JP6322737B2 - 水性眼科組成物 - Google Patents
水性眼科組成物 Download PDFInfo
- Publication number
- JP6322737B2 JP6322737B2 JP2017019837A JP2017019837A JP6322737B2 JP 6322737 B2 JP6322737 B2 JP 6322737B2 JP 2017019837 A JP2017019837 A JP 2017019837A JP 2017019837 A JP2017019837 A JP 2017019837A JP 6322737 B2 JP6322737 B2 JP 6322737B2
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- JP
- Japan
- Prior art keywords
- ophthalmic composition
- aqueous ophthalmic
- component
- castor oil
- present
- Prior art date
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- FPIPGXGPPPQFEQ-OVSJKPMPSA-N all-trans-retinol Chemical compound OC\C=C(/C)\C=C\C=C(/C)\C=C\C1=C(C)CCCC1(C)C FPIPGXGPPPQFEQ-OVSJKPMPSA-N 0.000 claims description 64
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- VLARUOGDXDTHEH-UHFFFAOYSA-L disodium cromoglycate Chemical compound [Na+].[Na+].O1C(C([O-])=O)=CC(=O)C2=C1C=CC=C2OCC(O)COC1=CC=CC2=C1C(=O)C=C(C([O-])=O)O2 VLARUOGDXDTHEH-UHFFFAOYSA-L 0.000 description 1
- CEYULKASIQJZGP-UHFFFAOYSA-L disodium;2-(carboxymethyl)-2-hydroxybutanedioate Chemical compound [Na+].[Na+].[O-]C(=O)CC(O)(C(=O)O)CC([O-])=O CEYULKASIQJZGP-UHFFFAOYSA-L 0.000 description 1
- 238000009826 distribution Methods 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 238000001035 drying Methods 0.000 description 1
- 229960002534 ephedrine hydrochloride Drugs 0.000 description 1
- 229960003072 epinephrine hydrochloride Drugs 0.000 description 1
- 235000020774 essential nutrients Nutrition 0.000 description 1
- 150000002148 esters Chemical class 0.000 description 1
- 229960004756 ethanol Drugs 0.000 description 1
- BEFDCLMNVWHSGT-UHFFFAOYSA-N ethenylcyclopentane Chemical compound C=CC1CCCC1 BEFDCLMNVWHSGT-UHFFFAOYSA-N 0.000 description 1
- 238000001914 filtration Methods 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 238000005187 foaming Methods 0.000 description 1
- 230000008014 freezing Effects 0.000 description 1
- 238000007710 freezing Methods 0.000 description 1
- IPCSVZSSVZVIGE-UHFFFAOYSA-M hexadecanoate Chemical compound CCCCCCCCCCCCCCCC([O-])=O IPCSVZSSVZVIGE-UHFFFAOYSA-M 0.000 description 1
- 229920001903 high density polyethylene Polymers 0.000 description 1
- 239000004700 high-density polyethylene Substances 0.000 description 1
- 230000036571 hydration Effects 0.000 description 1
- 238000006703 hydration reaction Methods 0.000 description 1
- 239000000017 hydrogel Substances 0.000 description 1
- 239000001257 hydrogen Substances 0.000 description 1
- 229910052739 hydrogen Inorganic materials 0.000 description 1
- 230000002209 hydrophobic effect Effects 0.000 description 1
- 235000019447 hydroxyethyl cellulose Nutrition 0.000 description 1
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 description 1
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 description 1
- 229920003088 hydroxypropyl methyl cellulose Polymers 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
