JP7021301B2 - 無菌眼用水性プロピオン酸フルチカゾンa型ナノ結晶懸濁液の調製方法 - Google Patents
無菌眼用水性プロピオン酸フルチカゾンa型ナノ結晶懸濁液の調製方法 Download PDFInfo
- Publication number
- JP7021301B2 JP7021301B2 JP2020124238A JP2020124238A JP7021301B2 JP 7021301 B2 JP7021301 B2 JP 7021301B2 JP 2020124238 A JP2020124238 A JP 2020124238A JP 2020124238 A JP2020124238 A JP 2020124238A JP 7021301 B2 JP7021301 B2 JP 7021301B2
- Authority
- JP
- Japan
- Prior art keywords
- weight
- nanocrystals
- fluticasone propionate
- nanosuspension
- type
- 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
Links
- 239000002159 nanocrystal Substances 0.000 title claims description 140
- 238000000034 method Methods 0.000 title claims description 67
- 239000000725 suspension Substances 0.000 title claims description 36
- 229960002714 fluticasone Drugs 0.000 title claims description 33
- MGNNYOODZCAHBA-GQKYHHCASA-N fluticasone Chemical compound C1([C@@H](F)C2)=CC(=O)C=C[C@]1(C)[C@]1(F)[C@@H]2[C@@H]2C[C@@H](C)[C@@](C(=O)SCF)(O)[C@@]2(C)C[C@@H]1O MGNNYOODZCAHBA-GQKYHHCASA-N 0.000 title claims description 33
- XBDQKXXYIPTUBI-UHFFFAOYSA-N dimethylselenoniopropionate Natural products CCC(O)=O XBDQKXXYIPTUBI-UHFFFAOYSA-N 0.000 title claims description 18
- 235000019260 propionic acid Nutrition 0.000 title claims description 9
- IUVKMZGDUIUOCP-BTNSXGMBSA-N quinbolone Chemical compound O([C@H]1CC[C@H]2[C@H]3[C@@H]([C@]4(C=CC(=O)C=C4CC3)C)CC[C@@]21C)C1=CCCC1 IUVKMZGDUIUOCP-BTNSXGMBSA-N 0.000 title claims description 9
- 239000006070 nanosuspension Substances 0.000 claims description 119
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 115
- 229960000289 fluticasone propionate Drugs 0.000 claims description 112
- WMWTYOKRWGGJOA-CENSZEJFSA-N fluticasone propionate Chemical compound C1([C@@H](F)C2)=CC(=O)C=C[C@]1(C)[C@]1(F)[C@@H]2[C@@H]2C[C@@H](C)[C@@](C(=O)SCF)(OC(=O)CC)[C@@]2(C)C[C@@H]1O WMWTYOKRWGGJOA-CENSZEJFSA-N 0.000 claims description 112
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims description 75
- 239000002245 particle Substances 0.000 claims description 58
- 235000011187 glycerol Nutrition 0.000 claims description 48
- XBDQKXXYIPTUBI-UHFFFAOYSA-M Propionate Chemical compound CCC([O-])=O XBDQKXXYIPTUBI-UHFFFAOYSA-M 0.000 claims description 46
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims description 44
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 44
- 210000000744 eyelid Anatomy 0.000 claims description 44
- 239000000243 solution Substances 0.000 claims description 44
- 239000008135 aqueous vehicle Substances 0.000 claims description 41
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 41
- KGBXLFKZBHKPEV-UHFFFAOYSA-N boric acid Chemical compound OB(O)O KGBXLFKZBHKPEV-UHFFFAOYSA-N 0.000 claims description 38
- 239000004327 boric acid Substances 0.000 claims description 38
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims description 37
- 229920000053 polysorbate 80 Polymers 0.000 claims description 37
- 239000003981 vehicle Substances 0.000 claims description 37
- 208000010217 blepharitis Diseases 0.000 claims description 32
- 238000002360 preparation method Methods 0.000 claims description 32
- 229920000609 methyl cellulose Polymers 0.000 claims description 31
- 239000001923 methylcellulose Substances 0.000 claims description 31
- 235000010981 methylcellulose Nutrition 0.000 claims description 31
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims description 30
- 229940068968 polysorbate 80 Drugs 0.000 claims description 30
- 229960000686 benzalkonium chloride Drugs 0.000 claims description 29
- CADWTSSKOVRVJC-UHFFFAOYSA-N benzyl(dimethyl)azanium;chloride Chemical compound [Cl-].C[NH+](C)CC1=CC=CC=C1 CADWTSSKOVRVJC-UHFFFAOYSA-N 0.000 claims description 29
- 238000002156 mixing Methods 0.000 claims description 29
- 239000002002 slurry Substances 0.000 claims description 28
- 239000002055 nanoplate Substances 0.000 claims description 24
- 239000011780 sodium chloride Substances 0.000 claims description 22
- 230000000699 topical effect Effects 0.000 claims description 20
