Packaging system for ophthalmic lenses and solution for treating ophthalmic lenses used thereby

Abstract

The present application discloses a packaging system for ophthalmic lenses, in particular a packaging system for contact lenses, characterized in that it comprises: - a container, - a solution for treating ophthalmic lenses, contained in the container, - one or more ophthalmic lenses, immersed in the solution for treating ophthalmic lenses. The lenses in the packaging system for ophthalmic lenses of the present application have improved mechanical strength, such as increased elongation at break, etc.; and during wearing, the lenses achieve long-lasting release of moisturizing, providing suitable and long-lasting water-wet feeling for contact lens wearers, solving the problem of eye dryness and discomfort with increased wearing time.

Description

Technical Field

[0001] This invention relates to the field of contact lens technology, and particularly to an ophthalmic lens packaging system comprising an ophthalmic lens packaging system having improved mechanical properties and a long-lasting moisturizing and lubricating function, and a solution used for processing the ophthalmic lens. The invention also relates to a method for preparing the ophthalmic lens packaging system. Background Technology

[0002] In the field of contact lens technology, the mechanical properties of lenses are a perpetual requirement, especially in terms of mechanical strength. Market demands for these properties are constantly increasing. Among these, the flexibility of contact lenses has always been a pursuit for manufacturers. Good flexibility can increase the lifespan of the lens during use and reduce fragmentation caused by handling during insertion, removal, or cleaning. However, most contact lens manufacturers currently control lens flexibility primarily through lens material formulations. Further solutions are needed to enhance the mechanical properties of lenses, particularly their flexibility.

[0003] Furthermore, in addition to satisfactory mechanical performance, the requirements for comfort are becoming increasingly stringent, such as the requirements for lens wetness and the duration of continuous wetness. For normal human eyes, the tear film is responsible for the wettability and comfort of the ocular surface cells. However, when wearing contact lenses, the tear film not only needs to maintain the wettability of the ocular surface cells but also the inner and outer surfaces of the contact lens. This undoubtedly increases the burden on the wettability function of the tears. Therefore, for long-term contact lens wear, lens wetness is the most important factor affecting lens wearing comfort. To address this, various contact lens treatment solutions with wettability properties have been used to treat and preserve contact lenses, aiming to increase the wettability of the lens surface. These preservation solutions often contain various moisturizing components, such as sodium hyaluronate, hydroxypropyl methylcellulose (HPMC), MPC phosphocholine polymer, and trehalose. However, due to the limited adhesion of high molecular weight moisturizing components to the surface of contact lenses, the absorption of these components by contact lenses is limited. As a contact lens preservation solution, its bioavailability and residence time are relatively short, which cannot guarantee sufficient intake and long-lasting lubrication, and thus cannot meet the requirements for ophthalmic lenses. Summary of the Invention

[0004] To overcome the aforementioned unresolved technical problems in the prior art, this invention provides an ophthalmic lens packaging system that improves the mechanical properties (such as mechanical properties) of ophthalmic lenses (preferably contact lenses) and provides long-lasting moisturizing and lubricating functions, as well as a solution used for processing the ophthalmic lenses. This invention also relates to a method for preparing this ophthalmic lens packaging system.

[0005] These objectives can be achieved based on the technical solution of this invention.

[0006] According to the packaging system for ophthalmic lenses of the present invention, the lenses can achieve optimal moisturizing effects in the surface, middle, and deep layers, forming a gradient moisturizing effect. This avoids the problem of simply using existing moisturizers, especially large-molecule moisturizers, which can only form a moisturizing layer on the lens surface and are easily washed away by tears, making it difficult to achieve long-lasting moisturizing effects. This system allows a moisturizing layer to form not only in the lens surface but also in the middle and even deep layers of the lens, and this moisturizing layer can continuously release moisture.

[0007] The applicant of this invention discovered that for solutions used in the processing of ophthalmic lenses, high-temperature treatment is usually required to ensure aseptic production and processing. People have always only paid attention to the original molecular weight of sodium hyaluronate before high-temperature treatment, and have not paid attention to the molecular weight after treatment. However, for contact lenses, it is precisely the molecular weight of sodium hyaluronate after high-temperature treatment that determines whether sodium hyaluronate can penetrate into the lens and whether it can enter the middle and deep layers of the lens to form gradient moisturization.

[0008] The applicant of this invention has also discovered that for contact lenses, different materials, such as hydrogels and silicone hydrogels, and different cross-linking densities, result in different lens density and different molecular sizes of moisturizers that can be absorbed in the superficial, middle, and deep layers.

[0009] The applicant of this invention discovered a relationship between the cross-linking density of a lens (macroscopically manifested as the swelling rate) and the molecular weight of the humectant after high-temperature treatment. This allows for precise selection of the humectant's molecular weight, achieving the optimal moisturizing effect through gradient hydration of the lens's middle and deep layers. Based on this analysis, firstly, a treatment method is needed to increase the intake of sodium hyaluronate to enhance the humectant's absorption. Secondly, for lenses with different swelling rates, to obtain the best moisturizing effect, it is crucial to ensure that the humectant penetrates the middle and deep layers of the lens to form a moisturizing layer, and that this layer can slowly release contact lens treatment solution to meet the daily moisturizing needs. Therefore, it is necessary to precisely select the molecular weight of the humectant in the final solution, rather than roughly estimating the initial molecular weight.

