WO2024135344A1 - Produit ophtalmique - Google Patents

Produit ophtalmique Download PDF

Info

Publication number
WO2024135344A1
WO2024135344A1 PCT/JP2023/043479 JP2023043479W WO2024135344A1 WO 2024135344 A1 WO2024135344 A1 WO 2024135344A1 JP 2023043479 W JP2023043479 W JP 2023043479W WO 2024135344 A1 WO2024135344 A1 WO 2024135344A1
Authority
WO
WIPO (PCT)
Prior art keywords
ophthalmic
ophthalmic composition
sodium
acid
composition
Prior art date
Application number
PCT/JP2023/043479
Other languages
English (en)
Japanese (ja)
Inventor
恭平 椛嶋
Original Assignee
ライオン株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by ライオン株式会社 filed Critical ライオン株式会社
Publication of WO2024135344A1 publication Critical patent/WO2024135344A1/fr

Links

Definitions

  • the present invention relates to an ophthalmic product housed in a container that has been sterilized using electron beam or gamma radiation.
  • Ophthalmic compositions are required to remain sterile until they are opened.
  • Methods for sterilizing ophthalmic compositions include incorporating a preservative into the ophthalmic composition, but the containers used must also be sterilized, and a method for doing so has been proposed.
  • hyaluronic acid or a salt thereof is able to retain moisture on the surface of the eye for a long time due to its high water retention, and also has the effect of repairing damage to the surface of the eye.
  • Chlorhexidine is effective as a preservative. The inventors have found that when an ophthalmic composition containing these two components is stored in a container that has been sterilized with electron beams or gamma rays, insoluble matter is generated after freezing and thawing (freezing and then returning to room temperature), and the stability of the appearance is reduced. The objective of the present invention is to solve this problem.
  • the present invention provides an ophthalmic product comprising: 1. (A) hyaluronic acid or a salt thereof, An ophthalmic composition comprising (B) chlorhexidine and (C) epsilon aminocaproic acid or a salt thereof, An ophthalmic product housed in a container that has been sterilized by electron beam or gamma radiation. 2. The ophthalmic product according to 1, wherein the content mass ratio represented by (C)/(B) is 100 to 5,000. 3. The ophthalmic product according to 1 or 2, wherein the content of component (A) in the ophthalmic composition is 0.01 to 0.1 w/v %. 4.
  • the present invention provides an ophthalmic product that suppresses the generation of insoluble matter after freezing and thawing and has excellent appearance stability, and that contains an ophthalmic composition containing (A) hyaluronic acid or a salt thereof and (B) chlorhexidine, and that is housed in a container that has been sterilized with electron beams or gamma rays.
  • the hyaluronic acid or its salt of the present invention is not particularly limited, and any hyaluronic acid that is usually used in mucous membrane application preparations in the ophthalmic field can be used.
  • hyaluronic acids include hyaluronic acid, its derivatives, and their pharmacologic and physiologically acceptable salts. Those obtained by extraction from cockscomb, fermentation by microorganisms, etc. can be used, and the origin and manufacturing method are not particularly limited.
  • Hyaluronic acid or its salt can be used alone or in appropriate combination of two or more.
  • component (A) examples include hyaluronic acid, sodium hyaluronate, potassium hyaluronate, magnesium hyaluronate, calcium hyaluronate, etc. Among them, sodium hyaluronate is preferred.
  • component (A) commercially available products can be used, such as purified sodium hyaluronate (manufactured by Seikagaku Corporation, Kewpie Corporation, Kikkoman Biochemifa Corporation, Iwaki Pharmaceutical Co., Ltd., and Blue Meiji Biotechnology Co., Ltd.).
  • the average molecular weight of component (A) is preferably 500,000 to 5,000,000, more preferably 500,000 to 4,000,000, even more preferably 500,000 to 2,500,000, particularly preferably 500,000 to 2,000,000, and most preferably 500,000 to 1,490,000.
  • the average molecular weight of component (A) is measured by the method for measuring average molecular weight described in the "Purified Sodium Hyaluronate" section of the Japanese Pharmacopoeia, 18th Edition, Pharmaceutical Articles. Note that multiple types of hyaluronic acid and/or salts with different average molecular weights can be used.
