KR100434904B1 - Enteric formulations containing stabilized lansoprazole - Google Patents

Abstract

The present invention relates to a solid preparation containing lansoprazole, comprising a core and an enteric coating layer containing lansoprazole as an active ingredient and silicon dioxide as a stabilizer in a ratio of 1: 0.5 to 20 by weight. In the lansoprazole-containing solid preparation according to the present invention, lansoprazole is stably protected from external environment such as moisture, temperature, pH and the like.

Description

Enteric preparations containing stabilized lansoprazole {ENTERIC FORMULATIONS CONTAINING STABILIZED LANSOPRAZOLE}

The present invention relates to a solid preparation containing stabilized lansoprazole, and more particularly, to a lansoprazole comprising a core and an enteric coating layer containing a lansoprazole as an active ingredient and a silicon dioxide as a stabilizer in a ratio of 1: 0.5 to 20% by weight. It relates to one solid formulation.

Lansoprazole represented by the following formula is commercially available as an ulcer treatment agent.

Lansoprazole, a benzimidazole derivative such as omeprazole, is a prodrug that is metabolized to AG-1812 and AG-2000, metabolites of sulfenamides that are active in the acidic environment of gastric parietal ducts. This metabolite binds to the sulfhydryl group of the (H ⁺ / K ⁺ ) ATPase molecule and inactivates the proton pump, thereby preventing the exchange of potassium and hydrogen in the cell and inhibiting gastric acid secretion. Reduction of gastric acid secretion by lansoprazole acts as a negative feedback mechanism to increase plasma gastrin concentration and to increase the pH of the stomach to decrease the secretion and activity of pepsin and to increase the concentration of plasma pecinogen. On the other hand, lansoprazole has an inhibitory effect on Helicobacter pylori in patients with gastric / duodenal ulcer, which is known to reduce gastric acid secretion and increase the concentration and effect of concomitant antibiotics or the direct antimicrobial effect of lansoprazole. have. Lansoprazole also has a protective effect on the gastric mucosa and is drawing attention as a powerful treatment for gastrointestinal ulcers of the next generation.

Lansoprazole, however, has very low stability. It is vulnerable to heat, moisture and light in the solid state and decreases in stability as the pH decreases in aqueous or suspension state.

In formulations such as tablets, capsules, granules, powders, and the like, lansoprazole readily interacts with other compounds in the formulation and is therefore less stable than when alone. Thus, the formulations during the preparation and storage of the formulations discolor or decompose over time and fall in content.

For example, polyvinylpyrrolidone, carboxymethyl cellulose calcium, polyethylene glycol, Pluronic F 68 (polyoxyethylene-polyoxypropylene copolymer) and the like are also compounds which adversely affect the stability of lansoprazole.

Moreover, since lansoprazole is rapidly decomposed in acidic gastric juice, it is usually marketed by enteric skin. These enteric coatings include cellulose acetate phthalate, hydroxypropyl methylcellulose phthalate, hydroxypropyl methylcellulose, hydroxypropyl methylcellulose acetate succinate and eudragit, and these components contain free carboxyl groups in the molecule, It has low compatibility with lansoprazole as an active ingredient and causes a decrease in the content of lansoprazole and light discoloration.

Korean Patent Publication No. 1989 0001546 discloses 2-[[2-pyridyl] methylsulfonyl] benzimidazole or its derivatives having anti-ulcer activity and basic inorganic magnesium salts, basic inorganic calcium salts, or basic inorganic magnesium salts and Disclosed are compositions containing basic inorganic calcium salts and methods of making the same.

Korean Patent Publication No. 0019301 discloses a core by adding one or more highly swellable inorganic materials selected from zeolite, bentonite and high swellable clay to benzimidazole derivatives and mixing them with conventional excipients to prepare the core. Disclosed are compositions prepared by enteric coating with a coating composition obtained by adding at least one high swellable inorganic material selected from zeolite, bentonite and high swellable clay to the enteric coating.

Despite such lansoprazole stabilization techniques, stabilization of lansoprazole is not sufficient, and there is still a need for a technique for stabilizing lansoprazole.

Therefore, the present inventors have conducted a long study on enteric preparations containing stabilized lansoprazole, and when lansoprazole is adsorbed on silicon dioxide when silicon dioxide, a porous material having high adsorption capacity, is mixed at a specific ratio with lansoprazole as a stabilizer, The present invention is found to be protected from the external environment such as moisture, temperature, pH, and pharmaceutical carrier, showing excellent stability, stable in gastric acid, and fast dissolution rate in the intestine, showing a faster and better pharmacological effect. Came to complete.

