CN115379827A - 苯达莫司汀组合物及其用途 - Google Patents
苯达莫司汀组合物及其用途 Download PDFInfo
- Publication number
- CN115379827A CN115379827A CN202080099405.9A CN202080099405A CN115379827A CN 115379827 A CN115379827 A CN 115379827A CN 202080099405 A CN202080099405 A CN 202080099405A CN 115379827 A CN115379827 A CN 115379827A
- Authority
- CN
- China
- Prior art keywords
- cyclodextrin
- bendamustine
- glucose
- composition
- sodium chloride
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
- 239000000203 mixture Substances 0.000 title claims abstract description 86
- YTKUWDBFDASYHO-UHFFFAOYSA-N bendamustine Chemical compound ClCCN(CCCl)C1=CC=C2N(C)C(CCCC(O)=O)=NC2=C1 YTKUWDBFDASYHO-UHFFFAOYSA-N 0.000 title claims abstract description 83
- 229960002707 bendamustine Drugs 0.000 title claims abstract description 82
- 229920000858 Cyclodextrin Polymers 0.000 claims abstract description 111
- 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 claims abstract description 60
- 239000000460 chlorine Substances 0.000 claims abstract description 38
- 229910052801 chlorine Inorganic materials 0.000 claims abstract description 38
- 150000003839 salts Chemical class 0.000 claims abstract description 36
- 239000003381 stabilizer Substances 0.000 claims abstract description 22
- 239000003814 drug Substances 0.000 claims abstract description 18
- 238000000034 method Methods 0.000 claims abstract description 18
- 206010028980 Neoplasm Diseases 0.000 claims abstract description 10
- 201000011510 cancer Diseases 0.000 claims abstract description 9
- PJUIMOJAAPLTRJ-UHFFFAOYSA-N monothioglycerol Chemical compound OCC(O)CS PJUIMOJAAPLTRJ-UHFFFAOYSA-N 0.000 claims abstract description 6
- 229940035024 thioglycerol Drugs 0.000 claims abstract description 6
- 235000019136 lipoic acid Nutrition 0.000 claims abstract description 4
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims abstract description 4
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims abstract description 4
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims abstract description 4
- 229960002663 thioctic acid Drugs 0.000 claims abstract description 4
- 239000000126 substance Substances 0.000 claims abstract 3
- 125000001309 chloro group Chemical group Cl* 0.000 claims abstract 2
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical group [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 129
- 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 69
- 239000011780 sodium chloride Substances 0.000 claims description 67
- 239000008103 glucose Substances 0.000 claims description 52
- 239000001116 FEMA 4028 Substances 0.000 claims description 44
- 229960004853 betadex Drugs 0.000 claims description 44
- ZAMOUSCENKQFHK-UHFFFAOYSA-N Chlorine atom Chemical compound [Cl] ZAMOUSCENKQFHK-UHFFFAOYSA-N 0.000 claims description 36
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 32
- 239000008215 water for injection Substances 0.000 claims description 30
- 239000003085 diluting agent Substances 0.000 claims description 19
- 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 7
- 239000007924 injection Substances 0.000 claims description 6
- 238000002347 injection Methods 0.000 claims description 6
- 230000008569 process Effects 0.000 claims description 5
- 208000017604 Hodgkin disease Diseases 0.000 claims description 4
- 208000010747 Hodgkins lymphoma Diseases 0.000 claims description 4
- 208000034578 Multiple myelomas Diseases 0.000 claims description 4
- 206010035226 Plasma cell myeloma Diseases 0.000 claims description 4
- 239000001763 2-hydroxyethyl(trimethyl)azanium Substances 0.000 claims description 3
- 208000010839 B-cell chronic lymphocytic leukemia Diseases 0.000 claims description 3
- 206010006187 Breast cancer Diseases 0.000 claims description 3
- 208000026310 Breast neoplasm Diseases 0.000 claims description 3
