Contact lens package

Abstract

This invention provides a contact lens package that appropriately controls the volatilization and adsorption of terpenoids, thereby offering soft contact lenses with superior wearing comfort. [Solution] A contact lens package is provided comprising a resin container with a sealed lid, a soft contact lens housed in the resin container, and a contact lens packaging solution containing a terpenoid and a nonionic surfactant for immersing the soft contact lens, wherein the contact lens package is autoclaved, the nonionic surfactant content is 0.01 to 0.1% by mass relative to the total amount of the packaging solution, and the filling rate of the packaging solution in the resin container is 60% or more when the inner surface of the sealed lid is flat.

Description

Technical Field

[0001] The present invention relates to a contact lens package that enhances the stability of terpenoids in a contact lens packaging solution.

Background Art

[0002] The number of contact lens wearers in Japan is said to be 15.64 million (Yano Research Institute, Ltd. in 2018). Among them, the number of wearers of disposable soft contact lenses that are discarded within one month has been increasing, and the number of wearers in 2019 has become the mainstream at 14.49 million. Also, among the wearers of disposable soft contact lenses, 41% use frequently replaced soft contact lenses that are cleaned and disinfected and used for a certain period, and 59% are so-called one-day disposable soft contact lenses (hereinafter abbreviated as 1DSCL) that do not require cleaning and disinfection. The reason for the increase in 1DSCL to this extent is largely due to cost reduction in manufacturing by contact lens manufacturers. On the other hand, although there is a strong demand to improve the wearing feeling of contact lenses and to suppress dryness and itching sensations that are easily felt by contact lens wearers, coating and surface treatment, which are representative technologies for improving the wearing feeling of contact lenses, are the main factors that increase the manufacturing cost due to an increase in manufacturing man-hours. Therefore, in 1DSCL where cost reduction in manufacturing is essential, there is a strong demand for technologies that can improve the wearing feeling without particularly increasing the lens manufacturing man-hours (Patent Document 1).

[0003] On the other hand, a method of improving the wearing feeling by adding various functional components to a contact lens packaging solution is known (Patent Document 2, Non-Patent Document 1). However, the functional components in the packaging solution​​​​​​​​​​​​​ The active ingredient diffuses into the tear film within the conjunctival sac when contact lenses are worn, and its pharmacokinetics after instillation are similar to those of other ophthalmic agents. Most of it is excreted with tears within 1-2 minutes. Therefore, this functional ingredient improves wearing comfort. The time it takes to achieve this is far too short compared to the wearing time of more than 8 hours. Also, contact lenses A high-molecular-weight component and manufacturing method that provides sustained effects by physically adsorbing onto the polymer components of the lenses is known. However, such labor-intensive and specialized manufacturing methods drive up manufacturing costs. It is unsuitable for CL.

[0004] To reduce discomfort when inserting and wearing contact lenses, the 1DSCL packaging solution contains menthol. Products containing thor were commercially available (Non-Patent Document 2). [Prior art documents] [Patent Documents]

[0005] [Patent Document 1] Patent No. 5877793 [Patent Document 2] Patent No. 5247597 [Patent Document 3] Patent No. 5622589 [Non-patent literature]

[0006] [Non-Patent Document 1] MB Gorbet et al. Corneal epithelial cell biocompatibility to SiH & conventional hydrogel CL packaging solutions, Molecular Vision 2010; 16:272-282 [Non-Patent Document 2] Seed 1dayFine C (Cool) Package Insert, April 1, 2010 (New Format, 1st Edition) [Overview of the project]

Problems to be Solved by the Invention

[0007] However, in the packaging form such as the product, a blister pack in which a polypropylene container is aluminum-sealed, in the packaging liquid, the terpenoid volatilizes by high-pressure steam sterilization carried out in the manufacturing process, or adsorbs to the polyethylene or polypropylene on the adhesion surface of the polypropylene container and the aluminum sheet, resulting in a significant reduction in the terpenoid. We have newly found that this problem occurs. To solve this problem, there may be a method of adding an excessive amount of terpenoid in advance. However, due to the addition of a large amount of terpenoid, a large amount of terpenoid also adsorbs to the soft contact lens itself, and after wearing, it is released into the tear fluid, and eye irritation caused by excessive terpenoid becomes a further problem.

[0008] On the other hand, as a packaging container, there is also a packaging form using a glass container with less terpenoid adsorption. However, in the case of 1DSCL where the manufacturing cost must be kept low as described above, for one soft contact lens, a packaging form using a single glass container cannot be adopted, and in fact, glass bottles are not used. Therefore, an object of the present invention is to provide a contact lens package for providing a soft contact lens with excellent wearing comfort by appropriately controlling the volatilization and adsorption of terpenoids.