1 is a graph showing the results of a dissolution accumulation rate comparison experiment according to Test Example 3.

In a first aspect of the present invention, the present invention provides a lansoprazole-containing solid formulation comprising a core and an enteric coating layer comprising lansoprazole as an active ingredient and silicon dioxide as a stabilizer in a ratio of 1: 0.5 to 20% by weight.

The weight ratio of lansoprazole to silicon dioxide is preferably 1: 1 to 10. If the amount of silicon dioxide per 1 part by weight of lansoprazole is less than 0.5 parts by weight of lansoprazole is not completely adsorbed to the porous material has a low stabilizing effect, if more than 20 parts by weight is difficult to formulate difficult to fill and tableting.

Silicon Dioxide is a pharmaceutical excipient in the USP and is commonly used as a lubricant or glidant in the manufacture of pharmaceuticals. When silicon dioxide is used as a lubricant or glidant, it is usually added in small amounts at a ratio of 0.1 to 0.5% by weight of the total weight of the formulation before tableting after preparation of the core material.

The present inventors have long researched a method for stabilizing lansoprazole and have surprisingly found that lansoprazole is stabilized without additional stabilizer when the core is prepared by mixing silicon dioxide with lansoprazole in a specific ratio. Although the precise mechanism by which silicon dioxide stabilizes lansoprazole has not been proven, lansoprazole is adsorbed on silicon dioxide, a porous material with high adsorption capacity, thereby protecting the external environment such as moisture, temperature, pH, and enteric coatings, thereby increasing the stability of lansoprazole. It is assumed to play a role.

A chamber Lloyd 63FP ^TM (Syloid 63FP) silicon oxide is D, for example GRACE DAVISON's used in the solid preparation according to the invention, the chamber Lloyd 72FP ^TM, Lloyd chamber 244FP ^TM or the like.

The solid preparations containing lansoprazole according to the invention may further comprise a pharmaceutically acceptable carrier, for example pharmaceutically acceptable carriers, for example basic agents, excipients, binders, disintegrants, surfactants, antioxidants, Lubricants, colorants, coatings and the like.

The basicizing agent which may be included in the solid preparation according to the present invention is a conventional basicizing agent, preferably an alkali metal or alkaline earth metal such as calcium carbonate, magnesium carbonate, potassium carbonate, lithium carbonate, sodium carbonate, potassium hydrogen carbonate, sodium bicarbonate, or the like. Carbonates and bicarbonates, sodium hydroxide, potassium hydroxide, lithium hydroxide, calcium hydroxide, magnesium hydroxide and the like and hydroxides of alkali or alkaline earth metals and aluminum hydroxide, magnesium silicate, magnesium aluminate, and combinations thereof. The basicizing agent is preferably included in an amount of 0.1 to 50.0% by weight relative to the total weight of the formulation.

Excipients which may be included in the solid preparations according to the invention are conventional excipients, preferably lactose, white sugar, glucose, fructose, corn starch, potato starch, wheat starch, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, di-mannitol , Precipitated calcium carbonate, dextrin and methylcellulose, and combinations thereof. Excipients are preferably included in amounts of 0.1 to 90.0% by weight relative to the total weight of the formulation.

Binders that may be included in the solid preparations according to the present invention are conventional binders such as polyvinylpyrrolidone, hydroxypropylcellulose, microcrystalline cellulose, hydroxypropyl methylcellulose, carboxymethylcellulose, dextrin, gelatin, methylcellulose, hydroxycellulose , Hydroxy methylcellulose, polyvinyl alcohol, and combinations thereof. The binder is preferably included in an amount of 0.1 to 90.0% by weight relative to the total weight of the formulation.

Disintegrants which can be included in the solid preparations according to the invention are conventional disintegrants, preferably starch, sodium starch glycolate, crospovidone, croscarmellose sodium, carboxymethylcellulose calcium, sodium alginate, low-substituted hydroxypropylcellulose , Hydroxypropyl methylcellulose, polyvinylpyrrolidone, and combinations thereof. Disintegrants are preferably included in amounts of 0.1 to 90.0% by weight, based on the total weight of the formulation.

