CN116963720A - 眼用溶液 - Google Patents
眼用溶液 Download PDFInfo
- Publication number
- CN116963720A CN116963720A CN202280019437.2A CN202280019437A CN116963720A CN 116963720 A CN116963720 A CN 116963720A CN 202280019437 A CN202280019437 A CN 202280019437A CN 116963720 A CN116963720 A CN 116963720A
- Authority
- CN
- China
- Prior art keywords
- ophthalmically compatible
- compatible solution
- total weight
- ophthalmically
- erythritol
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
- 239000002997 ophthalmic solution Substances 0.000 title description 10
- WCUXLLCKKVVCTQ-UHFFFAOYSA-M Potassium chloride Chemical compound [Cl-].[K+] WCUXLLCKKVVCTQ-UHFFFAOYSA-M 0.000 claims abstract description 68
- KIUKXJAPPMFGSW-DNGZLQJQSA-N (2S,3S,4S,5R,6R)-6-[(2S,3R,4R,5S,6R)-3-Acetamido-2-[(2S,3S,4R,5R,6R)-6-[(2R,3R,4R,5S,6R)-3-acetamido-2,5-dihydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-2-carboxy-4,5-dihydroxyoxan-3-yl]oxy-5-hydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-3,4,5-trihydroxyoxane-2-carboxylic acid Chemical compound CC(=O)N[C@H]1[C@H](O)O[C@H](CO)[C@@H](O)[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@@H]([C@@H](O[C@H]3[C@@H]([C@@H](O)[C@H](O)[C@H](O3)C(O)=O)O)[C@H](O)[C@@H](CO)O2)NC(C)=O)[C@@H](C(O)=O)O1 KIUKXJAPPMFGSW-DNGZLQJQSA-N 0.000 claims abstract description 61
- 229920002674 hyaluronan Polymers 0.000 claims abstract description 61
- 229960003160 hyaluronic acid Drugs 0.000 claims abstract description 61
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims abstract description 51
- 150000003839 salts Chemical class 0.000 claims abstract description 42
- 239000004386 Erythritol Substances 0.000 claims abstract description 40
- UNXHWFMMPAWVPI-UHFFFAOYSA-N Erythritol Natural products OCC(O)C(O)CO UNXHWFMMPAWVPI-UHFFFAOYSA-N 0.000 claims abstract description 40
- UNXHWFMMPAWVPI-ZXZARUISSA-N erythritol Chemical compound OC[C@H](O)[C@H](O)CO UNXHWFMMPAWVPI-ZXZARUISSA-N 0.000 claims abstract description 40
- 229940009714 erythritol Drugs 0.000 claims abstract description 40
- 235000019414 erythritol Nutrition 0.000 claims abstract description 40
- 239000000872 buffer Substances 0.000 claims abstract description 35
- 239000001103 potassium chloride Substances 0.000 claims abstract description 34
- 235000011164 potassium chloride Nutrition 0.000 claims abstract description 34
- 239000011780 sodium chloride Substances 0.000 claims abstract description 25
- 239000000243 solution Substances 0.000 claims description 213
- 238000000034 method Methods 0.000 claims description 49
- 239000000314 lubricant Substances 0.000 claims description 23
- 208000003556 Dry Eye Syndromes Diseases 0.000 claims description 19
- 206010013774 Dry eye Diseases 0.000 claims description 19
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 17
- KGBXLFKZBHKPEV-UHFFFAOYSA-N boric acid Chemical compound OB(O)O KGBXLFKZBHKPEV-UHFFFAOYSA-N 0.000 claims description 15
- 239000004327 boric acid Substances 0.000 claims description 15
- 210000004087 cornea Anatomy 0.000 claims description 14
- 229920002385 Sodium hyaluronate Polymers 0.000 claims description 11
- 229940010747 sodium hyaluronate Drugs 0.000 claims description 11
- YWIVKILSMZOHHF-QJZPQSOGSA-N sodium;(2s,3s,4s,5r,6r)-6-[(2s,3r,4r,5s,6r)-3-acetamido-2-[(2s,3s,4r,5r,6r)-6-[(2r,3r,4r,5s,6r)-3-acetamido-2,5-dihydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-2-carboxy-4,5-dihydroxyoxan-3-yl]oxy-5-hydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-3,4,5-trihydroxyoxane-2- Chemical compound [Na+].CC(=O)N[C@H]1[C@H](O)O[C@H](CO)[C@@H](O)[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@@H]([C@@H](O[C@H]3[C@@H]([C@@H](O)[C@H](O)[C@H](O3)C(O)=O)O)[C@H](O)[C@@H](CO)O2)NC(C)=O)[C@@H](C(O)=O)O1 YWIVKILSMZOHHF-QJZPQSOGSA-N 0.000 claims description 11
- 229910021538 borax Inorganic materials 0.000 claims description 9
- 235000010339 sodium tetraborate Nutrition 0.000 claims description 9
- BSVBQGMMJUBVOD-UHFFFAOYSA-N trisodium borate Chemical compound [Na+].[Na+].[Na+].[O-]B([O-])[O-] BSVBQGMMJUBVOD-UHFFFAOYSA-N 0.000 claims description 9
- 239000012530 fluid Substances 0.000 claims description 7
- 235000011187 glycerol Nutrition 0.000 claims description 7