[0010] The applicant of this invention discovered that poloxamer 407 (P407) is commonly used as a high-molecular-weight nonionic surfactant. Its chemical structure is a triblock copolymer composed of hydrophilic polyethylene oxide (PEO) at both ends and hydrophobic polypropylene oxide (PPO) in the middle. The hydrophilic ends of P407 bind to hyaluronic acid (HA) through hydrogen bonding, while the hydrophobic ends aggregate to the lens surface through hydrophobic interactions, facilitating the binding of HA to the lens surface. Simultaneously, the triblock structure of P407 makes it temperature-sensitive, undergoing a shift in intermolecular forces during high-temperature lens processes, promoting the uptake of sodium hyaluronate by the lens. Specifically, at room temperature, the interaction between the polymer and water dominates, preventing the aggregation of PPO groups with the lens. At this time, sodium hyaluronate and the PEO groups in P407 are bound together through hydrogen bonding. As the high-temperature process progresses and the temperature gradually increases, the hydrophobic interaction between the PPO groups and the lens strengthens, while the interaction between the polymer and water decreases. At this point, the hydrophobic interaction dominates, and P407 carrying sodium hyaluronate is attracted and absorbed by the lens. Therefore, the presence of P407 is more conducive to HA uptake; the HA uptake of contact lens solutions with added P407 can be increased by up to two times. It can also act as a moisturizing enhancer in humectants.

[0011] Furthermore, this invention provides a method for selecting large, medium, and small molecular weight humectants for lenses with different swelling rates by determining the molecular weight of the humectant in the final contact lens treatment solution. Utilizing the differences in penetration depth of humectants with different molecular weights in different contact lenses, a gradient distribution of the humectant is achieved within the contact lens, forming a humectant sponge network with large molecules on the surface, medium molecules in the middle layer, and small molecules in the deep layer. This locks moisture in on the surface and inside of the contact lens, achieving deep humectant moisturization and optimal moisturizing effect.

[0012] Surprisingly, the applicant of this invention also discovered that the mechanical properties of lenses, in addition to being related to the material properties of the lens itself, can also be related to the solutions used for preserving and / or handling ophthalmic lenses in the packaging system of ophthalmic lens products. Lenses retrieved from packaging systems containing solutions according to the invention for preserving and / or handling ophthalmic lenses have been found to have unexpectedly enhanced mechanical properties, such as mechanical properties.

[0013] This invention provides a packaging system containing a solution according to the invention for preserving and / or processing ophthalmic lenses, wherein the solution for preserving and / or processing ophthalmic lenses can form a moisturizing layer on the outer surface, middle layer, and deep layer of lenses with different swelling rates, achieving a sustained, layered release of the moisturizing agent. This meets the moisturizing needs of daily wear of contact lenses.

[0014] The packaging system for ophthalmic lenses according to the present invention, particularly a packaging system for contact lenses, comprises:

[0015] -container,

[0016] - A solution for treating ophthalmic lenses, contained in the container.

[0017] - One or more ophthalmic lenses, immersed in the solution used to treat the ophthalmic lenses.

[0018] Wherein, relative to the total weight of the solution used to process ophthalmic lenses, the solution used to process ophthalmic lenses includes:

[0019] -(1) Moisturizing component: 0.003% to 0.9% relative to the total weight of the solution used to treat ophthalmic lenses, wherein the moisturizing component comprises:

[0020] - One or more first moisturizers with high molecular weight, having an Mn / S ratio greater than 600,000, and present in a concentration of 0.001% to 0.6%.

[0021] - One or more second moisturizers having a medium molecular weight, with an Mn / S ratio greater than 350,000 and less than 600,000, and a content of 0.001% to 0.6%, and

[0022] - One or more third moisturizers with low molecular weight, having an Mn / S ratio of less than 350,000, and a content of 0.001% to 0.6%.

[0023] Where Mn is the number-average molecular weight in Daltons, and S is the swelling ratio of the ophthalmic lens, with a value ranging from 1.1 to 1.5.

[0024] -(2) Toughening agent: 0.01%-0.8% relative to the total weight of the solution used to treat ophthalmic lenses.

[0025] -(3) Chelating agent: 0.01-0.5% relative to the total weight of the solution used to treat ophthalmic lenses.

[0026] -(4) Buffer: 0.01-1.2% by weight relative to the total weight of the solution used to treat ophthalmic lenses.

[0027] -(5) Osmotic pressure regulator: 0.02-1.2% relative to the total weight of the solution used to treat ophthalmic lenses.

[0028] -(6) The remainder is water.

[0029] Here, Mn is the number-average molecular weight of the humectant in the final packaging system of the present invention, in Daltons.

[0030] According to one specific embodiment of the present invention, the ophthalmic lens may be selected from medical treatment devices such as devices for treating intraocular diseases, particularly ophthalmic endoscopes, such as contact lenses, especially daily disposable contact lenses, chromatic contact lenses, colored contact lenses, orthokeratology lenses, corneal contact lenses, and intracorneal lenses.

[0031] According to one specific embodiment of the present invention, the moisturizing component is selected from at least one of hyaluronic acid, its salts or derivatives such as sodium hyaluronate, polyvinylpyrrolidone, hydroxypropyl methylcellulose, carboxypropyl methylcellulose trehalose and its derivatives, preferably sodium hyaluronate.

[0032] According to one specific embodiment of the present invention, the toughening agent is selected from polyoxyethylene-polyoxypropylene block copolymers. Preferably, the toughening agent is selected from poloxamer, particularly poloxamer P407.

[0033] According to one specific embodiment of the present invention, the chelating agent is selected from at least one of disodium edetate, sodium citrate, and diethylenetriaminepentamethylphosphonic acid.

[0034] According to one specific embodiment of the present invention, the buffer is selected from at least one of phosphate buffer solutions, borate-borax buffer solutions, and Tris. For example, it is selected from alkali metal hydrogen phosphates and / or alkali metal dihydrogen phosphates, such as disodium hydrogen phosphate and / or potassium dihydrogen phosphate, dipotassium hydrogen phosphate and / or sodium dihydrogen phosphate.