Surfactants that can be included in the solid preparations according to the invention are conventional surfactants, preferably selected from the group consisting of sodium lauryl sulfate, polysorbate (Tween ^TM ), span, and combinations thereof. The surfactant is preferably included in an amount of 0.01 to 30.0% by weight relative to the total weight of the formulation.

Antioxidants that may be included in the solid preparations according to the invention are conventional antioxidants and are preferably selected from the group consisting of sodium ascorbate, sodium sulfite, L-cysteine, and combinations thereof. Antioxidants are preferably included in amounts of 0.1 to 50.0% by weight relative to the total weight of the formulation.

Glidants which can be included in the solid preparations according to the invention are conventional glidants and are preferably selected from the group consisting of magnesium stearate, talc, stearic acid, light silicic anhydride, and combinations thereof. Glidants are preferably included in amounts of 0.01 to 30.0% by weight, based on the total weight of the formulation.

The solid preparation according to the present invention may contain a colorant as necessary, for example, blue 1 aluminum lake, red 40 and the like in an appropriate amount.

The formulation of the solid preparation according to the present invention is preferably a solid preparation for oral administration such as tablets, capsules, granules, powders, pills, dry syrups, and more preferably tablets or capsules.

The route of administration of the solid preparations according to the invention is preferably oral administration.

The coating agent used in the solid preparation according to the present invention is a conventional enteric or sustained release coating agent, for example hydroxypropyl methylcellulose, hydroxymethylcellulose, hydroxypropylcellulose, ethylcellulose, polyoxyethylene glycol, polysorb Bate 80 (Twin 80 ^TM ), diethyl phthalate, cellulose acetate phthalate, hydroxypropyl methylcellulose phthalate, hydroxypropyl methylcellulose acetate succinate, Eudragit (methacrylic acid-acrylic acid copolymer), talc, polywax 6000 , Triethyl citrate, shellac, dichloromethane, triacetin and the like. The coating agent is preferably included in an amount of 0.1 to 50.0% by weight relative to the total weight of the formulation.

The human dose of lansoprazole, an active ingredient of the preparation according to the present invention, is appropriately selected depending on the absorption rate, inactivation rate, excretion rate, age, sex and condition of the patient, severity of disease, etc. It is preferable to administer 30 mg once a day.

In a second aspect of the invention, the invention provides a process for preparing a core after mixing lansoprazole and silicon dioxide in a ratio of 1: 0.5 to 20 and adding a pharmaceutically acceptable carrier thereto, and the enteric coating solution for the core. It provides a method for producing an enteric preparation containing lansoprazole, comprising the step of coating with.

In the process for preparing a lansoprazole-containing medicament according to the present invention, the silicon dioxide is contained in a ratio of preferably 1 to 10 parts by weight with respect to 1 part by weight of lansoprazole.

Hereinafter, the present invention will be described in more detail with reference to Examples. However, this does not limit the scope of the invention.

Example

Example 1

(1) manufacture of uncoated tablets

A pharmaceutical composition having the following composition was prepared by the following method.

Content (% by weight)

Lansoprazole 16.0

Sodium bicarbonate 18.6

Room Lloyd 244FP ^TM 16.0

Sodium Lauryl Sulfate 3.2

Low Substituted Hydroxypropyl Cellulose 16.0

Starch Glycolate Sodium 26.5

Magnesium Stearate 3.7

Total 100.0

After adding lansoprazole and sodium bicarbonate to an aqueous solution of 2% by weight of sodium lauryl sulfate, and mixing the mixture with homogeneous well by adding siloid 244FP ^TM , sufficiently adsorbing and drying at 40 ° C. for 5 hours. Low-substituted hydroxypropyl cellulose and starch glycolate sodium are mixed well with the obtained beads, and then granulated by passing through an 18-mesh sieve using a roller compactor. The granules are mixed well with magnesium stearate again and compressed into tablets.

(2) coating with enteric coating

A coating liquid having the following composition was prepared in the following manner.

First coating liquid

Content (% by weight)

Methylene Chloride 95.0

Diethyl Phthalate 1.0

Hydroxypropyl methylcellulose 4.0

Total 100.0

Second coating liquid

Content (% by weight)

Eudragit L 30D 16.0

Talc 4.0

Polywax 6000 2.0

Purified water 78.0

Total 100.0

Hydroxypropyl methylcellulose, diethyl phthalate was completely dissolved in a methyl chloride solution to prepare a first coating liquid.

