Sucralfate-containing jelly-like pharmaceutical composition

Abstract

Provided is a jelly-like pharmaceutical composition containing a sucralfate hydrate.　This jelly-like pharmaceutical composition contains a sucralfate hydrate and includes agar as a jelly base agent.

Description

Sucralfate-containing jelly-like pharmaceutical composition

[0001] The present invention relates to a jelly-like pharmaceutical composition containing sucralfate hydrate as an active ingredient.

[0002] Sucralfate hydrate is widely used as a prescription and over-the-counter (OTC) drug for treating peptic ulcers. It is a hydrate of aluminum sucrose sulfate, represented by formula (1), consisting of a complex of sucrose octasulfate and aluminum hydroxide. It is a poorly water-soluble white powder. It selectively binds to the ulcers in the digestive tract, forming a protective layer that protects the digestive mucosa from excess gastric acid and pepsin, neutralizes gastric acid, and inhibits the activity of enzymes such as pepsin, thereby promoting the body's own mucosal repair function and promoting healing.

[0003]

[0004] Pharmaceuticals containing sucralfate hydrate are manufactured and sold in dosage forms such as suspension granules or tablets (e.g., Non-Patent Document 1). Suspensions are the most commonly used sucralfate hydrate formulations due to the sucralfate hydrate's high dispersibility in the stomach and its adhesion to the stomach wall. However, problems exist, such as the sucralfate hydrate remaining in the oral cavity, resulting in a lingering drug taste and a powdery texture, and the contents scattering and causing soiling when the sachet is opened. Granules, like suspensions, may remain in the oral cavity and may enter the trachea upon ingestion, potentially inducing coughing. Tablets can be difficult for elderly people and children who have difficulty swallowing. Sucralfate hydrate requires water to be taken, making it difficult to take in situations or areas where water is difficult to obtain. Therefore, a formulation that can solve these problems is desired.

[0005] Oral jellies are an example of pharmaceutical preparations that are easy for elderly patients to take. The 18th Edition of the Japanese Pharmacopoeia defines jellies as non-flowable, molded gel preparations for oral administration. Jellies generally consist of an active ingredient, a polymeric gelling agent, and water, and may contain additives such as dispersants and preservatives as needed depending on the properties of the active ingredient. Patent Document 1, for example, discloses a jelly containing three branched-chain amino acids (isoleucine, leucine, and valine) that allows for a small intake, has a good flavor and smooth texture, and is highly stable. Patent Document 2 also discloses a jelly-like pharmaceutical composition containing a gelling agent, 0.005-0.1 wt.% parabens, and 0.02-0.5 wt.% benzoic acid or a salt thereof, and has an osmotic pressure of 1000-3500 mOsm. The jelly has high preservative activity, a good taste, texture, and ease of administration. Furthermore, Patent Document 3 discloses a chemically stable and easy-to-take jelly-like pharmaceutical composition containing milbemycin oxime, which contains milbemycin oxime as a medicinal ingredient, agar powder as a gelling agent, a sucrose fatty acid ester or a glycerin fatty acid ester as a dispersant, and purified water.

[0006] As a technique relating to sucralfate, for example, Patent Document 4 discloses a gel composition comprising A) 18 to 70 mass % of sucralfate, (B) 7 to 30 mass % of an organic acid, (C) water, and (D) a neutralizing thickener, the gel composition being composed of a dispersion medium and a dispersoid, the sucrose octasulfate / aluminum ratio in the dispersoid being 0.3 to 1.4 by mass, and the pH being 5.0 to 8.0. However, the incorporation of an organic acid, a neutralizing thickener such as an alkali metal, and a water-soluble anionic polymer compound is essential, and no examples of the production of a jelly are disclosed, nor are there any specific reports on jellies containing sucralfate hydrate.

[0007] Patent No. 6093181 Patent No. 5611672 Patent No. 6499970 Patent No. 6627485

[0008] "Ulcermin® Granules 90%, Ulcermin Oral Solution 10%" Pharmaceutical Interview Form, Revised September 2019 (Revised 6th Edition)

[0009] The present invention provides a sucralfate hydrate-containing jelly-like pharmaceutical composition that can be easily ingested without water and leaves no feeling of powder remaining after ingestion, and further provides a sucralfate hydrate-containing jelly-like pharmaceutical composition that is excellent in formulation stability and moldability, as well as a method for producing the same.