- 239000000607 artificial tear Substances 0.000 claims description 6
- 239000003889 eye drop Substances 0.000 claims description 6
- 239000006196 drop Substances 0.000 claims description 5
- 239000002736 nonionic surfactant Substances 0.000 claims description 5
- 239000004094 surface-active agent Substances 0.000 claims description 5
- 230000001050 lubricating effect Effects 0.000 claims description 3
- 229960002645 boric acid Drugs 0.000 claims 4
- 235000010338 boric acid Nutrition 0.000 claims 4
- 229960002816 potassium chloride Drugs 0.000 claims 4
- 229960004599 sodium borate Drugs 0.000 claims 4
- 229920000036 polyvinylpyrrolidone Polymers 0.000 description 9
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 description 9
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 description 8
- 239000000047 product Substances 0.000 description 8
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 description 6
- 239000001267 polyvinylpyrrolidone Substances 0.000 description 6
- 208000024891 symptom Diseases 0.000 description 6
- 150000001875 compounds Chemical class 0.000 description 4
- 239000000203 mixture Substances 0.000 description 4
- 230000001954 sterilising effect Effects 0.000 description 4
- 238000004659 sterilization and disinfection Methods 0.000 description 4
- BTBUEUYNUDRHOZ-UHFFFAOYSA-N Borate Chemical compound [O-]B([O-])[O-] BTBUEUYNUDRHOZ-UHFFFAOYSA-N 0.000 description 3
- RVGRUAULSDPKGF-UHFFFAOYSA-N Poloxamer Chemical compound C1CO1.CC1CO1 RVGRUAULSDPKGF-UHFFFAOYSA-N 0.000 description 3
- 239000007864 aqueous solution Substances 0.000 description 3
- 229920001222 biopolymer Polymers 0.000 description 3
- 239000007853 buffer solution Substances 0.000 description 3
- 230000015556 catabolic process Effects 0.000 description 3
- 239000001913 cellulose Substances 0.000 description 3
- 229920002678 cellulose Polymers 0.000 description 3
- 238000004140 cleaning Methods 0.000 description 3
- 239000000463 material Substances 0.000 description 3
- 239000000178 monomer Substances 0.000 description 3
- 229960000502 poloxamer Drugs 0.000 description 3
- 229920001983 poloxamer Polymers 0.000 description 3
- 229920000642 polymer Polymers 0.000 description 3
- 229940069328 povidone Drugs 0.000 description 3
- 206010015946 Eye irritation Diseases 0.000 description 2
- XEEYBQQBJWHFJM-UHFFFAOYSA-N Iron Chemical compound [Fe] XEEYBQQBJWHFJM-UHFFFAOYSA-N 0.000 description 2
- 208000009319 Keratoconjunctivitis Sicca Diseases 0.000 description 2
- 239000002253 acid Substances 0.000 description 2
- 230000003139 buffering effect Effects 0.000 description 2
- 230000008859 change Effects 0.000 description 2
- 239000003795 chemical substances by application Substances 0.000 description 2
- 238000006731 degradation reaction Methods 0.000 description 2
- 230000000249 desinfective effect Effects 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 229940012356 eye drops Drugs 0.000 description 2
- 231100000013 eye irritation Toxicity 0.000 description 2
- 238000009472 formulation Methods 0.000 description 2
- 229920001519 homopolymer Polymers 0.000 description 2
- -1 hydroxide ions Chemical class 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 229920001206 natural gum Polymers 0.000 description 2
- 229940054534 ophthalmic solution Drugs 0.000 description 2
- 230000008569 process Effects 0.000 description 2
- 102000004169 proteins and genes Human genes 0.000 description 2
- 108090000623 proteins and genes Proteins 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 2
- 230000004580 weight loss Effects 0.000 description 2
- 238000009736 wetting Methods 0.000 description 2
- WCDDVEOXEIYWFB-VXORFPGASA-N (2s,3s,4r,5r,6r)-3-[(2s,3r,5s,6r)-3-acetamido-5-hydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-4,5,6-trihydroxyoxane-2-carboxylic acid Chemical compound CC(=O)N[C@@H]1C[C@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](C(O)=O)O[C@@H](O)[C@H](O)[C@H]1O WCDDVEOXEIYWFB-VXORFPGASA-N 0.000 description 1
- VAZJLPXFVQHDFB-UHFFFAOYSA-N 1-(diaminomethylidene)-2-hexylguanidine Polymers CCCCCCN=C(N)N=C(N)N VAZJLPXFVQHDFB-UHFFFAOYSA-N 0.000 description 1
- NIXOWILDQLNWCW-UHFFFAOYSA-M Acrylate Chemical compound [O-]C(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-M 0.000 description 1