Eudragit L 30D, talc, and Polywax 6000 are homogeneously mixed in purified water to prepare a second coating liquid.

The uncoated tablet of (1) was coated with the first coating liquid until the weight of the core was increased by 2% and dried, and then coated with the second coating liquid until the weight of the core was increased by 7%, thereby preparing the enteric tablet. .

Example 2

(1) manufacture of uncoated tablets

A pharmaceutical composition having the following composition was prepared by the following method.

Content (% by weight)

Lansoprazole 13.8

Sodium bicarbonate 16.1

Room Lloyd 72FP ^TM 27.5

Sodium Lauryl Sulfate 2.7

Low Substituted Hydroxypropyl Cellulose 9.2

Lactose 27.5

Magnesium Stearate 3.2

Total 100.0

After adding lansoprazole and sodium bicarbonate to an aqueous solution of 2% by weight of sodium lauryl sulfate, mix the mixture with homogeneous well by adding siloid 72FP ^™ , and dry it at 40 ° C. for 5 hours. Low-substituted hydroxypropyl cellulose and lactose are mixed with the obtained beads and mixed well, and then granulated by passing through an 18 mesh sieve using a roller compactor. The granules are mixed well with magnesium stearate again and compressed into tablets.

(2) coating with enteric coating

A coating liquid having the following composition was prepared in the following manner.

Coating liquid

Content (% by weight)

Hydroxypropyl methylcellulose phthalate 7.0

Talc 0.7

Triethyl Citrate 0.7

Polysorbate 80 0.6

Acetone 88.0

Purified water 3.0

Total 100.0

Hydroxypropyl methylcellulose phthalate, talc, triethyl citrate, and polysorbate 80 are homogeneously swollen in acetone and purified water mixture to prepare a coating solution.

The uncoated tablet of (1) was coated with the coating solution until it increased by 7% of the core weight by the pan coating method to prepare an enteric tablet.

Example 3

(1) manufacture of uncoated tablets

A pharmaceutical composition having the following composition was prepared by the following method.

Content (% by weight)

Lansoprazole 14.0

Sodium bicarbonate 16.0

Room Lloyd 244FP ^TM 9.0

Sodium Lauryl Sulfate 1.0

Microcrystalline Cellulose 17.0

Low Substituted Hydroxypropyl Cellulose 27.0

Hydroxypropylcellulose 1.0

Crospovidone 9.0

Croscarmellose Sodium 5.0

Magnesium Stearate 1.0

Total 100.0

After swelling by adding hydroxypropyl cellulose to an aqueous solution of 2% by weight of sodium lauryl sulfate, lansoprazole, sodium bicarbonate, siloid 244FP ^TM , microcrystalline cellulose, and low-substituted hydroxypropyl cellulose were added, mixed well and homogeneously, and then sufficiently adsorbed. Dry for 5 hours at. The resulting beads are mixed with sodium croscarmellose sodium, crospovidone, and magnesium stearate, mixed well, and then compressed.

(2) coating with enteric coating

A coating liquid having the following composition was prepared in the following manner.

First coating liquid

Content (% by weight)

Methylene Chloride 45.0

Ethanol 45.0

Hydroxypropyl methylcellulose 9.0

Triethyl Citrate 1.0

Total 100.0

Second coating liquid

Content (% by weight)

Hydroxypropyl methylcellulose phthalate 7.0

Talc 0.7

Triethyl Citrate 0.7

Polysorbate 80 0.6

Ethanol 73.0

Purified water 18.0

Total 100.0

Hydroxypropyl methylcellulose and triethyl citrate were completely dissolved in a methylene chloride and ethanol mixture to prepare a first coating solution.

Hydroxypropyl methylcellulose phthalate, talc, triethyl citrate, and polysorbate 80 are homogenously swollen in a mixture of ethanol and purified water to prepare a second coating liquid.

The uncoated tablet of (1) was coated with the first coating liquid until the weight of the core was increased by 2%, and dried, and then coated with the second coating liquid until the weight of the core was increased by 7%, thereby preparing the enteric tablet. .

Example 4

(1) manufacture of uncoated tablets

A pharmaceutical composition having the following composition was prepared by the following method.