- 239000013078 crystal Substances 0.000 claims description 16
- 208000003556 Dry Eye Syndromes Diseases 0.000 claims description 15
- 238000000634 powder X-ray diffraction Methods 0.000 claims description 15
- 208000024891 symptom Diseases 0.000 claims description 15
- 239000003814 drug Substances 0.000 claims description 14
- 229940079593 drug Drugs 0.000 claims description 13
- 210000000720 eyelash Anatomy 0.000 claims description 13
- 238000001914 filtration Methods 0.000 claims description 13
- 239000007853 buffer solution Substances 0.000 claims description 12
- 239000008194 pharmaceutical composition Substances 0.000 claims description 11
- 230000008569 process Effects 0.000 claims description 11
- 230000001954 sterilising effect Effects 0.000 claims description 11
- 206010065062 Meibomian gland dysfunction Diseases 0.000 claims description 9
- 229920012266 Poly(ether sulfone) PES Polymers 0.000 claims description 9
- 239000008215 water for injection Substances 0.000 claims description 8
- OQAPLBZOHJKLII-UHFFFAOYSA-N O.O.[Na].[Na].[Na].[Na] Chemical compound O.O.[Na].[Na].[Na].[Na] OQAPLBZOHJKLII-UHFFFAOYSA-N 0.000 claims description 7
- 238000004519 manufacturing process Methods 0.000 claims description 7
- 238000000527 sonication Methods 0.000 claims description 7
- FGUUSXIOTUKUDN-IBGZPJMESA-N C1(=CC=CC=C1)N1C2=C(NC([C@H](C1)NC=1OC(=NN=1)C1=CC=CC=C1)=O)C=CC=C2 Chemical compound C1(=CC=CC=C1)N1C2=C(NC([C@H](C1)NC=1OC(=NN=1)C1=CC=CC=C1)=O)C=CC=C2 FGUUSXIOTUKUDN-IBGZPJMESA-N 0.000 claims description 6
- 239000002202 Polyethylene glycol Substances 0.000 claims description 6
- 229920001223 polyethylene glycol Polymers 0.000 claims description 6
- 229920001451 polypropylene glycol Polymers 0.000 claims description 6
- 238000005406 washing Methods 0.000 claims description 6
- GNFTZDOKVXKIBK-UHFFFAOYSA-N 3-(2-methoxyethoxy)benzohydrazide Chemical compound COCCOC1=CC=CC(C(=O)NN)=C1 GNFTZDOKVXKIBK-UHFFFAOYSA-N 0.000 claims description 4
- 239000002253 acid Substances 0.000 claims description 4
- 238000000137 annealing Methods 0.000 claims description 4
- 229920002565 Polyethylene Glycol 400 Polymers 0.000 claims description 3
- 229940068918 polyethylene glycol 400 Drugs 0.000 claims description 3
- BBMHARZCALWXSL-UHFFFAOYSA-M sodium dihydrogenphosphate monohydrate Chemical compound O.[Na+].OP(O)([O-])=O BBMHARZCALWXSL-UHFFFAOYSA-M 0.000 claims description 3
- 238000004659 sterilization and disinfection Methods 0.000 claims description 3
- 239000007979 citrate buffer Substances 0.000 claims description 2
- 238000001816 cooling Methods 0.000 claims description 2
- 238000007865 diluting Methods 0.000 claims description 2
- KDQPSPMLNJTZAL-UHFFFAOYSA-L disodium hydrogenphosphate dihydrate Chemical compound O.O.[Na+].[Na+].OP([O-])([O-])=O KDQPSPMLNJTZAL-UHFFFAOYSA-L 0.000 claims description 2
- 230000036512 infertility Effects 0.000 claims description 2
- 239000007788 liquid Substances 0.000 claims description 2
- 238000009210 therapy by ultrasound Methods 0.000 claims description 2
- ZGTMUACCHSMWAC-UHFFFAOYSA-L EDTA disodium salt (anhydrous) Chemical compound [Na+].[Na+].OC(=O)CN(CC([O-])=O)CCN(CC(O)=O)CC([O-])=O ZGTMUACCHSMWAC-UHFFFAOYSA-L 0.000 claims 6
- 239000003607 modifier Substances 0.000 claims 2
- 239000008177 pharmaceutical agent Substances 0.000 claims 1
- 239000000203 mixture Substances 0.000 description 20
- 238000009826 distribution Methods 0.000 description 17
- 238000003860 storage Methods 0.000 description 13
- 230000002776 aggregation Effects 0.000 description 11
- OVBJJZOQPCKUOR-UHFFFAOYSA-L EDTA disodium salt dihydrate Chemical compound O.O.[Na+].[Na+].[O-]C(=O)C[NH+](CC([O-])=O)CC[NH+](CC([O-])=O)CC([O-])=O OVBJJZOQPCKUOR-UHFFFAOYSA-L 0.000 description 10
- 229940068196 placebo Drugs 0.000 description 9
- 239000000902 placebo Substances 0.000 description 9
- 206010013774 Dry eye Diseases 0.000 description 7
- 238000004220 aggregation Methods 0.000 description 7
- 239000003381 stabilizer Substances 0.000 description 7
- 230000009885 systemic effect Effects 0.000 description 7