- 241000416162 Astragalus gummifer Species 0.000 description 1
- 229940123208 Biguanide Drugs 0.000 description 1
- 229920002134 Carboxymethyl cellulose Polymers 0.000 description 1
- IAJILQKETJEXLJ-UHFFFAOYSA-N Galacturonsaeure Natural products O=CC(O)C(O)C(O)C(O)C(O)=O IAJILQKETJEXLJ-UHFFFAOYSA-N 0.000 description 1
- 229920002683 Glycosaminoglycan Polymers 0.000 description 1
- 229920002907 Guar gum Polymers 0.000 description 1
- UFHFLCQGNIYNRP-UHFFFAOYSA-N Hydrogen Chemical compound [H][H] UFHFLCQGNIYNRP-UHFFFAOYSA-N 0.000 description 1
- 239000004354 Hydroxyethyl cellulose Substances 0.000 description 1
- 229920001479 Hydroxyethyl methyl cellulose Polymers 0.000 description 1
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 description 1
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 description 1
- 208000011671 Lacrimal disease Diseases 0.000 description 1
- 241001465754 Metazoa Species 0.000 description 1
- OVRNDRQMDRJTHS-UHFFFAOYSA-N N-acelyl-D-glucosamine Natural products CC(=O)NC1C(O)OC(CO)C(O)C1O OVRNDRQMDRJTHS-UHFFFAOYSA-N 0.000 description 1
- OVRNDRQMDRJTHS-FMDGEEDCSA-N N-acetyl-beta-D-glucosamine Chemical compound CC(=O)N[C@H]1[C@H](O)O[C@H](CO)[C@@H](O)[C@@H]1O OVRNDRQMDRJTHS-FMDGEEDCSA-N 0.000 description 1
- MBLBDJOUHNCFQT-LXGUWJNJSA-N N-acetylglucosamine Natural products CC(=O)N[C@@H](C=O)[C@@H](O)[C@H](O)[C@H](O)CO MBLBDJOUHNCFQT-LXGUWJNJSA-N 0.000 description 1
- ZQYUHRVUJCLGRX-UHFFFAOYSA-N NCC(=O)NCC(O)=O.NCC(=O)NCC(O)=O Chemical compound NCC(=O)NCC(O)=O.NCC(=O)NCC(O)=O ZQYUHRVUJCLGRX-UHFFFAOYSA-N 0.000 description 1
- 206010052143 Ocular discomfort Diseases 0.000 description 1
- 208000002193 Pain Diseases 0.000 description 1
- 229920001090 Polyaminopropyl biguanide Polymers 0.000 description 1
- 229920002413 Polyhexanide Polymers 0.000 description 1
- ZLMJMSJWJFRBEC-UHFFFAOYSA-N Potassium Chemical compound [K] ZLMJMSJWJFRBEC-UHFFFAOYSA-N 0.000 description 1
- 208000003251 Pruritus Diseases 0.000 description 1
- 229920001615 Tragacanth Polymers 0.000 description 1
- 241000251539 Vertebrata <Metazoa> Species 0.000 description 1
- 206010048222 Xerosis Diseases 0.000 description 1
- FZQSLXQPHPOTHG-UHFFFAOYSA-N [K+].[K+].O1B([O-])OB2OB([O-])OB1O2 Chemical compound [K+].[K+].O1B([O-])OB2OB([O-])OB1O2 FZQSLXQPHPOTHG-UHFFFAOYSA-N 0.000 description 1
- 150000007513 acids Chemical class 0.000 description 1
- 230000009471 action Effects 0.000 description 1
- AEMOLEFTQBMNLQ-WAXACMCWSA-N alpha-D-glucuronic acid Chemical compound O[C@H]1O[C@H](C(O)=O)[C@@H](O)[C@H](O)[C@H]1O AEMOLEFTQBMNLQ-WAXACMCWSA-N 0.000 description 1
- 150000004283 biguanides Chemical class 0.000 description 1
- 229920002988 biodegradable polymer Polymers 0.000 description 1
- 239000004621 biodegradable polymer Substances 0.000 description 1
- 239000012620 biological material Substances 0.000 description 1
- 230000033228 biological regulation Effects 0.000 description 1
- 239000001768 carboxy methyl cellulose Substances 0.000 description 1
- 235000010948 carboxy methyl cellulose Nutrition 0.000 description 1
- 239000008112 carboxymethyl-cellulose Substances 0.000 description 1
- 239000002738 chelating agent Substances 0.000 description 1
- 210000002808 connective tissue Anatomy 0.000 description 1
- 239000000882 contact lens solution Substances 0.000 description 1
- 239000000356 contaminant Substances 0.000 description 1
- 238000001816 cooling Methods 0.000 description 1
- 239000002537 cosmetic Substances 0.000 description 1
- 238000000354 decomposition reaction Methods 0.000 description 1
- 230000007423 decrease Effects 0.000 description 1
- 230000018044 dehydration Effects 0.000 description 1
- 238000006297 dehydration reaction Methods 0.000 description 1
- 230000001627 detrimental effect Effects 0.000 description 1
- 150000002016 disaccharides Chemical group 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 239000003974 emollient agent Substances 0.000 description 1
- 150000002334 glycols Chemical class 0.000 description 1
- 239000000665 guar gum Substances 0.000 description 1
- 235000010417 guar gum Nutrition 0.000 description 1
- 229960002154 guar gum Drugs 0.000 description 1
