NO329382B1 - Fremgangsmate for fremstilling av umiddelbart loselige, faste produkter, selve produktet samt anvendelse derav og fremgangsmate for forebyggelse av selvaggregering og prematur utfelling av et taksoid - Google Patents

Fremgangsmate for fremstilling av umiddelbart loselige, faste produkter, selve produktet samt anvendelse derav og fremgangsmate for forebyggelse av selvaggregering og prematur utfelling av et taksoid Download PDF

Info

Publication number: NO329382B1
Authority: NO; Norway
Prior art keywords: cyclodextrin; paclitaxel; taxoid; docetaxel; acetyl
Prior art date: 1997-11-10

Application number

NO20002165A

Other languages

English (en)

Norwegian (no)

Other versions

NO20002165D0 (no

NO20002165L (no

Inventor

Josef-Michael Geczy

Original Assignee

Hexal Ag

Priority date (The priority date 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 date listed.)

1997-11-10

Filing date

2000-04-27

Publication date

2010-10-04

2000-04-27 Application filed by Hexal Ag filed Critical Hexal Ag

2000-04-27 Publication of NO20002165D0 publication Critical patent/NO20002165D0/no

2000-07-07 Publication of NO20002165L publication Critical patent/NO20002165L/no

2010-10-04 Publication of NO329382B1 publication Critical patent/NO329382B1/no

Links

239000000047 product Substances 0.000 title claims description 29
238000000034 method Methods 0.000 title claims description 22
238000002360 preparation method Methods 0.000 title claims description 14
238000001556 precipitation Methods 0.000 title claims description 10
239000012265 solid product Substances 0.000 title claims description 8
238000004220 aggregation Methods 0.000 title claims description 5
230000002028 premature Effects 0.000 title claims description 5
230000002265 prevention Effects 0.000 title 1
229960001592 paclitaxel Drugs 0.000 claims description 85
RCINICONZNJXQF-MZXODVADSA-N taxol Chemical compound O([C@@H]1[C@@]2(C[C@@H](C(C)=C(C2(C)C)[C@H](C([C@]2(C)[C@@H](O)C[C@H]3OC[C@]3([C@H]21)OC(C)=O)=O)OC(=O)C)OC(=O)[C@H](O)[C@@H](NC(=O)C=1C=CC=CC=1)C=1C=CC=CC=1)O)C(=O)C1=CC=CC=C1 RCINICONZNJXQF-MZXODVADSA-N 0.000 claims description 85
229930012538 Paclitaxel Natural products 0.000 claims description 84
239000000243 solution Substances 0.000 claims description 79
229920000858 Cyclodextrin Polymers 0.000 claims description 65
LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 62
ZDZOTLJHXYCWBA-VCVYQWHSSA-N N-debenzoyl-N-(tert-butoxycarbonyl)-10-deacetyltaxol Chemical compound O([C@H]1[C@H]2[C@@](C([C@H](O)C3=C(C)[C@@H](OC(=O)[C@H](O)[C@@H](NC(=O)OC(C)(C)C)C=4C=CC=CC=4)C[C@]1(O)C3(C)C)=O)(C)[C@@H](O)C[C@H]1OC[C@]12OC(=O)C)C(=O)C1=CC=CC=C1 ZDZOTLJHXYCWBA-VCVYQWHSSA-N 0.000 claims description 50
229960003668 docetaxel Drugs 0.000 claims description 50
239000000203 mixture Substances 0.000 claims description 36
229940080345 gamma-cyclodextrin Drugs 0.000 claims description 26
WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims description 25
HFHDHCJBZVLPGP-UHFFFAOYSA-N schardinger α-dextrin Chemical class 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 claims description 20
XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 17
239000003814 drug Substances 0.000 claims description 16
239000007787 solid Substances 0.000 claims description 16
229940079593 drug Drugs 0.000 claims description 15
239000007864 aqueous solution Substances 0.000 claims description 14
239000008103 glucose Substances 0.000 claims description 14
239000003125 aqueous solvent Substances 0.000 claims description 13
239000002904 solvent Substances 0.000 claims description 11
FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 10
ODLHGICHYURWBS-FOSILIAISA-N molport-023-220-444 Chemical compound CC(O)COC[C@@H]([C@@H]([C@H]([C@@H]1O)O)O[C@@H]2O[C@H]([C@H](O[C@@H]3O[C@@H](COCC(C)O)[C@@H]([C@H]([C@@H]3O)O)O[C@@H]3O[C@@H](COCC(C)O)[C@@H]([C@H]([C@@H]3O)O)O[C@@H]3O[C@@H](COCC(C)O)[C@@H]([C@H]([C@@H]3O)O)O[C@@H]3O[C@@H](COCC(C)O)[C@@H]([C@H]([C@@H]3O)O)O3)[C@@H](O)[C@@H]2O)COCC(O)C)O[C@H]1O[C@@H]1[C@@H](O)[C@H](O)[C@H]3O[C@H]1COCC(C)O ODLHGICHYURWBS-FOSILIAISA-N 0.000 claims description 8
239000008121 dextrose Substances 0.000 claims description 7
239000011780 sodium chloride Substances 0.000 claims description 6
WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 claims description 5
239000004480 active ingredient Substances 0.000 claims description 4
-1 hydroxypropyl groups Chemical group 0.000 claims description 4
