JPS63502027A - Cleaning and preservation compositions for hydrophilic contact lenses - Google Patents

Abstract

(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

[Detailed description of the invention] Cleaning and preservation composition for hydrophilic contact lenses The present invention is suitable for use in the ophthalmological field. Regarding the storage and cleaning of contact lenses used in Used in direct contact with the mucous membranes of the eye, in addition to the preservation and cleaning of similar articles of the eye. Prolonged contact with biological tissues or fluids, as in the case of contact lenses. It should be understood that it is also applicable to uses that include.

The invention more particularly relates to so-called soft contact lenses, or hard or Hydrophilic with an organic polymer base, like other soft biocompatible objects Concerning the processing of articles of this type made of the material.

In particular, it is known that hydrophilic contact lenses should be stored in an aqueous medium; Because of this, users should keep their lenses soaked while not wearing them on their eyes, especially at night. liquid is supplied. The lenses also allow eye fluids to accumulate on their surfaces and interfere with vision. They should be disinfected regularly to remove deposits that can damage and irritate the pupils. It is also well known that This type of cleaning action is suitable for regular overnight storage. Usually not available under these conditions.

To allow disinfection of contact lenses, they can be used cold if necessary. , but it is proposed to use compositions containing disinfectants that are most effective in heated conditions. There is. However, between the disinfectant used and the material that makes up the lens, the latter Obviously, it must not be attacked by the solution, so compatibility problems arise. actual The materials typically used to make hard organic lenses are heated even below the boiling point of water. However, since the active compound deforms when heated, it is necessary to use the active compound in the cold state. Soft wood-loving lenses and such highly water-loving lenses that withstand especially thermal processing lenses are more easily disinfected by common disinfectants such as 4th VL ammonium salts. be invaded.

Currently the best solution to the non-coexistence problem consists of the use of hydrogen peroxide. but However, this problem can only be solved under conditions where neutralization of the processing solution is required before using the lens. and may encounter eye irritation problems. Furthermore, hydrogen peroxide coexists in the solution. Regardless of possible additives, the use of hydrogen peroxide does not allow for satisfactory cleaning of lenses. stomach.

As can be seen, it is stable and effective in aqueous solution and harmless during handling operations. allows contact lenses to be immersed for long periods of time without deteriorating their constituent materials. and irritate the pupil or mucous membrane of the eye after a immersion period of e.g. 1 to 2 hours. Contact lens users benefit from a composition that does not leave harmful compounds in solution. However, it would be of considerable benefit to make storage and cleaning operations more convenient.

In order to meet these practical needs, the present invention utilizes organic peracids that have recently appeared on the market. We propose to rely on one type of compound, namely the alkaline earth salts of monobelphthalic acid. come up with a plan These compounds have been commercialized as ingredients in household detergents, but These properties have to date never been tested for potential applications in contact lens processing. It had never been considered.

It is therefore an object of the present invention to provide a monopel filter for the storage or cleaning of contact lenses. lies in the use of alkaline earth salts of tarric acid. The present invention also uses monopeptides as active compounds. Preservation of contact lenses characterized by containing an alkaline earth salt of luphthalic acid or for compositions suitable for cleaning. For the intended use, this composition is advantageously is dissolved in water at a concentration containing from 0.5 to 10% by weight of the active compound.

According to another feature of the invention, the composition containing said organic peroxide salt is preferably ensures complete complexation of all alkaline earth ions of this salt into aqueous solution. , containing a complexing agent for this salt in a proportion at least equal to the stoichiometric proportion. I'm reading. Complexing agents that are particularly suitable for this purpose due to their bacteriostatic properties are ED TA alkali salts (nibutates) and alkali hexametaphosphates, especially hexametaphosphates. Sodium quinametaphosphate.

The composition according to the invention contains 0.5 to 10% by weight of active substance in distilled water and preferably preferably in the form of a solution at a concentration of the order of 0.5 to 5% by weight, at room temperature. For maintenance and preservation of contact lenses, or for cleaning treatments in fully heated conditions. can be used to advantage. However, the composition may contain non-distilled water and also Specifically, it can be used as a solution in normal drinking water. The composition itself is Additional ingredients for sodium carbonate, and especially those intended for preparing solutions such as buffering agents such as, or complexing agents for the purpose of removing drinking water hardness (those previously mentioned can be the same as ).