- 235000019743 Choline chloride Nutrition 0.000 claims description 3
- 208000021519 Hodgkin lymphoma Diseases 0.000 claims description 3
- 208000031422 Lymphocytic Chronic B-Cell Leukemia Diseases 0.000 claims description 3
- 208000015914 Non-Hodgkin lymphomas Diseases 0.000 claims description 3
- SGMZJAMFUVOLNK-UHFFFAOYSA-M choline chloride Chemical group [Cl-].C[N+](C)(C)CCO SGMZJAMFUVOLNK-UHFFFAOYSA-M 0.000 claims description 3
- 229960003178 choline chloride Drugs 0.000 claims description 3
- 208000032852 chronic lymphocytic leukemia Diseases 0.000 claims description 3
- 239000008355 dextrose injection Substances 0.000 claims description 2
- 238000004519 manufacturing process Methods 0.000 claims description 2
- QCQCHGYLTSGIGX-GHXANHINSA-N 4-[[(3ar,5ar,5br,7ar,9s,11ar,11br,13as)-5a,5b,8,8,11a-pentamethyl-3a-[(5-methylpyridine-3-carbonyl)amino]-2-oxo-1-propan-2-yl-4,5,6,7,7a,9,10,11,11b,12,13,13a-dodecahydro-3h-cyclopenta[a]chrysen-9-yl]oxy]-2,2-dimethyl-4-oxobutanoic acid Chemical compound N([C@@]12CC[C@@]3(C)[C@]4(C)CC[C@H]5C(C)(C)[C@@H](OC(=O)CC(C)(C)C(O)=O)CC[C@]5(C)[C@H]4CC[C@@H]3C1=C(C(C2)=O)C(C)C)C(=O)C1=CN=CC(C)=C1 QCQCHGYLTSGIGX-GHXANHINSA-N 0.000 claims 2
- AGBQKNBQESQNJD-UHFFFAOYSA-N alpha-Lipoic acid Natural products OC(=O)CCCCC1CCSS1 AGBQKNBQESQNJD-UHFFFAOYSA-N 0.000 claims 2
- 229910010272 inorganic material Inorganic materials 0.000 claims 2
- 239000011147 inorganic material Substances 0.000 claims 2
- 239000011368 organic material Substances 0.000 claims 2
- AGBQKNBQESQNJD-SSDOTTSWSA-N (R)-lipoic acid Chemical compound OC(=O)CCCC[C@@H]1CCSS1 AGBQKNBQESQNJD-SSDOTTSWSA-N 0.000 claims 1
- 238000002360 preparation method Methods 0.000 abstract description 9
- AGBQKNBQESQNJD-UHFFFAOYSA-M lipoate Chemical compound [O-]C(=O)CCCCC1CCSS1 AGBQKNBQESQNJD-UHFFFAOYSA-M 0.000 abstract description 2
- 239000008186 active pharmaceutical agent Substances 0.000 description 48
- 238000010790 dilution Methods 0.000 description 24
- 239000012895 dilution Substances 0.000 description 24
- 238000004128 high performance liquid chromatography Methods 0.000 description 20
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 19
- 238000003756 stirring Methods 0.000 description 19
- 238000001914 filtration Methods 0.000 description 18
- 230000015556 catabolic process Effects 0.000 description 16
- 238000001816 cooling Methods 0.000 description 16
- 238000006731 degradation reaction Methods 0.000 description 16
- 229940093181 glucose injection Drugs 0.000 description 16
- 238000007865 diluting Methods 0.000 description 15
- 238000001802 infusion Methods 0.000 description 15
- 239000000843 powder Substances 0.000 description 11
- VEXZGXHMUGYJMC-UHFFFAOYSA-M Chloride anion Chemical compound [Cl-] VEXZGXHMUGYJMC-UHFFFAOYSA-M 0.000 description 10
- 239000007788 liquid Substances 0.000 description 10
- ZHSKUOZOLHMKEA-UHFFFAOYSA-N 4-[5-[bis(2-chloroethyl)amino]-1-methylbenzimidazol-2-yl]butanoic acid;hydron;chloride Chemical compound Cl.ClCCN(CCCl)C1=CC=C2N(C)C(CCCC(O)=O)=NC2=C1 ZHSKUOZOLHMKEA-UHFFFAOYSA-N 0.000 description 8
- 238000009472 formulation Methods 0.000 description 8
- 239000000243 solution Substances 0.000 description 8
- 238000001035 drying Methods 0.000 description 7
- 238000004108 freeze drying Methods 0.000 description 7
- 239000012535 impurity Substances 0.000 description 7
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 description 6
- 229940097362 cyclodextrins Drugs 0.000 description 6
- 239000007864 aqueous solution Substances 0.000 description 5
- 229940079593 drug Drugs 0.000 description 5
- 239000008176 lyophilized powder Substances 0.000 description 5
- 239000002504 physiological saline solution Substances 0.000 description 5
- 239000000047 product Substances 0.000 description 5
- 239000002904 solvent Substances 0.000 description 5
- -1 bendeka) Chemical compound 0.000 description 4
- 235000011175 beta-cyclodextrine Nutrition 0.000 description 4
