Preparation composition

Abstract

To provide a new preparation composition with which it is possible to improve the disintegrability of a solid preparation. Provided is a preparation composition containing bacterial cells, at least one disintegrant selected from the group consisting of croscarmellose sodium, crospovidone, and sodium starch glycolate, and an excipient (excluding croscarmellose sodium, crospovidone, and sodium starch glycolate), wherein the content of the bacterial cells is 3.0-35.0 mass%, the content of the disintegrant is 5.0-14.0 mass% when the content of the bacterial cells is 3.0-29.5 mass%, and the content of the disintegrant is 10.0-14.0 mass% when the content of the bacterial cells is more than 29.5 mass% and less than or equal to 35.0 mass%.

Description

Pharmaceutical Composition

[0001] The present invention relates to pharmaceutical compositions.

[0002] One type of formulation is a solid formulation. A solid formulation is a commonly used dosage form, and refers to a solid formulation such as a capsule or tablet. A solid formulation contains additives such as excipients in addition to medicinal ingredients and active ingredients.

[0003] Microorganisms are attracting attention as one of the medicinal and active ingredients in pharmaceutical preparations. Probiotics, which are "live microorganisms that have a positive effect on the health of the host by improving the balance of intestinal flora," are being used as such microorganisms.

[0004] In solid preparations containing microorganisms, the content of the microorganisms in the solid preparation is changed depending on the situation. However, if the content of the microorganisms is increased, there is a risk that the disintegration property of the solid preparation will decrease.

[0005] To solve this problem, Japanese Patent Application Laid-Open No. 2022-031035 discloses a tablet containing lactic acid bacteria powder, maltose powder, and a binder in a specific ratio.

[0006] An object of the present invention is to provide a novel pharmaceutical composition that can improve the disintegration properties of solid pharmaceutical preparations.

[0007] The present inventors have surprisingly found that the disintegration property of a solid preparation can be improved by adjusting the content of a specific disintegrant relative to the content of bacterial cells (microorganisms) within a predetermined range, and have completed the present invention based on this finding.

[0008] That is, one embodiment of the present invention provides a formulation composition comprising bacterial cells, at least one disintegrant selected from the group consisting of croscarmellose sodium, crospovidone, and sodium starch glycolate, and an excipient (excluding croscarmellose sodium, crospovidone, and sodium starch glycolate), wherein the content of the bacterial cells is 3.0% by mass or more and 35.0% by mass or less, and when the content of the bacterial cells is 3.0% by mass or more and 29.5% by mass or less, the content of the disintegrant is 5.0% by mass or more and 14.0% by mass or less, and when the content of the bacterial cells is more than 29.5% by mass and 35.0% by mass or less, the content of the disintegrant is 10.0% by mass or more and 14.0% by mass or less.

[0009] 1 is a graph showing the results of a disintegration test for the capsules of Comparative Example 1. FIG. 2 is a graph showing the results of a disintegration test for the capsules of Comparative Example 2. FIG. 3 is a graph showing the results of a disintegration test for the capsules of Examples 4-5 and Comparative Examples 3-8. FIG. 4 is a graph showing the results of a disintegration test for the capsules of Examples 6-8. FIG. 5 is a graph showing the results of a disintegration test for the capsules of Examples 9-10. FIG. 6 is a graph showing the measurement results of the filling amount of the capsules of Examples 3 and 11.

[0010] An embodiment of the present invention will be described below, but the present invention is not limited to the following embodiment.

[0011] In this specification, the range "X to Y" means "X or more and Y or less." Unless otherwise specified, operations and measurements of physical properties are performed under conditions of room temperature (20 to 25°C) and a relative humidity of 40 to 50% RH.