  • component (A) such as “Sodium Hyaluronate “Seikagaku”” (average molecular weight 500,000 to 1,200,000) and “Cosmetic Sodium Hyaluronate (HC)” (average molecular weight 530,000 to 1,330,000) manufactured by Seikagaku Corporation, “Hyaluronic Acid FCH-60” (average molecular weight 500,000 to 700,000), “Hyaluronic Acid FCH-80” (average molecular weight 600,000 to 1,000,000), “Hyaluronic Acid FCH-120” (average molecular weight 1,000,000 to 1,400,000), and “Hyaluronic Acid FCH-150” (average molecular weight 1,400,000 to 1,800,000) manufactured by Kikkoman Biochemifa Corporation.
  • HC Cosmetic Sodium Hyaluronate
  • “Hyaluronic acid FCH-151C” (average molecular weight 1.4 million to 1.8 million), “Hyaluronic acid FCH-200” (average molecular weight 1.8 million to 2.2 million), “Hyaluronic acid FCH-201C” (average molecular weight 1.8 million to 2.2 million), “Hyaluronic acid FCH-80LE” (average molecular weight 600,000 to 1.2 million), “Hyaluronic acid GS-100” (average molecular weight 500,000 to 1.49 million), “Hyaluronic acid HA-QA” (average molecular weight 600,000 to 1.2 million), “Hyaluronic acid HA-AM” (average molecular weight 600,000 to 1.2 million), “Hyaluronic acid HA-Q” (average molecular weight 530,000 to 1.13 million), “Hyaluronic Acid M5070” (average molecular weight 500,000 to 700,000), “Hyaluronic Acid HA-LQ” (average molecular weight 850,000
  • the content of component (A) in the ophthalmic composition is preferably 0.001 w/v% (mass/volume %, g/100 mL) or more, more preferably 0.005 w/v% or more, and even more preferably 0.001-0.3 w/v%, 0.005-0.2 w/v%, 0.01-0.15 w/v%, 0.01-0.1 w/v%, and 0.05-0.1 w/v% in that order. If the content of component (A) is too high, the viscosity of the ophthalmic composition may be too high, which may cause blurring, etc. By keeping the content at 0.1 w/v% or less, the occurrence of insoluble matter after freezing and thawing is further suppressed and the appearance stability is further improved.
  • the chlorhexidine is not particularly limited, and any chlorhexidine generally used in preparations for mucosal application in the ophthalmic field can be used, and one type can be used alone or two or more types can be used in combination.
  • Chlorhexidine may be in the form of a salt, and examples of the salt include chlorhexidine gluconate, chlorhexidine acetate, and chlorhexidine hydrochloride. Among these, chlorhexidine gluconate is preferred.
  • the content of component (B) in the ophthalmic composition is preferably 0.0001 to 0.01 w/v%, more preferably 0.0002 to 0.005 w/v%, even more preferably 0.0002 to 0.002 w/v%, and particularly preferably 0.0002 to 0.0005 w/v%.
  • the content of component (B) is preferably 0.0001 to 0.01 w/v%, more preferably 0.0002 to 0.005 w/v%, even more preferably 0.0002 to 0.002 w/v%, and particularly preferably 0.0002 to 0.0005 w/v%.
  • Component (C) In the present invention, by blending (C) epsilon aminocaproic acid or a salt thereof in an ophthalmic composition, the ophthalmic composition containing (A) hyaluronic acid or a salt thereof and (B) chlorhexidine suppresses the generation of insoluble matter after freezing and thawing, which is a problem specific to ophthalmic products contained in a container sterilized by electron beam or gamma ray, and improves the appearance stability.
  • Epsilon-aminocaproic acid is a known compound as a neutral amino acid also called 6-aminohexanoic acid.
  • the salt of epsilon aminocaproic acid used in the present invention is not particularly limited as long as it is medicamentarily, pharmacologically (pharmaceutical) or physiologically acceptable, and can be used alone or in combination of two or more.
  • Specific examples of salts of epsilon aminocaproic acid include organic acid salts [e.g., monocarboxylates (acetates, trifluoroacetates, butyrates, palmitates, stearates, etc.), polycarboxylates (fumarates, maleates, succinates, malons, etc.), oxycarboxylates (lactates, tartrates, citrates, etc.), organic sulfonates (methanesulfonates, toluenesulfonates, tosylates, etc.)], inorganic acid salts (e.g., hydrochlorides, sulfates, nitrates, hydrobromides, phosphates
  • epsilon aminocaproic acid is preferred.
