JP6091780B2 - 水性眼科組成物 - Google Patents
水性眼科組成物 Download PDFInfo
- Publication number
- JP6091780B2 JP6091780B2 JP2012153510A JP2012153510A JP6091780B2 JP 6091780 B2 JP6091780 B2 JP 6091780B2 JP 2012153510 A JP2012153510 A JP 2012153510A JP 2012153510 A JP2012153510 A JP 2012153510A JP 6091780 B2 JP6091780 B2 JP 6091780B2
- Authority
- JP
- Japan
- Prior art keywords
- ophthalmic composition
- aqueous ophthalmic
- castor oil
- pantothenic acid
- polyoxyethylene castor
- 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.)
- Active
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- 239000000203 mixture Substances 0.000 title claims description 311
- -1 polyoxyethylene Polymers 0.000 claims description 194
- 229920003171 Poly (ethylene oxide) Polymers 0.000 claims description 126
- 239000004359 castor oil Substances 0.000 claims description 118
- 235000019438 castor oil Nutrition 0.000 claims description 117
- ZEMPKEQAKRGZGQ-XOQCFJPHSA-N glycerol triricinoleate Natural products CCCCCC[C@@H](O)CC=CCCCCCCCC(=O)OC[C@@H](COC(=O)CCCCCCCC=CC[C@@H](O)CCCCCC)OC(=O)CCCCCCCC=CC[C@H](O)CCCCCC ZEMPKEQAKRGZGQ-XOQCFJPHSA-N 0.000 claims description 117
- GHOKWGTUZJEAQD-ZETCQYMHSA-N (D)-(+)-Pantothenic acid Chemical compound OCC(C)(C)[C@@H](O)C(=O)NCCC(O)=O GHOKWGTUZJEAQD-ZETCQYMHSA-N 0.000 claims description 99
- 150000003839 salts Chemical class 0.000 claims description 74
- 238000000034 method Methods 0.000 claims description 60
- GHOKWGTUZJEAQD-UHFFFAOYSA-N Chick antidermatitis factor Natural products OCC(C)(C)C(O)C(=O)NCCC(O)=O GHOKWGTUZJEAQD-UHFFFAOYSA-N 0.000 claims description 51
- 235000019161 pantothenic acid Nutrition 0.000 claims description 51
- 239000011713 pantothenic acid Substances 0.000 claims description 51
- 229940055726 pantothenic acid Drugs 0.000 claims description 51
- VWWQXMAJTJZDQX-UYBVJOGSSA-N flavin adenine dinucleotide Chemical compound C1=NC2=C(N)N=CN=C2N1[C@@H]([C@H](O)[C@@H]1O)O[C@@H]1CO[P@](O)(=O)O[P@@](O)(=O)OC[C@@H](O)[C@@H](O)[C@@H](O)CN1C2=NC(=O)NC(=O)C2=NC2=C1C=C(C)C(C)=C2 VWWQXMAJTJZDQX-UYBVJOGSSA-N 0.000 claims description 46
- 235000019162 flavin adenine dinucleotide Nutrition 0.000 claims description 44
- 239000011714 flavin adenine dinucleotide Substances 0.000 claims description 44
- 229940093632 flavin-adenine dinucleotide Drugs 0.000 claims description 44
- SNPLKNRPJHDVJA-ZETCQYMHSA-N D-panthenol Chemical compound OCC(C)(C)[C@@H](O)C(=O)NCCCO SNPLKNRPJHDVJA-ZETCQYMHSA-N 0.000 claims description 27
- 238000002156 mixing Methods 0.000 claims description 25
- 235000015112 vegetable and seed oil Nutrition 0.000 claims description 15
- 239000008158 vegetable oil Substances 0.000 claims description 15
- 229940101267 panthenol Drugs 0.000 claims description 14
- 235000020957 pantothenol Nutrition 0.000 claims description 14
