JP6589979B2 - Tablet composition and method for improving disintegration and dissolution of tablet composition - Google Patents

Description

  The present invention relates to a tablet composition containing lactoferrin, and a method for improving disintegration / dissolution properties of the tablet composition.

  In order to take lactoferrin, which is known to have various actions, more effectively, it needs to be absorbed into the body as soon as possible. In addition, it is useful to make tablets in order to make lactoferrin easy to carry and ingest, but in order to absorb it quickly into the body, it is necessary to improve the disintegration of the tablets and the dissolution of lactoferrin as much as possible. Is important.

  A tablet containing lactoferrin at a high concentration has a low binding force of lactoferrin powder, and therefore it is necessary to compress the tablet at a high pressure in order to reduce the friability of the tablet. Tablets molded at high pressure tend to be less disintegratable than tablets compressed at low pressure using the binding force of powder, and contain a high concentration of powder with low binding force such as lactoferrin Tablets inevitably have a problem of poor disintegration.

JP 2007-031403 A JP 2006-083089 A Japanese Patent No. 4278473 Japanese Patent Laid-Open No. 2001-354583 Japanese Patent No. 3183378 International Publication No. 2014/136857 JP 2012-121909 A

  In tableting, a lubricant is blended to suppress tableting troubles. As the lubricant, stearates, sucrose fatty acid esters, glycerin fatty acid esters and the like are used. Generally, sucrose fatty acid esters with low lubrication effect are selected for powders with low binding properties, and lubricants with high lubrication effects such as stearate are used for powders with high binding strength. Agents have been selected. Following this example, a sucrose fatty acid ester has been selected as a lubricant for tablet compositions containing lactoferrin at a high concentration. However, it has been found that tablets containing lactoferrin and sucrose fatty acid ester have good initial disintegration and lactoferrin elution, but the lactoferrin elution decreases with time.

  The present invention has been made in view of the above-mentioned problems. Despite containing lactoferrin at a high concentration, the tablet moldability (no adhesion of tableting powder to mortar and board surface at the time of tableting: hereinafter abbreviated as adhesion) It is an object of the present invention to provide a tablet composition containing lactoferrin, which is excellent in disintegration and dissolution, and has good disintegration and dissolution even after long-term storage.

  As a result of intensive studies to achieve the above object, the present inventors have used stearate as a lubricant for a tablet composition containing lactoferrin at a high concentration. Contrary to the characteristics of stearates that delay disintegration by action, the disintegration and lactoferrin elution are good without decreasing the initial disintegration and without delaying the disintegration time even after long-term storage. The headline and the present invention were completed.

That is, the present invention provides the following tablet composition and a method for improving the disintegration and dissolution properties of the tablet composition.
[1]. (A) 30 to 70 wt% of lactoferrin, (B) .12-1.0 wt% stearic acid salt, and (C) maltitol, a sugar alcohol selected from isomalt and erythritol seen including, (B) / (A) × 100 The blending mass ratio of the component (A) and the component (B) represented by 100 is 0.4 to 1.6, and the component (C) represented by (C) / (A) (A) The tablet composition whose compounding mass ratio with a component is 0.3-0.8 .
[2]. The tablet composition according to [1], wherein the (B) stearate is calcium stearate or magnesium stearate.
[3]. (C) The tablet composition as described in [1] or [2] whose compounding quantity is 15-50 mass%.
[4]. (A) A method for improving disintegration of a tablet composition containing 30 to 70% by mass of lactoferrin and dissolution of the lactoferrin, wherein (B) 0.12 to 1.0% by mass of the tablet composition The blending mass ratio of the (A) component and the (B) component represented by (B) / (A) × 100 is 0 for the sugar alcohol selected from stearates and (C) maltitol, isomalt and erythritol. .4 to 1.6, and the blending mass ratio of the component (C) and the component (A) represented by (C) / (A) is 0.3 to 0.8. A method for improving disintegration and dissolution of a tablet composition.
[5]. A tablet composition comprising (A) 30% by mass or more of lactoferrin and (B1) 0.12-1.0% by mass of calcium stearate.
[6]. The tablet composition according to [ 5 ], wherein the blending mass ratio of the component (A) and the component (B1) represented by (B1) / (A) × 100 is 0.25 to 3 .
[7]. (C) The tablet composition according to [5] or [6], further comprising 5 % by mass or more of sugar or sugar alcohol.
[8]. (A) A method for improving the disintegration of a tablet composition containing 30% by mass or more of lactoferrin and the dissolution property of the lactoferrin, wherein (B1) 0.12-1.0% by mass of stearin A method for improving disintegration and dissolution properties of a tablet composition, characterized by comprising calcium acid.

