more preferably 0.01 to 10% by mass.

[0022] The dextromethorphan or salt thereof used in the present invention is represented by the chemical formula C 18 H 25 The compound represented by the formula (I) is a compound represented by the formula (I) or a salt thereof, and one of these may be used alone or two or more may be used in combination. Such dextromethorphan or a salt thereof can be produced by known methods, or commercially available products can be used. The dextromethorphan or a salt thereof is not particularly limited as long as it is pharmaceutically acceptable. Examples of the salt include salts of inorganic acids such as hydrochloride, hydrobromide, phenolphthalate, and phosphate, and salts of organic acids such as acetate, oxalate, malonate, succinate, fumarate, maleate, lactate, malate, citrate, tartrate, and carbonate, and the hydrobromide or phenolphthalate is particularly preferred.

[0023] The content of dextromethorphan or a salt thereof in the solid composition of the present invention (when two or more of dextromethorphan or a salt thereof are contained, the total content thereof; the same applies hereinafter) is not particularly limited as long as it is an amount that exhibits its medicinal effect, but is usually 0.01 to 30% by mass, preferably 0.05 to 20% by mass, and more preferably 0.1 to 10% by mass.

[0024] The carbocisteine ​​used in the present invention is a compound represented by the chemical formula CHNOS. There are no particular limitations on the type of carbocisteine ​​used as long as it is pharmaceutically acceptable, but L-carbocysteine ​​is usually used. Carbocisteine ​​can be produced by known methods, or commercially available products can be used.

[0025] The content of carbocisteine ​​in the solid composition of the present invention is not particularly limited, but is usually 1 to 90% by mass, preferably 5 to 70% by mass, and more preferably 10 to 50% by mass.

[0026] The blending ratio of (a) ibuprofen to (b) ambroxol or a salt thereof is 11 parts by mass or more, preferably 12 parts by mass or more, and more preferably 13 parts by mass or more of (a) ibuprofen per part by mass of (b) ambroxol or a salt thereof. In the blending ratio of (a) ibuprofen to (b) ambroxol or a salt thereof, the upper limit of (a) ibuprofen per part by mass of (b) ambroxol or a salt thereof is not particularly limited, but is preferably 25 parts by mass or less, more preferably 24 parts by mass or less, and even more preferably 23 parts by mass or less.

[0027] The blending ratio of (b) ambroxol or a salt thereof to (c) pseudoephedrine or a salt thereof is not particularly limited, but is preferably 0.1 parts by mass or more, more preferably 1 part by mass or more, and even more preferably 1.3 parts by mass or more of (c) pseudoephedrine or a salt thereof per 1 part by mass of (b) ambroxol or a salt thereof. The upper limit is not particularly limited, but is preferably 50 parts by mass or less, more preferably 10 parts by mass or less, and even more preferably 5 parts by mass or less.

[0028] The blending ratio of (b) ambroxol or a salt thereof to (d1) dihydrocodeine or a salt thereof is not particularly limited, but is preferably 0.01 parts by mass or more, more preferably 0.05 parts by mass or more, and even more preferably 0.1 parts by mass or more of (d1) dihydrocodeine or a salt thereof per 1 part by mass of (b) ambroxol or a salt thereof, and is not particularly limited to the upper limit, but is preferably 50 parts by mass or less, more preferably 30 parts by mass or less, and even more preferably 20 parts by mass or less.

[0029] The blending ratio of (b) ambroxol or a salt thereof to (d2) dextromethorphan or a salt thereof is not particularly limited, but is preferably 0.01 parts by mass or more, more preferably 0.1 parts by mass or more, and even more preferably 0.5 parts by mass or more of (d2) dextromethorphan or a salt thereof per 1 part by mass of (b) ambroxol or a salt thereof, and although the upper limit is not particularly limited, is preferably 50 parts by mass or less, more preferably 30 parts by mass or less, and even more preferably 20 parts by mass or less.

