Ophthalmic products

Abstract

To provide an ophthalmic product in which an ophthalmic composition is filled in a container in which a pressing deformation part is formed by using an elastic material, and although the ophthalmic composition contains chlorpheniramine, diphenhydramine or a salt thereof, adsorption of these components is suppressed.SOLUTION: An ophthalmic product comprising an ophthalmic composition and a container filled with the ophthalmic composition, wherein the container comprises a container body having a discharge port and a press-deforming part, and a cap, and the press-deforming part is formed using an elastic material, (A) one or more selected from the group consisting of chlorpheniramine, diphenhydramine, and pharmaceutically acceptable salts thereof, and (B) one or more selected from the group consisting of an amino acid and a salt thereof, glycyrrhizic acid and a salt thereof, a mucopolysaccharide and a salt thereof, trometamol and a salt thereof, ethylenediaminetetraacetic acid and a salt thereof, and a vitamin and a derivative thereof.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present invention relates to ophthalmic products. [Background technology]

[0002] Ophthalmic products are known in which a liquid ophthalmic composition is contained in a plastic container. For example, eye drops are contained in the container body of a liquid dropper container. When in use, the container body is deformed by applying pressure with a finger while the discharge port is facing the target (eyeball), and droplets of liquid corresponding to the volume change are dispensed from the discharge port.

[0003] When an ophthalmic composition is filled in a plastic container, components of the ophthalmic composition may be adsorbed onto the plastic that makes up the container. If such adsorption of components occurs, the composition of the ophthalmic composition during use may change. Patent Document 1 proposes a method of incorporating cyclodextrins to solve the problem that when an ophthalmic composition containing chlorpheniramine maleate, an active ingredient for treating itching, redness, etc., is filled in a polyolefin container, the chlorpheniramine maleate is adsorbed to the container. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] Japanese Patent Application Laid-Open No. 2004-359679 Summary of the Invention [Problem to be solved by the invention]

[0005] The present inventors have discovered that when an ophthalmic composition containing chlorpheniramine, diphenhydramine, or a pharmaceutically acceptable salt thereof comes into contact with certain elastic materials, such as styrene-based elastomers, adsorption occurs. The present invention aims to provide an ophthalmic product in which an ophthalmic composition is filled in a container in which a pressure-deformable portion is formed using a specific elastic material, and in which, even though the ophthalmic composition contains chlorpheniramine, diphenhydramine, or salts thereof, adsorption of these components is suppressed. [Means for solving the problem]

[0006] The present invention has the following aspects. [1] An ophthalmic product comprising an ophthalmic composition and a container filled with the ophthalmic composition, wherein the container has a container body having a discharge outlet and a pressure-deformable portion, and a cap, the pressure-deformable portion being formed using an elastic material selected from the group consisting of styrene-based elastomers, low-density polyethylene, and silicone rubber, and the ophthalmic composition comprising the following component (A) and component (B): (A) One or more members selected from the group consisting of chlorpheniramine, diphenhydramine, and pharmaceutically acceptable salts thereof. (B) One or more selected from the group consisting of amino acids and their salts, glycyrrhizic acid and its salts, mucopolysaccharides and their salts, trometamol and its salts, ethylenediaminetetraacetic acid and its salts, and vitamins and their derivatives. [2] The ophthalmic product according to [1], wherein the component (B) contains one or more selected from the amino acids and salts thereof, and the amino acids and salts thereof are potassium L-aspartate, aminoethylsulfonic acid, and epsilon-aminocaproic acid. [3] The ophthalmic product according to [1] or [2], wherein the component (B) contains one or more selected from the vitamins and their derivatives, and the vitamins and their derivatives are pyridoxine hydrochloride and d-α-tocopherol acetate. [4] The ophthalmic product according to any one of [1] to [3], wherein the component (B) comprises one or more selected from the group consisting of mucopolysaccharides and salts thereof, and the mucopolysaccharides and salts thereof are sodium chondroitin sulfate and sodium hyaluronate. [5] The ophthalmic product according to any one of [1] to [4], wherein the pH of the ophthalmic composition at 25°C is 3.5 to 8.0. [6] The ophthalmic product according to any one of [1] to [5], wherein the elastic material is a styrene-based elastomer. [7] An ophthalmic product described in any one of [1] to [6], wherein the pressure-deformable portion elastically deforms between a first position where it protrudes outside the container body when not pressed and forms a space inside that communicates with the storage space, and a second position where it is located closer to the storage space than the first position when pressed, and the ophthalmic composition is ejected from the ejection outlet due to the change in volume between the first position and the second position. [Effects of the Invention]

[0007] According to the present invention, an ophthalmic composition is filled in a container in which a pressure-deformed portion is formed using a specific elastic material, and an ophthalmic product is obtained in which the adsorption of these components is suppressed even though the ophthalmic composition contains chlorpheniramine, diphenhydramine, or salts thereof. [Brief explanation of the drawings]

[0008] [Figure 1] 1 is a front view showing the liquid dripping container 1 according to the first embodiment in an upright state. [Figure 2] FIG. 2 is a vertical cross-sectional view of the liquid dripping container 1 in an upright position. [Figure 3] FIG. 2 is a right side view of the liquid dripping container 1. [Figure 4] 3 is an enlarged partial cross-sectional view of a pressure-deformed portion 30 in a non-pressed state in FIG. 2. FIG. [Figure 5] FIG. 10 is an enlarged partial cross-sectional view of a pressure-deformed portion 30 in a non-pressed state according to a second embodiment. [Figure 6] FIG. 10 is a perspective view showing a liquid dripping container 1 according to a third embodiment. [Figure 7] FIG. 10 is a front view showing the liquid dripping container 1 according to the third embodiment in an upright state. [Figure 8] 8 is an enlarged partial cross-sectional view of a protrusion 50 in FIG. 7. [Figure 9] FIG. 10 is a front view showing the liquid dripping container 1 according to the fourth embodiment in an upright state. [Figure 10]FIG. 10 is a plan view of a liquid dripping container 1 according to a fourth embodiment. [Figure 11] 10 is an enlarged partial cross-sectional view of a protrusion 50 in FIG. 9. [Figure 12] FIG. 10 is a front view showing a modified liquid dripping container 1 in an upright position. DETAILED DESCRIPTION OF THE INVENTION

[0009] The following definitions of terms apply throughout the specification and claims. A numerical range expressed by "to" means that the numerical values ​​before and after "to" are the lower and upper limits of the numerical range. "Ophthalmic composition" means any ophthalmic composition such as eye drops (synonymous with eye drops or eye drops, including eye drops that can be applied to the eyes while wearing contact lenses), artificial tears, eyewash (synonymous with eyewash or eyewash, including eyewash that can be applied to the eyes while wearing contact lenses), contact lens wetting solution, contact lens removal solution, or contact lens care products (including disinfectants, preservatives, cleaners, etc.). "Water-soluble" means that the solubility in 1 L of water at 25°C is 0.1 g or more. The unit of content (concentration) of each component, "w / v%," stands for "mass / volume %," and represents the mass (g) of the compounded component contained in 100 mL of the ophthalmic composition, and is synonymous with "g / 100 mL."

[0010] ≪Ophthalmic products≫ The ophthalmic product of the present invention comprises an ophthalmic composition and a container filled with the ophthalmic composition. ≪Ophthalmic composition≫ The ophthalmic composition of the present invention contains component (A) and component (B). In the following description, the unit of content, "%", is "w / v%" unless otherwise specified.

[0011] <Component (A)> Component (A) is chlorpheniramine, diphenhydramine, or a pharmaceutically acceptable salt thereof. Examples of pharmaceutically acceptable salts include hydrochloride, maleate, salicylate, tannate, and laurate. Specific examples include diphenhydramine hydrochloride, diphenhydramine salicylate, diphenhydramine tannate, diphenhydramine laurate, and chlorpheniramine maleate. Among these, chlorpheniramine maleate and diphenhydramine hydrochloride are preferred because they provide a higher effect when applied to the present invention. Component (A) may be used alone or in combination of two or more. The content of component (A) in the ophthalmic composition is preferably 0.005 to 0.5%, more preferably 0.01 to 0.3%, and even more preferably 0.01 to 0.05%. By containing the component (A) at or above the lower limit, the medicinal effects (antihistamine and antipruritic effects) are more easily achieved. By containing the component (A) at or below the upper limit, adsorption to the elastic material is more effectively suppressed.

[0012] <(B) component> Component (B) is one or more selected from the group consisting of amino acids and their salts, glycyrrhizinic acid and its salts, mucopolysaccharides and their salts, trometamol and its salts, ethylenediaminetetraacetic acid and its salts, and vitamins and their derivatives, and two or more can be used in combination.

[0013] Examples of amino acids and salts thereof include potassium L-aspartate, magnesium L-aspartate, potassium and magnesium L-aspartate (equal mixture), aminoethylsulfonic acid (taurine), epsilon-aminocaproic acid, etc. Among these, potassium L-aspartate, aminoethylsulfonic acid (taurine), and epsilon-aminocaproic acid are preferred because they provide greater suppression of adsorption of component (A). The content of the amino acid and its salt in the ophthalmic composition is preferably 0.03 to 5%, and more preferably 0.1 to 3%. More specifically, the content of potassium L-aspartate in the ophthalmic composition is preferably 0.03 to 5%, and more preferably 0.2 to 3%. The content of aminoethylsulfonic acid (taurine) in the ophthalmic composition is preferably 0.03 to 5%, and more preferably 0.1 to 1%. The content of epsilon aminocaproic acid in the ophthalmic composition is preferably 0.5 to 5%, and more preferably 1 to 5%. By containing the amino acid and its salt in an amount equal to or greater than the lower limit, adsorption of component (A) to the elastic material is further suppressed and the pharmacological effects of the amino acid and its salt are more easily achieved. By containing the amino acid and its salt in an amount equal to or less than the upper limit, irritation caused by the ophthalmic composition is further suppressed.