  According to the present invention, even a tablet composition containing lactoferrin at high concentration has excellent tablet moldability, good disintegration and dissolution, and good disintegration and dissolution after long-term storage. Certain tablet compositions can be provided.

[(A) Lactoferrin]
The tablet composition of the present invention comprises (A) 30% by mass or more of lactoferrin. Lactoferrin is a functional ingredient that has a high fat reducing effect. (A) As for the minimum of the compounding quantity of a lactoferrin, 32 mass% is preferable in a composition, and 35 mass% is more preferable. On the other hand, the upper limit is not particularly limited and is preferably 99.88% by mass, but from the viewpoint of moldability when tableting, 80% by mass is preferable, 70% by mass is more preferable, and 50% by mass is even more preferable. .

  As lactoferrin, from colostrum, transitional milk, normal milk, end milk, etc. of mammals (eg, humans, cows, sheep, goats, horses, etc.) or processed products of these milks, skim milk, whey, etc. Examples thereof include lactoferrin separated by (for example, ion exchange chromatography), lactoferrin produced from plants (tomato, rice, tobacco), lactoferrin obtained by gene recombination, and the like. These can be used individually by 1 type or in combination of 2 or more types. Lactoferrin is preferably derived from bovine. In addition, a lactoferrin may use a commercial item and may prepare and use it by a well-known method. As the lactoferrin, a product produced by an ordinary production method can be used.

  When lactoferrin is a lyophilized product, its shape may be regular or irregular, and its average particle size is 40 to 300 μm, preferably 50 to 300 μm, more preferably 80 to 250 μm. When the average particle size is 40 μm or more, the disintegration property of the tablet and the dissolution property of lactoferrin are good, and when it is 300 μm or less, the friability is low. In the present invention, the average particle diameter refers to a 50% diameter (median diameter, volume basis) in a laser diffraction / scattering particle size distribution. In the distribution, the ratio (mass%) of what passes through a 63 μm mesh (235 mesh) is preferably 60% by mass or less, more preferably 50% by mass or less, still more preferably 30% by mass or less, and 20% by mass. % Or less is most preferable.

[(B) stearate]
In the tablet composition of the present invention, (B) stearate functions as a lubricant. When the tablet composition of the present invention contains (B) stearate, a decrease in dissolution properties over time is suppressed, and dissolution properties are good even after long-term storage.

  (B) The stearate is not particularly limited as long as it is a salt of stearic acid and a monovalent or divalent metal, but calcium stearate, magnesium stearate and the like are preferable, and calcium stearate is more preferable.

  (B) The minimum of the compounding quantity of a stearate is 0.12 mass%, 0.14 mass% is preferable, and 0.15 mass% is more preferable. On the other hand, the upper limit is 1.0% by mass, preferably 0.8% by mass, and more preferably 0.6% by mass. (B) If the amount of stearate is at least the lower limit, the lubrication effect and moldability are good, and if it is below the upper limit, the disintegration and dissolution properties are good without causing a disintegration delay. .

  The blending mass ratio of the component (A) and the component (B) represented by (B) / (A) × 100 is preferably 0.25 to 3, and more preferably 0.4 to 1.6. By setting it as the above lower limit or more, disintegration, dissolution, and tablet moldability are improved without causing disintegration delay. By setting it to the upper limit or less, the initial disintegration property and dissolution property become better.

[(C) sugar or sugar alcohol]
The tablet composition of the present invention may contain sugar or sugar alcohol as component (C). (C) Sugar or sugar alcohol functions as an excipient. (C) The elution property of lactoferrin can be further improved by containing sugar or sugar alcohol.

  The sugar is not particularly limited and may be any of monosaccharide, disaccharide, oligosaccharide, and polysaccharide. In particular, lactose, starch (corn starch, potato starch, etc.), fructose, glucose, sucrose, sucrose, maltose, anhydrous lactose, dextran and the like are preferable, among which water-soluble components are preferable, and lactose, sucrose and the like are more preferable.

  Examples of the sugar alcohol include isomalt, maltitol, erythritol, sorbitol, xylitol and the like. Of these, isomalt, maltitol, and erythritol are preferable, and maltitol is more preferable.

