CN106687112A - 醋酸阿比特龙制剂和使用方法 - Google Patents
醋酸阿比特龙制剂和使用方法 Download PDFInfo
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- CN106687112A CN106687112A CN201580050453.8A CN201580050453A CN106687112A CN 106687112 A CN106687112 A CN 106687112A CN 201580050453 A CN201580050453 A CN 201580050453A CN 106687112 A CN106687112 A CN 106687112A
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- Prior art keywords
- abiraterone acetate
- less
- dosage
- abiraterone
- composition
- Prior art date
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- UVIQSJCZCSLXRZ-UBUQANBQSA-N abiraterone acetate Chemical compound C([C@@H]1[C@]2(C)CC[C@@H]3[C@@]4(C)CC[C@@H](CC4=CC[C@H]31)OC(=O)C)C=C2C1=CC=CN=C1 UVIQSJCZCSLXRZ-UBUQANBQSA-N 0.000 title claims abstract description 270
- 229960004103 abiraterone acetate Drugs 0.000 title claims abstract description 265
- 239000000203 mixture Substances 0.000 title claims abstract description 140
- 238000000034 method Methods 0.000 title claims abstract description 104
- 238000009472 formulation Methods 0.000 title claims description 20
- 239000002552 dosage form Substances 0.000 claims abstract description 51
- 239000008194 pharmaceutical composition Substances 0.000 claims abstract description 19
- -1 Abiraterone acetates Chemical class 0.000 claims description 159
- 238000000227 grinding Methods 0.000 claims description 126
- RCEAADKTGXTDOA-UHFFFAOYSA-N OS(O)(=O)=O.CCCCCCCCCCCC[Na] Chemical compound OS(O)(=O)=O.CCCCCCCCCCCC[Na] RCEAADKTGXTDOA-UHFFFAOYSA-N 0.000 claims description 124
- 238000004090 dissolution Methods 0.000 claims description 66
- 239000002245 particle Substances 0.000 claims description 64
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 claims description 59
- 229960000853 abiraterone Drugs 0.000 claims description 38
- 239000003814 drug Substances 0.000 claims description 34
- 238000009837 dry grinding Methods 0.000 claims description 31
- 239000003153 chemical reaction reagent Substances 0.000 claims description 25
- 229910019142 PO4 Inorganic materials 0.000 claims description 24
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- 238000012360 testing method Methods 0.000 claims description 24
- GZOSMCIZMLWJML-VJLLXTKPSA-N abiraterone Chemical compound C([C@H]1[C@H]2[C@@H]([C@]3(CC[C@H](O)CC3=CC2)C)CC[C@@]11C)C=C1C1=CC=CN=C1 GZOSMCIZMLWJML-VJLLXTKPSA-N 0.000 claims description 21
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 claims description 21
- 239000003795 chemical substances by application Substances 0.000 claims description 19
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims description 19
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- FEWJPZIEWOKRBE-UHFFFAOYSA-N Tartaric acid Natural products [H+].[H+].[O-]C(=O)C(O)C(O)C([O-])=O FEWJPZIEWOKRBE-UHFFFAOYSA-N 0.000 claims description 14
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- 235000019345 sodium thiosulphate Nutrition 0.000 description 1
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- QORWJWZARLRLPR-UHFFFAOYSA-H tricalcium bis(phosphate) Chemical compound [Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O QORWJWZARLRLPR-UHFFFAOYSA-H 0.000 description 1
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- 229910052721 tungsten Inorganic materials 0.000 description 1
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Classifications
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- 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
- A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
- A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
-
- 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
- A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
- A61P13/08—Drugs for disorders of the urinary system of the prostate
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Urology & Nephrology (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Epoxy Compounds (AREA)
Applications Claiming Priority (5)
Application Number | Priority Date | Filing Date | Title |
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US201462052294P | 2014-09-18 | 2014-09-18 | |
US62/052,294 | 2014-09-18 | ||
US14/707,922 US20150246060A1 (en) | 2013-03-15 | 2015-05-08 | Abiraterone Acetate Formulation and Methods of Use |
