Contact lens packaging solution and contact lens product
By using a specific proportion of hyaluronic acid hydrolyzed derivatives in the contact lens packaging solution, the problems of reduced pH and insufficient wetting after high-temperature sterilization are solved, and the initial comfort and moisturizing properties of contact lenses are improved.
Patent Information
- Application Number
- CN202410194074.7
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2024-02-21
- Publication Date
- 2025-08-22
AI Technical Summary
The pH value of existing contact lens packaging solutions is excessively reduced after high temperature sterilization, resulting in discomfort in wearing and insufficient wetness, affecting the comfort of wearing.
The moisturizing agent consists of hyaluronic acid and sodium hyaluronic acid hydrolyzed derivatives with a molecular weight of 850,000 to 2,200,000 and alkyl glycerol hydrolyzed hyaluronic acid hydrolyzed derivatives with a molecular weight of no more than 10,000. The pH value is controlled between 6.8 and 7.5 to enhance wetting and osmotic pressure.
It provides good wetting and initial comfort for contact lenses, improves dry eye problems caused by contact lenses, and maintains appropriate pH and color after high temperature sterilization.
Smart Images
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Abstract
Description
Technical Field
[0001] The present invention relates to a contact lens packaging solution and a contact lens product, and in particular to a packaging solution capable of improving the initial comfort of contact lenses, and a contact lens product comprising the contact lens packaging solution and a contact lens immersed in the contact lens packaging solution. Background Art
[0002] Soft contact lenses are individually packaged, shipped, and sold in plastic containers containing a buffer solution. This buffer solution is typically a physiological saline solution, ensuring the lens remains ready for wear after removal. Therefore, the pH and osmotic pressure of this buffer solution must be comparable to tear fluid to avoid initial discomfort. To enhance wearer comfort, the buffer solution typically also contains non-ionic surfactants, surface lubricants, and wetting agents.
[0003] Wetting agents known to be suitable for soft contact lens packaging solutions include poly(meth)acrylamide, polyhydroxyalkyl(meth)acrylates, polyvinylpyrrolidone, hyaluronic acid, xanthan gum, gum arabic, and starch. Hyaluronic acid, a natural polysaccharide, is widely used in ophthalmic preparations due to its biocompatibility, absorbability, and moisturizing and lubricating properties. However, due to the high viscosity of hyaluronic acid, increasing its dosage to enhance wettability results in a high viscosity packaging solution. During use, the water film formed by the highly viscous packaging solution on the lens easily absorbs oil and grease, potentially causing stains. In recent years, hydrolyzed hyaluronic acid derivatives have also been proposed for use in multifunctional contact lens care solutions and eye drops. These hydrolyzed hyaluronic acid derivatives not only make the contact lens surface hydrophilic but also inhibit the adsorption of cationic biocides onto the lens. However, since contact lenses need to undergo a high-temperature sterilization process after packaging, this low-molecular-weight hyaluronic acid hydrolyzed derivative will undergo a hydrolysis reaction at high temperatures, causing the pH of the contact lens packaging solution to drop excessively after the sterilization process and making the packaging solution appear yellow. If the lenses are taken out of the packaging and worn directly, it may cause discomfort to the wearer.
[0004] Therefore, the present invention discloses a new contact lens packaging solution that can provide sufficient initial comfort to the wearer, that is, the lens can be worn immediately after being taken out of the package. It can also increase the moisture retention of the contact lens, prevent the lens surface from drying out, reduce eye fatigue caused by wearing contact lenses for a long time, and improve the comfort of wearing contact lenses. Summary of the Invention
[0005] The present invention provides a packaging solution capable of improving the initial comfort and moisturizing property of contact lenses, providing good wettability for contact lenses and improving the problem of dry eyes caused by wearing contact lenses.
[0006] The contact lens packaging solution provided by the present invention comprises a buffer solution and 0.1 wt% to 0.4 wt% of a moisturizing agent, wherein the moisturizing agent contains hyaluronic acid salt and a hyaluronic acid hydrolyzed derivative, and the usage ratio of the hyaluronic acid salt and the hyaluronic acid hydrolyzed derivative is between 1:4 and 4:1.