- 239000011619 pantothenol Substances 0.000 claims description 14
- 239000008159 sesame oil Substances 0.000 claims description 8
- 235000011803 sesame oil Nutrition 0.000 claims description 8
- MRAMPOPITCOOIN-VIFPVBQESA-N (2r)-n-(3-ethoxypropyl)-2,4-dihydroxy-3,3-dimethylbutanamide Chemical compound CCOCCCNC(=O)[C@H](O)C(C)(C)CO MRAMPOPITCOOIN-VIFPVBQESA-N 0.000 claims description 5
- ZNXZGRMVNNHPCA-UHFFFAOYSA-N pantetheine Chemical compound OCC(C)(C)C(O)C(=O)NCCC(=O)NCCS ZNXZGRMVNNHPCA-UHFFFAOYSA-N 0.000 claims description 5
- KNGQILZSJUUYIK-VIFPVBQESA-N [(2R)-4-hydroxy-3,3-dimethyl-1-oxo-1-[[3-oxo-3-(2-sulfanylethylamino)propyl]amino]butan-2-yl] dihydrogen phosphate Chemical compound OCC(C)(C)[C@@H](OP(O)(O)=O)C(=O)NCCC(=O)NCCS KNGQILZSJUUYIK-VIFPVBQESA-N 0.000 claims description 4
- DJWYOLJPSHDSAL-UHFFFAOYSA-N Pantethine Natural products OCC(C)(C)C(O)C(=O)NCCC(=O)NCCSSCCNC(=O)CCNC(=O)C(O)C(C)(C)CO DJWYOLJPSHDSAL-UHFFFAOYSA-N 0.000 claims 3
- 229960001948 caffeine Drugs 0.000 claims 3
- DJWYOLJPSHDSAL-ROUUACIJSA-N pantethine Chemical compound OCC(C)(C)[C@@H](O)C(=O)NCCC(=O)NCCSSCCNC(=O)CCNC(=O)[C@H](O)C(C)(C)CO DJWYOLJPSHDSAL-ROUUACIJSA-N 0.000 claims 3
- 235000008975 pantethine Nutrition 0.000 claims 3
- 239000011581 pantethine Substances 0.000 claims 3
- 229960000903 pantethine Drugs 0.000 claims 3
- RYYVLZVUVIJVGH-UHFFFAOYSA-N trimethylxanthine Natural products CN1C(=O)N(C)C(=O)C2=C1N=CN2C RYYVLZVUVIJVGH-UHFFFAOYSA-N 0.000 claims 3
- 235000002639 sodium chloride Nutrition 0.000 description 87
- RMRCNWBMXRMIRW-BYFNXCQMSA-M cyanocobalamin Chemical compound N#C[Co+]N([C@]1([H])[C@H](CC(N)=O)[C@]\2(CCC(=O)NC[C@H](C)OP(O)(=O)OC3[C@H]([C@H](O[C@@H]3CO)N3C4=CC(C)=C(C)C=C4N=C3)O)C)C/2=C(C)\C([C@H](C/2(C)C)CCC(N)=O)=N\C\2=C\C([C@H]([C@@]/2(CC(N)=O)C)CCC(N)=O)=N\C\2=C(C)/C2=N[C@]1(C)[C@@](C)(CC(N)=O)[C@@H]2CCC(N)=O RMRCNWBMXRMIRW-BYFNXCQMSA-M 0.000 description 60
- 150000002948 pantothenic acids Chemical class 0.000 description 42
- 235000000639 cyanocobalamin Nutrition 0.000 description 30
- 239000011666 cyanocobalamin Substances 0.000 description 30
- 229960002104 cyanocobalamin Drugs 0.000 description 30
- 239000003889 eye drop Substances 0.000 description 28
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 26
- 230000000694 effects Effects 0.000 description 25
- IAYPIBMASNFSPL-UHFFFAOYSA-N Ethylene oxide Chemical compound C1CO1 IAYPIBMASNFSPL-UHFFFAOYSA-N 0.000 description 24
- 238000012360 testing method Methods 0.000 description 24
- 238000003860 storage Methods 0.000 description 23
- 229940012356 eye drops Drugs 0.000 description 21
- 238000009472 formulation Methods 0.000 description 20
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 14
- 239000004094 surface-active agent Substances 0.000 description 14