[0014] Examples of glycyrrhizinic acid and salts thereof include glycyrrhizinic acid, dipotassium glycyrrhizinate, disodium glycyrrhizinate, diammonium glycyrrhizinate, etc. Dipotassium glycyrrhizinate is preferred because it can more effectively inhibit the adsorption of component (A). The content of glycyrrhizinic acid and its salts in the ophthalmic composition is preferably 0.01 to 1%, more preferably 0.03 to 0.25%. By containing at least the lower limit, adsorption of component (A) to the elastic material is further suppressed and the anti-inflammatory effect is more easily obtained, while by containing at most the upper limit, foaming of the solution is suppressed, resulting in good usability.

[0015] Examples of mucopolysaccharides and salts thereof include chondroitin sulfate and salts thereof, and hyaluronic acid and salts thereof. Sodium chondroitin sulfate and sodium hyaluronate are preferred because they can more effectively inhibit the adsorption of component (A). The content of mucopolysaccharides and salts thereof in the ophthalmic composition is preferably 0.001 to 3%, more preferably 0.01 to 1%. More specifically, the content of sodium chondrotin sulfate is preferably 0.01 to 3%, more preferably 0.03 to 1%. The content of sodium hyaluronate is preferably 0.001 to 1%, more preferably 0.01 to 0.2%. By containing at least the lower limit, adsorption of component (A) to the elastic material is further suppressed and the pharmacological effects of the mucopolysaccharides and salts thereof are more easily achieved. By containing at most the upper limit, the sticky feeling when the ophthalmic composition is instilled is further suppressed.

[0016] Examples of trometamol and its salts include trometamol and trometamol hydrochloride. Trometamol is preferred because it can more effectively inhibit the adsorption of component (A). The content of trometamol in the ophthalmic composition is preferably 0.01 to 3%, more preferably 0.1 to 1%. By containing more than the lower limit, adsorption of component (A) to the elastic material is further suppressed and the preservative effect of the ophthalmic composition is further improved, while by containing less than the upper limit, irritation of the ophthalmic composition is further suppressed.

[0017] Examples of ethylenediaminetetraacetic acid and salts thereof include ethylenediaminetetraacetic acid (edetic acid), sodium ethylenediaminetetraacetate (sodium edetate), disodium ethylenediaminetetraacetate (disodium edetate), and hydrates thereof. Disodium ethylenediaminetetraacetate is preferred because it more effectively inhibits adsorption of component (A). The content of ethylenediaminetetraacetic acid and its salts in the ophthalmic composition is preferably 0.01 to 3%, more preferably 0.1 to 1%. By containing it in an amount equal to or greater than the lower limit, adsorption of component (A) to the elastic material is further suppressed, and by containing it in an amount equal to or less than the upper limit, irritation caused by the ophthalmic composition is further suppressed.

[0018] Examples of vitamins and derivatives thereof include water-soluble vitamins such as vitamin B and vitamin C; and fat-soluble vitamins such as vitamin A and vitamin E. Specific examples of vitamin B include flavin adenine dinucleotide sodium, cyanocobalamin, pyridoxine hydrochloride, panthenol, calcium pantothenate, and sodium pantothenate. Specific examples of vitamin C include sodium ascorbate. Specific examples of vitamin A include retinol palmitate (retinol palmitate ester) and retinol acetate. Specific examples of vitamin E include tocopherol acetate (d-α-tocopherol acetate), tocopherol succinate, and tocopherol nicotinate. Among these vitamins, pyridoxine hydrochloride and d-α-tocopherol acetate are preferred because they provide greater adsorption inhibition of component (A). The content of vitamins and derivatives thereof in the ophthalmic composition is preferably 0.001 to 1%, more preferably 0.005 to 0.3%. More specifically, the content of pyridoxine hydrochloride in the ophthalmic composition is preferably 0.001 to 1%, more preferably 0.01 to 0.3%. The content of d-α-tocopherol acetate in the ophthalmic composition is preferably 0.001 to 1%, more preferably 0.005 to 0.3%. By containing the vitamins and derivatives in an amount equal to or greater than the lower limit, adsorption of component (A) to the elastic material is further suppressed and the pharmacological effects of the vitamins are more easily achieved. By containing the vitamins and derivatives in an amount equal to or less than the upper limit, the appearance stability (clarity) of the formulation is improved.

[0019] <Water> The ophthalmic composition of the present invention is preferably an aqueous ophthalmic composition. Here, the term "aqueous ophthalmic composition" refers to an ophthalmic composition whose medium is water. That is, the ophthalmic composition of the present invention is preferably in a liquid form. The water used in the ophthalmic composition is not particularly limited as long as it is medicamentarily, pharmacologically or physiologically acceptable, and examples thereof include purified water and sterilized water. The content of water in the ophthalmic composition is preferably 90 to 99.9%, more preferably 93 to 98%. Preferred examples of aqueous ophthalmic compositions include eye drops (including eye drops that can be applied while wearing contact lenses), artificial tears, eyewashes (including eyewashes that can be used to wash the eyes while wearing contact lenses), contact lens wetting solutions, and contact lens removal solutions, with eye drops being particularly preferred. Contact lenses include, but are not limited to, hard contact lenses (including O2 hard contact lenses), soft contact lenses (including both ionic and non-ionic), silicone hydrogel contact lenses, colored contact lenses, etc. When no preservative is added, the composition is particularly suitable for use with soft contact lenses and silicone hydrogel contact lenses.

[0020] <Other ingredients> The ophthalmic composition may contain appropriate amounts of other components in addition to component (A), component (B), and water, as long as the effects of the present invention are not impaired. Other components may be any known components used in ophthalmic compositions, such as drugs other than components (A) and (B), surfactants, preservatives, sugars, buffers, pH adjusters, isotonicity agents, stabilizers, cooling agents, polyhydric alcohols, thickeners, and oily components other than fat-soluble vitamins.

[0021] The ophthalmic composition of the present invention preferably contains boric acid or borax as a buffer. When boric acid is added, the amount of boric acid in the ophthalmic composition is preferably 0.5 to 3%, more preferably 1 to 2%.

[0022] Examples of drugs other than component (A) and component (B) include decongestant agents (e.g., epinephrine, epinephrine hydrochloride, ephedrine hydrochloride, naphazoline hydrochloride, naphazoline nitrate, phenylephrine hydrochloride, dl-methylephedrine hydrochloride, tetrahydrozoline hydrochloride, etc.), anti-inflammatory / astringent agents (e.g., berberine chloride, berberine sulfide, allantoin, azulene sodium sulfonate, zinc sulfate, zinc lactate, lysozyme hydrochloride, neostigmine methylsulfate, etc.), antihistamines other than component (A), sulfa drugs (sulfamethoxazole, sulfisoxazole, and salts thereof), etc. When these drugs are contained, the content can be selected based on the effective amount of each drug, but is preferably 0.001 to 5% of the ophthalmic composition, more preferably 0.001 to 1%, and even more preferably 0.001 to 0.1%.

