TR2021015778A2 - MULTIFUNCTIONAL ECONOMIC CONTACT LENS CLEANING SOLUTION AND PRODUCTION METHOD - Google Patents

Abstract

This invention relates to the multifunctional economic contact lens cleaning solution and production method that can be used in the contact lens cleaning solution production sector, especially in the fields of medicine, cosmetics etc. 0.025% polyvinylprolidone (PVD) as a viscosity adjuster and wetting agent that facilitates the wearing and removal of the contact lens, Poloxamer 407 to adjust the surface tension/increase the cleaning capacity, protein remover and eye liquid pH? borate buffer (boric acid; 1.25%)-Na2B4O7.10H2O; 0.18%), sodium 15 chloride (NaCl), edetate disodium (Na2EDTA) and polyhexamethylene biguanide (PHMB) for osmolarity adjustment.

Description

DESCRIPTION MULTIFUNCTIONAL ECONOMIC CONTACT LENS CLEANING SOLUTION AND PRODUCTION METHOD Technological Field: This invention is particularly useful in the fields of medicine, cosmetics, etc., in contact lens cleaning solution production. Multifunctional economic contact lens cleaning used in the industry solution and production method.

State of the Art: Multi-purpose contact lens solutions (GMDN: 48074 and Class IIb) moderate risk It is in the medical device class. Contact Lens Cleaning Solution (KLTS-mps) is a contact lens the lens (regardless of the type) must be cleaned and disinfected after use, It must be rinsed and heated before use. Two types according to material composition Since there are contact lens types (hard gas permeable and soft hydrogel), the used that the cleaning (disinfection) method is suitable for the lens material required. Multi-purpose cleaning (disinfection) solutions, a single solution for cleaning, disinfection, washing and keeping contact lenses safely the solutions used. The advantages of these solutions include low toxicity to the eye. contact lenses, thanks to their single display and low absorption by the contact lens. can extend their lifespan. At the same time, multi-purpose cleaning (disinfection) Disinfection activities provide continuity as the solutions do not deteriorate. This The solutions are an easy-to-use solution for contact lens wearers. seen as an advantage. More than one product together in contact lens care difficulties in using it and demands for simpler systems development In line with this, the steps in contact lens care systems are brought together. new, completely native, suitable for all lenses and multi-purpose in accordance with ISO 14729 standards development and production of cleaning (disinfection) solutions is the main purpose of our project. When market review is done, contact lens cleaning and The care solution market is dominated by the USA, China, India and Europe. is seen. Therefore, the import of contact lens cleaning and care solution Our country spends millions of dollars annually. Contact lens cleaning and care It is important for our country to reduce our dependence on foreign products and even to export them. will be of great benefit.