- 239000000872 buffer Substances 0.000 description 13
- 230000002708 enhancing effect Effects 0.000 description 13
- XLRHXNIVIZZOON-WFUPGROFSA-L Flavin adenine dinucleotide disodium Chemical compound [Na+].[Na+].C1=NC2=C(N)N=CN=C2N1[C@@H]([C@H](O)[C@@H]1O)O[C@@H]1COP([O-])(=O)OP([O-])(=O)OC[C@@H](O)[C@@H](O)[C@@H](O)CN1C2=NC(=O)NC(=O)C2=NC2=C1C=C(C)C(C)=C2 XLRHXNIVIZZOON-WFUPGROFSA-L 0.000 description 12
- FDJOLVPMNUYSCM-UVKKECPRSA-L cobalt(3+);[(2r,3s,4r,5s)-5-(5,6-dimethylbenzimidazol-1-yl)-4-hydroxy-2-(hydroxymethyl)oxolan-3-yl] [(2r)-1-[3-[(2r,3r,4z,7s,9z,12s,13s,14z,17s,18s,19r)-2,13,18-tris(2-amino-2-oxoethyl)-7,12,17-tris(3-amino-3-oxopropyl)-3,5,8,8,13,15,18,19-octamethyl-2,7, Chemical compound [Co+3].N#[C-].C1([C@H](CC(N)=O)[C@@]2(C)CCC(=O)NC[C@@H](C)OP([O-])(=O)O[C@H]3[C@H]([C@H](O[C@@H]3CO)N3C4=CC(C)=C(C)C=C4N=C3)O)[N-]\C2=C(C)/C([C@H](C\2(C)C)CCC(N)=O)=N/C/2=C\C([C@H]([C@@]/2(CC(N)=O)C)CCC(N)=O)=N\C\2=C(C)/C2=N[C@]1(C)[C@@](C)(CC(N)=O)[C@@H]2CCC(N)=O FDJOLVPMNUYSCM-UVKKECPRSA-L 0.000 description 12
- 230000000052 comparative effect Effects 0.000 description 12
- 238000004519 manufacturing process Methods 0.000 description 11
- 239000002736 nonionic surfactant Substances 0.000 description 11
- 239000003755 preservative agent Substances 0.000 description 11
- 230000006872 improvement Effects 0.000 description 10
- 239000006260 foam Substances 0.000 description 9
- 230000002335 preservative effect Effects 0.000 description 9
- 150000001875 compounds Chemical class 0.000 description 8
- 238000007796 conventional method Methods 0.000 description 8
- 239000000463 material Substances 0.000 description 8
- 230000003204 osmotic effect Effects 0.000 description 8
- 229920000139 polyethylene terephthalate Polymers 0.000 description 8
- 239000005020 polyethylene terephthalate Substances 0.000 description 8
- 238000004090 dissolution Methods 0.000 description 7
- 239000000047 product Substances 0.000 description 7
- 238000004904 shortening Methods 0.000 description 7
- 239000011780 sodium chloride Substances 0.000 description 7
- 241000894006 Bacteria Species 0.000 description 6
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 6
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 6
- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical compound OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 description 6
- 239000004698 Polyethylene Substances 0.000 description 6
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 description 6
- RWRDLPDLKQPQOW-UHFFFAOYSA-N Pyrrolidine Chemical compound C1CCNC1 RWRDLPDLKQPQOW-UHFFFAOYSA-N 0.000 description 6
- ZMANZCXQSJIPKH-UHFFFAOYSA-N Triethylamine Chemical compound CCN(CC)CC ZMANZCXQSJIPKH-UHFFFAOYSA-N 0.000 description 6
