WO2024025497A1 - A chemical neutralisation eyewash and preparation method thereof - Google Patents
A chemical neutralisation eyewash and preparation method thereof Download PDFInfo
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- WO2024025497A1 WO2024025497A1 PCT/TR2023/050665 TR2023050665W WO2024025497A1 WO 2024025497 A1 WO2024025497 A1 WO 2024025497A1 TR 2023050665 W TR2023050665 W TR 2023050665W WO 2024025497 A1 WO2024025497 A1 WO 2024025497A1
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- Prior art keywords
- chemical
- eye
- eyewash
- neutralisation
- preparation
- Prior art date
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- 239000000126 substance Substances 0.000 title claims abstract description 46
- 238000006386 neutralization reaction Methods 0.000 title claims abstract description 21
- 238000002360 preparation method Methods 0.000 title claims abstract description 12
- 235000010339 sodium tetraborate Nutrition 0.000 claims abstract description 14
- 229910021538 borax Inorganic materials 0.000 claims abstract description 12
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 11
- 238000000034 method Methods 0.000 claims abstract description 9
- 210000004087 cornea Anatomy 0.000 claims abstract description 8
- 238000004458 analytical method Methods 0.000 claims abstract description 7
- KGBXLFKZBHKPEV-UHFFFAOYSA-N boric acid Chemical compound OB(O)O KGBXLFKZBHKPEV-UHFFFAOYSA-N 0.000 claims abstract description 7
- 230000006378 damage Effects 0.000 claims abstract description 7
- 239000004328 sodium tetraborate Substances 0.000 claims abstract description 7
- 238000004090 dissolution Methods 0.000 claims abstract description 6
- 239000004480 active ingredient Substances 0.000 claims abstract description 5
- BSVBQGMMJUBVOD-UHFFFAOYSA-N trisodium borate Chemical compound [Na+].[Na+].[Na+].[O-]B([O-])[O-] BSVBQGMMJUBVOD-UHFFFAOYSA-N 0.000 claims abstract description 5
- 230000001954 sterilising effect Effects 0.000 claims abstract description 4
- 238000004659 sterilization and disinfection Methods 0.000 claims abstract description 4
- BTBUEUYNUDRHOZ-UHFFFAOYSA-N Borate Chemical compound [O-]B([O-])[O-] BTBUEUYNUDRHOZ-UHFFFAOYSA-N 0.000 claims description 7
- 208000009043 Chemical Burns Diseases 0.000 claims description 4
- 208000018380 Chemical injury Diseases 0.000 claims description 4
- 238000004448 titration Methods 0.000 claims description 4
- 229910004844 Na2B4O7.10H2O Inorganic materials 0.000 claims description 2
- CDMADVZSLOHIFP-UHFFFAOYSA-N disodium;3,7-dioxido-2,4,6,8,9-pentaoxa-1,3,5,7-tetraborabicyclo[3.3.1]nonane;decahydrate Chemical compound O.O.O.O.O.O.O.O.O.O.[Na+].[Na+].O1B([O-])OB2OB([O-])OB1O2 CDMADVZSLOHIFP-UHFFFAOYSA-N 0.000 claims description 2
- 238000000207 volumetry Methods 0.000 claims description 2
- 230000002378 acidificating effect Effects 0.000 abstract description 5
- 238000005553 drilling Methods 0.000 abstract description 2
- 239000000428 dust Substances 0.000 abstract description 2
- 238000009434 installation Methods 0.000 abstract description 2
- 229910052751 metal Inorganic materials 0.000 abstract description 2
- 239000002184 metal Substances 0.000 abstract description 2
- 239000002023 wood Substances 0.000 abstract description 2
- 239000000243 solution Substances 0.000 description 35
- 229910019142 PO4 Inorganic materials 0.000 description 12
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 description 12
- 239000010452 phosphate Substances 0.000 description 12
- 239000000872 buffer Substances 0.000 description 6
- 201000001891 corneal deposit Diseases 0.000 description 5
- 239000000203 mixture Substances 0.000 description 5
- HEMHJVSKTPXQMS-UHFFFAOYSA-M sodium hydroxide Inorganic materials [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 5