- 229940014041 hyaluronate Drugs 0.000 description 1
- 230000036571 hydration Effects 0.000 description 1
- 238000006703 hydration reaction Methods 0.000 description 1
- 239000001257 hydrogen Substances 0.000 description 1
- 229910052739 hydrogen Inorganic materials 0.000 description 1
- 230000007062 hydrolysis Effects 0.000 description 1
- 238000006460 hydrolysis reaction Methods 0.000 description 1
- 235000019447 hydroxyethyl cellulose Nutrition 0.000 description 1
- 239000001863 hydroxypropyl cellulose Substances 0.000 description 1
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 description 1
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 description 1
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 description 1
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 description 1
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 description 1
- 230000002163 immunogen Effects 0.000 description 1
- 229910052742 iron Inorganic materials 0.000 description 1
- 230000007794 irritation Effects 0.000 description 1
- 210000000629 knee joint Anatomy 0.000 description 1
- 150000002632 lipids Chemical class 0.000 description 1
- 238000005461 lubrication Methods 0.000 description 1
- 229920000609 methyl cellulose Polymers 0.000 description 1
- 239000001923 methylcellulose Substances 0.000 description 1
- 235000010981 methylcellulose Nutrition 0.000 description 1
- 239000012569 microbial contaminant Substances 0.000 description 1
- 229950006780 n-acetylglucosamine Drugs 0.000 description 1
- 230000007935 neutral effect Effects 0.000 description 1
- 231100000065 noncytotoxic Toxicity 0.000 description 1
- 230000002020 noncytotoxic effect Effects 0.000 description 1
- 230000008520 organization Effects 0.000 description 1
- 230000003647 oxidation Effects 0.000 description 1
- 238000007254 oxidation reaction Methods 0.000 description 1
- 230000001590 oxidative effect Effects 0.000 description 1
- 239000003002 pH adjusting agent Substances 0.000 description 1
- 230000001717 pathogenic effect Effects 0.000 description 1
- 229910052700 potassium Inorganic materials 0.000 description 1
- 239000011591 potassium Substances 0.000 description 1
- JVUYWILPYBCNNG-UHFFFAOYSA-N potassium;oxido(oxo)borane Chemical compound [K+].[O-]B=O JVUYWILPYBCNNG-UHFFFAOYSA-N 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- 239000003755 preservative agent Substances 0.000 description 1
- 230000001681 protective effect Effects 0.000 description 1
- 239000008213 purified water Substances 0.000 description 1
- 230000009467 reduction Effects 0.000 description 1
- 210000002374 sebum Anatomy 0.000 description 1
- 229910052708 sodium Inorganic materials 0.000 description 1
- 239000011734 sodium Substances 0.000 description 1
- 239000001509 sodium citrate Substances 0.000 description 1
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 description 1
- 159000000000 sodium salts Chemical class 0.000 description 1
- 238000010186 staining Methods 0.000 description 1
- 235000000346 sugar Nutrition 0.000 description 1
- 150000008163 sugars Chemical class 0.000 description 1
- 125000000472 sulfonyl group Chemical group *S(*)(=O)=O 0.000 description 1
- 239000013589 supplement Substances 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- 230000002459 sustained effect Effects 0.000 description 1
- 230000000699 topical effect Effects 0.000 description 1
- WUUHFRRPHJEEKV-UHFFFAOYSA-N tripotassium borate Chemical compound [K+].[K+].[K+].[O-]B([O-])[O-] WUUHFRRPHJEEKV-UHFFFAOYSA-N 0.000 description 1
- 125000000391 vinyl group Chemical group [H]C([*])=C([H])[H] 0.000 description 1
- 229920002554 vinyl polymer Polymers 0.000 description 1
- 239000004034 viscosity adjusting agent Substances 0.000 description 1
- 238000005406 washing Methods 0.000 description 1
- 229920003169 water-soluble polymer Polymers 0.000 description 1
Classifications
-
- C—CHEMISTRY; METALLURGY
- C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
- C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
- C11D3/00—Other compounding ingredients of detergent compositions covered in group C11D1/00
- C11D3/0005—Other compounding ingredients characterised by their effect