[0023] When the ophthalmic composition of the present invention is an aqueous ophthalmic composition and contains a fat-soluble vitamin or an oily component, it is preferable to add a surfactant. The surfactant is preferably a nonionic surfactant, such as polyoxyethylene polyoxypropylene glycol, polyoxyethylene castor oil (POE castor oil), polyoxyethylene hydrogenated castor oil (POE hydrogenated castor oil), or polyoxyethylene sorbitan fatty acid ester (POE sorbitan fatty acid ester). Polyoxyethylene polyoxypropylene glycols listed in the Pharmaceutical Excipients Standards (2018) can be suitably used. The average degree of polymerization of ethylene oxide is preferably 3 to 200, more preferably 20 to 200, and the average degree of polymerization of propylene oxide is preferably 5 to 100, more preferably 17 to 70. While either block or random copolymers are acceptable, block copolymers are preferred. Specific examples include polyoxyethylene (200) polyoxypropylene (70) glycol, polyoxyethylene (196) polyoxypropylene (67) glycol, polyoxyethylene (120) polyoxypropylene (40) glycol, polyoxyethylene (160) polyoxypropylene (30) glycol, polyoxyethylene (42) polyoxypropylene (67) glycol, polyoxyethylene (54) polyoxypropylene (39) glycol, and polyoxyethylene (20) polyoxypropylene (20) glycol. These can be used alone or in combination of two or more. Among these, polyoxyethylene (200) polyoxypropylene (70) glycol, polyoxyethylene (196) polyoxypropylene (67) glycol, and polyoxyethylene (120) polyoxypropylene (40) glycol are preferred because they enhance the stability of vitamin A and the corneal repair effect of vitamin A. Examples of commercially available products include polyoxyethylene (196) polyoxypropylene (67) glycol under the trade name Kolliphor P407 [BASF Japan Ltd.] and trade name Pronon #407P [NOF Corporation]; and polyoxyethylene (120) polyoxypropylene (40) glycol under the trade name Kolliphor P237 [BASF Japan Ltd.]. Polyoxyethylene castor oil (POE castor oil) is a compound obtained by addition polymerization of ethylene oxide (EO) to castor oil, and several types with different average moles of ethylene oxide are known. The average moles of ethylene oxide added in polyoxyethylene castor oil is not particularly limited, but examples include 3 to 60 moles. Specific examples include polyoxyethylene castor oil 3 (average moles of EO added: 3), polyoxyethylene castor oil 10 (average moles of EO added: 10), polyoxyethylene castor oil 20 (average moles of EO added: 20), polyoxyethylene castor oil 35 (average moles of EO added: 35), polyoxyethylene castor oil 40 (average moles of EO added: 40), polyoxyethylene castor oil 50 (average moles of EO added: 50), and polyoxyethylene castor oil 60 (average moles of EO added: 60). Polyoxyethylene hydrogenated castor oil (POE hydrogenated castor oil) is a compound obtained by addition polymerization of ethylene oxide to hydrogenated castor oil, and several types are known with different average number of moles of ethylene oxide added. The average number of moles of ethylene oxide added in polyoxyethylene hydrogenated castor oil is not particularly limited, but is, for example, 5 to 100 moles. Specific examples include polyoxyethylene hydrogenated castor oil 5 (average number of moles of EO added: 5), polyoxyethylene hydrogenated castor oil 10 (average number of moles of EO added: 10), polyoxyethylene hydrogenated castor oil 20 (average number of moles of EO added: 20), polyoxyethylene hydrogenated castor oil 30 (average number of moles of EO added: 30), polyoxyethylene hydrogenated castor oil 40 (average number of moles of EO added: 40), polyoxyethylene hydrogenated castor oil 50 (average number of moles of EO added: 50), polyoxyethylene hydrogenated castor oil 60 (average number of moles of EO added: 60), polyoxyethylene hydrogenated castor oil 80 (average number of moles of EO added: 80), and polyoxyethylene hydrogenated castor oil 100 (average number of moles of EO added: 100). Examples of polyoxyethylene sorbitan fatty acid esters (POE sorbitan fatty acid esters) include polyoxyethylene (20) sorbitan monolaurate (polysorbate 20), polyoxyethylene (20) sorbitan monopalmitate (polysorbate 40), polyoxyethylene (20) sorbitan monostearate (polysorbate 60), polyoxyethylene (20) sorbitan tristearate (polysorbate 65), and polyoxyethylene (20) sorbitan monooleate (polysorbate 80). Among these nonionic surfactants, polyoxyethylene (196) polyoxypropylene (67) glycol, polyoxyethylene castor oil 35, polyoxyethylene hydrogenated castor oil 60, and polyoxyethylene (20) sorbitan monooleate (polysorbate 80) are preferred from the viewpoint of stabilizing emulsions with oil-soluble components. When a surfactant is added, the amount thereof is preferably 0.005 to 1.5%, more preferably 0.01 to 1%, in the ophthalmic composition.

[0024] Examples of preservatives include chlorhexidine gluconate, chlorobutanol, and benzalkonium chloride. These preservatives can enhance the preservative effectiveness of the ophthalmic composition. When a preservative is added, its content in the ophthalmic composition is preferably 0.00005 to 0.2%, and more preferably 0.0001 to 0.1%.

[0025] Examples of sugars include glucose, cyclodextrin, xylitol, sorbitol, and mannitol. These may be in the d-, l-, or dl-form. Sugars have moisturizing properties and are effective in increasing moisture when applied to the eye, and can also be used as isotonic agents. When sugars are incorporated, their amount in the ophthalmic composition is preferably 0.001 to 5%, more preferably 0.003 to 2%, and even more preferably 0.005 to 1%.

[0026] Examples of buffering agents include citric acid or its salts (such as sodium citrate), phosphoric acid or its salts (such as sodium hydrogen phosphate and sodium dihydrogen phosphate), tartaric acid or its salts (such as sodium tartrate), gluconic acid or its salts (such as sodium gluconate), acetic acid or its salts (such as sodium acetate), glacial acetic acid, carbonic acid or its salts (such as sodium carbonate and sodium bicarbonate), and various amino acids. These may also be hydrates. When a buffering agent is incorporated, its amount is preferably 0.001 to 5% of the ophthalmic composition, more preferably 0.005 to 2%, and even more preferably 0.01 to 1%.

[0027] Examples of isotonicity agents include sodium chloride, potassium chloride, calcium chloride, sodium bicarbonate, sodium carbonate, dry sodium carbonate, magnesium sulfate, sodium hydrogen phosphate, sodium dihydrogen phosphate, and potassium dihydrogen phosphate. To further improve symptoms caused by destabilization of the tear lipid layer, it is preferable to incorporate sodium chloride or potassium chloride to achieve isotonicity. The osmotic pressure ratio of the ophthalmic composition to saline is preferably 0.60 to 2.00, more preferably 0.60 to 1.55, and most preferably 0.83 to 1.20. Osmotic pressure is measured at 25°C using an automatic osmometer (A2O, Advanced Instruments).

[0028] Examples of stabilizers include cyclodextrin and monoethanolamine. Examples of fat-soluble antioxidants include dibutylhydroxytoluene (BHT) and butylhydroxyanisole (BHA). When a fat-soluble antioxidant is incorporated, its amount is preferably 0.001 to 0.05% in the ophthalmic composition. Specifically, when dibutylhydroxytoluene is incorporated, its content is preferably 0.001 to 0.05%, more preferably 0.003 to 0.01%, in the ophthalmic composition. Within the above ranges, the decrease in transmittance of the ophthalmic composition is further suppressed, the appearance stability can be further improved, and the viscosity retention rate is further improved. Furthermore, the stability of vitamin A is further improved.

[0029] Examples of the refreshing agent include menthol, camphor, borneol, geraniol, cineol, linalool, etc. Any of the d-, l-, or dl-isomers may be used. When a refreshing agent is contained, the amount of the refreshing agent in the ophthalmic composition is preferably 0.0001 to 0.2%.

[0030] Examples of polyhydric alcohols include glycerin, propylene glycol, butylene glycol, polyethylene glycol, etc. When polyhydric alcohols are incorporated, the amount thereof is preferably 0.001 to 5%, more preferably 0.001 to 1%, and even more preferably 0.001 to 0.1% in the ophthalmic composition.

[0031] Examples of thickeners include polyvinylpyrrolidone, hydroxyethyl cellulose, hydroxypropylmethylcellulose (hypromellose), methylcellulose, polyvinyl alcohol, polyacrylic acid, carboxyvinyl polymer, etc. When a thickener is incorporated, the amount thereof is preferably 0.001 to 5%, more preferably 0.001 to 1%, and even more preferably 0.001 to 0.1%, of the ophthalmic composition. The viscosity of the ophthalmic composition at 20° C. is preferably 1 to 400 mPa·s, more preferably 1 to 100 mPa·s, even more preferably 1 to 60 mPa·s, and particularly preferably 1 to 30 mPa·s. The viscosity is measured using a B-type viscometer.

[0032] Examples of oily components other than fat-soluble vitamins include liquid paraffin, castor oil, soybean oil, olive oil, sesame oil, corn oil, coconut oil, almond oil, medium-chain fatty acid triglycerides, white petrolatum, liquid paraffin, wax esters, sterol esters, etc. When an oily component is incorporated, the amount thereof is preferably 0.001 to 1% of the ophthalmic composition.

[0033] Examples of pH adjusters include inorganic acids and inorganic alkali agents. Specific examples of inorganic acids include (dilute) hydrochloric acid. Examples of inorganic alkali agents include sodium hydroxide, potassium hydroxide, sodium carbonate, and sodium bicarbonate. An appropriate amount is blended to achieve the desired pH.

[0034] <ph> The pH of the ophthalmic composition of the present invention at 25° C. is preferably 3.5 to 8.0, more preferably 5.0 to 7.8, and particularly preferably 6.5 to 7.0. Within this range, the effect of inhibiting adsorption of component (A) is more easily achieved. The pH of the ophthalmic composition can be measured at 25° C. using a pH meter, for example, HM-25R, manufactured by DKK-Toa Corporation.

[0035] <Efficacy> The ophthalmic composition of the present invention can be used as an over-the-counter eye drop effective in treating eye fatigue, blurred vision (when there is a lot of eye mucus, etc.), conjunctival congestion, itchy eyes, blepharitis (sore eyelids), prevention of eye diseases (after swimming, when dust or sweat gets into the eyes, etc.), ophthalmitis caused by ultraviolet rays or other light (snow blindness, etc.), discomfort when wearing hard contact lenses, etc., or as an artificial tear effective in treating discomfort when wearing soft or hard contact lenses, lacrimal supplementation (dry eyes), eye fatigue, blurred vision (when there is a lot of eye mucus, etc.), etc. In particular, when vitamin A is contained as component (B), it repairs corneal scratches and corneal damage caused by mild rubbing, and is effective in treating fatigue (eye fatigue), blurred vision, itching, congestion, etc., which are common causes of these conditions. <Dosage> When the ophthalmic composition of the present invention is used as eye drops, it is preferable to instill 1 to 3 drops of 10 to 100 μL per administration, 1 to 6 times per day, more preferably 1 to 3 drops of 10 to 50 μL per administration, 1 to 6 times per day, and even more preferably 1 to 3 drops of 10 to 30 μL per administration, 1 to 6 times per day.