- WUWFMDMBOJLQIV-UHFFFAOYSA-N 7-(3-aminopyrrolidin-1-yl)-1-(2,4-difluorophenyl)-6-fluoro-4-oxo-1,4-dihydro-1,8-naphthyridine-3-carboxylic acid Chemical compound C1C(N)CCN1C(C(=C1)F)=NC2=C1C(=O)C(C(O)=O)=CN2C1=CC=C(F)C=C1F WUWFMDMBOJLQIV-UHFFFAOYSA-N 0.000 description 4
- 239000002253 acid Substances 0.000 description 4
- 239000003518 caustics Substances 0.000 description 4
- 239000008194 pharmaceutical composition Substances 0.000 description 4
- 150000003839 salts Chemical class 0.000 description 4
- 229950008187 tosufloxacin Drugs 0.000 description 4
- KWYUFKZDYYNOTN-UHFFFAOYSA-M Potassium hydroxide Chemical compound [OH-].[K+] KWYUFKZDYYNOTN-UHFFFAOYSA-M 0.000 description 3
- 239000003513 alkali Substances 0.000 description 3
- 239000002585 base Substances 0.000 description 3
- 238000006243 chemical reaction Methods 0.000 description 3
- 230000003472 neutralizing effect Effects 0.000 description 3
- QGZKDVFQNNGYKY-UHFFFAOYSA-N Ammonia Chemical compound N QGZKDVFQNNGYKY-UHFFFAOYSA-N 0.000 description 2
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 description 2
- BHPQYMZQTOCNFJ-UHFFFAOYSA-N Calcium cation Chemical compound [Ca+2] BHPQYMZQTOCNFJ-UHFFFAOYSA-N 0.000 description 2
- 208000003556 Dry Eye Syndromes Diseases 0.000 description 2
- 206010013774 Dry eye Diseases 0.000 description 2
- ALLWOAVDORUJLA-UHFFFAOYSA-N Rebamipida Chemical compound C=1C(=O)NC2=CC=CC=C2C=1CC(C(=O)O)NC(=O)C1=CC=C(Cl)C=C1 ALLWOAVDORUJLA-UHFFFAOYSA-N 0.000 description 2
- 239000007853 buffer solution Substances 0.000 description 2
- 239000008366 buffered solution Substances 0.000 description 2
- 239000011575 calcium Substances 0.000 description 2
- 229910052791 calcium Inorganic materials 0.000 description 2
- 229910001424 calcium ion Inorganic materials 0.000 description 2
- 238000011109 contamination Methods 0.000 description 2
- ZPWVASYFFYYZEW-UHFFFAOYSA-L dipotassium hydrogen phosphate Chemical compound [K+].[K+].OP([O-])([O-])=O ZPWVASYFFYYZEW-UHFFFAOYSA-L 0.000 description 2
- 229910000396 dipotassium phosphate Inorganic materials 0.000 description 2
- KDQPSPMLNJTZAL-UHFFFAOYSA-L disodium hydrogenphosphate dihydrate Chemical compound O.O.[Na+].[Na+].OP([O-])([O-])=O KDQPSPMLNJTZAL-UHFFFAOYSA-L 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 229940012356 eye drops Drugs 0.000 description 2
- 230000007935 neutral effect Effects 0.000 description 2
- 239000008363 phosphate buffer Substances 0.000 description 2
- 230000002335 preservative effect Effects 0.000 description 2
- 230000008569 process Effects 0.000 description 2
- 229950004535 rebamipide Drugs 0.000 description 2
- 239000002904 solvent Substances 0.000 description 2
- ZOXJGFHDIHLPTG-UHFFFAOYSA-N Boron Chemical compound [B] ZOXJGFHDIHLPTG-UHFFFAOYSA-N 0.000 description 1
- 208000033856 Chemical eye injury Diseases 0.000 description 1
- 208000020564 Eye injury Diseases 0.000 description 1
- 206010040880 Skin irritation Diseases 0.000 description 1
- JLFVIEQMRKMAIT-UHFFFAOYSA-N ac1l9mnz Chemical compound O.O.O JLFVIEQMRKMAIT-UHFFFAOYSA-N 0.000 description 1
- 150000007513 acids Chemical class 0.000 description 1
- 229910001514 alkali metal chloride Inorganic materials 0.000 description 1
- 229910052782 aluminium Inorganic materials 0.000 description 1
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 description 1
- 229910021529 ammonia Inorganic materials 0.000 description 1
- 239000012491 analyte Substances 0.000 description 1
- 230000000844 anti-bacterial effect Effects 0.000 description 1
- 229910052796 boron Inorganic materials 0.000 description 1
- 239000006172 buffering agent Substances 0.000 description 1
- 230000003139 buffering effect Effects 0.000 description 1
- 150000001767 cationic compounds Chemical class 0.000 description 1
- 239000004568 cement Substances 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 238000009614 chemical analysis method Methods 0.000 description 1