[0035] According to one specific embodiment of the present invention, the osmotic pressure regulator is selected from at least one of alkali metal salts or alkaline earth metal salts such as sodium chloride, potassium chloride, glycerol, polyols such as propylene glycol, and mannitol.

[0036] According to one specific embodiment of the present invention, the one or more first moisturizers having a high molecular weight have an Mn / S ratio greater than or equal to 620,000, particularly greater than or equal to 650,000, or even greater than or equal to 680,000; or an Mn / S ratio less than or equal to 1,800,000, or even less than or equal to 1,600,000, especially less than or equal to 1,400,000.

[0037] According to one specific embodiment of the invention, the content of the one or more first moisturizers having a high molecular weight is 0.001% to 0.6%, particularly 0.005% to 0.2%.

[0038] According to one specific embodiment of the present invention, the one or more second moisturizers having a medium molecular weight have an Mn / S ratio greater than or equal to 350,000, or even greater than or equal to 400,000, particularly greater than or equal to 450,000; or an Mn / S ratio less than or equal to 580,000, or even less than or equal to 550,000, particularly less than or equal to 500,000.

[0039] According to one specific embodiment of the invention, the content of the one or more second moisturizers having a medium molecular weight is 0.001% to 0.6%, particularly 0.005% to 0.2%.

[0040] According to one specific embodiment of the present invention, the one or more third moisturizers having a low molecular weight have an Mn / S ratio of less than 330,000, or even less than or equal to 300,000, particularly less than or equal to 280,000.

[0041] According to one specific embodiment of the invention, the content of the one or more third moisturizers having a small molecular weight is 0.001% to 0.6%, particularly 0.005% to 0.2%.

[0042] According to one specific embodiment of the present invention, the continuous release time of the moisturizer in ophthalmic lenses can be greater than 4 hours, preferably greater than 8 hours, particularly greater than 10 hours, or even greater than 12 hours, and preferably the continuous release time of the moisturizer is greater than 4 hours to 24 hours.

[0043] The present invention also relates to a method for preparing a packaging system for ophthalmic lenses, comprising the following steps:

[0044] - Provides a moisturizing component comprising at least one or more first moisturizers having a high molecular weight, one or more second moisturizers having a medium molecular weight, and one or more third moisturizers having a low molecular weight.

[0045] - Mix the moisturizing components, toughening agents, and chelating agents, and dissolve them in water, for example, by mixing evenly using a spray system.

[0046] - Add a buffer to adjust the pH to approximately neutral, such as between pH 6.5 and 7.8.

[0047] - Add an osmotic pressure regulator to adjust the osmotic pressure to between 260 and 340 mosmol / kg.

[0048] -Add lenses, and optionally, repackage them.

[0049] - High-temperature treatment, such as temperatures between 100°C and 150°C, and treatment times between 1 and 60 minutes.

[0050] - Cool down to room temperature.

[0051] According to one specific embodiment of the invention, the temperature is between 101°C and 140°C, particularly between 110°C and 130°C; or the time is between 15 and 45 minutes, particularly between 30 ± 5 minutes.

[0052] The present invention also relates to the solution for treating ophthalmic lenses as described in the present invention, and the application of the solution for treating ophthalmic lenses as described in the present invention in a packaging system for preparing ophthalmic lenses.

[0053] Contact lenses treated with this technology exhibit long-lasting moisturizing effects and improved resilience. Compared to existing technologies, this invention offers the following advantages:

[0054] 1. This invention achieves excessive intake of moisturizer through the synergistic effect of the moisturizer and the toughening agent described in this invention.

[0055] 2. The moisturizer of this invention not only forms a moisturizing layer on the surface of the lens, but also in the middle and deep layers, achieving multi-dimensional moisturization. By mixing and compounding moisturizers of different molecular weights (large, medium, and small), and utilizing the differences in penetration depth of different molecular weight moisturizers in contact lenses, a gradient distribution of moisturizers is achieved in different contact lenses. This forms a moisturizer sponge network with large molecules on the surface, medium molecules in the middle layer, and small molecules in the deep layer, locking moisture in the surface and interior of the contact lens.

[0056] 3. During wear, the lens of this invention releases the moisturizer slowly from the outer layer to the inner layer. First, large molecules are released from the surface layer, followed by medium-molecule moisturizers in the middle layer, and finally small-molecule moisturizers in the deep layer. This achieves sustained moisturizing through continuous release of the moisturizer, providing contact lens wearers with a long-lasting hydrated feeling and solving the problem of dry eyes with prolonged lens wear.

[0057] 4. Unexpectedly, the technical solution described in this invention achieves the beneficial effect of improving the mechanical properties of the lens, such as its mechanical properties, making the lens more elastic and flexible.

[0058] It is not easily damaged during wear.

[0059] In summary, this invention allows for precise selection of the molecular weight of the moisturizer that can penetrate the surface, middle, and deep layers of lenses with different swelling rates, achieving optimal lens moisturizing effects. The contact lens treatment solution can extend lens wearing time, alleviate eye dryness and other problems caused by prolonged contact lens wear, and improve wearing comfort. It also increases lens toughness, making the lenses less prone to breakage.

[0060] This application relates to the following specific implementation plan:

[0061] Item 1. A packaging system for ophthalmic lenses, particularly a packaging system for contact lenses, characterized in that it comprises:

[0062] -container,

[0063] - A solution for treating ophthalmic lenses, contained in the container.

[0064] - One or more ophthalmic lenses, immersed in the solution used to treat the ophthalmic lenses.