In certain embodiments of the invention, the composition comprises polyglycols, polyvinylpyrrolidine, Granular particles coated with soluble organic materials such as lydones or cellulose conductors Supplied in powder form. This powder will fit the capacity of a contact lens storage container. i.e. generally providing individual doses taken to dissolve in 5 to 20 ml of water. It can be advantageously accommodated in a sachet.

In another embodiment, the composition of the invention is prepared by adding 5 to 20 mI of water for each tablet. It can be provided in the form of tablets with similar dosages for dissolution in t.

The invention now lies within the scope of specific applications, which are not given in a limiting sense. will be more fully described.

Example 1 in distilled water, formula 1% by weight of magnesium monoverphthalate with ILLiO2000 Prepare a solution containing mg.

The decomposition rate of this organic peroxide is examined by Merck peroxide test. given below The obtained results were observed and expressed in equivalent concentration of hydrogen peroxide as a function of time. Ru.

Ichi Akane"" concentration (mg/4) 0 10.000 (initial) Up to 15 100 or more 17.5 30-100 2010-30 30 3-10 To test ocular drug tolerance, 0.1 mj of the same solution 30 minutes after solution preparation! take one by one and applied by drop to the right eye of four rabbits, the left eye serving as a control.

Observation of rabbit eyes immediately after instillation, 1 hour, 3 hours, 24 hours and 72 hours later do. No signs of irritation or intolerance are observed. 2 in 90 minutes after the first instillation Repeat this experiment by performing a second instillation. This second instillation is The test is carried out using a 0.1 mjl sample of the solution 30 minutes after preparation. Rabbit's eye condition Observe in the same manner as before. No signs of irritation or intolerance are detected.

In other experiments, for various microbial strains at a concentration of 1% by weight and for 10 minutes at room temperature. To study the disinfection effectiveness of freshly prepared solutions with respect to contact time. Observed results The results are given below.

Strain inoculation amount result Escherichiacoli NCTC81981, 2x 10' completely dead PseudomonasAer, ATCC154422, 8x 10' Complete Death Klebsiella Pneu, ATCC45322, IX 10' Complete Total death 5taphi1. Aureus ATCC65382, 3x 10’ Completely killed 5trept, Faecalis ATCC105411, Ox 1 0' Completely extinct Candida A1bicans ATCC102316, 2x to’ Completely extinct Saccharomices cer, NcYNLO263 , 6x IQ' completely killed.It is noteworthy that its pathogenicity and frequency in the ocular medium against gram-negative strains, including Pseudomonas strains, which are particularly fearsome due to their Outstanding treatment effectiveness.

In other test series, in one case hard type and in the other case In this case, the above-mentioned single layer with soft type commercially available contact lens material is used. Compatibility of volume % solutions is taken into account. Therefore, the organic peroxide used and its decomposition products are The absorption spectrum of a lens in the ultraviolet region, which corresponds to the sensitive wavelength range for objects. is measured. The spectrum of the lens is determined on the one hand before processing and on the other hand The sample is measured after being immersed in the solution. The recorded spectra are identical.

If this process is repeated 20 times for the same lens, the spectrum will not change. .

The polymers that make up the lenses subjected to these tests are Methyl methacrylate or cellulose acetate butyrate, oxygen permeable For hard lenses, it is acrylic polymer, and for soft lenses, it is polyhydrocarbon. xyethyl methacrylate, or hydroxyethyl methacrylate or vinyl It is a polymer based on a copolymer of lupyrrolidone.

Example 2 Prepare a 1% by weight solution of magnesium monoperphthalate in distilled water, and add directly into this solution. Soft hydrophilic lenses with a base of polyhydroxyethyl methacrylate Soak. The solution containing these lenses was heated to 85°C and this temperature was increased to 2 Hold for 0 minutes.

After cooling, remove the lens from the solution and rinse with distilled water. The lens cleaned in this way is Store in prefectural salt water.

Example 3 Ethyl cellulose containing sodium edetate and anhydrous sodium carbonate as complexing agents Composition having a base of magnesium monoperphthalate in the form of granules coated with This powder is divided into individual doses enclosed in sachets or plates. Ru.

Each usage amount is Magnesium monoperphthalate 1100II1 Sodium edetate (EDTA Na2,2H20) 80mg Sodium carbonate (N82COs) 130 mg ethylcellulose・4mg Contains.