- C11D3/0078—Compositions for cleaning contact lenses, spectacles or lenses
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L12/00—Methods or apparatus for disinfecting or sterilising contact lenses; Accessories therefor
- A61L12/08—Methods or apparatus for disinfecting or sterilising contact lenses; Accessories therefor using chemical substances
- A61L12/14—Organic compounds not covered by groups A61L12/10 or A61L12/12
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
- A61K31/726—Glycosaminoglycans, i.e. mucopolysaccharides
- A61K31/728—Hyaluronic acid
-
- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- A01N33/00—Biocides, pest repellants or attractants, or plant growth regulators containing organic nitrogen compounds
- A01N33/02—Amines; Quaternary ammonium compounds
- A01N33/12—Quaternary ammonium compounds
-
- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- A01N37/00—Biocides, pest repellants or attractants, or plant growth regulators containing organic compounds containing a carbon atom having three bonds to hetero atoms with at the most two bonds to halogen, e.g. carboxylic acids
- A01N37/52—Biocides, pest repellants or attractants, or plant growth regulators containing organic compounds containing a carbon atom having three bonds to hetero atoms with at the most two bonds to halogen, e.g. carboxylic acids containing groups, e.g. carboxylic acid amidines
-
- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01P—BIOCIDAL, PEST REPELLANT, PEST ATTRACTANT OR PLANT GROWTH REGULATORY ACTIVITY OF CHEMICAL COMPOUNDS OR PREPARATIONS
- A01P1/00—Disinfectants; Antimicrobial compounds or mixtures thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/02—Inorganic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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Abstract
一种眼用相容溶液包含(a)基于所述眼用相容溶液的总重量,约0.005wt.%至约2wt.%的透明质酸或其盐;(b)基于所述眼用相容溶液的总重量,约0.01wt.%至约1wt.%的赤藓糖醇;(c)氯化钠、氯化钾或其任何组合;以及(d)一种或多种缓冲液。
Description
优先权声明
本申请要求于2021年3月10日提交的题为“眼用溶液(Ophthalmic Solutions)”的美国临时专利申请序列号63/159,097的优先权,所述美国临时专利申请的内容通过引用整体并入本文。
背景技术
在正常使用期间,隐形眼镜会被各种各样的可能降低镜片的性能的化合物染污或污染。例如,隐形眼镜将被泪液中存在并粘附到镜片表面的生物材料,如蛋白质或脂质染污。而且,通过操作隐形眼镜,皮脂(皮肤油)、化妆品或其它材料可能会染污隐形眼镜。这些生物和外部污染物可能在使用期间和一天结束时影响视力和患者舒适度。因此,重要的是从镜片表面去除任何碎屑,以便与含有一种或多种清洁组分的镜片护理清洁和消毒溶液一起继续舒适使用。同样重要的是,镜片护理清洁和消毒溶液为隐形眼镜消费者提供一定程度的眼部舒适度或水合作用,尤其是被诊断为患有干燥性角膜结膜炎的消费者,这种病状通常被称为干眼综合征。
发明内容
根据一说明性实施例,一种眼用相容溶液包括(a)基于所述眼用相容溶液的总重量,约0.005wt.%至约2wt.%的透明质酸或其盐;(b)基于所述眼用相容溶液的总重量,约0.01wt.%至约1wt.%的赤藓糖醇;(c)氯化钠、氯化钾或其任何组合;以及(d)一种或多种缓冲液。眼用相容溶液可以施用于未佩戴隐形眼镜的眼睛,例如以重新润湿角膜。
根据另一说明性实施例,一种用于减少、改善、治疗或控制干眼症的方法,所述方法包括向患者的受感染的眼睛施用眼用相容溶液,所述眼用相容溶液包括(a)基于所述眼用相容溶液的总重量,约0.005wt.%至约2wt.%的透明质酸或其盐;(b)基于所述眼用相容溶液的总重量,约0.01wt.%至约1wt.%的赤藓糖醇;(c)氯化钠、氯化钾或其任何组合;以及(d)一种或多种缓冲液。
根据另外的说明性实施例,一种重新润湿角膜的方法包括向角膜施用眼用相容溶液,其中所述眼用相容溶液包括(a)基于所述眼用相容溶液的总重量,约0.005wt.%至约2wt.%的透明质酸或其盐;(b)基于所述眼用相容溶液的总重量,约0.01wt.%至约1wt.%的赤藓糖醇;(c)氯化钠、氯化钾或其任何组合;以及(d)一种或多种缓冲液。
根据又另外的说明性实施例,提供了一种可用作人工泪液或用于重新润湿或润滑角膜的系统,所述系统包括液滴分配器,所述液滴分配器能够容纳约1ml至约30ml的眼用相容溶液,所述眼用相容溶液包括(a)基于所述眼用相容溶液的总重量,约0.005wt.%至约2wt.%的透明质酸或其盐;(b)基于所述眼用相容溶液的总重量,约0.01wt.%至约1wt.%的赤藓糖醇;(c)氯化钠、氯化钾或其任何组合;以及(d)一种或多种缓冲液。
根据仍又另外的说明性实施例,一种眼用相容溶液的用途,其用于重新润湿角膜,所述眼用相容溶液包括(a)基于所述眼用相容溶液的总重量,约0.005wt.%至约2wt.%的透明质酸或其盐;(b)基于所述眼用相容溶液的总重量,约0.01wt.%至约1wt.%的赤藓糖醇;(c)氯化钠、氯化钾或其任何组合;以及(d)一种或多种缓冲液。
根据仍又另外的说明性实施例,一种眼用相容溶液的用途,其用于减少、改善、治疗或控制患者的干眼症,所述眼用相容溶液包括(a)基于所述眼用相容溶液的总重量,约0.005wt.%至约2wt.%的透明质酸或其盐;(b)基于所述眼用相容溶液的总重量,约0.01wt.%至约1wt.%的赤藓糖醇;(c)氯化钠、氯化钾或其任何组合;以及(d)一种或多种缓冲液。
具体实施方式
本文所描述的各种说明性实施例包含眼用溶液,如眼用相容溶液,可用作例如可以施用于未佩戴隐形眼镜的眼睛的重新润湿液滴或滴眼液,例如以重新润湿角膜。本文所描述的其它说明性实施例还涉及眼用相容溶液,其可用于例如减少、改善、治疗或控制干眼症。
干眼症,通常也称为干燥性角膜结膜炎和泪液障碍(dyslacrima),是一种影响数百万人的常见眼科病症。患有干眼症的患者可能经历灼热、干燥感和持续刺激。在严重的情况下,干眼症可能严重损害患者的视力,并且因此阻碍患者进行如驾驶等活动。某些疾病如干燥病表现为干眼症症状。而且,随着年龄的增长,眼睛中的泪管可能会产生较少的水分,导致眼睛变得干燥、发炎、发痒和有砂砾感。
尽管看起来干眼症可能是由各种潜在的、不相关的致病原因引起的,但病状的所有表现都共享共同的影响,即眼前泪膜破裂,这通常会导致眼睛的暴露的外表面脱水,并且因此出现上述症状。
有多种用于治疗干眼症的方法。一种常见的方法是全天用人工泪液补充眼部泪膜。泪液替代方法的实例包含使用缓冲的等渗盐水溶液和含有水溶性聚合物的水溶液,所述水溶液使溶液更具粘性,并且不易通过泪液的洗涤作用从眼睛流出。
自二十世纪八十年代以来,已可获得软性隐形眼镜。虽然有很多人可以成功佩戴隐形眼镜,但也有一些人由于隐形眼镜相关的干眼症,只能短时间段佩戴隐形眼镜。这种病症的症状包含薄和/或不稳定的泪膜、角膜染色和主观症状,如眼部不适、灼热/刺痛和干燥。佩戴隐形眼镜可能触发这些症状的发作或者可能加剧症状。患有隐形眼镜相关的干眼症的人通常只能在有限的时间段内舒适地佩戴隐形眼镜(例如,少于6小时,并且在某些情况下少于四小时)。
透明质酸是一种非免疫原性物质,并且由于其粘弹特性和亲水特性,透明质酸多年来一直被用作眼睛玻璃体或关节液的替代品,或眼科手术中的支持介质。在关节液中,透明质酸溶液用作润滑剂,以为细胞提供保护环境,并且因此,其用于治疗发炎的膝关节。消费者使用包含透明质酸的产品需要制造商对消费品进行灭菌,并且如果用作开放式多剂量调配物,则必须采取另外的步骤来保存调配物产品。