238000004519 manufacturing process Methods 0.000 claims description 4
150000003839 salts Chemical class 0.000 claims description 4
230000004663 cell proliferation Effects 0.000 claims description 3
239000003085 diluting agent Substances 0.000 claims description 3
238000001035 drying Methods 0.000 claims description 3
239000000825 pharmaceutical preparation Substances 0.000 claims description 3
239000000654 additive Substances 0.000 claims description 2
230000000996 additive effect Effects 0.000 claims description 2
238000001704 evaporation Methods 0.000 claims description 2
238000004108 freeze drying Methods 0.000 claims description 2
150000004677 hydrates Chemical class 0.000 claims description 2
239000000463 material Substances 0.000 claims description 2
239000012453 solvate Substances 0.000 claims description 2
ODLHGICHYURWBS-LKONHMLTSA-N trappsol cyclo Chemical compound CC(O)COC[C@H]([C@H]([C@@H]([C@H]1O)O)O[C@H]2O[C@@H]([C@@H](O[C@H]3O[C@H](COCC(C)O)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](COCC(C)O)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](COCC(C)O)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](COCC(C)O)[C@H]([C@@H]([C@H]3O)O)O3)[C@H](O)[C@H]2O)COCC(O)C)O[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@@H]3O[C@@H]1COCC(C)O ODLHGICHYURWBS-LKONHMLTSA-N 0.000 claims description 2
125000002777 acetyl group Chemical group [H]C([H])([H])C(*)=O 0.000 claims 2
230000021736 acetylation Effects 0.000 claims 2
238000006640 acetylation reaction Methods 0.000 claims 2
238000006467 substitution reaction Methods 0.000 claims 2
239000000843 powder Substances 0.000 description 13
239000011230 binding agent Substances 0.000 description 11
229940097362 cyclodextrins Drugs 0.000 description 11
238000009472 formulation Methods 0.000 description 11
238000004128 high performance liquid chromatography Methods 0.000 description 11
238000001990 intravenous administration Methods 0.000 description 10
239000011521 glass Substances 0.000 description 9
238000003860 storage Methods 0.000 description 8
CURLTUGMZLYLDI-UHFFFAOYSA-N Carbon dioxide Chemical compound O=C=O CURLTUGMZLYLDI-UHFFFAOYSA-N 0.000 description 7
235000011089 carbon dioxide Nutrition 0.000 description 7
JVFGXECLSQXABC-UHFFFAOYSA-N ac1l3obq Chemical compound O1C(C(C2O)O)C(COCC(C)O)OC2OC(C(C2O)O)C(COCC(C)O)OC2OC(C(C2O)O)C(COCC(C)O)OC2OC(C(C2O)O)C(COCC(C)O)OC2OC(C(C2O)O)C(COCC(C)O)OC2OC(C(O)C2O)C(COCC(O)C)OC2OC(C(C2O)O)C(COCC(C)O)OC2OC2C(O)C(O)C1OC2COCC(C)O JVFGXECLSQXABC-UHFFFAOYSA-N 0.000 description 6
239000012153 distilled water Substances 0.000 description 6
244000025254 Cannabis sativa Species 0.000 description 5
230000015572 biosynthetic process Effects 0.000 description 5
150000001875 compounds Chemical class 0.000 description 5
230000000694 effects Effects 0.000 description 5
239000002245 particle Substances 0.000 description 5
206010020751 Hypersensitivity Diseases 0.000 description 4
238000001914 filtration Methods 0.000 description 4
238000012360 testing method Methods 0.000 description 4
230000001988 toxicity Effects 0.000 description 4
231100000419 toxicity Toxicity 0.000 description 4
QGMRQYFBGABWDR-UHFFFAOYSA-M Pentobarbital sodium Chemical compound [Na+].CCCC(C)C1(CC)C(=O)NC(=O)[N-]C1=O QGMRQYFBGABWDR-UHFFFAOYSA-M 0.000 description 3
239000012141 concentrate Substances 0.000 description 3
230000002526 effect on cardiovascular system Effects 0.000 description 3
210000001105 femoral artery Anatomy 0.000 description 3
230000002209 hydrophobic effect Effects 0.000 description 3
238000002347 injection Methods 0.000 description 3
239000007924 injection Substances 0.000 description 3
239000012528 membrane Substances 0.000 description 3
239000000126 substance Substances 0.000 description 3
206010002091 Anaesthesia Diseases 0.000 description 2
IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 description 2
HTTJABKRGRZYRN-UHFFFAOYSA-N Heparin Chemical compound OC1C(NC(=O)C)C(O)OC(COS(O)(=O)=O)C1OC1C(OS(O)(=O)=O)C(O)C(OC2C(C(OS(O)(=O)=O)C(OC3C(C(O)C(O)C(O3)C(O)=O)OS(O)(=O)=O)C(CO)O2)NS(O)(=O)=O)C(C(O)=O)O1 HTTJABKRGRZYRN-UHFFFAOYSA-N 0.000 description 2
NTYJJOPFIAHURM-UHFFFAOYSA-N Histamine Chemical compound NCCC1=CN=CN1 NTYJJOPFIAHURM-UHFFFAOYSA-N 0.000 description 2
241001465754 Metazoa Species 0.000 description 2
208000002463 Sveinsson chorioretinal atrophy Diseases 0.000 description 2
208000026935 allergic disease Diseases 0.000 description 2
