Ophthalmologist acceptable composition for neutralizing residual peroxide, ophthalmologist secure method of identification in the solution of the absence of peroxide and ophthalmologist safe composition for contact lenses

 

(57) Abstract:

The invention relates to compositions and method to quickly and efficiently determine whether it's been functional component, such as catalase, transparent solution, such as hydrogen peroxide solution, by mixing with the specified functional component of an effective amount of vitamin B-12 so that when adding the mixture into a clear solution, this solution took the pink color. By observation pink color of the solution, the user can determine whether there was added to the clear solution of the specified functional component. The composition is intended for ophthalmic use. 3 C. and 15 C.p. f-crystals.

The invention relates to ophthalmically safe compositions for the identification of a solution. In particular, the present invention relates to compositions and methods to quickly and effectively identify the presence of a peroxide solution, providing irritant effect on the eye.

To prevent infections and other adverse from the point of view of hygiene eyes of impacts that may be associated with wearing contact lenses, these contact Lin is mimih systems and methods allowing the user to clean and disinfect contact lenses at certain intervals of time between their wearing. In one of such methods are cleaning the lens using a solution containing cleanser, and rinse with saline. This lens is placed in a disinfectant solution for a certain convenient period of time, for example overnight, so in the morning these lenses were cleaned and disinfected, and preferably after washing with saline, were ready to use. All these solutions are transparent, so that they can be easily confused with each other.

All standard system for cleaning and disinfecting can be divided into two types: "heat" and "cold" system. Thermal system for disinfection of contact lenses require heating; whereas cold system for disinfection include the use of disinfectant chemicals at ambient temperatures.

Such a cold disinfectant systems include systems that use disinfected with hydrogen peroxide. Disinfectant solutions of hydrogen peroxide are elective for the destruction of bacteria and fungi, to which only lasts a certain amount of residual unreacted hydrogen peroxide. Therefore, after removal of the lens from the solution, on the surface there can be some amount of hydrogen peroxide. This residual amount of hydrogen peroxide that is present on contact lenses can cause irritation, burning or injury to the eye, if the hydrogen peroxide will not be neutralized. Therefore, to ensure safety and comfort when wearing disinfected contact lenses, it is necessary to neutralize the residual hydrogen peroxide in the liquid medium, in which are to be disinfected contact lens.

Aqueous solutions of hydrogen peroxide, currently used for disinfection of contact lenses, contain relatively high concentrations of hydrogen peroxide, for example about 3% wt. in volume. Such high concentrations of hydrogen peroxide are used for contact lens can be disinfected in a relatively short period of time, for example 10 minutes

It would be highly desirable to obtain such a system for disinfection of contact lenses that would allow visually and with sufficient ease to determine whether the residual hydrogen peroxide in the liquid medium in which the impact transparent saline, transparent fluorescent cleaner, transparent disinfecting solution containing 3% hydrogen peroxide and neutralizing tablets, which contain a neutralizer hydrogen peroxide - catalase (see, for example, [2]).

Basically, the scheme for treatment of contact lenses includes the following stages.

1. Cleaning lenses transparent sterile saline and transparent natural cleaning solution;

2. Room cleaned lenses in transparent disinfectant and maintaining in the solution of these lenses from 10 min (at least) until a period of time, continuing throughout the night;

3. Adding to the transparent solution tablets to neutralize the residual hydrogen peroxide; however, the solution obtained after adding tablets, is also transparent.

The main drawback of the above scheme is that everything used in it solutions are transparent. Therefore, the user, especially if he is in a state of fatigue, can easily get them mixed up. For example, if the user not knowing what he mistakenly did not pronaturaleza residual hydrogen peroxide present in dezinfitsiruyuschim solution, immediately put these lenses on the eye, tel, and the solution containing neutralized peroxide are both transparent, it is easy to confuse. Therefore, it would be desirable to obtain such a system for disinfection of contact lenses, which would allow the user to easily and visually distinguish the solution containing the peroxide from the solution, which either does not contain peroxide or contains neutralized peroxide.

Known composition for disinfecting contact lenses, which has a solid form and is designed to add in water and which includes a means for disinfecting contact lenses, which are a source of hydrogen peroxide when added to water; inactivating the means for neutralizing the source of hydrogen peroxide and the indicator color changes, such as phenolphthalein, which changes its color from intense (in solution with hydrogen peroxide) to colorless (mainly in neutral solutions) [1]. However, the phenolphthalein is not suitable for use with contact lenses, because keeping the contact lenses in solution, it stains them.

In the article titled "Vatamin and Polymers in the Treatment of Ocular Surface Disease Spectrum" (may 1990) describes the preparation of the artificial tears called "Natratear is provided, that vitamin B-12 gives the drug the color pink, but the solution, however, does not stain any clothing or contact lenses. The specified medication vitamin B-12 is intended for instillation into the eye when the so-called "dry eye". Vitamin b-12 is also shown as a means to restore or even eliminate epithelial damage, which is usually observed at the surface of the eye diseases.