Means for Solving the Problems

[0009]

[0010]

[0011] ​​​​​​​​​In order to solve the above problems, as a result of various studies by the present inventors, a contact lens packaging solution contains a certain amount of nonionic surfactant, and this packaging solution is adjusted to a certain filling rate with respect to the packaging container so that the volatilization and adsorption of terpenoids during the manufacturing process of the contact lens package can be appropriately controlled. As a result, it has been found that while suppressing the discomfort during and while wearing the contact lens, it does not give excessive irritation, and the present invention has been completed to .

[0012] That is, the present invention provides a contact lens package described below. [1] A resin container with a sealed lid, A soft contact lens housed in the resin container, A contact lens packaging solution that immerses the soft contact lens and contains (A) terpenoid and (B) nonionic surfactant A contact lens package comprising: wherein the contact lens package is sterilized by high-pressure steam, the content of the (B) nonionic surfactant is 0.001 to 0. 5% by mass with respect to the total amount of the packaging solution, when the inner surface of the sealed lid is flat, the filling rate of the packaging solution with respect to the resin container is 60 % or more, a contact lens package.

[0013] High-pressure steam sterilization of the contact lens package is usually performed using an autoclave in order to ensure sterility. In this specification, sterilization means a method used to make the contact lens package free from viable microorganisms. The contact lens package has a sterilization step in the manufacturing process ​​​It then goes through a process before being commercialized.

[0014] Contact lens packages containing soft contact lenses are typically made of polypropylene. It has a structure in which a resin container such as a len is heat-sealed with a sealed lid. Soft contact lenses are immersed in contact lens packaging solution to prevent drying, etc. It is being done.

[0015] When terpenoids are incorporated into this contact lens packaging solution, the component is volatile. Therefore, under sterilization conditions using an autoclave, terpenos are produced inside the contact lens package. The iodide evaporates and, over time, is adsorbed onto the resin container and airtight lid, and the terpene in the packaging liquid is absorbed. A new problem was discovered: a massive decrease in iodine content.

[0016] According to the contact lens package of the present invention, (B) the content of nonionic surfactants However, since it is 0.001 to 0.5% by mass relative to the total amount of packaging liquid, soft contact lenses Even when contact lens packages containing lenses are sterilized by autoclaving, terpenos To suppress the volatilization of the id and / or to suppress its adsorption to resins used in packaging containers, etc. This becomes possible. In addition, the packaging liquid contains a nonionic surfactant along with a terpenoid. By doing so, the nonionic surfactant conjugates the terpenoid, By loosening the binding to cold receptors in the cornea and conjunctiva, the discomfort caused by terpenoids is reduced. It is possible to suppress the sensation for a long period of time while also mitigating the initial peak of excessive coldness upon wearing. This is the result.

[0017] Furthermore, according to the contact lens package of the present invention, when the inner surface of the sealing lid is flat The filling rate of the packaging liquid in the resin container is 60% or more. Conventionally, commercially available products In contact lens packaging, the filling rate of the packaging liquid into the resin container varies depending on the product. There are also products with a filling rate of less than 60%, and the purpose of increasing the filling rate is not clearly defined. i. According to the present invention, by increasing the filling rate of the packaging liquid in the resin container to a certain level or higher, Furthermore, the volatilization of terpenoids contained in the packaging liquid into the gas phase is significant, especially when combined with other components. This makes it possible to suppress it.

[0018] [2] The content of (A) terpenoids in the packaging liquid after autoclaving is 0.00005 The contact lens package described in [1] is approximately 0.015% by mass.

[0019] According to the contact lens package of the present invention, even when sterilized by high-pressure steam, To suppress the volatilization of lupenoids and / or their adsorption to resins used in packaging containers, etc. This makes it possible to achieve a comfortable concentration of terpenoids when wearing contact lenses. It is maintained at the above content. As mentioned above, terpenoids are maintained at the above content. Conjugation with nonionic surfactants leads to the binding of terpenoids to cold receptors in the cornea and conjunctiva. By slowing down the reaction, the discomfort suppression by terpenoids is sustained for a longer period. This makes it possible to moderate the excessive cold sensation peak that occurs during the initial period of wear.

[0020] [3] In the packaging solution after autoclaving, (A) terpenoids per 1 part by mass, (B) non-io The content of the ion surfactant is 0.2 to 2000 parts by mass, as described in [1] or [2]. Contact lens packaging.

[0021] According to the present invention, terpenoids are appropriately maintained in the packaging liquid after autoclaving. Therefore, by efficiently performing conjugation with nonionic surfactants, when wearing contact lenses This makes it possible to enhance the senses.

[0022] [4] The resin in the aforementioned resin container is a thermoplastic resin, and is one of any one of [1] to [3]. The contact lens package as described.

[0023] When the resin used in a resin container is a thermoplastic resin, the constituent polymer of the resin is subjected to high pressure. The above-mentioned problem of terpenoid adsorption onto resin containers, which is susceptible to the effects of steam sterilization, is a significant issue. It occurs noticeably.