- 239000004035 construction material Substances 0.000 description 1
- 230000006866 deterioration Effects 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 230000018109 developmental process Effects 0.000 description 1
- 235000019797 dipotassium phosphate Nutrition 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 239000003221 ear drop Substances 0.000 description 1
- 229940047652 ear drops Drugs 0.000 description 1
- 238000011156 evaluation Methods 0.000 description 1
- 239000003889 eye drop Substances 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 230000008014 freezing Effects 0.000 description 1
- 238000007710 freezing Methods 0.000 description 1
- 150000002337 glycosamines Chemical class 0.000 description 1
- 230000036541 health Effects 0.000 description 1
- 230000006872 improvement Effects 0.000 description 1
- 230000008595 infiltration Effects 0.000 description 1
- 238000001764 infiltration Methods 0.000 description 1
- 229910001411 inorganic cation Inorganic materials 0.000 description 1
- 230000007794 irritation Effects 0.000 description 1
- 230000000670 limiting effect Effects 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 150000002736 metal compounds Chemical class 0.000 description 1
- 229940100662 nasal drops Drugs 0.000 description 1
- 239000008055 phosphate buffer solution Substances 0.000 description 1
- 239000003755 preservative agent Substances 0.000 description 1
- 230000001681 protective effect Effects 0.000 description 1
- 102000004169 proteins and genes Human genes 0.000 description 1
- 108090000623 proteins and genes Proteins 0.000 description 1
- 239000012487 rinsing solution Substances 0.000 description 1
- 239000011833 salt mixture Substances 0.000 description 1
- 230000036556 skin irritation Effects 0.000 description 1
- 231100000475 skin irritation Toxicity 0.000 description 1
- AJPJDKMHJJGVTQ-UHFFFAOYSA-M sodium dihydrogen phosphate Chemical compound [Na+].OP(O)([O-])=O AJPJDKMHJJGVTQ-UHFFFAOYSA-M 0.000 description 1
- 229910000162 sodium phosphate Inorganic materials 0.000 description 1
- KMZJRCPGGAQHGC-UHFFFAOYSA-N trisodium boric acid borate Chemical compound [Na+].[Na+].[Na+].OB(O)O.[O-]B([O-])[O-] KMZJRCPGGAQHGC-UHFFFAOYSA-N 0.000 description 1
- 229910021642 ultra pure water Inorganic materials 0.000 description 1
- 239000012498 ultrapure water Substances 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P27/00—Drugs for disorders of the senses
- A61P27/02—Ophthalmic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/22—Boron compounds
Definitions
- the invention relates to a chemical neutralisation eyewash and the preparation method thereof, as a solution used to stop the chemical burn of the eye against chemical splashes, which ensures that a layer is formed on the eye to prevent the daily pH balance of the eye from burning the cornea after a chemical splash.
- the invention relates to a chemical neutralisation eyewash that forms a layer on the eye, allowing it to reach the daily pH level of 7.4 between 1 and 20 seconds, preventing damage to the eye upon a chemical splash to prevent the burning of the cornea by disrupting the daily pH balance of the eye with chemicals that, despite depending on the structure of the chemical, act particularly acidic and alkaline, developed for use in homes, schools, offices, hospitals and ambulances, including but not limited to, workplaces where there are intense chemical applications such as mines, oil drilling stations and oil platforms, where wood, metal burrs, dust are present, and where there is no water installation and electrical networks, and to the preparation method thereof.
- a pharmaceutical composition comprising tosufloxacin or a salt thereof, having a stability and preservative effect and an anti-contamination effect is mentioned herein.