In France, also distributed the preparation of the artificial tears, manufactured by Allergan France under the name "Dulcis", which contains 0.05% of vitamin B-12.

Pills are also various periods of release that includes the component, demoralizing peroxide, such as catalase, and which have a coating that provides prolonged release (see, for example, Schafer and others, the application for Europatent, and Kaspar U.S. patent N 4568517).

The present invention relates to ophthalmically safe composition and to a method of identifying a solution, and in particular to ophthalmically safe composition and method that allows you to verify the absence of residual hydrogen peroxide in the solution resulting from the neutralization of hydrogen peroxide using pendulously pink color.

Basically, the present invention relates to an ophthalmic solution containing a diluent, such as water; an effective amount of vitamin B-12; and a component selected from the group comprising a neutralizer hydrogen peroxide cleaner, disinfectant, and salt, such as sodium chloride.

In another embodiment, the present invention relates to ophthalmic tablet containing an effective amount of vitamin b-12 and a functional component, such as the neutralizer hydrogen peroxide cleaner or disinfectant.

In the following embodiment, the present invention relates to ophthalmically safe compositions for identifying the presence of hydrogen peroxide. This composition includes a compound that neutralizes hydrogen peroxide, and vitamin B-12, and is made, preferably, in the form of pills, which can be coated (but not necessarily), providing a certain time of the release.

In yet another embodiment, the present invention relates to ophthalmically safe method of determining the presence of hydrogen peroxide in solution. This method includes the following stages: manufactured by Garrett, Borg is In-12; adding the obtained composition to the solution containing hydrogen peroxide, and the observation of the colour of the solution.

The value of the present invention is that it allows you to identify the specific solution and to distinguish this solution from other solutions used for eye care, or for other purposes, providing direct contact of these solutions with the tissues of a living organism. A particular advantage of the present invention is that it allows you to identify a solution that does not contain hydrogen peroxide.

The undoubted advantage of the present invention is the finding that vitamin B-12 is ophthalmically safe and gives the solution pink. This pink color may serve as an indicator solution containing dissolved vitamin B-12. Mixing vitamin B-12 with a functional component, such as catalase, makes it easy to determine whether it's been specified functional component to a transparent solution.

In one embodiment, the present invention provides for the use of vitamin B-12 as an indicator systems, designed the stroke lenses with the use of hydrogen peroxide, these lenses are usually placed in a solution containing approximately 10 ml of 3% (wt./about.) the hydrogen peroxide. This solution is transparent. After keeping the contact lenses in the specified solution 10 min before period of time lasting one night lenses be disinfected, but the solution may be a certain amount of hydrogen peroxide. However, the user often cannot exactly say whether the residual hydrogen peroxide, since in any case the solution remains clear. In the described mode to care for the lenses, the user typically adds to a solution of the compound, neutralizing the hydrogen peroxide, such as catalase. Basically, catalase is used in the form of an aqueous solution or tablets that can be covered (but not necessarily) by the shell, providing a certain time of the release. Vitamin B-12 can be manufactured in the form of tablets, which will contain the appropriate level of catalase to neutralize residual hydrogen peroxide, and some vitamin B-12, effective to change the color of the solution from clear to pink.

Adding to the solution containing residual peroxide vodart pinkish or intense pink color. This color will indicate to the user that the solution, which are to be disinfected lens was added tablet containing peroxide-neutralizing compound. The composition of the present invention may include any suitable compound that neutralizes hydrogen peroxide. Specified peroxide neutralizing the connection must have the ability to effectively decomposition of residual hydrogen peroxide, and thus, does not adversely impact on the disinfected lens and the eye, where these lenses are inserted. Soedineniya used to neutralize hydrogen peroxide, are reducing agents hydrogen peroxide, enzymes, decomposing hydrogen peroxide, such as peroxidase and catalase; and mixtures thereof.

Examples of reducing agents are hydrogen peroxide, which can be used in the present invention are the sulfites of alkali metals, in particular sodium sulphites; thiosulfate; thiourea; diglycerin; N-acetylcysteine; formats of alkali metals, in particular formats sodium; ascorbic acid; isoascorbic acid, Glyoxylic acid, pyruvic acid; ophthalmically acceptable salts such as salts of Molochny the La neutralization of hydrogen peroxide is catalase, because, thanks to its efficiency, it is able to almost completely eliminate hydrogen peroxide from a liquid medium over a relatively short period of time, for example from about 1 minute to about 12 hours, and preferably from about 5 min to about 1 h after the beginning of its release into the environment containing hydrogen peroxide.