As it is known, the cornea is directly exposed to the air during the daytime and to the eye during the night. Since the caps are closed, oxygen from the capillaries on the back surface of the caps takes. While the lens is in the eye, it is washed with a layer of tears. The lipid contained in this layer, residues such as protein, mucus, environmental contaminants and cosmetic residues may cover the lens surface. Environmental contaminants adhering to the lens surface It is affected by the quality and amount of tears, as well as the properties of the lens material. Especially Since wmusk lenses are hydrophilic, they do not attach to the lens surface or attach to the lens matrix. They attract too much contaminants that tend to pass. For all these reasons Cleaning solutions are important in lens care. Caution in these solutions the required point is sterile, isotonic, at the correct pH and viscosity, compatible with the lens and suitable They must be produced to contain bactericide. Compounds and methods for the treatment of LFA-1-mediated diseases in the application file is explained. In particular, LFA-1 antagonists are described herein and antagonists are used in the treatment of LFA-1-mediated diseases. find one The aspect is that after the patient has been diagnosed with an LFA-1-mediated disease, an LFA-1-mediated disease provides diagnosis of the disease and administration of an LFA-1 antagonist. Some diseases treated by LFA-1 in embodiments are dry eye disorders. Moreover Here, methods for identifying compounds that are LFA-1 antagonists is provided. Among the additives used in the invention, isotonizing agents (e.g., sodium chloride, etc.), buffering agent (e.g., boric acid, sodium monohydrogen phosphate, sodium dihydrogen phosphate, etc.), preservatives (eg, Benzalkonium chloride, benzetonium chloride, chlorobutanol, etc.) thickeners (eg, lactose, mannitol, maltose, etc. saccharide such as; for example, hyaluronic acid or its salt, eg sodium hyaluronate, potassium hyaluronate, etc.; eg, chondroitin sulfate etc. mucopolysaccharide such as; e.g. sodium polyacrylate, carboxyvinyl polymer, cross-linked polyacrylate, polyvinyl alcohol, polyvinyl pyrrolidone, methyl cellulose, hydroxy propyl methylcellulose, hydroxyethyl cellulose, carboxymethyl cellulose, hydroxy propyl cellulose or known to those skilled in the art other agents) were used. Other hydrophilic nonionic surfactants without limitation PEG-10 laurate, PEG-12 laurate, PEG-20 laurate, PEG-32 distearate, PEG-40 stearate, PEG-100 stearate, PEG-20 dilaurate, PEG-25 glyceryl trioleate, PEG-32 dioleate, PEG-20 glyceryl laurate, PEG-30 glyceryl laurate, PEG-20 glyceryl stearate, PEG-20 glyceryl oleate, PEG-30 glyceryl oleate, PEG-30 glyceryl laurate, PEG-40 glyceryl laurate, PEG-40 palm kernel oil, PEG-50 hydrogenated castor oil, PEG-40 castor oil, PEG-35 castor oil, PEG-60 castor oil, PEG-40 hydrogenated castor oil, PEG-60 hydrogenated castor oil, PEG-60 corn oil, PEG-6 caprate / caprylate glycerides, PEG-8 caprate / caprylate glycerides, polyglyceryl-10 laurate, PEG-30 cholesterol, PEG-25 phytosterol, PEG-30 soy sterol, PEG-20 trioleate, PEG-40 sorbitan oleate , PEG-80 sorbitan laurate, polysorbate 20 , polysorbate 80, POE-9 lauryl ether, POE-23 lauryl ether, POE-10 oleyl ether, POE-20 oleyl ether, POE-20 stearyl ether, tocopheryl PEG-100 succinate, PEG-24 cholesterol, polyglyceryl- 1001eat, Tween 40, Tween 60, sucrose monostearate, sucrose monolaurate, sucrose poloxamers.

Patent titled “Lens Care Composition and Method” with publication number CA2501396A1 have a much lower concentration of disinfecting agents in the application file, and buffered aqueous contact lens disinfecting solution that is less irritating to the eye is explained. The tonicity of the solutions is 200 to 450 mOsm / kg, the pH value is 6 to 8 and the chloride ion concentration is below 1500 ppm. less than 1 ppm Despite containing antimicrobial, solutions are susceptible to C. albicans within 15 minutes of contact. counter effective. The present compositions preferably contain an effective amount of a chelating component.

Ethylenediaminetetraacetic acid (EDTA), salts and mixtures thereof are particularly effective. However, any suitable, preferably ophthalmically acceptable The chelating component can be included in existing compositions. Suitable viscosity inducer components include, but are not limited to, polyvinylpyrrolidone, water-soluble natural gums, polymers derived from cellulose, and the like. Tyloxapol, 0.005% used appropriately in varying concentrations. If the solution contains thyroxapol, It contains a poloxamer or a mixture of poloxamers at a concentration of from 0.2% to 0.2%. Moreover The present invention includes biguanide and borate buffer. Existing compositions are preferably effective quantity of a clamping component. Ethylenediaminetetraacetic acid (EDTA) Although salts and mixtures thereof are particularly effective, any suitable, preferably The ophthalmically acceptable chelating component may be included in existing compositions.

Preferred polymeric antimicrobial agents include: a polymeric quaternary polyquaternium-1, which is an ammonium compound, and a polymeric biguanide. polyhexamethylene biguanide ("PHMB").

The above references are an innovative stepping stone for lens solution formulations. increasing eye comfort, compliance with TSE-ISO 14729 standard, high cleaning and disinfection properties, suitable for all contact lens types a system that provides all the features of convenience and economic advantage. Contact lens solution production has not been possible until now.

Description of the Invention: This invention is a multifunctional device that can overcome the above mentioned disadvantages. It is an economical contact lens cleaning solution and production method. eyelash Cleaning and disinfection in accordance with the TSE-ISO 14729 standard, increasing the comfort high features, suitable for all contact lens types and being economically advantageous It is a contact lens solution that provides all of its properties together.

