CN112957334B - 含alpelisib的药物组合物 - Google Patents

含alpelisib的药物组合物 Download PDF

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Publication number
CN112957334B
CN112957334B CN202110187770.1A CN202110187770A CN112957334B CN 112957334 B CN112957334 B CN 112957334B CN 202110187770 A CN202110187770 A CN 202110187770A CN 112957334 B CN112957334 B CN 112957334B
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tablet
amide
total weight
pharmaceutically acceptable
dispersible
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Chinese (zh)
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CN112957334A (zh
Inventor
F·艾尔巴茨
C·科赫哈
D·斯丁奇林
M·A·M·博克
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Novartis AG
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Novartis AG
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    • 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
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/10—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of compressed tablets
    • 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
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
    • A61K31/4439—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole
    • 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
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445—Non condensed piperidines, e.g. piperocaine
    • A61K31/4523—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems
    • A61K31/454—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. pimozide, domperidone
    • 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
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • 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
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • 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
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • 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
    • 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
    • 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
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • 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
    • A61K9/2095—Tabletting processes
    • 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
    • A61P35/02—Antineoplastic agents specific for leukemia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Physiology (AREA)
  • Dispersion Chemistry (AREA)
  • Nutrition Science (AREA)
  • Engineering & Computer Science (AREA)
  • Inorganic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Hematology (AREA)
  • Oncology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Zoology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Plural Heterocyclic Compounds (AREA)
CN202110187770.1A 2014-10-03 2015-10-01 含alpelisib的药物组合物 Active CN112957334B (zh)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN202110187770.1A CN112957334B (zh) 2014-10-03 2015-10-01 含alpelisib的药物组合物

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201462059331P 2014-10-03 2014-10-03
US62/059,331 2014-10-03
CN202110187770.1A CN112957334B (zh) 2014-10-03 2015-10-01 含alpelisib的药物组合物
PCT/IB2015/057523 WO2016051374A1 (en) 2014-10-03 2015-10-01 Pharmaceutical compositions comprising alpelisib
CN201580054000.2A CN107106497A (zh) 2014-10-03 2015-10-01 含alpelisib的药物组合物

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
CN201580054000.2A Division CN107106497A (zh) 2014-10-03 2015-10-01 含alpelisib的药物组合物

Publications (2)

Publication Number Publication Date
CN112957334A CN112957334A (zh) 2021-06-15
CN112957334B true CN112957334B (zh) 2023-08-04

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CN202110187770.1A Active CN112957334B (zh) 2014-10-03 2015-10-01 含alpelisib的药物组合物
CN201580054000.2A Pending CN107106497A (zh) 2014-10-03 2015-10-01 含alpelisib的药物组合物

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CN201580054000.2A Pending CN107106497A (zh) 2014-10-03 2015-10-01 含alpelisib的药物组合物