The quantity used of the component, neutralizing the hydrogen peroxide should preferably be sufficient to decompose all the hydrogen peroxide present in the environment, to which was added the indicated neutralizing component. This can be used an excessive amount of the component to neutralize the hydrogen peroxide. However, you should avoid too much excess neutralizing component, as specified component itself may adversely impact disinfected lens and/or the safety and comfort of their use. If the component that neutralizes hydrogen peroxide, using catalase, it is preferable that the amount ranged from about 100 to about 1000, and more preferably from about 150 to 700 units of catalase activity per milliliter of liquid medium. For example, in aqueous solution, stepnote/ml.

Component, neutralizing the hydrogen peroxide may be used in combination with one or more other components, which, for example, can all be contained in the core of the tablets produced in accordance with the present invention. Such other components can be, for example, fillers, binders, toning agents, agents, providing air conditioning/wetting contact lenses; buffers; lubricating agents, etc., Each of these components may be present (if present at all) in an amount which is effective to implement the intended function (or functions). Examples of such compounds are well known to any specialist. Therefore, this description does not provide a detailed description of the aforementioned components.

To illustrate, below is an example of tablets containing vitamin B-12 and the component that neutralizes hydrogen peroxide, and having the following composition, wt.%:

Component, neutralizing the hydrogen peroxide - 1 - 30

Vitamin B-12 - 0,005 - 1,0

Filler - 15 - 90

Toning agent - 1 - 90

The buffer agent is 1 - 50

Lubricating agent - 0 - 30

As toning agents which P CLASS="ptx2">

As agents, providing air conditioning/wetting contact lenses, can be used polyvinyl alcohol, poloxamer, polyvinylpyrrolidone, hypromellose and mixtures thereof, and other suitable for these purposes the compounds. Some of the components used in the present invention for coating (see below), may exercise one or more other functions after their dissolution in an environment containing hydrogen peroxide.

Normal saline solutions have a pH ranging from about 6 to 8 and include a buffer component is present in an amount that is effective to maintain the pH of the salt solution in the desired range. As a suitable buffer components or agents, indicating the buffer action can be used standard components that are typically used in systems for the care of contact lenses. Examples of such buffer components are compounds having a carbonate, bicarbonate, phosphate, borate, etc., functional groups, and mixtures thereof. Such buffers can be salts of alkali and alkaline earth metals, in particular sodium and potassium salts. For pH correction of the considered compositions doganov, which can be used in the present invention, can serve as (but not limited to) a polyalkylene glycols such as polyethylene glycols, having, preferably, a molecular weight ranging from about 500 to about 10,000. Tablets made in accordance with the present invention may also be used and other materials that are typically used as lubricating agents in ophthalmically acceptable tablets.

The inclusion of one or more of these other components in the composition of the present invention may alleviate the functional activity of such compositions and to facilitate the implementation of the methods of the present invention. For example, they can help maintain pH and/or osmolarity of the liquid water environment within certain limits, and to promote the solubility of the component used for the coating, and/or physiological acceptability. One or more of such other components can be included in the mixture, which is applied to the core tablet and which remains on the tablet in the form of a coating. Specified other component or components may also be included in the composition of the present invention otdc catalase in solution, containing residual hydrogen peroxide, this catalase reacts with hydrogen peroxide to release oxygen. As a result, the solution begins to bubble and foam, becoming warmer. Then bubbles and foam begins to subside, and the neutralization reaction between catalase and hydrogen peroxide is completed. After that contact lenses can be safely placed on the eye, although it is preferable to first rinsed with isotonic saline.

In another embodiment, the present invention vitamin B-12 can be added to almost any ophthalmic solution in a quantity able to paint this solution in pinkish or pink color. Thus, it is possible to identify a given solution and to distinguish it from other solutions. For example, an effective amount of vitamin B-12 can be added to an isotonic saline solution to make this solution pinkish. Due to this salt solution will differ from other solutions. Vitamin B-12 can also be added to aqueous peroxide solution, the solid peroxide-producing dosage forms, such as perborates and persulfates, solid acherousian solution and/or solid dosage forms, including all cleaning and/or disinfecting solutions and tablets. Specific examples of commercial compounds, to which may be added vitamin B-12, are Opti-freeTM(policestations Amin), ReNuTMOxysept 1 (hydrogen peroxide), liquid enzyme (Lugued Enzyme), Oxysept 2 (catalase), and UltrazymeTMand Heat Enzyme (subtilisin).