230000037005 anaesthesia Effects 0.000 description 2
230000001093 anti-cancer Effects 0.000 description 2
230000004872 arterial blood pressure Effects 0.000 description 2
WHGYBXFWUBPSRW-FOUAGVGXSA-N beta-cyclodextrin Chemical compound OC[C@H]([C@H]([C@@H]([C@H]1O)O)O[C@H]2O[C@@H]([C@@H](O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O3)[C@H](O)[C@H]2O)CO)O[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@@H]3O[C@@H]1CO WHGYBXFWUBPSRW-FOUAGVGXSA-N 0.000 description 2
229960004853 betadex Drugs 0.000 description 2
230000017531 blood circulation Effects 0.000 description 2
210000004027 cell Anatomy 0.000 description 2
210000000170 cell membrane Anatomy 0.000 description 2
HVYWMOMLDIMFJA-DPAQBDIFSA-N cholesterol Chemical compound C1C=C2C[C@@H](O)CC[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@H]([C@H](C)CCCC(C)C)[C@@]1(C)CC2 HVYWMOMLDIMFJA-DPAQBDIFSA-N 0.000 description 2
230000001472 cytotoxic effect Effects 0.000 description 2
239000003599 detergent Substances 0.000 description 2
YWEUIGNSBFLMFL-UHFFFAOYSA-N diphosphonate Chemical compound O=P(=O)OP(=O)=O YWEUIGNSBFLMFL-UHFFFAOYSA-N 0.000 description 2
239000002552 dosage form Substances 0.000 description 2
GDSRMADSINPKSL-HSEONFRVSA-N gamma-cyclodextrin Chemical compound OC[C@H]([C@H]([C@@H]([C@H]1O)O)O[C@H]2O[C@@H]([C@@H](O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O3)[C@H](O)[C@H]2O)CO)O[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@@H]3O[C@@H]1CO GDSRMADSINPKSL-HSEONFRVSA-N 0.000 description 2
229960002897 heparin Drugs 0.000 description 2
229920000669 heparin Polymers 0.000 description 2
230000009610 hypersensitivity Effects 0.000 description 2
238000001802 infusion Methods 0.000 description 2
230000003993 interaction Effects 0.000 description 2
150000002632 lipids Chemical class 0.000 description 2
238000005259 measurement Methods 0.000 description 2
229940127557 pharmaceutical product Drugs 0.000 description 2
DLYUQMMRRRQYAE-UHFFFAOYSA-N phosphorus pentoxide Inorganic materials O1P(O2)(=O)OP3(=O)OP1(=O)OP2(=O)O3 DLYUQMMRRRQYAE-UHFFFAOYSA-N 0.000 description 2
235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 description 2
239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 description 2
229920000053 polysorbate 80 Polymers 0.000 description 2
229940068968 polysorbate 80 Drugs 0.000 description 2
238000012950 reanalysis Methods 0.000 description 2
230000006641 stabilisation Effects 0.000 description 2
238000011105 stabilization Methods 0.000 description 2
239000012085 test solution Substances 0.000 description 2
239000008215 water for injection Substances 0.000 description 2
206010067484 Adverse reaction Diseases 0.000 description 1
241000282472 Canis lupus familiaris Species 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
239000001116 FEMA 4028 Substances 0.000 description 1
229930195725 Mannitol Natural products 0.000 description 1
206010028980 Neoplasm Diseases 0.000 description 1
241000396922 Pontia daplidice Species 0.000 description 1
231100000632 Spindle poison Toxicity 0.000 description 1
PCBOWMZAEDDKNH-HOTGVXAUSA-N [4-(trifluoromethoxy)phenyl]methyl (3as,6as)-2-(3-fluoro-4-sulfamoylbenzoyl)-1,3,3a,4,6,6a-hexahydropyrrolo[3,4-c]pyrrole-5-carboxylate Chemical compound C1=C(F)C(S(=O)(=O)N)=CC=C1C(=O)N1C[C@H]2CN(C(=O)OCC=3C=CC(OC(F)(F)F)=CC=3)C[C@@H]2C1 PCBOWMZAEDDKNH-HOTGVXAUSA-N 0.000 description 1
125000000218 acetic acid group Chemical group C(C)(=O)* 0.000 description 1
230000006838 adverse reaction Effects 0.000 description 1
238000001949 anaesthesia Methods 0.000 description 1
230000003444 anaesthetic effect Effects 0.000 description 1
230000002052 anaphylactic effect Effects 0.000 description 1
229940125715 antihistaminic agent Drugs 0.000 description 1
239000000739 antihistaminic agent Substances 0.000 description 1
238000013459 approach Methods 0.000 description 1
235000011175 beta-cyclodextrine Nutrition 0.000 description 1
239000008280 blood Substances 0.000 description 1
210000004369 blood Anatomy 0.000 description 1
230000036772 blood pressure Effects 0.000 description 1
238000009530 blood pressure measurement Methods 0.000 description 1
230000036760 body temperature Effects 0.000 description 1
201000011510 cancer Diseases 0.000 description 1
210000000748 cardiovascular system Anatomy 0.000 description 1
210000001715 carotid artery Anatomy 0.000 description 1
239000004359 castor oil Substances 0.000 description 1