- 239000007924 injection Substances 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 150000007529 inorganic bases Chemical class 0.000 description 1
- 229910017053 inorganic salt Inorganic materials 0.000 description 1
- 238000007689 inspection Methods 0.000 description 1
- 230000005722 itchiness Effects 0.000 description 1
- 229960003630 ketotifen fumarate Drugs 0.000 description 1
- YNQQEYBLVYAWNX-WLHGVMLRSA-N ketotifen fumarate Chemical compound OC(=O)\C=C\C(O)=O.C1CN(C)CCC1=C1C2=CC=CC=C2CC(=O)C2=C1C=CS2 YNQQEYBLVYAWNX-WLHGVMLRSA-N 0.000 description 1
- 229940010454 licorice Drugs 0.000 description 1
- 229940040452 linolenate Drugs 0.000 description 1
- DTOSIQBPPRVQHS-PDBXOOCHSA-M linolenate Chemical compound CC\C=C/C\C=C/C\C=C/CCCCCCCC([O-])=O DTOSIQBPPRVQHS-PDBXOOCHSA-M 0.000 description 1
- 239000004325 lysozyme Substances 0.000 description 1
- 235000010335 lysozyme Nutrition 0.000 description 1
- 229960000274 lysozyme Drugs 0.000 description 1
- 229910052749 magnesium Inorganic materials 0.000 description 1
- 239000011777 magnesium Substances 0.000 description 1
- ZLNQQNXFFQJAID-UHFFFAOYSA-L magnesium carbonate Chemical compound [Mg+2].[O-]C([O-])=O ZLNQQNXFFQJAID-UHFFFAOYSA-L 0.000 description 1
- 239000001095 magnesium carbonate Substances 0.000 description 1
- 229910000021 magnesium carbonate Inorganic materials 0.000 description 1
- 235000014380 magnesium carbonate Nutrition 0.000 description 1
- 229910052943 magnesium sulfate Inorganic materials 0.000 description 1
- 235000019341 magnesium sulphate Nutrition 0.000 description 1
- 229940091250 magnesium supplement Drugs 0.000 description 1
- VZCYOOQTPOCHFL-UPHRSURJSA-N maleic acid Chemical compound OC(=O)\C=C/C(O)=O VZCYOOQTPOCHFL-UPHRSURJSA-N 0.000 description 1
- HEBKCHPVOIAQTA-UHFFFAOYSA-N meso ribitol Natural products OCC(O)C(O)C(O)CO HEBKCHPVOIAQTA-UHFFFAOYSA-N 0.000 description 1
- 229910052751 metal Inorganic materials 0.000 description 1
- 239000002184 metal Substances 0.000 description 1
- 150000002739 metals Chemical class 0.000 description 1
- 229920000609 methyl cellulose Polymers 0.000 description 1
- 125000002496 methyl group Chemical group [H]C([H])([H])* 0.000 description 1
- 239000001923 methylcellulose Substances 0.000 description 1
- 235000010981 methylcellulose Nutrition 0.000 description 1
- 229940051020 methylephedrine hydrochloride Drugs 0.000 description 1
- 235000019691 monocalcium phosphate Nutrition 0.000 description 1
- 150000002762 monocarboxylic acid derivatives Chemical class 0.000 description 1
- HWPKGOGLCKPRLZ-UHFFFAOYSA-M monosodium citrate Chemical compound [Na+].OC(=O)CC(O)(C([O-])=O)CC(O)=O HWPKGOGLCKPRLZ-UHFFFAOYSA-M 0.000 description 1
- 239000002524 monosodium citrate Substances 0.000 description 1
- 235000018342 monosodium citrate Nutrition 0.000 description 1
- TZBAVQKIEKDGFH-UHFFFAOYSA-N n-[2-(diethylamino)ethyl]-1-benzothiophene-2-carboxamide;hydrochloride Chemical compound [Cl-].C1=CC=C2SC(C(=O)NCC[NH+](CC)CC)=CC2=C1 TZBAVQKIEKDGFH-UHFFFAOYSA-N 0.000 description 1