Alternatively, vitamin B-12 can be added to dezinfitsiruyuschim the solution containing a chemical disinfectant, such as Muramune or WSCP. For example, vitamin B-12 can be added to the cleansing and dezinfitsiruyuschim solution AllerganHydrocarecontaining 0.13% of Miramine [Tris(2-hydroxy-ethyl)fatty ammonium chloride]; 0,002% thimerosal; bis(2-hydroxy-ethyl) fatty ammonium chloride; sodium bicarbonate; dibasic anhydrous sodium phosphate; monobasic sodium phosphate, propylene glycol; Polysorbate; polygamy; hydrochloric acid in sterile isotonic zbuffering solution. This solution must then take the pink color that distinguishes it from other normal isotonic salt solutions, which remain transparent. Thus, the present invention relates to ophthalmically safe way to identify the solution by adding the observation of the development of color from clear to pink, and observation of the development of the coloration of the obtained solution.

Vitamin B-12, used for the purposes of the present invention, can be either cyanocobalamin or any derivative of cobalamin, such as methylcobalamin, hydroxycobalamin, and deoxyadenosylcobalamin, provided that these derivatives are ophthalmically safe and have the ability to observe the change of color of an aqueous solution. Of these preferred compounds is cyanocobalamin.

When implementing the present invention vitamin B-12 is used at least in such quantity that when it is dissolved in the aqueous solution is sufficient to produce the observed color changes of the solution, preferably to pink or bright pink. Basically, the amount of vitamin B-12 in the solution is preferably from 5 to 50 ppm (parts per million), and more preferably from 8 to 10 ppm.

Below are examples of tablets to neutralize the hydrogen peroxide prepared in accordance with the present invention, but these examples should not be construed as a limitation of the scope of the invention.

Example 1. (Without the ringer, grade 1 - 1,5

Sodium chloride - 89,40

Dibasic anhydrous sodium phosphate - 12,50

Polyethylene glycol 3350 - 1,05

Monobasic sodium phosphate, monohydrate - 1,00

Cyanocobalamin - of 0.081

Example 2. (Coated for prolonged release)

Ingredients mg/tablet

Crystalline catalase, Boehringer, grade 1 - 1,5

Sodium chloride - 89,40

Dibasic anhydrous sodium phosphate - 12,50

Polyethylene glycol 3350 - 1,05

Monobasic sodium phosphate, monohydrate - 1,00

Cyanocobalamin - of 0.081

Methocel E15 Premium (cover) - 5,00

Example 3. (With coating for sustained release and cleansing enzyme)

Ingredients mg/tablet

Crystalline catalase, Boehringer, grade 1 - 1,5

Sodium chloride - 89,40

Dibasic anhydrous sodium phosphate USP - 12,50

The glycol - 1,05

Monobasic sodium phosphate, monohydrate, USP - 1,00

Cyanocobalamin - of 0.081

Subtilisin A (floor) - 0,0031

Methocel E15LV Premium (cover) - 5,00

The number of added catalase was determined by analysis of the party used the product. The above tablets contained about 5200 units of activity.

In normal mode, one tablet, manufactured with the contact lenses were immersed in this peroxide solution for at least 10 minutes After the bubbles formed in the solution, will disappear, i.e., after approximately 10 min, the solution turns pink, indicating that the disinfected lenses, mostly, do not contain residual peroxide.

Coated tablets for sustained release, obtained in accordance with example 2, was used for disinfection standard soft contact lenses as follows. Received 10 ml of 3% (wt./about.) aqueous hydrogen peroxide solution at room temperature. Disinfected contact lenses and tablet coated was placed in the solution at the same time. Within about 10 min the solution remained unchanged, i.e., there were no bubbles (gas evolution) and the solution was transparent. Then over the next approximately 20 to 25 minutes start to stand out the bubbles. After this period the solution again becomes calm, but at the same time acquires a pinkish color. Two hours after the contact lenses were placed in the solution, they can be removed from solution and placed directly on the eye. It was found that the contact lens is effectively disinfected after 1 h after placing them in the solution. The user is also the indicates, this solution is the decomposition of hydrogen peroxide. Termination selection of bubbles and the colour of the solution in the pink color indicates that the decomposition of hydrogen peroxide was completed.

A tablet with a coating made in accordance with example 3, used for disinfection and cleaning of soft contact lenses contaminated with protein debris. To do this, at room temperature received 10 ml of 3% (wt. /about. ) aqueous solution of hydrogen peroxide. Then to this solution were simultaneously placed contact lenses, which should be disinfected, and sidezym enzymatic tablet is coated. Within about 10 min the solution remained unchanged. Then over the next approximately 20 - 24 min start to stand out bubbles and the solution becomes pink. After this period of time the solution again becomes calm. Two hours after the contact lenses were placed in the solution, they were taken out, washed with physiological saline to remove subtilisin A and placed directly on the user's eyes. It was found that after 1 h after placing in the solution of the contact lens is effectively disinfected and cleaned belokameni these lenses.

