TWI761696B - Solid formulation including celecoxib and method for manufacturing the same - Google Patents

Abstract

The present invention relates to a solid formulation including celecoxib and method for manufacturing the same. Based on a total mass of the solid formulation as 100 mass %, the solid formulation is characterized by 1 mass % to 15 mass % of a surfactant and 1 mass % to 5 mass % of a binder without disintegrants therein. Moreover, the method for manufacturing the solid formulation including celecoxib is characterized that the solid formulation is made by wet granulation method.

Description

Solid preparations containing Celecoxib Agent and method of making the same

The present invention relates to a solid preparation containing Celecoxib and a manufacturing method thereof, in particular to a solid preparation containing Celecoxib which can improve the solubility of Celecoxib without adding a disintegrating agent and its manufacturing method.

Medicines exist in various shapes, and solid preparations such as lozenges and capsules or liquid preparations such as injections and sprays are generally known. Among them, the solid preparation is suitable for oral administration and has the advantages of excellent stability and is widely used. In order to exert the medicinal effect of a solid preparation, it is necessary to disintegrate and disperse in the digestive juice of the stomach or intestine, and to dissolve the medicinal ingredient contained therein. However, in solid preparations, due to the influence of drugs or additives, it may not be able to disintegrate well in the digestive juice. In this case, the medicinal components in the digestive organs are not completely dissolved and their medicinal effects cannot be fully obtained. .

In order to improve the disintegration of solid preparations in digestive juice, one of the methods is to add disintegrating agents. The disintegrating agent will be affected by moisture and expand its volume, Helps to improve the disintegration of solid preparations in vivo. For medicaments that are still difficult to disintegrate after adding disintegrating agents, use super disintegrating agents with better disintegration properties (such as croscarmellose sodium, crospovidone, low-substituted hydroxypropyl Cellulose (low substituted hydroxypropylcellulose), etc.]. However, the use of disintegrating powders usually has doubts about the shape stability due to its high volume expansion rate, especially when the addition amount is large, the tablet may be prone to cracks, cracks, etc. (for example, refer to Japanese Patent Laid-Open No. 2006-131581).

On the other hand, Celecoxib (4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazole-1-yl]benzenesulfonamide) belongs to the non-steroidal anti-inflammatory analgesic anti-inflammatory drugs; NSAIDs). Celebrex can selectively inhibit cyclooxygenase-2 (COX-2), with specificity, without the common gastrointestinal side effects of NSAIDs. However, Celebrex is a poorly soluble drug and is prone to aggregation. In order to improve the dissolution of Celebrex from solid preparations, various methods have been adopted in the prior art, such as reducing particle size, combining with super disintegrating powder, etc. ( For example, refer to Japanese Patent No. 3563036).

For example, Japanese Patent Publication No. 3563036 has disclosed a formulation containing a disintegrating powder and the results of its disintegration test. However, whether it is a tablet or a solid preparation, there is especially a problem of disintegration. No matter what kind of formulation, the super disintegrating agent of croscarmellose sodium is a necessary ingredient.

In view of this, there is an urgent need to develop a solid preparation of Celebrex and its manufacturing method, so that the solid preparation can also be improved without adding a disintegrating agent. Celebrex dissociation.

After in-depth research, the inventor of the present case found that with a specific content of surfactant and binder, even without adding a disintegrating agent, a solid preparation with excellent dissolution of Celecoxib can be obtained. this invention. That is, the present invention provides the following solid preparation containing xelecosumab and a method for producing the same.

Therefore, one aspect of the present invention is to provide a solid preparation containing Celebrex, characterized in that, taking the total mass of the solid preparation as 100% by mass, the solid preparation comprises 1% to 15% by mass of a surfactant and 1% to 5% by mass of binder and no disintegrating agent.

In one embodiment, the above-mentioned surfactant is an anionic surfactant.

In one embodiment, the anionic surfactant is sodium lauryl sulfate (SLS).