- 229960005016 naphazoline Drugs 0.000 description 1
- 229960004760 naphazoline hydrochloride Drugs 0.000 description 1
- 229930014626 natural product Natural products 0.000 description 1
- 150000002823 nitrates Chemical class 0.000 description 1
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 description 1
- WWZKQHOCKIZLMA-UHFFFAOYSA-N octanoic acid Chemical compound CCCCCCCC(O)=O WWZKQHOCKIZLMA-UHFFFAOYSA-N 0.000 description 1
- 229940023490 ophthalmic product Drugs 0.000 description 1
- 239000002997 ophthalmic solution Substances 0.000 description 1
- 229940054534 ophthalmic solution Drugs 0.000 description 1
- 150000007530 organic bases Chemical class 0.000 description 1
- VGTPKLINSHNZRD-UHFFFAOYSA-N oxoborinic acid Chemical compound OB=O VGTPKLINSHNZRD-UHFFFAOYSA-N 0.000 description 1
- 150000002926 oxygen Chemical class 0.000 description 1
- 229960001257 oxyquinoline sulfate Drugs 0.000 description 1
- 229940101267 panthenol Drugs 0.000 description 1
- 235000020957 pantothenol Nutrition 0.000 description 1
- 239000011619 pantothenol Substances 0.000 description 1
- 229960004439 pemirolast Drugs 0.000 description 1
- HIANJWSAHKJQTH-UHFFFAOYSA-N pemirolast Chemical compound CC1=CC=CN(C2=O)C1=NC=C2C=1N=NNN=1 HIANJWSAHKJQTH-UHFFFAOYSA-N 0.000 description 1
- WVDDGKGOMKODPV-ZQBYOMGUSA-N phenyl(114C)methanol Chemical compound O[14CH2]C1=CC=CC=C1 WVDDGKGOMKODPV-ZQBYOMGUSA-N 0.000 description 1
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 description 1
- 239000010452 phosphate Substances 0.000 description 1
- 230000000704 physical effect Effects 0.000 description 1
- 229920003207 poly(ethylene-2,6-naphthalate) Polymers 0.000 description 1
- 229920001230 polyarylate Polymers 0.000 description 1
- 229920000728 polyester Polymers 0.000 description 1
- 229920001223 polyethylene glycol Polymers 0.000 description 1
- 239000011112 polyethylene naphthalate Substances 0.000 description 1
- 229940093158 polyhexanide Drugs 0.000 description 1
- 229920001721 polyimide Polymers 0.000 description 1
- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 description 1
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 description 1
- 235000010483 polyoxyethylene sorbitan monopalmitate Nutrition 0.000 description 1
- 239000000249 polyoxyethylene sorbitan monopalmitate Substances 0.000 description 1
- 235000010989 polyoxyethylene sorbitan monostearate Nutrition 0.000 description 1
- 239000001818 polyoxyethylene sorbitan monostearate Substances 0.000 description 1
- 235000010988 polyoxyethylene sorbitan tristearate Nutrition 0.000 description 1
- 239000001816 polyoxyethylene sorbitan tristearate Substances 0.000 description 1
- 229920001296 polysiloxane Polymers 0.000 description 1
- 229940068977 polysorbate 20 Drugs 0.000 description 1
- 229940101027 polysorbate 40 Drugs 0.000 description 1
- 229940113124 polysorbate 60 Drugs 0.000 description 1
- 229940099511 polysorbate 65 Drugs 0.000 description 1