[0007] The pH value of the contact lens packaging solution of the present invention is between 6.8 and 7.5.
[0008] The hyaluronic acid salt contained in the moisturizing agent of the contact lens packaging solution of the present invention is sodium hyaluronate having a molecular weight ranging from 850,000 to 2,200,000.
[0009] The hyaluronic acid hydrolyzed derivative contained in the moisturizing agent of the contact lens packaging solution of the present invention is an alkylglycerol hydrolyzed hyaluronic acid having a molecular weight of not more than 10,000, which has a structure as shown in the following formula (I):
[0010]
[0011] The buffer in the contact lens packaging solution of the present invention is 0.1 wt % to 3 wt % of borate buffer or phosphate buffer.
[0012] In one embodiment of the present invention, the contact lens packaging solution may further comprise 0.005 wt % to 0.05 wt % of alginic acid.
[0013] The buffer in the contact lens packaging solution of the present invention is a borate buffer, which comprises water, sodium chloride, boric acid and sodium borate.
[0014] In one embodiment of the present invention, the contact lens packaging solution of the present invention may further comprise an antibacterial agent, a thickener, a lubricant, or a combination thereof.
[0015] The present invention further provides a contact lens product comprising a packaging solution and a contact lens soaked in the packaging solution, wherein the packaging solution comprises a buffer solution and 0.1 wt % to 0.4 wt % of a moisturizer, wherein the moisturizer comprises hyaluronic acid and a hydrolyzed hyaluronic acid derivative, and the ratio of hyaluronic acid to the hydrolyzed hyaluronic acid derivative is between 1:4 and 4:1.
[0016] The contact lens product of the present invention, wherein the contact lens is a hydrogel contact lens or a silicone hydrogel contact lens. DETAILED DESCRIPTION
[0017] In order to make the above and other objects, features, and advantages of the present invention more clearly understood, preferred embodiments are given below and described in detail with reference to the accompanying chemical formulas.
[0018] The present invention provides a contact lens packaging solution, comprising a buffer and a moisturizing agent, wherein the moisturizing agent contains hyaluronic acid and a hydrolyzed hyaluronic acid derivative, so as to provide good wettability for the contact lens to have sufficient initial comfort and improve the problem of dry eyes caused by wearing contact lenses.
[0019] The contact lens packaging solution of the present invention comprises 0.1 wt% to 0.4 wt% of a moisturizing agent, wherein the ratio of hyaluronic acid salt to the hydrolyzed hyaluronic acid derivative is between 1:4 and 4:1. In a preferred embodiment of the present invention, the contact lens packaging solution of the present invention comprises 0.2 wt% to 0.3 wt% of a moisturizing agent, wherein the ratio of hyaluronic acid salt to the hydrolyzed hyaluronic acid derivative is between 1:2 and 3:1.
[0020] Since soft contact lenses can be worn directly after being removed from their packaging containers, the packaging solution will adsorb onto them. Therefore, a contact lens packaging solution with a pH closer to the pH and osmotic pressure of tear fluid will improve eye comfort. The initial pH and post-sterilization pH of the contact lens packaging solution of the present invention can both be between 6.8 and 7.5, and preferably between 6.9 and 7.3. The moisturizing agent of the contact lens packaging solution of the present invention, comprising hyaluronic acid salt and a hydrolyzed hyaluronic acid derivative, not only maintains the pH of the packaging solution between 6.8 and 7.5 and an osmotic pressure greater than 300 mOsmol / kg, but also prevents hydrolysis of the hydrolyzed hyaluronic acid derivative during high-temperature sterilization, which could lower the pH of the packaging solution or affect its color, potentially causing discomfort to the wearer due to absorption of the packaging solution by the contact lens.
[0021] The hyaluronic acid salt contained in the moisturizing agent of the contact lens packaging solution of the present invention is sodium hyaluronate having a molecular weight between 850,000 and 2,200,000. Suitable sodium hyaluronate may be, for example, HA-LQ or HA-LQH produced by Kewpie, Japan.