235000019438 castor oil Nutrition 0.000 description 1
238000006243 chemical reaction Methods 0.000 description 1
OJYGBLRPYBAHRT-IPQSZEQASA-N chloralose Chemical compound O1[C@H](C(Cl)(Cl)Cl)O[C@@H]2[C@@H](O)[C@@H]([C@H](O)CO)O[C@@H]21 OJYGBLRPYBAHRT-IPQSZEQASA-N 0.000 description 1
229950009941 chloralose Drugs 0.000 description 1
235000012000 cholesterol Nutrition 0.000 description 1
238000010549 co-Evaporation Methods 0.000 description 1
238000010668 complexation reaction Methods 0.000 description 1
231100000433 cytotoxic Toxicity 0.000 description 1
239000008367 deionised water Substances 0.000 description 1
229910021641 deionized water Inorganic materials 0.000 description 1
230000001419 dependent effect Effects 0.000 description 1
230000003205 diastolic effect Effects 0.000 description 1
238000009792 diffusion process Methods 0.000 description 1
238000004090 dissolution Methods 0.000 description 1
238000001647 drug administration Methods 0.000 description 1
238000012377 drug delivery Methods 0.000 description 1
238000002474 experimental method Methods 0.000 description 1
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 description 1
229960001340 histamine Drugs 0.000 description 1
229940077716 histamine h2 receptor antagonists for peptic ulcer and gord Drugs 0.000 description 1
239000004615 ingredient Substances 0.000 description 1
239000003112 inhibitor Substances 0.000 description 1
239000007972 injectable composition Substances 0.000 description 1
238000007918 intramuscular administration Methods 0.000 description 1
238000007912 intraperitoneal administration Methods 0.000 description 1
238000010253 intravenous injection Methods 0.000 description 1
210000005240 left ventricle Anatomy 0.000 description 1
230000003902 lesion Effects 0.000 description 1
239000000594 mannitol Substances 0.000 description 1
235000010355 mannitol Nutrition 0.000 description 1
230000000394 mitotic effect Effects 0.000 description 1
239000002547 new drug Substances 0.000 description 1
229910052757 nitrogen Inorganic materials 0.000 description 1
239000007764 o/w emulsion Substances 0.000 description 1
210000000056 organ Anatomy 0.000 description 1
239000003960 organic solvent Substances 0.000 description 1
238000007911 parenteral administration Methods 0.000 description 1
239000006201 parenteral dosage form Substances 0.000 description 1
239000003182 parenteral nutrition solution Substances 0.000 description 1
239000008194 pharmaceutical composition Substances 0.000 description 1
239000003186 pharmaceutical solution Substances 0.000 description 1
239000008389 polyethoxylated castor oil Substances 0.000 description 1
230000008092 positive effect Effects 0.000 description 1
230000003389 potentiating effect Effects 0.000 description 1
239000002244 precipitate Substances 0.000 description 1
230000001681 protective effect Effects 0.000 description 1
108090000623 proteins and genes Proteins 0.000 description 1
102000004169 proteins and genes Human genes 0.000 description 1
230000010076 replication Effects 0.000 description 1
230000000241 respiratory effect Effects 0.000 description 1
230000036387 respiratory rate Effects 0.000 description 1
210000002345 respiratory system Anatomy 0.000 description 1
239000000523 sample Substances 0.000 description 1
239000008247 solid mixture Substances 0.000 description 1
230000003381 solubilizing effect Effects 0.000 description 1
238000003797 solvolysis reaction Methods 0.000 description 1
239000008174 sterile solution Substances 0.000 description 1
150000003431 steroids Chemical class 0.000 description 1
238000007920 subcutaneous administration Methods 0.000 description 1
239000004094 surface-active agent Substances 0.000 description 1
230000002459 sustained effect Effects 0.000 description 1
230000035488 systolic blood pressure Effects 0.000 description 1
238000011287 therapeutic dose Methods 0.000 description 1
238000002560 therapeutic procedure Methods 0.000 description 1
AWLILQARPMWUHA-UHFFFAOYSA-M thiopental sodium Chemical compound [Na+].CCCC(C)C1(CC)C(=O)NC([S-])=NC1=O AWLILQARPMWUHA-UHFFFAOYSA-M 0.000 description 1
231100000331 toxic Toxicity 0.000 description 1
230000002588 toxic effect Effects 0.000 description 1
210000003437 trachea Anatomy 0.000 description 1
239000003981 vehicle Substances 0.000 description 1
210000003462 vein Anatomy 0.000 description 1
230000002861 ventricular Effects 0.000 description 1