已知透明质酸是一种对热灭菌过程相对敏感的生物聚合物。已知透明质酸的热灭菌会加速透明质酸的水解或氧化,由此导致生物聚合物的平均分子量显著且通常有害地降低。对于许多药物应用,调配物中相对低分子量形式的透明质酸是不期望的。通常,低分子量形式的透明质酸不能提供高分子量形式的透明质酸所期望的流变特性。为了补偿透明质酸在上述热灭菌方法中的分解,可以从具有比期望的分子量更高的分子量的透明质酸开始。然而,这种调节导致工艺效率低下,这是因为透明质酸的产物产率随着生物聚合物的平均分子量的增加而降低。
本文所描述的说明性实施例通过调配透明质酸或其盐的改善的无菌眼用相容水溶液克服了上述问题,所述溶液可以在透明质酸没有实质降解的情况下进行灭菌。具体地,通过在本文所公开的眼用溶液中将透明质酸与赤藓糖醇组合,当经受灭菌条件,如高压灭菌时,透明质酸随时间推移的分子量损失在统计学上显著好于在不存在赤藓糖醇的情况下含有透明质酸的眼用溶液。因此,本文所公开的其中透明质酸的分子量损失得到改善的眼用溶液将有利地表现出更少的pH问题、更少的功效问题、改善的粘度和更少的氧化和热降解,由此导致更高的稳定性和更长的保质期。另外,本文所公开的眼用溶液还有利地对用于制备溶液的水中所含的任何铁表现出更高的耐受性,这是通过将透明质酸与赤藓糖醇组合来实现的,并且由此提供更稳健的溶液。
在一个或多个非限制性说明性实施例中,眼用溶液可以是眼用相容溶液,其包括(a)基于所述眼用相容溶液的总重量,约0.005wt.%至约2wt.%的透明质酸或其盐;(b)基于所述眼用相容溶液的总重量,约0.01wt.%至约1wt.%的赤藓糖醇;(c)氯化钠、氯化钾或其任何组合;以及(d)一种或多种缓冲液。
本文所公开的眼用相容溶液将包含基于所述眼用相容溶液的总重量,至少约0.005wt.%至约2wt.%的透明质酸或其盐。透明质酸是一种众所周知的天然水溶性生物可降解聚合物,由两种交替连接的糖,D-葡萄糖醛酸和N-乙酰葡糖胺构成,通过交替的β-(1,4)和β-(1,3)糖苷键连接。透明质酸与其它糖胺聚糖不同,因为其与蛋白质和磺酰基没有共价连接。透明质酸在动物体内普遍存在,其中发现在软结缔组织中浓度最高。透明质酸对于身体的机械和运输目的两者都发挥着重要作用,例如,其赋予关节弹性和脊椎动物椎间盘刚性,并且也是眼睛玻璃体的重要组成。
透明质酸聚合物在相对低的溶质浓度的水溶液中具有亲水性和高粘性。其通常以钠盐、透明质酸钠的形式天然存在。制备可商购获得的透明质酸和其盐的方法是众所周知的。透明质酸可以从以下购买:例如,生化学工业株式会社公司(Seikagaku Company);清液生物技术有限公司(Clear Solutions Biotech,Inc.);法玛西亚有限公司(PharmaciaInc.);西格玛有限公司(Sigma Inc.);HTL生物技术公司(HTL Biotechnology);Contipro公司;华熙生物科技公司(Bloomage Biotechnology Corporation)以及许多其它供应商。透明质酸具有由下式表示的结构的重复单元:
因此,透明质酸中的重复单元可以如下:
通常,透明质酸或其盐,如透明质酸钠和透明质酸钾的二糖单元可以为约2个至约1,500,000个。在一个实施例中,透明质酸或其盐的重均分子量可以在约10,000至约3,000,000道尔顿(Da)的范围内,其中下限为约10,000、约20,000、约30,000、约40,000、约50,000、约60,000、约70,000、约80,000、约90,000、约100,000、约200,000、约300,000、约400,000、约500,000或约600,000Da,并且上限为约200,000、约300,000、约400,000、约500,000、约600,000、约700,000、约800,000、约900,000、约1,000,000或约至多2,800,000Da,其中任何下限可以与任何上限组合。
在一说明性实施例中,基于眼用相容溶液的总重量,透明质酸或其盐以范围为约0.005wt.%至约2wt.%的量存在于本文所公开的眼用相容溶液中。在另一说明性实施例中,基于眼用相容溶液的总重量,透明质酸或其盐以范围为约0.01wt.%至约0.2wt.%的量存在于本文所公开的眼用相容溶液中。
本文所公开的眼用相容溶液进一步含有赤藓糖醇。在一说明性实施例中,基于眼用相容溶液的总重量,赤藓糖醇以范围为约0.01wt.%至约1wt.%的量存在于本文所公开的眼用相容溶液中。在另一说明性实施例中,基于眼用相容溶液的总重量,赤藓糖醇以范围为约0.05wt.%至约0.5wt.%的量存在于本文所公开的眼用相容溶液中。在另一说明性实施例中,基于眼用相容溶液的总重量,赤藓糖醇以范围为约0.08wt.%至约0.4wt.%的量存在于本文所公开的眼用相容溶液中。
本文所公开的眼用相容溶液进一步含有有效量的一种或多种张力调节组分。合适的张力调节组分包含例如眼用产品中常规使用的组分,如各种无机盐。在一说明性实施例中,合适的张力调节组分包含氯化钠、氯化钾和其组合。所述一种或多种张力调节组分的量是有效地为溶液提供期望张力程度的量。
在一说明性实施例中,基于眼用相容溶液的总重量,所述一种或多种张力调节组分以范围为约0.01wt.%至约5wt.%的量存在于本文所公开的眼用相容溶液中。在另一说明性实施例中,基于眼用相容溶液的总重量,所述一种或多种张力调节组分以范围为约0.01wt.%至约1wt.%的量存在于本文所公开的眼用相容溶液中。在另一说明性实施例中,基于眼用相容溶液的总重量,所述一种或多种张力调节组分以范围为约0.01wt.%至约0.08wt.%的量存在于本文所公开的眼用相容溶液中。
本文所公开的眼用相容溶液进一步含有一种或多种缓冲液。术语“缓冲液”和“缓冲液系统”被理解为意指单独或与至少一种其它化合物组合在溶液中提供缓冲系统的化合物,所述缓冲系统表现出缓冲能力,即在其中原始pH变化相对较小或没有变化的一定范围内中和酸或碱(base/alkali)的能力。术语“缓冲能力”被理解为意指当添加到一升(标准单位)缓冲溶液中时,将pH值改变一个单位所需的强酸或强碱(或分别为氢或氢氧根离子)的毫摩尔(mM)。缓冲容量将取决于缓冲组分的类型和浓度。缓冲容量是在约6至约8、或约7.4至约8.4的起始pH下测量的。
合适的缓冲液包含例如硼酸和其盐,如硼酸钠或硼酸钾。硼酸盐缓冲液还包含缓冲化合物,如例如在溶液中产生硼酸或其盐的四硼酸钾或偏硼酸钾。已知硼酸盐缓冲液增强某些聚合双胍的功效。例如,美国专利第4,758,595号描述了一种含有聚(六亚甲基双胍),也称为PHMB或PAPB的隐形眼镜溶液,如果与硼酸盐缓冲液组合,其可以表现出增强的功效。其它合适的缓冲液包含双甘肽(双甘氨肽)和柠檬酸钠。
在一说明性实施例中,所述一种或多种缓冲液以范围为约0.1%至约10%(w/w)的量存在于本文所公开的眼用相容溶液中。在另一说明性实施例中,所述一种或多种缓冲液以范围为约0.5%至约5%(w/w)的量存在于本文所公开的眼用相容溶液中。在另一说明性实施例中,所述一种或多种缓冲液以范围为约0.75%至约2%(w/w)的量存在于本文所公开的眼用相容溶液中。
本文所公开的眼用相容溶液可以进一步含有有效量的一种或多种润滑剂组分。合适的润滑剂组分包含例如眼用产品中常规使用的润滑剂组分。在一说明性实施例中,合适的润滑剂组分包含非离子二醇,如甘油和丙二醇和其组合。
在一说明性实施例中,基于眼用相容溶液的总重量,所述一种或多种润滑剂组分以范围为约0.01wt.%至约5wt.%的量存在于本文所公开的眼用相容溶液中。在另一说明性实施例中,基于眼用相容溶液的总重量,所述一种或多种润滑剂组分以范围为约0.01wt.%至约1wt.%的量存在于本文所公开的眼用相容溶液中。
除上述组分外,本文所公开的眼用相容溶液可以另外含有一种或多种防腐剂、舒适剂、pH调节剂、螯合剂、粘度调节剂、缓和剂等。例如,本文所公开的眼用相容溶液可以进一步含有一种或多种舒适或缓冲组分。舒适组分可以调节镜片表面,使其更亲水(不太亲脂性)和/或对眼睛起到缓和作用。舒适组分被认为在放置镜片期间缓冲对眼睛表面的影响,并且还用于减轻眼睛刺激。
合适的舒适组分包含例如水溶性天然树胶、纤维素衍生聚合物等。有用的天然树胶包含瓜尔胶、黄芪胶等。有用的纤维素衍生的舒适组分包含纤维素衍生的聚合物,如羟丙基纤维素、羟丙基甲基纤维素、羧甲基纤维素、甲基纤维素、羟乙基纤维素等。一些非纤维素舒适组分包含丙二醇或甘油。舒适组分可以以约0.01%至约1%(w/w)的量存在于溶液中。
在一说明性实施例中,据信维持水合角膜表面的舒适剂是聚乙烯吡咯烷酮(PVP)。PVP是线性均聚物或基本上包括至少90%衍生自1-乙烯基-2-吡咯烷酮单体的重复单元的线性均聚体,单体组合物的其余部分可以包含中性单体,例如乙烯基或丙烯酸盐。PVP的其它同义词包含聚维酮(povidone/polyvidone)、1-乙烯基-2-吡咯烷酮和1-乙烯基2-吡咯烷酮(CAS注册号9003-39-8)。PVP的重均分子量可以为约10,000至约250,000或约30,000至约100,000。此类材料由多家公司销售,包含ISP技术有限公司,商标为K-29/32;BASF公司,商标为/>例如/>K-30或K-90。还优选地使用药物级PVP。
在一说明性实施例中,本文所公开的眼用相容溶液不含表面活性剂。在一说明性实施例中,本文所公开的眼用相容溶液不含非离子表面活性剂。在一说明性实施例中,本文所公开的眼用相容溶液不包含泊洛沙姆(poloxamer)和泊洛沙明(poloxamine)中的一种或多种。