Content (% by weight)

Lansoprazole 14.0

Sodium bicarbonate 16.0

Room Lloyd 244FP ^TM 9.0

Polysorbate 80 1.0

Low Substituted Hydroxypropyl Cellulose 44.0

Hydroxypropylcellulose 1.0

Crospovidone 9.0

Croscarmellose Sodium 5.0

Magnesium Stearate 1.0

Total 100.0

Hydroxypropylcellulose was added to a 2% by weight aqueous solution of polysorbate 80, followed by swelling. Then, lansoprazole, sodium bicarbonate, siloid 244FP ^™ , and low-substituted hydroxypropylcellulose were added to the mixture, homogeneously mixed, and sufficiently adsorbed. To dry. The resulting beads are mixed with sodium croscarmellose sodium, crospovidone and magnesium stearate, mixed well, and then compressed.

(2) coating with enteric coating

The uncoated tablet of (1) was coated with the first coating liquid prepared in Example 3 (2) until the weight of the core was increased by 2% and dried, and then the second coating liquid prepared in Example 3 (2) was dried. Enteric tablets were prepared by coating until the weight of the core was increased by 7%.

Example 5

(1) Preparation of Granules

A capsule having the following composition was prepared in the following manner.

Content (% by weight)

Lansoprazole 25.4

Room Lloyd 244FP ^TM 17.0

Low Substituted Hydroxypropyl Cellulose 50.9

Hydroxypropyl cellulose 2.5

Crospovidone 4.2

Purified water

Total 100.0

After dissolving low-substituted hydroxypropyl cellulose and hydroxypropyl cellulose in purified water to prepare a binding nucleus, lansoprazole, siloid 244FP ^TM and crospovidone were added to a mixed phase to be combined and granules were prepared using an extruded granulator. Spherical granules are produced by a granulator.

(2) Filling coating and capsule with enteric coating

The prepared spherical granules were coated with the first coating liquid prepared in Example 3 (2) until the weight of the core was increased by 2% and dried, and then the second coating liquid prepared in Example 3 (2) was dried. Enteric coating was applied until the weight of the core was increased by 7%, and the capsules were filled to prepare an enteric capsule.

Comparative Example 1

(1) manufacture of uncoated tablets

A pharmaceutical composition having the following composition was prepared by the following method.

Content (% by weight)

Lansoprazole 19.0

Sodium bicarbonate 22.1

Sodium Lauryl Sulfate 3.8

Low Substituted Hydroxypropyl Cellulose 12.7

Lactose 38.0

Magnesium Stearate 4.4

Total 100.0

Lansoprazole and sodium bicarbonate were added to a 2% by weight aqueous solution of sodium lauryl sulfate, mixed and dried at 40 ° C. for 5 hours. Low-substituted hydroxypropyl cellulose and lactose are mixed and mixed well in the obtained dried product, and then granulated by passing through an 18-mesh sieve using a roller compactor. The granules are mixed well with magnesium stearate again and compressed into tablets.

(2) coating with enteric coating

A coating liquid having the following composition was prepared in the following manner.

First coating liquid

Content (% by weight)

Methylene Chloride 45.0

Ethanol 45.0

Hydroxypropyl methylcellulose 9.0

Triethyl Citrate 1.0

Total 100.0

Second coating liquid

Content (% by weight)

Hydroxypropyl methylcellulose phthalate 7.0

Talc 0.7

Triethyl Citrate 0.7

Polysorbate 80 0.6

Ethanol 73.0

Purified water 18.0

Total 100.0

Hydroxypropyl methylcellulose and triethyl citrate were completely dissolved in a methylene chloride and ethanol mixture to prepare a first coating solution. Hydroxypropyl methylcellulose phthalate, talc, triethyl citrate, and polysorbate 80 are homogenously swollen in a mixture of ethanol and purified water to prepare a second coating liquid.

The uncoated tablet prepared in (1) was coated with a first coating liquid until the weight of the core was increased by 2% and dried, and then coated with a second coating liquid until the weight of the core was increased by 7%. Prepared.

Test Example 1

Stability (appearance, acid resistance and content change) experiment

After changing the enteric tablets according to Example 3 for 4 months at 40 degrees Celsius, 75% relative humidity, changes in appearance were observed. In addition, the content per tablet was quantified using high performance liquid chromatography. In addition, after dissolution test in artificial gastric juice for 2 hours according to the dissolution test method of the Korean Pharmacopoeia, the external appearance of the tablet was observed to evaluate the acid resistance. The results are as shown in Table 1 below.