[0036] <Manufacturing method> The ophthalmic composition of the present invention can be obtained by mixing the components contained in the ophthalmic composition by a known method. When the ophthalmic composition is an aqueous ophthalmic composition, it can be obtained by adding components other than the pH adjuster to a portion of water, adjusting the pH with the pH adjuster as necessary, and then adjusting the total volume of the ophthalmic composition with the remaining water. When producing an ophthalmic composition containing an oily component such as a fat-soluble vitamin, the oily component and a solubilizer are first mixed to prepare mixture A. A nonionic surfactant is preferred as the solubilizer. Separately, aqueous components other than the pH adjuster are added to a portion of water to prepare aqueous solution B. Mixture A and aqueous solution B are then mixed to emulsify, and the pH is adjusted with a pH adjuster as needed. The total volume of the ophthalmic composition is then adjusted with the remaining water to obtain the ophthalmic composition. The mixing temperature for each component is not particularly limited. For example, when producing an ophthalmic composition containing an oily component and a nonionic surfactant, it is preferable that both the oily component and the nonionic surfactant have a melting point or higher, and specifically, the temperature is appropriately selected from the range of 40 to 95°C.

[0037] <Container> Hereinafter, an embodiment of the container will be described with reference to the drawings. Note that the following embodiment shows one aspect of the present invention, does not limit the present invention, and can be modified as desired within the scope of the technical concept of the present invention. In addition, in the following drawings, the scale and number of each structure are different from the actual structure to make each component easier to understand.

[0038] The container for the ophthalmic product of the present invention comprises a container body having a discharge outlet and a pressure-deformable portion, and a cap. When the ophthalmic composition is an aqueous ophthalmic composition, the container is preferably a liquid dropper container. 1 to 3 show a first embodiment of the container, and Fig. 1 is a front view showing a liquid dripping container 1 in an upright state according to the first embodiment. Fig. 2 is a vertical cross-sectional view of the liquid dripping container 1 in an upright state. Fig. 3 is a right side view of the liquid dripping container 1.

[0039] 1 to 3, the liquid dripping container 1 is a generally rectangular tubular container that extends vertically in an upright position and tapers toward the top. The liquid dripping container 1 has a storage space 1A therein for storing a liquid. The liquid (aqueous ophthalmic composition) is stored in the storage space 1A.

[0040] The up-down direction in the following description refers to the direction when the liquid dripping container 1 is placed and in an upright position, and does not limit the direction when the liquid is dripping. The horizontal direction in the front view shown in Figure 1 is called the width direction. The depth direction perpendicular to the paper surface in the front view shown in Figure 1 is called the thickness direction.

[0041] The liquid dripping container 1 has a container body 10, a discharge port 20, a pressure-deformable portion 30, and a cap 40. The container body 10 has a lower body 12 and an inner plug member 14 . The lower body 12 has a cylindrical shape with a bottom 13 on the lower side and an open top. The lower body 12 has a rectangular cylindrical shape that is open top. The lower body 12 has a fitting recess 12a. The fitting recess 12a is a recess formed on the inner surface of the lower body 12 and recessed from the upper end. The fitting recess 12a is formed around the entire periphery of the inner surface at the upper end of the lower body 12.

[0042] The material of the lower body 12 is not particularly limited, but it is preferable that the material has a strength that makes it difficult for deformation (squeezing) to occur when pressed in the thickness direction. Examples of materials for the lower body 12 having the above strength include polyethylene terephthalate resin (PET), polybutylene terephthalate resin (PBT), high-density polyethylene resin (HDPE), low-density polyethylene resin (LDPE), polypropylene resin (PP), or glass. Since foreign object inspection may be performed after the storage space 1A is filled with liquid, it is preferable that the lower body 12 be made of a transparent material that allows foreign object inspection. Furthermore, polyethylene terephthalate resin (PET) is more preferable in terms of the stability over time of the liquid stored in the storage space 1A and the impact resistance of the container body.

[0043] The inner plug member 14 has an inclined wall 15 and a curved wall 16 on the upper side, and is tubular with a rectangular cross section perpendicular to the vertical direction that opens downward. The inclined wall 15 is disposed to the left in the width direction of the center of the inside plug member 14. The inclined wall 15 is linearly inclined downward as it moves leftward. The curved wall 16 is disposed to the right in the width direction of the inclined wall 15 of the inside plug member 14. The curved wall 16 is curved in an arc shape downward as it moves to the right.

[0044] The inside plug member 14 has a fitting protrusion 14a. The fitting protrusion 14a protrudes downward from the inner surface at the lower end of the inside plug member 14. The fitting protrusion 14a is formed around the entire circumference of the lower end of the inside plug member 14. The fitting protrusion 14a fits into the fitting recess 12a of the lower main body 12 from the inside in the width direction and thickness direction around the entire circumference. By fitting the fitting protrusion 14a into the fitting recess 12a, the inside plug member 14 is fixed to the lower main body 12, and a storage space 1A is formed between the inside plug member 14 and the lower main body 12.

[0045] The material of the inside plug member 14 is not particularly limited, but it is preferable that the material has a strength that makes it difficult for deformation (squeezing) to occur when pressed in the thickness direction. Examples of materials for the inner plug member 14 having the above strength include polyethylene terephthalate resin (PET), polybutylene terephthalate resin (PBT), high-density polyethylene resin (HDPE), low-density polyethylene resin (LDPE), and polypropylene resin (PP), with high-density polyethylene resin (HDPE), low-density polyethylene resin (LDPE), and polypropylene resin (PP) being more preferred.

[0046] The discharge port 20 is provided in the inclined wall 15 of the inside plug member 14. The discharge port 20 extends in a direction perpendicular to the inclined wall 15. 2, the discharge port 20 has a discharge flow path 21. The discharge flow path 21 extends in a direction perpendicular to the inclined wall 15 and penetrates the discharge port 20. One end of the discharge flow path 21 communicates with the accommodation space 1A and the other end opens to the outside.

[0047] The inner diameter of the ejection port 20 (outer diameter of the ejection flow path 21) is set from the viewpoint of controlling the amount of one droplet of liquid. Specifically, the inner diameter of the ejection port 20 is set to a value such that, when the ejection port 20 faces downward and the liquid in the storage space 1A is in contact with the ejection flow path 21, the surface tension of the liquid becomes greater than the ejection force due to the weight of the liquid when the storage space 1A is at atmospheric pressure, and the liquid is not ejected from the ejection port 20.

[0048] Furthermore, when the pressure in the storage space 1A is higher than atmospheric pressure by a predetermined amount, the inner diameter of the discharge port 20 becomes larger than the surface tension of the liquid, and the liquid is discharged in the discharge direction 20A, which is the direction in which the discharge flow path 21 extends from the discharge port 20, and is set to a diameter that allows one drop of liquid to be dropped. The inner diameter of the discharge port 20 is preferably 2.0 mm or less, taking into consideration the surface tension of the liquid.

[0049] The discharge port 20 may be a molded body integrally formed with the inner plug member 14, or may be formed as a separate member made of a material different from that of the inner plug member 14. If the discharge port 20 is a separate member from the inner plug member 14, a step of attaching the discharge port 20 to the inner plug member 14 is required, which is time-consuming during manufacturing. Therefore, from the viewpoint of manufacturing efficiency, it is preferable that the discharge port 20 is a molded body that is integrally molded from the same material as the inner plug member 14.

[0050] Examples of materials for the outlet 20 include polyethylene terephthalate resin (PET), polybutylene terephthalate resin (PBT), high-density polyethylene resin (HDPE), low-density polyethylene resin (LDPE), and polypropylene resin (PP), with high-density polyethylene resin (HDPE), low-density polyethylene resin (LDPE), and polypropylene resin (PP) being more preferred.

[0051] The cap 40 is detachably fitted to the upper side of the container body 10. The cap 40 has a top and is a rectangular cylindrical shape that is open to the bottom. The cap 40 is fitted onto the container body 10 from above, covering both sides in the width direction and thickness direction as well as the top side of the container body 10. The lower end of the cap 40 is located below the lower end of the inner plug member 14. In other words, when attached to the container body 10, the cap 40 covers the inner plug member 14 and fits into the lower body 12.

[0052] The press-deformation portion 30 is provided on the curved wall 16 of the inner plug member 14. The press-deformation portion 30 is provided away from the discharge port 20. The press-deformation portion 30 is inserted from the inside into a hole 11 that penetrates the container body 10 and communicates with the storage space 1A. The press-deformation portion 30 inserted into the hole 11 closes the hole 11. The press-deformation portion 30 is made of an elastic material. The press-deformation portion 30 elastically deforms when pressed from the outside with the penetration direction of the hole 11 being the pressing direction 30A.

[0053] If the pressure-deformation portion 30 is provided on the lower main body 12, there is a possibility that the pressure-deformation portion 30 may hinder the foreign body inspection when performing the foreign body inspection after filling the storage space 1A with liquid. However, by providing the pressure-deformation portion 30 on the inner plug member 14, the foreign body inspection can be performed smoothly. Furthermore, since the cap 40 fits into the lower body 12, if the pressure-deforming portion 30 is provided on the lower body 12, there is a possibility that the shape of the lower body 12 will be restricted. However, by providing the pressure-deforming portion 30 on the middle plug member 14, it is possible to prevent restrictions on the shape of the lower body 12.

[0054] The pressure-deformable portion 30 elastically deforms between a first position A1, which protrudes outside the container body 10 when not pressed and forms a space 35 inside that communicates with the storage space 1A, and a second position A2, which is located closer to the storage space 1A than the first position A1 when pressed, so that the liquid (ophthalmic composition) is ejected from the ejection port due to the change in volume between the first position A1 and the second position A2.

[0055] FIG. 4 is an enlarged partial cross-sectional view of the pressure-deformed portion 30 in the non-pressed state in FIG. The pressure-deformable portion 30 has a first cylindrical portion 31, a first flange portion 32, a first closing portion 33, and a ring portion .