[0024] [5] The contact surface of the sealing lid with the resin container is made of thermoplastic resin, [1]~[ The contact lens package described in any one of the following four items.

[0025] If the contact surface of the airtight lid with the resin container is made of thermoplastic resin, then the resin The constituent polymer is susceptible to the effects of autoclaving, and terpenoids are adsorbed onto the sealed lid. The aforementioned problems become particularly pronounced.

[0026] [6] The sealing is achieved by a heat sealing process, one of [1] to [5] The contact lens package described in 1.

[0027] In the case of contact lens packaging lids, in many cases, they are in contact with at least the resin container. The contact surface is made of resin, and the lid member and the resin container are heat-sealed. The contact surfaces are sealed.

[0028] [7] The above-mentioned conditions for high-pressure steam sterilization are 100°C to 1°C using a high-pressure steam sterilizer (autoclave). The procedure is performed at 50°C for 5 to 30 minutes, and the contact is as described in any one of [1] to [6]. Lens packaging.

[0029] The conditions for high-pressure steam sterilization (autoclave) are for the manufacturing of contact lens packaging. There are no particular restrictions as long as the conditions under which it is used are met. For high-pressure steam sterilization, the conditions are 115°C. 30 minutes at 121°C for 20 minutes, 15 minutes at 126°C, or 10 minutes at 134°C. Spaces such as between are being used.

[0030] [8] The (B) nonionic surfactant is polyoxyethylene sorbitan fatty acid esters. Polyoxyethylene hydrogenated castor oils, polyoxyethylene castor oils, poloxamers and at least one selected from the group consisting of polyethylene glycol monostearate. The contact lens package is one of the following: [1] to [7].

[0031] This suppresses the volatilization of terpenoids and / or their adsorption to resins used in packaging containers, etc. From the perspective of controlling the process, and efficiently performing terpenoid conjugation with nonionic surfactants. Therefore, from the perspective of enhancing the comfort of wearing contact lenses, nonionic surfactants are preferred. It is commonly used. The above nonionic surfactant is chosen from the viewpoint of significantly achieving the effects of the present invention. It is preferred to use it.

[0032] [9] The packaging liquid further contains a buffering agent, according to any one of [1] to [8]. Lens packaging.

[0033] This suppresses the volatilization of terpenoids and / or their adsorption to resins used in packaging containers, etc. From a control standpoint, it is preferable to further include a buffering agent in the contact lens packaging solution. stomach.

[0034]

[10] The buffering agent is a phosphate buffering agent and / or a borate buffering agent, as described in [9]. Tact lens package.

[0035] The above-mentioned buffering agent is preferably used from the viewpoint of significantly achieving the effects of the present invention.

[0036] Furthermore, the present invention provides a method for manufacturing a contact lens package as described below.

[0037]

[11] A method for manufacturing contact lens packaging, A resin container contains soft contact lenses and (A) terpenoids and (B) nonionic A process of containing contact lens packaging solution containing a surfactant, The process of sealing the resin container with a lid, The process includes a step of sterilizing the resin container with a sealed lid using high-pressure steam, (A) 1 part by mass of terpenoid, (B) nonionic substrate The surfactant content is 0.001 to 200 parts by mass. When the inner surface of the sealing lid is flat, the filling rate of the packaging liquid into the resin container is 60 A method for manufacturing contact lens packaging, where the percentage is 1% or more.

[0038] In the manufacturing method of the present invention, the terpenoid and nonionic interface before autoclaving By adjusting the ratio of the content with the actionant, the volatilization and absorption of terpenoids during the manufacturing process can be controlled. It allows for proper control of clothing.

[0039]

[12] The residual rate of (A) terpenoids in the packaging liquid after autoclaving is 3% or more. The manufacturing method described in

[11] .

[0040] According to the manufacturing method of the present invention, the volatilization and adsorption of terpenoids during the manufacturing process can be appropriately controlled. Because it can be controlled, the remaining terpenoids in the packaging solution after autoclaving can be controlled. This makes it possible to effectively enhance [the desired effect]. [Effects of the Invention]

[0041] According to the present invention, in a contact lens package, a contact lens package containing a terpenoid Even when using a chlorine immersion solution, the volatilization and adsorption of terpenoids can be properly controlled. This allows for the reduction of discomfort during or while wearing contact lenses. This is the result. [Brief explanation of the drawing]

[0042] [Figure 1] Figure 1 is a front view showing an example of a contact lens package according to the present invention. [Figure 2] Figure 2 is a plan view showing an example of a contact lens package according to the present invention, with part of the lid removed. [Figure 3] Figure 3 is a plan view showing an example of a contact lens package according to the present invention with the lid removed. [Figure 4] Figure 4 is a graph showing the results of the menthol retention rate after autoclaving in the contact lens package of Test Example 1. [Figure 5] Figure 5 is a graph showing the results of the menthol retention rate after autoclaving in the contact lens package of Test Example 2. [Figure 6]Figure 6 is a graph showing the results of the menthol retention rate after autoclaving in the contact lens package of Test Example 3. [Modes for carrying out the invention]

[0043] Embodiments of the present invention will be described in detail below.