[0065] Wherein, relative to the total weight of the solution used to process ophthalmic lenses, the solution used to process ophthalmic lenses includes:

[0066] -(1) Moisturizing component: 0.003% to 0.9% relative to the total weight of the solution used to treat ophthalmic lenses, wherein the moisturizing component comprises:

[0067] - One or more first moisturizers with high molecular weight, having an Mn / S ratio greater than 600,000, and present in a concentration of 0.001% to 0.6%.

[0068] - One or more second moisturizers having a medium molecular weight, with an Mn / S ratio greater than 350,000 and less than 600,000, and a content of 0.001% to 0.6%, and

[0069] - One or more third moisturizers with low molecular weight, having an Mn / S ratio of less than 350,000, and a content of 0.001% to 0.6%.

[0070] Where Mn is the number-average molecular weight in Daltons, and S is the swelling ratio of the ophthalmic lens, with a value ranging from 1.1 to 1.5.

[0071] -(2) Toughening agent: 0.01%-0.8% relative to the total weight of the solution used to treat ophthalmic lenses.

[0072] -(3) Chelating agent: 0.01-0.5% relative to the total weight of the solution used to treat ophthalmic lenses.

[0073] -(4) Buffer: 0.01-1.2% by weight relative to the total weight of the solution used to treat ophthalmic lenses.

[0074] -(5) Osmotic pressure regulator: 0.02-1.2% relative to the total weight of the solution used to treat ophthalmic lenses.

[0075] -(6) The remainder is water.

[0076] Item 2. The packaging system for ophthalmic lenses as described in Item 1, characterized in that the moisturizing component is selected from at least one of hyaluronic acid, its salts or derivatives such as sodium hyaluronate, polyvinylpyrrolidone, hydroxypropyl methylcellulose, carboxypropyl methylcellulose, trehalose and its derivatives.

[0077] Item 3. The packaging system for ophthalmic lenses as described in any of the preceding items, characterized in that the toughening agent is selected from polyoxyethylene polyoxypropylene block copolymers.

[0078] Item 4. The packaging system for ophthalmic lenses as described in any of the preceding items, characterized in that the chelating agent is selected from at least one of disodium edetate, sodium citrate, and diethylenetriaminepentamethylenephosphonic acid.

[0079] Item 5. The packaging system for ophthalmic lenses as described in any of the preceding items, characterized in that the buffer is selected from at least one of phosphate buffer solution, borate-borax buffer solution, and Tris.

[0080] Item 6. The packaging system for ophthalmic lenses as described in any of the preceding items, characterized in that the osmotic pressure regulator is selected from at least one of alkali metal salts or alkaline earth metal salts such as sodium chloride, potassium chloride, glycerol, polyols such as propylene glycol, and mannitol.

[0081] Item 7. The packaging system for ophthalmic lenses as described in any of the preceding items, characterized in that the one or more first moisturizers having a high molecular weight have an Mn / S ratio greater than or equal to 650,000, or even greater than or equal to 680,000; or an Mn / S ratio less than or equal to 1,800,000, or even less than or equal to 1,600,000, particularly less than or equal to 1,400,000.

[0082] Item 8. The packaging system for ophthalmic lenses as described in any of the preceding items, characterized in that the content of the one or more first humectants having a high molecular weight is 0.001% to 0.5%, particularly 0.005% to 0.2%.

[0083] Item 9. The packaging system for ophthalmic lenses as described in any of the preceding items, characterized in that the one or more second moisturizers having a medium molecular weight have an Mn / S ratio greater than or equal to 380,000, or even greater than or equal to 400,000, particularly greater than or equal to 450,000; or an Mn / S ratio less than or equal to 580,000, or even less than or equal to 550,000, particularly less than or equal to 500,000.

[0084] Item 10. The packaging system for ophthalmic lenses as described in any of the preceding items, characterized in that the content of the one or more second humectants having a medium molecular weight is 0.001% to 0.5%, particularly 0.005% to 0.2%.

[0085] Item 11. The packaging system for ophthalmic lenses as described in any of the preceding items, characterized in that the one or more third moisturizing agents having a medium molecular weight have an Mn / S ratio of less than or equal to 330,000, or even less than or equal to 320,000, particularly an Mn / S ratio of less than or equal to 300,000.

[0086] Item 12. The packaging system for ophthalmic lenses as described in any of the preceding items, characterized in that the content of the one or more second humectants having a medium molecular weight is 0.001% to 0.5%, particularly 0.005% to 0.2%.

[0087] Item 13. The packaging system for ophthalmic lenses as described in any of the preceding items, characterized in that the moisturizing component is selected from sodium hyaluronate.

[0088] Item 14. The packaging system for ophthalmic lenses as described in any of the preceding items, characterized in that the toughening agent is selected from poloxamer, particularly poloxamer P407.

[0089] Item 15. The packaging system for ophthalmic lenses as described in any of the preceding items, characterized in that the ophthalmic lenses are contact lenses, particularly daily disposable contact lenses.

[0090] Item 16. A method for preparing a packaging system for ophthalmic lenses as described in any of the preceding items, characterized in that it comprises the following steps:

[0091] - Provides a moisturizing component comprising at least one or more first moisturizers having a high molecular weight, one or more second moisturizers having a medium molecular weight, and one or more third moisturizers having a low molecular weight.

[0092] - Mix the moisturizing components, toughening agents, and chelating agents, and dissolve them in water, for example, by mixing them evenly using a mechanical stirring system.

[0093] - Add a buffer to adjust the pH to approximately neutral, such as between pH 6.5 and 7.8.

[0094] - Add an osmotic pressure regulator to adjust the osmotic pressure to between 260 and 340 mOsmol / kg.

[0095] -Optionally, add lenses and repackage.