[0030] The compounding ratio of (b) ambroxol or a salt thereof to (d3) carbocisteine ​​is not particularly limited, but is preferably 1 part by mass or more, more preferably 3 parts by mass or more, and even more preferably 5 parts by mass or more of (d3) carbocisteine ​​per 1 part by mass of (b) ambroxol or a salt thereof, and the upper limit is not particularly limited, but is preferably 50 parts by mass or less, more preferably 30 parts by mass or less, and even more preferably 20 parts by mass or less.

[0031] The blending ratio of (a) ibuprofen and (c) pseudoephedrine or a salt thereof is not particularly limited, but is preferably 0.001 to 10 parts by mass, more preferably 0.01 to 5 parts by mass, of (c) pseudoephedrine or a salt thereof per 1 part by mass of (a) ibuprofen.

[0032] The solid composition of the present invention may contain other commonly used active ingredients, excipients, disintegrants, binders, fluidizing agents, lubricants, refreshing agents, colorants, flavoring agents, fragrances, coating agents, etc., within qualitative and quantitative ranges that do not impair the effects of the present invention.

[0033] Other active ingredients that can be incorporated into the solid composition of the present invention include, for example, antipyretics, analgesics, antihistamines, antitussives, noscapines, bronchodilators, expectorants, hypnotics and sedatives, vitamins, anti-inflammatory agents, gastric mucosa protectants, herbal medicines, Chinese herbal medicines, caffeines, and the like, and the solid composition may contain one or more selected from the group consisting of these.

[0034] Examples of excipients that can be incorporated into the solid composition of the present invention include lactose, starches, crystalline cellulose, sucrose, sugar alcohols, etc.; disintegrants include low-substituted hydroxypropyl cellulose, sodium starch glycolate, crospovidone, carmellose, carmellose sodium, carmellose calcium, pregelatinized starch, etc.; binders include hydroxypropyl cellulose, hypromellose, gelatin, pregelatinized starch, polyvinylpyrrolidone, pullulan, etc.; flow agents include light anhydrous silicic acid, hydrated silicon dioxide, etc.; lubricants include sucrose fatty acid esters, hardened oils, stearic acid, magnesium stearate, calcium stearate, etc.; and freshening agents include menthol, peppermint oil, eucalyptus oil, etc.

[0035] The solid composition of the present invention can be produced by a conventional method, and the method is not particularly limited. For example, (a) ibuprofen (hereinafter also referred to as component (a)), (b) ambroxol or a salt thereof (hereinafter also referred to as component (b)), and (c) pseudoephedrine or a salt thereof (hereinafter also referred to as component (c)) may be simply mixed, or may be granulated after mixing, and the resulting granules may be coated. Furthermore, component (a), component (b), and component (c) do not necessarily need to be contained in the same granule. For example, a granule containing components (a) and (c) may be produced and then mixed with component (b), or a granule containing components (a) and (b) may be produced and then mixed with component (c), or a granule containing components (a) and (c) and a granule containing components (b) and (c) may be produced and then the two granules may be mixed, etc.

[0036] Furthermore, when (d1) dihydrocodeine or a salt thereof, (d2) dextromethorphan or a salt thereof, and (d3) carbocisteine ​​((d1), (d2), and (d3) are collectively referred to as component (d)), there are no particular limitations on the amount of the compounded ingredients. For example, the ingredients (a), (b), (c), and (d) may simply be mixed together, or the mixture may be granulated or coated after mixing.

[0037] The granulation method is not particularly limited, and can be produced by wet granulation, dry granulation, melt granulation, etc., but wet granulation is preferred. Wet granulation methods include, for example, stirring granulation, fluidized bed granulation, kneading granulation, extrusion granulation, tumbling fluidized granulation, and centrifugal fluidized granulation. Conventional pharmaceutical additives such as the active ingredients and excipients may also be blended with the resulting granules as appropriate. The mixture thus obtained can also be compressed into tablets. When producing tablets, they may be produced by direct compression.