- 229920002451 polyvinyl alcohol Polymers 0.000 description 1
- 239000001267 polyvinylpyrrolidone Substances 0.000 description 1
- 229920000036 polyvinylpyrrolidone Polymers 0.000 description 1
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 description 1
- 229960003975 potassium Drugs 0.000 description 1
- 229910052700 potassium Inorganic materials 0.000 description 1
- 239000011591 potassium Substances 0.000 description 1
- 235000011056 potassium acetate Nutrition 0.000 description 1
- 239000011736 potassium bicarbonate Substances 0.000 description 1
- 235000015497 potassium bicarbonate Nutrition 0.000 description 1
- 229910000028 potassium bicarbonate Inorganic materials 0.000 description 1
- 229910000027 potassium carbonate Inorganic materials 0.000 description 1
- 235000011181 potassium carbonates Nutrition 0.000 description 1
- 239000001508 potassium citrate Substances 0.000 description 1
- 229960002635 potassium citrate Drugs 0.000 description 1
- QEEAPRPFLLJWCF-UHFFFAOYSA-K potassium citrate (anhydrous) Chemical compound [K+].[K+].[K+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O QEEAPRPFLLJWCF-UHFFFAOYSA-K 0.000 description 1
- 235000011082 potassium citrates Nutrition 0.000 description 1
- TYJJADVDDVDEDZ-UHFFFAOYSA-M potassium hydrogencarbonate Chemical compound [K+].OC([O-])=O TYJJADVDDVDEDZ-UHFFFAOYSA-M 0.000 description 1
- 229940086066 potassium hydrogencarbonate Drugs 0.000 description 1
- LWIHDJKSTIGBAC-UHFFFAOYSA-K potassium phosphate Substances [K+].[K+].[K+].[O-]P([O-])([O-])=O LWIHDJKSTIGBAC-UHFFFAOYSA-K 0.000 description 1
- 235000010241 potassium sorbate Nutrition 0.000 description 1
- 239000004302 potassium sorbate Substances 0.000 description 1
- 229940069338 potassium sorbate Drugs 0.000 description 1
- JVUYWILPYBCNNG-UHFFFAOYSA-N potassium;oxido(oxo)borane Chemical compound [K+].[O-]B=O JVUYWILPYBCNNG-UHFFFAOYSA-N 0.000 description 1
- 229960003101 pranoprofen Drugs 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- 230000002335 preservative effect Effects 0.000 description 1
- 230000001737 promoting effect Effects 0.000 description 1
- 235000010409 propane-1,2-diol alginate Nutrition 0.000 description 1
- 239000000770 propane-1,2-diol alginate Substances 0.000 description 1
- 125000001436 propyl group Chemical group [H]C([*])([H])C([H])([H])C([H])([H])[H] 0.000 description 1
- 235000013772 propylene glycol Nutrition 0.000 description 1
- 125000004805 propylene group Chemical group [H]C([H])([H])C([H])([*:1])C([H])([H])[*:2] 0.000 description 1
- 238000000746 purification Methods 0.000 description 1
- ZUFQODAHGAHPFQ-UHFFFAOYSA-N pyridoxine hydrochloride Chemical compound Cl.CC1=NC=C(CO)C(CO)=C1O ZUFQODAHGAHPFQ-UHFFFAOYSA-N 0.000 description 1
- 229960004172 pyridoxine hydrochloride Drugs 0.000 description 1
- 235000019171 pyridoxine hydrochloride Nutrition 0.000 description 1