Table 1

Results of stability (appearance, acid resistance and content change)

storage duration Immediately after manufacture 1 month 2 months 4 months Exterior maroon maroon maroon maroon Acid resistance No change No change No change No change content(%) 101.5 102.9 101.9 101.6

As can be seen from Table 1, the enteric tablet according to Example 3 was found to have no change in appearance for 4 months when stored by the usual preservation method, and the active ingredient content was also very stable. Moreover, even after 4 months of storage, there was no change in acid resistance characteristics.

Test Example 2

Experimental Stability (Appearance, Content Change) with or without Silicon Dioxide

The enteric tablets according to Example 4 and the enteric tablets according to Comparative Example 1 were stored for 4 weeks at 40 degrees Celsius and 75% relative humidity, and then the appearance changes were observed. The results are as shown in Table 2 below.

TABLE 2

Results of stability (appearance, content change) with or without silicon dioxide

Example 4 Comparative Example 1 Immediately after manufacture 1 week 4 Weeks Immediately after manufacture 1 week 4 Weeks Exterior maroon maroon maroon White Pale purple Dark purple content(%) 101.0 100.0 100.5 100 89.5 78.5

As can be seen from Table 2, the enteric tablet according to Example 4 with the addition of silicon dioxide as a stabilizer was more stable in appearance and content compared to the enteric tablet according to Comparative Example 1 without the addition of silicon dioxide.

Test Example 3

Dissolution Accumulation Rate Comparison Experiment

Enteric tablet according to Example 3 of the dissolution test method of the Korean Pharmacopoeia, Cheil Pharm Lanston ^™ capsule of Comparative Example 2 (components: lansoprazole, sugas pears, corn starch, white sugar , hydroxypropyl cellulose, low-substituted hydride Roxypropyl cellulose, ethyl methacrylate acrylic copolymer, polyethylene glycol 6000, titanium oxide, polysorbate 80, talc and hard silicic anhydride) and Koryo Pharmaceutical Lanside ^™ capsules (components: lansoprazole, Sugaspears, corn), which are Comparative Example 3 Comparison of elution accumulation ratio for starch, white sugar, gum arabic, bentonite, sodium lauryl sulfate, sodium bicarbonate, ethyl methacrylate acrylic acid, talc, triacetin, polysorbate 80, silicone resin, and hard silicic anhydride) Was done. That is, according to the second method using a pH 6.8 buffer of 37 ± 0.5 ℃, the paddle was made 50 revolutions per minute, the eluate was taken every time and filtered and analyzed by high-performance liquid chromatography. Experimental results are as shown in Table 3 and FIG.

TABLE 3

Dissolution Accumulation Rate Comparison Experiment Results

Minutes Elution accumulation rate (%) Example 3 Comparative Example 2 Comparative Example 3 0 0 0 0 15 57.0 23.3 25.0 30 75.4 63.6 65.0 45 81.9 67.4 73.0 60 84.5 70.3 75.0 90 86.6 74.2 78.0 120 87.0 75.6 81.0

As can be seen in Table 3, the enteric tablet of Example 3 according to the present invention showed a faster dissolution rate than the comparative example.

Therefore, the enteric solid preparation according to the present invention containing 0.5 to 20 parts by weight of silicon dioxide per 1 part by weight of lansoprazole can not only sufficiently perform pharmacological action of lansoprazole by stabilizing lansoprazole as an active ingredient by silicon dioxide, By expressing a faster dissolution rate than the existing compositions can be expected to express the drug more quickly.

Claims (7)

A solid preparation containing lansoprazole consisting of a core and an enteric coating layer comprising lansoprazole as an active ingredient and silicon dioxide as a stabilizer in a ratio of 1: 0.5 to 20 by weight. The formulation of claim 1, wherein the lansoprazole and silicon dioxide are in a weight ratio of 1: 1 to 10. The formulation of claim 1 in the form of a tablet. The formulation of claim 1 which is in the form of a capsule. The formulation of claim 1 comprising a pharmaceutically acceptable carrier selected from a basicizing agent, excipient, binder, disintegrant, surfactant, antioxidant, glidant, colorant or coating or combinations thereof. 6. The formulation of claim 5, wherein the basicizing agent is sodium bicarbonate. Mixing lansoprazole and silicon dioxide in a weight ratio of 1: 0.5 to 20, adding a pharmaceutically acceptable carrier thereto, to prepare a core, and Method for producing a solid preparation for oral administration containing lansoprazole, comprising the step of coating the core with an enteric coating solution.