  (C) As for the minimum of the compounding quantity of sugar or sugar alcohol, 5 mass% is preferred in a composition, 10 mass% is more preferred, and 15 mass% is still more preferred. On the other hand, the upper limit is preferably 69.88% by mass, more preferably 50% by mass, and still more preferably 40% by mass. (C) If the amount of sugar or sugar alcohol is at least the lower limit, the disintegration and dissolution properties are good, and if it is below the upper limit, the tablet moldability is good.

  The blending mass ratio of the component (C) represented by (C) / (A) and the component (A) is preferably 0.15 to 1.0, and more preferably 0.3 to 0.8. By setting it to the above lower limit or more, disintegration, dissolution and tablet moldability are improved without causing disintegration delay. By setting it to the upper limit or less, the decay property is improved without causing the decay delay.

[Other ingredients]
The tablet composition of the present invention can be used in an appropriate amount by singly or in combination of two or more other components as long as the effects of the present invention are not impaired. Other components include, for example, a functional component other than the component (A), a lubricant other than the component (B), an excipient other than the component (C), an oily component, a disintegrant, a fluidizing agent, and a binder. , Medicinal ingredients, plant extracts, pigments, fragrances and the like. Specifically, the following components can be mentioned. In addition, the component which has the overlapping role is described redundantly.

  Examples of functional components other than the component (A) include Lactobacillus brevis, which is a type of lactic acid bacterium. The cells may be live or dead. As the Lactobacillus brevis cells, commercially available products or those obtained by a known culture method can be used.

  The amount of Lactobacillus brevis is preferably 100 million or more, more preferably 1 billion or more, and even more preferably 10 billion or more if it is a living bacterium per person per day. If it is dead bacteria, 1 billion or more are preferable, 10 billion or more are more preferable, and 18 billion or more are still more preferable. Although both live and dead bacteria are discharged even if they are ingested in large amounts, they are not particularly limited, but they are 10 trillion or less. Within this range, the effects of the present invention can be obtained. For identification of lactic acid bacteria, API 50CHL Biomelieu (manufactured by Japan Biomelieu) is used. For the measurement of the number of viable bacteria, an anaerobic culture is performed using an MRS agar medium, and the grown colonies are counted. In the case of dead bacteria, before the sterilization treatment, the value measured using the MRS agar medium as with the live bacteria is defined as the number of dead bacteria.

  Examples of the functional component other than the component (A) include plant extracts selected from pepper family, ginger family, and solanaceous family having blood flow improving effect. The blood flow improvement effect can be expected by blending the plant extract.

  Specific examples of such plants include pepper (Piper nigrum L.), Hiperu (Piper longum L.), Hiperid (Piper retrofractum Vahl), ginger (Zingiber officinale), and pepper as a solanaceae. (Capsicum annuum). These can be used individually by 1 type or in combination of 2 or more types.

  As the plant extract, commercially available products or those obtained by a known extraction method can be used. Examples of the solvent used in the extraction method include water; alcohols such as methanol, ethanol, propanol, and butanol; polyhydric alcohols such as propylene glycol and butylene glycol, and the like. These may be used alone or in combination of two or more. Can be used as Various conditions in the extraction method are not particularly limited, but the ratio of the extraction raw material to the extraction solvent is usually in a range of about 1: 2 to 1:50 extraction raw material: extraction solvent = 1: 50 by mass ratio. preferable. The extraction temperature is preferably in the range of 5 to 80 ° C., and is preferably performed by immersing or stirring in the extraction solvent for 1 hour to 1 week. The extraction pH is not particularly limited as long as it is not extremely acidic or alkaline. When the extraction solvent is a non-toxic solvent such as water, ethanol, water / ethanol (hydrous ethanol), the extract may be used as it is, or may be used as a diluent. Further, the extract may be a concentrated extract, which may be formed into a dry powder by freeze-drying or the like, or may be prepared in a paste form. When other solvents are used, it is preferable to distill the solvent and dilute the dried portion with a non-toxic solvent.

  0.01-30 mass% is preferable in a composition, and, as for the compounding quantity of the said plant extract, 0.1-20 mass% is more preferable.