[0010] The present inventors have conducted extensive research into jelly-like pharmaceutical compositions containing sucralfate hydrate and have found that a good jelly-like pharmaceutical composition can be prepared by using agar as a jelly base, and that by incorporating a nonionic dispersant, sucralfate hydrate can be dispersed more uniformly in the formulation, and a jelly-like pharmaceutical composition that is excellent in stability and moldability and has a good taste and texture can be prepared, thereby completing the present invention.

[0011] That is, the present invention relates to: [1] a jelly-like pharmaceutical composition containing sucralfate hydrate, the jelly-like pharmaceutical composition comprising agar as a jelly base. [2] The present invention also relates to a jelly-like pharmaceutical composition containing sucralfate hydrate, the jelly-like pharmaceutical composition comprising agar as a jelly base and a non-ionic dispersant. [3] The present invention also relates to the jelly-like pharmaceutical composition described in [1] or [2] above, wherein the agar content is 0.1 to 5% by mass in the jelly-like pharmaceutical composition. [4] The present invention also relates to the jelly-like pharmaceutical composition described in [2] or [3] above, wherein the sucralfate hydrate content is 1 to 50% by mass and the non-ionic dispersant content is 0.1 to 20% by mass. [5] The present invention also relates to the jelly-like pharmaceutical composition described in [2] to [4] above, wherein the non-ionic dispersant is hydroxypropyl starch. [6] The present invention also relates to the jelly-like pharmaceutical composition according to any one of [1] to [5] above, further comprising a sugar. [7] The present invention also relates to the jelly-like pharmaceutical composition according to [6] above, wherein the sugar content in the jelly-like pharmaceutical composition is 0.1 to 50% by mass. [8] The present invention also relates to the jelly-like pharmaceutical composition according to [6] or [7] above, wherein the sugar is one or more of sorbitol, erythritol, xylitol, and glucose. [9] The present invention also relates to a method for producing a jelly-like pharmaceutical composition containing sucralfate hydrate, comprising the step of mixing a sucralfate suspension with an aqueous solution containing a jelly base and a nonionic dispersant.

[0012] According to the present invention, sucralfate hydrate can be highly dispersed, thereby suppressing sedimentation of sucralfate hydrate in a jelly formulation, and providing a jelly-like pharmaceutical composition that has excellent moldability as a jelly formulation and an excellent feeling when taken, free from the bitterness and gritty feeling (powderyness) inherent in sucralfate hydrate.

[0013] The present invention will be described in detail below. The jelly-like pharmaceutical composition of the present invention is a jelly-like pharmaceutical composition containing sucralfate hydrate as an active ingredient and using agar as a jelly base. In the present invention, commercially available sucralfate hydrate can be used, or sucralfate hydrate produced by the methods described in Japanese Patent Publication Nos. 44-11673, 44-16037, and 5-76927, International Publication WO 92 / 04030, etc. Sucralfate hydrate is a solid, and the particle size is not particularly limited. However, fine sucralfate hydrate is preferred because it exerts its medicinal effect by easily binding to ulcerated areas in the digestive tract, does not cause roughness in the oral cavity, and prevents sedimentation during the manufacturing process. For example, sucralfate hydrate having an average particle size of 0.1 to 150 μm can be used, preferably 0.1 to 100 μm, more preferably 0.1 to 50 μm, and even more preferably 0.1 to 20 μm. In the present invention, the average particle size refers to the median diameter (D ５０ (Mean particle size refers to the particle size corresponding to 50% of the cumulative distribution curve) and is measured based on volume. The average particle size can be measured using known methods and measuring instruments, such as laser light scattering particle size distribution measurement or dynamic light scattering particle size distribution measurement. The amount of sucralfate hydrate in the jelly-like pharmaceutical composition of the present invention is not particularly limited, but is preferably 1 to 50% by mass, more preferably 3 to 30% by mass, and even more preferably 5 to 25% by mass per unit dosage form. The amount may be the amount administered in one dose; for example, the amount of sucralfate hydrate in one dosage form may be 1 g.

[0014] In the present invention, a jelly-like pharmaceutical composition refers to a pharmaceutical composition that can be used as a jelly formulation, and is a jelly-like composition that contains at least a jelly base and water in addition to the active ingredient. The water content in the composition is usually 10 to 99% by mass, preferably 20 to 95% by mass, and more preferably 30 to 90% by mass. The amount of sucralfate hydrate is calculated on a dry basis. Note that a jelly formulation refers to a formulation for oral administration that uses a polymer gel as a base and has a fixed shape and no fluidity (Japanese Pharmacopoeia, 18th Edition).