- 239000000654 additive Substances 0.000 description 6
- 229910052783 alkali metal Inorganic materials 0.000 description 6
- 229910052784 alkaline earth metal Inorganic materials 0.000 description 6
- KGBXLFKZBHKPEV-UHFFFAOYSA-N boric acid Chemical compound OB(O)O KGBXLFKZBHKPEV-UHFFFAOYSA-N 0.000 description 6
- 239000006172 buffering agent Substances 0.000 description 6
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 6
- 238000012790 confirmation Methods 0.000 description 6
- 239000007951 isotonicity adjuster Substances 0.000 description 6
- 229920000573 polyethylene Polymers 0.000 description 6
- 238000004321 preservation Methods 0.000 description 6
- 239000000243 solution Substances 0.000 description 6
- JNYAEWCLZODPBN-JGWLITMVSA-N (2r,3r,4s)-2-[(1r)-1,2-dihydroxyethyl]oxolane-3,4-diol Chemical compound OC[C@@H](O)[C@H]1OC[C@H](O)[C@H]1O JNYAEWCLZODPBN-JGWLITMVSA-N 0.000 description 5
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 5
- 239000002253 acid Substances 0.000 description 5
- 239000004480 active ingredient Substances 0.000 description 5
- 239000004327 boric acid Substances 0.000 description 5
- 239000000470 constituent Substances 0.000 description 5
- 238000004128 high performance liquid chromatography Methods 0.000 description 5
- 239000007788 liquid Substances 0.000 description 5
- 238000006303 photolysis reaction Methods 0.000 description 5
- 239000008213 purified water Substances 0.000 description 5
- 239000002904 solvent Substances 0.000 description 5
- 238000005979 thermal decomposition reaction Methods 0.000 description 5
- BTBUEUYNUDRHOZ-UHFFFAOYSA-N Borate Chemical group [O-]B([O-])[O-] BTBUEUYNUDRHOZ-UHFFFAOYSA-N 0.000 description 4
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 description 4
- BAVYZALUXZFZLV-UHFFFAOYSA-N Methylamine Chemical compound NC BAVYZALUXZFZLV-UHFFFAOYSA-N 0.000 description 4
- YNAVUWVOSKDBBP-UHFFFAOYSA-N Morpholine Chemical compound C1COCCN1 YNAVUWVOSKDBBP-UHFFFAOYSA-N 0.000 description 4
- GLUUGHFHXGJENI-UHFFFAOYSA-N Piperazine Chemical compound C1CNCCN1 GLUUGHFHXGJENI-UHFFFAOYSA-N 0.000 description 4
- 229920001214 Polysorbate 60 Polymers 0.000 description 4
- WCUXLLCKKVVCTQ-UHFFFAOYSA-M Potassium chloride Chemical compound [Cl-].[K+] WCUXLLCKKVVCTQ-UHFFFAOYSA-M 0.000 description 4
- CDBYLPFSWZWCQE-UHFFFAOYSA-L Sodium Carbonate Chemical compound [Na+].[Na+].[O-]C([O-])=O CDBYLPFSWZWCQE-UHFFFAOYSA-L 0.000 description 4
- 239000003795 chemical substances by application Substances 0.000 description 4
- 239000011521 glass Substances 0.000 description 4
- 150000007529 inorganic bases Chemical class 0.000 description 4
- 230000002093 peripheral effect Effects 0.000 description 4
- 239000008363 phosphate buffer Substances 0.000 description 4
- 229920003023 plastic Polymers 0.000 description 4