Classifications

- 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
- A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- 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
- 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
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/337—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having four-membered rings, e.g. taxol
- 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
- A61K47/40—Cyclodextrins; Derivatives thereof
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/69—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit
- A61K47/6949—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes
- A61K47/6951—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes using cyclodextrin
- 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
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
- 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
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
- A61P35/04—Antineoplastic agents specific for metastasis

Landscapes

Health & Medical Sciences (AREA)
Chemical & Material Sciences (AREA)
Life Sciences & Earth Sciences (AREA)
General Health & Medical Sciences (AREA)
Medicinal Chemistry (AREA)
Pharmacology & Pharmacy (AREA)
Public Health (AREA)
Animal Behavior & Ethology (AREA)
Veterinary Medicine (AREA)
Epidemiology (AREA)
Engineering & Computer Science (AREA)
Bioinformatics & Cheminformatics (AREA)
Nanotechnology (AREA)
Dermatology (AREA)
Biotechnology (AREA)
Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
General Chemical & Material Sciences (AREA)
Chemical Kinetics & Catalysis (AREA)
Inorganic Chemistry (AREA)
Biophysics (AREA)
Organic Chemistry (AREA)
General Engineering & Computer Science (AREA)
Medical Informatics (AREA)
Molecular Biology (AREA)
Crystallography & Structural Chemistry (AREA)
Oncology (AREA)
Medicinal Preparation (AREA)
Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

NO20002165A 1997-11-10 2000-04-27 Fremgangsmate for fremstilling av umiddelbart loselige, faste produkter, selve produktet samt anvendelse derav og fremgangsmate for forebyggelse av selvaggregering og prematur utfelling av et taksoid NO329382B1 (no)

Applications Claiming Priority (2)

Application Number	Priority Date	Filing Date	Title
HU9701945A HUP9701945A3 (en)	1997-11-10	1997-11-10	Pharmaceutical composition for injection containing cyclodextrin and taxoids
PCT/HU1998/000097 WO1999024073A1 (en)	1997-11-10	1998-11-09	Pharmaceutical compositions containing cyclodextrins and taxoids

Publications (3)

Publication Number	Publication Date
NO20002165D0 NO20002165D0 (no)	2000-04-27
NO20002165L NO20002165L (no)	2000-07-07
NO329382B1 true NO329382B1 (no)	2010-10-04

Family

ID=89995733

Family Applications (1)

Application Number	Title	Priority Date	Filing Date
NO20002165A NO329382B1 (no)	1997-11-10	2000-04-27	Fremgangsmate for fremstilling av umiddelbart loselige, faste produkter, selve produktet samt anvendelse derav og fremgangsmate for forebyggelse av selvaggregering og prematur utfelling av et taksoid