[0056] The pressure-deformed portion 30 when not pressed will be described below. The first cylindrical portion 31 has a cylindrical shape that passes through the hole 11. The first cylindrical portion 31 fits into the hole 11. Both ends of the first cylindrical portion 31 protrude from the curved wall 16 on both the outer and inner sides. The first flange portion 32 is annular and extends radially outward from the end of the first cylindrical portion 31 on the housing space 1A side. The first flange portion 32 engages with the inner surface of the container body 10 (curved wall 16) from the inside.

[0057] The first closing portion 33 closes the outer end of the storage space 1A in the first cylindrical portion 31. The first closing portion 33 is the portion that comes into contact when the press-deformation portion 30 is pressed from the outside in the pressing direction 30A. The ring portion 34 is provided around the entire outer peripheral surface of the first cylindrical portion 31 on the outside of the container body 10. The ring portion 34 engages with the outer surface of the container body 10 from the outside.

[0058] When not pressed, the pressure-deformable portion 30 projects outward from the container body 10 and assumes a first position A1 where it forms a space 35 therein that communicates with the storage space 1A. When pressed, the pressure-deformation portion 30 assumes a second position A2 indicated by a two-dot chain line, where the portion outside the ring portion 34 is recessed inside the hole 11. The second position A2 is closer to the accommodation space 1A than the first position A1.

[0059] The total volume of the storage space 1A when the pressure-deformation portion 30 is in the second position A2 is smaller than the total volume of the storage space 1A including the space 35 when the pressure-deformation portion 30 is in the first position A1, because the part of the pressure-deformation portion 30 outside the ring portion 34 is submerged inside the hole portion 11.

[0060] Therefore, the volume of air in the storage space 1A when the pressure-deformation portion 30 is in the second position A2, minus the amount of liquid contained in the storage space 1A, is smaller than the volume of air in the storage space 1A when the pressure-deformation portion 30 is in the first position A1.

[0061] That is, when the pressure-sensitive deformation portion 30 elastically deforms from the first position A1 to the second position A2 with the discharge port 20 facing downward and the liquid in the storage space 1A in contact with the discharge flow path 21, the air in the storage space 1A is not discharged from the discharge port 20 and remains at a constant amount. On the other hand, when the pressure-sensitive deformation portion 30 elastically deforms from the first position A1 to the second position A2, the volume of the storage space 1A decreases, causing a volume change in the air in the storage space 1A such that the volume decreases. As the volume of the air in the storage space 1A decreases, the air pressure in the storage space 1A increases. As a result, the ejection force on the liquid increases, causing the liquid to be ejected from the ejection port 20.

[0062] Therefore, by setting the volume change of the storage space 1A when the pressure-deformation portion 30 elastically deforms from the first position A1 to the second position A2 to a volume change equivalent to one drop of liquid, one drop of liquid can be dripped from the outlet 20 when the pressure-deformation portion 30 is pressed from the first position A1 to the second position A2.

[0063] Furthermore, since the pressure deformation portion 30 is provided on the curved wall 16 which is curved in an arc shape, when viewed from the front, the outer surface of the curved wall 16 curves in a direction away from the tangent line at the intersection with the central axis of the hole portion 11 as it moves away from the hole portion 11. Therefore, when the pressure-deformable portion 30 is pressed with a finger, the surface of the finger is prevented from coming into contact with the outer peripheral surface of the curved wall 16.

[0064] Therefore, when the pressure-deformation portion 30 is pressed with a finger, the finger surface can be pressed firmly to the second position A2 where the portion outside the ring portion 34 is sunk inside the hole portion 11, while preventing contact between the surface of the finger and the outer surface of the curved wall 16. From the viewpoint of ease of pressing, it is preferable that the pressure-deformable portion 30 has a cylindrical shape rather than a rectangular tubular shape such as a square pillar.

[0065] In addition, when the pressure-deformation portion 30 elastically deforms from the first position A1 to the second position A2, liquid is ejected from the outlet 20, but if the pressure on the pressure-deformation portion 30 is stopped halfway through the elastic deformation reaching the second position A2, it is preferable to set the size of the space 35 so that liquid is not ejected from the outlet 20.

[0066] From the viewpoint of dripping an appropriate amount of liquid by the elastic deformation of the pressure-deformation portion 30, it is preferable that the material of the pressure-deformation portion 30 is different from the material of the lower main body 12 and the middle plug member 14, and is a material having elasticity with less hardness than the lower main body 12 and the middle plug member 14. In other words, from the viewpoint of controlling the amount of liquid dripped, it is preferable that only the pressure-deformation portion 30 is deformable, and that the lower body 12 and the inner plug member 14 are formed of a material with high hardness so that they are less likely to deform even when pressed and liquid is not ejected.

[0067] For example, in the case of the lower body 12 and the inside plug member 14 made of polyethylene terephthalate resin (PET), the thickness is preferably 0.8 mm or more. In terms of specific strength, the relationship between the squeeze pressure and the deformation amount of the flattened portion (thickness direction) of the lower body 12 and the center plug member 14 is such that the deformation amount is preferably 2.0 mm or less at a squeeze pressure of 0.5 N or more and 12 N or less, and more preferably 0.3 mm or less at a squeeze pressure of 1.5 N or more and 8 N or less.

[0068] The squeeze pressure and deformation amount are values ​​measured by the following measurement methods. With the discharge outlet 20 facing downward, a push-pull gauge with a rod-shaped jig with a diameter of 25 mm attached to the tip is used to apply pressure to the flat portion (thickness direction) of the container body 10, and the squeeze pressure when one drop is dispensed is measured. In addition, a microgauge is installed on the container body 10, and the amount of deformation of the container body 10 at that time is read.

[0069] The material of the pressure-deformation portion 30 is an elastic material. The elastic material used for the pressure-deformation portion of the present invention is selected from styrene-based elastomer, low-density polyethylene, and silicone rubber. From the viewpoints of moldability and ease of pressing, styrene-based elastomer is preferred. Examples of styrene-based elastomers include styrene-butadiene-styrene block copolymers, styrene-ethylene-butylene-styrene block copolymers, styrene-isoprene-styrene block copolymers, styrene-isobutylene-styrene block copolymers, and styrene-ethylene-propylene-styrene block copolymers. Low density polyethylene has a density (kg / m 3 ) is polyethylene with a molecular weight of over 911 and less than 925, and is standardized in JIS K6922-1:2018 (ISO 17855-1). The silicone rubber is made primarily from polyorganosiloxane having a degree of polymerization of preferably 600 to 10,000, and either a high-temperature vulcanization type or a room-temperature or low-temperature vulcanization type can be used. Among these, styrene-based elastomers are preferred because the effect of inhibiting adsorption of component (A) by component (B) can be more easily achieved.

[0070] The amount of liquid dropped from the outlet 20 is 5 mm 3 Above 50mm 3 It is preferable that the volume is not more than 5 μL and not more than 50 μL. If the liquid content is eye drops (ophthalmic composition), one drop of liquid should be 5mm 3 By keeping the volume at 50mm or more, the contents will be more likely to exert their full efficacy. 3 Doing the following will reduce the risk of the liquid dripping onto the eyeball overflowing. A drop of liquid is 5mm 3 Above 50mm 3 By setting the amount as below, it is possible to drip an amount of liquid that can fully exert the efficacy of the contents without wasting the contents. For the same reasons as above, the amount of liquid dropped from the discharge port 20 is preferably 5 mg or more and 50 mg or less, and more preferably 20 mg or more and 40 mg or less.

[0071] When the liquid content is an eye drop (ophthalmic composition), the capacity of the container body 10 is preferably 5 mL or more and 20 mL or less. Considering the action of holding the container body 10 in one hand, fixing it in a position above the face, and pressing the pressure-deformable portion 30 with a finger to eject and drip the liquid, the capacity of the container body 10 is preferably in the above range, and keeping the volume of the eye drops (ophthalmic composition) to 20 mL or less improves usability rather than reducing it in some cases. As shown in Figure 2, if the first intersection angle, which is the not smaller of the intersection angles between the pressing direction 30A of the pressure deformation portion 30 and the ejection direction 20A of the liquid from the ejection port 20, is θ1, the first intersection angle θ1 is preferably greater than or equal to 90° and less than 180°, and more preferably greater than or equal to 90° and less than or equal to 115°, for example, 102°.

[0072] For example, when the container body 10 is held in one hand with the thumb on the front side of the container body 10 and the middle finger, ring finger, and little finger on the back side, and the index finger is pressed in the pressing direction 30A with the container body 10 fixed in a position above the face, by setting the first intersection angle θ1 to be 90° or more and less than 180°, the distance between the discharge outlet 20 and the eye (eyeball) can be maintained at an appropriate value, and the user can be induced to adopt a posture with their arms tucked in when the index finger is pressed in the pressing direction 30A with the container body 10 fixed in a position above the face. By administering eye drops with your arms folded, it becomes easier to aim at the target (eyeball) and the pressing action becomes more stable, improving usability.

[0073] Furthermore, by making the position of the outlet 20 of the pressure-deformation portion 30 the same in the thickness direction, when the pressure-deformation portion 30 is fixed in a position above the face and pressed with the index finger in the pressing direction 30A, it becomes easier to guide the user into a posture with the arms tucked in to administer eye drops, thereby improving usability when administering eye drops, such as preventing hand shake.