[0012] <Preparation Composition> One aspect of the present invention relates to a preparation composition comprising a bacterial cell, at least one disintegrant selected from the group consisting of croscarmellose sodium, crospovidone, and sodium starch glycolate, and an excipient (excluding croscarmellose sodium, crospovidone, and sodium starch glycolate), wherein the content of the bacterial cell is 3.0% by mass to 35.0% by mass, and when the content of the bacterial cell is 3.0% by mass to 29.5% by mass, the content of the disintegrant is 5.0% by mass to 14.0% by mass, and when the content of the bacterial cell is more than 29.5% by mass to 35.0% by mass, the content of the disintegrant is 10.0% by mass to 14.0% by mass. This configuration improves the disintegration property of the solid preparation.

[0013] In this specification, "at least one disintegrant selected from the group consisting of croscarmellose sodium, crospovidone, and sodium starch glycolate" is also simply referred to as "the disintegrant according to the present invention."

[0014] In this specification, when disintegrants other than "croscarmellose sodium, crospovidone, and sodium starch glycolate" have uses as excipients, these disintegrants are treated as excipients.

[0015] In this specification, when the formulation composition according to the present invention contains bacterial cells in the form of bacterial powder, components in the bacterial powder other than the bacterial cells are treated as the corresponding components (disintegrants, excipients, lubricants, or other components).

[0016] The formulation composition of the present invention contains bacterial cells.

[0017] The bacterial cells are not particularly limited, and any bacterial cells used in pharmaceutical preparations can be used. The bacterial cells are preferably cells of at least one type of bacteria selected from the group consisting of butyric acid bacteria, lactic acid bacteria, and bifidobacteria.

[0018] Examples of butyric acid bacteria include non-pathogenic butyric acid bacteria belonging to the genus Clostridium. A specific example of butyric acid bacteria is Clostridium butyricum. Butyric acid bacteria are known and can be obtained by conventional methods.

[0019] Specific examples of Clostridium butyricum include Clostridium butyricum Miyairi 588 (Clostridium butyricum MIYAIRI 588, FERM BP-2789), Clostridium butyricum NIP1020 (Clostridium butyricum NIP1020), Clostridium butyricum NIP1021 (Clostridium butyricum NIP1021), Clostridium butyricum (FERM P-11868), Clostridium butyricum (FERM P-11868), Clostridium butyricum (FERM P-11869), Clostridium butyricum (FERM P-11870), Clostridium butyricum ATCC859, Clostridium butyricum NBRC3315, Clostridium butyricum ATCC860, Clostridium butyricum ATCC19398, etc. All of these have been deposited and stored at the Patent Microorganisms Depositary Center of the National Institute of Technology and Evaluation. The Clostridium butyricum is preferably one or more species selected from the group consisting of Clostridium butyricum Miyairi 588 (FERM BP-2789), Clostridium butyricum Miyairi 585 (FERM BP-06815), Clostridium butyricum Miyairi 595 (FERM BP-06816) and Clostridium butyricum Miyairi 630 (FERM BP-06817), and more preferably Clostridium butyricum Miyairi 588 (FERM BP-2789).Clostridium butyricum Miyairi 588 strain was deposited on May 1, 1981, at the Fermentation Research Institute, Agency of Industrial Science and Technology, Ministry of International Trade and Industry (currently the Patent Organism Depositary, National Institute of Technology and Evaluation, Room 120, 2-5-8 Kazusa Kamatari, Kisarazu City, Chiba Prefecture, 292-0818, Japan) under accession number FERM BP-2789, and was transferred to an international depository organization under the Budapest Treaty on March 6, 1990, where it is deposited under accession number FERM BP-2789.

[0020] Examples of lactic acid bacteria include non-pathogenic lactic acid bacteria belonging to the genera Lactobacillus and Enterococcus. Specific examples of lactic acid bacteria include Lactobacillus acidophilus, Lactobacillus casei, Lactobacillus paracasei, Lactobacillus plantarum, Lactobacillus bulgaricus, Lactobacillus rhamnosus, and Lactobacillus gasseri. Lactobacillus gasseri, Lactobacillus fermentum, Lactobacillus curvatus, Lactobacillus reuteri, Lactobacillus brevis, Lactobacillus buchneri, Lactobacillus delbrueckii, Lactobacillus helveticus Examples of lactic acid bacteria include Lactobacillus helveticus, Lactobacillus salivarius, Lactobacillus farciminis, Enterococcus faecalis, and Enterococcus faecium. These lactic acid bacteria are known and can be obtained by conventional methods.