Country Status (19)

Country	Link
US (1)	US7671042B2 (zh)
EP (1)	EP1059942B1 (zh)
JP (1)	JP3656550B2 (zh)
KR (1)	KR100607391B1 (zh)
CN (1)	CN1222321C (zh)
AR (1)	AR015482A1 (zh)
AT (1)	ATE387916T1 (zh)
AU (1)	AU742036B2 (zh)
BR (1)	BR9814015A (zh)
CA (1)	CA2309326C (zh)
DE (1)	DE69839224T2 (zh)
EA (1)	EA002776B1 (zh)
HU (1)	HUP9701945A3 (zh)
IL (1)	IL135990A0 (zh)
NO (1)	NO329382B1 (zh)
NZ (1)	NZ504098A (zh)
PL (1)	PL199652B1 (zh)
WO (1)	WO1999024073A1 (zh)
ZA (1)	ZA989779B (zh)

Families Citing this family (30)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
PE20020300A1 (es)	2000-08-22	2002-05-10	Pharmacia Corp	Composicion de solucion de un farmaco antibiotico a base de oxazolidinona con mejoramiento de la carga de farmaco
WO2003015828A1 (en) *	2001-08-20	2003-02-27	Boehringer Ingelheim Pharmaceuticals, Inc.	Parenteral formulations of 1-(5-tert-butyl-2-p-tolyl-2h-pryrazol-3-yl)-3-[4-(2-morpholin-4-yl-ethoxy)-naphthalen-1-yl]-urea and a cyclodextrin
CN100384865C (zh) *	2001-11-02	2008-04-30	嵌入治疗公司	用于rna干扰的治疗用途的方法及组合物
JP2006500387A (ja) *	2002-08-15	2006-01-05	雲清劉	固形ナノ医薬およびその調製方法
AR054215A1 (es)	2006-01-20	2007-06-13	Eriochem Sa	Una formulacion farmaceutica de un taxano, una composicion solida de un taxano liofilizado a partir de una solucion de acido acetico, un procedimiento para la preparacion de dicha composicion solida de un taxano, una composicion solubilizante de un taxano liofilizado, y un conjunto de elementos (kit
CN101020059B (zh) *	2006-02-15	2011-01-05	中国科学院上海药物研究所	一种含多烯紫杉醇类物质的药物组合物及其制备方法
KR100917809B1 (ko) *	2006-05-22	2009-09-18	에스케이케미칼주식회사	우수한 저장안정성을 갖는 도세탁셀 함유 주사제 조성물
WO2007142440A1 (en) *	2006-06-02	2007-12-13	Sk Chemicals Co., Ltd.	Stable pharmaceutical composition containing paclitaxel and a method of manufacturing the same
KR100917810B1 (ko) *	2006-06-02	2009-09-18	에스케이케미칼주식회사	저장안정성이 우수한 파클리탁셀 함유 주사제 조성물
CN100411688C (zh) *	2006-09-12	2008-08-20	南京师范大学	含有环糊精/多烯紫杉醇包合物的药物组合物及其制备方法
CN100486645C (zh)	2006-09-12	2009-05-13	南京师范大学	含有环糊精紫杉醇包合物的药物组合物及其制备方法
WO2008092084A2 (en)	2007-01-26	2008-07-31	Centocor, Inc.	Injectable non-aqueous suspension with high concentration of therapeutic agent
CA2683712A1 (en) *	2007-04-20	2009-01-15	Sun Pharmaceutical Industries Limited	Pharmaceutical compositions
WO2009002425A2 (en) *	2007-06-22	2008-12-31	Scidose Llc	Solubilized formulation of docetaxel without tween 80
US20090087460A1 (en) *	2007-10-02	2009-04-02	Hamamatsu Photonics K.K.	Solid composition, microparticles, microparticle dispersion liquid, and manufacturing methods for these
AR063111A1 (es)	2007-10-03	2008-12-30	Eriochem Sa	Una formulacion farmaceutica de taxano
KR101478779B1 (ko) *	2007-11-22	2015-01-05	에스케이케미칼주식회사	재수화시간이 향상된 택산 유도체 함유 동결건조 조성물 및이의 제조방법
KR101502533B1 (ko) *	2007-11-22	2015-03-13	에스케이케미칼주식회사	우수한 안정성을 갖는 택산 유도체 함유 주사제용동결건조 조성물 및 이의 제조방법
EP2106786A1 (de) *	2008-04-04	2009-10-07	Roewer, Norbert, Univ.-Prof. Dr. med.	Pharmazeutische Zubereitung mit permethyliertem Cyclodextrin
US8912228B2 (en)	2009-10-19	2014-12-16	Scidose Llc	Docetaxel formulations with lipoic acid
KR20120130740A (ko) *	2011-05-23	2012-12-03	에스케이케미칼주식회사	도세탁셀을 함유하는 액상 주사용 조성물
US11406595B2 (en) *	2012-05-21	2022-08-09	University Of Maryland, College Park	Highly stable colloid from aqueous solutions of small organic molecules
CN104870001B (zh)	2012-11-15	2019-01-18	赛博尔泰克股份公司	用作消炎或免疫抑制有效成分的飞燕草素络合物
US9511047B2 (en)	2012-12-11	2016-12-06	Sapiotec Gmbh	Delphinidin for combating melanoma cells
CN105823810A (zh) *	2016-01-04	2016-08-03	杭州电子科技大学	紫杉醇化疗效果检测装置及检测方法
KR101829705B1 (ko) *	2016-09-21	2018-02-19	씨제이헬스케어 주식회사	안정성이 향상된 주사용 조성물
KR102262743B1 (ko)	2017-07-07	2021-06-09	에이치케이이노엔 주식회사	주사용 조성물
CN113456586B (zh)	2018-07-25	2022-06-10	比卡生物科技（广州）有限公司	一种注射用多西他赛组合物及其制备方法
WO2022250469A1 (ko) *	2021-05-26	2022-12-01	주식회사 대웅제약	1-(5-(2,4-다이플루오로페닐)-1-((3-플루오로페닐)술포닐)-4-메톡시-1h-피롤-3-일)-n-메틸메탄아민을 포함하는 신규한 주사용 제제
CN115960834B (zh) *	2023-03-07	2023-06-09	浙江省肿瘤医院	一种pd-1/ptx联合pd-1耐药模型建立的方法