[0074] As shown in FIG. 2, when the liquid dripping container 1 is in an upright position, the second intersection angle θ2 is the smaller of the intersection angles of the pressing direction 30A with respect to the up-down direction. The second intersection angle θ2 is preferably greater than or equal to 0° and less than 90°, more preferably greater than or equal to 30° and less than or equal to 60°, for example, 45°. By setting the second intersection angle θ2 to be greater than or equal to 0° and less than 90°, when the container body 10 is held in one hand with the thumb placed on the front side of the container body 10 and the middle finger, ring finger, and little finger placed on the back side, and the container body 10 is fixed in a position above the face, and the index finger is pressed against the pressure-deformation portion 30 in the pressing direction 30A, the index finger can be placed on the pressure-deformation portion 30 without applying undue force to the joints of the finger, and the container body 10 can be held so as to be supported by the palm of the hand, allowing for pressing in a more stable posture.

[0075] As explained above, in the liquid dripping container 1 of this embodiment, the discharge port 20 and the pressure-deformation portion 30 are positioned above the center of the container body 10 in the vertical direction, and the first intersection angle θ1 between the pressing direction 30A of the pressure-deformation portion 30 and the discharge direction 20A of the liquid from the discharge port 20 is preferably 90° or more and less than 180°. Therefore, by pressing the pressure-deformation portion 30 formed of an elastic material in the pressing direction 30A, there is no need to adjust the amount of pressure, and during use, an appropriate amount of liquid can be quickly dripped onto the discharge target with a simple operation while the container body 10 is held in a comfortable position.

[0076] Furthermore, in the liquid dripping container 1 of this embodiment, an appropriate amount of one drop can be dripped by fully pressing the pressure-deforming portion 30, making it easier for the user to recognize the timing at which the liquid will be ejected and preventing an unnecessary amount of liquid from being dripped.

[0077] Furthermore, in the liquid dripping container 1 of this embodiment, the second intersection angle θ2 is preferably set to be equal to or greater than 0° and less than 90°, so that the pressure-deformable portion 30 can be pressed in a more stable posture. [Second embodiment of liquid dripping container] Next, a second embodiment of the liquid dripping container 1 will be described with reference to FIG. In this figure, the same elements as those in the first embodiment shown in FIGS. 1 to 4 are given the same reference numerals, and the description thereof will be omitted. In the second embodiment, the configuration of the pressure-deformation portion 30 is different from that in the first embodiment.

[0078] 5 is an enlarged partial cross-sectional view of the pressure-deformation portion 30 in the non-pressed state according to the second embodiment. As shown in FIG. 5, the pressure-deformation portion 30 has a second tubular portion 41, a second flange portion 42, and a second closing portion 43.

[0079] The second cylindrical portion 41 has a cylindrical shape that extends outward from the outer surface of the container body 10 at the periphery of the hole 11 when the press-deformation portion 30 is not pressed. The inner peripheral surface of the second cylindrical portion 41 is flush with the inner peripheral surface of the hole 11. The second flange portion 42 has an annular shape that extends radially outward from the end of the second cylindrical portion 41 on the housing space 1A side. The second flange portion 42 is flush with the outer surface of the container body 10. The second flange portion 42 engages with the outer surface of the container body 10. The second closing portion 43 closes the outer end of the container body 10 in the second cylindrical portion 41. The second closing portion 43 is a portion that comes into contact when the press-deformable portion 30 is pressed from the outside in the pressing direction 30A.

[0080] The pressure-deformable portion 30 and the inside plug member 14 (container body 10) are an integrally molded body. The second flange portion 42 is fixed to the inside plug member 14 by welding. The other configurations are the same as those of the first embodiment.

[0081] In the liquid dripping container 1 of this embodiment, in addition to obtaining the same functions and effects as those of the first embodiment, since the pressure-deformation portion 30 and the inner plug member 14 are integrally molded into a molded body, the process of incorporating the pressure-deformation portion 30 into the inner plug member 14 is not required, thereby improving manufacturing efficiency.

[0082] [Third embodiment of liquid dripping container] Next, a third embodiment of the liquid dripping container 1 will be described with reference to FIGS. In these figures, the same elements as those in the first embodiment shown in FIGS. 1 to 4 are denoted by the same reference numerals, and the description thereof will be omitted.

[0083] Fig. 6 is a perspective view showing a liquid dripping container 1 according to a third embodiment. Fig. 7 is a front view showing the liquid dripping container 1 in an upright state according to the third embodiment. Fig. 8 is a partial cross-sectional view showing an enlarged view of the pressure-deformable portion 30 in an unpressed state in Fig. 7.

[0084] 6 and 7, the liquid dripping container 1 has a container body 10 and a protrusion 50. The container body 10 has an elliptical outer contour extending in the width direction (left-right direction in FIG. 7) and extends in the up-down direction. The container body 10 is formed so that the maximum dimension in the width direction is larger than the maximum dimension in the thickness direction (direction perpendicular to the plane of the paper in FIG. 7), which is perpendicular to the up-down direction and width direction.

[0085] Since the maximum width dimension of the container body 10 is formed to be larger than the maximum thickness dimension, for example, when the container body 10 is held with the thumb in contact with the front side of the container body 10 and the middle finger, ring finger, and little finger in contact with the back side, the index finger can easily press the pressure deformation portion 30 described later from the side opposite the discharge outlet 20.

[0086] The container body 10 has a mouth 10A that opens upward. The mouth 10A is cylindrical and extends in the vertical direction. A protrusion 50 is inserted into the mouth 10A from above and fixed thereto.

[0087] The protrusion 50 is cylindrical and protrudes upward from the container body 10. The protrusion 50 has a discharge outlet 20 and a pressure-deformation portion 30. The protrusion 50 has an inclined portion 51 that slopes downward as it approaches the right side, which is the other side in the width direction. The discharge outlet 20 is provided on the left side, which is one side in the width direction of the protrusion 50. The pressure-deformation portion 30 is provided on the right side in the width direction. The pressure-deformation portion 30 protrudes from the inclined portion 51, with the pressing direction being perpendicular to the inclined portion 51. The pressure-deformation portion 30 is cylindrical and has a top portion that protrudes upward from the inclined portion 51.

[0088] The protrusion 50 and the pressure-deforming portion 30 may be made of the same material, and may be integrally molded by, for example, injection molding. Examples of materials for the protrusion 50 include polyethylene terephthalate resin (PET), polybutylene terephthalate resin (PBT), high-density polyethylene resin (HDPE), low-density polyethylene resin (LDPE), and polypropylene resin (PP), with high-density polyethylene resin (HDPE), low-density polyethylene resin (LDPE), and polypropylene resin (PP) being more preferred.

[0089] The material of the pressure-deformable portion 30 may be the same elastic material as in the first embodiment, and a styrene-based elastomer is preferred from the viewpoints of formability and ease of pressing. Specific examples of preferred elastic materials are the same as in the first embodiment.

[0090] If the material of the pressure-deformation portion 30 is less hard than the protrusion 50, when the pressure-deformation portion 30 is pressed toward the inclined portion 51, the pressure-deformation portion 30 deforms to follow the hardness of the inclined portion 51, and therefore the pressing direction 30A of the pressure-deformation portion 30 is perpendicular to the inclined portion 51. As shown in Figures 7 and 8, for example, by holding the container body 10 with the thumb in contact with the front side of the container body 10 and the middle finger, ring finger, and little finger in contact with the back side, and pressing the right end of the upper end of the pressure-deformation portion 30 with the index finger from the side opposite the discharge outlet 20 toward the inclined portion 51 in the pressing direction 30A, one drop of liquid can be dispensed from the discharge outlet 20.

[0091] Of the intersection angles between the pressing direction 30A of the pressure deformation portion 30 and the ejection direction 20A of the liquid from the ejection port 20, the first intersection angle θ1 on the not-smaller side is preferably greater than or equal to 90° and less than 180°, and more preferably greater than or equal to 90° and less than or equal to 125°, for example, 115°.

[0092] Of the intersection angles of the pressing direction 30A with the up-down direction when the liquid dripping container 1 is in an upright state, the smaller second intersection angle θ2 is preferably greater than or equal to 0° and less than 90°, more preferably greater than or equal to 15° and less than or equal to 60°, for example, 30°.

[0093] In the liquid dripping container 1 of this embodiment, in addition to obtaining the same functions and effects as those of the first embodiment, the protrusion 50 and the pressure-deforming portion 30 are integrally molded from one or more materials, thereby reducing manufacturing costs.

[0094] [Fourth embodiment of liquid dripping container] Next, a fourth embodiment of the liquid dripping container 1 will be described with reference to FIGS. In these figures, the same elements as those in the third embodiment shown in FIGS. 6 to 8 are denoted by the same reference numerals, and the description thereof will be omitted.

[0095] Fig. 9 is a front view showing the liquid dripping container 1 in an upright state according to the fourth embodiment. Fig. 10 is a plan view of the liquid dripping container 1 according to the fourth embodiment. Fig. 11 is an enlarged partial cross-sectional view of the protrusion 50 in Fig. 9.

[0096] As shown in Fig. 9, the liquid dripping container 1 has a container body 10 and a protrusion 50. As shown in Fig. 10, the container body 10 has an elliptical outer contour extending in the width direction and extends in the up-down direction. The container body 10 is formed so that the maximum dimension in the width direction is larger than the maximum dimension in the thickness direction, which is perpendicular to the up-down direction and the width direction.

[0097] Since the maximum width dimension of the container body 10 is formed to be larger than the maximum thickness dimension, for example, when the container body 10 is held with the thumb in contact with the front side of the container body 10 and the middle finger, ring finger, and little finger in contact with the back side, the index finger can easily press the pressure deformation portion 30 described later from the side opposite the discharge outlet 20.