[0021] Examples of bifidobacteria include non-pathogenic bifidobacteria belonging to the genus Bifidobacterium. Specific examples of bifidobacteria include Bifidobacterium bifidum, Bifidobacterium infantis, Bifidobacterium longum, Bifidobacterium breve, Bifidobacterium lactis, Bifidobacterium animalis, etc. These bifidobacteria are known and can be obtained by conventional methods.

[0022] In the formulation composition of the present invention, the content of the bacterial cells is 3.0% by mass to 35.0% by mass, or may be 4.0% by mass to 34.0% by mass, 8.0% by mass to 34.0% by mass, 20.0% by mass to 34.0% by mass, or 25.0% by mass to 34.0% by mass, based on the total mass of the formulation composition.

[0023] In the formulation composition of the present invention, the bacterial cells are preferably in the form of a dry product (bacterial powder), more preferably in the form of a dry product prepared by spray drying or fluidized bed granulation. The method for making the bacterial cells into a dry product (preferably spray drying or fluidized bed granulation) is not particularly limited, and any conventionally known method can be used. In this specification, the excipients in the dried bacterial cell product are treated as the excipients described below. When the dried bacterial cell product further contains a disintegrant, a lubricant, and other components, the disintegrant, lubricant, and other components are treated as the disintegrant, lubricant, and other components described below, respectively.

[0024] The pharmaceutical composition of the present invention comprises at least one disintegrant selected from the group consisting of croscarmellose sodium, crospovidone, and sodium starch glycolate.

[0025] In the formulation composition of the present invention, when the content of bacterial cells is 3.0% by mass or more and 29.5% by mass or less, relative to the total mass of the formulation composition, the content of disintegrant is 5.0% by mass or more and 14.0% by mass or less, relative to the total mass of the formulation composition; and when the content of bacterial cells is more than 29.5% by mass or more and 35.0% by mass or less, relative to the total mass of the formulation composition, the content of disintegrant is 10.0% by mass or more and 14.0% by mass or less, relative to the total mass of the formulation composition.

[0026] In one embodiment, when the content of bacterial cells is 4.0% by mass or more and 29.5% by mass or less, relative to the total mass of the formulation composition, the content of the disintegrant is 5.0% by mass or more and 14.0% by mass or less, 5.0% by mass or more and 10.0% by mass or less and 14.0% by mass or less, relative to the total mass of the formulation composition; when the content of bacterial cells is 8.0% by mass or more and 29.5% by mass or less, relative to the total mass of the formulation composition, the content of the disintegrant is 5.0% by mass or more and 14.0% by mass or less, 5.0% by mass or more and 10.0% by mass or more and 14.0% by mass or less, relative to the total mass of the formulation composition; When the content of bacterial cells is 20.0% by mass or more and 29.5% by mass or less, relative to the total mass of the formulation composition, the content of disintegrant is 5.0% by mass or more and 14.0% by mass or less, 5.0% by mass or more and 10.0% by mass or more and 14.0% by mass or less, relative to the total mass of the formulation composition; when the content of bacterial cells is 25.0% by mass or more and 29.5% by mass or less, relative to the total mass of the formulation composition, the content of disintegrant is 5.0% by mass or more and 14.0% by mass or less, 5.0% by mass or more and 10.0% by mass or more and 14.0% by mass or less, relative to the total mass of the formulation composition; when the content of bacterial cells is more than 29.5% by mass or less and 34.0% by mass or less, relative to the total mass of the formulation composition, the content of disintegrant is 10.0% by mass or more and 14.0% by mass or less, relative to the total mass of the formulation composition.

[0027] The pharmaceutical compositions of the present invention include excipients (excluding croscarmellose sodium, crospovidone, and sodium starch glycolate).