- 241000282472 Canis lupus familiaris Species 0.000 description 6
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 description 6
- 230000015572 biosynthetic process Effects 0.000 description 6
- 230000000694 effects Effects 0.000 description 6
- 238000010828 elution Methods 0.000 description 6
- 238000009472 formulation Methods 0.000 description 6
- 238000003756 stirring Methods 0.000 description 6
- 230000000052 comparative effect Effects 0.000 description 5
- 238000000265 homogenisation Methods 0.000 description 5
- 208000002193 Pain Diseases 0.000 description 4
- 238000005054 agglomeration Methods 0.000 description 4
- 238000011156 evaluation Methods 0.000 description 4
- 239000011521 glass Substances 0.000 description 4
- 239000002105 nanoparticle Substances 0.000 description 4
- 239000000546 pharmaceutical excipient Substances 0.000 description 4
- 229920005862 polyol Polymers 0.000 description 4
- 239000000126 substance Substances 0.000 description 4
- VEXZGXHMUGYJMC-UHFFFAOYSA-M Chloride anion Chemical compound [Cl-] VEXZGXHMUGYJMC-UHFFFAOYSA-M 0.000 description 3
- 238000010521 absorption reaction Methods 0.000 description 3
- 239000004480 active ingredient Substances 0.000 description 3
- 239000007900 aqueous suspension Substances 0.000 description 3
- 238000005119 centrifugation Methods 0.000 description 3
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 3
- 150000001875 compounds Chemical class 0.000 description 3
- 239000003246 corticosteroid Substances 0.000 description 3
- 238000000502 dialysis Methods 0.000 description 3
- 239000006185 dispersion Substances 0.000 description 3
- 230000004410 intraocular pressure Effects 0.000 description 3
- 239000000463 material Substances 0.000 description 3
- 239000008188 pellet Substances 0.000 description 3
- 239000008363 phosphate buffer Substances 0.000 description 3
- 238000000746 purification Methods 0.000 description 3
- 238000012360 testing method Methods 0.000 description 3
- BTBUEUYNUDRHOZ-UHFFFAOYSA-N Borate Chemical compound [O-]B([O-])[O-] BTBUEUYNUDRHOZ-UHFFFAOYSA-N 0.000 description 2
- 229920000858 Cyclodextrin Polymers 0.000 description 2
- 241001465754 Metazoa Species 0.000 description 2
- 238000003991 Rietveld refinement Methods 0.000 description 2
- 206010047513 Vision blurred Diseases 0.000 description 2
- 230000004520 agglutination Effects 0.000 description 2
- 238000003556 assay Methods 0.000 description 2
- 230000008901 benefit Effects 0.000 description 2
- 239000000872 buffer Substances 0.000 description 2
- 230000008859 change Effects 0.000 description 2
- 238000002144 chemical decomposition reaction Methods 0.000 description 2
- 239000013024 dilution buffer Substances 0.000 description 2
- 238000007922 dissolution test Methods 0.000 description 2
- -1 hypromerose Substances 0.000 description 2
- 239000012535 impurity Substances 0.000 description 2
- 230000004968 inflammatory condition Effects 0.000 description 2
- 208000027866 inflammatory disease Diseases 0.000 description 2
- 230000007774 longterm Effects 0.000 description 2
- 239000002609 medium Substances 0.000 description 2
- 210000004175 meibomian gland Anatomy 0.000 description 2
- 239000000047 product Substances 0.000 description 2
- 239000008213 purified water Substances 0.000 description 2
- 238000011084 recovery Methods 0.000 description 2
- 238000012216 screening Methods 0.000 description 2
- 230000035807 sensation Effects 0.000 description 2
- 230000000087 stabilizing effect Effects 0.000 description 2
- 238000011200 topical administration Methods 0.000 description 2
- 239000000080 wetting agent Substances 0.000 description 2
- IIZPXYDJLKNOIY-JXPKJXOSSA-N 1-palmitoyl-2-arachidonoyl-sn-glycero-3-phosphocholine Chemical compound CCCCCCCCCCCCCCCC(=O)OC[C@H](COP([O-])(=O)OCC[N+](C)(C)C)OC(=O)CCC\C=C/C\C=C/C\C=C/C\C=C/CCCCC IIZPXYDJLKNOIY-JXPKJXOSSA-N 0.000 description 1
- 206010001382 Adrenal suppression Diseases 0.000 description 1
- 206010006784 Burning sensation Diseases 0.000 description 1
- 208000002177 Cataract Diseases 0.000 description 1