[0096] - High-temperature treatment, such as temperatures between 100°C and 150°C, and treatment times between 1 and 60 minutes.

[0097] - Cool down to room temperature.

[0098] Item 17. The method as described in Item 16 above, wherein the temperature is between 101°C and 140°C, particularly between 110°C and 130°C; or the time is between 15 and 45 minutes, particularly between 30 ± 5 minutes.

[0099] Item 18. A solution for treating ophthalmic lenses, as defined in the packaging system for ophthalmic lenses described in any one of items 1-15 above, such as being composed of the following components:

[0100] -(1) Moisturizing component: 0.003% to 0.9% relative to the total weight of the solution used to treat ophthalmic lenses, wherein the moisturizing component comprises:

[0101] - One or more first moisturizers with high molecular weight, having an Mn / S ratio greater than 600,000, and present in a concentration of 0.001% to 0.6%.

[0102] - One or more second moisturizers having a medium molecular weight, with an Mn / S ratio greater than 350,000 and less than 600,000, and a content of 0.001% to 0.6%, and

[0103] - One or more third moisturizers with low molecular weight, having an Mn / S ratio of less than 350,000, and a content of 0.001% to 0.6%.

[0104] Where Mn is the number-average molecular weight in Daltons, and S is the swelling ratio of the ophthalmic lens, with a value ranging from 1.1 to 1.5.

[0105] -(2) Toughening agent: 0.01%-0.8% relative to the total weight of the solution used to treat ophthalmic lenses.

[0106] -(3) Chelating agent: 0.01-0.5% relative to the total weight of the solution used to treat ophthalmic lenses.

[0107] -(4) Buffer: 0.01-1.2% by weight relative to the total weight of the solution used to treat ophthalmic lenses.

[0108] -(5) Osmotic pressure regulator: 0.02-1.2% relative to the total weight of the solution used to treat ophthalmic lenses.

[0109] -(6) The remainder is water.

[0110] Item 19. The use of the solution for treating ophthalmic lenses as described in Item 18 above in a packaging system for the preparation of ophthalmic lenses. Attached Figure Description

[0111] Figure 1 The HA intake of Example 1 and Comparative Example 1 are illustrated.

[0112] Figure 2 The HA intake ratios of Example 1 and Comparative Example 4 are illustrated.

[0113] Figure 3 Examples illustrate the molecular weight of HA released at different times in the embodiments. Detailed Implementation

[0114] Various exemplary embodiments of the present invention are now described in detail. This detailed description should not be considered as a limitation of the present invention, but rather as a more detailed description of certain aspects, characteristics, and embodiments of the present invention. Unless otherwise specified, the following test methods and detection methods are conventional methods; the reagents and raw materials mentioned are commercially available unless otherwise specified.

[0115] The lens material of the contact lens in Example 1 is as follows:

[0116] The lens model is HRC107, registration certificate number: National Medical Device Registration Certificate 20243162178. The lens is made of hydroxyethyl methacrylate, N-vinylpyrrolidone, ethylene glycol dimethacrylate, 2-methyl-2-acrylate-2,3-dihydroxypropyl methacrylate, methacrylic acid, (methacryloyloxy-2-hydroxypropoxy)propylbis(trimethylsiloxy)methyl, etc.

[0117] The lens material of the contact lens in Example 2 is as follows:

[0118] The lens model is HRW102, registration certificate number: National Medical Device Registration Certificate 20243162200. The lens is made of hydroxyethyl methacrylate, N-vinylpyrrolidone, ethylene glycol dimethacrylate, 2-methyl-2-acrylate-2,3-dihydroxypropyl methacrylate, methacrylic acid, 3-methacryloyloxypropyltris(trimethylsiloxy)silane, etc.

[0119] The lens material of the contact lens in Example 3 is as follows:

[0120] The lens model is HRC106, registration certificate number: National Medical Device Registration Certificate 20243162221. The lens is made of hydroxyethyl methacrylate, N-vinylpyrrolidone, ethylene glycol dimethacrylate, 2-methyl-2-acrylate-2,3-dihydroxypropyl methacrylate, methacrylic acid, 3-methacryloyloxypropyltris(trimethylsiloxy)silane, etc.

[0121] The contact lenses of Comparative Examples 1-4 are made of the same lens material as the contact lenses of Example 1.

[0122] The contact lenses in Comparative Examples 5-6 are made of the same lens material as those in Example 2.

[0123] Example A (Examples 1-3 and Comparative Examples 1-6): Preparation of a Packaging System for Contact Lenses

[0124] 1. Preparation of a solution for treating lenses

[0125] Mix HA, poloxamer, and disodium edetate in the proportions shown in Table 1 below, dissolve in water, and mix thoroughly.

[0126] Add disodium hydrogen phosphate and potassium dihydrogen phosphate to adjust the pH to 7.3.

[0127] Add sodium chloride to adjust the osmotic pressure to 309 mOsmol / kg.

[0128] 2. Place a solution prepared as described above into a PP cup with a diameter of 2.5 cm and a height of 1.5 cm. Immerse the lens (14.2 mm in diameter) in the solution and perform high-temperature treatment using autoclaving at a temperature of [temperature missing].

[0129] The glasses were processed at 121°C and 180 kPa for 30 minutes, then cooled to room temperature to obtain the eyeglasses packaging system.

[0130]

[0131]

[0132] Example B: Performance Testing and Evaluation

[0133] Test method:

[0134] In this invention, the maximum load, tensile strength, elastic modulus, elongation, and elongation at break of the lenses in the ophthalmic lens packaging system are tested according to the following methods.