[0028] In the pharmaceutical composition of the present invention, the content of the excipient can be appropriately adjusted depending on the content of the bacterial cells and the disintegrant, and the content of the excipient is preferably 50.0% by mass or more and 85.0% by mass or less based on the total mass of the pharmaceutical composition.

[0029] The excipient is not particularly limited as long as it is an excipient used in pharmaceuticals.Examples of excipients include: sugars and sugar alcohols such as lactose (lactose hydrate), sucrose, sucrose, glucose, candy powder, cellulose, mannitol, etc.; starches such as wheat starch, potato starch, corn starch, etc.; dextrins such as cyclodextrin; cellulose derivatives such as carboxymethylcellulose (CMC), hydroxyethylcellulose, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, hydroxypropylmethylcellulose, etc.; synthetic polymer compounds such as polyvinyl alcohol, polyvinylpyrrolidone, etc.; minerals (components) such as talc, light anhydrous silicic acid, etc.; inorganic salts such as precipitated calcium carbonate, etc.

[0030] In a preferred embodiment, the pharmaceutical composition of the present invention contains at least one of lactose hydrate and mannitol, and corn starch as excipients.

[0031] When the excipient contains at least one of lactose hydrate and mannitol and corn starch, the content of at least one of lactose hydrate and mannitol is preferably 12.0% by mass to 47.0% by mass, based on the total mass of the excipient. The content of corn starch is preferably 47.0% by mass to 78.0% by mass, based on the total mass of the excipient. The mass ratio of the corn starch to at least one of lactose hydrate and mannitol is preferably 1.0 to 6.4.

[0032] In a preferred embodiment, the pharmaceutical composition according to the present invention further comprises, as an excipient, microcrystalline cellulose in addition to at least one of lactose hydrate and mannitol and corn starch.

[0033] When the excipient further contains crystalline cellulose in addition to at least one of lactose hydrate and mannitol and corn starch, the content of crystalline cellulose is preferably 5.9% by mass or more and 9.8% by mass or less relative to the total mass of the excipient. The mass ratio of crystalline cellulose to at least one of lactose hydrate and mannitol is preferably 0.12 to 0.80.

[0034] When the excipient contains at least one of lactose hydrate and mannitol, corn starch, and crystalline cellulose, the content of at least one of lactose hydrate and mannitol, corn starch, and crystalline cellulose is preferably 95% by mass or more and 100% by mass or less, more preferably 98% by mass or more and 100% by mass or less, and even more preferably 100% by mass, relative to the total mass of the excipient.

[0035] The pharmaceutical composition of the present invention may further comprise a lubricant.

[0036] Lubricants include stearates (for example, magnesium stearate), purified talc, borax, polyethylene glycol, and the like.

[0037] In the pharmaceutical composition of the present invention, the content of the lubricant is, for example, from 0.1% by mass to 2% by mass, and preferably from 0.5% by mass to 1.5% by mass, relative to the total mass of the pharmaceutical composition.

[0038] The pharmaceutical composition of the present invention may contain other ingredients in addition to the above ingredients, such as additives, pharmaceutically acceptable carriers, auxiliary ingredients, etc.

[0039] The additives include stabilizers, preservatives, wetting agents, emulsifiers, sweeteners, colorants, flavors, buffers, antioxidants, pH adjusters, binders, thickeners, dispersants, suspending agents, bacteriostatic agents, surfactants, disintegrants (excluding croscarmellose sodium, crospovidone, and sodium starch glycolate), and the like.

[0040] Examples of pharmaceutically acceptable carriers include binders such as dextrin and cellulose; and solvents such as water and organic solvents.

[0041] Examples of auxiliary ingredients include antibiotics, vitamins (e.g., vitamin C, vitamin E), amino acids, peptides, minerals (e.g., zinc, iron, copper, manganese, etc.), nucleic acids, polysaccharides, fatty acids, and herbal medicines.

[0042] The method for producing the pharmaceutical composition of the present invention is not particularly limited, and examples thereof include a method of mixing the bacterial cells, the disintegrant of the present invention, an excipient, and, if necessary, a lubricant and other ingredients.