[0022] The hyaluronic acid hydrolyzed derivative contained in the moisturizing agent of the contact lens packaging solution of the present invention is an alkylglycerol hydrolyzed hyaluronic acid having a molecular weight of not more than 10,000, and preferably an alkylglycerol hydrolyzed hyaluronic acid having a structure represented by the following formula (I):
[0023]
[0024] Suitable alkyl glycerol hydrolyzed hyaluronic acid can be, for example, the one produced by Kewpie, Japan.
[0025] The contact lens packaging solution provided by the present invention is suitable for packaging hydrogel contact lenses and silicone hydrogel contact lenses.
[0026] The buffer used in the contact lens packaging solution can be any physiologically compatible buffer, such as borate, phosphate, citrate, boric acid, carbonate, or acetate buffer. The aforementioned salts can be, for example, alkali metal salts, such as sodium or potassium salts. The salt concentration in the buffer can range from 0.1 wt% to 3 wt%, and the buffer can be a borate buffer or a phosphate buffer. In one embodiment of the present invention, the buffer in the contact lens packaging solution preferably comprises water, sodium chloride, boric acid, and borate.
[0027] The humectant in the contact lens packaging solution of the present invention not only provides an appropriate pH value and osmotic pressure, but also maintains a water film on the contact lens for a longer period of time after the contact lens is removed from the packaging, thereby providing the wearer with sufficient moisturization and initial comfort.
[0028] The contact lens packaging solution of the present invention can further contain alginic acid as a moisturizing agent to enhance the wettability of the contact lens, helping to alleviate dry eyes when wearing contact lenses. The weight-average molecular weight of alginic acid suitable for use in the contact lens packaging solution of the present invention can range from 1,000 to 30,000, preferably from 5,000 to 20,000, and the amount added can range from 0.005 wt% to 0.05 wt%.
[0029] In the moisturizing agent of the contact lens packaging solution proposed in the present invention, the components forming the moisturizing agent can be mixed and then added to the buffer solution, or can be added to the buffer solution individually, without particular limitation.
[0030] In addition, the contact lens packaging solution of the present invention may optionally further comprise an antibacterial agent, a thickener, a lubricant, or a combination thereof.
[0031] The present invention further provides a contact lens product comprising a packaging solution and a contact lens soaked in the packaging solution, wherein the packaging solution comprises a buffer solution and 0.1 wt % to 0.4 wt % of a moisturizer, wherein the moisturizer contains hyaluronic acid salt and a hyaluronic acid hydrolyzed derivative, and the usage ratio of the hyaluronic acid salt to the hyaluronic acid hydrolyzed derivative is between 1:4 and 4:1.
[0032] The contact lens product of the present invention is a hydrogel contact lens or a silicone hydrogel contact lens. The hydrogel contact lens or silicone hydrogel contact lens can be worn directly after being removed from the packaging container. Because the moisturizing agent of the contact lens packaging solution of the present invention contains hyaluronic acid salt and a hydrolyzed hyaluronic acid derivative, the packaging solution adsorbed on the soft contact lens can provide good wettability and initial comfort to the contact lens. In addition, the packaging solution has a moderate pH value and a non-excessively yellowish color and appearance, making it suitable for use in contact lens packaging.
[0033] The following examples are provided to further illustrate the present invention, but the present invention is not limited thereto.
[0034] Preparation of Example 1-Buffer I
[0035] Buffer solution I was prepared by adding 0.71 g of sodium chloride, 0.043 g of sodium borate, and 0.43 g of boric acid to 98.607 g of deionized water and stirring until they were completely dissolved.
[0036] Example 1
[0037] 0.10 g of alkyl glycerol hydrolyzed hyaluronic acid (trade name) was added to 99.79 g of buffer solution I. 0.10 g of sodium hyaluronate (trade name HA-LQH, produced by Kewpie, Japan) and 0.01 g of alginate were stirred evenly until completely dissolved, placed in a sterilizer, heated to 121°C, and sterilized after 30 minutes to prepare a packaging solution.
[0038] Example 2
[0039] 0.05 g of alkyl glycerol hydrolyzed hyaluronic acid (trade name) was added to 99.79 g of buffer I. 0.15g of sodium hyaluronate (trade name HA-LQH, produced by Kewpie, Japan) and 0.01g of alginate were stirred evenly until completely dissolved, placed in a sterilizer, heated to 121°C, and sterilized after 30 minutes to prepare a packaging solution.