[0044] [Contact lens package] The contact lens package 1 of the present invention, for example, as shown in Figure 1, has a sealing lid 2. A resin container 3, a soft contact lens 4 housed in the resin container 3, and the soft The contact lens 4 is immersed in (A) a terpenoid and (B) a nonionic surfactant. It comprises a contact lens packaging solution 5.

[0045] In this specification, a contact lens package is a resin container containing contact lenses The contact lenses are contained and packaged together with the contact lens packaging solution. This refers to contact lens products. As mentioned above, contact lens packaging is made of high-quality materials to ensure sterility. It is subjected to steam sterilization.

[0046] (Contact lens packaging solution) The contact lens packaging solution contains at least (A) terpenoids and (B) nonionic bonds. Contains surfactants.

[0047] (A) Terpenoids Examples of terpenoids include menthol, menthone, camphor, borneol, and geranium. Laniol, cineole, citronellol, carvone, anethole, eugenol, limonol Examples include linalool, linalyl acetate, and their derivatives. The compound may be in the d-isomer, l-isomer, or dl-isomer.

[0048] Among these, menthol, menthone, camphor, borneol, and geraniol At least one terpenoid selected from the group is preferred, which improves wearing comfort. From this perspective, menthol and / or camphor are more preferred. Essential oils containing these are Examples include cool mint oil, peppermint oil, spearmint oil, camphor oil, and rose oil.

[0049] More specifically, when using menthol or camphor, it improves the wearing comfort. From this perspective, l-menthol, dl-menthol, d-camphor, and dl-camphor are used. It is preferable to use l-menthol and d-camphor, and more preferably dl-camphor. l-menthol is particularly preferred.

[0050] The terpenoid content is, for example, 0.000 of the total volume of the packaging liquid after autoclaving. Preferably 0.05 to 0.015 mass%, and more preferably 0.00006 to 0.014 mass%. 0.00007 to 0.013 mass% is more preferable, and 0.00008 to 0.012 mass% is also preferable. % is more preferable, 0.00009 to 0.011 mass% is particularly preferable, and 0.0001 to 0.01% by mass is most preferred.

[0051] (B) Nonionic surfactants Nonionic surfactants are permitted to the extent that they are pharmaceutically, pharmacologically (pharmaceutically) or physiologically acceptable. There are no particular restrictions. Examples of such nonionic surfactants include polyoxyethylene (hereinafter referred to as P Also known as OE. )-Polyoxypropylene (hereinafter also known as POP) block copolymer - (For example, poloxamer 407, poloxamer 235, poloxamer 188, etc.) Xamers; POE-POP block copolymers of ethylenediamines such as poloxamine - Adducts; monolauric acid POE(20) sorbitan (polysorbate 20), monoole POE(20) sorbitan ionic acid (polysorbate 80), POE sorbitan monostearate Polysorbate 60, POE sorbitan tristearate (Polysorbate 60) 5) POE sorbitan fatty acid esters such as; POE hydrogenated castor oil 5, POE hydrogenated castor oil Castor oil 10, POE hydrogenated castor oil 20, POE hydrogenated castor oil 40, POE hydrogenated castor oil 50 POE hydrogenated castor oils such as POE hydrogenated castor oil 60, POE hydrogenated castor oil 100; P POE castor oils such as OE castor oil 3, POE castor oil 10, POE castor oil 35; P OE(9) Lauryl ether and other POE alkyl ethers; POE(20) POP( 4) POE·POP alkyl ethers such as cetyl ethers; POE(10) nonyl ethers POE alkylphenyl ethers such as phenyl ethers; polyoxyl 4 stearate Examples include polyethylene glycol monostearate, such as 0. (Note: The numbers in parentheses are not part of the definition.) The letters indicate the number of moles added.

[0052] Among these, the volatilization of terpenoids is effectively suppressed and / or utilized in packaging containers, etc. From the viewpoint of effectively suppressing adsorption to the resin, polyoxyethylene sorbitan fatty acid Esters, polyoxyethylene hydrogenated castor oils, polyoxyethylene castor oils, por Selected from the group consisting of xamers and polyethylene glycol monostearate. At least one is preferred, such as poloxamer 407, poloxamer 188, and polyoxyethylene Castor oil 10%, polyoxyethylene castor oil 35%, polysorbate 80%, polyoxy Ethylene hydrogenated castor oil 40, polyoxyethylene hydrogenated castor oil 60, and stearic acid More preferably, at least one selected from the group consisting of polyoxyl 40 is polysorbate. Castor oil 80 and / or polyoxyethylene hydrogenated castor oil 60 are more preferred.