- 239000011764 pyridoxine hydrochloride Substances 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 230000029058 respiratory gaseous exchange Effects 0.000 description 1
- HFHDHCJBZVLPGP-UHFFFAOYSA-N schardinger α-dextrin Chemical compound O1C(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(O)C2O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC2C(O)C(O)C1OC2CO HFHDHCJBZVLPGP-UHFFFAOYSA-N 0.000 description 1
- 239000008159 sesame oil Substances 0.000 description 1
- 235000011803 sesame oil Nutrition 0.000 description 1
- 239000000741 silica gel Substances 0.000 description 1
- 229910002027 silica gel Inorganic materials 0.000 description 1
- 229910052708 sodium Inorganic materials 0.000 description 1
- 239000011734 sodium Substances 0.000 description 1
- 235000010413 sodium alginate Nutrition 0.000 description 1
- 239000000661 sodium alginate Substances 0.000 description 1
- 229940005550 sodium alginate Drugs 0.000 description 1
- WXMKPNITSTVMEF-UHFFFAOYSA-M sodium benzoate Chemical compound [Na+].[O-]C(=O)C1=CC=CC=C1 WXMKPNITSTVMEF-UHFFFAOYSA-M 0.000 description 1
- 239000004299 sodium benzoate Substances 0.000 description 1
- 235000010234 sodium benzoate Nutrition 0.000 description 1
- 229960003885 sodium benzoate Drugs 0.000 description 1
- 229910000030 sodium bicarbonate Inorganic materials 0.000 description 1
- 235000017557 sodium bicarbonate Nutrition 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
- 235000011083 sodium citrates Nutrition 0.000 description 1
- 235000019259 sodium dehydroacetate Nutrition 0.000 description 1
- 229940079839 sodium dehydroacetate Drugs 0.000 description 1
- 229940010747 sodium hyaluronate Drugs 0.000 description 1
- 229940079827 sodium hydrogen sulfite Drugs 0.000 description 1
- 235000010267 sodium hydrogen sulphite Nutrition 0.000 description 1
- 239000001488 sodium phosphate Substances 0.000 description 1
- 235000010265 sodium sulphite Nutrition 0.000 description 1
- AKHNMLFCWUSKQB-UHFFFAOYSA-L sodium thiosulfate Chemical compound [Na+].[Na+].[O-]S([O-])(=O)=S AKHNMLFCWUSKQB-UHFFFAOYSA-L 0.000 description 1
- 235000019345 sodium thiosulphate Nutrition 0.000 description 1
- DSOWAKKSGYUMTF-GZOLSCHFSA-M sodium;(1e)-1-(6-methyl-2,4-dioxopyran-3-ylidene)ethanolate Chemical compound [Na+].C\C([O-])=C1/C(=O)OC(C)=CC1=O DSOWAKKSGYUMTF-GZOLSCHFSA-M 0.000 description 1
- 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 description 1
- 230000003381 solubilizing effect Effects 0.000 description 1
- 235000010199 sorbic acid Nutrition 0.000 description 1
- 239000004334 sorbic acid Substances 0.000 description 1
- 229940075582 sorbic acid Drugs 0.000 description 1
- 229960002920 sorbitol Drugs 0.000 description 1
- 230000000087 stabilizing effect Effects 0.000 description 1
- 230000001954 sterilising effect Effects 0.000 description 1
- 238000004659 sterilization and disinfection Methods 0.000 description 1
- 238000003756 stirring Methods 0.000 description 1
- KDYFGRWQOYBRFD-UHFFFAOYSA-L succinate(2-) Chemical compound [O-]C(=O)CCC([O-])=O KDYFGRWQOYBRFD-UHFFFAOYSA-L 0.000 description 1