The use of this powder is recommended for preserving hard or soft contact lenses. The individual amounts used are intended to be dissolved in about 11 liters of distilled water. lens It is recommended to leave them soaked in this solution for at least 1 hour, and they are more It is understood that one can be immersed in the solution for an extended period of time. Or rinse the lens with water before reusing it. Rinsing is recommended.

Example 4 Using the powder prepared according to Example 3, magnesium monoperphthalate 100 Tablets with polyethylene glycol 4000 at a rate of 35 mg per tablet in mg doses Compress into dosage form.

These tablets are intended to be used as in the individual dosages of Example 3. preparation The solution is essentially isotonic.

Example 5 Tablets similar to Example 4 were prepared by adding magnesium monoperphthalate to an equivalent amount of monoperphthalate. and replacing polyethylene glycol with polyvinyl pyrrolidate. and replacing ethylcellulose with methylcellulose. Manufactured in the same manner by.

Example 6 The composition according to the invention can be used in individual doses to be dissolved in 10 ml of distilled water. As described in the above examples in the form of powder or tablets in sachets with the ingredients and amounts given. Manufactured to carry.

Magnesium monoperphthalate 250IOg Sodium carbonate 122mg Sodium edetate (possible DTA 'Na2,2H20)' 15mg hexameta Sodium phosphate 770 mg This solution is isotonic.

Example 7 For the same use and in the same form as Example 6, the ingredients and amounts (mg Individual doses of the composition according to the invention are prepared containing:

Magnesium monoperphthalate 100 100 50 100 Na2COs 54 70 27 10EDTA Naz, 2H201579-EDTA Na4,4H2018-- Sodium hexametaphosphate 158 158 158 -NTANas-- --55 A similar composition combines magnesium monoperphthalate with an equivalent amount of sodium monoperphthalate. Manufactured by replacing it with lium.

Example 8 The composition according to the invention is dissolved in 8 mal of distilled water with the following ingredients and amounts: Manufactured and presented in tablet form, intended for use in

Magnesium monoperphthalate 80mg 80mg EDTA Na4.4H2 012mg 108mg Sodium hexametaphosphate 128mg -Na 2 COs 43mg 61.5mg Polyvinylpyrrolidone 22mg 15m g Polyethylene glycol 4000 21mg 35mg Example 9 The composition according to the invention is prepared with the following ingredients, and for each tablet the following ingredients: compressed to produce a tablet containing.

Magnesium monoperphthalate 80mg 88BEDTA Na4. 4H2 015mg 105mg Sodium Hexametaphosphate 163mg 55mg None Sodium hydrcarbonate 40mg 18mg Polyvinylpyrrolidone 21mg 15 mg polyethylene glycol 4000 24 mg 17 mg boric acid 3 mg To use these tablets, dissolve each tablet in 8mf of drinking water and then use contact lenses. Recommended for preservation.

The invention is of course not limited in any way to the embodiments described above; on the contrary, the invention All changes that differ from the examples, in particular with respect to the nature of the ingredients, their proportions and combinations. This includes any changes that may occur.

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Claims (1)

[Claims] 1. Characterized by containing an alkaline earth salt of monobelphthalic acid as an active compound A composition suitable for storing or cleaning contact lenses. 2. 2. The composition of claim 1, further comprising a complexing agent for said salt. 3. The complexing agent may be sodium edetate, sodium hexametaphosphate, or the like. 2. The composition according to item 2, comprising a mixture thereof. 4. Particularly, the active compound is dissolved in water to a concentration of 0.5 to 10% by weight. The composition according to any one of Items 1 to 3, wherein the composition has the following characteristics. 5. Powder in sachets providing individual doses suitable for dissolving in 5 to 20 ml of water 5. The composition according to any one of paragraphs 1 to 4, characterized in that the composition is provided in the form of a powder. 6. Provided in tablet form, dosed to dissolve in 5 to 20 ml of water The composition according to any one of Items 1 to 4, characterized by: 7. Items 1 to 6, further comprising sodium carbon. Any composition. 8. The active compound is monobelphthalate in individual doses of 0.5 to 5 mg. 8. The composition according to any one of items 1 to 7, which is magnesium. 10. Alkaline monobelphthalic acid for preserving or cleaning contact lenses Uses of lithium salts.