  Lubricants other than the component (B) include gum arabic, cacao butter, carnauba wax, hydrous silicon dioxide, dry aluminum hydroxide gel, glycerin fatty acid ester, magnesium silicate, liquid paraffin, sucrose fatty acid ester, stearyl alcohol, stearin Examples include acids, gelatin, hydroxypropyl cellulose, hydroxypropyl methylcellulose, carboxymethylcellulose, fumaric acid, beeswax sugar and the like. When the tablet composition of the present invention contains a lubricant other than the component (B), the blending amount is preferably 0.01 to 5% by mass.

  As excipients other than the component (C), crystalline cellulose, starch, gum arabic, ethyl cellulose, methyl cellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose, polyvinyl alcohol, crospovidone, croscarmellose sodium, croscarmellose calcium, kaolin, Examples include cocoa butter, silicon dioxide, fine silicon dioxide, citric acid or a salt thereof, stearic acid, polyvinyl pyrrolidone, macrogol, calcium hydrogen phosphate, sodium hydrogen phosphate and the like. When the tablet composition of this invention contains excipient | fillers other than (C) component, the compounding quantity has preferable 1-50 mass%.

  Examples of the oil component include various fatty acid esters, hydrocarbons, higher fatty acids, higher alcohols and the like. Examples of the disintegrant include agar, cellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose, carboxymethylcellulose calcium, carboxymethylcellulose sodium, and other cellulose derivatives, starch or derivatives thereof. Examples of the fluidizing agent include finely divided silicon dioxide. Examples of the binder include hydroxypropyl cellulose, methyl cellulose, ethyl cellulose, carboxymethyl cellulose, gelatin, vinyl pyrrolidone, and partially pregelatinized starch. Examples of the medicinal components include carotenoid substances (α-carotene, β-carotene, γ-carotene, lycopene, lutein, astaxanthin, zeaxanthin, etc.), coenzyme Q10, vitamin E, tocotrienol, DHA, EPA, and the like.

  When the tablet composition of the present invention contains the oil component, the blending amount is preferably 0.01 to 25% by mass in the composition, and when the disintegrant is contained, the blending amount is 0.01 to 50 in the composition. % By weight, when the fluidizing agent is included, the blending amount is preferably 0.01 to 5% by weight in the composition, and when the binder is included, the blending amount is 0.01 to 50% by weight in the composition. % Is preferable, and when the medicinal component is included, the blending amount is preferably 0.01 to 50% by mass in the composition.

  The tablet composition of the present invention is not particularly limited, such as normal oral, that is, a swallowable tablet, orally disintegrating tablet, but in the case of a normal swallowable tablet, it is preferably an enteric preparation. For enteric preparations, shellac, water-soluble shellac, zein, hydroxymethylcellulose phthalate, hydroxypropylmethylcellulose, hydroxypropylcellulose, carboxymethylcellulose, cellulose acetate phthalate, methacrylic acid copolymer, ethylcellulose, aminoalkyl methacrylate copolymer, beer Enteric components such as yeast cell wall (for example, brand name yeast wrap), tapioca starch, gelatin, pectin, fats and oils such as hydrogenated oil, and the like may be blended. In the present invention, whether or not it is an enteric preparation depends on the 16th revision Japanese Pharmacopoeia / Disintegration Test Method.

  The tablet composition of the present invention can be obtained by mixing lactoferrin and optional components and tableting. Molding conditions such as tableting pressure vary depending on the tableting machine, the type and amount of ingredients, the tablet diameter, etc., but are adjusted as appropriate in consideration of disintegration properties, tablet strength, oral disintegration rate, and the like. When making an enteric preparation, the uncoated tablet is coated with the enteric component. The amount of the enteric component is preferably 0.1 to 20% by mass, more preferably 0.5 to 10% by mass with respect to the uncoated tablet. In addition, glycerin, alginic acid or a salt thereof, talc, and fine silicon dioxide may be coated.

  Although the magnitude | size of the tablet composition of this invention is not specifically limited, About 5-12 mm in diameter is preferable, 200-400 mg per tablet is preferable, and 250-350 mg is more preferable. In the case of not an orally disintegrating tablet, that is, an oral type tablet, the tablet hardness is preferably 5 to 30 kgf, more preferably 8 to 30 kgf. In the case of an orally disintegrating tablet, 3 to 20 kgf is preferable, and 5 to 15 kgf is more preferable. In addition, tablet hardness can be measured in accordance with a conventional method.

  The present invention is a method for improving the disintegration of a tablet composition containing 30% by mass or more of lactoferrin and the dissolution property of the lactoferrin, wherein 0.12 to 1.0% by mass of stearin is added to the tablet composition. Disclosed is a method for improving the disintegration and dissolution properties of a tablet composition, which comprises adding an acid salt. Suitable components, amounts, etc. are the same as above.