[0098] The protrusion 50 protrudes upward from the container body 10. The protrusion 50 is formed in a truncated cone shape with a diameter that decreases toward the top. The protrusion 50 has a discharge outlet 20 and a pressure-deformation portion 30. The protrusion 50 has an inclined portion 51 that slopes downward toward the right side, which is the other side in the width direction. The protrusion 50 has a second inclined portion 52 that slopes downward toward the left side, which is one side in the width direction.

[0099] The discharge port 20 is provided on the left side in the width direction of the protrusion 50. The discharge port 20 is provided in the second inclined portion 52. The pressure-deformable portion 30 is provided on the right side in the width direction. The pressure-deformable portion 30 protrudes from the inclined portion 51, with the pressing direction being perpendicular to the inclined portion 51. The pressure-deformable portion 30 has a spherical portion 30B protruding from the inclined portion 51. By having the spherical portion 30B in the pressure-deformable portion 30, the feel when pressing the pressure-deformable portion 30 with a finger can be made softer.

[0100] The protrusion 50 and the pressure-deforming portion 30 may be made of the same material, and may be integrally molded by, for example, injection molding. Examples of materials for the protrusion 50 include polyethylene terephthalate resin (PET), polybutylene terephthalate resin (PBT), high-density polyethylene resin (HDPE), low-density polyethylene resin (LDPE), and polypropylene resin (PP), with high-density polyethylene resin (HDPE), low-density polyethylene resin (LDPE), and polypropylene resin (PP) being more preferred.

[0101] The material of the pressure-deformable portion 30 may be the same elastic material as in the first embodiment, and from the viewpoint of moldability and ease of pressure, styrene elastomer and low-density polyethylene are preferred.

[0102] Of the intersection angles between the pressing direction 30A of the pressure deformation portion 30 and the liquid ejection direction 20A from the ejection port 20, the first intersection angle θ1 on the not smaller side is preferably greater than 90° and less than 180°, more preferably greater than 90° and less than 115°, for example, 90°.

[0103] Of the intersection angles of the pressing direction 30A with the up-down direction when the liquid dripping container 1 is in an upright state, the second intersection angle θ2 on the smaller side is preferably greater than or equal to 0° and less than 90°, more preferably greater than or equal to 30° and less than or equal to 60°, for example, 45°.

[0104] In the liquid dripping container 1 described above, for example, the container body 10 can be held with the thumb touching the front side of the container body 10 and the middle finger, ring finger, and little finger touching the back side, and one drop of liquid can be dripped from the discharge outlet 20 by pressing the spherical portion 30B of the pressure-deformation portion 30 with the index finger from the side opposite the discharge outlet 20 toward the inclined portion 51 along the pressing direction 30A.

[0105] In the liquid dripping container 1 of this embodiment, in addition to obtaining the same functions and effects as those of the first embodiment, it is possible to reduce manufacturing costs by integrally molding the protrusion 50 and the press-deformation portion 30 from one or more materials. Furthermore, in the liquid dripping container 1 of this embodiment, the press-deformation portion 30 has a spherical portion 30B, which makes it possible to soften the feel when pressing the press-deformation portion 30 with a finger.

[0106] While the preferred embodiments of the present invention have been described above with reference to the accompanying drawings, it goes without saying that the present invention is not limited to these examples. The shapes and combinations of the components shown in the above examples are merely examples, and various modifications can be made based on design requirements, etc., without departing from the spirit of the present invention.

[0107] For example, in the first and second embodiments, the container body 10 is shaped like a rectangular tube, but the container body 10 is not limited to this configuration. As shown in the modified example of Fig. 12, the container body 10 may have a configuration in which the lower body 12 has a disk-shaped bottom 13, is cylindrical in shape with a circular cross section, and extends in the vertical direction, and the inner plug member 14 has an inclined wall 15 and an inclined wall 16A. The inclined wall 16A is located to the right of the inclined wall 15 and is linearly inclined downward as it goes to the right. The discharge port 20 is provided in the inclined wall 15, and the pressure-deforming portion 30 is provided in the inclined wall 16A.

[0108] In the container body 10 of the liquid dripping container 1 in this modified example, in addition to being able to obtain the same functions and effects as the above embodiment, the lower body 12 is cylindrical, which makes it feel gentle to hold. The shape of the container body 10 can be selected from various shapes such as a cylindrical shape, an oval shape, and the like, in addition to the above.

[0109] In the third embodiment, the protrusion 50 is cylindrical, but the present invention is not limited to this. For example, the protrusion 50 may be frustum-shaped as in the fourth embodiment, and the discharge port 20 may be provided on a second inclined portion that is inclined downward as it approaches one side in the width direction.

[0110] <Sterilization> Since the ophthalmic composition is a sterile preparation, it is preferable that the container body be sterilized. Specifically, the sterilization method can be any of ethylene oxide gas sterilization, electron beam sterilization, and gamma ray sterilization. Electron beam sterilization is more preferable because there is no concern about residual gas and the sterilization can be completed in a short time.

[0111] <Enclosure> The ophthalmic product may have a housing for packaging the container, such as polyethylene, polyethylene terephthalate, polypropylene, polybutylene, polycarbonate, polyester, nylon, cellophane, polyvinyl chloride film, aluminum foil, aluminum-deposited polyvinyl alcohol or polyamide film, polyvinylidene chloride-coated film or laminate film, or composite or multilayer film thereof.

[0112] An inert gas such as nitrogen may be sealed in the space formed between the container and the enclosure, and the ophthalmic composition may be filled into the container and then sealed in the enclosure together with an oxygen scavenger. Examples of the means include (1) injecting an inert gas into the enclosure, (2) packaging an oxygen absorber in the enclosure, (3) a container having oxygen absorbing capacity, or (4) an enclosure having oxygen absorbing capacity. By using such means, the problems of the present invention can be solved, the decrease in transmittance of the ophthalmic composition can be further suppressed, and the appearance stability can be improved. (1) Injection of inert gas into the enclosure Examples of inert gases include nitrogen, helium, neon, and argon. Of these, nitrogen gas is preferred. The concentration of the inert gas is preferably 50% by volume or more, more preferably 80% by volume or more, and even more preferably 90% by volume or more, of the volume of the space formed between the enclosure and the plastic container. There is no particular upper limit, but it is 100% by volume or less. To achieve such a concentration, the space formed between the enclosure and the plastic container may be replaced with the inert gas. (2) Packing oxygen absorbers inside the enclosure Specifically, Ageless (registered trademark) (FX, SP, SS, SPE, ZP, Z-PT, Z-PKC, GLS, GL-M, Z-20PK) manufactured by Mitsubishi Gas Chemical Company, Inc., PharmaKeep, Vitalon manufactured by Tokiwa Sangyo Co., Ltd., Sansoles manufactured by Hakuyo Co., Ltd., WonderKeep manufactured by Powder Tech Co., Ltd., Sansocut manufactured by Iris Fine Products Co., Ltd., etc. can be used. (3) Containers with oxygen absorption capacity Specifically, for example, Oxyblock manufactured by Toyo Seikan Co., Ltd. can be used. (4) Oxygen-absorbing enclosure Specifically, Oxycatch (registered trademark) ICA manufactured by Kyodo Printing Co., Ltd., Cryovac (registered trademark) OS Film manufactured by Sealed Air Japan Co., Ltd., Hyster O2 manufactured by Star Plastics Industries Co., Ltd., Ageless Omac manufactured by Mitsubishi Gas Chemical Company, Inc., Oxydec manufactured by Toyo Seikan Co., Ltd., etc. can be used. The above means can be combined as appropriate, with (2) and (4) being preferred, and a combination of (1) and (2) and a combination of (1) and (4) being more preferred. [Example]

[0113] The present invention will be described in detail below with reference to examples, but the present invention is not limited to the following descriptions. The amounts of components used in each example are pure amounts unless otherwise specified.

[0114] <Measurement method> The pH was measured using a pH meter (manufactured by DKK-TOA Corporation, product name "HM-25R") The temperature of the ophthalmic composition to be measured was adjusted to 25°C, and the pH was measured.

[0115] <Evaluation method: (A) Inhibitory effect on adsorption of component> 15 mL of each ophthalmic composition and 25 styrene-based elastomer pellets (30 mg each, styrene-ethylene-butylene-styrene block copolymer) were placed in a 20 mL glass vial, sealed, and stored at 60°C for one week. Component (A) in the ophthalmic composition was evaluated before and after storage according to the following method. [Measurement of the residual rate of component (A) before and after storage] The concentration of component (A) in the ophthalmic composition was analyzed by the following liquid chromatography method. The adsorption rate and adsorption improvement rate of component (A) after storage were calculated using the following formula. Two measurements were taken, and the average value was used as the measurement result. Adsorption rate (%) = (labeled amount of component (A) before storage - labeled amount of component (A) after storage) / labeled amount of component (A) before storage × 100 Adsorption improvement rate (%) = (adsorption rate of component (A) in corresponding comparative example - adsorption rate of component (A) in example) / (adsorption rate of component (A) in corresponding comparative example) × 100 The higher the adsorption improvement rate, the greater the adsorption suppression effect of component (A). [Liquid chromatography method] The ophthalmic compositions stored under the above conditions were used as samples, and the content of component (A) (chlorpheniramine maleate or diphenhydramine hydrochloride) was measured by HPLC. [HPLC measurement conditions] Mobile phase: Water / acetonitrile mixture (containing sodium dihydrogen phosphate dihydrate, sodium 1-octanesulfonate, phosphoric acid) (17:8) Measurement wavelength: 220 nm (chlorpheniramine maleate), 258 nm (diphenhydramine) Column temperature: about 40°C Column: ODS column (φ4.6 mm × 15 cm, 5 μm)

[0116] [Raw materials used] The raw materials used are listed below. Unless otherwise specified, the amount of each ingredient in the table is the pure equivalent. The terms "JP," "extra-pharmacy standards," "pharmaceutical additive standards," and "extra-raw material standards" below refer to raw materials that comply with the 18th Revised Japanese Pharmacopoeia Standards, the Japanese Pharmacopoeia Extra-Pharmacopoeia Standards, Pharmaceutical Additive Standards (2018), and the Quasi-drug Raw Materials Standards (2021), respectively. <Component (A)> Chlorpheniramine maleate (trade name: Chlorpheniramine maleate (Chlorpheniramine maleate), Kongo Chemical Co., Ltd., Japanese Pharmacopoeia). Diphenhydramine hydrochloride: (trade name: Diphenhydramine Hydrochloride, Kongo Chemical Co., Ltd., Japanese Pharmacopoeia).