- 229940090044 injection Drugs 0.000 description 4
- 238000003860 storage Methods 0.000 description 4
- 238000006467 substitution reaction Methods 0.000 description 4
- 229940066958 treanda Drugs 0.000 description 4
- 239000013065 commercial product Substances 0.000 description 3
- 238000004090 dissolution Methods 0.000 description 3
- 238000000634 powder X-ray diffraction Methods 0.000 description 3
- 238000001694 spray drying Methods 0.000 description 3
- 230000006641 stabilisation Effects 0.000 description 3
- 238000011105 stabilization Methods 0.000 description 3
- NLXLAEXVIDQMFP-UHFFFAOYSA-N Ammonia chloride Chemical compound [NH4+].[Cl-] NLXLAEXVIDQMFP-UHFFFAOYSA-N 0.000 description 2
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 2
- 206010020772 Hypertension Diseases 0.000 description 2
- 208000001647 Renal Insufficiency Diseases 0.000 description 2
- 239000002253 acid Substances 0.000 description 2
- 229960001215 bendamustine hydrochloride Drugs 0.000 description 2
- 229940038302 bendeka Drugs 0.000 description 2
- 238000002425 crystallisation Methods 0.000 description 2
- 230000008025 crystallization Effects 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 230000006872 improvement Effects 0.000 description 2
- 201000006370 kidney failure Diseases 0.000 description 2
- 230000009467 reduction Effects 0.000 description 2
- 239000008354 sodium chloride injection Substances 0.000 description 2
- 230000002195 synergetic effect Effects 0.000 description 2
- NWUYHJFMYQTDRP-UHFFFAOYSA-N 1,2-bis(ethenyl)benzene;1-ethenyl-2-ethylbenzene;styrene Chemical compound C=CC1=CC=CC=C1.CCC1=CC=CC=C1C=C.C=CC1=CC=CC=C1C=C NWUYHJFMYQTDRP-UHFFFAOYSA-N 0.000 description 1
- 229920001450 Alpha-Cyclodextrin Polymers 0.000 description 1
- 206010003445 Ascites Diseases 0.000 description 1
- 206010048962 Brain oedema Diseases 0.000 description 1
- 206010007559 Cardiac failure congestive Diseases 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
- 206010016654 Fibrosis Diseases 0.000 description 1
- 206010019280 Heart failures Diseases 0.000 description 1
- 101000777134 Homo sapiens Ubiquitin carboxyl-terminal hydrolase 43 Proteins 0.000 description 1
- 208000031226 Hyperlipidaemia Diseases 0.000 description 1
- 208000019025 Hypokalemia Diseases 0.000 description 1
- 206010024119 Left ventricular failure Diseases 0.000 description 1
- 229930195725 Mannitol Natural products 0.000 description 1
- 206010030113 Oedema Diseases 0.000 description 1
- 102100031311 Ubiquitin carboxyl-terminal hydrolase 43 Human genes 0.000 description 1
- 230000002159 abnormal effect Effects 0.000 description 1
- 230000002378 acidificating effect Effects 0.000 description 1
- 230000001154 acute effect Effects 0.000 description 1
- 238000013019 agitation Methods 0.000 description 1
- HFHDHCJBZVLPGP-RWMJIURBSA-N alpha-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)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 HFHDHCJBZVLPGP-RWMJIURBSA-N 0.000 description 1
- 229940043377 alpha-cyclodextrin Drugs 0.000 description 1
- 235000019270 ammonium chloride Nutrition 0.000 description 1
- 206010003119 arrhythmia Diseases 0.000 description 1
- 230000006793 arrhythmia Effects 0.000 description 1
- 239000000022 bacteriostatic agent Substances 0.000 description 1
- 229940043761 bendamustine injection Drugs 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000008901 benefit Effects 0.000 description 1
- 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 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 208000006752 brain edema Diseases 0.000 description 1
- 238000005341 cation exchange Methods 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 230000007882 cirrhosis Effects 0.000 description 1
- 208000019425 cirrhosis of liver Diseases 0.000 description 1
- 239000013078 crystal Substances 0.000 description 1