[0053] These nonionic surfactants may be used individually or in combination of two or more as desired. They can be used in combination.

[0054] The content of nonionic surfactants effectively suppresses the volatilization of terpenoids, and / or From the viewpoint of effectively suppressing adsorption to resins used in packaging containers, etc., the total amount of packaging liquid is The amount is 0.001 to 0.5 mass%, preferably 0.002 to 0.4 mass%, and 0.00 3 to 0.3 mass% is more preferable, and 0.004 to 0.2 mass% is even more preferable.

[0055] Nonionic surfactant activity relative to 1 part by mass of terpenoid in packaging solution after autoclaving. The amount of the agent is such that conjugation by nonionic surfactants is efficient, and contact lens wear From the perspective of enhancing the sensory experience, for example, it can be 0.2 to 2000 parts by mass, and 0.5 Preferably ~1800 parts by mass, more preferably 1 to 1500 parts by mass, and 2 to 1200 parts by mass More preferably, 5 to 1000 parts by mass is particularly preferred.

[0056] Furthermore, in the packaging solution before autoclaving, the nonionic bounding cells per 1 part by mass of terpenoids The amount of surfactant is such that conjugation by nonionic surfactants is efficient, and contact lenses From the perspective of enhancing the sensory experience when wearing the sunglasses, the amount is 0.001 to 200 parts by mass, and 0.005 to 18 Preferably 0 parts by mass, more preferably 0.01 to 150 parts by mass, and 0.05 to 130 parts by mass. More preferably, and particularly preferably 0.1 to 110 parts by mass.

[0057] Furthermore, the residual rate of (A) terpenoids in the packaging liquid after high-pressure steam sterilization is, for example, It can be 3% or more, preferably 3.1% or more, more preferably 3.2% or more, and 3 A concentration of 0.3% or more is more preferable, 3.5% or more is particularly preferable, and 4% or more is most preferable.

[0058] (C) buffering agent The contact lens packaging solution suppresses the volatilization of terpenoids and / or the packaging container. From the viewpoint of suppressing adsorption to the resin used, it is preferable to further include a buffering agent.

[0059] Examples of buffering agents include phosphate buffers, borate buffers, citrate buffers, and acetate buffers. You can use the following.

[0060] Examples of phosphate buffering agents include phosphoric acid, or alkali metal phosphates, and alkali metal phosphates. Examples include phosphates such as phosphate earth metal salts.

[0061] Examples of boric acid buffers include boric acid, or alkali metal borate, and alkali metal borate. Borates such as nitrate metal salts can be used.

[0062] Among these, from the viewpoint of significantly demonstrating the effects of the present invention, a phosphate buffer and / or a phosphate buffer is used. A boric acid buffer is preferred, and phosphoric acid and / or boric acid are more preferred.

[0063] These cushioning materials may be used individually or in any combination of two or more types. It may be used.

[0064] The amount of buffering agent effectively suppresses the volatilization of terpenoids and / or the contents of the packaging container, etc. From the viewpoint of effectively suppressing adsorption to the resin used, the amount of the total packaging liquid should be 0.01 to The amount is 1% by mass, preferably 0.02 to 0.9% by mass, and more preferably 0.03 to 0.8% by mass. More preferably, 0.04 to 0.7 mass% is preferred.

[0065] (Other ingredients) In addition to the components mentioned above, the contact lens packaging solution contains surfactants other than component (B), and isotonic compounds. It can be formulated with additives such as thickeners, chelating agents, stabilizers, pH adjusters, and aqueous solvents such as water. These ingredients can be used individually or in combination of two or more. You may do so.

[0066] (B) Surfactants other than component include amphoteric surfactants, cationic surfactants, or Anionic surfactants are one example. Examples of amphoteric surfactants include alkyldiaminoethyl Examples include glycine, and cationic surfactants include benzalkonium chloride and benzalkonium chloride. Examples include benzonium. Furthermore, alkylbenzene is an example of anionic surfactants. Sulfonates, alkyl sulfates, polyoxyethylene alkyl sulfates, aliphatic α-sulfonates Examples include methyl esters and α-olefin sulfonates.

[0067] For example, isotonic agents include sodium chloride, potassium chloride, glycerin, and propylene Examples include glycols, glucose, mannitol, sorbitol, and borax. From the viewpoint of controlling the swelling of contact lens material, sodium chloride and salts are used as isotonic agents. Potassium chloride is preferred, and sodium chloride is particularly preferred. Also, from a similar viewpoint, The concentration of the isotonic agent in the Ktorens packaging solution is preferably 0.2-5 (w / v)%, and is less than 0.5- 2(w / v)% is more preferable.