[0038] The solid composition of the present invention is not particularly limited as long as it is in a dosage form specified in the General Rules for Preparations of the Japanese Pharmacopoeia, but is preferably in the form of a tablet, powder, fine granules, granules, pill, or capsule. Tablets specified in the General Rules for Preparations of the Japanese Pharmacopoeia include orally disintegrating tablets, chewable tablets, effervescent tablets, dispersible and dissolving tablets, film-coated tablets, sugar-coated tablets, dry-coated tablets, and layered tablets. Furthermore, the tablets may be provided with a score line or a mark or stamp for improved identification. Furthermore, the tablets of the present formulation may be round or irregularly shaped. [Example]

[0039] The present invention will be explained in more detail below with reference to examples, control examples and comparative examples, but the present invention is not limited to these examples.

[0040] (Control Examples 1-2, Comparative Example 1, Examples 1-5) According to the formulation shown in Table 1, each component was weighed and mixed, and an appropriate amount of water / ethanol mixture was added to this, mixed, and then dried to obtain a preparation.

[0041] (Test Example 1) The preparations of Control Examples 1 and 2, Comparative Example 1, and Examples 1 to 5 were stored at 65°C for 12 days. After storage, the ambroxol content in each solid composition was measured and the residual rate (%) was calculated. The results are shown in Table 1.

[0042] (Test Example 2) The preparations of Control Examples 1 and 2, Comparative Example 1, and Examples 1 to 5 were stored at 5°C and 65°C for 12 days. After storage, the solid compositions were visually evaluated for the degree of change in appearance between the samples stored at 65°C and those stored at 5°C. The change in appearance was evaluated by evaluating the color tone of the solid composition according to the following criteria. The results are shown in Table 1.

[0043] Degree of change in appearance 1: No change in color tone 2: Slight change in color tone 3: There is a change in color tone

[0044] [Table 1]

[0045] As shown in Table 1, in Control Example 1, the ambroxol content did not decrease, and the color of the composition did not change. In Control Example 2, the ambroxol content decreased, but the color of the composition did not change. In Comparative Example 1, a decrease in the ambroxol content and a change in the color of the composition were observed. On the other hand, in Examples 1 and 2, the decrease in the ambroxol content and the change in the appearance of the composition were suppressed. Furthermore, in Examples 3 to 5, the decrease in the ambroxol content and the change in the appearance of the composition were suppressed to a degree equal to or greater than that of Example 2. That is, when at least one selected from dihydrocodeine or a salt thereof, dextromethorphan or a salt thereof, and carbocisteine ​​was further added, the decrease in the ambroxol content and the change in the appearance of the composition over time were suppressed to a degree equal to or greater than that in the absence of these ingredients. In particular, in Example 5, which contained carbocisteine, the effect of suppressing the decrease in the ambroxol content and the change in the appearance of the composition was remarkable.

[0046] An example of formulation preparation is given below.

[0047] (Formulation Example 1) Based on the amounts in Table 2, the granule ingredients were wet granulated, and then the resulting granules were mixed with the post-addition ingredients to prepare tablets each weighing approximately 274.5 mg. A formulation was produced to be taken with 9 tablets per day.

[0048] [Table 2]

[0049] (Formulation Example 2) Granulated granules A were prepared by wet granulation of granulated granule A component based on the amounts in Table 3. Granulated granules B component was also prepared by wet granulation. The obtained granulated granules A and B were mixed with the final additive component, and then tablets of approximately 300 mg each were prepared, producing a formulation with a dosage of 9 tablets per day.

[0050] [Table 3]

[0051] (Formulation Examples 3 and 4) Based on the amounts in Table 4, the granulated and coated granule ingredients were wet granulated and coated, and then the resulting granulated and coated granules were mixed with the post-addition ingredients to prepare granules of approximately 1.34 g per packet for Formulation Example 3 and approximately 1.49 g per packet for Formulation Example 4. Both formulations were manufactured to be taken three packets per day.