  • component (C) a commercially available product can be used, for example, " ⁇ -amino-n-caproic acid EKD" manufactured by Sekisui Medical Co., Ltd.
  • the content of component (C) in the ophthalmic composition is preferably 0.005 to 3 w/v%, more preferably 0.015 to 2 w/v%, even more preferably 0.01 to 2 w/v%, even more preferably 0.1 to 1 w/v%, even more preferably 0.2 to 0.8 w/v%, particularly preferably 0.2 to 0.5 w/v%, and most preferably 0.3 to 0.5 w/v%.
  • Component (D) By further blending (D) propylene glycol in the ophthalmic composition of the present invention, the generation of insoluble matters after freezing and thawing can be further suppressed, and the appearance stability can be further improved.
  • the content of component (D) in the ophthalmic composition is preferably 0.01 to 1 w/v%, more preferably 0.03 to 0.5 w/v%, and even more preferably 0.05 to 0.4 w/v%.
  • Component (E) By further blending sodium chloride (E) in the ophthalmic composition of the present invention, the generation of insoluble matters after freezing and thawing can be further suppressed, and the appearance stability can be further improved.
  • the content of component (E) in the ophthalmic composition is preferably 1.0 w/v% or less, more preferably 0.9 w/v% or less, and even more preferably 0.7 w/v% or less. More specifically, it is preferably 0.1 to 1.0 w/v%, more preferably 0.2 to 0.9 w/v%, and even more preferably 0.3 to 0.7 w/v%.
  • the preferred range of the mass ratio of each component in the ophthalmic composition is shown below. Note that this ratio is a w/v % ratio, but is the same value as the mass ratio.
  • (C)/(B) is preferably 100 or more, and more preferably 200 or more. More specifically, (C)/(B) is preferably 100 to 5,000, more preferably 150 to 3,000, even more preferably 200 to 2,000, particularly preferably 350 to 2,000, and most preferably 400 to 2,000.
  • (D)/(C) is preferably 0.01 to 3.0, more preferably 0.1 to 2.0, even more preferably 0.2 to 1.2, and particularly preferably 0.3 to 1.0.
  • (A)/(E) is preferably 0.05 to 0.70, more preferably 0.10 to 0.50, and even more preferably 0.13 to 0.30.
  • ((C)+(D))/(B) is preferably 100 to 5,000, more preferably 150 to 4,000, and even more preferably 200 to 3,000.
  • the ophthalmic composition of the present invention may contain other components in appropriate amounts within the range that does not impair the effects of the present invention.
  • other components include drugs, surfactants, buffers, local anesthetics or soothing agents, pH adjusters, stabilizers, sugars, polyhydric alcohols, thickeners, cooling agents, other inorganic compounds, oily components, etc. These components may be used alone or in appropriate combinations of two or more. The contents of the components shown below are the preferred ranges when they are used, and are the amounts in the composition.
  • Drugs include, for example, congestion relief ingredients (vasoconstrictors) (e.g., epinephrine, epinephrine hydrochloride, methylnorepinephrine, norepinephrine, ephedrine, methylephedrine, pseudoephedrine, ephedrine hydrochloride, tetrahydrozoline hydrochloride, naphazoline nitrate, phenylephrine hydrochloride, dl-methylephedrine hydrochloride, oxymetazoline, methoxamine, phenylpropanolamine, etilefrine, midodrine, tramazoline, synephrine ...
  • congestion relief ingredients e.g., epinephrine, epinephrine hydrochloride, methylnorepinephrine, norepinephrine, ephedrine, methylephedrine, pseudoe
  • the amount can be selected based on the effective amount of each drug, but it is preferably 0.001 to 5.0 w/v% in the ophthalmic composition, more preferably 0.001 to 1 w/v%, and even more preferably 0.001 to 0.1 w/v%.
  • Surfactants include nonionic surfactants (e.g., polyoxyethylene castor oil, polyoxyethylene hydrogenated castor oil, polyoxyethylene sorbitan fatty acid esters, polyoxyethylene polyoxypropylene glycol, polyethylene glycol monostearate, etc.), amphoteric surfactants (e.g., glycine-type amphoteric surfactants such as alkyl diaminoethyl glycine and alkyl polyaminoethyl glycine, betaine-type amphoteric surfactants such as lauryl dimethyl amino acetate betaine and imidazolium betaine), and cationic surfactants (e.g., benzalkonium chloride, benzethonium chloride, etc.).