- This composition comprises tosufloxacin or a salt thereof, an aluminum-containing metal compound, borax, an alkali metal chloride, and a preservative. It is mentioned that this composition, which can be used as eye, nose and ear drops, has strong stability and protective effects and anti-contamination effects.
- the product here comprises borax, the active ingredient here is tosufloxacin or a salt thereof.
- the product here is not a product for use after chemical splashes on the eyes, but a product with an antibacterial effect. In this context, it is thought that the subject of the invention has novelty over this document.
- the present invention relates to a chemical neutralisation eyewash and the preparation method thereof, which meet the above-mentioned requirements, eliminate all the disadvantages and bring some additional advantages.
- the primary aim of the invention is to develop a chemical neutralisation eyewash with borate buffer, which ensures that a layer is formed on the eye to prevent burns of the cornea by disrupting the daily pH balance of the eye after a chemical splash, stops the chemical burn of the eye against chemical splashes and prevents damage to the eye.
- Another aim of the invention is to develop a chemical neutralisation eyewash which can be used for the first time in Turkey and in the world, instead of phosphate buffered solution that is not produced in Turkey, the domestic market demands of which are met by importing 100% from abroad and that has been proven by academic studies that it is harmful to the eye, thanks to its borate buffering, and the preparation method thereof,
- H3BO3 boric acid
- Na 2 [B 4 O 5 (0H) 4 ] 8H 2 O sodium borate or borax
- the chemical neutralisation eyewash that is the subject of the invention basically comprises boric acid (H3BO3), sodium borate or borax (Na 2 [B 4 O 5 (0H) 4 ] 8H 2 O) as an active ingredient.
- H3BO3 boric acid
- borate or borax Na 2 [B 4 O 5 (0H) 4 ] 8H 2 O
- 0.4 moles of borate is used in the invention. In this way, the buffer capacity of the subject of the invention is increased by 33% compared to the products in the state of the art.
- the subject of the invention enables the eye to reach the daily pH level of 7.4 between 1 and 20 seconds, and the operating range of the subject of the invention is 6.8 - 9.2 at this pH value. It has been proven that the subject of the invention is more effective in alkaline environment than the products of the state of the art.
- the method of preparing the chemical neutralisation eyewash that is the subject of the invention basically comprises titrimetry (volumetry) analysis, formulation of the recipe, dissolution, pH calibration, volume calculations and sterilization steps. These steps are explained in detail below.
- titration analysis which is a quantitative chemical analysis method based on measuring the volume required to complete the titration reaction (reaction) of a solution whose concentration (concentration) is known.
- the amount of substance (analyte) in the solution and the boron buffer capacity are determined: After that, the buffer solution's prescription is determined according to the amount of substances determined for the borate solution, and thus the recipe is created.
- H3BO3 15.00-32.00g Boric Acid (H3BO3) is put into the volumetric flask for each 12.50-25.00 grams of Sodium Tetraborate Decahydrate (Na2B4O7.10H2O) and its dissolution is realised by adding enough (approximately 800 millilitres) ultrapure water (non-ionised and filtered pure water) to dissolve.
- sodium hydroxide, ammonia, and potassium hydroxide are added to balance the solution pH and the solution volume is made up to 100 mL, 250 mL, 500 mL and 1000 mL.
- solutions are kept for 1 , 2, 3, 4, 5, 6, 7, 8, 9 and 10 days at room temperature, in a refrigerator at 8 °C, in a cold environment at a temperature of 4-5 °C, and in a freezer at a temperature of - 18 °C.
- no collapse, deterioration or similar change should be observed in the solution at temperatures other than freezing.
- the pH value of the solution should remain constant at values of 6.0, 6.1 , 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9, 7.0, 7.1 , 7.2, 7.3, 7.4, 7.5, 7.6, 7.7, 7.8 7.9 and 8.0.
- the pH value of the solution is measured as 6.0, 6.1 , 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9, 7.0, 7.1 , 7.2, 7.3, 7.4, 7.5, 7.6, 7.7, 7.8 7.9 and 8.0, and the pH value of the solution should remain constant after it is mixed by shaking.
- the recipe components created as a result of the above analyses are dissolved in a suitable solvent.
- a suitable solvent preferably water is used.
- the pH is adjusted to 7.4 by using a calibrated pH meter after the boric acid-sodium borate mixing process.