Production technology to be developed with formulation, especially production in sterile environment It will be a new alternative for products that are mandatory and it will be possible to obtain different products. the door will open. In our country, especially in the less developed regions of the industry, Operating in other regions, especially in the Southeast Anatolian Region, obtaining products in aseptic conditions between companies, R&D and innovation awareness will search. First of all, formulations in KLTS production are generally; in the first harvest raising the solutions to the boiling temperature of the water and returning them to room temperature The need for processes such as cooling the This This situation will result in both time and electricity and labor costs. It imposes an additional burden on manufacturers in terms of extra costs. Again at this stage The dissolution difficulty of cellulose derivatives is another negative factor. is coming our way. Therefore, they are available in the same market and at least as effective as they are. The production of contact lens solutions attracts a lot of attention. Therefore the eye The necessity of developing new formulas that increase comfort and economically are among our goals. In addition, cleaning and cleaning in accordance with the TSE-ISO 14729 standard. Its disinfection properties are higher than its counterparts, suitable for all contact lens types, more economical lens solutions will be tried to be produced and when the relevant targets are met The advantages provided by the invention will become clearer.

Explanation of Figures: The invention will be described with reference to the accompanying figures so that the features of the invention will be more clearly understood and appreciated, but the purpose of this It's not about limiting yourself with regulations. On the contrary, the invention is satisfied by the appended claims. all alternatives, changes and It is intended to cover the equivalences. Details shown are present invention only shown for illustration of preferred embodiments and both methods formulation, as well as the rules and conceptual features of the invention. and it should be understood that they are presented to provide an easy-to-understand definition. This in drawings; Figure 1 is a tabular representation of the manufacturing steps of the invention.

Figure 2 is a tabular representation of the manufacturing steps of the invention.

Figures to assist in understanding this invention are as indicated in the attached picture. are numbered and given below with their names.

Explanation of References: . Addition of PVD . 15 min. mixing . Addition of Poloxamer 407 40. Addition of borate buffer 50. Addition of NaCl 60. Mixing at 1200 rpm 70. Addition of NazEDTA, 80. 30 min. mixing 90. Addition of PHMB 100. 1 hour stirring 110. passing through filters 120. Resting Description of the Invention: Meet; Viscosity that makes it easy to put on and remove the contact lens from the eye. % as setting and wetting agent, surface tension Poloxamer 407, protein remover and Contains polyhexamethylene biguanide (PHMB).

Production steps of the invention; 0.025% by weight polyvinyl prolidone in 100 mL water at 50°C (PVD) is added (10), the temperature is reduced to 25 0C and 15 min. mixing (20), disodium (NazEDTA) addition (70), 25 0C, at least 30 minutes. mixing (80), % by weight, at least at 25 0C Mixing for 1 hour (100), filtering under aseptic conditions (110) and 2 hours resting (120). ( Figure 1 and Figure 2) Detailed Description of the Invention: In hard and gas permeable lenses, wetting agents are used to provide a hydrophilic surface.

These are 5-10 minutes after the lens is attached. then they are cleaned with natural tears. The main ones are: Polyvinyl alcohol (keeps the lens surface wet for a long time, with preservatives and cornea compatible), duasorb (a water-soluble polymeric system, DUASORB (01% dextran) 70, 03% hypromellose), polyoxamer 407 (nonionic surfactant (surfactant); emulsifier. Separation of two liquids that would not normally be in a mixture prevents), PVP is methyl cellulose. Apart from this, multi-purpose contact lens solutions To prevent ions and salts such as Ca2+ from forming chelate with the preservative and to protect the preservative. EDTA and disodium edetate are added for synergistic effect. Protein chains interlocking While bonding, it also bridges the calcium ions to the contact lens. they connect. The negatively charged groups of EDTA are the positively charged groups of calcium. they break the bridge formed by binding to the charge and remove the proteins from the lens.

In addition, it is necessary to prevent the lens from adhering to the cornea during insertion and to increase the co-osmolarity of the lacrimal fluid. Salts such as NaCl and KCl are used as tonicity adjusters. mainly borate, Tear pH' in citrate and phosphate buffers rinse and wash/hold solutions (pH: all The secret of destroying microorganisms is a very effective microorganism in its combination. polymer substance named polyhexanide (polyhexamethylene biguanide), which is lethal thanks. Polyhexanide (polyhexamethylene biguanide) repetitive It consists of biguanide chemical groups. High activity of polyhexanide with very low concentration to kill microorganisms due to Disinfection efficiency is provided without damaging the corneal cells.

Polyhexanide, 'soothing' by reducing surface tension in skin and mucous membranes It is a fast-acting bactericidal and fungicidal effect while providing the effect of is the substance. In particular, polyhexanide is biocompatible with tissues. Tissue It has a very positive cleaning effect on the surfaces and Provides continuous moistening in areas.