Vitamin B-12 can be added directly to the solution or, as shown above, it may be present, for example, in the form of tablets, capsules, one or more solid particles, etc. that represent the covered part of the preparation, for example the middle of the tablets containing vitamin B-12 and, for example, catalase, and covered with the barrier component. The barrier component may be used for slow release of the catalase and vitamin B-12 from the core over a period of time, preferably sufficient to disinfect the lens.

Prolonged release vitamin B-12 and/or catalase in the liquid medium can be carried out by any of conventional methods that are well known in the art. For example, the barrier component, such as a floor, may consist of a slowly dissolving material for coatings.

Barrier components that can be used either as a coating or as a matrix, are water-soluble vinyl polymers, such as polyvinylpyrrolidone, polyvinyl alcohol and polyethylene glycol; water-soluble protein; polysaccharides; cellulose derivatives such as methylcellulose, hypromellose, noticebox who has used barrier component is not critical to the present invention, provided however, what functions do not go beyond the above. Basically, the barrier component or components may be present in an amount of from about 1 to about 60% by weight of catalase and vitamin B-12.

The preferred coating for sustained release or barrier coating is prepared from a mixture containing water, a ketone component and a water-soluble component of the coating. This mixture is applied on the core containing the component to neutralize hydrogen peroxide, in an amount sufficient to cover the specified core, preferably all of the core, resulting in getting the top layer of the coating. Then this is covered with a top layer of the drug is removed at least partially water and ketone component, resulting in get covered in the core, i.e. the core with a barrier coating.

Water-soluble components for coatings used in this invention are those components that dissolve in water for a certain period of time. Selected component (or components) to cover need not (should not) have an adverse impact on the processed lenses, or the process of disinfecting and cleaning omponent, used in the barrier coatings of the present invention, the number and the thickness of the barrier coating is chosen so that the specified barrier coating is dissolved in a medium containing hydrogen peroxide, only after a certain period of time sufficient to disinfect the lens, placed in the peroxide-containing medium.

Water-soluble component (or components) for coating can be selected from ophthalmicus suitable material, preferably polymeric materials, whose functions are described above. Particularly preferred components for the coating are water-soluble cellulose derivatives, water-soluble polymers based on methacrylate, water-soluble polymers based on vinylpyrrolidone and mixtures thereof. Can also be used copolymers metilfenidato ether and maleic anhydride, and polyvinyl alcohols.

Water-soluble polymers based on methacrylate are polymers derived from methacrylic acid and/or esters of methacrylic acid. Water-soluble polymers based on the methanol used in the present invention are polymers obtained in whole or hour of the ethers and esters, and mixtures thereof. Specific examples of polymers on the basis of vinylpyrrolidone is polyvinylpyrrolidone, for example, the product supplied by the company BASF under the trademark Kollidon VA-64. These water-soluble polymers based on vinylpyrrolidone and mixtures thereof are suitable for use in the present invention.

More preferred water-soluble components for coating include at least one water-soluble derivative of cellulose.

Water-soluble derivatives of cellulose used in the present invention, can be obtained by derivatization of cellulose to achieve the desired degree of water solubility. For inclusion in the cellulose derivatives of the present invention is especially preferred are substituting group selected from hydrocarbon groups and substituted hydrocarbon groups. To obtain cellulose derivatives with the desired solubility are very effective such replacement groups that contain from 1 to about 10 carbon atoms, and such groups, which include polar groups such as hydroxyl group, carbonyl group, carboxyl group, etc., These water-soluble is Osho.

Water-soluble derivatives of cellulose may be selected from water-soluble ethers of cellulose, water-soluble cellulose ethers and mixtures thereof, and preferably the water-soluble ethers and mixtures thereof. Examples of water-soluble cellulose ethers are acetated cellulose phthalate of hydroxypropylmethylcellulose etc.

From simple water-soluble cellulose ethers can be used water-soluble alkalemia ethers, and/or hydroxyalkyl ethers of cellulose. While it is preferable that the alkyl groups have from 1 to about 6, and more preferably from 1 to about 3 or 4 carbon atoms. Specific examples of suitable water-soluble ethers of cellulose can serve hypromellose, ethylcellulose, methylcellulose, hydroxyethylmethylcellulose, hydroxypropylcellulose, hydroxyethylcellulose, metal salts, in particular alkali metals, ethers of cellulose such as sodium carboxymethyl cellulose, etc., and mixtures thereof. Especially preferred water-soluble derivative of cellulose is hypromellose.

Used ketone components (or componentsin to have a significant adverse impact on the activity of the component, neutralizing the hydrogen peroxide, in particular catalase, or the cleansing activity of the enzyme or enzymes, if they are present in the compositions of the present invention. Ketone component has a characteristic ketone structure and can be preferably selected from ketones having from 3 to about 6 carbon atoms per molecule. Ketone component or components may include one or more of the groups of substituents, provided that the specified group or groups do not prevent the main function of ketone component or components in the present invention. Specific examples of suitable ketone components are acetone, methyl ethyl ketone, methyl isobutyl ketone, etc., and mixtures thereof.