- 229960005404 sulfamethoxazole Drugs 0.000 description 1
- BDHFUVZGWQCTTF-UHFFFAOYSA-M sulfonate Chemical compound [O-]S(=O)=O BDHFUVZGWQCTTF-UHFFFAOYSA-M 0.000 description 1
- 239000002600 sunflower oil Substances 0.000 description 1
- 230000001629 suppression Effects 0.000 description 1
- 229940095064 tartrate Drugs 0.000 description 1
- 229940021790 tetrahydrozoline hydrochloride Drugs 0.000 description 1
- BJORNXNYWNIWEY-UHFFFAOYSA-N tetrahydrozoline hydrochloride Chemical compound Cl.N1CCN=C1C1C2=CC=CC=C2CCC1 BJORNXNYWNIWEY-UHFFFAOYSA-N 0.000 description 1
- 229940042585 tocopherol acetate Drugs 0.000 description 1
- JOXIMZWYDAKGHI-UHFFFAOYSA-N toluene-4-sulfonic acid Chemical compound CC1=CC=C(S(O)(=O)=O)C=C1 JOXIMZWYDAKGHI-UHFFFAOYSA-N 0.000 description 1
- 235000010487 tragacanth Nutrition 0.000 description 1
- 239000000196 tragacanth Substances 0.000 description 1
- 229940116362 tragacanth Drugs 0.000 description 1
- WYXIGTJNYDDFFH-UHFFFAOYSA-Q triazanium;borate Chemical compound [NH4+].[NH4+].[NH4+].[O-]B([O-])[O-] WYXIGTJNYDDFFH-UHFFFAOYSA-Q 0.000 description 1
- 235000013337 tricalcium citrate Nutrition 0.000 description 1
- LENZDBCJOHFCAS-UHFFFAOYSA-N tris Chemical compound OCC(N)(CO)CO LENZDBCJOHFCAS-UHFFFAOYSA-N 0.000 description 1
- BSVBQGMMJUBVOD-UHFFFAOYSA-N trisodium borate Chemical compound [Na+].[Na+].[Na+].[O-]B([O-])[O-] BSVBQGMMJUBVOD-UHFFFAOYSA-N 0.000 description 1
- RYFMWSXOAZQYPI-UHFFFAOYSA-K trisodium phosphate Chemical compound [Na+].[Na+].[Na+].[O-]P([O-])([O-])=O RYFMWSXOAZQYPI-UHFFFAOYSA-K 0.000 description 1
- 229910000406 trisodium phosphate Inorganic materials 0.000 description 1
- 235000019801 trisodium phosphate Nutrition 0.000 description 1
- NCYCYZXNIZJOKI-UHFFFAOYSA-N vitamin A aldehyde Natural products O=CC=C(C)C=CC=C(C)C=CC1=C(C)CCCC1(C)C NCYCYZXNIZJOKI-UHFFFAOYSA-N 0.000 description 1
- 239000008215 water for injection Substances 0.000 description 1
- 239000000811 xylitol Substances 0.000 description 1
- 235000010447 xylitol Nutrition 0.000 description 1
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 description 1
- 229960002675 xylitol Drugs 0.000 description 1
- 239000004711 α-olefin Substances 0.000 description 1
Classifications
-
- 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
- A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
- A61K31/07—Retinol compounds, e.g. vitamin A
-
- 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
- A61K31/69—Boron 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
- A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0048—Eye, e.g. artificial tears
-
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/02—Nutrients, e.g. vitamins, minerals
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Engineering & Computer Science (AREA)
- Organic Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Ophthalmology & Optometry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Obesity (AREA)
