Contact lens packaging solution and contact lens product comprising the same

Abstract

To provide a contact lens packaging solution and a contact lens product.SOLUTION: A contact lens packaging solution comprises a buffer solution and 0.1 wt.%-0.4 wt.% of a moisturizing agent. The moisturizing agent comprises a salt of hyaluronic acid and a hydrolyzed hyaluronic acid derivative. The weight ratio of the hyaluronic acid salt to the hydrolyzed hyaluronic acid derivative is 1:4-4:1. The contact lens product comprises the packaging solution and a contact lens soaked in the packaging solution. The contact lens packaging solution according to the present invention can provide the contact lens wearer with sufficient initial comfort.SELECTED DRAWING: None

Description

[Technical Field]

[0001] The present invention relates to a contact lens packaging solution and a contact lens product, and more particularly to a packaging solution that can improve the initial comfort of contact lenses, and a contact lens product that includes the contact lens packaging solution and a contact lens immersed in the contact lens packaging solution. [Background technology]

[0002] Soft contact lenses are transported and sold individually packaged in plastic cases containing a buffer solution. The buffer solution in the plastic case is usually a saline buffer solution to maintain the contact lens so that it can be worn directly after removal. Therefore, the pH value and osmolality of this buffer solution must be similar to those of intraocular tears to avoid discomfort to the wearer during initial wear. However, in order to provide comfort to the wearer, the packaged buffer solution generally also contains nonionic surfactants, surface lubricants, wetting agents, etc. to provide comfort to the contact lens wearer.

[0003] Known wetting agents suitable for soft contact lens packaging solutions include poly(meth)acrylamide, polyhydroxyalkyl(meth)acrylate, polyvinylpyrrolidone, hyaluronic acid, xanthan gum, gum arabic, and starch. Among these, natural polyphosphonium hyaluronic acid is widely used in ophthalmic formulations due to its biocompatibility, absorbency, and moisturizing / lubricating properties. However, due to the high viscosity of hyaluronic acid, increasing its amount to enhance wetting results in increased viscosity of the packaging solution. During use, the water film formed on the lens surface by the highly viscous packaging solution is prone to adsorbing oils and fats, which can cause staining. 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 can not only provide hydrophilicity to the contact lens surface, but also inhibit the adsorption of cationic disinfectants to the contact lens. However, since contact lenses must be sterilized at high temperatures after packaging, small molecular weight hydrolyzed hyaluronic acid derivatives can undergo hydrolysis at high temperatures, excessively lowering the pH of the contact lens packaging solution after sterilization and turning the packaging solution yellow, which can cause discomfort to the wearer if the lenses are taken out of the package and worn directly.

[0004] Therefore, the present invention discloses a novel contact lens packaging solution that can provide sufficient initial comfort to the wearer. That is, the lenses can be worn immediately after being removed from the packaging. Moreover, the moisture content of the contact lenses can be increased, making the lens surface less likely to dry out, thereby reducing eye fatigue caused by wearing contact lenses for long periods of time and improving comfort when wearing contact lenses. Summary of the Invention [Problem to be solved by the invention]

[0005] The present invention provides a packing solution that can improve the initial comfort and moisturizing properties of contact lenses, which can provide good wetting of contact lenses and improve the problem of dry eyes caused by wearing contact lenses. [Means for solving the problem]

[0006] The contact lens packaging solution according to the present invention contains a buffer solution and 0.1 wt% to 0.4 wt% of a moisturizing agent. The moisturizing agent includes a hyaluronate and a hydrolyzed hyaluronic acid derivative. The ratio of the amount of the hyaluronate to the amount of the hydrolyzed hyaluronic acid derivative used is 1:4 to 4:1.

[0007] The pH value of the contact lens packaging solution according to the present invention is 6.8 to 7.5.

[0008] The hyaluronate contained in the moisturizing agent in the contact lens packaging solution according to the present invention is sodium hyaluronate having a molecular weight of 850,000 to 2,200,000.

[0009] The hydrolyzed hyaluronic acid derivative contained in the moisturizing agent in the packaging solution for contact lenses according to the present invention is a hydrolyzed alkylglyceryl hyaluronate having a molecular weight of 10,000 or less, and having a structure represented by the following formula (I): JPEG2025125493000001.jpg63124(I).