EXAMPLES Hereinafter, although an Example and a comparative example are shown and this invention is demonstrated concretely, this invention is not limited to the following Example. In addition, the used raw material is as follows.
・ Lactoferrin: manufactured by Morinaga Milk Industry Co., Ltd., lactoferrin MLF-FG (median diameter: 80 μm)
・ Hihatsu extract: manufactured by Maruzen Pharmaceutical Co., Ltd., Tie2 hihatsu extract powder MF
・ Crystalline cellulose: Asahi Kasei Chemicals Corporation, Theolas UF-F711
-Maltitol: Powdered maltitol G-3 manufactured by Mitsubishi Corporation Foodtech
・ Isomalto: Freund Sangyo Co., Ltd., Isomalt Granule ・ Erythritol: Micro Foods Japan Co., Ltd., Erythritol Granules ・ Sorbitol: Mitsubishi Corporation Food Tech Co., Ltd. , Xylit / lactose: manufactured by Freund Sangyo Co., Ltd., lactose granulated carboxymethylcellulose calcium: manufactured by Nichirin Chemical Industries, ECG-FA
・ Fine silicon dioxide: DSL Japan Co., Ltd., Carplex FPS-500
Silopage 720, manufactured by Fuji Silysia Chemical Ltd.
・ Calcium stearate: manufactured by Taihei Chemical Industry Co., Ltd., calcium stearate ・ Magnesium stearate: manufactured by Taihei Chemical Industrial Co., Ltd., calcium stearate ・ sucrose fatty acid ester: manufactured by Mitsubishi Chemical Foods Co., Ltd.
・ Glycerin fatty acid ester: Sakamoto Yakuhin Kogyo Co., Ltd., SY Glister, Labre Bacteria: Labre Soken Co., Ltd., Nano-type Labre bacterium (6 billion / 10 mg)
・ Hydroxypropyl methylcellulose: Metrows, manufactured by Shin-Etsu Chemical Co., Ltd., SE-06
・ Glycerin: Sakamoto Yakuhin Kogyo Co., Ltd., food additive glycerin ・ Sodium alginate: Kimika Co., Ltd., Kimika Algin IL-2
・ Talc: Kihara Kasei Co., Ltd., Lisblanc

[Examples 1 to 23, Comparative Examples 1 to 6, Reference Example 1]
[1] Preparation of tablets Each raw material described in Tables 1 to 4 below was weighed and mixed, and tableted using a rotary tableting machine so that the tablet hardness was 8 to 15 kgf or more. Subsequently, the obtained uncoated tablet was coated using a pan rotary coating machine. In addition, the coating agent used the composition described in the following Tables 1-3. The tablet shape was a two-stage R tablet (R1 = 3.6 mm, R2 = 10.5 mm, H = 1.5 mm).

[2] Disintegration test Regarding the tablets immediately after production (initial stage) and the tablets filled in plastic bottles and stored for 4 months in a constant temperature bath at 40 ° C. and 75% RH, the 16th revision Japanese Pharmacopoeia The disintegration test was conducted according to the disintegration test method for the tablets. The disintegration time (minutes) of the tablets was measured, an average value of 6 measurements was calculated, and disintegration was evaluated according to the following evaluation criteria. The results are shown in Tables 1-3.
Collapse time less than 40 minutes: ◎
Collapse time 40 minutes or more and less than 50 minutes: ○
Collapse time 50 minutes or more and less than 60 minutes: △
Collapse time 60 minutes or more: ×

[3] Dissolution test Immediately after manufacturing (initial) tablets and tablets filled in plastic bottles and stored in a constant temperature bath at 40 ° C. and 75% RH for 4 months, the 16th revised Japanese Pharmacopoeia A dissolution test was performed according to the dissolution test method for the tablets contained, and the dissolution rate (%) of lactoferrin was measured. Specifically, the second solution of dissolution test (pH about 6.8) was used as a test solution, and the test was performed at 50 revolutions per minute by the paddle method. One tablet was used and 900 mL of the second dissolution test solution was used. The eluate 2 hours after the start of the dissolution test was taken, and the eluted lactoferrin was quantified by the HPLC method to calculate the dissolution rate. The measurement was performed three times, the average value of the dissolution rate was calculated, and the dissolution property was evaluated according to the following evaluation criteria. The results are shown in Tables 1-3.
Elution rate after 2 hours 80% or more: ◎
Elution rate after 2 hours 70% or more and less than 80%: ○
Elution rate after 2 hours 60% or more and less than 70%: Δ
Less than 60% elution rate after 2 hours: x