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- VZCYOOQTPOCHFL-UHFFFAOYSA-N trans-butenedioic acid Natural products OC(=O)C=CC(O)=O VZCYOOQTPOCHFL-UHFFFAOYSA-N 0.000 description 4
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 description 3
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 description 3
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 description 3
- CKLJMWTZIZZHCS-REOHCLBHSA-N L-aspartic acid Chemical compound OC(=O)[C@@H](N)CC(O)=O CKLJMWTZIZZHCS-REOHCLBHSA-N 0.000 description 3
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- 235000014113 dietary fatty acids Nutrition 0.000 description 3
- BNIILDVGGAEEIG-UHFFFAOYSA-L disodium hydrogen phosphate Chemical compound [Na+].[Na+].OP([O-])([O-])=O BNIILDVGGAEEIG-UHFFFAOYSA-L 0.000 description 3
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- DRGAZIDRYFYHIJ-UHFFFAOYSA-N 2,2':6',2''-terpyridine Chemical compound N1=CC=CC=C1C1=CC=CC(C=2N=CC=CC=2)=N1 DRGAZIDRYFYHIJ-UHFFFAOYSA-N 0.000 description 2
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- 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
- WTWSHHITWMVLBX-DKWTVANSSA-M sodium;(2s)-2-aminobutanedioate;hydron Chemical compound [Na+].[O-]C(=O)[C@@H](N)CC(O)=O WTWSHHITWMVLBX-DKWTVANSSA-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
- GEYJUFBPCGDENK-UHFFFAOYSA-M sodium;3,8-dimethyl-5-propan-2-ylazulene-1-sulfonate Chemical compound [Na+].CC(C)C1=CC=C(C)C2=C(S([O-])(=O)=O)C=C(C)C2=C1 GEYJUFBPCGDENK-UHFFFAOYSA-M 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
- 239000003549 soybean oil Substances 0.000 description 1
- 235000012424 soybean oil Nutrition 0.000 description 1
- 238000013112 stability test Methods 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
- KDYFGRWQOYBRFD-UHFFFAOYSA-N succinic acid Chemical class OC(=O)CCC(O)=O KDYFGRWQOYBRFD-UHFFFAOYSA-N 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
- JLKIGFTWXXRPMT-UHFFFAOYSA-N sulphamethoxazole Chemical compound O1C(C)=CC(NS(=O)(=O)C=2C=CC(N)=CC=2)=N1 JLKIGFTWXXRPMT-UHFFFAOYSA-N 0.000 description 1
- 239000002600 sunflower oil Substances 0.000 description 1
- 230000001502 supplementing effect Effects 0.000 description 1
- 230000001629 suppression Effects 0.000 description 1
- XOAAWQZATWQOTB-UHFFFAOYSA-N taurine Chemical compound NCCS(O)(=O)=O XOAAWQZATWQOTB-UHFFFAOYSA-N 0.000 description 1
- 238000010998 test method Methods 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
- 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
- IYKMDRMCUIFHRA-UHFFFAOYSA-H tripotassium;trisodium;2-hydroxypropane-1,2,3-tricarboxylate;hydrate Chemical compound O.[Na+].[Na+].[Na+].[K+].[K+].[K+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O.[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O IYKMDRMCUIFHRA-UHFFFAOYSA-H 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