[0010] The buffer solution in the contact lens packaging solution according to the present invention is a 0.1 wt% to 3 wt% borate buffer or phosphate buffer.

[0011] In one embodiment of the present invention, the contact lens packaging solution may further contain 0.005 wt% to 0.05 wt% alginic acid.

[0012] The buffer in the contact lens packaging solution of the present invention is a borate buffer, which includes water, sodium chloride, boric acid, and sodium borate.

[0013] In one embodiment of the present invention, the contact lens packaging solution of the present invention may further comprise an antimicrobial agent, a thickening agent, a lubricant, or a combination thereof.

[0014] The present invention further provides a contact lens product comprising a packaging solution and a contact lens immersed in the packaging solution. The packaging solution contains a buffer solution and 0.1 wt% to 0.4 wt% of a moisturizing agent. The moisturizing agent includes a hyaluronate and a hydrolyzed hyaluronic acid derivative. The ratio of the amount of hyaluronic acid to the amount of hydrolyzed hyaluronic acid derivative used is 1:4 to 4:1.

[0015] In the contact lens product according to the present invention, the contact lens is a hydrogel contact lens or a silicone hydrogel contact lens. DETAILED DESCRIPTION OF THE INVENTION

[0016] In order to make the above and other objects, features and advantages of the present invention more clearly comprehensible, the present invention will be described in detail below by way of particularly preferred examples in conjunction with the accompanying chemical formulas.

[0017] The present invention provides a contact lens packaging solution, comprising a buffer solution and a humectant, which comprises hyaluronic acid salt and a hydrolyzed hyaluronic acid derivative, and provides good wetting of the contact lens, providing sufficient initial comfort and alleviating the problem of dry eyes caused by contact lens wear.

[0018] The contact lens packaging solution according to the present invention contains 0.1 wt% to 0.4 wt% of a moisturizing agent, with the ratio of hyaluronic acid salt to hydrolyzed hyaluronic acid derivative being 1:4 to 4:1. In one preferred embodiment of the present invention, the contact lens packaging solution according to the present invention contains 0.2 wt% to 0.3 wt% of a moisturizing agent, with the ratio of hyaluronic acid salt to hydrolyzed hyaluronic acid derivative being 1:2 to 3:1.

[0019] The soft contact lens can be removed from the packaging container and worn directly. Since the packaging solution is adsorbed to the soft contact lens, the closer the pH value of the contact lens packaging solution is to the pH value and osmotic pressure of tears, the more comfortable the eyes will be. The initial pH value and the pH value after the sterilization process of the contact lens packaging solution according to the present invention may both be 6.8 to 7.5, preferably 6.9 to 7.3. The moisturizing agent in the contact lens packaging solution according to the present invention contains a hyaluronate salt and a hydrolyzed hyaluronic acid derivative, which not only maintains the pH value of the packaging solution at 6.8 to 7.5 and an osmotic pressure of greater than 300 mOsmol / kg, but also prevents the pH value of the packaging solution from decreasing or the color of the packaging solution from being affected by hydrolysis of the hydrolyzed hyaluronic acid derivative during the high-temperature sterilization process. This avoids the discomfort experienced by the wearer due to the adsorption of the packaging solution to the contact lens.

[0020] The hyaluronate contained in the moisturizing agent in the packaging solution for contact lenses according to the present invention is sodium hyaluronate having a molecular weight of 850,000 to 2,200,000. Suitable sodium hyaluronates include, for example, HA-LQ or HA-LQH manufactured by Kewpie Corporation.

[0021] The hydrolyzed hyaluronic acid derivative contained in the moisturizer in the packaging solution for contact lenses according to the present invention is a hydrolyzed alkylglyceryl hyaluronate having a molecular weight of 10,000 or less, preferably an alkylglyceryl hydrolyzed hyaluronate having a structure represented by the following formula (I): JPEG2025125493000002.jpg63124(I)

[0022] A suitable example of hydrolyzed alkylglyceryl hyaluronate that can be used is Halorepair (registered trademark) manufactured by Kewpie Japan.

[0023] The contact lens packaging solution of the present invention is suitable for packaging hydrogel contact lenses and silicone hydrogel contact lenses.