[0068] The thickening agents used include gum arabic powder, sodium alginate, and propylene glycol alginate. Coal ester, chondroitin sulfate sodium, sorbitol, dextran 70, Laganth powder, methylcellulose, carboxymethylcellulose, hydroxyethylcellulose cellulose, hydroxypropyl methylcellulose, carboxyvinyl polymer, polyvinyl acetate Examples include ethanol, polyvinylpyrrolidone, and macrogol 4000.

[0069] As chelating agents, edetate and edetate salts (disodium edetate, calcium edetate) are used. (Sodium thiosodium, trisodium edetate, tetrasodium edetate), nitrilotriacetic acid and their salts, trihydroxymethylaminomethane, sodium hexametaphosphate, citric acid, etc. These are some examples.

[0070] Examples of stabilizers include the aforementioned EDTA and EDTA salts, as well as sodium bisulfite. It can be done.

[0071] Examples of pH adjusting agents include sodium hydroxide, potassium hydroxide, hydrochloric acid, sulfuric acid, and acetic acid. It is possible.

[0072] The method for manufacturing contact lens packaging solution is not particularly limited and is a method commonly practiced by those skilled in the art. This can be done by law. For example, by adding the above-mentioned components to sterilized purified water at a predetermined concentration. It can be obtained by adding it in such a way that it dissolves uniformly, and then adjusting the pH.

[0073] (Contact lenses) As for contact lenses, they are soft contact lenses that meet the standards of the U.S. Food and Drug Administration (FDA). It can be used regardless of whether it is classified into lens classification groups I to IV. Among them, Group I (water content less than 50%, nonionic), Group II (water content 5 (0% or more, nonionic), or belonging to Group IV (water content of 50% or more, ionic) Contact lenses are preferred, Group I or Group IV are more preferred, and manufacturing cost From the viewpoint of suppression, etc., contact lenses classified as Group I are even more preferable. "Irish" means that the ionic component content in the contact lens is less than 1 mol%. say.

[0074] Also, the US certification name for contact lenses (United States Approved d Names, USAN) uses the term metafilcon, Omafu Omafilcon, Stenfilcon, Somov Somofilcon, Alfafilcon, Te tetrafilcon, ocufilcon , nelfilcon, nefilcon, fem Phemfilcon, Polymacon, Hirafil hilafilcon, nesofilcon, and etaf At least one species selected from the group consisting of etafilcon is particularly preferred. , nelfilcon A, etafilcon A, metafilcon A, omafilcon n) A, tetrafilcon A, and oc At least one selected from the group consisting of ufilcon)B is particularly preferred.

[0075] Furthermore, as a contact lens, 2-hydroxyethyl methacrylate is used as the hydrogel. Hydrogel contact lenses containing phosphate (HEMA) are preferably used.

[0076] For contact lenses, there are Nelfilcon A or Etaf. Etafilcon A is particularly preferred from the viewpoint of significantly exhibiting the effects of the present invention. It's nice.

[0077] Another example of contact lens packaging types is one-day disposable lenses. Contact lenses (daily disposable lenses), frequently replaced lenses (e.g., every 14 days), Disposable contact lenses for continuous wear (e.g., weekly disposable lenses) Whether it's contact lenses or conventional lenses (including regularly replaced soft contact lenses) It may be. In particular, in the present invention, it is necessary to reduce manufacturing costs, and the lens manufacturing man-hours From the perspective of improving wearing comfort without increasing the number of lenses, disposable contact lenses are preferred. Furthermore, daily disposable contact lenses or frequently replaced lenses are preferred. Therefore, one-day disposable contact lenses are particularly preferable.

[0078] [Manufacturing method for contact lens packaging] Next, we will describe an example of a method for manufacturing contact lens packaging. The manufacturing method of the lenses is not limited to the methods shown below, but any conventionally known method is acceptable. It can also be a method.

[0079] As shown in Figure 1, the contact lens package 1 consists of a resin container 3 containing soft contact lenses. It contains the contact lens 4 and the contact lens packaging solution 5. Specifically, the resin container 3 contains Then, add the contact lens packaging solution 5 and immerse the soft contact lenses 4 in it.

[0080] The resin in the resin container 3 is an element that can be used in the contact lens package 1. There are no particular restrictions on the material, but the constituent polymer of the resin is affected by high-pressure steam sterilization. From the perspective that it is easy to absorb and the above-mentioned problem of terpenoid adsorption to resin containers becomes particularly pronounced, For example, thermoplastic resins are one such example.

[0081] Thermoplastic resins include olefin resins (polyethylene (PE), (low-density polyethylene) Polypropylene (including LDPE, high-density polyethylene (HDPE)), cyclic olefin Polyethylene copolymer (COC), polyester resin (polyethylene terephthalate, etc.) Polybutylene terephthalate, polybutylene succinate, etc., polyphenylene ethers Resins, polycarbonate resins, polysulfone resins, polyamide resins, rigid polyvinyl chloride Polystyrene resin, styrene-based resin (polystyrene, acrylonitrile butadiene styrene copolymer) Examples include acrylonitrile-styrene copolymers (AS resins), including ABS resin. It can be done.