- 229960004791 tropicamide Drugs 0.000 description 1
- 229940088594 vitamin Drugs 0.000 description 1
- 229930003231 vitamin Natural products 0.000 description 1
- 235000013343 vitamin Nutrition 0.000 description 1
- 239000011782 vitamin Substances 0.000 description 1
- 235000019156 vitamin B Nutrition 0.000 description 1
- 239000011720 vitamin B Substances 0.000 description 1
- 239000008215 water for injection Substances 0.000 description 1
- 239000010497 wheat germ oil 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
- 239000011576 zinc lactate Substances 0.000 description 1
- 235000000193 zinc lactate Nutrition 0.000 description 1
- 229940050168 zinc lactate Drugs 0.000 description 1
- NWONKYPBYAMBJT-UHFFFAOYSA-L zinc sulfate Chemical compound [Zn+2].[O-]S([O-])(=O)=O NWONKYPBYAMBJT-UHFFFAOYSA-L 0.000 description 1
- 229960001763 zinc sulfate Drugs 0.000 description 1
- 229910000368 zinc sulfate Inorganic materials 0.000 description 1
- 239000004711 α-olefin Substances 0.000 description 1
Landscapes
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Description
項1-1.(A) ポリオキシエチレンヒマシ油と、(B)フラビンアデニンジヌクレオチド、ビタミンB12類、パントテン酸、パントテン酸誘導体及びそれらの塩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2〜70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. (A)成分が、酸化エチレンの平均付加モル数が2〜35であるポリオキシエチレンヒマシ油である、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、(A) 成分の総含有量が0.0005〜5w/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、(B)成分の総含有量が0.0001〜2w/v%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0.00002〜5000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.(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0.0005〜20重量部である、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.更に、植物油を含有する項1-1乃至項1-7のいずれかに記載の水性眼科組成物。
項1-9.植物油が、ゴマ油及びヒマシ油からなる群より選択される少なくとも一種である、項1-8に記載の水性眼科組成物。
項1-10 水性眼科組成物の総量を基準として、植物油の総含有量が0.0001〜5w/v%である、項1-8又は1-9に記載の水性眼科組成物。
項1-11.更に緩衝剤を含有する、項1-1乃至1-10のいずれかに記載の水性眼科組成物。
項1-12.緩衝剤がホウ酸緩衝剤である、項1-11に記載の水性眼科組成物。
項1-13.水性眼科組成物の総量を基準として、緩衝剤の総含有量が0.01〜15w/v%である、項1-11又は1-12に記載の水性眼科組成物。
項1-14. 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1-13のいずれかに記載の水性眼科組成物。
項1-15.(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、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1種である、項1-14に記載の水性眼科組成物。
項1-16.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1-14又は1-15に記載の水性眼科組成物。
項1-17.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1-16のいずれかに記載の水性眼科組成物。
項1-18.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1-17のいずれかに記載の水性眼科組成物。
項1-19.点眼剤である項1-1乃至1-18のいずれかに記載の水性眼科組成物。
項1-20.洗眼剤である項1-1乃至1-18のいずれかに記載の水性眼科組成物。
項1-21.コンタクトレンズ装着液である項1-1乃至1-18のいずれかに記載の水性眼科組成物。
項1-22.コンタクトレンズケア用剤である項1-1乃至1-18のいずれかに記載の水性眼科組成物。