[0052] [Table 4]

[0053] (Formulation Examples 5 to 20) Table 5 lists example formulations.

[0054] [Table 5]

[0055] The amounts of ingredients, flavors, packaging forms, granulation methods, and dosage forms in Formulation Examples 5 to 20 are as follows. The amounts of the ingredients in each formulation example can be increased or decreased as appropriate. For example, the amount of D-mannitol in the formulation is preferably 40 to 70% by mass, more preferably 50 to 60% by mass. The amount of light anhydrous silicic acid in the formulation is preferably 1 to 15% by mass, more preferably 3 to 10% by mass. The amount of the active ingredient in the formulation is preferably 10 to 40% by mass, more preferably 20 to 30% by mass. The total amount of one or more selected from crospovidone, carmellose sodium, and low-substituted hydroxypropyl cellulose in the formulation is preferably 3 to 15% by mass, more preferably 5 to 10% by mass. The total amount of one or more selected from magnesium stearate, stearic acid, hydrogenated oil, and calcium stearate in the formulation is preferably 0.5 to 2% by mass, more preferably 0.7 to 1.8% by mass. Flavorings can be selected and blended as appropriate. Depending on the flavor of the active ingredient, ethyl-3-p-menthane-3-carboxamide acetate, vanilla flavoring, green tea flavoring, black tea flavoring, chocolate flavoring, and milk flavoring are preferred. The packaging form is not particularly limited as long as it can be used for pharmaceuticals, and is preferably a sealed container such as a bottle or an airtight container such as a PTP, and more preferably a sealed container formed by wrapping a pillow around a bottle or PTP. The granulation method is not particularly limited, and may be a dry granulation method or a wet granulation method, but is preferably a wet granulation method. Preferred wet granulation methods are agitation granulation, fluidized bed granulation, tumbling granulation, and extrusion granulation, and more preferably fluidized bed granulation. The dosage form is not particularly limited as long as it is a solid preparation, and powders, granules, tablets, and capsules are preferred, with tablets being particularly preferred. The tablets are not particularly limited as long as they can be produced using a rotary tablet press, and may be effervescent tablets, multi-layer tablets, scored tablets, mini-tablets, or caplets. [Industrial Applicability]

[0056] The present invention provides a solid composition containing ibuprofen and ambroxol or a salt thereof, which has excellent stability of ambroxol or a salt thereof, and which is suppressed from changing in appearance of the formulation.Furthermore, the present invention makes it possible to maintain the formulation stability of a solid composition containing ibuprofen and ambroxol or a salt thereof by a simple method.

Claims

1. A solid composition comprising (a) ibuprofen, (b) ambroxol or a salt thereof, and (c) pseudoephedrine or a salt thereof, wherein the amount of (a) ibuprofen is 11 parts by mass or more per part by mass of (b) ambroxol or a salt thereof.

2. The solid composition according to claim 1, further comprising at least one selected from (d1) dihydrocodeine or a salt thereof, (d2) dextromethorphan or a salt thereof, and (d3) carbocisteine.

3. 3. The solid composition according to claim 1 or 2, wherein (b) ambroxol or a salt thereof is ambroxol hydrochloride.

4. (c) A solid composition according to any one of claims 1 to 3, wherein the pseudoephedrine or a salt thereof is pseudoephedrine hydrochloride.

5. 5. The solid composition according to claim 1, which is in the form of a tablet, a powder, fine granules, granules, pills, or capsules.

6. A method for suppressing a decrease in the content of (b) ambroxol or a salt thereof and a change in appearance of a solid composition containing (a) ibuprofen and (b) ambroxol or a salt thereof, characterized in that the solid composition further contains (c) pseudoephedrine or a salt thereof.

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