  • nonionic surfactants e.g., polyoxyethylene castor oil, polyoxyethylene hydrogenated castor oil, polyoxyethylene sorbitan fatty acid esters, polyoxyethylene polyoxypropylene glycol, polyethylene glycol monoste
  • the amount in the ophthalmic composition is preferably 0.0001 to 5 w/v%, more preferably 0.0003 to 3 w/v%, and even more preferably 0.003 to 1 w/v%.
  • buffering agents include boric acid or its salts (e.g., borax), trometamol, citric acid or its salts (e.g., sodium citrate), phosphoric acid or its salts (e.g., sodium hydrogen phosphate, sodium dihydrogen phosphate), tartaric acid or its salts (e.g., sodium tartrate), gluconic acid or its salts (e.g., sodium gluconate), acetic acid or its salts (e.g., sodium acetate), glacial acetic acid, carbonic acid or its salts (e.g., sodium carbonate, sodium bicarbonate), various amino acids (potassium aspartate, aminoethylsulfonic acid, glutamic acid, sodium glutamate), etc.
  • boric acid or its salts e.g., borax
  • phosphoric acid or its salts e.g., sodium hydrogen phosphate, sodium
  • the amount is preferably 0.001 to 5.0 w/v % in the ophthalmic composition, more preferably 0.001 to 2 w/v %, and even more preferably 0.001 to 1 w/v %.
  • isotonicity agents examples include potassium chloride, calcium chloride, sodium bicarbonate, sodium carbonate, dry sodium carbonate, magnesium sulfate, sodium hydrogen phosphate, sodium dihydrogen phosphate, potassium dihydrogen phosphate, glycerin, etc.
  • the amount thereof in the ophthalmic composition is preferably 0.00001 to 3 w/v%, more preferably 0.0001 to 2 w/v%, and even more preferably 0.005 to 1.5 w/v%.
  • Local anesthetics or soothing agents include, for example, chlorobutanol, oxybuprocaine hydrochloride, dibucaine hydrochloride, tetracaine hydrochloride, piperocaine hydrochloride, procaine hydrochloride, proparacaine hydrochloride, hexothiocaine hydrochloride, lidocaine hydrochloride, etc.
  • the amount thereof in the ophthalmic composition is preferably 0.001 to 1.0 w/v %, more preferably 0.01 to 0.5 w/v %.
  • pH adjusters include inorganic acids and inorganic alkali agents.
  • an example of an inorganic acid is (dilute) hydrochloric acid.
  • examples of inorganic alkali agents include sodium hydroxide, potassium hydroxide, sodium carbonate, and sodium bicarbonate.
  • Examples of monoethanolamine and diethanolamine are also included.
  • the pH of the composition can be set to 3.5 to 13.0, and is preferably 3.5 to 8.0, and more preferably 5.5 to 8.0, from the viewpoint of further improving the various symptoms caused by destabilization of the tear lipid layer.
  • the pH is measured at 25°C using a pH meter (HM-25R, manufactured by DKK-TOA Corporation).
  • stabilizers examples include sodium edetate, sodium edetate hydrate, cyclodextrin, monoethanolamine, etc.
  • stabilizers (antioxidants) include fat-soluble antioxidants such as dibutylhydroxytoluene (BHT), butylhydroxyanisole (BHA), and vitamin E (e.g., tocopherol acetate, tocopherol nicotinate, tocopherol succinate, etc.).
  • water-soluble stabilizers examples include sulfites such as sodium sulfite, potassium sulfite, dried sodium sulfite (anhydrous sodium sulfite), sodium pyrosulfite, potassium pyrosulfite, sodium hydrogensulfite, and potassium hydrogensulfite, ascorbic acid, sodium ascorbate, etc.
  • a stabilizer When a stabilizer is to be incorporated into an ophthalmic composition for soft contact lenses, it is preferable to use one that has low lens adsorption and accumulation properties, and examples of such stabilizers include sodium edetate, sodium edetate hydrate, cyclodextrin, vitamin E, vitamin A, sodium sulfite, potassium sulfite, dried sodium sulfite (anhydrous sodium sulfite), sodium pyrosulfite, potassium pyrosulfite, sodium hydrogensulfite, and potassium hydrogensulfite, ascorbic acid, sodium ascorbate, etc.
  • the amount is preferably 0.001 to 5.0 w/v% in the ophthalmic composition, more preferably 0.001 to 1 w/v%, and even more preferably 0.001 to 0.1 w/v%.
  • sugars examples include glucose, cyclodextrin, xylitol, sorbitol, mannitol, etc. 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 isotonicity agents. When sugars are added, their amount in the ophthalmic composition is preferably 0.001 to 5.0 w/v%, more preferably 0.001 to 1 w/v%, and even more preferably 0.001 to 0.1 w/v%.