[0117] <(B) component> Potassium L-aspartate (trade name: Potassium L-aspartate, Alps Pharmaceutical Co., Ltd., extra-governmental regulations). Taurine: Aminoethylsulfonic acid (trade name: Taurine, Three F Co., Ltd., JP). Epsilon aminocaproic acid (trade name: ε-amino-n-caproic acid EKD, Nippon Bulk Pharmaceutical Co., Ltd., Japan Pharmacopoeia). Dipotassium glycyrrhizinate (trade name: Dipotassium glycyrrhizinate, Maruzen Pharmaceutical Co., Ltd., non-regulated). · Pyridoxine hydrochloride (trade name: Pyridoxine hydrochloride, Hydrochloride pyridoxine, BASF Japan Ltd., Japanese Pharmacopoeia). · Retinol palmitate (trade name: Retinol palmitate 1.74 mIU / g, with BHA / BHT added, DSM Co., Ltd., Japanese Pharmacopoeia). · d-α-Tocopherol acetate (trade name: RIKEN E acetate α, Riken Vitamin Co., Ltd., off-the-Japanese-Pharmacopoeia). · Cyanocobalamin (trade name: Cyanocobalamin (CBL12), Mitsubishi Chemical Corporation, Japanese Pharmacopoeia). · Panthenol (trade name: D-Pantothenyl alcohol, DSM Co., Ltd., off-the-Japanese-Pharmacopoeia). · Sodium chondroitin sulfate (trade name: Off-the-Japanese-Pharmacopoeia Sodium chondroitin sulfate, Maruha Nichiro Corporation, off-the-Japanese-Pharmacopoeia). · Sodium hyaluronate (trade name: Hyaluron San HA-AML (Japanese Pharmacopoeia), Kewpie Corporation, Japanese Pharmacopoeia). · Tromethamine (trade name: 2-Amino-2-hydroxymethyl-1,3-propanediol, Kanto Chemical Co., Inc., off-the-Japanese-Pharmacopoeia). · Sodium edetate hydrate (EDTA) (trade name: Sodium edetate hydrate "for manufacturing only", Fujifilm Wako Pure Chemical Corporation, Japanese Pharmacopoeia).

[0118] <pH adjuster> · pH adjuster: Dilute hydrochloric acid: (trade name: Dilute hydrochloric acid, Kosakai Pharmaceutical Co., Ltd., Japanese Pharmacopoeia) or Sodium hydroxide: (trade name: Sodium hydroxide, Kosakai Pharmaceutical Co., Ltd., Japanese Pharmacopoeia). <Water> · Purified water.

[0119] <Other components> · Polyoxyethylene hydrogenated castor oil 60 (nonionic surfactant, average number of added EO moles 60, trade name: HCO-60 (for pharmaceutical use), Nippon Surfactant Industry Co., Ltd., pharmaceutical additive specification). · Boric acid: (trade name: Boric acid, Kanto Chemical Co., Inc., Japanese Pharmacopoeia). · Neostigmine methylsulfate (trade name: Neostigmine methylsulfate, Shionogi & Co., Ltd., Japanese Pharmacopoeia). Tetrahydrozoline hydrochloride (trade name: Tetrahydrozoline hydrochloride, Nippon Bulk Pharmaceutical Co., Ltd., extra-official regulations). Allantoin (product name: Allantoin, Permakem Asia Co., Ltd., extra-official regulations) Zinc sulfate hydrate (trade name: Zinc sulfate hydrate (UE), Kanto Chemical Co., Ltd., Japanese Pharmacopoeia). Polyoxyethylene (196) polyoxypropylene (67) glycol (trade name: Kolliphor P407, BASF Japan Ltd., Pharmaceutical Additives Regulations). Polyoxyethylene (20) sorbitan monooleate (polysorbate 80) (trade name: Rheodol TW-0120V, Kao Corporation, Pharmaceutical Additives Regulations). Borax (Borax (powder), Kosakai Pharmaceutical Co., Ltd., JP).

[0120] [Examples 1 to 7, corresponding comparative example 1] [Examples 8 to 13, corresponding comparative example 1] [Example 14, corresponding comparative example 2] [Examples 15 to 20, corresponding comparative example 1] [Examples 21 to 25, corresponding comparative example 1] [Example 26, corresponding comparative example 3] [Example 27, corresponding comparative example 4] Ophthalmic compositions were prepared to have the compositions shown in Tables 1 to 5. Specifically, components other than the pH adjuster were added to an aqueous solution in which boric acid had been dissolved, and mixed. Next, the pH was adjusted using the pH adjuster as necessary, and the total volume was adjusted with purified water to obtain ophthalmic compositions. In Example 14, a mixed solution of d-α-tocopherol acetate and a nonionic surfactant was first heated to 85°C, and then mixed with an aqueous solution containing a buffering agent and the like heated to the same temperature to emulsify the mixture. After that, the pH and the total volume were adjusted. In the table, the "appropriate amount" of the content of the pH adjuster means the amount required to adjust the pH of the ophthalmic composition of each example at 25°C to the value shown in the table. For the ophthalmic compositions obtained in each example, the adsorption rate and adsorption improvement rate of component (A) after storage were determined by the above-mentioned method, and the adsorption suppression effect of component (A) was evaluated. The results are shown in the table.

[0121] [Table 1]

[0122] [Table 2]

[0123] [Table 3]

[0124] [Table 4]

[0125] [Table 5]

[0126] As shown in the results in Tables 1 to 5, the ophthalmic compositions of the examples containing components (A) and (B) suppressed adsorption of component (A) compared to the ophthalmic compositions of the comparative examples not containing component (B).

[0127] Formulation examples of ophthalmic compositions are shown in Tables 6 to 8. The unit of content of each component is w / v % unless otherwise specified.

[0128] [Table 6]

[0129] [Table 7]

[0130] [Table 8] [Explanation of symbols]

[0131] 1...liquid drip container, 1A...accommodation space, 10...Container body, 11...hole, 12...lower main body, 14...Inner plug member, 20...Discharge port, 20A…Discharge direction, 30...Pressure deformation portion, 30A...Pressing direction, 30B…spherical part, 31...first cylinder part, 32...first flange portion, 33...first occlusion part, 34...Ring section, 35...space, 41...Second cylinder part, 42...second flange portion, 43...second occlusion part, 50...Protruding body, 51...slanted part, 52...second slope part, θ1: First intersection angle θ2...Second intersection angle.< / ph>

Claims

1. An ophthalmic product comprising an ophthalmic composition and a container filled with the ophthalmic composition, the container has a container body having a discharge port and a pressure-deformable portion, and a cap; the pressure-deformation portion is formed using an elastic material selected from the group consisting of styrene-based elastomer, low-density polyethylene, and silicone rubber, An ophthalmic product, wherein the ophthalmic composition comprises the following component (A) and the following component (B): (A) One or more members selected from the group consisting of chlorpheniramine, diphenhydramine, and pharmaceutically acceptable salts thereof. (B) One or more selected from the group consisting of amino acids and their salts, glycyrrhizinic acid and its salts, mucopolysaccharides and their salts, trometamol and its salts, ethylenediaminetetraacetic acid and its salts, and vitamins and their derivatives.

2. 2. The ophthalmic product according to claim 1, wherein the component (B) comprises one or more selected from the group consisting of amino acids and salts thereof, and the amino acids and salts thereof are potassium L-aspartate, aminoethylsulfonic acid, and epsilon-aminocaproic acid.

3. 2. The ophthalmic product according to claim 1, wherein the component (B) comprises one or more selected from the group consisting of vitamins and derivatives thereof, and the vitamins and derivatives thereof are pyridoxine hydrochloride and d-α-tocopherol acetate.

4. 2. The ophthalmic product according to claim 1, wherein the component (B) comprises one or more selected from the group consisting of mucopolysaccharides and salts thereof, and the mucopolysaccharides and salts thereof are sodium chondroitin sulfate and sodium hyaluronate.

5. 2. The ophthalmic product according to claim 1, wherein the ophthalmic composition has a pH of 3.5 to 8.0 at 25°C.

6. The ophthalmic product of claim 1 , wherein the elastic material is a styrene-based elastomer.

7. The ophthalmic product according to any one of claims 1 to 6, wherein the pressure-deforming portion elastically deforms between a first position where it protrudes outside the container body when not pressed and forms a space inside that communicates with the storage space, and a second position where it is located closer to the storage space than the first position when pressed, and the ophthalmic composition is ejected from the ejection port due to the change in volume between the first position and the second position.

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