本文所公开的眼用相容溶液在生理上是相容的。具体地,溶液必须是“眼用安全的”,也就是说,溶液在日常与眼睛接触时是安全且舒适的。眼用安全溶液具有与眼睛相容的张力和pH,并且包括根据ISO(国际标准组织)标准和美国FDA规定的非细胞毒性的材料和其量。溶液应是无菌的,因为在释放之前,必须在统计学上证明此类产品中不存在微生物污染物,达到此类产品所需的程度。
在非限制性说明性实施例中,本文所公开的眼用相容溶液的渗透压的范围可以在至少约200mOsmol/kg到至多约400mOsmol/kg、或约250到至多约400mOsmol/kg的范围内。在非限制性说明性实施例中,本文所公开的眼用相容溶液的渗透压的范围可以在至少约200mOsmol/kg到至多约300mOsmol/kg、或约250到至多约300mOsmol/kg的范围内。眼用相容溶液是基本上等渗的或高渗的(例如,轻微高渗的),并且是眼用可接受的。
在非限制性说明性实施例中,本文所公开的眼用相容溶液的pH可以在约4.0至约9.0、或约5.0至约8.0、或约6.0至约8.0或约6.5至约7.8的pH范围内。
在说明性实施例中,本文所公开的眼用相容溶液可以施用于未佩戴隐形眼镜的眼睛,例如以重新润湿角膜。在说明性实施例中,本文所公开的眼用相容溶液可以被调配成滴眼液以减轻眼睛刺激。滴眼液的实例是用于干眼的局部人工泪液和润滑剂,无需处方即可在非处方药(OTC)上买到。这些泪液替代物增加了眼部表面的湿度并改善了润滑。另外,人工泪液使干眼症患者的角膜表面光滑,有助于改善视力。
在一说明性实施例中,提供了一种用于减少、改善、治疗或控制干眼症的方法。在一说明性实施例中,所述方法包括向患者的受感染的眼睛施用本文所公开的眼用相容溶液。
根据另外的说明性实施例,提供了一种重新润湿角膜的方法。在一说明性实施例中,所述方法包括施用本文所公开的眼用相容重新润湿溶液。
在非限制性说明性实施例中,可用作人工泪液或用于重新润湿或润滑角膜的系统包括液滴分配器,所述液滴分配器能够容纳约1ml至约30ml的本文所公开的眼用相容溶液。
提供以下实例以使本领域技术人员能够实践本发明,并且以下实例仅是说明性的。实例不应被认为限制如权利要求中所限定的本发明的范围。
实例1
适于重新润湿角膜的眼用相容溶液的制备。量是基于溶液的总重量的wt%或ppm,其中纯化水用于q.s至100wt.%。
第一溶液通过添加硼酸(0.6wt.%)、硼酸钠(0.25wt.%)、氯化钾(0.21wt.%)、赤藓糖醇(0.3wt.%)和甘油(0.5wt.%)来制备。然后将溶液样品加热至40℃或75℃。
在冷却至室温之后,添加透明质酸钠(0.15wt.%)并搅拌过夜。
为了简洁起见,在单个实施例的上下文中描述的本文所公开的眼用相容溶液的各种特征也可以单独地或以任何合适的子组合提供。说明性实施例具体涵盖实施例的所有组合,并且在本文中公开,就好像每个和每个组合被单独和明确地公开一样。另外,描述这些变量的实施例中列出的所有子组合也被明确地涵盖在本发明组合物中,并且在本文中公开,如同每个此类子组合在本文中单独和明确地公开一样。
将理解,可对本文中所公开的实施例进行各种修改。因此,以上说明不应该被解释为限制性的,但是仅作为优选实施例的例示。例如,上文所描述的并且实施为用于操作本发明的最佳模式的功能仅用于说明目的。在不脱离本发明的范围和精神的情况下,本领域技术人员可以实施其它布置和方法。此外,所属领域技术人员将构想出在所附特征和优点的范围和精神内的其它修改。
Claims (66)
1.一种眼用相容溶液,其包括:
(a)基于所述眼用相容溶液的总重量,约0.005wt.%至约2wt.%的透明质酸或其盐;
(b)基于所述眼用相容溶液的总重量,约0.01wt.%至约1wt.%的赤藓糖醇;
(c)氯化钠、氯化钾或其任何组合;以及
(d)一种或多种缓冲液。
2.根据权利要求1所述的眼用相容溶液,其中所述透明质酸或其盐的重均分子量在约100,000至约3,000,000道尔顿(Da)的范围内。
3.根据权利要求1或2所述的眼用相容溶液,其包括:
基于所述眼用相容溶液的总重量,约0.01wt.%至约0.2wt.%的透明质酸或其盐;以及
基于所述眼用相容溶液的总重量,约0.05wt.%至约0.5wt.%的赤藓糖醇。
4.根据权利要求1至3所述的眼用相容溶液,其包括:
基于所述眼用相容溶液的总重量,约0.01wt.%至约5wt.%的氯化钠、氯化钾或其任何组合;以及
约0.1%至约10%(w/w)的所述一种或多种缓冲液。
5.根据权利要求1至4所述的眼用相容溶液,其中所述一种或多种缓冲液包括硼酸或其盐。
6.根据权利要求1至5所述的眼用相容溶液,其包括:
(a)基于所述眼用相容溶液的总重量,约0.01wt.%至约0.2wt.%的透明质酸或其盐;
(b)基于所述眼用相容溶液的总重量,约0.05wt.%至约0.5wt.%的赤藓糖醇;以及
(c)基于所述眼用相容溶液的总重量,约0.01wt.%至约1wt.%的氯化钠、氯化钾或其任何组合。
7.根据权利要求1至5所述的眼用相容溶液,其包括:
(a)基于所述眼用相容溶液的总重量,约0.01wt.%至约0.2wt.%的透明质酸或其盐;
(b)基于所述眼用相容溶液的总重量,约0.08wt.%至约0.4wt.%的赤藓糖醇;以及
(c)基于所述眼用相容溶液的总重量,约0.01wt.%至约0.08wt.%的氯化钠、氯化钾或其任何组合。
8.根据权利要求1所述的眼用相容溶液,其包括透明质酸钠、赤藓糖醇、氯化钾、硼酸和硼酸钠。
9.根据权利要求8所述的眼用相容溶液,其包括:
(a)基于所述眼用相容溶液的总重量,约0.01wt.%至约0.2wt.%的透明质酸钠;
(b)基于所述眼用相容溶液的总重量,约0.05wt.%至约0.5wt.%的赤藓糖醇;
(c)基于所述眼用相容溶液的总重量,约0.01wt.%至约1wt.%的氯化钾;以及
(d)约0.1%至约10%(w/w)的硼酸和硼酸钠。
10.根据权利要求1至9所述的眼用相容溶液,其进一步包括一种或多种润滑剂。
11.根据权利要求1至9所述的眼用相容溶液,其进一步包括基于所述眼用相容溶液的总重量,约0.01wt.%至约5wt.%的一种或多种润滑剂。
12.根据权利要求1至9所述的眼用相容溶液,其进一步包括基于所述眼用相容溶液的总重量,约0.01wt.%至约1wt.%的一种或多种润滑剂。
13.根据权利要求10至12所述的眼用相容溶液,其中所述一种或多种润滑剂包括甘油。
14.根据权利要求1至13所述的眼用相容溶液,其呈滴眼液的形式。
15.根据权利要求1至14所述的眼用相容溶液,其不含表面活性剂。
16.根据权利要求1至14所述的眼用相容溶液,其不含非离子表面活性剂。
17.一种用于减少、改善、治疗或控制干眼症的方法,所述方法包括向患者的受感染的眼睛施用眼用相容溶液,所述眼用相容溶液包括(a)基于所述眼用相容溶液的总重量,约0.005wt.%至约2wt.%的透明质酸或其盐;(b)基于所述眼用相容溶液的总重量,约0.01wt.%至约1wt.%的赤藓糖醇;(c)氯化钠、氯化钾或其任何组合;以及(e)一种或多种缓冲液。
18.根据权利要求17所述的方法,其中所述透明质酸或其盐的重均分子量在约100,000至约3,000,000道尔顿(Da)的范围内。
19.根据权利要求17或18所述的方法,其中所述眼用相容溶液包括:基于所述眼用相容溶液的总重量,约0.01wt.%至约0.2wt.%的透明质酸或其盐;以及基于所述眼用相容溶液的总重量,约0.05wt.%至约0.5wt.%的赤藓糖醇。
20.根据权利要求17或18所述的方法,其中所述眼用相容溶液包括:基于所述眼用相容溶液的总重量,约0.01wt.%至约5wt.%的氯化钠、氯化钾或其任何组合;以及约0.1%至约10%(w/w)的所述一种或多种缓冲液。
21.根据权利要求17至20所述的方法,其中所述一种或多种缓冲液包括硼酸或其盐。
22.根据权利要求17至21所述的方法,其中所述眼用相容溶液包括:
(a)基于所述眼用相容溶液的总重量,约0.01wt.%至约0.2wt.%的透明质酸或其盐;
(b)基于所述眼用相容溶液的总重量,约0.05wt.%至约0.5wt.%的赤藓糖醇;以及
(c)基于所述眼用相容溶液的总重量,约0.01wt.%至约1wt.%的氯化钠、氯化钾或其任何组合。
23.根据权利要求17至21所述的方法,其中所述眼用相容溶液包括:
(a)基于所述眼用相容溶液的总重量,约0.01wt.%至约0.2wt.%的透明质酸或其盐;
(b)基于所述眼用相容溶液的总重量,约0.08wt.%至约0.4wt.%的赤藓糖醇;以及
(c)基于所述眼用相容溶液的总重量,约0.01wt.%至约0.08wt.%的氯化钠、氯化钾或其任何组合。
24.根据权利要求17所述的方法,其中所述眼用相容溶液包括透明质酸钠、赤藓糖醇、氯化钾、硼酸和硼酸钠。
25.根据权利要求24所述的方法,其中所述眼用相容溶液包括:
(a)基于所述眼用相容溶液的总重量,约0.01wt.%至约0.2wt.%的透明质酸钠;
(b)基于所述眼用相容溶液的总重量,约0.05wt.%至约0.5wt.%的赤藓糖醇;
(c)基于所述眼用相容溶液的总重量,约0.01wt.%至约1wt.%的氯化钾;以及
(d)约0.1%至约10%(w/w)的硼酸和硼酸钠。
26.根据权利要求17至25所述的方法,其中所述眼用相容溶液进一步包括一种或多种润滑剂。
27.根据权利要求17至25所述的方法,其中所述眼用相容溶液进一步包括基于所述眼用相容溶液的总重量,约0.01wt.%至约5wt.%的一种或多种润滑剂。
28.根据权利要求17至25所述的方法,其中所述眼用相容溶液进一步包括基于所述眼用相容溶液的总重量,约0.01wt.%至约1wt.%的一种或多种润滑剂。
29.根据权利要求26至28所述的方法,其中所述一种或多种润滑剂包括甘油。
30.根据权利要求17至29所述的方法,其中所述眼用相容溶液呈滴眼液的形式。
31.根据权利要求17至30所述的方法,其中所述眼用相容溶液不含表面活性剂。