[0082] Among these, from the perspective of where the above problems are most pronounced, a thermoplastic resin such as is: Olefin resin or polyester resin is used, polyethylene, polyethylene Terephthalate, cyclic olefin copolymer (COC), or polypropylene is used. It can be used as a thermoplastic resin. Polyethylene, polyethylene terephthalate, cyclic olefin When using polypolymer (COC) or polypropylene, these are the total resin components. It contains 50% or more by weight of the body, preferably 70% or more by weight, and more preferably 90% or more by weight. That's all that matters.

[0083] Next, the aforementioned resin container 3 is sealed with the lid 2. The shape is not limited, but the resin container 3 is sealed by the lid 2, forming a blister pack. It is preferable to have it.

[0084] The material of lid 2 can be any material that can be used in contact lens packaging 1. There are no restrictions, but examples include aluminum film.

[0085] It is preferable that the contact surface of the airtight lid 2 with the resin container 3 is made of thermoplastic resin. The portion having thermoplastic resin may be the entire surface of the lid 2, and in a manner that provides airtight sealing. It may be only a part of it. The thermoplastic resin in the lid 2 is the same as described above in the resin container 3. Thermoplastic resins can be used in a similar manner.

[0086] Although not limited to this, the resin container 3 is covered with a lid 2 and heat-sealed (heat-welded) It is preferable that it be tightly sealed. At the contact surface of the sealing lid 2 with the resin container 3, If both the resin container 3 and the lid 2 are made of thermoplastic resin, heat welding will be performed effectively. This is preferable from the viewpoint of container airtightness. In this case, the materials of the resin container 3 and the lid 2 are different types of heat It may also be a plastic resin.

[0087] As shown in Figure 2, remove the contact lens 4 from the contact lens package 1. To do this, you need to remove lid 2. Figure 3 shows the state with lid 2 completely removed. From the perspective of ease of use, among the contact surfaces of the sealed lid 2 with the resin container 3, the peeling opening It is preferable that the portion excluding the specified area contains a thermoplastic resin.

[0088] By performing high-pressure steam sterilization using an autoclave, the contact lens package To be manufactured.

[0089] The volatilization of terpenoids contained in the packaging liquid into the gas phase is significant, especially when combined with other components. From the perspective of suppressing leakage, when the inner surface of the sealed lid 2 is flat, the packaging liquid in the resin container 3 The filling rate can be 60% or more, preferably 65% ​​or more, and more preferably 70% or more. More preferably 75% or more, and especially preferably 80% or more. The upper limit of the above filling rate is The present invention is not limited to, as long as it achieves its effects, and may include 100% or less, 99% or less, 98% or less, and 97%. % or less, 96% or less, 95% or less, 94% or less, 93% or less, 92% or less, 91% or less, Examples include percentages of 90% or less.

[0090] The above method for measuring the filling rate is as follows: When the inner surface of the sealed lid 2 is flat, the resin container 3 Determine the maximum capacity, and the volume of the contact lens packaging solution 5 relative to that maximum capacity. It can be calculated by determining the ratio. For example, if the container has a maximum capacity of 1 mL, then the soft Remove the contact lens from the container, and check that the amount of contact lens packaging solution is 0.6 mL. If so, the filling rate will be 60%. [Examples]

[0091] [Test Example 1. Menthol Stability Test in Contact Lens Packaging Solution 1] The effects of the nonionic surfactant content in contact lens packaging solution were evaluated. Ta. Prepare the contact lens packaging solution according to the formulation in Table 1 below using a conventional method, and use polypropylene (PP ) Resin container (maximum capacity 5mL, product name: TSE-5ML(PP), Taisei Chemical Co., Ltd.) Each of the following containers (manufactured by [manufacturer name]) was filled with 3 mL each (60% filling rate) with N=10 each, and a contact lens (1da) was used. Immerse the y Fresh View (manufactured by Rohto Pharmaceutical Co., Ltd.) and lid (PP cap (product name: TSC) -16×19) combined with a PE inner stopper (TPG-8.2×16(N)), Taisei Chemical Co., Ltd. The contact lenses are sealed in a container (manufactured by a certain company) and autoclaved at 121°C for 20 minutes. The package was manufactured. The weight was measured before and after autoclaving. The l-menthol content was measured. The results are shown in Figure 4. In Figure 4, the vertical axis is autoclavian. This shows the percentage of l-menthol remaining, calculated from the l-menthol content before and after the re-evaluation process.