[0024] The buffer solution used in the contact lens packing solution may be any physiologically compatible buffer, such as a borate, phosphate, citrate, boric acid, carbonate, or acetate buffer. The salt may be, for example, an alkali metal salt such as a sodium salt or a potassium salt. The salt concentration in the buffer may be 0.1 wt% to 3 wt%. The buffer may be a borate buffer or a phosphate buffer. In one embodiment of the present invention, the buffer solution in the contact lens packing solution preferably contains water, sodium chloride, boric acid, and a borate salt.

[0025] The moisturizing agent contained in the contact lens packaging solution of the present invention can provide an appropriate pH value and osmotic pressure, and the packaging solution can maintain a water film on the lens surface for a long time after the contact lens is removed from the package, thereby providing the wearer with a sufficient moist feeling and initial comfort.

[0026] The contact lens packing solution of the present invention may further contain alginic acid as a moisturizing aid. This enhances the wettability of the contact lens and alleviates dryness of the eyes when wearing the contact lens. The weight-average molecular weight of the alginic acid suitable for use in the contact lens packing solution of the present invention is in the range of 1,000 to 30,000, preferably 5,000 to 20,000, and the amount added may be 0.005 wt% to 0.05 wt%.

[0027] In the moisturizing agent in the contact lens packaging solution according to the present invention, the components forming the moisturizing agent may be mixed together and then added to the buffer solution, or may be added individually to the buffer solution, and there is no particular limitation.

[0028] Additionally, the contact lens packaging solution of the present invention may optionally further comprise an antimicrobial agent, a thickening agent, a lubricant, or a combination thereof.

[0029] The present invention also provides a contact lens product comprising a packaging solution and a contact lens immersed in the packaging solution. The packaging solution contains a buffer solution and 0.1 wt% to 0.4 wt% of a moisturizing agent. The moisturizing agent contains a hyaluronate and a hydrolyzed hyaluronic acid derivative. The ratio of the amount of the hyaluronate to the amount of the hydrolyzed hyaluronic acid derivative used is 1:4 to 4:1.

[0030] In the contact lens product according to the present invention, the contact lens is a hydrogel contact lens or a silicone hydrogel contact lens. The hydrogel contact lens or the silicone hydrogel contact lens can be removed from the packaging and worn directly. The moisturizing agent in the contact lens packaging solution according to the present invention contains hyaluronate and a hydrolyzed hyaluronic acid derivative, so that the packaging solution adsorbed on the soft contact lens can provide good wettability and initial comfort for the contact lens. Furthermore, the pH value of the packaging solution is appropriate, so the color appearance does not become excessively yellow, making it suitable for packaging contact lenses.

[0031] The following examples are used to further illustrate the present invention, but the present invention is not limited thereto.

[0032] Preparative Example 1 - Preparation of Buffer I

[0033] To 98.607 g of deionized water, 0.71 g of sodium chloride, 0.043 g of sodium borate, and 0.43 g of boric acid were added, and the mixture was stirred until completely dissolved to obtain Buffer Solution I.

[0034] Example 1

[0035] 99.79 g of buffer solution I was mixed with 0.10 g of hydrolyzed alkylglyceryl hyaluronate (trade name: Halorepair (registered trademark), manufactured by Kewpie Japan), 0.10 g of sodium hyaluronate (trade name: HA-LQH, manufactured by Kewpie Japan), and 0.01 g of alginic acid, and the mixture was stirred until completely dissolved. The mixture was then placed in a sterilized pot, heated to 121°C, and sterilized after 30 minutes to obtain a packaging solution.

[0036] Example 2

[0037] 99.79 g of buffer solution I was mixed with 0.05 g of hydrolyzed alkylglyceryl hyaluronate (trade name: Halorepair (registered trademark), manufactured by Kewpie Japan), 0.15 g of sodium hyaluronate (trade name: HA-LQH, manufactured by Kewpie Japan), and 0.01 g of alginic acid, and the mixture was stirred until completely dissolved. The mixture was then placed in a sterilized pot, heated to 121°C, and sterilized after 30 minutes to obtain a packaging solution.