  • polyhydric alcohols examples include glycerin, butylene glycol, polyethylene glycol, xylitol, mannitol, and sorbitol.
  • Polyhydric alcohols have moisturizing properties and can increase the moisture content of the eye when applied, and can also be used as isotonicity agents.
  • Glycerin can also be used as a solubilizer for cooling agents.
  • their amount in the ophthalmic composition is preferably 0.001 to 5.0 w/v%, more preferably 0.001 to 1 w/v%, and even more preferably 0.001 to 0.1 w/v%.
  • Thickening agents include water-soluble polymeric compounds, such as polyvinylpyrrolidone, hydroxyethyl cellulose, hydroxypropyl methylcellulose, methyl cellulose, polyvinyl alcohol, sodium chondroitin sulfate, polyacrylic acid, carboxyvinyl polymer, polyethylene glycol, dextran, alginic acid, sodium alginate, and xanthan gum.
  • thickening agents When thickening agents are added, they can be added to an extent that does not impair the feeling of use, such as stickiness or blurring.
  • the amount is preferably 0.001 to 5.0 w/v% in the ophthalmic composition, more preferably 0.001 to 1 w/v%, and even more preferably 0.001 to 0.1 w/v%.
  • the refreshing agent may be, for example, menthol, camphor, borneol, geraniol, cineole, linalool, anethole, eugenol, limonene, ryunou, etc. Any of the d-, l- or dl-isomers may be used.
  • essential oils such as peppermint oil, cool mint oil, spearmint oil, peppermint oil, eucalyptus oil, rose oil, fennel oil, bergamot oil, and cinnamon oil may be used.
  • the refreshing agent can enhance the feeling of the effect of sustained moisture.
  • the amount thereof in the ophthalmic composition is preferably 0.0001 to 1 w/v%, more preferably 0.0005 to 0.2 w/v%, and even more preferably 0.001 to 0.1 w/v%.
  • inorganic compounds include sodium thiosulfate, titanium oxide, zinc chloride, etc. When these are added, the amount is preferably 0.001 to 5 w/v% in the ophthalmic composition, more preferably 0.001 to 1 w/v%, and even more preferably 0.001 to 0.1 w/v%.
  • the ophthalmic composition of the present invention is preferably an "aqueous ophthalmic composition".
  • the "aqueous ophthalmic composition” refers to an ophthalmic composition in which the medium is water.
  • the content of water in the composition is preferably 90.0 to 99.5 w/v %, and more preferably 95.0 to 99.0 w/v %.
  • the transmittance of the ophthalmic composition at 600 nm is preferably 98.0 to 100.0%, and more preferably 99.0 to 100.0%.
  • the transmittance of the ophthalmic composition at 600 nm after freezing and thawing is preferably 98.0% or more, more preferably 98.5% or more, and even more preferably 99.0% or more.
  • the formulation of the composition of the present invention is not particularly limited, and can be suitably used, for example, as eye drops (including eye drops that can be applied while wearing contact lenses), eyewash, contact lens application solution, contact lens removal solution, etc. It can be particularly suitably used as eye drops and contact lens application solution, with eye drops being particularly preferred. Among these, it is suitable as an ophthalmic composition for contact lenses used by contact lens wearers, such as eye drops that can be applied while wearing contact lenses, contact lens application solution, contact lens removal solution, etc.
  • 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 soft contact lenses and silicone hydrogel contact lenses.
  • the method for producing the composition of the present invention is not particularly limited, but for example, the composition can be obtained by pre-dissolving (A), then mixing the solution with a solution containing an aqueous component such as component (B), adjusting the pH, and then adjusting the total volume with water.
  • the method for mixing each liquid may be a general method, and is appropriately carried out using a pulsator, propeller blade, paddle blade, turbine blade, etc., but the rotation speed is not particularly limited, and it is preferable to set it to a level that does not cause vigorous foaming.
  • the mixing temperature of each liquid is not particularly limited, but it is preferable that it is not high from the viewpoint of the stability of component (A), and is appropriately selected from the range of 20 to 60°C.