[0015] In the jelly-like pharmaceutical composition of the present invention, agar is used as the jelly base. For example, when xanthan gum, pectin, gellan gum, carrageenan, carob bean gum, or the like is used as the main jelly base, sufficient moldability cannot be obtained. In the present invention, the moldability of an oral jelly means that (1) the particles of sucralfate hydrate are uniformly dispersed, and the entire oral jelly is white and transparent without any unevenness, with a uniform overall color and the white color inherent to sucralfate hydrate, (2) it is a gel-like substance that is non-flowable and maintains a constant shape, and (3) its syneresis rate is below a certain level. Examples of agar used in the present invention include a neutral polysaccharide (agarose) consisting of repeating units of β-D-galactopyranose linked at the 1,3-position and 3,6-anhydro-L-galactopyranose linked at the 1,4-position, and an acidic polysaccharide (agaropectin) containing ionic groups such as sulfate ester, pyruvic acid, and methoxyl in a backbone with the same bonding pattern as agarose. The jelly strength of the agar is not particularly limited, but commercially available agar has a jelly strength of 100 to 1500 g / cm. 2 and preferably 300 to 1000 g / cm 2 Examples include those listed below. Jelly strength is measured by the method specified in the Japanese Pharmacopoeia. The amount of agar in the jelly-like pharmaceutical composition of the present invention is not particularly limited, but is preferably 0.1 to 5% by mass, more preferably 0.1 to 3% by mass, more preferably 0.1 to 2% by mass, and even more preferably 0.2 to 1.5% by mass per unit dosage form. The amount of agar can be increased or decreased as desired to achieve the desired jelly strength of the jelly-like pharmaceutical composition of the present invention. In addition to the above-mentioned regular agar, fast-dissolving types of agar can also be used. Although it varies depending on the type, it dissolves in water at a lower temperature than regular agar, preferably at 70°C or higher, more preferably at 80°C or higher. The jelly strength is 100 to 800 g / cm 2The lower the jelly strength, the greater the amount that can be incorporated, and the amount of agar in the jelly pharmaceutical composition of the present invention is 0.2 to 5% by mass. The jelly strength of the jelly pharmaceutical composition of the present invention is not particularly limited, but in consideration of maintaining the shape of the jelly and ease of swallowing, it is a molded gel composition with no fluidity. The properties of the jelly pharmaceutical composition of the present invention are those specified for jellies in the Japanese Pharmacopoeia, the United States Pharmacopoeia, or the European Pharmacopoeia. In order to achieve the desired jelly strength in the jelly pharmaceutical composition of the present invention, the amount of agar can be changed; for example, a higher amount can result in a pudding-like, gummy, or yokan-like consistency, while a lower amount can result in a gel-like consistency with low strength.

[0016] The jelly-like pharmaceutical composition of the present invention preferably contains a nonionic dispersant as a dispersant. Sucralfate hydrate tends to settle and separate in an aqueous solution, but the addition of a nonionic dispersant increases the viscosity of the solution, thereby preventing sucralfate hydrate from settling and dispersing it. Examples of nonionic dispersants include celluloses such as methylcellulose, ethylcellulose, hydroxyethylcellulose, hydroxypropylcellulose, and hydroxypropylmethylcellulose, and nonionic modified starches such as acetylated adipate-crosslinked starch, acetylated phosphate-crosslinked starch, acetylated oxidized starch, hydroxypropyl starch, oxidized starch, acetate starch, phosphated starch, and hydroxypropylated phosphate-crosslinked starch. In terms of the anti-settling effect of sucralfate, nonionic modified starch is preferred, and hydroxypropyl starch is even more preferred. The amount of nonionic dispersant in the jelly-like pharmaceutical composition of the present invention is not particularly limited, but is preferably 0.1 to 20% by weight, more preferably 0.2 to 15% by weight, and even more preferably 0.3 to 10% by weight per unit dosage form.