The choice of the relative amounts of components used, such as water, a ketone component and a water-soluble component of the coating, preferably carried out so as to obtain an effective barrier coating, which would be very minor adverse effects, or did not had any adverse effects on the activity of the component to neutralize hydrogen peroxide, and the cleansing activity of the enzyme or enzymes, the EU is her than about 50% (by volume), and the ketone component in larger quantities, i.e., more than about 50% (by volume) of the total amount of water and ketone component present in a mixture. It was found that relatively high concentrations of water have an adverse impact on the activity of the peroxide-neutralizing component, and in particular on catalase. For this reason, even more preferably, the amount of water in the mixture was not more than about 20% (by volume). However, preferably, in the mixture was attended by the amount of water that would be sufficient to ensure complete solubilization of water-soluble components to cover present in the mixture. In the case of complete solubilization of the component to cover in the mixture, the barrier coating is sufficiently homogeneous, for example basically has the same thickness, as well as reliable and predictable prolonged release. Tablets, coated composition that does not contain water, are less homogeneous barrier coatings and less reliable and predictable characteristics regarding prolonged release.

The amount of water-soluble component of the coating that is included with the specific time of release. Preferably, the quantity of the component to cover sufficient to fully solubilize it in the mixture. In one of the embodiments of the present invention, this amount is from about 0.1 to about 20%, and preferably from about 0.2 to about 10%, and more preferably from about 0.5 to about 5% (wt./about.) from the total mass of the mixture.

The preferred mixture comprises 3% (wt./about.) hydroxypropylmethylcellulose in a liquid medium consisting of 90% (vol./about.) and 10% (vol./about.) water.

Thus the mixture may include one or more of the other components that contribute, for example, to facilitate deposition of the mixture on the core, to facilitate removal of water and/or ketone component or components with the pre-coated core, and/or barrier coating with one or more desired properties, and/or components that are desirable for processing lenses when released to the environment containing hydrogen peroxide. For example, the mixture may include one or more sizing agents and/or agents, to prevent deposition in order to maintain the integrity of the barrier coating and reducing sedimentation in liquid want to cover is relatively hygroscopic, then on to a covered product or products or the outer layer is covered product (or products) can be applied to the final protective coating containing, for example, one or more water-soluble cellulose derivatives, for the protection of covered products or outer layer coated products, for example, during storage, with the specified protective coating can be carried out, in particular, using the method of the present invention. This protective coating, which is often relatively thin, dissolves in water very quickly, and preferably almost immediately after the protected product is placed in a liquid water environment.

The mixture, preferably a liquid solution can be applied on the core, covered with a barrier layer, using a standard technique used, for example, for applying liquid initial mixture for formation of a coating of prolonged action on the product, such as a tablet, pill, microgranule, powder, etc., for Example, this mixture may be applied by spraying onto the core, covered with a barrier layer. Alternatively, the core is covered with a barrier layer may be immersed in this mixture.

The heart is working, for example, the evaporation of at least part of the water and the ketone component of the barrier coating, and thus, forming a core, covered by a shell. Such conditions are, for example, ambient temperature or slightly elevated temperature.

In another embodiment, the present invention vitamin B - 12 can be added to the composition, designed for the efficient removal of a certain amount of debris from the surface of contact lenses, in order to produce the pink color of the solution when adding the specified composition in a liquid environment.

In a preferred embodiment of the present invention, the above compositions include at least one enzyme that is designed to effectively remove debris from the surface of contact lenses. Among the different types of debris, usually formed on a contact lens in normal use, can be a protein containing debris, muensteri debris, oil containing debris and carbonaceous debris. On one contact lens may be one or more types of debris.

Used for these purposes, the enzyme may be selected from the invention can be used, for example, the enzymes described in the replacement U.S. patent 32672 (Huth and others) and in U.S. patent 3910296 (Karageozian, and others ). These patents are introduced in the present description by reference. Suitable enzymes are enzymes selected from proteolytic enzymes, lipases and mixtures thereof.

A preferred group of proteolytic enzymes is a group of enzymes derived from alkaline proteases called subtilisin. See details Deayl L., Moser P. Wildi W. and B. S. "Proteases of the Genus Bacillus. //Alkaline Proteases", Biotechnology and Bioenginering, vol. XII, S. 213-249 (1970); and Keay L. and Moser, P. W. "the Differentiation of Alkaline Proteases from Bacillus Species," Biochemical and Biophysical Reseash Cornm Vol. 34, No. 5, S. 600-604 (1969).