[0135] The contact lens prepared in the examples was tested using an A1-3000 benchtop tensile testing machine and an ET-3 electronic thickness gauge. The lens was cut into dumbbell-shaped specimens (4 mm wide), placed in a clamp, and then the tensile testing machine was started for testing. Detailed methods are described in ASTM D882 Standard Test Method for Tensile Properties of Thin Plastic Sheeting. Measurements were performed with N=8, and the average of the N=6 values ​​(excluding the maximum and minimum values) was taken as the test result.

[0136] HA Intake Detection: The total HA content in the lenses was determined by immersing the lenses in methanol-PBS buffer and autoclaving at 121°C for 30 min to extract HA. The treated solution was transferred to centrifuge tubes, enzyme solution was added, followed by phosphate buffer (pH 6.0), and the mixture was thoroughly mixed. The mixture was then incubated in a 42°C water bath for 2 h, followed by a boiling water bath for 2 min to terminate the reaction. After cooling to room temperature, the solution was filtered before use. The sample solution was analyzed by high-performance liquid chromatography (HPLC) to determine the sodium hyaluronate content. The HPLC analysis conditions were: column temperature 40°C; mobile phase A: water; mobile phase B: 0.4 mol / L sodium dihydrogen phosphate solution; flow rate 0.6 mL / min; detection wavelength 232 nm.

[0137] Lens HA release detection: Remove the lens and rinse the surface of the lens with PBS standard saline solution to remove HA. Blot the lens dry with lens paper. Then, place the lens in a fixed volume (1-10 ml) of PBS and shake on a shaker. Remove the lens at different time points (1 h, 4 h, 8 h, 12 h) and add it to a new fixed volume (1-10 ml) of PBS solution. The solution after lens removal is the test solution. HPLC is used to determine the HA content in the test solution.

[0138] HA gradient release assay: The lens was removed and placed in PBS solution. The lens was removed and placed in fresh PBS solution at 10 min, 1 h-4 h, and 4 h - the end of HA release. The solution after lens removal was the test solution. The molecular weight in the test solution was determined by laser scattering-gel permeation chromatography (LLS-GPC).

[0139] Example B-1: Mechanical Properties

[0140] Tensile strength, elastic modulus, and elongation at break are key parameters describing the mechanical properties of contact lenses. Tensile strength refers to the maximum tensile force a material can withstand before breaking under tension. High tensile strength indicates good durability, meaning the contact lens is less likely to break or be damaged during normal use. Elastic modulus indicates a material's ability to maintain its shape under pressure. Materials with high elastic modulus resist pressure better and more easily return to their original shape after the force is removed. For contact lenses, a high elastic modulus means the lens is more resistant to deformation. Elongation at break is the percentage increase in length of a material when subjected to tensile force until it breaks. Elongation at break reflects the lens's toughness, i.e., the degree of deformation the lens can withstand before breaking. A higher elongation at break indicates better lens flexibility.

[0141] Unconstrained by theory, this invention may involve compounding HA molecules of different molecular weights to allow HA to fully penetrate the lens interior, achieving a gradient distribution of HA within the contact lens. This forms a hyaluronic acid sponge network with macromolecules on the surface, medium molecules in the middle layer, and small molecules in the deep layer. The gradient arrangement of HA, with its high water retention capacity, locks moisture into the surface and interior of the contact lens, making the lens softer and more resilient. Elongation at break is the most direct indicator of lens toughness. Test results show that in Comparative Example 3, the macromolecules of HA could only be arranged on the lens surface, resulting in the lowest elongation at break (216.88%). In Comparative Examples 2 and 1, some HA molecules could penetrate the lens interior, leading to a slightly higher elongation at break. In Example 1, the gradient arrangement of HA synergistically increased the elongation at break to 353.13%, significantly improving lens toughness, extending and stabilizing its lifespan, and making it more comfortable to wear. The results of Comparative Example 5 showed that when a moisturizing component other than that described in this invention (i.e., poly-2-methacryloyloxyethylphosphorylcholine) was added, the mechanical properties of the lens, such as elongation at break and modulus of elasticity, were reduced, and the toughness was decreased.

[0142] Table 2: Results of Lens Tensile Performance Tests

[0143]

[0144]

[0145] Example B-2: HA intake detection, the effect of different molecular weight HA combinations on increasing HA intake.

[0146] The contact lens preservation solution of this invention mixes and blends different molecular weight HAs (high, medium, and low molecular weight HAs). By utilizing the difference in penetration depth of HAs with different molecular weights in contact lenses, a gradient distribution of HAs is achieved in the contact lenses, forming a layered structure with large molecules on the surface, medium molecules in the middle layer, and small molecules in the deep layer. This allows HAs to be absorbed sufficiently into the lens, increasing the amount of HA intake and the adhesion time in the lens.

[0147] Test results showed that, compared to the single small-molecule, medium-molecule, and large-molecule formulations in Comparative Examples 1, 2, and 3, the HA intake of the compound formulation with different molecular weights in Example 1 was significantly increased, proving that the gradient arrangement of HA can fully penetrate into the lens, increasing the HA intake within the lens. The test results are as follows: Figure 1 And as shown in Table 3 below:

[0148] Table 3: HA intake ratio under different molecular weight HA combinations

[0149] HA intake ratio Example 1 1 Comparative Example 1 0.67 Comparative Example 2 0.53 Comparative Example 3 0.46

[0150] Example B-3: HA intake detection, the effect of P407 on increasing HA intake

[0151] Poloxamer 407 (P407) has a triblock copolymer structure consisting of hydrophilic polyethylene oxide (PEO) at both ends and a hydrophobic polypropylene oxide (PPO) in the middle. In the preservation solution, the hydrophilic ends of P407 bind to HA (hyaluronic acid) through hydrogen bonding, while the hydrophobic ends aggregate to the lens surface through hydrophobic interactions, facilitating HA binding to the lens surface. Simultaneously, the triblock structure of P407 makes it temperature-sensitive, causing a shift in intermolecular forces during the high-temperature sterilization process of the lens, promoting HA uptake by the lens. Specifically, before sterilization, the interaction between the polymer and water is dominant, preventing the aggregation of PPO groups to the lens. At this time, HA and the PEO groups in P407 are bound together through hydrogen bonding. As the sterilization process progresses and the temperature gradually increases, the hydrophobic interaction between the PPO groups and the lens strengthens, while the interaction between the polymer and water decreases. At this point, the hydrophobic interaction becomes dominant, and P407 carrying HA is attracted to and absorbed by the lens.