- 206010010741 Conjunctivitis Diseases 0.000 description 1
- 206010010744 Conjunctivitis allergic Diseases 0.000 description 1
- 229920000742 Cotton Polymers 0.000 description 1
- WQZGKKKJIJFFOK-CBPJZXOFSA-N D-Gulose Chemical compound OC[C@H]1OC(O)[C@H](O)[C@H](O)[C@H]1O WQZGKKKJIJFFOK-CBPJZXOFSA-N 0.000 description 1
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 description 1
- 206010015995 Eyelid ptosis Diseases 0.000 description 1
- 208000010412 Glaucoma Diseases 0.000 description 1
- 206010020751 Hypersensitivity Diseases 0.000 description 1
- 229930195725 Mannitol Natural products 0.000 description 1
- 208000006550 Mydriasis Diseases 0.000 description 1
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 description 1
- 241000549556 Nanos Species 0.000 description 1
- XMEKHKCRNHDFOW-UHFFFAOYSA-N O.O.[Na].[Na] Chemical compound O.O.[Na].[Na] XMEKHKCRNHDFOW-UHFFFAOYSA-N 0.000 description 1
- 238000001016 Ostwald ripening Methods 0.000 description 1
- 206010034960 Photophobia Diseases 0.000 description 1
- RVGRUAULSDPKGF-UHFFFAOYSA-N Poloxamer Chemical compound C1CO1.CC1CO1 RVGRUAULSDPKGF-UHFFFAOYSA-N 0.000 description 1
- 239000004695 Polyether sulfone Substances 0.000 description 1
- 208000003251 Pruritus Diseases 0.000 description 1
- 206010040844 Skin exfoliation Diseases 0.000 description 1
- 238000009825 accumulation Methods 0.000 description 1
- 230000001154 acute effect Effects 0.000 description 1
- 230000009798 acute exacerbation Effects 0.000 description 1
- 239000003732 agents acting on the eye Substances 0.000 description 1
- 208000002205 allergic conjunctivitis Diseases 0.000 description 1
- 208000026935 allergic disease Diseases 0.000 description 1
- 230000000172 allergic effect Effects 0.000 description 1
- 230000001668 ameliorated effect Effects 0.000 description 1
- 238000004458 analytical method Methods 0.000 description 1
- 210000003484 anatomy Anatomy 0.000 description 1
- 230000000844 anti-bacterial effect Effects 0.000 description 1
- 239000012296 anti-solvent Substances 0.000 description 1
- 239000012736 aqueous medium Substances 0.000 description 1
- 239000007864 aqueous solution Substances 0.000 description 1
- 208000003464 asthenopia Diseases 0.000 description 1
- 208000024998 atopic conjunctivitis Diseases 0.000 description 1
- 208000010668 atopic eczema Diseases 0.000 description 1
- 230000004888 barrier function Effects 0.000 description 1
- 229960001716 benzalkonium Drugs 0.000 description 1
- CYDRXTMLKJDRQH-UHFFFAOYSA-N benzododecinium Chemical compound CCCCCCCCCCCC[N+](C)(C)CC1=CC=CC=C1 CYDRXTMLKJDRQH-UHFFFAOYSA-N 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 210000000988 bone and bone Anatomy 0.000 description 1
- 125000005619 boric acid group Chemical group 0.000 description 1
- 230000015556 catabolic process Effects 0.000 description 1
- 229920002678 cellulose Polymers 0.000 description 1
- 239000001913 cellulose Substances 0.000 description 1
- 238000013329 compounding Methods 0.000 description 1
- 239000000882 contact lens solution Substances 0.000 description 1
- 229960001334 corticosteroids Drugs 0.000 description 1
- 230000003247 decreasing effect Effects 0.000 description 1
- 238000006731 degradation reaction Methods 0.000 description 1
- 238000013461 design Methods 0.000 description 1
- 239000000645 desinfectant Substances 0.000 description 1
- 230000035618 desquamation Effects 0.000 description 1
- 239000003599 detergent Substances 0.000 description 1
- 238000009792 diffusion process Methods 0.000 description 1
- 238000004090 dissolution Methods 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 231100000673 dose–response relationship Toxicity 0.000 description 1
- 239000003937 drug carrier Substances 0.000 description 1
- 230000005713 exacerbation Effects 0.000 description 1
- 239000013020 final formulation Substances 0.000 description 1
- 239000012467 final product Substances 0.000 description 1
- 230000006870 function Effects 0.000 description 1
- 238000007429 general method Methods 0.000 description 1