[0043] The pharmaceutical composition according to the present invention is preferably used in the form of a solid preparation (oral solid preparation) because of its excellent disintegrability. Examples of solid preparations include capsules, tablets, powders, fine granules, granules, pills, and sustained-release preparations. The pharmaceutical composition according to the present invention is preferably in the form of a capsule because it has good disintegrability and can reduce variations in the filling amount. Therefore, one embodiment of the present invention relates to a capsule containing the pharmaceutical composition according to the present invention.

[0044] The method for producing a solid formulation is not particularly limited, and conventionally known methods can be used. For example, capsules can be produced by filling capsules with the formulation composition of the present invention using a capsule filling machine. Known capsules can be used. Examples of capsules include hydroxypropyl methylcellulose (HPMC) capsules and gelatin capsules. The size of the capsule is not particularly limited, and can be selected appropriately depending on the amount of the formulation composition to be filled. The capsule filling machine is not particularly limited, and a fully automatic capsule filling machine, a desktop capsule filling machine, or the like can be used. It is preferable to use a fully automatic capsule filling machine for the formulation composition of the present invention, as this can reduce variation in the filling amount.

[0045] <Embodiments> Examples of embodiments of the present invention are described below: [1] A formulation composition comprising bacterial cells, at least one disintegrant selected from the group consisting of croscarmellose sodium, crospovidone, and sodium starch glycolate, and an excipient (excluding croscarmellose sodium, crospovidone, and sodium starch glycolate), wherein the content of the bacterial cells is 3.0% by mass or more and 35.0% by mass or less, relative to the total mass of the formulation composition, when the content of the bacterial cells is 3.0% by mass or more and 29.5% by mass or less, relative to the total mass of the formulation composition, the content of the disintegrant is 5.0% by mass or more and 14.0% by mass or less, relative to the total mass of the formulation composition, and when the content of the bacterial cells is more than 29.5% by mass but 35.0% by mass or less, relative to the total mass of the formulation composition, the content of the disintegrant is 10.0% by mass or more and 14.0% by mass or less, relative to the total mass of the formulation composition. [2] The formulation composition according to [1], wherein the bacterial cells are those of at least one species of bacteria selected from the group consisting of butyric acid bacteria, lactic acid bacteria, and bifidobacteria. [3] The formulation composition according to [1] or [2], wherein the bacterial cells are in the form of a dried product prepared by spray drying or fluidized bed granulation. [4] The formulation composition according to any one of [1] to [3], wherein the content of the excipient is 50.0% by mass or more and 85.0% by mass or less, based on the total mass of the formulation composition. [5] The formulation composition according to any one of [1] to [4], wherein the excipient comprises at least one of lactose hydrate and mannitol, and corn starch. [6] The formulation composition according to [5], wherein the content of at least one of lactose hydrate and mannitol is 12.0% by mass or more and 47.0% by mass or less, based on the total mass of the excipient. [7] The formulation composition according to [5] or [6], wherein the mass ratio of the corn starch to at least one of the lactose hydrate and mannitol is 1.0 or more and 6.4 or less. [8] The formulation composition according to any one of claims [5] to [7], wherein the excipient further comprises crystalline cellulose. [9] The formulation composition according to [8], wherein the mass ratio of the crystalline cellulose to at least one of the lactose hydrate and mannitol is 0.12 or more and 0.80 or less.

[10] The pharmaceutical composition according to any one of [1] to [9], further comprising a lubricant.

[11] A capsule comprising the pharmaceutical composition according to any one of [1] to

[10] .

[0046] The present invention will be described below using specific examples, but the present invention is not limited to these examples. Unless otherwise specified, the operations were carried out at room temperature (25° C.).