In one embodiment, the above-mentioned binder is a cellulose derivative.

In one embodiment, the above-mentioned cellulose derivative is hydroxypropyl cellulose.

In one embodiment, the above-mentioned solid preparation containing Celebrex further comprises at least one of the group consisting of sugar alcohol and disaccharide.

In one embodiment, the above-mentioned disaccharide is lactose.

In one embodiment, the above-mentioned solid preparation contains 40% by mass to 60% by mass of Celebrex.

In one embodiment, the above-mentioned solid preparation is a lozenge.

In one embodiment, the above-mentioned solid preparation is an orally disintegrating tablet.

Another aspect of the present invention is to provide a method for producing a solid preparation containing Celebrex, which is characterized in that the above-mentioned solid preparation containing Celebrex is produced by a wet granulation method.

In one embodiment, the above-mentioned wet granulation method is a fluidized bed granulation method.

Using the solid preparation containing xilecosubac according to the present invention, even if it does not contain a disintegrating agent, it can quickly disintegrate in the body. Therefore, when the above-mentioned solid preparation containing Celebrex is applied to an oral drug, a good therapeutic effect can be achieved.

All documents cited herein by reference are deemed to be specifically and individually incorporated by reference for each individual document or patent application. If the definition or usage of a term in a citation is inconsistent with or contrary to the definition of the term herein, the definition of the term herein applies and not the definition of the term in the citation.

For the purpose of interpreting the specification, the following definitions will apply, where appropriate, nouns in the singular also include the plural and vice versa. Additional definitions are set forth throughout the detailed description.

Unless the context is inappropriate, "a (a/an)" and "the/said" are defined as "one or more" and include the plural.

The present invention discloses a solid preparation containing Celecoxib, which is characterized in that, taking the total mass of the solid preparation as 100 mass %, the solid preparation comprises 1 to 15 mass % of a surfactant and 1 to 15 mass % of a surfactant. 5% by mass of binder and no disintegrating agent. The solid preparation containing Celebrex of the present invention can achieve excellent disintegration degree in digestive juice even without disintegrating disintegrating agent by adding specific content of surfactant and binder. Therefore, when the above-mentioned solid preparation containing Celebrex is applied to an oral drug, a good therapeutic effect can be achieved. In addition, since the solid preparation containing the above-mentioned Celebrex does not contain a disintegrating powder, the concern about the shape stability can be reduced.

Disintegrating agent refers to an additive added to a solid preparation, which can swell by water absorption, thereby increasing the disintegration degree. Specifically, the disintegrating agent of the present invention can be exemplified as follows: carboxymethyl cellulose (Carmellose), croscarmellose sodium, and carboxymethyl-cellulose calcium , low substituted hydroxypropylcellulose (low substituted hydroxypropylcellulose, L-HPC), crystalline cellulose (crystalline cellulose), crospovidone (crospovidone) and alginic acid (alginic acid). Also, the low-substituted hydroxypropyl cellulose is to replace the hydroxyl group on the glucose constituting the cellulose with a hydroxypropoxy group, and the number of moles substituted by the hydroxypropoxy group at each glucose 1 residue of the hydroxypropyl cellulose is: 0.11~0.39. That is to say, the dried product of low-substituted hydroxypropyl cellulose contains 5.0~16.0% of hydroxypropoxy (Japanese Pharmacopoeia 17th Revised Edition, also Known as the Seventeenth Corrected Japanese Pharmacopoeia).

With regard to the raw material used for the solid preparation containing seletrope of the present invention, the shape of the seletrope powder is not particularly limited. For example, Celebrex powder obtained by pulverizing needle-like crystals can be used, or Celebrex powder obtained by precipitation and then drying can also be used. The pulverization treatment of the above-mentioned Celebrex crystals can be carried out in a known manner using, for example, a mixer and a pulverizer such as a ball mill, a hammer mill, and a jet mill. In addition, the synthesis or precipitation method of the needle-like crystal of Celebrex can also be performed by a conventional method (for example, Japanese Patent Publication No. 3563036).