項2. (A) 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) フラビンアデニンジヌクレオチド、ビタミンB12類、パントテン酸、パントテン酸誘導体及びそれらの塩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光安定性を向上させる方法。
項3. (A) ポリオキシエチレンヒマシ油、並びに(B) フラビンアデニンジヌクレオチド、ビタミンB12類、パントテン酸、パントテン酸誘導体及びそれらの塩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中に配合することを含む、該水性眼科組成物における光安定性を向上させる方法。
項4. (B) フラビンアデニンジヌクレオチド、ビタミンB12類、パントテン酸、パントテン酸誘導体及びそれらの塩からなる群より選択される少なくとも一種を含有する水性眼科組成物に、(A)ポリオキシエチレンヒマシ油を配合することを含む、該水性眼科組成物における熱安定性を向上させる方法。
項5. (A) ポリオキシエチレンヒマシ油、並びに(B) フラビンアデニンジヌクレオチド、ビタミンB12類、パントテン酸、パントテン酸誘導体及びそれらの塩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中に配合することを含む、該水性眼科組成物における熱安定性を向上させる方法。
項6. (A) ポリオキシエチレンヒマシ油と、(B) フラビンアデニンジヌクレオチド、ビタミンB12類、パントテン酸、パントテン酸誘導体及びそれらの塩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7. (A)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) フラビンアデニンジヌクレオチド、ビタミンB12類、パントテン酸、パントテン酸誘導体及びそれらの塩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8. (A) ポリオキシエチレンヒマシ油と、(B) フラビンアデニンジヌクレオチド、ビタミンB12類、パントテン酸、パントテン酸誘導体及びそれらの塩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9. (A) ポリオキシエチレンヒマシ油と、(B) フラビンアデニンジヌクレオチド、ビタミンB12類、パントテン酸、パントテン酸誘導体及びそれらの塩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保存効力を増強する方法。
項10. 水性眼科組成物の製造のための、(A) ポリオキシエチレンヒマシ油、並びに(B) フラビンアデニンジヌクレオチド、ビタミンB12類、パントテン酸、パントテン酸誘導体及びそれらの塩からなる群より選択される少なくとも一種の使用。
項11. 水性眼科組成物が、上記項1-1乃至1-22のいずれかに記載の組成物である、項10に記載の使用。
項12. 水性眼科組成物としての、(A) ポリオキシエチレンヒマシ油、並びに(B) フラビンアデニンジヌクレオチド、ビタミンB12類、パントテン酸、パントテン酸誘導体及びそれらの塩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13. 組成物が、上記項1-1乃至1-22のいずれかに記載の組成物である、項12に記載の使用。
項14. 水性眼科組成物としての使用のための、(A) ポリオキシエチレンヒマシ油、並びに(B) フラビンアデニンジヌクレオチド、ビタミンB12類、パントテン酸、パントテン酸誘導体及びそれらの塩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15. 上記項1-1乃至1-22のいずれかに記載されたものである、項14に記載の組成物。
項16. 水を含む担体に、(A) ポリオキシエチレンヒマシ油、並びに(B) フラビンアデニンジヌクレオチド、ビタミンB12類、パントテン酸、パントテン酸誘導体及びそれらの塩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17. 水性眼科組成物が、上記項1-1乃至1-22のいずれかに記載の組成物である、項16に記載の製造方法。
(1)本発明によれば、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おいて、光を晒した場合に生じ易いポリオキシエチレンヒマシ油の光分解を抑制することができる。よって、本発明の水性眼科組成物は、安全性や品質を低下させることなく、ポリオキシエチレンヒマシ油の有する優れた性能を長期間安定して発揮することができる。
(2)本発明によれば、フラビンアデニンジヌクレオチド、ビタミンB12類、パントテン酸、パントテン酸誘導体及びそれらの塩からなる群より選択される少なくとも一種((B)成分)を含有する水性眼科組成物において、加熱した状態で保存する場合に生じ易い(B)成分の熱分解を抑制することができる。よって、本発明の水性眼科組成物は、安全性や品質を低下させることなく、(B)成分の有する優れた性能を長期間安定して発揮することができる。
(3)本発明によれば、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おける消泡時間を短縮させることができる。その結果、水性眼科組成物の製造時の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。更に、消泡時間が短縮されることにより、滴下量のバラツキをも抑制することができる。
(4)本発明の水性眼科組成物は、保存効力が増強されている。このため、菌汚染に対して特に高い安全性が要求される眼科分野においても、使用時の水性眼科組成物の汚染、及び微生物感染症のリスク等を低減できる。
本発明の水性眼科組成物は、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、フラビンアデニンジヌクレオチド、ビタミンB12類、パントテン酸、パントテン酸誘導体及びそれらの塩からなる群より選択される少なくとも一種((B)成分)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。