  • the present invention is an ophthalmic product comprising the above-mentioned ophthalmic composition contained in a container that has been sterilized with electron beams or gamma rays.
  • the container is preferably a plastic container, and may be made of materials such as polyethylene (PE), polyethylene terephthalate (PET), polypropylene (PP), polybutylene, polycarbonate, polyarylate, vinyl chloride, or a composite of these materials. Among these, polyethylene, polyethylene terephthalate, and polypropylene are preferred.
  • the amount of the ophthalmic composition in the product can be appropriately selected depending on the product and its method of use. For example, in the case of eye drops, 2 to 20 mL is preferred, and 5 to 20 mL is more preferred.
  • the container for the ophthalmic composition is not particularly limited, and may be a multi-dose (multi-unit) container or a single-use unit-dose container. A multi-dose (multi-unit) container is preferred.
  • the method of sterilization using electron beams or gamma rays is not particularly limited, and can be carried out according to conventionally known sterilization conditions.
  • the ophthalmic composition may be contained in a container that has been sterilized with electron beams or gamma rays, and an inert gas such as nitrogen may be sealed in the space formed between the container and the packaging body, or the ophthalmic composition may be filled into the container, and then sealed in the packaging body together with an oxygen scavenger.
  • the inner stopper and cap may be made of a material used for known containers of ophthalmic products.
  • the material of the inner stopper is preferably polyethylene or polypropylene having a melt flow rate of 2.0 or less, preferably 1.2 to 1.8.
  • the material of the cap is preferably polyethylene or polypropylene.
  • the method of the present invention is a method for stabilizing the appearance of the ophthalmic composition, which comprises (A) hyaluronic acid or its salt and (B) chlorhexidine, and is contained in a container that is sterilized by electron beam or gamma ray, and (C) epsilon aminocaproic acid or its salt is added to the ophthalmic composition.
  • the preferred components and amounts are the same as above.
  • this appearance stabilization method refers to suppressing the deterioration of the appearance of the ophthalmic product after freezing and thawing (freezing and then returning to room temperature).Specifically, the appearance stability after freezing and thawing is evaluated by the method described in Examples.
  • the 600 nm transmittance of the ophthalmic composition product of the present invention is preferably 99.0 to 100.0%, and the transmittance after three repeated freezing and thawing operations is preferably 97.5 to 100.0%, more preferably 98.0 to 100.0%.
  • the present invention will be described in detail below with examples and comparative examples, but the present invention is not limited to the following examples.
  • the present invention will be described in detail below with examples and comparative examples, but the present invention is not limited to the following examples.
  • the "%" of the composition is "w/v % (g/100 mL)" and the ratio is w/v % ratio, which is the same value as the mass ratio.
  • Examples and Comparative Examples In order to obtain the composition shown in the table, the components other than purified water and the pH adjuster were dissolved in 90 mL of purified water and mixed by stirring at room temperature (25°C) for 18 hours. Next, the pH of the ophthalmic composition was adjusted with a pH adjuster as necessary so that the pH of the ophthalmic composition at 25°C would be 6.5, and the remaining purified water was added to make the total volume 100 mL to obtain an ophthalmic composition. A pH meter (manufactured by DKK-TOA Corporation, product name "HM-25R”) was used to measure the pH. The obtained composition was evaluated as follows. The results are also shown in the table. The pH of the composition was in the range of 6.0 to 7.0.
  • Propylene glycol Japanese Pharmacopoeia Propylene Glycol, manufactured by ADEKA Corporation
  • Sodium chloride Japanese Pharmacopoeia Sodium Chloride SG, manufactured by Tomita Pharmaceutical Co., Ltd.
  • Sodium edetate Sodium edetate hydrate "For manufacturing only", manufactured by Fujifilm Wako Pure Chemical Industries, Ltd.