With regard to the raw material used for the solid preparation containing seletrope of the present invention, the size of the seletrope powder is not particularly limited. From the viewpoint of content uniformity or fluidity in the manufacture of solid preparations, the D ₉₀ of the particle size of the Celebrex powder (the particle size at which the frequency is accumulated at 90%) is preferably 1 to 200 μm, and 5 to 100 μm. 5~50μm is better, and 5~30μm is even better. In addition, the particle size of each fine particle of the Celebrex powder can be determined by a mesh sieving method (JIS K 0069: 1992), a laser diffraction method (JIS Z 8825: 2013), a small hole passing method (Coulter particle size) analytical method, Coulter Counter method), sedimentation method or microscopic method. When measured by mesh sieving method, its particle size is the mesh aperture; when measured by laser diffraction method, its particle size is equivalent to the diameter of spherical particles; when measured by microscopy, its particle size is The diameter is the maximum length of each particle.

There is no particular limitation on the content of the celebrex in the solid preparation containing celebrex according to the present invention. The surfactants and binders of the present invention are formulated in specific amounts, even in solid preparations with a high content of Celebrex In the middle, excellent disintegration can also be achieved. Therefore, based on the total mass of the solid preparation being 100% by mass, the content of the solid preparation containing Celebrex in the present invention is preferably 30% by mass or more, preferably 35% by mass or more, and more than 40% by mass More preferably, 45 mass % or more is still more preferable. In addition, since the necessary excipients can be mixed in a sufficient amount, based on the total mass of the solid preparation of 100% by mass, the content of Celebrex is preferably 70% by mass or less, preferably 65% by mass or less, and 60% by mass. The mass % or less is more preferable.

The raw material of the surfactant suitable for the solid preparation containing Celebrex of the present invention can be a substance that can be used as a medicine, and is not particularly limited. The above-mentioned surfactant can be, for example, anionic surfactants such as sodium lauryl sulfate (SLS); polyoxyethylene sorbitan (for example, Tween, registered trademark) 20, 40, 60, 80, or 85 nonionic surfactants; and other sorbitols [eg, Span (registered trademark) 20, 40, 60, 80, or 85]. The above-mentioned surfactants may be used alone or in combination of two or more. The surfactant used in the present invention is preferably an anionic surfactant, and preferably SLS.

The binder suitable for the solid preparation containing Celebrex of the present invention can be a substance that can be used as a medicine, and is not particularly limited. The above-mentioned binders can be, for example, cellulose derivatives, polyvinylpyrrolidone, gelatin, cold days, sodium alginate, partially saponified polyvinyl alcohol, pullulan, dextrin ), chitonsan gum, gum arabic powder, etc. Cellulose derivatives For example, methylcellulose, hydroxyethyl cellulose, hydroxypropylcellulose, hypromellose and the like can be used. The above-mentioned binders may be used alone or in combination of two or more. The binder used in the present invention is preferably a cellulose derivative, but preferably hydroxypropyl cellulose. In addition, hydroxypropyl cellulose replaces the hydroxyl groups on glucose constituting cellulose with hydroxypropoxy groups, and the number of moles substituted by hydroxypropoxy groups at each glucose 1 residue of hydroxypropyl cellulose is 53.4~ 80.5%. In other words, the dried product of hydroxypropyl cellulose contains 53.4 to 80.5% of hydroxypropoxy groups (Japanese Pharmacopoeia, 17th revised edition).

Hydroxypropyl cellulose can be classified according to viscosity. The viscosity of the hydroxypropyl cellulose used in the present invention is not particularly limited, but it ranges from 2 to 400 mPa. s is better, and 2~10mPa. s is better. In addition, the viscosity of hydroxypropyl cellulose refers to the viscosity of its 2 mass % aqueous solution at 20°C, which is based on the "General Test Method Annual Measurement Method 2 Method 2 Rotational Viscometer Method" of the 17th revised edition of the Japanese Pharmacopoeia. , using a rotational viscometer.