- 239000003862 glucocorticoid Substances 0.000 description 1
- 238000004128 high performance liquid chromatography Methods 0.000 description 1
- 230000009610 hypersensitivity Effects 0.000 description 1
- 238000000338 in vitro Methods 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
- 230000002458 infectious effect Effects 0.000 description 1
- 230000002757 inflammatory effect Effects 0.000 description 1
- 231100000016 inhalation toxicity Toxicity 0.000 description 1
- 229910052500 inorganic mineral Inorganic materials 0.000 description 1
- 230000003993 interaction Effects 0.000 description 1
- 238000002955 isolation Methods 0.000 description 1
- 230000007803 itching Effects 0.000 description 1
- 206010023332 keratitis Diseases 0.000 description 1
- 201000010666 keratoconjunctivitis Diseases 0.000 description 1
- 238000011031 large-scale manufacturing process Methods 0.000 description 1
- 239000000787 lecithin Substances 0.000 description 1
- 235000010445 lecithin Nutrition 0.000 description 1
- 229940067606 lecithin Drugs 0.000 description 1
- 238000012423 maintenance Methods 0.000 description 1
- 239000000594 mannitol Substances 0.000 description 1
- 235000010355 mannitol Nutrition 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 239000012528 membrane Substances 0.000 description 1
- 239000011707 mineral Substances 0.000 description 1
- NJTGANWAUPEOAX-UHFFFAOYSA-N molport-023-220-454 Chemical compound OCC(O)CO.OCC(O)CO NJTGANWAUPEOAX-UHFFFAOYSA-N 0.000 description 1
- 239000002086 nanomaterial Substances 0.000 description 1
- 231100001079 no serious adverse effect Toxicity 0.000 description 1
- 229940023490 ophthalmic product Drugs 0.000 description 1
- 238000010979 pH adjustment Methods 0.000 description 1
- 230000002572 peristaltic effect Effects 0.000 description 1
- 229940124531 pharmaceutical excipient Drugs 0.000 description 1
- 229920001983 poloxamer Polymers 0.000 description 1
- 229960000502 poloxamer Drugs 0.000 description 1
- 229920006393 polyether sulfone Polymers 0.000 description 1
- 229920000642 polymer Polymers 0.000 description 1
- 150000003077 polyols Chemical class 0.000 description 1
- 229920000136 polysorbate Polymers 0.000 description 1
- 229950008882 polysorbate Drugs 0.000 description 1
- 229920000036 polyvinylpyrrolidone Polymers 0.000 description 1
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 description 1
- 229940069328 povidone Drugs 0.000 description 1
- 238000012545 processing Methods 0.000 description 1
- 235000013772 propylene glycol Nutrition 0.000 description 1
- 201000003004 ptosis Diseases 0.000 description 1
- 230000009467 reduction Effects 0.000 description 1
- 230000003252 repetitive effect Effects 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 230000002441 reversible effect Effects 0.000 description 1
- 238000005185 salting out Methods 0.000 description 1
- 238000005070 sampling Methods 0.000 description 1
- 238000013341 scale-up Methods 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
- 238000006748 scratching Methods 0.000 description 1
- 230000002393 scratching effect Effects 0.000 description 1
- 230000028327 secretion Effects 0.000 description 1
- 238000010008 shearing Methods 0.000 description 1
- 239000002904 solvent Substances 0.000 description 1
- 238000013112 stability test Methods 0.000 description 1
- 238000012430 stability testing Methods 0.000 description 1
- 238000012027 sterile manufacturing Methods 0.000 description 1
- 238000013190 sterility testing Methods 0.000 description 1
- 150000003431 steroids Chemical class 0.000 description 1
- 230000008961 swelling Effects 0.000 description 1
- 231100000057 systemic toxicity Toxicity 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 210000001519 tissue Anatomy 0.000 description 1
- 231100000331 toxic Toxicity 0.000 description 1
- 230000002588 toxic effect Effects 0.000 description 1
- 231100001265 toxicological assessment Toxicity 0.000 description 1
- 231100000041 toxicology testing Toxicity 0.000 description 1
- 239000003053 toxin Substances 0.000 description 1