[0040] Example 3
[0041] 0.15 g of alkyl glycerol hydrolyzed hyaluronic acid (trade name) was added to 99.74 g of buffer I. 0.10 g of sodium hyaluronate (trade name HA-LQH, produced by Kewpie, Japan) and 0.01 g of alginate were stirred evenly until completely dissolved, placed in a sterilizer, heated to 121°C, and sterilized after 30 minutes to prepare a packaging solution.
[0042] Example 4
[0043] 0.20 g of alkyl glycerol hydrolyzed hyaluronic acid (trade name) was added to 99.69 g of buffer I. 0.10 g of sodium hyaluronate (trade name HA-LQH, produced by Kewpie, Japan) and 0.01 g of alginate were stirred evenly until completely dissolved, placed in a sterilizer, heated to 121°C, and sterilized after 30 minutes to prepare a packaging solution.
[0044] Comparative Example 1
[0045] 0.10 g of sodium hyaluronate (trade name HA-LQH) and 0.01 g of alginic acid were added to 99.89 g of buffer solution I, and the mixture was stirred evenly until completely dissolved. The mixture was then placed in an autoclave, heated to 121° C., and sterilized after 30 minutes to prepare a packaging solution.
[0046] Comparative Example 2
[0047] 0.30 g of alkyl glycerol hydrolyzed hyaluronic acid (trade name) was added to 99.69 g of buffer solution I. ) and 0.01g of alginic acid, stirred evenly until completely dissolved, then placed in a sterilizer, heated to 121°C, and sterilized after 30 minutes to prepare a packaging solution.
[0048] The contact lens packaging solutions prepared in Examples 1 to 4 and Comparative Examples 1 to 2 were then subjected to property evaluation using the following methods. The evaluation results are listed in Table 1.
[0049] Viscosity measurement
[0050] 6.7 ml of the contact lens packaging solutions prepared in Examples 1 to 4 and Comparative Examples 1 to 2 were taken out and their viscosities were measured at 25° C. using a viscometer (Brookfield LVDV-E, manufactured by Brookfield Engineering Lab., Inc., USA). The measured values are listed in Table 1.
[0051] Contact angle test
[0052] Contact lenses (silicone hydrogel contact lenses, manufactured by BenQ Materials) packaged with the contact lens packaging solutions prepared in Examples 1 to 4 and Comparative Examples 1 to 2 were removed from their packaging. A dry cloth was pressed against the lens sample to absorb moisture from the lens surface. The lens was then placed on the test platform of a contact angle measurement device (DGD Fast / 60 Contact AngleMeter, manufactured by GBX Scientific Ltd., Ireland). A water droplet was placed on the lens surface, and the contact angle was automatically measured. The measured values are listed in Table 1.
[0053] Mean water breakup time assessment
[0054] The contact lenses (silicone hydrogel lenses, manufactured by BenQ Materials Co., Ltd.) packaged with the contact lens packaging solutions prepared in Examples 1 to 4 and Comparative Examples 1 to 2 were taken out of the packaging box and placed on the curved tool for 1 minute before being scanned with a corneal topographer (OCULUS Keratograph 5M Topographer, manufactured by OCULUS, Germany). In vitro water film rupture time was measured (manufactured by OCULUS GmbH). Furthermore, contact lenses (silicone hydrogel lenses, manufactured by BenQ Materials Co., Ltd.) packaged with the packaging solutions prepared in Examples and Comparative Examples were removed from their packaging boxes and worn by subjects for 10-15 minutes. The subjects then kept their eyes open and were monitored directly with a corneal topographer (OCULUS Keratograph 5M Topographer, manufactured by OCULUS GmbH, Germany). The water film rupture time (BRT) on the contact lenses worn by the test subjects was measured using a BRET (manufactured by BRET GmbH). The result is the in vivo BRT. The test results are listed in Table 1.