Enzymes subtilisin can be divided into two subclasses: subtilisin and subtilisin Century group subtilisin And include enzymes derived from such species as B. Subtilis, B. licheniformis and B. pumilis. Organisms of this subclass produce in small quantities or are not neutral protease or amylase. Subtilisin subclass B refers to enzymes derived from such species as B. subtilis, B. subtilis var amylosaechariticus, B. amyloliguefaciens and B. subtilis NRBL. B3411. These organisms produce a neutral protease and amylase at a level comparable with the level of production of alkaline protease. The person who tx2">

Also preferred are other enzymes, such as Pancreatin, trypsin, collagenase, keratinase, carboxylase, aminopeptidase, elastase, aspergillomas A and B, pronase E (from S. griseus) and dispose (from Bacillus polymyxa).

In the practice of this version of the present invention uses an effective amount of this enzyme. This amount is the amount effective to remove within a reasonable period of time (e.g. over night), in General, all the amount of at least one type of debris from the surface of the lens formed in the process of normal wear lenses. Normal sweating is lens is a standard established for media contact lenses with normal growth dynamics of debris on the lens, however, this does not involve a small group of people using contact lenses that have one time or another there is a much higher rate of deposition of debris on the lens, such that they are forced to clean lenses every day or even two or three times a day.

The amount of enzyme required for effective cleaning depends on several factors, including the natural activity of the enzyme, and be a working solution, which contains a sufficient amount of enzyme to produce from about 0.001 to about 3 units of activity (Anson), and preferably from about 0.01 to about 1 unit of activity (Anson) for processing one lens. However, it can be used in smaller or larger quantities.

Enzyme activity for each of these enzymes is pH-dependent value, and therefore, in a particular range of this enzyme will act most effectively. The identification of such a range can be easily implemented using standard techniques.

In yet another embodiment of the present invention vitamin B-12 can be added as identifying, producing a coloring component in the tablet or solution containing disinfectants or antimicrobial agents such as Quaternary ammonium salt, commonly used in ophthalmic preparations, such as poly [(dimethylimino)-2-butene-1,4-villoria, -[4 - Tris(2-hydroxyethyl)ammonium-2-butenyl-W-Tris(2-hydroxyethyl) ammonium]-dichloride (chemical. registration number 75345-27-6), known under the trademark Poly-guaternium Iand delivered by the Corporation ONYX, and benzalkonium, WSCP, WSCP/Croguat dioxide chlorine and biguanide, still the minimum level (see, U.S. patent N 4758595, which is introduced into the present description by reference).

Salt alexidine and chlorhexidine can be organic or inorganic and are usually disinfectant nitrates, acetates, phosphates, sulfates, halidome, etc. Preferred antimicrobial agents include biguanides, and hexamethylenebiguanide, their polymers and their water-soluble salts are most preferred. The polymers of hexamethylenebiguanide, also known as polyaminopropylbiguanide (RRV), have a molecular weight generally up to about 100,000. These compounds are known and described in U.S. patent N 4758595, which is introduced into the present description by reference.

Another connection that meet the above criteria for detoxification, is a compound having the structural formula A (see U.S. patent N 4029817 (Allergan, Inc.) which is introduced into the present description by reference.

The formula A

,

where

R is alkyl or alkilinity radical having 12 to 20 carbon atoms, and preferably a radical of the fatty series, i.e. consisting of mixtures-C17H35; R1, R2and R3may be the same or is used in combination with a detoxifying amount of toxic compounds, selected from the group comprising water-soluble polyhydroxyethylmethacrylate, carboxymethylcellulose, nonionic surfactants, such as complex polyoxyethylenesorbitan fatty acids and simple polyoxyethylene esters, polyvinylpyrrolidone, polyvinyl alcohol, hypromellose and mixtures thereof.

The preferred compound of the above formula And is the chloride of triethanolamine, where the alkyl group is a fatty radical. This connection is known as Miramine TA-30and delivered by the company Miranol Chemical Company. Specified preferred compound can be obtained in the form of a 30% aqueous acid solution. This connection is quite stable at acid pH, but under alkaline conditions it tends to be precipitated from solution in the form of a base.

Although the present invention described above, presents fairly full, but each expert it is clear that it can be made various changes or modifications not beyond being and scope of the invention.

1. Ophthalmologist acceptable composition for neutralizing residual peroxide containing aqueous Gerrit vitamin B12in the amount of 0.005 to 1.0 wt.%.

2. The composition according to p. 1, characterized in that as peroxynitrite connection contains catalase in the amount of 100 - 1000 IU/ml

3. The composition according to PP.1 and 2, characterized in that it further comprises a coating of catalase for slow release of the enzyme.

4. Ophthalmologist safe way to identify a solution in the absence of peroxide by inclusion in the study indicator solution, followed by observing the change in color of the solution, wherein the quality indicator add vitamin B12in an amount of 5 to 50 ppm.