前述した通り、水性眼科組成物中に、(A) ポリオキシエチレンヒマシ油と共に、(B) フラビンアデニンジヌクレオチド、ビタミンB12類、パントテン酸、パントテン酸誘導体及びそれらの塩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によって、該水性眼科組成物に含まれる(A)成分の光分解を抑制することができる。
前述した通り、水性眼科組成物中に、(A) ポリオキシエチレンヒマシ油と共に、(B) フラビンアデニンジヌクレオチド、ビタミンB12類、パントテン酸、パントテン酸誘導体及びそれらの塩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によって、(B)成分を含有する水性眼科組成物を加熱した状態で保存する場合に生じ易い (B)成分の熱分解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)成分を併用することによって、(A)成分を含有する水性眼科組成物における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。
また、前述したように、(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保存効力を増強させることができる。
下記表1に示す水性眼科組成物を常法により調製し、光安定性を評価した。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。フラビンアデニンジヌクレオチドナトリウムとしては、第十六改正日本薬局方の規格に適合するものを用い、シアノコバラミンとしては、WAKO製のものを用い、パンテノールとしては、日本薬局方外医薬品規格に適合するものを用いた。ゴマ油としては、SIGMA製のものを用いた。
更には、次式を用いて、光安定性改善率(%)を算出した。算出の結果を表1に併せて示す。
下記表2に示す水性眼科組成物を常法により調製し、光安定性を評価した。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のものを用いた。フラビンアデニンジヌクレオチドナトリウム、シアノコバラミン、及びパンテノールとしては、試験例1と同じものを用いた。
更には、次式を用いて、光安定性改善率(%)を算出した。算出の結果を表2に併せて示す。
下記表3に示す組成の水性眼科組成物を常法により調製し、熱安定性を評価した。なお、ポリオキシエチレンヒマシ油10、ポリオキシエチレンヒマシ油35、及びフラビンアデニンジヌクレオチドナトリウムとしては、試験例1及び2と同じものを用いた。
更には、次式を用いて、熱安定性改善率(%)を算出した。算出の結果を表3に併せて示す。
下記表4に示す組成の水性眼科組成物を常法により調製し、熱安定性を評価した。ポリオキシエチレンヒマシ油10、ポリオキシエチレンヒマシ油35、及びシアノコバラミンとしては、試験例1及び2と同じものを用いた。
更には、次式を用いて、熱安定性改善率(%)を算出した。算出の結果を表4に併せて示す。
下記表5に示す組成の水性眼科組成物を常法により調製し、熱安定性を評価した。ポリオキシエチレンヒマシ油10、ポリオキシエチレンヒマシ油35、及びパンテノールとしては、試験例1及び2と同じものを用いた。
更には、次式を用いて、熱安定性改善率(%)を算出した。算出の結果を表5に併せて示す。
下記表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。ポリオキシエチレンヒマシ油35及びシアノコバラミンとしては、試験例1と同じものを用いた。
下記表7に示す組成の水性眼科組成物を常法により調製し、保存効力を評価した。ポリオキシエチレンヒマシ油35及びシアノコバラミンとしては試験例1と同じものを用いた。
表8及び表9に記載の処方で、点眼剤(製剤例1−6)、洗眼剤(製剤例7)、並びにソフトコンタクトレンズ用点眼剤(製剤例8)が調製される。
Claims (5)
- (A)ポリオキシエチレンヒマシ油と、(B)フラビンアデニンジヌクレオチド、ビタミンB12類、パントテン酸、パンテノール、パントテニルアルコール、パントテニルエチルエーテル、パンテテインパントテニルアルコール、アセチルパントテニルエチルエーテル、ベンゾイルパントテニルエチルエーテル、ジカルボエトキシパントテン酸エチルエステル、パンテテイン、パンテチン、ホスホパンテテイン及びそれらの塩からなる群より選択される少なくとも一種を含有する水性眼科組成物。
- 更に、(A)成分以外の植物油を含有する、請求項1に記載の水性眼科組成物。
- 植物油が、ゴマ油及びヒマシ油からなる群より選択される少なくとも一種である、請求項2に記載の水性眼科組成物。
- (A)ポリオキシエチレンヒマシ油と、(B)フラビンアデニンジヌクレオチド、ビタミンB12類、パントテン酸、パンテノール、パントテニルアルコール、パントテニルエチルエーテル、パンテテインパントテニルアルコール、アセチルパントテニルエチルエーテル、ベンゾイルパントテニルエチルエーテル、ジカルボエトキシパントテン酸エチルエステル、パンテテイン、パンテチン、ホスホパンテテイン及びそれらの塩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(A)成分の光安定性を向上させる方法。
- (A)ポリオキシエチレンヒマシ油と、(B)フラビンアデニンジヌクレオチド、ビタミンB12類、パントテン酸、パンテノール、パントテニルアルコール、パントテニルエチルエーテル、パンテテインパントテニルアルコール、アセチルパントテニルエチルエーテル、ベンゾイルパントテニルエチルエーテル、ジカルボエトキシパントテン酸エチルエステル、パンテテイン、パンテチン、ホスホパンテテイン及びそれらの塩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(B)成分の熱安定性を向上させる方法。
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