[0047] <Materials> (Bacterial powder) Clostridium butyricum Miyairi 588 (Clostridium butyricum MIYAIRI 588, FERM BP-2789) powder (preparation method: spray drying, bacterial content: 42.1% by mass, excipient content: 57.9% by mass) (Excipient) Lactose hydrate (Sheffield ＴＭ Spray Dried 315, KERRY GROUP P. L. C. , Tralee) Cornstarch (Cornstarch White W-4P, Japan Cornstarch Co., Ltd.) Microcrystalline cellulose (Ceolas PH-101, Asahi Kasei Corporation) (disintegrant) Croscarmellose sodium (Kiccolate ND-2HS, Asahi Kasei Corporation) Crospovidone (Kollidon CL, BASF Japan Ltd.) Sodium starch glycolate (Primojel, DFE Pharma GmbH & Co. KG, Goch) (lubricant) Magnesium stearate (Magnesium stearate-S, NOF Corporation) (capsule) Hypromellose capsule No. 3 (Medical HPMC capsule QUALI-V, Qualicaps Co., Ltd.).

[0048] <Preparation of Capsules> Each material was added to a bag in the mass percentage shown in Table 1, and mixed by inversion for 2 minutes to prepare a formulation. The formulation and hypromellose capsules were added to a capsule filling machine (F-40, Qualicaps Co., Ltd.) to prepare capsules (approximately 246 mg (contents 200 mg), length approximately 15.8 mm). The operating speed was set to 40,000 caps / h.

[0049]

[0050]

[0051]

[0052] <Disintegration Test> The disintegration test was carried out using a disintegration tester (NT-610, Toyama Sangyo Co., Ltd., Osaka Prefecture) in accordance with the capsule disintegration test method 6.09 Disintegration Test Method in the 18th Edition of the Japanese Pharmacopoeia. Purified water was used for the test, and the test conditions were a temperature of 37±2°C, without an auxiliary disc. The disintegration time was defined as the time required for the capsule or its contents to completely disappear from the stainless steel mesh of the tester. The test was carried out once for each sample, and the average disintegration time of six capsules was calculated.

[0053] FIG. 1 shows the test results for the capsules of Comparative Example 1 (operating time: 15 minutes), and FIG. 2 shows the test results for the capsules of Comparative Example 2 (operating time: 0 minutes). Table 2 also shows the test results for the capsules of Examples 1 to 3 (operating time: 0 minutes, 5 minutes, or 15 minutes). The operating time indicates the time period during which the capsules were produced. An operating time of 0 minutes indicates that the capsules were produced between 0 seconds and 59 seconds after the start of production, an operating time of 5 minutes indicates that the capsules were produced between 4 minutes 0 seconds and 4 minutes 59 seconds after the start of production, and an operating time of 15 minutes indicates that the capsules were produced between 15 minutes 0 seconds and 15 minutes 59 seconds after the start of production.

[0054] As shown in Figures 1 and 2, it can be seen that the capsules of Comparative Examples 1 and 2 exceed the standard value (20 minutes) set forth in the Japanese Pharmacopoeia.

[0055] On the other hand, as shown in Table 2, it can be seen that the capsules of Examples 1 to 3 had improved disintegration properties due to the inclusion of 10% by mass of a disintegrant (croscarmellose sodium).

[0056]

[0057] FIG. 3 shows the test results for the capsules of Examples 4 and 5 and Comparative Examples 3 to 8 (operation time: 5 minutes).

[0058] As shown in Figure 3, in the capsules of Comparative Examples 3 to 6 (bacterial cell content: 0.8% by mass or 2.1% by mass), the addition of 10% by mass of a disintegrant (croscarmellose sodium) extended the disintegration time.

[0059] Furthermore, it can be seen that the capsules of Examples 4 and 5 and Comparative Examples 7 and 8 (bacterial cell content: 4.2% by mass or 8.4% by mass) contained 10% by mass of a disintegrant (croscarmellose sodium), and thus the disintegration properties were improved.

[0060] 4 shows the test results for the capsules of Examples 6 to 8 (operation time: 0 or 5 minutes). The capsule of Example 6 contains crospovidone as a disintegrant, the capsule of Example 7 contains sodium starch glycolate as a disintegrant, and the capsule of Example 8 contains croscarmellose sodium as a disintegrant.