Landscapes

  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

Ce produit ophtalmique est une composition destinée à une utilisation ophtalmique contenue dans un récipient qui a été stérilisé par des faisceaux d'électrons ou des rayons gamma. La composition contient (A) de l'acide hyaluronique ou un sel de celui-ci, (B) de la chlorhexidine, et (C) un acide epsilon-aminocaproïque ou un sel de celui-ci.
PCT/JP2023/043479 2022-12-21 2023-12-05 Produit ophtalmique WO2024135344A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2022-204451 2022-12-21
JP2022204451 2022-12-21

Publications (1)

Publication Number Publication Date
WO2024135344A1 true WO2024135344A1 (fr) 2024-06-27

Family

ID=91588459

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2023/043479 WO2024135344A1 (fr) 2022-12-21 2023-12-05 Produit ophtalmique

Country Status (1)

Country Link
WO (1) WO2024135344A1 (fr)

Similar Documents

Publication Publication Date Title
JP5549669B2 (ja) 眼科用組成物、ドライアイ治療剤及びビタミンａの安定化方法
JP5736635B2 (ja) ドライアイ治療剤
JP4694773B2 (ja) 粘膜適用液状組成物
JP7120018B2 (ja) 眼科用製品及び粘度低下抑制方法
JP2009173638A (ja) 眼科用組成物及びビタミンａ類の安定化方法
JP2018177820A (ja) 水性眼科組成物
JP2023052927A (ja) 水性眼科組成物
JP2024061871A (ja) 眼科組成物
US9050369B2 (en) Aqueous ophthalmic composition
JP7314986B2 (ja) 眼科用製品及び粘度低下抑制方法
JP2011213599A (ja) ソフトコンタクトレンズ用眼科組成物
JP7104553B2 (ja) 眼科組成物
JP2019202166A (ja) 眼科組成物
JP5518608B2 (ja) 粘膜適用液状組成物
MX2014006056A (es) Composicion de gel de celulosa con una mejor estabilidad de la viscosidad.
JP2023126377A (ja) 眼科組成物
JP5922505B2 (ja) グリチルリチン酸含有水性眼科組成物
WO2024135344A1 (fr) Produit ophtalmique
JP5984531B2 (ja) 水性眼科組成物
JP2021155414A (ja) ソフトコンタクトレンズ用眼科組成物
JP2007277233A (ja) 眼科用組成物
JP2018115119A (ja) 眼科組成物
JP7014078B2 (ja) 眼科用組成物及び析出抑制方法
JP7379913B2 (ja) ソフトコンタクトレンズ用眼科組成物及び眼科用製品
JP2003300871A (ja) 眼科用組成物