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
US5602112A (en) *	1992-06-19	1997-02-11	Supergen, Inc.	Pharmaceutical formulation
JPH06157330A (ja) *	1992-11-27	1994-06-03	Ensuiko Sugar Refining Co Ltd	タキソールのサイクロデキストリン包接物，その製造法と用途
JPH0753396A (ja) *	1993-08-19	1995-02-28	Ensuiko Sugar Refining Co Ltd	タキソールのサイクロデキストリン包接物，その製造法および用途
HU213200B (en) *	1993-05-12	1997-03-28	Chinoin Gyogyszer Es Vegyeszet	The cyclodextrin or cyclodextrin derivative cluster complexes of taxol, taxotere, or taxus, pharmaceutical preparations containing them and process for their production
DE4414138A1 (de) *	1994-04-22	1995-10-26	Consortium Elektrochem Ind	Acylierte gamma-Cyclodextrine
HUT73844A (en) *	1994-11-11	1996-09-30	Chinoin Gyogyszer Es Vegyeszet	New taxol complexes and pharmaceutical compositions containing them
CA2163837C (en) *	1994-12-13	1999-07-20	Robert K. Perrone	Crystalline paclitaxel hydrates
CN1596250A (zh) *	2001-11-30	2005-03-16	布里斯托尔-迈尔斯斯奎布公司	紫杉醇溶剂化物

1997
- 1997-11-10 HU HU9701945A patent/HUP9701945A3/hu unknown
1998
- 1998-10-27 ZA ZA989779A patent/ZA989779B/xx unknown
- 1998-11-06 AR ARP980105607A patent/AR015482A1/es unknown
- 1998-11-09 WO PCT/HU1998/000097 patent/WO1999024073A1/en active IP Right Grant
- 1998-11-09 JP JP2000520158A patent/JP3656550B2/ja not_active Expired - Fee Related
- 1998-11-09 AT AT98955818T patent/ATE387916T1/de active
- 1998-11-09 EA EA200000494A patent/EA002776B1/ru not_active IP Right Cessation
- 1998-11-09 PL PL340505A patent/PL199652B1/pl not_active IP Right Cessation
- 1998-11-09 CN CNB988110105A patent/CN1222321C/zh not_active Expired - Fee Related
- 1998-11-09 AU AU12538/99A patent/AU742036B2/en not_active Ceased
- 1998-11-09 IL IL13599098A patent/IL135990A0/xx unknown
- 1998-11-09 BR BR9814015-9A patent/BR9814015A/pt not_active Application Discontinuation
- 1998-11-09 DE DE69839224T patent/DE69839224T2/de not_active Expired - Lifetime
- 1998-11-09 KR KR1020007005076A patent/KR100607391B1/ko not_active IP Right Cessation
- 1998-11-09 CA CA2309326A patent/CA2309326C/en not_active Expired - Fee Related
- 1998-11-09 EP EP98955818A patent/EP1059942B1/en not_active Expired - Lifetime
- 1998-11-09 NZ NZ504098A patent/NZ504098A/xx not_active IP Right Cessation
2000
- 2000-04-27 NO NO20002165A patent/NO329382B1/no not_active IP Right Cessation
2006
- 2006-10-04 US US11/542,797 patent/US7671042B2/en not_active Expired - Fee Related