US14/707,922 | 2015-05-08 | ||
PCT/US2015/050889 WO2016044701A1 (en) | 2014-09-18 | 2015-09-18 | Abiraterone acetate formulation and methods of use |
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CN106687112A true CN106687112A (zh) | 2017-05-17 |
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CN201580050453.8A Pending CN106687112A (zh) | 2014-09-18 | 2015-09-18 | 醋酸阿比特龙制剂和使用方法 |
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Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN110742870A (zh) * | 2019-12-04 | 2020-02-04 | 武汉大学 | 醋酸阿比特龙制剂及其制备方法 |
CN111110646A (zh) * | 2020-02-19 | 2020-05-08 | 纳兰迦(上海)生物医药科技有限公司 | 一种低规格醋酸阿比特龙口服制剂的处方及制备方法 |
Families Citing this family (11)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP3280448B1 (en) | 2015-04-10 | 2020-12-30 | Capsugel Belgium NV | Abiraterone acetate lipid formulations |
CN110891549A (zh) | 2017-04-07 | 2020-03-17 | 玛亚实验室公司 | 改善治疗剂的溶解度和生物利用度的方法 |
CN113473974A (zh) * | 2019-01-25 | 2021-10-01 | 深圳市药欣生物科技有限公司 | 药物组合物 |
CA3131034A1 (en) | 2019-03-06 | 2020-09-10 | Matthew J. Sharp | Abiraterone prodrugs |
CN113384542B (zh) * | 2020-03-14 | 2024-03-29 | 鲁南制药集团股份有限公司 | 一种甾体cyp17抑制剂固体分散体的片剂及其制备方法 |
KR20220166856A (ko) * | 2020-04-16 | 2022-12-19 | 타반타 테라퓨틱스 헝가리 인코포레이티드 | 전립선암을 치료하기 위한 방법 및 조성물 |
CA3177094A1 (en) * | 2020-05-08 | 2021-11-11 | Janssen Pharmaceutica Nv | Treatment of prostate cancer with a combination of abiraterone acetate and niraparib |
EP3944860A1 (en) | 2020-07-30 | 2022-02-02 | Galenicum Health S.L.U. | Abiraterone for use in a method of treating cancer |
CA3207282A1 (en) | 2021-02-15 | 2022-08-18 | Matthew J. Sharp | Abiraterone prodrugs |
KR20240044329A (ko) | 2022-09-28 | 2024-04-04 | 한미약품 주식회사 | 아비라테론 아세테이트 및 프레드니솔론을 포함하는 경구용 복합정제 |
KR20240145412A (ko) | 2023-03-27 | 2024-10-07 | 한미약품 주식회사 | 아비라테론 아세테이트 및 프레드니솔론을 포함하는 약제학적 제제 및 이의 제조방법 |
Citations (2)
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WO2013164473A1 (en) * | 2012-05-04 | 2013-11-07 | Jagotec Ag | Pharmaceutical composition comprising abiraterone acetate |
CN105246598A (zh) * | 2013-03-15 | 2016-01-13 | 艾塞尤提卡公司 | 乙酸阿比特龙酯制剂 |
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JP6141013B2 (ja) * | 2009-04-24 | 2017-06-07 | イシューティカ ピーティーワイ リミテッド | 商業的規模での封入ナノ粒子の製造 |
WO2014009436A1 (en) * | 2012-07-11 | 2014-01-16 | Sandoz Ag | Nanosuspension of abiraterone acetate |
WO2014009437A1 (en) * | 2012-07-11 | 2014-01-16 | Sandoz Ag | Oxidation stability of abiraterone acetate |
WO2014009434A1 (en) * | 2012-07-11 | 2014-01-16 | Sandoz Ag | Self-microemulsifying drug delivery system of abiraterone or abiraterone acetate |
CN102743393A (zh) * | 2012-07-27 | 2012-10-24 | 海南盛科生命科学研究院 | 一种含有醋酸阿比特龙的药物组合物及制备工艺 |
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- 2015-09-18 MD MDA20170048A patent/MD20170048A2/ro not_active Application Discontinuation
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Patent Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
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WO2013164473A1 (en) * | 2012-05-04 | 2013-11-07 | Jagotec Ag | Pharmaceutical composition comprising abiraterone acetate |
CN105246598A (zh) * | 2013-03-15 | 2016-01-13 | 艾塞尤提卡公司 | 乙酸阿比特龙酯制剂 |
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN110742870A (zh) * | 2019-12-04 | 2020-02-04 | 武汉大学 | 醋酸阿比特龙制剂及其制备方法 |
CN111110646A (zh) * | 2020-02-19 | 2020-05-08 | 纳兰迦(上海)生物医药科技有限公司 | 一种低规格醋酸阿比特龙口服制剂的处方及制备方法 |
Also Published As
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KR20230014878A (ko) | 2023-01-30 |
TN2017000098A1 (en) | 2018-10-19 |
KR20170070025A (ko) | 2017-06-21 |
KR102617537B1 (ko) | 2023-12-22 |
IL250270A0 (en) | 2017-03-30 |
JP2017528457A (ja) | 2017-09-28 |
IL250270B (en) | 2021-02-28 |
CO2017002472A2 (es) | 2017-07-11 |
EP3193857A4 (en) | 2018-04-11 |
MX2017003525A (es) | 2017-06-21 |
BR112017003219A2 (pt) | 2017-11-28 |
CA2958316A1 (en) | 2016-03-24 |
WO2016044701A1 (en) | 2016-03-24 |
AP2017009804A0 (en) | 2017-03-31 |
AU2015317466A1 (en) | 2017-02-23 |
PH12017500239A1 (en) | 2017-07-03 |
SG11201701139YA (en) | 2017-03-30 |
MD20170048A2 (ro) | 2017-08-31 |
EA201790650A1 (ru) | 2017-07-31 |
KR102491439B1 (ko) | 2023-01-25 |
EP3193857A1 (en) | 2017-07-26 |
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