- 231100000765 toxin Toxicity 0.000 description 1
- 238000009827 uniform distribution Methods 0.000 description 1
- 230000000007 visual effect Effects 0.000 description 1
- 238000005303 weighing Methods 0.000 description 1
Images
Classifications
-
- 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
- A61K9/08—Solutions
-
- 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
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
-
- 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
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
- A61K31/567—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in position 17 alpha, e.g. mestranol, norethandrolone
-
- 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
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
- A61K31/568—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
- A61K31/569—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone substituted in position 17 alpha, e.g. ethisterone
-
- 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
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
-
- 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
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/186—Quaternary ammonium compounds, e.g. benzalkonium chloride or cetrimide
-
- 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
- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
-
- 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
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/10—Dispersions; Emulsions
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
-
- 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
-
- 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
- A61P27/00—Drugs for disorders of the senses
- A61P27/02—Ophthalmic agents
- A61P27/04—Artificial tears; Irrigation solutions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B82—NANOTECHNOLOGY
- B82Y—SPECIFIC USES OR APPLICATIONS OF NANOSTRUCTURES; MEASUREMENT OR ANALYSIS OF NANOSTRUCTURES; MANUFACTURE OR TREATMENT OF NANOSTRUCTURES
- B82Y5/00—Nanobiotechnology or nanomedicine, e.g. protein engineering or drug delivery
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07B—GENERAL METHODS OF ORGANIC CHEMISTRY; APPARATUS THEREFOR
- C07B2200/00—Indexing scheme relating to specific properties of organic compounds
- C07B2200/13—Crystalline forms, e.g. polymorphs
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07J—STEROIDS
- C07J31/00—Normal steroids containing one or more sulfur atoms not belonging to a hetero ring
- C07J31/006—Normal steroids containing one or more sulfur atoms not belonging to a hetero ring not covered by C07J31/003
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Ophthalmology & Optometry (AREA)
- Inorganic Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Dispersion Chemistry (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Nanotechnology (AREA)
- Rheumatology (AREA)
- Biophysics (AREA)
- Biotechnology (AREA)
- General Engineering & Computer Science (AREA)
- Medical Informatics (AREA)
- Crystallography & Structural Chemistry (AREA)
- Pain & Pain Management (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Steroid Compounds (AREA)
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2022015508A JP7494230B2 (ja) | 2019-07-23 | 2022-02-03 | 無菌眼用水性プロピオン酸フルチカゾンa型ナノ結晶懸濁液の調製方法 |
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201962877599P | 2019-07-23 | 2019-07-23 | |
| US62/877,599 | 2019-07-23 | ||
| US201962942551P | 2019-12-02 | 2019-12-02 | |
| US62/942,551 | 2019-12-02 |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2022015508A Division JP7494230B2 (ja) | 2019-07-23 | 2022-02-03 | 無菌眼用水性プロピオン酸フルチカゾンa型ナノ結晶懸濁液の調製方法 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2021017449A JP2021017449A (ja) | 2021-02-15 |
| JP2021017449A5 JP2021017449A5 (enExample) | 2021-12-23 |
| JP7021301B2 true JP7021301B2 (ja) | 2022-02-16 |
Family
ID=71738074
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2020124238A Active JP7021301B2 (ja) | 2019-07-23 | 2020-07-21 | 無菌眼用水性プロピオン酸フルチカゾンa型ナノ結晶懸濁液の調製方法 |