- Hematology (AREA)
- Diabetes (AREA)
- Nutrition Science (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Eyeglasses (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines Containing Plant Substances (AREA)
Description
項1-1.(A) 酸化エチレンの付加モル数が2〜30であるポリオキシエチレンヒマシ油と、(B) ヒマシ油及びビタミンAからなる群より選択される少なくとも一種を含む、水性眼科組成物。
項1-2.(A)成分が、酸化エチレンの平均付加モル数が2〜12であるポリオキシエチレンヒマシ油である、項1-1に記載の水性眼科組成物。
項1-3.水性眼科組成物の総量を基準として、(A)成分の総含有量が0.0005〜5w/v%である、項1-1又は1-2に記載の水性眼科組成物。
項1-4.水性眼科組成物の総量を基準として、(B)成分の総含有量が0.0001〜5w/v%である、項1-1乃至1-3のいずれかに記載の水性眼科組成物。
項1-5.水性眼科組成物の総量を基準として、ビタミンAの総含有量が200〜5000000IU/100mLである、項1-1乃至1-4のいずれかに記載の水性眼科組成物。
項1-6.(A)成分の総含有量1重量部に対して、(B)成分の総含有量が0.00002〜10000重量部である、項1-1乃至1-5のいずれかに記載の水性眼科組成物。
項1-7. 更に、ホウ酸及びその塩からなる群から選択される少なくとも一種(以下、「(C)成分」ということがある)を含有する、項1-1乃至1-6のいずれかに記載の水性眼科組成物。
項1-8.水性眼科組成物の総量を基準として、(C)成分の総含有量が0.01〜10w/v%である、項1-7に記載の水性眼科組成物。
項1-9.更に緩衝剤を含有する項1-1乃至1-8いずれかに記載の水性眼科組成物。
項1-10. 更に(A)成分以外の非イオン性界面活性剤を含有する、項1-1乃至1-9のいずれかに記載の水性眼科組成物。
項1-11.(A)成分以外の非イオン性界面活性剤が、ポリオキシエチレンソルビタン脂肪酸エステル、ポリオキシエチレン硬化ヒマシ油、30を上回る酸化エチレンの付加モル数のポリオキシエチレンヒマシ油、及びポリオキシエチレン・ポリオキシプロピレン・ブロックコポリマーからなる群より選択される少なくとも一種である、項1-10に記載の水性眼科組成物。
項1-12.水性眼科組成物の総量を基準として、(A)成分以外の非イオン性界面活性剤の総含有量が0.001〜3w/v%である、項1-10又は1-11に記載の水性眼科組成物。
項1-13. 更に、等張化剤を含有する、項1-1乃至項1-12のいずれかに記載の水性眼科組成物。
項1-14. 等張化剤が、グリセリン、プロピレングリコール、ブドウ糖、塩化ナトリウム、塩化カリウム、塩化カルシウム、及び塩化マグネシウムからなる群より選択される少なくとも一種である、項1-13に記載の水性眼科組成物。
項1-15. 水性眼科組成物の総量を基準として、等張化剤の総含有量が0.005〜10w/v%である、項1-13又は1-14に記載の水性眼科組成物。
項1-16. 更に、グリセリン及び(A)成分以外の非イオン性界面活性剤からなる群より選択される少なくとも一種(以下、(「(D)成分」ということがある)を含有する、項1-1乃至1-9のいずれかに記載の水性眼科組成物。
項1-17.(D)成分が、グリセリン、ポリオキシエチレンソルビタン脂肪酸エステル、ポリオキシエチレン硬化ヒマシ油、ポリオキシエチレン硬化ヒマシ油、30を上回る酸化エチレンの付加モル数のポリオキシエチレンヒマシ油及びポリオキシエチレン・ポリオキシプロピレン・ブロックコポリマーからなる群より選択される少なくとも一種である、項1-16に記載の水性眼科組成物。
項1-18.水性眼科組成物の総量を基準として、(D)成分の総含有量が0.01〜10w/v%である、項1-16又は1-17に記載の水性眼科組成物。
項1-19.(B)成分の総含有量1重量部に対して、(A)成分及び(D)成分の総含有量が2〜50000重量部である、項1-16乃至1-18のいずれかに記載の水性眼科組成物。
項1-20.ポリエチレンテレフタレート製容器に充填されてなる、項1-1乃至1-19のいずれかに記載の水性眼科組成物。
項1-21.ポリエチレン製ノズルが装着された容器に充填されてなる、項1-1乃至1-20のいずれかに記載の水性眼科組成物。
項1-22.点眼剤である項1-1乃至1-21のいずれかに記載の水性眼科組成物。
項1-23.洗眼剤である項1-1乃至1-21のいずれかに記載の水性眼科組成物。
項1-24.コンタクトレンズ装着液である項1-1乃至1-21のいずれかに記載の水性眼科組成物。
項1-25.コンタクトレンズケア用剤である項1-1乃至1-21のいずれかに記載の水性眼科組成物。
項2.(A) 酸化エチレンの付加モル数が2〜30であるポリオキシエチレンヒマシ油と、(B) ヒマシ油及びビタミンAからなる群より選択される少なくとも一種を、水性眼科組成物に配合することを含む、該水性眼科組成物における消泡時間を短縮させる方法。
項3.(A) 酸化エチレンの付加モル数が2〜30であるポリオキシエチレンヒマシ油を含有する水性眼科組成物に、(B) ヒマシ油及びビタミンAからなる群より選択される少なくとも一種を配合することを含む、該水性眼科組成物における消泡時間を短縮させる方法。
項4.(A) 酸化エチレンの付加モル数が2〜30であるポリオキシエチレンヒマシ油と、(B) ヒマシ油及びビタミンAからなる群より選択される少なくとも一種を、水性眼科組成物に配合することを含む、該水性眼科組成物における使用時の滴下量のバラツキを抑制する方法。
項5. (A) 酸化エチレンの付加モル数が2〜30であるポリオキシエチレンヒマシ油、(B) ヒマシ油及びビタミンAからなる群より選択される少なくとも一種、並びに(D)グリセリン及び(A)成分以外の非イオン性界面活性剤からなる群より選択される少なくとも一種を、水性眼科組成物に配合することを含む、該水性眼科組成物の澄明性を向上させる方法。
項6. 水性眼科組成物の製造のための、(A) 酸化エチレンの付加モル数が2〜30であるポリオキシエチレンヒマシ油と、(B) ヒマシ油及びビタミンAからなる群より選択される少なくとも一種の使用。
項7. 水性眼科組成物が、上記項1-1乃至1-25のいずれかに記載の組成物である、項6に記載の使用。
項8. 水性眼科組成物としての、(A) 酸化エチレンの付加モル数が2〜30であるポリオキシエチレンヒマシ油と、(B) ヒマシ油及びビタミンAからなる群より選択される少なくとも一種を含む組成物の使用。