[0092] [Table 1]

[0093] The l-menthol content was calculated using the following analytical conditions. The same conditions were used in the test examples below. That is the case. <Analysis conditions> Detector: Flame ionization detector Column: Agilent DB-WAX (0.53 x 300 mm, 1 μm) Column temperature: The temperature was increased at a rate of 3°C per minute from 100°C to 160°C. The temperature of the sample solution alone was then increased at a rate of 10°C per minute until it reached 220°C. Carrier gas: Helium Flow rate: l-menthol leaching time is approximately 10 minutes. Injection volume: 2μL Injection method: Split (split ratio 1:5) Inlet temperature: 230℃

[0094] As shown in Figure 4, the contact lens packaging solution contains a nonionic surfactant. This effectively increases the retention rate of menthol in contact lens packaging. This was confirmed.

[0095] [Test Example 2. Menthol Stability Test in Contact Lens Packaging Solution 2] The filling rate of contact lens packaging solution in the container, and the menthol content before autoclaving. The effect of quantity on the amount of menthol remaining in contact lens packaging was evaluated. . Prepare the contact lens packaging solution according to the formulation in Table 2 below using a conventional method, and use polypropylene (PP ) Resin container (maximum capacity 5mL, product name: TSE-5ML(PP), Taisei Chemical Co., Ltd.) Each of the following containers contained 1.5 mL (30% filling rate, Comparative Example 2-1) and 3 mL (60% filling rate, Example 2) of the same product. -1), and 3.75 mL (75% filling rate, Example 2-2) were each filled in N=10 units. Immerse the contact lenses (Rohto 1day Freshview, manufactured by Rohto Pharmaceutical Co., Ltd.) The lid (PP cap (product name: TSC-16×19) has a PE inner stopper (TPG-8.2× The combination of 16(N)) is sealed with Taisei Chemical Co., Ltd. and baked at 121°C for 20 minutes. The contact lens packaging was manufactured using an autoclave. The following was measured. The l-menthol content was also measured before and after autoclaving. The results are shown in Figure 5. As shown in Figure 5, the vertical axis is calculated from the l-menthol content before and after autoclaving. This indicates the percentage of l-menthol remaining.

[0096] [Table 2]

[0097] As shown in Figure 5, by filling the resin container with packaging liquid at a rate of 60% or more, This allows for an effective increase in the retention rate of menthol in contact lens packaging. Confirmed.

[0098] [Test Example 3. Menthol Stability Test in Contact Lens Packaging Solution 3] The filling rate of contact lens packaging solution in the container and the type of cushioning material are related to the contact lenses. The impact on the amount of menthol remaining in the menthol packaging was evaluated. Prepare the contact lens packaging solution according to the formulation in Table 3 below by conventional methods, using polypropylene (PP Each 1.5 mL (30% filling rate, Comparative Example 3-1) was placed in a resin container made of ) (maximum capacity 5 mL), 3 mL (60% filling rate, Example 3-1), and 3.75 mL (75% filling rate, Example 3 -2) Each N=10 is filled, and contact lenses (Rohto 1day FreshView, Immerse the product (manufactured by Rohto Pharmaceutical Co., Ltd.), seal it with a polyethylene lid, and heat at 121°C for 20 minutes. The contact lens packaging was manufactured by autoclaving it for several minutes. The weight was measured. The l-menthol content was also measured before and after autoclaving. The results were... This is shown in Figure 6. In Figure 6, the vertical axis is calculated from the l-menthol content before and after autoclaving. This shows the percentage of l-menthol remaining.

[0099] [Table 3]

[0100] As shown in Figure 6, the contact lens packaging solution contains boric acid or phosphoric acid as a buffer. By doing so, the retention rate of menthol in contact lens packaging can be effectively increased. It was confirmed that it could be done.

[0101] Contact lens packages are manufactured according to the formulations and packaging forms listed in Table 4 below. The menthol retention rate after toclaving and the wearing comfort of the removed contact lenses were evaluated. The results are shown in Table 4.

[0102] The sensory evaluation of wearing comfort was conducted according to the following criteria. ◎: When wearing contact lenses after removing them from the contact lens package. The cooling sensation from Tall is perceived as being equivalent to that of Comparative Example 01. ○: When wearing contact lenses after removing them from the contact lens package. The cooling sensation from Thor is noticeable, although it is less pronounced than in Comparative Example 01. Lack of cooling sensation: The menthol evaporates and is absorbed, so the cooling sensation from menthol is not felt. do not have Excessive stimulation: A stimulating sensation from menthol is felt, but it is not perceived as a cooling sensation.

[0103] The menthol retention rate after autoclaving was evaluated according to the following criteria. ◎: 4% or more ○: 3-4% △: 2-3% ×: Less than 2%

[0104] [Table 4] [Explanation of Symbols]

[0105] 1 Contact lens package 2 lid 3. Plastic containers 4 Contact lenses 5. Contact lens packaging solution 6. Liquid level of contact lens packaging solution

Claims

[Claim 1] The invention described in the specification.

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