[0017] The jelly-like pharmaceutical composition of the present invention can further contain sugars, which can improve jelly strength, syneresis rate, taste, and texture. Examples of sugars include sugars such as sucrose, palatinose, and fructooligosaccharides; starch sugars such as glucose, maltose, starch syrup, and fructose; lactoses such as lactose, isomerized lactose, and reduced lactose; and sugar alcohols such as sorbitol, mannitol, reduced maltose syrup (maltitol), reduced starch syrup, xylitol, reduced palatinose, erythritol, and sorbitol. From the standpoint of taste and texture, starch sugars and sugar alcohols are preferred, with erythritol, xylitol, sorbitol, and glucose being more preferred, with erythritol and sorbitol being even more preferred, and sorbitol being even more preferred. These sugars may be used alone or in combination. The amount of sugars in the jelly-like pharmaceutical composition of the present invention is not particularly limited, but is preferably 0.1 to 50% by mass per unit preparation, more preferably 0.5 to 40% by mass, even more preferably 1 to 30% by mass, and most preferably 3 to 20% by mass.

[0018] Pharmaceutical additives may be used appropriately in the jelly-like pharmaceutical composition of the present invention as needed, for example, preservatives, sweeteners, flavorings, organic solvents, pH adjusters, etc.

[0019] Examples of preservatives include benzoic acids such as benzoic acid, benzyl benzoate, and sodium benzoate; parabens such as methylparaben, ethylparaben, propylparaben, isopropylparaben, butylparaben, isobutylparaben, and benzylparaben; and one or more selected from benzalkonium chloride, cetylpyridinium chloride, benzethonium chloride, and aminoethylsulfonic acid, among others. Parabens are preferred, and one or more selected from methylparaben, ethylparaben, propylparaben, isopropylparaben, butylparaben, and isobutylparaben are more preferred. The amount of preservative in the jelly-like pharmaceutical composition of the present invention is not particularly limited as long as it is within the scope of usage regulations, but is preferably 0.00001 to 2% by mass, more preferably 0.0001 to 1.5% by mass, and even more preferably 0.002 to 0.5% by mass per unit dosage form.

[0020] The sweetener may be one or more selected from sugar, oligosaccharide, maltitol, erythritol, sorbitol, xylitol, aspartame, acesulfame potassium, sucralose, stevia, etc. The amount of the sweetener in the jelly-like pharmaceutical composition of the present invention may be 0.001 to 40% by mass per unit preparation.

[0021] The flavor may be, for example, a flavor of apple, orange, grapefruit, strawberry, peach, lemon, yogurt, etc. The amount of flavor in the jelly-like pharmaceutical composition of the present invention may be 0.0001 to 2% by mass per unit preparation.

[0022] The organic solvent is used to dissolve lipophilic ingredients such as the preservatives and fragrances, and for example, an alcohol or a polyhydric alcohol can be used. The alcohol includes ethanol, and the polyhydric alcohol includes glycerin, ethylene glycol, propylene glycol, etc., and preferably includes ethanol, glycerin, and a mixture thereof.

[0023] The pH adjuster is preferably one that can adjust the pH to 4 or higher, such as sodium hydroxide, potassium hydroxide, sodium hydroxide, calcium hydroxide, magnesium hydroxide, sodium carbonate, sodium hydrogen carbonate, aqueous ammonia, sodium citrate, sodium hydrogen citrate, trisodium phosphate, sodium monohydrogen phosphate, sodium dihydrogen phosphate, tripotassium phosphate, potassium monohydrogen phosphate, potassium dihydrogen phosphate, monoethanolamine, etc. Sodium hydroxide is preferred because it can be added in small amounts and does not have a crosslinking effect on the acidic polymer.

[0024] The jelly-like pharmaceutical composition of the present invention may contain pharmaceutical additives other than those mentioned above to maintain desired physical properties. For example, a gelling agent may be added to prevent or improve the jelly strength. Examples of gelling agents include xanthan gum, carrageenan, locust bean gum, pectin, and gellan gum, and the amount of gelling agent added is 0.001 to 1%.

[0025] The jelly-like pharmaceutical composition of the present invention can be provided in a form that is easy for patients to take by sealing it in a single dose in, for example, a cup container, Cheer Pack (registered trademark), or a stick packaging container.

[0026] The jelly-like pharmaceutical composition of the present invention has excellent moldability, and the jelly filled in a container has sucralfate hydrate dispersed at a uniform concentration, resulting in a uniform white color overall. The jelly-like pharmaceutical composition of the present invention is also characterized by little water separation, which can be expressed by the syneresis rate. The syneresis rate of the jelly-like pharmaceutical composition of the present invention is 0 to 15%, preferably 0.1 to 10%. When the jelly-like pharmaceutical composition is filled in a stick-shaped packet, syneresis water is not released upon ingestion, and does not adhere to the body or clothing.