[0152] According to the comparative test method for HA intake, the test results showed that, compared with the formula in Comparative Example 4 that did not contain poloxamer P407, the HA intake of Example 1, which included poloxamer P407, was nearly twice as high. The test results are as follows... Figure 2 And as shown in Table 4 below:

[0153] Table 4: HA intake ratio with P407 assistance

[0154] HA intake ratio Example 1 1 Comparative Example 4 0.563

[0155] Example B-4: Comparison of HA release performance of lenses

[0156] By using a combination of HA molecules with varying molecular weights and the assistance of P407, the uptake of HA is increased, improving the limited adhesion of HA to the lens surface and interior. The gradient-penetrating HA is layered in the surface, middle, and deep layers of the contact lens, locking moisture in and enhancing lens lubrication and comfort. During use, the layered HA is released gradually, slowing down the release rate and providing users with long-lasting comfort.

[0157] Test results show that the HA release time in Example 1 can reach 12 hours. While the small molecule HA in Comparative Example 1 can penetrate the lens, its release rate is relatively fast due to the weak adhesion of a single small molecule, with a release time of 8 hours. The medium and large molecule HA in Comparative Examples 2 and 3 can only adhere to the surface and middle layer, resulting in a shorter release time of only 4 hours.

[0158] Table 5: HA release rate in lenses

[0159]

[0160]

[0161] Example B-5: Verification of Gradient Release of Moisturizer

[0162] Due to the gradient distribution of HA molecules of different molecular weights within the lens, hyaluronic acid exhibits a gradient release effect. Molecular weight tests were conducted on the HA released from the contact lenses in Example 1 at different times. The results show that in the initial stage, the surface HA is released first, with the HA in the release solution being large molecules with a molecular weight of approximately 80 kDa. In the middle stage, the HA in the middle layer of the contact lens begins to be released gradually, with the HA in the release solution being medium molecules with a molecular weight of approximately 60 kDa. In the later stage, small HA molecules that have penetrated into the interior of the contact lens are released, with the HA in the release solution having a molecular weight of approximately 35 kDa. This conclusion also corroborates that these hyaluronic acid molecules achieve gradient penetration during the penetration process. The molecular weights of HA released at different times are shown below. Figure 3 As shown.

[0163] As can be seen from the above embodiments and comparative examples, the packaging system for ophthalmic lenses of the present invention, while improving moisturizing performance, unexpectedly improves the mechanical properties of lens materials impregnated in solutions used for treating ophthalmic lenses, such as tensile strength and elongation at break.

[0164] Example C: Different preparation method conditions

[0165] Comparative Example c is the same as Example 1, except that it is used without high-temperature treatment, and 0.0001% polyhexamethylene biguanide is used as a disinfectant.

[0166] 1. Preparation of a solution for treating lenses

[0167] Mix HA, poloxamer, and disodium edetate in the proportions shown in Table 1, dissolve in water, and mix thoroughly.

[0168] Add disodium hydrogen phosphate and potassium dihydrogen phosphate to adjust the pH to 7.3.

[0169] - Add sodium chloride to adjust the osmotic pressure to 309 mOsmol / kg.

[0170] - Add 0.0001% polyhexamethylene biguanide for use as a disinfectant.

[0171] 2. Place a solution prepared as described above into a PP cup with a diameter of 2.5 cm and a height of 1.5 cm, and immerse the lens with a size of 14.2 mm in the solution used for processing ophthalmic lenses to obtain a packaging system for eyeglasses.

[0172] The lens in the packaging system obtained in this embodiment C was tested, and its performance is as follows:

[0173] Table 6: Results of Lens Tensile Performance Tests

[0174]

[0175] It can be seen that the preparation method described in this application (including high-temperature treatment) results in a significant improvement in the mechanical properties of the lenses stored in the packaging system of the eyeglasses obtained by a preparation method that does not involve high-temperature treatment (but instead involves the addition of a disinfectant).

[0176] The above embodiments are merely exemplary implementations of the present invention and are only used to explain the present invention, not to limit the present invention. Any changes, substitutions, modifications, etc., made by those skilled in the art without departing from the spirit and essence of the present invention should be within the protection scope of the present invention.

Claims

1. A packaging system for ophthalmic lenses, particularly a packaging system for contact lenses, characterized in that, Include: -container, - A solution for treating ophthalmic lenses, contained in the container. - One or more ophthalmic lenses, immersed in the solution used to treat the ophthalmic lenses. Wherein, relative to the total weight of the solution used to process ophthalmic lenses, the solution used to process ophthalmic lenses includes: -(1) Moisturizing component: 0.003% to 0.9% relative to the total weight of the solution used to treat ophthalmic lenses, wherein the moisturizing component comprises: - One or more first moisturizers with high molecular weight, having an Mn / S ratio greater than 600,000, and present in a concentration of 0.001% to 0.6%. - One or more second moisturizers having a medium molecular weight, with an Mn / S ratio greater than 350,000 and less than 600,000, and a content of 0.001% to 0.6%, and - One or more third moisturizers with low molecular weight, having an Mn / S ratio of less than 350,000, and a content of 0.001% to 0.6%. Where Mn is the number-average molecular weight in Daltons, and S is the swelling ratio of the ophthalmic lens, with a value ranging from 1.1 to 1.