- the prepared solutions are sterilised by aseptic method and bottled.
- the chemical neutralisation eyewash that is the subject of the invention is obtained.
- the subject of the invention is a first aid solution to stop the chemical burn of the eye against chemical splashes.
- the products on the market that provide a neutralising effect for acid and alkali-induced caustic burns are rinsing solutions with 4.9% phosphate buffer solution.
- These provide eye first aid by fixing the pH level of the eye to 7.4, which is the daily pH level of the eye, in a period of 1 -17 seconds in chemical eye injuries caused by acid, alkali, and caustic infiltration into the eye, and by preventing the cornea from burning by providing eye neutralisation.
- the solutions that are imported and sold in the market contain 4.9% phosphate buffer and neutralise the pH level of the chemical in the eye or skin to make it harmless in the fastest way.
- the solution developed within the scope of the invention is both more effective in alkaline environment, which is more dangerous for skin irritation, compared to the products in the state of the art, and the buffer quality of the solution developed within the scope of the invention is 33% higher compared to the products in the state of the art.
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- Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Chemical & Material Sciences (AREA)
- Medicinal Preparation (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Ophthalmology & Optometry (AREA)
- Inorganic Chemistry (AREA)
- Epidemiology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Organic Chemistry (AREA)
Abstract
The invention relates to a chemical neutralisation eyewash that forms a layer on the eye, allowing it to reach the daily pH level of 7.4 between 1 and 20 seconds, preventing damage to the eye upon a chemical splash to prevent the burning of the cornea by disrupting the daily pH balance of the eye with chemicals that, despite depending on the structure of the chemical, act particularly acidic and alkaline, developed for use in homes, schools, offices, hospitals and ambulances, including but not limited to, workplaces where there are intense chemical applications such as mines, oil drilling stations and oil platforms, where wood, metal burrs, dust are present, and where there is no water installation and electrical networks, and to the preparation method thereof. In order to fulfill this, the chemical neutralisation eyewash that is the subject of the invention comprises water and boric acid (H3BO3), sodium borate or borax (Na2 [B4 O5 (OH)4 ] 8H2 O) as an active ingredient and the method of the invention comprises titrimetric (volumetric) analysis, recipe creation, dissolution pH calibration, volume calculations and sterilization steps.
Description
A chemical neutralisation eyewash and preparation method thereof
Technical Field
The invention relates to a chemical neutralisation eyewash and the preparation method thereof, as a solution used to stop the chemical burn of the eye against chemical splashes, which ensures that a layer is formed on the eye to prevent the daily pH balance of the eye from burning the cornea after a chemical splash.
In particular, the invention relates to a chemical neutralisation eyewash that forms a layer on the eye, allowing it to reach the daily pH level of 7.4 between 1 and 20 seconds, preventing damage to the eye upon a chemical splash to prevent the burning of the cornea by disrupting the daily pH balance of the eye with chemicals that, despite depending on the structure of the chemical, act particularly acidic and alkaline, developed for use in homes, schools, offices, hospitals and ambulances, including but not limited to, workplaces where there are intense chemical applications such as mines, oil drilling stations and oil platforms, where wood, metal burrs, dust are present, and where there is no water installation and electrical networks, and to the preparation method thereof.
State of the Art
Today, there are sterile buffer solutions prepared with NasHPC / NaH2PO4, which provide a neutralizing effect for acid and alkali-induced caustic burns. These solutions, which comprise 4.9% phosphate therein, comprise approximately 0.3 mol (0.3 M) phosphate per litre. These solutions that are available in the market are not produced in Turkey and are imported from abroad.
It is known that human skin is more sensitive to bases in chemical accidents because bases dissolve protein. Therefore, bases cause more irritation in both skin and eye contact. It is known that the phosphate buffers used in the state of the art have a pH value of 7.4, and the operating range is between 5.8 - 8.0. By using 0.4 mol borate in the solution that is the subject of the invention, the buffer capacity is increased by 33% compared to the existing products. The operating range of the borate buffered eye solution that is the subject of the invention at the same pH value is 6.8 - 9.2. Accordingly, it has been proven that the solution of the invention is more effective in alkaline environment.