| JP2022015508A Active JP7494230B2 (ja) | 2019-07-23 | 2022-02-03 | 無菌眼用水性プロピオン酸フルチカゾンa型ナノ結晶懸濁液の調製方法 |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2022015508A Active JP7494230B2 (ja) | 2019-07-23 | 2022-02-03 | 無菌眼用水性プロピオン酸フルチカゾンa型ナノ結晶懸濁液の調製方法 |
Country Status (23)
| Country | Link |
|---|---|
| US (3) | US11406596B2 (enExample) |
| EP (1) | EP3769753B1 (enExample) |
| JP (2) | JP7021301B2 (enExample) |
| KR (1) | KR20220038443A (enExample) |
| CN (2) | CN115120557B (enExample) |
| AU (1) | AU2020317084A1 (enExample) |
| CA (1) | CA3145055A1 (enExample) |
| CY (1) | CY1124930T1 (enExample) |
| DK (1) | DK3769753T3 (enExample) |
| ES (1) | ES2905793T3 (enExample) |
| HR (1) | HRP20220165T1 (enExample) |
| HU (1) | HUE057416T2 (enExample) |
| LT (1) | LT3769753T (enExample) |
| MD (1) | MD3769753T2 (enExample) |
| MX (1) | MX420447B (enExample) |
| PH (1) | PH12022550003A1 (enExample) |
| PL (1) | PL3769753T3 (enExample) |
| PT (1) | PT3769753T (enExample) |
| RS (1) | RS62932B1 (enExample) |
| SI (1) | SI3769753T1 (enExample) |
| SM (1) | SMT202200082T1 (enExample) |
| TW (1) | TWI864053B (enExample) |
| WO (1) | WO2021014348A1 (enExample) |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| AU2020317084A1 (en) * | 2019-07-23 | 2022-03-03 | Nicox Ophthalmics, Inc. | Process for the preparation of sterile ophthalmic aqueous fluticasone propionate form a nanocrystals suspensions |
| CN115887372A (zh) * | 2022-10-25 | 2023-04-04 | 苏州欧康维视生物科技有限公司 | 丙酸氟替卡松混悬液及其制备方法 |
| CN115554238A (zh) * | 2022-10-25 | 2023-01-03 | 苏州欧康维视生物科技有限公司 | 眼用混悬液及其制备方法 |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2002177369A (ja) | 1992-05-06 | 2002-06-25 | Alcon Lab Inc | 眼科用組成物におけるホウ酸塩−ポリオール複合体の使用 |
| JP2008538823A (ja) | 2005-04-11 | 2008-11-06 | アドバンスト メディカル オプティクス, インコーポレーテッド | 緩衝系としてのボレート−ポリオール混合物 |
| US20130065888A1 (en) | 2011-08-15 | 2013-03-14 | Biserka Cetina-Cizmek | Ophthalmic formulations and processes for their preparation |
| JP2015520149A (ja) | 2012-05-08 | 2015-07-16 | アシエクス セラピューティクス インコーポレイテッドAciex Therapeutics, Inc. | 疎水性治療剤の調製物、製造方法およびその使用 |
Family Cites Families (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP3450805B2 (ja) * | 2000-08-08 | 2003-09-29 | わかもと製薬株式会社 | 水性医薬組成物 |
| US6900184B2 (en) * | 2003-04-14 | 2005-05-31 | Wyeth Holdings Corporation | Compositions containing pipercillin and tazobactam useful for injection |
| US8010032B2 (en) * | 2005-05-23 | 2011-08-30 | Xerox Corporation | Fuser member comprising deflocculated material |
| WO2010141834A1 (en) | 2009-06-05 | 2010-12-09 | Aciex Therapeutics, Inc. | Ophthalmic formulations of fluticasone and methods of use |
| TWI489997B (zh) | 2009-06-19 | 2015-07-01 | Alcon Res Ltd | 含有硼酸-多元醇錯合物之水性藥學組成物 |
| CA2893654A1 (en) * | 2012-12-17 | 2014-06-26 | Glaxo Group Limited | Combination of levocabastine and fluticasone furoate for the treatment of inflammatory and/or allergic conditions |
| TWI773641B (zh) | 2015-05-08 | 2022-08-11 | 日商活效製藥股份有限公司 | 含有糖皮質類固醇(glucocorticoids)之奈米微粒子之水性懸浮液劑 |
| AU2020317084A1 (en) * | 2019-07-23 | 2022-03-03 | Nicox Ophthalmics, Inc. | Process for the preparation of sterile ophthalmic aqueous fluticasone propionate form a nanocrystals suspensions |
-
2020
- 2020-07-21 AU AU2020317084A patent/AU2020317084A1/en not_active Abandoned
- 2020-07-21 US US16/934,807 patent/US11406596B2/en active Active
- 2020-07-21 LT LTEP20186965.8T patent/LT3769753T/lt unknown
- 2020-07-21 PH PH1/2022/550003A patent/PH12022550003A1/en unknown
- 2020-07-21 TW TW109124497A patent/TWI864053B/zh active
- 2020-07-21 HR HRP20220165TT patent/HRP20220165T1/hr unknown
- 2020-07-21 KR KR1020227006020A patent/KR20220038443A/ko active Pending
- 2020-07-21 CN CN202210807241.1A patent/CN115120557B/zh active Active
- 2020-07-21 SM SM20220082T patent/SMT202200082T1/it unknown
- 2020-07-21 MD MDE20210297T patent/MD3769753T2/ro unknown
- 2020-07-21 DK DK20186965.8T patent/DK3769753T3/da active
- 2020-07-21 US US17/629,267 patent/US20220241296A1/en not_active Abandoned