- 238000000354 decomposition reaction Methods 0.000 description 1
- 230000007423 decrease Effects 0.000 description 1
- 230000003247 decreasing effect Effects 0.000 description 1
- 230000006735 deficit Effects 0.000 description 1
- 238000001212 derivatisation Methods 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 239000008121 dextrose Substances 0.000 description 1
- 206010012601 diabetes mellitus Diseases 0.000 description 1
- 150000002148 esters Chemical class 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 238000007710 freezing Methods 0.000 description 1
- 230000006870 function Effects 0.000 description 1
- 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 1
- 229940080345 gamma-cyclodextrin Drugs 0.000 description 1
- 230000004190 glucose uptake Effects 0.000 description 1
- 230000036541 health Effects 0.000 description 1
- 208000019622 heart disease Diseases 0.000 description 1
- 230000007062 hydrolysis Effects 0.000 description 1
- 238000006460 hydrolysis reaction Methods 0.000 description 1
- 201000001421 hyperglycemia Diseases 0.000 description 1
- 238000005286 illumination Methods 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
- 150000002484 inorganic compounds Chemical class 0.000 description 1
- 239000003456 ion exchange resin Substances 0.000 description 1
- 229920003303 ion-exchange polymer Polymers 0.000 description 1
- 230000003907 kidney function Effects 0.000 description 1
- 208000032839 leukemia Diseases 0.000 description 1
- 235000014659 low sodium diet Nutrition 0.000 description 1
- 239000000594 mannitol Substances 0.000 description 1
- 235000010355 mannitol Nutrition 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 230000007935 neutral effect Effects 0.000 description 1
- 150000002894 organic compounds Chemical class 0.000 description 1
- 230000003204 osmotic effect Effects 0.000 description 1
- 229920001282 polysaccharide Polymers 0.000 description 1
- 239000005017 polysaccharide Substances 0.000 description 1
- 208000024896 potassium deficiency disease Diseases 0.000 description 1
- 238000001556 precipitation Methods 0.000 description 1
- 239000003223 protective agent Substances 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 238000005057 refrigeration Methods 0.000 description 1
- 239000011734 sodium Substances 0.000 description 1
- 229910052708 sodium Inorganic materials 0.000 description 1
- 239000011343 solid material Substances 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
Images
Classifications
-
- 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
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/4164—1,3-Diazoles
- A61K31/4184—1,3-Diazoles condensed with carbocyclic rings, e.g. benzimidazoles
-
- 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
- A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
-
- 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
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
-
- 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
- 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
- A61K9/08—Solutions
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Inorganic Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Dermatology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
苯达莫司汀组合物及其用途,该组合物包含以下组分:a)苯达莫司汀或其盐,b)环糊精,c)任选的稳定剂,其中所述稳定剂选自含氯元素的无机物或有机物、硫辛酸、硫代甘油、聚乙烯吡咯烷酮以及它们的任意组合,并且其中所述苯达莫司汀或其盐与所述环糊精的质量比为1∶5~1∶100。并提供了一种使用所述组合物预防或治疗癌症的方法以及所述组合物在制备用于治疗癌症的药物中的用途。
Description
PCT国内申请,说明书已公开。
Claims (20)
- PCT国内申请,权利要求书已公开。
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
PCT/CN2020/084038 WO2021203377A1 (zh) | 2020-04-09 | 2020-04-09 | 苯达莫司汀组合物及其用途 |
Publications (1)
Publication Number | Publication Date |
---|---|
CN115379827A true CN115379827A (zh) | 2022-11-22 |
Family
ID=78022443
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CN202080099405.9A Pending CN115379827A (zh) | 2020-04-09 | 2020-04-09 | 苯达莫司汀组合物及其用途 |