[0061] As shown in FIG. 4, it can be seen that crospovidone and sodium starch glycolate can improve disintegration properties in the same way as croscarmellose sodium.

[0062] FIG. 5 shows the test results for the capsules of Examples 9 and 10 (operation time: 0 or 5 minutes).

[0063] As shown in Figure 5, when the bacterial cell content was 25.3% by mass (Example 9) or 29.5% by mass (Example 10), the disintegration property was improved by including 5% by mass of a disintegrant (croscarmellose sodium).

[0064] Table 3 shows the test results for the capsules of Examples 3 and 11 and Comparative Example 9 (operating time: 0 minutes, 5 minutes, 10 minutes, or 15 minutes (Example 3 and Comparative Example 9), operating time: 0 minutes, 5 minutes, or 10 minutes (Example 11)).

[0065] As shown in Table 3, when the bacterial cell content was 33.7% by mass, the addition of 5% by mass of disintegrant (croscarmellose sodium) did not sufficiently improve disintegrability (Comparative Example 9). On the other hand, the addition of 10% by mass (Example 3) and 14% by mass (Example 11) of disintegrant (croscarmellose sodium) improved disintegrability.

[0066]

[0067] <Measurement of Filling Amount> For 10 capsules (Examples 3 and 11), the mass of the contents of each capsule (operation time: 0, 5, 10, or 15 minutes) was measured using an electronic balance (GH-252, A&D Co., Ltd., Tokyo), and the average value and standard deviation were calculated. The results are shown in Figure 6.

[0068] As shown in FIG. 6, it is clear that the capsules using the formulation compositions of Examples 3 and 11 can suppress variations in the filling amount.

Claims

1. A formulation composition comprising: bacterial cells; at least one disintegrant selected from the group consisting of croscarmellose sodium, crospovidone, and sodium starch glycolate; and an excipient (excluding croscarmellose sodium, crospovidone, and sodium starch glycolate), wherein the content of the bacterial cells is 3.0% by mass or more and 35.0% by mass or less, based on the total mass of the formulation composition; when the content of the bacterial cells is 3.0% by mass or more and 29.5% by mass or less, based on the total mass of the formulation composition, the content of the disintegrant is 5.0% by mass or more and 14.0% by mass or less, based on the total mass of the formulation composition; and when the content of the bacterial cells is more than 29.5% by mass and 35.0% by mass or less, based on the total mass of the formulation composition, the content of the disintegrant is 10.0% by mass or more and 14.0% by mass or less, based on the total mass of the formulation composition.

2. The formulation composition according to claim 1, wherein the bacterial cells are cells of at least one type of bacteria selected from the group consisting of butyric acid bacteria, lactic acid bacteria and bifidobacteria.

3. The formulation composition according to claim 1, wherein the bacterial cells are in the form of a dry product prepared by spray drying or fluidized bed granulation.

4. The pharmaceutical composition according to claim 1, wherein the content of the excipient is 50.0% by mass or more and 85.0% by mass or less based on the total mass of the pharmaceutical composition.

5. The pharmaceutical composition of claim 1, wherein the excipient comprises at least one of lactose hydrate and mannitol, and corn starch.

6. The pharmaceutical composition according to claim 5, wherein the content of at least one of the lactose hydrate and mannitol is 12.0% by mass or more and 47.0% by mass or less based on the total mass of the excipient.

7. The formulation composition according to claim 5, wherein the mass ratio of said corn starch to at least one of said lactose hydrate and mannitol is 1.0 or more and 6.4 or less.

8. The pharmaceutical composition of claim 5, wherein the excipient further comprises microcrystalline cellulose.

9. The pharmaceutical composition according to claim 8, wherein the mass ratio of crystalline cellulose to at least one of lactose hydrate and mannitol is 0.12 or more and 0.80 or less.

10. The pharmaceutical composition of claim 1, further comprising a lubricant.

11. A capsule comprising the pharmaceutical composition according to any one of claims 1 to 10.

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