Included in the ideal daily cleaning efficiency formula of contact lens solution It happens thanks to poloxamer. Mechanical during daily cleaning The friction and rinsing process becomes even stronger with the effect of poloxamer. A lot While the purpose-built contact lens is stored in solution, the poloxamer maintains its effect. It prevents the accumulation of protein, lipid and other deposits on it. Amphitheater structures polymers are surfactants, which makes them useful in industrial applications. has features. Among other things, hydrophobic, oily substances in water to increase the solubility of two substances with different hydrophobicities. can be used to increase their miscibility. Therefore, these polymers are industrial widely used in applications, cosmetic products and pharmaceutical preparations is used. Wetting and lubricating, which also aids in poloxamer lens comfort. It is a chemical substance with properties. As nonionic surfactants The poloxamines (Tetronic) used are polyethylene bonded to a central ethylenediamine moiety. by the four branches of (ethylene oxide)-poly (propylene oxide) (PEO-PPO) blocks X-shaped amphiphilic block copolymers formed. Such a structure, temperature and pH It provides highly responsive behaviors such as sensitivity. At relatively low concentrations but above the critical micelle concentration (CMC), poloxamines are polymeric micelles. produces. Due to the presence of a hydrophobic core, these nanocartridges do well in water. It is useful in dissolving and stabilizing insoluble drugs.

with normal tear film properties (eg pH, osmolarity, viscosity, surface tension) Differences in properties of lens solutions may cause eye discomfort.

Lens solutions are formulated for cleaning, comfort and disinfecting agents.

However, due to the different formulations, physical properties, comfort level and The degree of disinfection also differs. Cleaning lenses and keeping them free of debris reduces the risk of eye infection. Protecting tear proteins against denaturation It increases the comfort of the patient and contributes to the antimicrobial activity.

In the present invention, the production steps of the product are as follows; 50°C by weight of 100 mL water (optimal viscosity especially for contact lens insertion and removal) provides convenience. In addition, high Viscosity values are the first time the contact lens gets into the eye. At the time of attachment, it not only causes blurred vision, but also adhesion. It starts with the addition of the . Then the temperature was reduced to 25°C. The process is continued with an average of 15 minutes of mixing. Then in order KLTS to adjust the surface tension of the solution/increase the cleaning capacity 0.205 wt% poloxamer 407 and protein remover and to maintain eye fluid pH Deviation in standard values, tingling and pain sensation while causing irreversible damage to the eye can create. Then, 0.171 wt% sodium 15 chloride (NaCl) was added to the solution. (osmotic pressure plays an extremely important role in eye comfort, especially eye dryness. High osmolarity significantly reduces eye comfort in patients with and the mixture is mixed at 1200 rpm for 10 minutes. Next Adding % by weight to the solution in step is being done. After mixing the mixture at 25 0C for at least 30 minutes, After mixing for about an hour, it is filtered under aseptic conditions and is rested for an hour. (Figure 1 and Figure 2) 50°C, additional to be made. 15 minutes by reducing the temperature to 25 ° C. mixing, adding 0.205 wt% Poloxamer 407, adding, adding 0.171 wt% sodium 15 chloride (NaCl), min. Mixing at 1200 rpm, adding % by weight, At least 30 min at °C. mixing, adding % by weight, 111111111 Stirring for at least 1 hour at °C, filtering under aseptic conditions and 2 hours rest.

Claims (1)

CLIENTS The invention relates to a multifunctional economic contact lens cleaning solution and its production method, and its features are; Polyvinylpyrrolidone (PVD) 0.025% as a viscosity adjuster and wetting agent that facilitates wearing and removing the contact lens from the eye, Poloxamer 407 to adjust the surface tension/increase the cleaning capacity, sodium 15 chloride WaCl to provide protein remover and eye fluid pH), edetate disodium (NagEDTA) and polyhexamethylene biguanide (PHMB). It is the multifunctional economic contact lens cleaning solution and production method mentioned in the request, its feature is; 50°C, adding (10), reducing the temperature to 25 0C for 15 min. mixing (20), adding 0.205 wt% Poloxamer 407 (30), adding 0.171 wt.% sodium 15 chloride (NaCl) (50), 10 min. Mixing at 1200 rpm (60), % by weight, at 25 0C, for at least 30 minutes. It consists of mixing (80), mixing % by weight, at 25 0C for at least 1 hour (100), filtering under aseptic conditions (110) and resting for 2 hours (120).