It has been proven that phosphate-buffered eyewash solutions that come into contact with the eyes for only 2 minutes pose a risk of permanent damage to the eye. In contrast, many eyewash liquids available on the market in the state of the art are phosphate buffered. Although it is known that phosphate has a neutralizing effect on corrosive acids and alkalis, it has been determined that phosphate creates a reaction that can cause corneal calcification if it comes into contact with calcium ions. These studies reveal that, although the abrasive substance that comes into contact with the eye does not contain calcium (lye, cement, various construction materials contain intense calcium), corneal calcification is seen in patients who use phosphate solutions. The reason for this is explained as the calcium ions naturally found in the eye can be released after the cornea is damaged as a result of the corrosive substance coming into contact with the eye. As a result, it has been proven that the risk of corneal calcification is high when eye contact with phosphate buffered eyewash solution occurs even after just 2 minutes of rinsing. In addition, the importance of this subject was underlined in the publication "Questions and Answers Regarding the Use of Phosphate in Eye Drops" published by the European Medicine Agency on 13 December 2012. It is stated here that eye solutions comprising phosphate can cause corneal calcification and therefore, warning information should be placed on the solution bottles. In short, the products of the state of the art may cause permanent risks for human health. Therefore, developments on this subject are needed.
In the literature, the application no EP2285413B1 titled “A pharmaceutical composition” has been found. In this document, a pharmaceutical composition that comprises rebamipide, does not need to be redistributed, has sufficient transparency and exhibits a neutral to weakly acidic pH value so as not to keratoconjunctival damage to a patient suffering from dry eye is explained. This composition contains rebamipide, an amino sugar and a buffering agent and is free of inorganic cations. Although the solution here has a neutral to weakly acidic pH value, it has quite different contents from the components of the invention. In addition, this composition only provides a solution for the use of patients suffering from dry eye, not a product for use after chemical splashes on the eye. In this context, it is thought that the subject of the invention has novelty over to this document.
In the literature, the application no TR 2011/02734, titled “Pharmaceutical composition containing Tosufloxacin or a salt thereof” was also found. A pharmaceutical composition comprising tosufloxacin or a salt thereof, having a stability and preservative effect and an anti-contamination effect is mentioned herein. This composition comprises tosufloxacin or a salt thereof, an aluminum-containing metal compound, borax, an alkali metal chloride,
and a preservative. It is mentioned that this composition, which can be used as eye, nose and ear drops, has strong stability and protective effects and anti-contamination effects. Although the product here comprises borax, the active ingredient here is tosufloxacin or a salt thereof. In addition, the product here is not a product for use after chemical splashes on the eyes, but a product with an antibacterial effect. In this context, it is thought that the subject of the invention has novelty over this document.
As a result, due to the negativities described above and the inadequacy of the existing solutions on the subject, it was necessary to make an improvement in the relevant technical field.
Brief Description of the Invention
The present invention relates to a chemical neutralisation eyewash and the preparation method thereof, which meet the above-mentioned requirements, eliminate all the disadvantages and bring some additional advantages.
The primary aim of the invention is to develop a chemical neutralisation eyewash with borate buffer, which ensures that a layer is formed on the eye to prevent burns of the cornea by disrupting the daily pH balance of the eye after a chemical splash, stops the chemical burn of the eye against chemical splashes and prevents damage to the eye.
Another aim of the invention is to develop a chemical neutralisation eyewash which can be used for the first time in Turkey and in the world, instead of phosphate buffered solution that is not produced in Turkey, the domestic market demands of which are met by importing 100% from abroad and that has been proven by academic studies that it is harmful to the eye, thanks to its borate buffering, and the preparation method thereof,
In order to fulfill the above-mentioned aims, the chemical neutralisation eyewash that is the subject of the invention comprises water and boric acid (H3BO3), sodium borate or borax (Na2 [B4 O5 (0H)4 ] 8H2 O) as an active ingredient and the method of the invention comprises titrimetric (volumetric) analysis, recipe creation, dissolution pH calibration, volume calculations and sterilization steps.
The structural and characteristic features of the invention and all its advantages will be understood more clearly by means of the detailed explanation written, and therefore the evaluation should be made by taking these detailed explanation into consideration.
Detailed Description of the Invention
In this detailed description, the chemical neutralisation eyewash and the preparation method thereof are explained only for a better understanding of the subject and without any limiting effect.