[0027] The pH of the jelly-like pharmaceutical composition of the present invention is preferably high because, if the composition is held at about 55°C or higher for a long time in the production process described below, the decomposition of the agar progresses and the strength of the composition decreases. The pH is 3 to 8, preferably 4 to 7, and more preferably 5 to 7.

[0028] The jelly-like pharmaceutical composition of the present invention has the same medicinal effect as existing sucralfate suspensions. This can be confirmed by the fact that the antacid potency and enzyme adsorption capacity are equivalent. The antacid potency is 130 mL / g or more, preferably 150 mL / g or more, per 1 g of sucralfate (single dose), as determined by the Japanese Pharmacopoeia test.

[0029] The jelly-like pharmaceutical composition of the present invention can be produced by known methods for producing jellies. For example, agar is dissolved in water at about 85°C or higher, and a nonionic dispersant, a sweetener, and sucralfate hydrate are added to prepare a base solution. When hydroxypropyl starch is used as a dispersant, the dispersant is added to water, and the aqueous solution is gelatinized at about 75°C or higher to adjust the viscosity of the solution. The temperature of both the hydroxypropyl starch and agar may be set at 85°C or higher. However, when fast-dissolving agar is used, it is dissolved at 70°C or higher. When sucralfate hydrate is added, it is preferable to prepare a sucralfate hydrate suspension beforehand and then add it. The sucralfate hydrate suspension only needs to have a flowable viscosity, and the sucralfate hydrate concentration is 10-40%. The sucralfate hydrate suspension is preferably heated to 30-70°C before addition. Furthermore, when adding lipophilic ingredients such as preservatives or flavorings, these can be dissolved separately in an organic solvent and added to the aforementioned base solution and mixed uniformly to prepare a jelly solution. To adjust the pH of the pharmaceutical composition of the present invention, a pH adjuster can be added directly or as an aqueous solution when preparing the suspension or jelly solution of sucralfate hydrate. The jelly solution can then be filled into containers at 50 to 80°C and cooled to room temperature to produce the product. When a sterilization step is performed, heat treatment can be performed between the preparation of the jelly solution and filling, or sterilization can be performed after filling into the container.

[0030] The present invention will be described in more detail below with reference to examples, comparative examples and test examples, but the present invention is not limited to these.

[0031] 1. Effect of various dispersants on preventing sucralfate hydrate from settling A base solution was prepared by adding and dissolving a predetermined amount of the dispersant shown in Table 1 in purified water. Sucralfate hydrate was added to this solution and dispersed using a homomixer to prepare a drug solution.

[0032] For each drug solution, the effect of the dispersant on preventing the settling of sucralfate hydrate was evaluated. The blending ratio of each component was the amount of sucralfate hydrate equivalent to 10% sucralfate in anhydrous terms, the amount of dispersant shown in Table 1, and the amount of water to make the total amount 100% (note that % in the table means % by mass). Evaluation was performed visually after leaving it for one day. The results are also shown in Table 1.

[0033]

[0034] When hydroxypropyl starch, a non-ionic dispersant, was used as the dispersant, the highest anti-settling effect of sucralose hydrate was observed. When an ionic dispersant was added, an artificial salmon roe-like appearance was observed, which was found to be problematic when used as a jelly agent.

[0035] 2. Preparation of Jelly-like Pharmaceutical Composition (Example 1) Hydroxypropyl starch, agar, erythritol, acesulfame potassium, and sucralose were added to purified water, and the mixture was heated to approximately 90°C to dissolve all ingredients, preparing a base solution. Sucralfate hydrate was added to water and dispersed using a homomixer to prepare a drug solution. Methylparaben and flavoring were dissolved in ethanol, and the resulting mixture was added to glycerin to prepare an oily solution. The drug solution was added to the base solution and mixed, and the oily solution was further added and mixed to prepare a jelly solution, which was then cooled to room temperature to prepare a jelly-like pharmaceutical composition. The pH was 4.1. The blending amounts (% by mass) of each component are shown in Table 2. Sucralfate hydrate was mild sucralfate (average particle size: approximately 6 μm) manufactured by Fuji Chemical Industry Co., Ltd., and agar was mild sucralfate (average particle size: approximately 6 μm) manufactured by Ina Food Industry Co., Ltd., with a jelly strength of approximately 600 g / cm. 2 The following was used.