Based on the total mass of the solid preparation being 100% by mass, the solid preparation containing Celebrex according to the present invention may contain 1-15% by mass of the surfactant and 1-5% by mass of the binder. Based on the total mass of the solid preparation being 100% by mass, the content of the aforementioned surfactant is preferably 1-12% by mass, preferably 1-10% by mass, more preferably 1-8% by mass, and more preferably 2-8% by mass . Based on the total mass of the solid preparation being 100% by mass, the content of the aforementioned binder is preferably 2-5% by mass, and more preferably 2-4% by mass.

The solid preparation containing Celebrex according to the present invention, in addition to containing Celebrex In addition to Lexicol, surfactants and binders, additives can also be used, and the additives can be used in various appropriate combinations and contain the necessary content. The aforementioned additives do not contain disintegrating agents, and are not particularly limited as long as they do not impair the effects of the present invention. The aforementioned additives may be, for example, excipients, lubricants, flavors, colorants, fragrances, pH adjusters, plasticizers, and the like.

The above-mentioned excipients can be starches such as corn starch, potato starch, wheat starch, rice starch, partially pregelatinized starch, hydroxypropyl starch, etc.; glucose (glucose), galactose (galactose), mannose (mannose), fructose (fructose) and other monosaccharides; lactose (lactose), sucrose (sucrose, also known as white sugar, refined white sugar, powder sugar), maltose (maltose), trehalose (trehalose) and other disaccharides; dextran (dextran), Dextrin (dextrin) and other polysaccharides; D-mannitol (D-mannitol), xylitol (xylitol), sorbitol (sorbitol), erythritol (erythritol) and other sugar alcohols; glycerol fatty acid ester (glycerin fatty acid ester), magnesium metasilicate aluminate, synthetic hydrotalcite, anhydrous calcium phosphate, precipitated calcium carbonate, calcium silicate ), calcium hydrogen phosphate hydrate (calcium hydrogen phosphate hydrate), sodium bicarbonate (sodium bicarbonate) and other inorganic salts. The excipients contained in the solid preparation containing xilexabin according to the present invention are preferably at least one selected from the group consisting of sugar alcohols and disaccharides, disaccharides are more preferred, and lactose is more preferred. Lactose also has acid anhydride and hydrate, but hydrate is preferred.

With regard to the content of the solid preparation containing xilexabin of the present invention The content of the excipient is not particularly limited. For example, based on the total mass of the solid preparation being 100% by mass, the content of the aforementioned excipients is preferably 10-55% by mass, preferably 20-50% by mass, and more preferably 25-45% by mass.

The lubricant can be stearic acid such as stearic acid, sodium stearyl fumarate, magnesium stearate, calcium stearate, etc.; sucrose fatty acid sucrose fatty acid ester, polyethylene glycol, light anhydrous silicic acid, hydrogenated oil, glycerin fatty acid ester, talc ( talc) etc., but sodium stearate fumarate, magnesium stearate, calcium stearate and sucrose fatty acid ester are preferred. The above-mentioned lubricants may be used alone or in combination of two or more. The lubricant used in the present invention is preferably stearic acid, and preferably magnesium stearate.

The content of the lubricant used in the present invention is not particularly limited. For example, based on the total mass of the solid preparation being 100 mass %, the content of the aforementioned lubricant is preferably 0.5 to 5 mass %, and more preferably 1 to 5 mass %.

The above-mentioned flavoring agents may be, for example, aspartame, stevia, saccharin sodium, glycyrrhizin dipotassium, thaumatin, acesulfame potassium potassium), sucralose, etc. The above-mentioned flavoring agents may be used alone or in combination of two or more.