32.根据权利要求17至30所述的方法,其中所述眼用相容溶液不含非离子表面活性剂。
33.一种重新润湿角膜的方法,所述方法包括向角膜施用眼用相容溶液,其中所述眼用相容溶液包括(a)基于所述眼用相容溶液的总重量,约0.005wt.%至约2wt.%的透明质酸或其盐;(b)基于所述眼用相容溶液的总重量,约0.01wt.%至约1wt.%的赤藓糖醇;(c)氯化钠、氯化钾或其任何组合;以及(d)一种或多种缓冲液。
34.根据权利要求33所述的方法,其中所述透明质酸或其盐的重均分子量在约100,000至约3,000,000道尔顿(Da)的范围内。
35.根据权利要求33或34所述的方法,其中所述眼用相容溶液包括:基于所述眼用相容溶液的总重量,约0.01wt.%至约0.2wt.%的透明质酸或其盐;以及基于所述眼用相容溶液的总重量,约0.05wt.%至约0.5wt.%的赤藓糖醇。
36.根据权利要求33或34所述的方法,其中所述眼用相容溶液包括:基于所述眼用相容溶液的总重量,约0.01wt.%至约5wt.%的氯化钠、氯化钾或其任何组合;以及约0.1%至约10%(w/w)的所述一种或多种缓冲液。
37.根据权利要求33至36所述的方法,其中所述一种或多种缓冲液包括硼酸或其盐。
38.根据权利要求33至37所述的方法,其中所述眼用相容溶液包括:
(a)基于所述眼用相容溶液的总重量,约0.01wt.%至约0.2wt.%的透明质酸或其盐;
(b)基于所述眼用相容溶液的总重量,约0.05wt.%至约0.5wt.%的赤藓糖醇;以及
(c)基于所述眼用相容溶液的总重量,约0.01wt.%至约1wt.%的氯化钠、氯化钾或其任何组合。
39.根据权利要求33至37所述的方法,其中所述眼用相容溶液包括:
(a)基于所述眼用相容溶液的总重量,约0.01wt.%至约0.2wt.%的透明质酸或其盐;
(b)基于所述眼用相容溶液的总重量,约0.08wt.%至约0.4wt.%的赤藓糖醇;以及
(c)基于所述眼用相容溶液的总重量,约0.01wt.%至约0.08wt.%的氯化钠、氯化钾或其任何组合。
40.根据权利要求33所述的方法,其中所述眼用相容溶液包括透明质酸钠、赤藓糖醇、氯化钾、硼酸和硼酸钠。
41.根据权利要求40所述的方法,其中所述眼用相容溶液包括:
(a)基于所述眼用相容溶液的总重量,约0.01wt.%至约0.2wt.%的透明质酸钠;
(b)基于所述眼用相容溶液的总重量,约0.05wt.%至约0.5wt.%的赤藓糖醇;
(c)基于所述眼用相容溶液的总重量,约0.01wt.%至约1wt.%的氯化钾;以及
(d)约0.1%至约10%(w/w)的硼酸和硼酸钠。
42.根据权利要求33至41所述的方法,其中所述眼用相容溶液进一步包括一种或多种润滑剂。
43.根据权利要求33至41所述的方法,其中所述眼用相容溶液进一步包括基于所述眼用相容溶液的总重量,约0.01wt.%至约5wt.%的一种或多种润滑剂。
44.根据权利要求33至41所述的方法,其中所述眼用相容溶液进一步包括基于所述眼用相容溶液的总重量,约0.01wt.%至约1wt.%的一种或多种润滑剂。
45.根据权利要求42至44所述的方法,其中所述一种或多种润滑剂包括甘油。
46.根据权利要求33至45所述的方法,其中所述眼用相容溶液呈滴眼液的形式。
47.根据权利要求33至46所述的方法,其中所述眼用相容溶液不含表面活性剂。
48.根据权利要求33至46所述的方法,其中所述眼用相容溶液不含非离子表面活性剂。
49.一种能用作人工泪液或用于重新润湿或润滑角膜的系统,所述系统包括液滴分配器,所述液滴分配器能够容纳约1ml至约30ml的眼用相容溶液,所述眼用相容溶液包括(a)基于所述眼用相容溶液的总重量,约0.005wt.%至约2wt.%的透明质酸或其盐;(b)基于所述眼用相容溶液的总重量,约0.01wt.%至约1wt.%的赤藓糖醇;(c)氯化钠、氯化钾或其任何组合;以及(d)一种或多种缓冲液。
50.根据权利要求49所述的系统,其中所述透明质酸或其盐的重均分子量在约100,000至约3,000,000道尔顿(Da)的范围内。
51.根据权利要求49或50所述的系统,其中所述眼用相容溶液包括:基于所述眼用相容溶液的总重量,约0.01wt.%至约0.2wt.%的透明质酸或其盐;以及基于所述眼用相容溶液的总重量,约0.05wt.%至约0.5wt.%的赤藓糖醇。
52.根据权利要求49或50所述的系统,其中所述眼用相容溶液包括:基于所述眼用相容溶液的总重量,约0.01wt.%至约5wt.%的氯化钠、氯化钾或其任何组合;以及约0.1%至约10%(w/w)的所述一种或多种缓冲液。
53.根据权利要求49至52所述的系统,其中所述一种或多种缓冲液包括硼酸或其盐。
54.根据权利要求49至53所述的系统,其中所述眼用相容溶液包括:
(a)基于所述眼用相容溶液的总重量,约0.01wt.%至约0.2wt.%的透明质酸或其盐;
(b)基于所述眼用相容溶液的总重量,约0.05wt.%至约0.5wt.%的赤藓糖醇;以及
(c)基于所述眼用相容溶液的总重量,约0.01wt.%至约1wt.%的氯化钠、氯化钾或其任何组合。
55.根据权利要求49至53所述的系统,其中所述眼用相容溶液包括:
(a)基于所述眼用相容溶液的总重量,约0.01wt.%至约0.2wt.%的透明质酸或其盐;
(b)基于所述眼用相容溶液的总重量,约0.08wt.%至约0.4wt.%的赤藓糖醇;以及
(c)基于所述眼用相容溶液的总重量,约0.01wt.%至约0.08wt.%的氯化钠、氯化钾或其任何组合。
56.根据权利要求49所述的系统,其中所述眼用相容溶液包括透明质酸钠、赤藓糖醇、氯化钾、硼酸和硼酸钠。
57.根据权利要求56所述的系统,其中所述眼用相容溶液包括:
(a)基于所述眼用相容溶液的总重量,约0.01wt.%至约0.2wt.%的透明质酸钠;
(b)基于所述眼用相容溶液的总重量,约0.05wt.%至约0.5wt.%的赤藓糖醇;
(c)基于所述眼用相容溶液的总重量,约0.01wt.%至约1wt.%的氯化钾;以及
(d)约0.1%至约10%(w/w)的硼酸和硼酸钠。
58.根据权利要求49至57所述的系统,其中所述眼用相容溶液进一步包括一种或多种润滑剂。
59.根据权利要求49至57所述的系统,其中所述眼用相容溶液进一步包括基于所述眼用相容溶液的总重量,约0.01wt.%至约5wt.%的一种或多种润滑剂。
60.根据权利要求49至57所述的系统,其中所述眼用相容溶液进一步包括基于所述眼用相容溶液的总重量,约0.01wt.%至约1wt.%的一种或多种润滑剂。
61.根据权利要求58至60所述的系统,其中所述一种或多种润滑剂包括甘油。
62.根据权利要求49至61所述的系统,其中所述眼用相容溶液呈滴眼液的形式。
63.根据权利要求49至62所述的系统,其中所述眼用相容溶液不含表面活性剂。
64.根据权利要求49至63所述的系统,其中所述眼用相容溶液不含非离子表面活性剂。
65.一种根据权利要求1至16所述的眼用相容溶液的用途,其用于重新润湿角膜。
66.一种根据权利要求1至16所述的眼用相容溶液的用途,其用于减少、改善、治疗或控制患者的干眼症。
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US20220290072A1 (en) | 2022-09-15 |
BR112023017725A2 (pt) | 2023-10-03 |
US20220290073A1 (en) | 2022-09-15 |
JP2024508961A (ja) | 2024-02-28 |
CA3212315A1 (en) | 2022-09-15 |
MX2023010375A (es) | 2023-09-12 |
EP4305142A1 (en) | 2024-01-17 |
EP4305143A1 (en) | 2024-01-17 |
MX2023010373A (es) | 2023-09-12 |
CN116981761A (zh) | 2023-10-31 |
MX2023010372A (es) | 2023-09-12 |
WO2022189557A1 (en) | 2022-09-15 |
AU2022231886A1 (en) | 2023-09-14 |
BR112023017376A2 (pt) | 2023-10-03 |
US11944638B2 (en) | 2024-04-02 |
CA3212309A1 (en) | 2022-09-15 |
WO2022189548A1 (en) | 2022-09-15 |
WO2022189552A1 (en) | 2022-09-15 |
KR20230156932A (ko) | 2023-11-15 |
JP2024509214A (ja) | 2024-02-29 |
KR20230156748A (ko) | 2023-11-14 |
US20220288107A1 (en) | 2022-09-15 |
AU2022233951A1 (en) | 2023-09-14 |
EP4304555A1 (en) | 2024-01-17 |
CN116940662A (zh) | 2023-10-24 |
JP2024508986A (ja) | 2024-02-28 |
KR20230156747A (ko) | 2023-11-14 |
AU2022235192A1 (en) | 2023-09-14 |
US20240189342A1 (en) | 2024-06-13 |
BR112023017375A2 (pt) | 2023-10-03 |
CA3212305A1 (en) | 2022-09-15 |
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