- 2020-07-21 EP EP20186965.8A patent/EP3769753B1/en active Active
- 2020-07-21 JP JP2020124238A patent/JP7021301B2/ja active Active
- 2020-07-21 RS RS20220142A patent/RS62932B1/sr unknown
- 2020-07-21 CN CN202010707466.0A patent/CN111821261B/zh active Active
- 2020-07-21 HU HUE20186965A patent/HUE057416T2/hu unknown
- 2020-07-21 PT PT201869658T patent/PT3769753T/pt unknown
- 2020-07-21 SI SI202030032T patent/SI3769753T1/sl unknown
- 2020-07-21 ES ES20186965T patent/ES2905793T3/es active Active
- 2020-07-21 CA CA3145055A patent/CA3145055A1/en active Pending
- 2020-07-21 WO PCT/IB2020/056832 patent/WO2021014348A1/en not_active Ceased
- 2020-07-21 PL PL20186965T patent/PL3769753T3/pl unknown
- 2020-07-21 MX MX2022000928A patent/MX420447B/es unknown
-
2022
- 2022-01-27 CY CY20221100069T patent/CY1124930T1/el unknown
- 2022-02-03 JP JP2022015508A patent/JP7494230B2/ja active Active
- 2022-06-27 US US17/850,515 patent/US20220323352A1/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2002177369A (ja) | 1992-05-06 | 2002-06-25 | Alcon Lab Inc | 眼科用組成物におけるホウ酸塩−ポリオール複合体の使用 |
| JP2008538823A (ja) | 2005-04-11 | 2008-11-06 | アドバンスト メディカル オプティクス, インコーポレーテッド | 緩衝系としてのボレート−ポリオール混合物 |
| US20130065888A1 (en) | 2011-08-15 | 2013-03-14 | Biserka Cetina-Cizmek | Ophthalmic formulations and processes for their preparation |
| JP2015520149A (ja) | 2012-05-08 | 2015-07-16 | アシエクス セラピューティクス インコーポレイテッドAciex Therapeutics, Inc. | 疎水性治療剤の調製物、製造方法およびその使用 |
Also Published As
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| JP5558582B2 (ja) | 眼科用医薬組成物の調製方法 | |
| JP7494230B2 (ja) | 無菌眼用水性プロピオン酸フルチカゾンa型ナノ結晶懸濁液の調製方法 | |
| JP2019535798A (ja) | 眼科用活性医薬成分送達のためのシクロデキストリン固体複合体の製造 | |
| CN107847432A (zh) | D2o稳定化的药物制剂 | |
| CN107613985A (zh) | 含有糖皮质激素的纳米微粒的水性悬浮液剂 | |
| CN104814924A (zh) | 一种布佐林胺脂质体眼用制剂及其制备方法 | |
| JP2013508420A (ja) | 点眼製剤およびその製造方法 | |
| CN104721136A (zh) | 一种布佐林胺眼用纳米混悬剂及其制备方法 | |
| HK40077423A (en) | Process for the preparation of sterile ophthalmic aqueous fluticasone propionate form a nanocrystals suspensions | |
| HK40077423B (zh) | 用於制备无菌眼用水性丙酸氟替卡松a型纳米晶体混悬液的方法 | |
| HK40038382A (en) | Process for the preparation of sterile ophthalmic aqueous fluticasone propionate form a nanocrystals suspensions | |
| HK40038382B (en) | Process for the preparation of sterile ophthalmic aqueous fluticasone propionate form a nanocrystals suspensions | |
| CN104721130B (zh) | 一种布林佐胺包合物眼用制剂及其制备方法 | |
| CN106714803A (zh) | 眼用混悬液制剂 | |
| JP7641566B2 (ja) | 超微細化水難溶性薬物及び水溶性薬物を含む点眼剤並びにその製造方法及び使用方法 | |
| WO2022195382A1 (en) | A stable ophthalmic nanosupension of brinzolamide | |
| WO2025144421A1 (en) | Aqueous nanomicelle ophthalmic formulations containing difluprednate | |
| WO2025220660A1 (ja) | チボザニブ原薬およびその製造方法 | |
| JP2024507326A (ja) | 点眼投与により乾燥型黄斑変性症および網膜光障害を予防・治療するための眼科用製剤 | |
| CN116669718A (zh) | 用于改善或预防视网膜循环障碍以及视网膜神经血管连接障碍的滴眼剂 | |
| HK1234413B (zh) | 用於治療眼部病症的膜附著性自組裝體系 | |
| HK1233540A1 (en) | Ophthalmic suspension formulation |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| A521 | Request for written amendment filed |
Free format text: JAPANESE INTERMEDIATE CODE: A523 Effective date: 20211111 |
|
| A621 | Written request for application examination |
Free format text: JAPANESE INTERMEDIATE CODE: A621 Effective date: 20211111 |
|
| A871 | Explanation of circumstances concerning accelerated examination |
Free format text: JAPANESE INTERMEDIATE CODE: A871 Effective date: 20211111 |
|
| TRDD | Decision of grant or rejection written | ||
| A01 | Written decision to grant a patent or to grant a registration (utility model) |
Free format text: JAPANESE INTERMEDIATE CODE: A01 Effective date: 20220104 |
|
| A61 | First payment of annual fees (during grant procedure) |
Free format text: JAPANESE INTERMEDIATE CODE: A61 Effective date: 20220203 |
|
| R150 | Certificate of patent or registration of utility model |
Ref document number: 7021301 Country of ref document: JP Free format text: JAPANESE INTERMEDIATE CODE: R150 |
|
| R250 | Receipt of annual fees |
Free format text: JAPANESE INTERMEDIATE CODE: R250 |