The chemical neutralisation eyewash that is the subject of the invention basically comprises boric acid (H3BO3), sodium borate or borax (Na2 [B4 O5 (0H)4 ] 8H2 O) as an active ingredient. In this way, after a chemical splash, it forms a layer on the eye to prevent burns of the cornea against chemicals, depending on the structure of the chemical, especially acidic and alkaline ones, disrupting the daily pH balance of the eye and, thus allowing the eye to reach the daily pH and preventing damage to the eye. In order to achieve this, 0.4 moles of borate is used in the invention. In this way, the buffer capacity of the subject of the invention is increased by 33% compared to the products in the state of the art. The subject of the invention enables the eye to reach the daily pH level of 7.4 between 1 and 20 seconds, and the operating range of the subject of the invention is 6.8 - 9.2 at this pH value. It has been proven that the subject of the invention is more effective in alkaline environment than the products of the state of the art.
The method of preparing the chemical neutralisation eyewash that is the subject of the invention basically comprises titrimetry (volumetry) analysis, formulation of the recipe, dissolution, pH calibration, volume calculations and sterilization steps. These steps are explained in detail below.
In the preparation of solutions, titration analysis, which is a quantitative chemical analysis method based on measuring the volume required to complete the titration reaction (reaction) of a solution whose concentration (concentration) is known, is performed. In the subject of the invention, using this method, the amount of substance (analyte) in the solution and the boron buffer capacity are determined: After that, the buffer solution's prescription is determined according to the amount of substances determined for the borate solution, and thus the recipe is created. During the determination of the buffer recipe, in a preferred embodiment, 15.00-32.00g Boric Acid (H3BO3) is put into the volumetric flask for each 12.50-25.00 grams of Sodium Tetraborate Decahydrate (Na2B4O7.10H2O) and its dissolution is realised by adding enough (approximately 800 millilitres) ultrapure water (non-ionised and filtered pure water) to dissolve. In order to bring the pH of the solution to 6.0, 6.1 , 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9, 7.0, 7.1 , 7.2, 7.3, 7.4, 7.5, 7.6, 7.7, 7.8 7.9 and 8.0, sodium hydroxide, ammonia, and potassium
hydroxide are added to balance the solution pH and the solution volume is made up to 100 mL, 250 mL, 500 mL and 1000 mL.
In order to test the stability of the prepared solutions at different temperatures, solutions are kept for 1 , 2, 3, 4, 5, 6, 7, 8, 9 and 10 days at room temperature, in a refrigerator at 8 °C, in a cold environment at a temperature of 4-5 °C, and in a freezer at a temperature of - 18 °C. Here, no collapse, deterioration or similar change should be observed in the solution at temperatures other than freezing.
The pH value of the solution should remain constant at values of 6.0, 6.1 , 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9, 7.0, 7.1 , 7.2, 7.3, 7.4, 7.5, 7.6, 7.7, 7.8 7.9 and 8.0. When the solution temperature reaches to room temperature, the pH value of the solution is measured as 6.0, 6.1 , 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9, 7.0, 7.1 , 7.2, 7.3, 7.4, 7.5, 7.6, 7.7, 7.8 7.9 and 8.0, and the pH value of the solution should remain constant after it is mixed by shaking.
The recipe components created as a result of the above analyses are dissolved in a suitable solvent. Here, as the solvent, preferably water is used. After this process, the pH is adjusted to 7.4 by using a calibrated pH meter after the boric acid-sodium borate mixing process. After the solution is completed to the required volume, the prepared solutions are sterilised by aseptic method and bottled. Thus, the chemical neutralisation eyewash that is the subject of the invention is obtained.