[0055] Moisture evaporation rate
[0056] Contact lenses were soaked in the contact lens packaging solutions prepared in Examples 1 to 4 and Comparative Examples 1 to 2 for 24 hours. The remaining liquid was wiped off, and the lenses were placed on a balance. The weight change per minute was recorded until 28 minutes had passed. The test results are listed in Table 1.
[0057] pH and osmotic pressure measurements
[0058] 5 ml of the contact lens packaging solutions prepared in Examples 1 to 4 and Comparative Examples 1 to 2 were taken to measure the pH using a pH meter (S220, manufactured by METTLER TOLEDO, Switzerland). 200 μl of the solutions were taken to measure the osmotic pressure using an osmometer (3250, manufactured by ADVANCEDINSTRUMENTS, USA). The test results are listed in Table 1.
[0059] Appearance color
[0060] The appearance and color of the contact lens packaging solutions prepared in Examples 1 to 4 and Comparative Examples 1 to 2 were visually observed.
[0061] Table 1 Test results of contact lens packaging solutions of Examples and Comparative Examples
[0062]
[0063] The results in Table 1 show that the contact lens packaging solutions of Examples 1 to 4 of the present invention all have pH values between 6.8 and 7.5 and osmotic pressures greater than 300 mOsmol / kg. Furthermore, their average in vitro water breakup times are greater than 72 seconds, and their average in vivo water breakup times are greater than 8 seconds. Therefore, after soaking contact lenses in the contact lens packaging solutions of the present invention, they provide sufficient wettability, resulting in adequate initial comfort and alleviating dry eye symptoms associated with contact lens wear. The packaging solution of Comparative Example 1, however, lacks effective wettability due to its short water breakup time. Furthermore, the packaging solution of Comparative Example 2 exhibits a low pH after heat sterilization and a distinctly yellow appearance, making it unsuitable for use as a packaging solution for contact lenses sterilized by heat.
[0064] Although the present invention has been disclosed above in terms of preferred embodiments, they are not intended to limit the present invention. Anyone skilled in the art should be able to make some modifications and changes without departing from the spirit and scope of the present invention. Therefore, the scope of protection of the present invention should be based on the appended claims.
Claims
1. A contact lens packaging solution comprising a buffer solution and 0.1 wt% to 0.4 wt% of a moisturizing agent, wherein the moisturizing agent comprises hyaluronic acid salt and a hyaluronic acid hydrolyzed derivative, and the usage ratio of the hyaluronic acid salt to the hyaluronic acid hydrolyzed derivative is between 1:4 and 4:
1.
2. The contact lens packaging solution according to claim 1, wherein the pH value of the packaging solution is between 6.8 and 7.
5. 3 . The contact lens packaging solution according to claim 1 , wherein the hyaluronic acid salt in the moisturizing agent is sodium hyaluronate having a molecular weight between 850,000 and 2,200,000.
4. The contact lens packaging solution according to claim 1, wherein the hyaluronic acid hydrolyzed derivative in the moisturizing agent is an alkyl glycerol hydrolyzed hyaluronic acid having a molecular weight of no more than 10,000 and having a structure represented by the following formula (I): The contact lens packaging solution according to claim 1 , wherein the buffer is 0.1 wt % to 3 wt % of a borate buffer or a phosphate buffer.
6. The contact lens packaging solution according to claim 1, wherein the buffer is a borate buffer comprising water, sodium chloride, boric acid and sodium borate.
7. The contact lens packaging solution of claim 1, further comprising 0.005 wt% to 0.05 wt% of alginic acid.
8. The contact lens packaging solution of claim 1, further comprising an antimicrobial agent, a thickener, a lubricant, or a combination thereof.
9. A contact lens product comprising a packaging solution and a contact lens soaked in the packaging solution, wherein the packaging solution comprises a buffer solution and 0.1 wt% to 0.4 wt% of a moisturizing agent, wherein the moisturizing agent contains hyaluronic acid salt and a hyaluronic acid hydrolyzed derivative, and the usage ratio of the hyaluronic acid salt to the hyaluronic acid hydrolyzed derivative is between 1:4 and 4:
1.
10. The contact lens product according to claim 9, wherein the contact lens is a hydrogel contact lens or a silicone hydrogel contact lens.