5. -(2) Toughening agent: 0.01%-0.8% relative to the total weight of the solution used to treat ophthalmic lenses. -(3) Chelating agent: 0.01-0.5% relative to the total weight of the solution used to treat ophthalmic lenses. -(4) Buffer: 0.01-1.2% by weight relative to the total weight of the solution used to treat ophthalmic lenses. -(5) Osmotic pressure regulator: 0.02-1.2% relative to the total weight of the solution used to treat ophthalmic lenses. -(6) The remainder is water.

2. The packaging system for ophthalmic lenses as described in claim 1, characterized in that, The moisturizing component is selected from at least one of hyaluronic acid, its salts or derivatives such as sodium hyaluronate, polyvinylpyrrolidone, hydroxypropyl methylcellulose, carboxypropyl methylcellulose, trehalose and its derivatives, preferably sodium hyaluronate; or, the toughening agent is selected from polyoxyethylene polyoxypropylene block copolymers, preferably poloxamer, particularly poloxamer P407; or, the chelating agent is selected from at least one of disodium edetate, sodium citrate, and diethylenetriaminepentamethylphosphonic acid; or, the buffer is selected from at least one of phosphate buffer solution, borate-borax buffer solution, and Tris; or, the osmotic pressure regulator is selected from at least one of alkali metal salts or alkaline earth metal salts such as sodium chloride, potassium chloride, glycerin, polyols such as propylene glycol, and mannitol.

3. The packaging system for ophthalmic lenses as described in any of the preceding claims, characterized in that, The one or more first moisturizers having a high molecular weight have an Mn / S ratio greater than or equal to 650,000, or even greater than or equal to 680,000; or an Mn / S ratio less than or equal to 1,800,000, or even less than or equal to 1,600,000, especially less than or equal to 1,400,000; or, the content of the one or more first moisturizers having a high molecular weight is 0.001% to 0.5%, particularly 0.005% to 0.2%.

4. The packaging system for ophthalmic lenses as described in any of the preceding claims, characterized in that, The one or more second moisturizers having a medium molecular weight have an Mn / S ratio greater than or equal to 380,000, or even greater than or equal to 400,000, particularly greater than or equal to 450,000; or an Mn / S ratio less than or equal to 580,000, or even less than or equal to 550,000, particularly less than or equal to 500,000; or, the content of the one or more second moisturizers having a medium molecular weight is 0.001% to 0.5%, particularly 0.005% to 0.2%; or, the one or more third moisturizers having a medium molecular weight have an Mn / S ratio less than or equal to 330,000, or even less than or equal to 320,000, particularly less than or equal to 300,000; or, the content of the one or more second moisturizers having a medium molecular weight is 0.001% to 0.5%, particularly 0.005% to 0.2%.

5. The packaging system for ophthalmic lenses as described in any of the preceding claims, characterized in that, The ophthalmic lenses mentioned are contact lenses, especially daily disposable contact lenses.

6. A method for preparing a packaging system for ophthalmic lenses as described in any of the preceding claims, characterized in that, It includes the following steps: - Provides a moisturizing component comprising at least one or more first moisturizers having a high molecular weight, one or more second moisturizers having a medium molecular weight, and one or more third moisturizers having a low molecular weight. - Mix the moisturizing components, toughening agents, and chelating agents, and dissolve them in water, for example, by mixing them evenly using a mechanical stirring system. - Add a buffer to adjust the pH to approximately neutral, such as between pH 6.5 and 7.

8. - Add an osmotic pressure regulator to adjust the osmotic pressure to between 260 and 340 mOsmol / kg. -Optionally, add lenses and repackage. - High-temperature treatment, such as temperatures between 100°C and 150°C, and treatment times between 1 and 60 minutes. - Cool down to room temperature.

7. The method as described in claim 6, wherein the temperature is between 101°C and 140°C, particularly between 110°C and 130°C; or the time is between 15 and 45 minutes, particularly between 30 ± 5 minutes.

8. A solution for treating ophthalmic lenses, as defined in the packaging system for ophthalmic lenses according to any one of claims 1-5, such as being composed of the following components: -(1) Moisturizing component: 0.003% to 0.9% relative to the total weight of the solution used to treat ophthalmic lenses, wherein the moisturizing component comprises: - One or more first moisturizers with high molecular weight, having an Mn / S ratio greater than 600,000, and present in a concentration of 0.001% to 0.6%. - One or more second moisturizers having a medium molecular weight, with an Mn / S ratio greater than 350,000 and less than 600,000, and a content of 0.001% to 0.6%, and - One or more third moisturizers with low molecular weight, having an Mn / S ratio of less than 350,000, and a content of 0.001% to 0.6%. Where Mn is the number-average molecular weight in Daltons, and S is the swelling ratio of the ophthalmic lens, with a value ranging from 1.1 to 1.

5. -(2) Toughening agent: 0.01%-0.8% relative to the total weight of the solution used to treat ophthalmic lenses. -(3) Chelating agent: 0.01-0.5% relative to the total weight of the solution used to treat ophthalmic lenses. -(4) Buffer: 0.01-1.2% by weight relative to the total weight of the solution used to treat ophthalmic lenses. -(5) Osmotic pressure regulator: 0.02-1.2% relative to the total weight of the solution used to treat ophthalmic lenses. -(6) The remainder is water.

9. The use of the solution for treating ophthalmic lenses as described in claim 8 in a packaging system for preparing ophthalmic lenses.

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