[0038] Example 3

[0039] 99.74 g of buffer solution I was mixed with 0.15 g of hydrolyzed alkylglyceryl hyaluronate (trade name: Halorepair (registered trademark), manufactured by Kewpie Japan), 0.10 g of sodium hyaluronate (trade name: HA-LQH, manufactured by Kewpie Japan), and 0.01 g of alginic acid, and the mixture was stirred until completely dissolved. The mixture was then placed in a sterilized pot, heated to 121°C, and sterilized after 30 minutes to obtain a packaging solution.

[0040] Example 4

[0041] 99.69 g of buffer solution I was mixed with 0.20 g of hydrolyzed alkylglyceryl hyaluronate (trade name: Halorepair (registered trademark), manufactured by Kewpie Japan), 0.10 g of sodium hyaluronate (trade name: HA-LQH, manufactured by Kewpie Japan), and 0.01 g of alginic acid until completely dissolved, and then placed in a sterilized pot, heated to 121°C, and sterilized after 30 minutes to obtain a packaging solution.

[0042] Comparative Example 1

[0043] To 99.89 g of buffer solution I, 0.10 g of sodium hyaluronate (trade name: HA-LQH) and 0.01 g of alginic acid were added and stirred until completely dissolved. The mixture was then placed in a sterilized pot, heated to 121°C, and sterilized after 30 minutes to obtain a packaging solution.

[0044] Comparative Example 2

[0045] 99.69 g of buffer solution I was mixed with 0.30 g of hydrolyzed alkylglyceryl hyaluronate (trade name: Halorepair (registered trademark)) and 0.01 g of alginic acid until completely dissolved, and then placed in a sterilized pot, heated to 121°C, and sterilized after 30 minutes to obtain a packaging solution.

[0046] Next, the properties of the contact lens packaging solutions prepared in Examples 1 to 4 and Comparative Examples 1 and 2 were evaluated according to the following methods, and the evaluation results are shown in Table 1.

[0047] Viscosity measurement

[0048] From the contact lens packing solutions prepared in Examples 1 to 4 and Comparative Examples 1 and 2, 6.7 ml of packing solution was taken and the viscosity was measured at 25° C. using a viscometer (Brookfield LVDV-E, manufactured by Brookfield Engineering Lab., Inc., USA). The measured values ​​are shown in Table 1.

[0049] Contact angle measurement

[0050] Contact lenses (silicone hydrogel contact lenses, manufactured by Meiki Materials Co., Ltd.) packaged with the contact lens packaging solutions prepared in Examples 1 to 4 and Comparative Examples 1 and 2 were removed from their packaging boxes, and the lens samples were pressed with a dry cloth to absorb moisture from the lens surface. The lenses were then placed on the measurement platform of a contact angle measuring device (DGD Fast / 60 Contact Angle Meter, manufactured by GBX Scientific Ltd., Ireland), and water was dropped onto the lens surface to automatically measure the contact angle. The measured values ​​are shown in Table 1.

[0051] Estimation of mean water film rupture time

[0052] Contact lenses (silicone hydrogel lenses, manufactured by Meiki Materials Co., Ltd.) packaged with the contact lens packaging solutions prepared in Examples 1 to 4 and Comparative Examples 1 and 2 were removed from their packaging boxes and placed on a circular tool for 1 minute. The extracorporeal water film rupture time was then measured using a corneal topograph (OCULUS Keratographh 5 M Topographer, manufactured by OCULUS Optikgerate GmbH, Germany). Furthermore, contact lenses (silicone hydrogel lenses, manufactured by Meiki Materials Co., Ltd.) packaged with the packaging solutions prepared in the Examples and Comparative Examples were removed from their packaging boxes and worn for 10 to 15 minutes. The water film rupture time on the surface of the contact lens worn by the subject was then directly measured using a corneal topograph (OCULUS Keratographh 5 M Topographer, manufactured by OCULUS Optikgerate GmbH, Germany) while the subject kept their eyes open. The measured values ​​were the intracorporeal water film rupture times. The measurement results are shown in Table 1.

[0053] Water evaporation rate

[0054] A contact lens was immersed in the contact lens packaging solutions prepared in Examples 1 to 4 and Comparative Examples 1 and 2 for 24 hours, the remaining liquid was wiped off, the lens was placed on a balance, and the weight change per minute was recorded up to 28 minutes. The measurement results are shown in Table 1.