Country Status (6)
Country | Link |
---|---|
US (1) | US20220304983A1 (zh) |
EP (1) | EP4134068A4 (zh) |
JP (1) | JP2023529033A (zh) |
CN (1) | CN115379827A (zh) |
CA (1) | CA3145107A1 (zh) |
WO (1) | WO2021203377A1 (zh) |
Families Citing this family (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20240148696A1 (en) * | 2022-10-25 | 2024-05-09 | Softkemo Pharma Inc. | Lyophilized bendamustine-cyclodextrin composition |
CN115770248B (zh) * | 2022-12-07 | 2023-08-04 | 郑州大学第一附属医院 | 一种盐酸伊伐布雷定制剂及其制备方法 |
Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101606934A (zh) * | 2009-07-27 | 2009-12-23 | 江苏奥赛康药业有限公司 | 盐酸苯达莫司汀组合物 |
CN102421451A (zh) * | 2009-02-25 | 2012-04-18 | 休普拉特克药品有限公司 | 苯达莫司汀环多糖组合物 |
CN103228296A (zh) * | 2010-07-19 | 2013-07-31 | 速沛达制药公司 | 苯达莫司汀阴离子-阳离子型环聚糖组合物 |
Family Cites Families (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
KR102450975B1 (ko) * | 2017-10-05 | 2022-10-07 | 튜브 파마수티칼스 게엠베하 | 경구 벤다무스틴 제형 |
CN111557904A (zh) * | 2020-04-09 | 2020-08-21 | 比卡生物科技(广州)有限公司 | 苯达莫司汀组合物及其用途 |
-
2020
- 2020-04-09 WO PCT/CN2020/084038 patent/WO2021203377A1/zh unknown
- 2020-04-09 EP EP20929900.7A patent/EP4134068A4/en active Pending
- 2020-04-09 CN CN202080099405.9A patent/CN115379827A/zh active Pending
- 2020-04-09 CA CA3145107A patent/CA3145107A1/en active Pending
- 2020-04-09 JP JP2022501141A patent/JP2023529033A/ja active Pending
- 2020-04-09 US US17/635,902 patent/US20220304983A1/en active Pending
Patent Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN102421451A (zh) * | 2009-02-25 | 2012-04-18 | 休普拉特克药品有限公司 | 苯达莫司汀环多糖组合物 |
CN101606934A (zh) * | 2009-07-27 | 2009-12-23 | 江苏奥赛康药业有限公司 | 盐酸苯达莫司汀组合物 |
CN103228296A (zh) * | 2010-07-19 | 2013-07-31 | 速沛达制药公司 | 苯达莫司汀阴离子-阳离子型环聚糖组合物 |
Also Published As
Publication number | Publication date |
---|---|
CA3145107A1 (en) | 2021-10-14 |
EP4134068A1 (en) | 2023-02-15 |
US20220304983A1 (en) | 2022-09-29 |
WO2021203377A1 (zh) | 2021-10-14 |
EP4134068A4 (en) | 2024-02-07 |
JP2023529033A (ja) | 2023-07-07 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
CN111093674B (zh) | 一种磺酰脲类药物的药物组合物及其制备方法 | |
JP6407221B2 (ja) | 抗菌性組成物 | |
CN115379827A (zh) | 苯达莫司汀组合物及其用途 | |
MX2008014948A (es) | Composicion farmaceutica estable que contiene docetaxel, y un metodo para fabricarla. | |
NO329382B1 (no) | 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 | |
EP2720723A1 (en) | Stabilized voriconazole composition | |
EP2827862A1 (en) | Formulations of bendamustine | |
JP2002507582A (ja) | 鉄欠乏症の予防または治療のための治療組成物の成分として用いる鉄−デキストラン化合物、前記鉄−デキストラン化合物の製造法、および非経口投与可能な治療組成物の製造のための前記化合物の使用 | |
CN108366963A (zh) | 包含丹曲林的水性组合物 | |
CN101744778A (zh) | 一种注射用伏立康唑磷酸酯及其制备方法 | |
CN111557904A (zh) | 苯达莫司汀组合物及其用途 | |
JPS59152320A (ja) | 水性製剤 | |
WO2016110225A1 (zh) | 一种磺酰胺类药物组合物 | |
CN102688183B (zh) | 一种稳定的盐酸莫西沙星注射剂 | |
USRE24642E (en) | Therapeutic preparations of iron | |
CN104940135A (zh) | 一种氟康唑注射液及其制备方法 | |
EP3687498A1 (en) | Parenteral formulation comprising siponimod | |
CN115746408A (zh) | 用于腹膜透析的新颖的葡萄糖聚合物 | |
WO2013026694A1 (en) | Pharmaceutical compositions comprising voriconazole | |
CN109078001A (zh) | 一种新型万古霉素纳米脂质体组合物及其制备方法 | |
EP2253329B1 (en) | Ibuprofen lysinate oral suspension | |
JP7267640B2 (ja) | 希釈安定性に優れたテニポシド注射用溶液及びその調製方法 | |
WO2024117070A1 (ja) | ナフタレン誘導体の眼科疾患用治療薬 | |
CN114617843A (zh) | 一种米力农注射液及其制备方法和应用 | |
WO2022147743A1 (en) | Pharmaceutical compositions of chemotherapeutic agents based on beta-substituted beta-amino acid derivatives |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
PB01 | Publication | ||
PB01 | Publication | ||
SE01 | Entry into force of request for substantive examination | ||
SE01 | Entry into force of request for substantive examination | ||
REG | Reference to a national code |
Ref country code: HK Ref legal event code: DE Ref document number: 40075585 Country of ref document: HK |