[4] Method for quantifying lactoferrin 75 mg of standard lactoferrin was placed in a 50 mL volumetric flask and diluted with a dissolution test solution. Standard solutions of 1/5, 1/20, and 1/50 of this standard solution are prepared, each standard solution is measured by high performance liquid chromatography (HPLC), the lactoferrin peak area of each standard solution is obtained, and a calibration curve is obtained. It was created.
The eluate 2 hours after the start of the dissolution test was measured by HPLC, and the lactoferrin peak area was determined. The lactoferrin concentration in each sample solution was calculated | required using the analytical curve, and the lactoferrin content was calculated | required.
<HPLC measurement conditions>
Detector: UV absorption photometer (measurement wavelength: 280 nm)
・ Column: Shodex Asahipak C4P-50 4D (Polymer type reverse phase chromatography column)
Butyl group (5μm × 4.6 × 150)
Shodex Asahipak C4P-50 4D: Guard column Column temperature 35 ° C
Introduction amount: 20 μL
Flow rate: 0.8 mL / min
Moving bed A: acetonitrile / sodium chloride solution (3 → 100) mixed solution (10:90) containing 0.03% by mass of trifluoroacetic acid
-Moving bed B: A mixture of acetonitrile / sodium chloride solution (3 → 100) containing 0.03% by mass of trifluoroacetic acid (50:50)
Concentration gradient: A linear concentration gradient from A: B (50:50) to (0: 100) was performed for 30 minutes.

[5] Adhesiveness (tablet moldability) test Continuous tableting for 2 hours was performed, and the mortar and board surface for tableting were observed and evaluated according to the following evaluation criteria. The results are shown in Tables 1-3.
○: No adhesion of tableting powder was observed on the mortar and board. ×: Adhesion of tableting powder was observed on the mortar and board.

The evaluation criteria for the comprehensive judgment are as follows.
◯: All of disintegration, dissolution and adhesion evaluation are Δ˜ ◎
×: Either disintegration, dissolution or adhesion evaluation ×

＊比較例１，２，６、参考例１は（Ｂ’）／（Ａ）×１００

* Comparative Examples 1, 2, 6 and Reference Example 1 are (B ′) / (A) × 100

Claims (8)

(A) 30 to 70 wt% of lactoferrin, (B) .12-1.0 wt% stearic acid salt, and (C) maltitol, a sugar alcohol selected from isomalt and erythritol seen including, (B) / (A) × 100 The blending mass ratio of the component (A) and the component (B) represented by 100 is 0.4 to 1.6, and the component (C) represented by (C) / (A) (A) The tablet composition whose compounding mass ratio with a component is 0.3-0.8 .   The tablet composition according to claim 1, wherein the (B) stearate is calcium stearate or magnesium stearate. The tablet composition according to claim 1 or 2, wherein the amount of component (C) is 15 to 50% by mass. (A) A method for improving disintegration of a tablet composition containing 30 to 70% by mass of lactoferrin and dissolution of the lactoferrin, wherein (B) 0.12 to 1.0% by mass of the tablet composition The blending mass ratio of the (A) component and the (B) component represented by (B) / (A) × 100 is 0 for the sugar alcohol selected from stearates and (C) maltitol, isomalt and erythritol. .4 to 1.6, and the blending mass ratio of the component (C) and the component (A) represented by (C) / (A) is 0.3 to 0.8. A method for improving disintegration and dissolution of a tablet composition. A tablet composition comprising (A) 30% by mass or more of lactoferrin and (B1) 0.12-1.0% by mass of calcium stearate. The tablet composition according to claim 5 , wherein the blending mass ratio of the component (A) and the component (B1) represented by (B1) / (A) x 100 is 0.25 to 3 . Furthermore, (C) The tablet composition of Claim 5 or 6 which contains 5 mass% or more of sugar or sugar alcohol. (A) A method for improving the disintegration of a tablet composition containing 30% by mass or more of lactoferrin and the dissolution property of the lactoferrin, wherein (B1) 0.12-1.0% by mass of stearin A method for improving disintegration and dissolution properties of a tablet composition, characterized by comprising calcium acid.