項9. 組成物が、上記項1-1乃至1-25のいずれかに記載の組成物である、項8に記載の使用。
項10. 水性眼科組成物としての使用のための、(A) 酸化エチレンの付加モル数が2〜30であるポリオキシエチレンヒマシ油と、(B) ヒマシ油及びビタミンAからなる群より選択される少なくとも一種を含む組成物。
項11. 上記項1-1乃至1-25のいずれかに記載されたものである、項10に記載の組成物。
項12. 水を含む担体に、(A) 酸化エチレンの付加モル数が2〜30であるポリオキシエチレンヒマシ油と、(B) ヒマシ油及びビタミンAからなる群より選択される少なくとも一種を添加することを含む、水性眼科組成物の製造方法。
項13. 水性眼科組成物が、上記項1-1乃至1-25のいずれかに記載の組成物である、項12に記載の製造方法。
本発明の水性眼科組成物は、酸化エチレンの平均付加モル数が2〜30であるポリオキシエチレンヒマシ油((A)成分)を含有するものである。これを、後述するヒマシ油及びビタミンAからなる群より選択される少なくとも一種と併用することによって、上記した本発明の優れた効果が発揮される。
油類:ゴマ油等。
前述したように、本発明の水性眼科組成物では、(A)成分及び(B)成分を含有させることによって、水性眼科組成物において消泡時間を短縮させることができ、更にその結果、使用時の滴下量のバラツキを抑制することができる。
前述したように、本発明の水性眼科組成物では、(A)成分及び(B)成分に加えて、(A)成分以外の非イオン性界面活性剤及びグリセリンからなる群より選択される少なくとも一種((D)成分)を含有させることによって、澄明性を大きく向上させ、水性眼科組成物として好ましい品質、外観を有するものとすることができる。その結果、水性眼科組成物の製造時における溶解確認又は異物確認を短時間で行うことが可能となり、製造効率を改善することができる。
下記表1〜表3に示す組成の水性眼科組成物を常法により調製し、これらを用いて、消泡時間を評価した。ポリオキシエチレンヒマシ油10としては、医薬品添加物規格2003のポリオキシエチレンヒマシ油の規格に適合する酸化エチレンの平均付加モル数が10のものを用い、ヒマシ油としては、WAKO製のものを用いた。
なお、対応するコントロールとは、具体的には、実施例1−1、1−2についてはコントロール1、実施例2−1、2−2についてはコントロール2、実施例3−1についてはコントロール3、実施例4−1についてはコントロール4である。結果を表1〜表3に併せて示す。
下記表4〜表6に示す組成の水性眼科組成物を常法により調製し、消泡時間を評価した。ビタミンA油としては、ビタミンAであるパルミチン酸レチノールを55重量%とヒマワリ油を45重量%含有するものであり、ビタミンAの量に関する国際単位であるIUに換算すると、100万I U/gのものを用いた。ポリオキシエチレンヒマシ油10としては試験例1と同じものを用いた。
なお、対応するコントロールとは、具体的には、実施例5−1、5−2についてはコントロール5、実施例6−1、6−2についてはコントロール6、実施例7−1についてはコントロール7、実施例8−1、8−2についてはコントロール8、実施例9−1についてはコントロール9、実施例10−1、10−2についてはコントロール10である。結果を表4〜表6に併せて示す。
下記表7及び表8に示す組成の水性眼科組成物を常法により調製し、消泡時間を評価した。ポリオキシエチレンヒマシ油35としては、医薬品添加物規格2003のポリオキシエチレンヒマシ油の規格に適合する酸化エチレンの平均付加モル数が35のものを用いた。ヒマシ油としては、試験例1と同じものを用い、ビタミンA油としては、試験例2と同じものを用いた。
なお、対応するコントロールとは、具体的には、比較例1についてはコントロール11、比較例2については12、比較例3、4についてはコントロール13である。結果を表7及び表8に併せて示す。
下記表9〜表12に示す組成の水性眼科組成物を常法により調製し、これらを用いて、澄明性を評価した。ポリオキシエチレンヒマシ油10及びヒマシ油としては、試験例1と同じものを用いた。
A0は蒸留水の吸光度、Aは各水性眼科組成物の吸光度を示す。
<澄明性の評価基準>
a:透過率が95%以上
b:透過率が90%以上95%未満
c:透過率が85%以上90%未満
d:透過率が75%以上85%未満
e:透過率が75%未満
表13及び表14に記載の処方で、点眼剤(製剤例1−8)、洗眼剤(製剤例9及び10)、並びにソフトコンタクトレンズ用点眼剤(製剤例11)が調製される。尚、パルミチン酸レチノールは、和光純薬工業(株)製 ビタミンAパルミタート(90万〜105万IU/g)である。
Claims (11)
- (A)酸化エチレンの平均付加モル数が2〜12であるポリオキシエチレンヒマシ油と、(B)ビタミンAと、を含む、水性眼科組成物。
- 水性眼科組成物の総量を基準として、(A)成分の総含有量が0.0005〜5w/v%である、請求項1に記載の水性眼科組成物。
- 水性眼科組成物の総量を基準として、(B)成分の総含有量が0.0001〜5w/v%である、請求項1又は2に記載の水性眼科組成物。
- 水性眼科組成物の総量を基準として、(B)成分の総含有量が200〜5000000IU/100mLである、請求項1〜3のいずれか1項に記載の水性眼科組成物。
- (A)成分の総含有量1重量部に対して、(B)成分の総含有量が0.00002〜10000重量部である、請求項1〜4のいずれか1項に記載の水性眼科組成物。
- 更に、(C)ホウ酸及びその塩からなる群から選択される少なくとも一種、を含有する、請求項1〜5のいずれか1項に記載の水性眼科組成物。
- 更に、(D)グリセリン及び(A)成分以外の非イオン性界面活性剤からなる群より選択される少なくとも一種、を含有する、請求項1〜6のいずれか1項に記載の水性眼科組成物。
- (B)成分の総含有量1重量部に対して、(A)成分及び(D)成分の総含有量が2〜50000重量部である、請求項7に記載の水性眼科組成物。
- 点眼剤である、請求項1〜8のいずれか1項に記載の水性眼科組成物。
- (A)酸化エチレンの平均付加モル数が2〜12であるポリオキシエチレンヒマシ油と、(B)ビタミンAと、を水性眼科組成物に配合することを含む、該水性眼科組成物における消泡時間を短縮させる方法。
- (A)酸化エチレンの平均付加モル数が2〜12であるポリオキシエチレンヒマシ油と、(B)ビタミンAと、を水性眼科組成物に配合することを含む、該水性眼科組成物における使用時の滴下量のバラツキを抑制する方法。
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