[0036]

[0037] Examples 2 to 4 Jelly pharmaceutical compositions were prepared in the same manner as in Example 1, except that among the ingredients described in Example 1, erythritol was replaced with the sugars listed in Table 3.

[0038] Comparative Examples 1 to 5 Jelly pharmaceutical compositions were prepared in the same manner as in Example 1, except that among the ingredients described in Example 1, agar was replaced with the jelly bases shown in Table 3.

[0039] [Evaluation of moldability and taste / texture] The moldability and taste / texture of the jelly-like pharmaceutical compositions of Examples 1 to 4 and Comparative Examples 1 to 5 were evaluated. The moldability was evaluated visually. The taste / texture was evaluated by a sensory test. The results are shown in Table 3.

[0040]

[0041] The preparations of Examples 1 to 4 exhibited good moldability as jelly pharmaceutical compositions. In addition, the jelly pharmaceutical composition of Example 1 exhibited good taste and texture. None of the preparations of Comparative Examples 1 to 5, which used a jelly base other than agar, could be used to prepare jelly pharmaceutical compositions.

[0042] (Examples 5) to (Examples 6) Jelly pharmaceutical compositions were prepared in the same manner as in Example 1, except that the amount of water was adjusted to match the amount of agar among the ingredients listed in Example 1, and the amount of agar added was changed to that listed in Table 4.

[0043]

[0044] The preparations of Examples 5 and 6 exhibited good moldability as a jelly-like pharmaceutical composition, as well as good taste and texture.

[0045] Example 7 Hydroxypropyl starch, agar, sorbitol, and acesulfame potassium were added to purified water, and the mixture was heated to approximately 85°C to dissolve all ingredients, preparing a base solution. Sucralfate hydrate and sodium hydroxide were added to water and dispersed using a homomixer to prepare a drug solution. Ethylparaben, propylparaben, and a flavoring were dissolved in ethanol, which was then added to glycerin to prepare an oily solution. The drug solution was added to the base solution and mixed, and the oily solution was further added and mixed to prepare a jelly solution. The mixture was then filled into a stick-shaped three-sided sealed container while maintaining the temperature at 40°C or higher, sealed, and cooled to room temperature to prepare a jelly-like pharmaceutical composition. The blending amounts (% by mass) of each component are shown in Table 4. Sucralfate hydrate was Mild Sucralfate (average particle size: approximately 6 μm) manufactured by Fuji Chemical Industry Co., Ltd., and agar was Mild Sucralfate (average particle size: approximately 6 μm) manufactured by Ina Food Industry Co., Ltd., with a jelly strength of approximately 830 g / cm. 2 The following was used.

[0046]

[0047] (Stability) The samples were kept for one month under conditions of a temperature of 40° C. and a humidity of 75%, and the analytical results shown in Table 6 were obtained.

[0048]

[0049] The jelly-like pharmaceutical composition of Example 7 remained stable even under accelerated conditions for one month, just like the initial condition.

Claims

1. A jelly-like pharmaceutical composition containing sucralfate hydrate, the jelly-like pharmaceutical composition using agar as a jelly base.

2. A jelly-like pharmaceutical composition containing sucralfate hydrate, which uses agar as a jelly base and contains a non-ionic dispersant.

3. 3. The jelly-like pharmaceutical composition according to claim 1, wherein the content of agar in the jelly-like pharmaceutical composition is 0.1 to 5% by mass.

4. 3. The jelly-like pharmaceutical composition according to claim 2, wherein the content of sucralfate hydrate in the jelly-like pharmaceutical composition is 1 to 50% by mass and the content of the nonionic dispersant is 0.1 to 20% by mass.

5. 3. The jelly-like pharmaceutical composition according to claim 2, wherein the non-ionic dispersing agent is hydroxypropyl starch.

6. The jelly-like pharmaceutical composition according to claim 1 or 2, further comprising a sugar.

7. 7. The jelly-like pharmaceutical composition according to claim 6, wherein the sugar content in the jelly-like pharmaceutical composition is 0.1 to 50% by mass.

8. 7. The jelly-like pharmaceutical composition according to claim 6, wherein the sugar is one or more of sorbitol, erythritol, xylitol and glucose.

9. A method for producing a jelly-like pharmaceutical composition containing sucralfate hydrate, comprising the step of mixing a sucralfate suspension with an aqueous solution containing a jelly base and a nonionic dispersant.