[0055] Measurement of pH value and osmotic pressure

[0056] Five milliliters of each of the contact lens packaging solutions prepared in Examples 1 to 4 and Comparative Examples 1 and 2 was taken and the pH value was measured using a pH meter (S220, manufactured by METTLER TOLEDO, Switzerland). 200 μl of each solution was taken and the osmotic pressure was measured using an osmometer (3250, manufactured by ADVANCED INSTRUMENTS, USA). The measurement results are shown in Table 1.

[0057] Appearance color

[0058] The external color of the contact lens packaging solutions prepared in Examples 1 to 4 and Comparative Examples 1 and 2 was visually observed. Measurement results of contact lens packaging solutions in Examples and Comparative Examples [Table 1]

[0059] As can be seen from the results in Table 1, the pH values ​​of the contact lens packing solutions according to Examples 1 to 4 of the present invention were all between 6.8 and 7.5, and the osmotic pressures were all greater than 300 mOsmol / kg. Furthermore, the average extracorporeal water film rupture times were all greater than 72 seconds, and the average intracorporeal water film rupture times were all greater than 8 seconds. Therefore, after immersing a contact lens in the contact lens packing solution according to the present invention, the contact lens can be provided with sufficient initial comfort. Furthermore, the problem of dry eyes caused by wearing contact lenses can be alleviated. The packing solution of Comparative Example 1 failed to effectively maintain wettability due to a short water film rupture time. On the other hand, the packing solution of Comparative Example 2 had a low pH value after heat sterilization and a distinctly yellow appearance, making it unsuitable as a packing solution for contact lenses to be sterilized by heat sterilization.

[0060] The present invention has been described above with preferred embodiments, but they are not used to limit the present invention. Those skilled in the art can make minor modifications and improvements without departing from the spirit and scope of the present invention, so the protection scope of the present invention is subject to those who are defined by the scope of the patent application attached later.

Claims

1. A contact lens packing solution comprising a buffer solution and 0.1 wt % to 0.4 wt % of a humectant; The moisturizing agent contains a hyaluronic acid salt and a hydrolyzed hyaluronic acid derivative, and the ratio of the amount of the hyaluronic acid salt to the amount of the hydrolyzed hyaluronic acid derivative used is 1:4 to 4:

1. Contact lens packaging solution.

2. 2. The contact lens packaging solution of claim 1, wherein the pH value of the packaging solution is 6.8 to 7.

5.

3. 2. The contact lens packaging solution of claim 1, wherein the hyaluronic acid salt in the moisturizing agent is sodium hyaluronate having a molecular weight of 850,000 to 2,200,000.

4. 2. The contact lens packaging solution of claim 1, wherein the hydrolyzed hyaluronic acid derivative in the moisturizer is a hydrolyzed alkylglyceryl hyaluronate having a molecular weight of 10,000 or less and having a structure represented by the following formula (I): (I).

5. 2. The contact lens packaging solution of claim 1, wherein the buffer solution is a 0.1 wt% to 3 wt% borate or phosphate buffer solution.

6. 10. The contact lens packaging solution of claim 1, wherein the buffer is a borate buffer comprising water, sodium chloride, boric acid, and sodium borate.

7. 10. The contact lens packaging solution of claim 1, further comprising 0.005 wt% to 0.05 wt% alginic acid.

8. 10. The contact lens packaging solution of claim 1, further comprising an antimicrobial agent, a thickening agent, a lubricant, or a combination thereof.

9. A contact lens product comprising: a packaging solution; and a contact lens immersed in the packaging solution; the packaging solution includes a buffer solution and 0.1 wt % to 0.4 wt % of a humectant; The moisturizing agent contains a hyaluronic acid salt and a hydrolyzed hyaluronic acid derivative, and the ratio of the amount of the hyaluronic acid salt to the amount of the hydrolyzed hyaluronic acid derivative used is 1:4 to 4:

1. Contact lens products.

10. 10. The contact lens product of claim 9, wherein the contact lens is a hydrogel contact lens or a silicone hydrogel contact lens.

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