Colorants can be, for example, Edible Blue No. 1, Edible Blue No. 2, Edible Yellow No. 4, Edible Yellow No. 5, Edible Red No. 2, Edible Red No. 3, Edible Red No. 102, Edible Blue No. 1 Aluminum Lake, Edible Blue No. 2 Aluminum Lake, Edible Yellow No. 4 Aluminum Lake, Edible Yellow No. 5 Aluminum Lake, Edible Red No. 2 Aluminum Lake , Edible Red No. 3 Aluminum Lily, Edible Red No. 102 Aluminum Liquor, Cesium Dioxide (Red), Titanium Oxide, Yellow Iron Oxide, Orange Essence, Caramel, Talc , green tea powder, etc. The above-mentioned colorants may be used alone or in combination of two or more.

Spices, mint, lemon scent, Orange Courton, Pineapple flavor, 1-menthol, Black tea micron, etc. The above-mentioned fragrances may be used alone or in combination of two or more.

Acids such as succinic acid, maleic acid, tartaric acid, citric acid, and aspartic acid can be used as pH adjusters; sodium hydroxide ), magnesium oxide (magnesium oxide), silicon dioxide (silicon dioxide), sodium bicarbonate (sodium bicarbonate), L-arginine (L-arginine) and other bases. The above pH adjusters may be used alone or in combination of two or more.

As a plasticizer, triethyl citrate (triethyl citrate), polyethylene glycol (polyethylene glycol), triacetin (triacetin) can be used. The above-mentioned plasticizers may be used alone or in combination of two or more.

The dosage form of the solid preparation containing Celebrex of the present invention is not particularly limited, for example, lozenges, orally disintegrating lozenges, capsules, granules, powders, buccal lozenges and the like can be used. The dosage form of the solid preparation containing celebrex according to the present invention can be particularly aimed at lozenges with disintegration problems or orally disintegrating lozenges. also, If necessary, the above-mentioned solid preparation can be subjected to a film coating process using a commonly used coating base.

The solid preparation containing Celebrex according to the present invention can be produced by using the manufacturing method of general solid preparations except that it contains Celebrex and the content of surfactant and binder is adjusted within a specific range (refer to Japanese Patent Gazette No. 3563036). For example, granules containing Celebrex powder, surfactant, binder and various necessary additives are granulated, and the obtained granules (granules) can be made into solid preparations by conventional preparation process. For example, in the case of a tablet, the aforementioned granules can be prepared by mixing the aforementioned granules with other necessary additives, for example, by tableting using a rotary tablet machine or the like. In the case of capsules, the aforementioned granules can be prepared by filling the capsules with the necessary mixture of other additives. As for the powder, it can be kept as it is, or can be obtained by appropriately carrying out a coating process. Orally disintegrating agents can use commonly known methods, such as the granules and additives of the present invention (excipients, disintegrating agents, etc.), mixed and shaped in the presence or absence of a solvent, and dried if necessary. be made of. The aforementioned mixing step can be performed using a V-type mixer, a universal mixer, a fluidized bed granulator, an octagonal mixer, and the like.

Wet granulation method or dry granulation method can be used for the method of granulating the above-mentioned Celebrex powder into granules. A solid preparation with better disintegration is obtained. The aforementioned wet granulation method can be, for example, extrusion granulation method, which is to extrude the kneaded material containing the drug and the additive from a screen with a fixed aperture, and cut it into particles with an appropriate size for granulation; spraying; Dry granulation method, which uses hot air flow to spray the solution or suspension containing drugs and additives, thereby rapidly drying And granulation; fluid bed granulation method, which is in the hot air flow, spraying atomized binder on the floating powder to granulate; and stirring granulation method, which uses high-speed rotating stirring blades, spraying The binder solution is atomized for granulation. All of the above methods can be used for granulation, but the fluidized bed granulation method is preferred. The fluidized bed granulation method can be performed using a commercially available fluidized bed granulation apparatus. The aforementioned fluid bed granulation device can be, for example, Glatt WSG, FD type (Powerex company) or GRANUREX, FLOW COATER, SPIR-A-FLOW, FLO-5 (machine type, Freund Industrial Co., Ltd.) and the like.