The subject of the invention is a first aid solution to stop the chemical burn of the eye against chemical splashes. In the state of the art, the products on the market that provide a neutralising effect for acid and alkali-induced caustic burns are rinsing solutions with 4.9% phosphate buffer solution. These provide eye first aid by fixing the pH level of the eye to 7.4, which is the daily pH level of the eye, in a period of 1 -17 seconds in chemical eye injuries caused by acid, alkali, and caustic infiltration into the eye, and by preventing the cornea from burning by providing eye neutralisation. The solutions that are imported and sold in the market contain 4.9% phosphate buffer and neutralise the pH level of the chemical in the eye or skin to make it harmless in the fastest way. The chemical components of these products in the state of the art are a buffered salt mixture consisting of 95.2% water and di-sodium hydrogen phosphate dihydrate (Na2 HP04 * 2 H2 O), Sodium hydrogen phosphate dihydrate (HNa2 04 P * 2 H2 O) and Potassium hydrogen phosphate (K2HPO4). However, as stated before, since phosphate buffered solutions cause corneal calcification, within the scope of this invention, a completely native solution
has been developed that can be used for first aid in eye injuries, consisting of 98.3% pure water, boric acid (H3BO3), sodium borate or borax (Na2 [B4 O5 (0H)4 ] 8H2 O). The solution developed within the scope of the invention is both more effective in alkaline environment, which is more dangerous for skin irritation, compared to the products in the state of the art, and the buffer quality of the solution developed within the scope of the invention is 33% higher compared to the products in the state of the art.
Claims
CLAIMS A chemical neutralisation eyewash comprising water, which causes a layer to form on the eye to prevent the cornea from burning due to the disruption of the daily pH balance of the eye upon a chemical splash, stops the chemical burn of the eye against chemical splashes and prevents damage to the eye characterized by comprising; boric acid (H3BO3), sodium borate or borax (Na2 [B4 O5 (0H)4 ] 8H2 O) as active ingredient. A chemical neutralisation eyewash according to Claim 1 , characterized by comprising; 0.4 moles of borate. A chemical neutralisation eyewash according to Claim 1 , characterized by comprising; 98.3% by weight pure water. A method comprising the steps of titration (volumetry) analysis, dissolution pH calibration, volume calculations, and sterilization steps for the preparation of a chemical neutralisation eyewash according to any of the previous claims, characterized by comprising; the process step of creating the recipe between the titrimetric (volumetric) analysis and dissolution steps. A chemical neutralisation eyewash preparation method according to claim 4, characterized by wherein, the components used in the step of creating the recipe are sodium tetraborate decahydrate (Na2B4O7.10H2O), boric acid (H3BO3) and water. A chemical neutralisation eyewash preparation method according to claim 4, characterized by wherein, in the pH calibration step, the pH value is 7.4.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| TR2022/011952A TR2022011952A2 (en) | 2022-07-28 | 2022-07-28 | A chemical neutralization eyewash and method of preparation |
| TR2022/011952 | 2022-07-28 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| WO2024025497A1 true WO2024025497A1 (en) | 2024-02-01 |
Family
ID=84101244
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/TR2023/050665 WO2024025497A1 (en) | 2022-07-28 | 2023-07-07 | A chemical neutralisation eyewash and preparation method thereof |
Country Status (2)
| Country | Link |
|---|---|
| TR (1) | TR2022011952A2 (en) |
| WO (1) | WO2024025497A1 (en) |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB923977A (en) * | 1960-01-16 | 1963-04-18 | Commissariat Energie Atomique | Improvements in or relating to eye-washing appliances |
| WO2008061536A1 (en) * | 2006-11-22 | 2008-05-29 | Ocumedic Aps | Compositions and methods of using same for treatment of a disease or disorder of the eye and/or the adnexa of the eye |
| CN104146994A (en) * | 2014-06-10 | 2014-11-19 | 苏州普洛赛医药科技有限公司 | Emergent protective liquid agent for chemistry and high temperature burn and preparation method thereof |
-
2022
- 2022-07-28 TR TR2022/011952A patent/TR2022011952A2/en unknown
-
2023
- 2023-07-07 WO PCT/TR2023/050665 patent/WO2024025497A1/en unknown
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB923977A (en) * | 1960-01-16 | 1963-04-18 | Commissariat Energie Atomique | Improvements in or relating to eye-washing appliances |
| WO2008061536A1 (en) * | 2006-11-22 | 2008-05-29 | Ocumedic Aps | Compositions and methods of using same for treatment of a disease or disorder of the eye and/or the adnexa of the eye |
| CN104146994A (en) * | 2014-06-10 | 2014-11-19 | 苏州普洛赛医药科技有限公司 | Emergent protective liquid agent for chemistry and high temperature burn and preparation method thereof |
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| Publication number | Publication date |
|---|---|
| TR2022011952A2 (en) | 2022-08-22 |
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