Also Published As

Publication number	Publication date
AU742036B2 (en)	2001-12-13
AR015482A1 (es)	2001-05-02
HUP9701945A1 (hu)	1999-09-28
EP1059942B1 (en)	2008-03-05
PL199652B1 (pl)	2008-10-31
ZA989779B (en)	1999-04-28
NO20002165D0 (no)	2000-04-27
KR20010031967A (ko)	2001-04-16
HU9701945D0 (en)	1998-01-28
WO1999024073B1 (en)	1999-07-08
CA2309326C (en)	2010-12-21
EA002776B1 (ru)	2002-08-29
BR9814015A (pt)	2000-09-26
AU1253899A (en)	1999-05-31
NO20002165L (no)	2000-07-07
DE69839224D1 (de)	2008-04-17
WO1999024073A1 (en)	1999-05-20
CN1222321C (zh)	2005-10-12
IL135990A0 (en)	2001-05-20
NZ504098A (en)	2003-06-30
EA200000494A1 (ru)	2000-10-30
PL340505A1 (en)	2001-02-12
ATE387916T1 (de)	2008-03-15
KR100607391B1 (ko)	2006-08-02
JP2001522816A (ja)	2001-11-20
HUP9701945A3 (en)	2000-04-28
CN1281373A (zh)	2001-01-24
US7671042B2 (en)	2010-03-02
JP3656550B2 (ja)	2005-06-08
US20070087999A1 (en)	2007-04-19
CA2309326A1 (en)	1999-05-20
EP1059942A2 (en)	2000-12-20
DE69839224T2 (de)	2009-04-16

Legal Events

Date	Code	Title	Description
2001-07-30	FC2A	Withdrawal, rejection or dismissal of laid open patent application
2013-06-24	MM1K	Lapsed by not paying the annual fees

Publication	Publication Date	Title
NO329382B1 (no)	2010-10-04	Fremgangsmate for fremstilling av umiddelbart loselige, faste produkter, selve produktet samt anvendelse derav og fremgangsmate for forebyggelse av selvaggregering og prematur utfelling av et taksoid
JP5587198B2 (ja)	2014-09-10	タキサン誘導体を含有する、安定性が改良された凍結乾燥医薬組成物、及びその製法
JP5369332B2 (ja)	2013-12-18	安定性を有するドセタキセル含有医薬組成物、及びその製造方法
CN111093674B (zh)	2023-03-28	一种磺酰脲类药物的药物组合物及其制备方法
HU217839B (hu)	2000-04-28	Eljárások taxánszármazékokat tartalmazó új stabil gyógyszerkészítmények előállítására
US20100267817A1 (en)	2010-10-21	Lyophilized pharmaceutical composition with improved reconstitution time containing taxane derivatives and method of manufacturing the same
JPS59152320A (ja)	1984-08-31	水性製剤
DK162510B (da)	1991-11-11	Toerstoffer til fremstilling af stabile suspensioner indeholdende 4-hydroxy- eller 4-acyloxy-4-androsten-3,17-dioner, fremgangsmaade til fremstilling af toersofferne samt suspensioner fremstillet ud fra toerstofferne
WO2012076988A1 (en)	2012-06-14	A complex of garcinol, cyclodextrin and method thereof
JP5462797B2 (ja)	2014-04-02	注射可能なメクリジン製剤および方法
CZ20001636A3 (cs)	2000-10-11	Farmaceutické přípravky obsahující cyklodextriny a taxoidy
JPH0429924A (ja)	1992-01-31	脂溶性薬物含有注射用製剤
JPH07316065A (ja)	1995-12-05	Ｆｒ９０１４６９物質製剤
JP2008509141A (ja)	2008-03-27	非経口製剤の組織刺激を軽減させる方法及び組成物
JP2022553010A (ja)	2022-12-21	脳腫瘍の治療のためのシクロデキストリンベースのγリノレン酸製剤
CN101366701A (zh)	2009-02-18	N，n-二甲基甘氨酸-2，6-二异丙基苯酯盐类注射剂
MXPA00004456A (en)	2001-12-13	Pharmaceutical compositions containing cyclodextrins and taxoids