The solid preparation containing Celebrex according to the present invention achieves a therapeutic or preventive effect by inhibiting COX-2, and can be used as a therapeutic drug for various patients (refer to Japanese Patent No. 3563036). The aforementioned patient can be, for example, an inflammatory patient, cancer, Alzheimer's disease, and the like. Inflammatory patients can be arthritis patients, such as chronic rheumatoid arthritis, spondyloarthritis, gouty arthritis, osteoarthritis, systemic lupus erythematosus, and juvenile arthritis; digestive system patients, such as gastritis, ulcerative large intestine Inflammation, irritable bowel syndrome, Crohn's disease, etc.; patients with eye diseases, such as retinitis, conjunctivitis, retinopathy, uveitis, photophobia, etc.; patients with respiratory system, such as asthma, bronchitis, allergic rhinitis, etc.; skin Patients, such as skin diseases, psoriasis, eczema, burns, etc.; patients with infectious diseases, such as viral infections, bacterial infections, etc. Cancer patients can be, for example, gastric cancer, small bowel cancer, duodenal cancer, colorectal cancer, Barrett's esophagus, liver cancer, bladder cancer, pancreatic cancer, ovarian cancer, prostate cancer, uterine cancer, breast cancer, squamous cell carcinoma and basal cell carcinoma Wait.

The dosage of the solid preparation containing xelecosumab of the present invention can be adjusted flexibly according to the content of xelecosumab in the solid preparation. In addition, this The dosage depends on the method of administration, the subject's age, body weight, sex, symptoms, susceptibility to the drug, and the like, but the dosage can be adjusted in time according to the improvement of symptoms. For example, for a patient whose therapeutic effect is obtained by inhibiting COX-2, the dosage of the celebrex in the solid preparation containing celebrex of the present invention can be administered to an adult from about 10 mg to about 1000 mg per day. The frequency of administration is about 1 to 3 times a day, preferably 1 to 2 times.

The following uses several examples, comparative examples and test examples to illustrate the application of the present invention, but it is not intended to limit the present invention. Those with ordinary knowledge in the technical field of the present invention can, without departing from the spirit and scope of the present invention, Make various changes and modifications.

【Example】

Tablets were prepared according to the formula in Table 1 (Tablet A, Tablet B, Tablet C did not contain disintegrating agents), and their dissolving properties were compared with those of commercially available tablets containing Celecox (Celecox tablets, containing 100 mg Xilecoshube) for comparison. In addition, the commercially available Celecox tablet contains 100 mg of Celecox, which is a tablet with a diameter of 8.0 mm and a thickness of 2.7 mm, and its additives contain disintegrating agent (L-HPC), surfactant (SLS), and binder (HPC), Also included are pharmaceutically acceptable carriers and/or excipients.

For tablet A, tablet B and tablet C, tablets with a diameter of 8.0 mm and a tablet thickness of about 2.7 mm can be obtained according to the following process. Briefly, firstly, Celebrex, HPC and SLS were put into water and stirred into a granulation solution. Next, this granulation liquid and a carrier (eg, lactose hydrate) are put into a fluidized bed granulator to obtain granulated and dried granules. After that, granulation is performed and mixed with a lubricant (eg, magnesium stearate), and then tableting is performed using a rotary tablet machine. The preparation of the granulation liquid, fluid bed granulation, drying, classification, granulation, mixing of granules and ingots are well known to those with ordinary knowledge in the technical field to which the present invention pertains, and will not be repeated here.