5. Ophthalmologist safe composition for contact lenses containing the indicator and the additional component, wherein the quality indicator contains vitamin B12and as an additional component, a substance selected from the group peroxidative connection, the Converter peroxide cleaner, disinfectant, their mixture, and the vitamin B12contained in an amount of 0.005 to 1.0 wt.%.

6. The composition according to p. 5, characterized in that as an additional component chosen neutralizer peroxide and the catalyst is that it is cleaner this cleaner is subtilisin A.

8. The composition according to p. 5, wherein the additional component is a sanitizer and a disinfectant is Miramon (Miramine).

9. The composition according to p. 5, wherein the additional component is hydrogen peroxide.

10. The composition according to p. 5, wherein the additional component is a salt of Quaternary ammonium.

11. The composition according to p. 5, wherein the additional component is sodium chloride.

12. The composition according to p. 5, wherein the additional component is biguanid.

13. The composition according to p. 5, wherein the additional component is chlorine dioxide.

14. The composition according to p. 5, wherein the additional component is WSCP.

15. The composition according to p. 5, wherein the additional component is a mixture of WSCP and Croquat.

16. The composition according to p. 5, characterized in that said components are present in solid form.

17. The composition according to p. 5, characterized in that said components are present in solution.

18. The composition according to p. 5, characterized in that said components are present in

 

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FIELD: animal science, veterinary science.

SUBSTANCE: the suggested composition includes either chalk or slaked lime, additionally, it may contain conservant-disinfectant FX at certain ratios of components. The innovation provides increased terms of residual biocidal (bactericidal and fungicidal) activity.

EFFECT: higher efficiency of disinfection.

8 ex

FIELD: animal science, veterinary science.

SUBSTANCE: the suggested composition for disinfecting objects of animal science includes dispersion dyestuff and active substance as conservant-disinfectant FH and, additionally, cationic surface active substance at certain quantitative ratios of components. Moreover, disinfecting composition contains either alkyldimethylbenzylammonium chloride, or cetylpiridinium chloride or hexidine chloride as cationic surface active substance. This innovation provides increased terms of residual biocidal (bactericidal and fungicidal) activity.

EFFECT: higher efficiency of disinfection.

1 cl, 11 ex

Disinfecting agent // 2246953

FIELD: sanitary and hygienic materials.

SUBSTANCE: water-based disinfecting composition contains water-soluble cyclodextrin-iodine inclusion complex and/or derivatives thereof, iodine, iodide ion source, organic solvent, and, if necessary, surfactant and/or functional additive, all in specified proportions. Agent possesses wide spectrum of antimicrobial effects at low concentrations. It does not irritates skin, shows no toxicity, and is stable upon storage within a wide temperature range.

EFFECT: increased choice of high-efficiency disinfecting agents.

19 cl, 2 tbl

FIELD: chemical methods for production of silver ion-containing disinfectant solution.

SUBSTANCE: silver concentration is carried out by chemical reaction and simultaneous dissolution in distilled water at room temperature of composition containing (g/l): powder citric acid 1.0-5.0; silver oxide 0.3-1.5; hydrogen peroxide 1.5-7.5; and balance: distilled water. Time of silver concentration is limited by reaction time.

EFFECT: non-toxic high stable disinfectant aqueous solution useful both in field conditions and stationary domestic objects.

2 cl, 3 ex

Disinfectant // 2249466

FIELD: medicine.

SUBSTANCE: the present innovation deals with disinfecting and sterilizing different objects. The suggested disinfecting preparation contains aqueous solution of oxidants obtained due to treating in anode chamber and low-molecular alcohol. The latter should be introduced into the above-mentioned solution of oxidants at the quantity of 0.1-5.0 volumetric % or after processing in anode chamber before application or - into initial solution before processing in anode chamber. The suggested preparation is of increased biocide activity at no increase in concentration of active substances.

EFFECT: more broadened functional capacities.

3 cl, 5 ex, 1 tbl

FIELD: medicine.

SUBSTANCE: the suggested disinfectant contains glutaric aldehyde, didecyldimethylammonium chloride, ethoxylated alcohol, propylene glycol and water at certain ratios. The method to treat objects, those of medicinal indications, among them, deals with treating an object with the above-mentioned disinfectant followed by keeping disinfectant on the object during the time and at temperature to provide disinfection and/or sterilization of the object followed by washing disinfectant off. The present innovation provides hermetic nature of elements and connective elements of flexible and rigid endoscopes, soldered and glued sites in the course of disinfection.

EFFECT: higher efficiency of application.

10 cl, 3 ex

FIELD: veterinary science, veterinary disinfection.

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2 ex, 1 tbl

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FIELD: veterinary science, veterinary disinfection.

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EFFECT: higher efficiency of disinfection.

1 ex, 1 tbl

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7 cl, 6 ex

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EFFECT: high quality of cleaning; preserved surface safety.

15 cl, 1 tbl

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