Dissolution test

The obtained tablet A, tablet B, tablet C and Celecox tablet were put into the first solution of the elution test solution of the Japanese Pharmacopoeia (pH 1.2) added with 0.5% (W/V) polysorbate (polysorbate) 80. ) in the test solution, and the dissociation test was carried out at 50 rpm according to the second method (paddle method) of the dissociation test of the Japanese Pharmacopoeia general test method.

The results of the dissolution test are shown in Table 2. As the result of Table 2, although Table 1 formula Table 1 Tablet A, Tablet B and Tablet C all do not contain disintegrating powder, but according to the Japanese "Bioequivalence Test Guidelines for Pharmaceuticals under Scientific Name", the dissociation similarity (f2 ) calculation, tablet A, tablet B, tablet C and Celecox tablet containing disintegrating agent, all have dissolution similarity (f2>42).

Content Uniformity Test

The content uniformity test of tablet A was carried out in accordance with the "content uniformity test of the preparation uniformity test method" described in the Japanese Pharmacopoeia, 17th revised edition. From the results, the judgment value of tablet A was 0.9%, which was in accordance with the judgment standard (judgment value 15.0% or less).

industry availability

Since the solid preparation containing Celebrex according to the present invention has excellent disintegration property, it can be used as a therapeutic agent for various diseases to achieve therapeutic or preventive effect by inhibiting COX-2.

To sum up, although the present invention takes a pharmaceutical composition with a specific formula, a specific dosage form or a specific evaluation method as an example to describe the solid preparation containing xelecosumab of the present invention and its manufacturing method, the present invention belongs to the technical field Anyone with ordinary knowledge in the present invention can understand that the present invention is not limited to this, and the pharmaceutical composition of the present invention can also be carried out using other dosage forms or other evaluation methods without departing from the spirit and scope of the present invention.

It is confirmed by the above-mentioned several examples that the solid preparation containing Celebrex and its manufacturing method of the present invention has the advantage that by adding specific content of surfactant and binder, even if it does not contain disintegrating agent, it can still improve. The dissolubility of Celebrex in solid preparations can also achieve a good therapeutic effect.

Although the present invention has been disclosed above with several embodiments, it is not intended to limit the present invention. Anyone with ordinary knowledge in the technical field to which the present invention belongs, without departing from the spirit and scope of the present invention, can make various Therefore, the scope of protection of the present invention should be determined by the scope of the appended patent application.

Claims (9)

A solid preparation containing Celecoxib, characterized in that with the total mass of the solid preparation being 100% by mass, the solid preparation comprises 1 to 15% by mass of a surfactant and 1 to 15% by mass. 5 mass % of one binder and no disintegrating agent, the binder is hydroxypropyl cellulose, and the molar number substituted by hydroxypropoxy at each glucose 1 residue of the hydroxypropyl cellulose is 53.4 % to 80.5%. According to the solid preparation containing Celebrex according to item 1 of the patent application scope, wherein the surfactant is an anionic surfactant. According to the solid preparation containing Celebrex according to item 2 of the patent application scope, the anionic surfactant is sodium lauryl sulfate (SLS). The solid preparation containing Celebrex according to item 1 of the patent application scope further comprises at least one of the group consisting of sugar alcohol and disaccharide. According to the 4th item of the patented scope of application, the solid preparation containing Xilexabin, wherein the disaccharide is lactose. According to the solid preparation containing xelecosumab according to item 1 of the scope of the application, wherein the solid preparation comprises 40% by mass to 60% by mass of the xelacoxabie. According to the first item of the patented scope of application, the solid preparation containing Xilexabin, wherein the solid preparation is a lozenge. A method for producing a solid preparation containing Xilexabux, characterized in that a wet granulation method is utilized to produce the invention as described in the No. 1 patent application scope. The solid preparation containing Celebrex according to any one of Items 1 to 7. According to the manufacturing method of the solid preparation containing Celebrex according to item 8 of the patent application scope, wherein the wet granulation method is a fluidized bed granulation method.