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US (3) US20170296523A1 (enExample)
EP (2) EP3200772B1 (enExample)
JP (1) JP6723229B2 (enExample)
KR (2) KR102598782B1 (enExample)
CN (2) CN112957334B (enExample)
AU (1) AU2015326392B2 (enExample)
BR (1) BR112017004694A2 (enExample)
CA (1) CA2962714C (enExample)
ES (1) ES2929554T3 (enExample)
MX (1) MX2017004359A (enExample)
PL (1) PL3200772T3 (enExample)
PT (1) PT3200772T (enExample)
RU (1) RU2690685C2 (enExample)
WO (1) WO2016051374A1 (enExample)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105919957A (zh) * 2016-06-13 2016-09-07 佛山市腾瑞医药科技有限公司 一种艾代拉利司分散片及其制备方法
DK3847157T3 (da) 2018-09-07 2022-08-08 Sanofi Sa Fremgangsmåde til fremstilling af methyl-[6-(2,4-dichlorphenyl)-5-[4-[(3s)-1-(3-fluorpropyl)pyrrolidin-3-yl]oxyphenyl]-8,9-dihydro-7h-benzo[7]annulen-2-carboxylat] og salt deraf
WO2021063967A1 (en) 2019-10-01 2021-04-08 Sanofi Novel substituted 6,7-dihydro-5h-benzo[7]annulene compounds, processes for their preparation and therapeutic uses thereof
CA3160897A1 (en) 2019-12-09 2021-06-17 Sanofi Crystalline form of a 7h-benzo[7]annulene-2-carboxylic acid derivative
TW202146007A (zh) 2020-02-27 2021-12-16 法商賽諾菲公司 包含阿培利司（ａｌｐｅｌｉｓｉｂ）與６－（２，４－二氯苯基）－５－［４－［（３ｓ）－１－（３－氟丙基）吡咯啶－３－基］氧苯基］－８，９－二氫－７ｈ－苯并［７］輪烯－２－羧酸之組合
IL302153B1 (en) 2020-10-19 2026-07-01 Sanofi Sa 6,7-DIHYDRO-5H-BENZO[7]ANNULENE COMPOUNDS AND THEIR DERIVATIVES, PROCESSES FOR THEIR PREPARATION AND THEIR THERAPEUTIC USES
IL302152B1 (en) 2020-10-19 2026-07-01 Sanofi Sa 6,7-DIHYDRO-5H-BENZO[7]ANNULENE COMPOUNDS AND THEIR DERIVATIVES, PROCESSES FOR THEIR PREPARATION AND THEIR THERAPEUTIC USES
AU2022232924A1 (en) * 2021-03-11 2023-07-06 Atossa Therapeutics, Inc. Endoxifen for treatment of ovarian cancer
WO2022234408A1 (en) * 2021-05-03 2022-11-10 Novartis Ag Alpelisib formulation

Citations (4)

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Publication number Priority date Publication date Assignee Title
US5747068A (en) * 1994-07-20 1998-05-05 Lilly S. A. Flouxetine pharmaceutical formulations
WO2012175522A1 (en) * 2011-06-21 2012-12-27 Novartis Ag Polymorphs of (s)-pyrrolidine-1,2-dicarboxylic acid 2-amide 1-({4-methyl-5-[2-(2,2,2-trifluoro-1,1-dimethyl-ethyl)-pyridin-4-yl]-thiazol-2-yl}-amide
WO2013144249A1 (en) * 2012-03-29 2013-10-03 Novartis Ag Pharmaceutical diagnostic
WO2013161823A1 (ja) * 2012-04-24 2013-10-31 第一三共株式会社 口腔内崩壊錠及びその製造方法

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US5698226A (en) * 1993-07-13 1997-12-16 Glaxo Wellcome Inc. Water-dispersible tablets
UA104147C2 (uk) 2008-09-10 2014-01-10 Новартис Аг Похідна піролідиндикарбонової кислоти та її застосування у лікуванні проліферативних захворювань
WO2011080502A2 (en) * 2009-12-29 2011-07-07 Orexo Ab New pharmaceutical dosage form for the treatment of gastric acid-related disorders
AR082418A1 (es) * 2010-08-02 2012-12-05 Novartis Ag Formas cristalinas de 1-(4-metil-5-[2-(2,2,2-trifluoro-1,1-dimetil-etil)-piridin-4-il]-tiazol-2-il)-amida de 2-amida del acido (s)-pirrolidin-1,2-dicarboxilico
WO2012148846A1 (en) * 2011-04-25 2012-11-01 Novartis Ag Combination of a phosphatidylinositol-3-kinase (pi3k) inhibitor and a mtor inhibitor
WO2012170488A1 (en) * 2011-06-07 2012-12-13 Zx Pharma, Llc Multiparticulate s-adenosylmethionine compositions and related methods
WO2014007780A1 (en) * 2012-07-06 2014-01-09 Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi Orally-disintegrating formulations of dexketoprofen
EP2742940B1 (en) * 2012-12-13 2017-07-26 IP Gesellschaft für Management mbH Fumarate salt of (R)-3-(6-(4-methylphenyl)-pyridin-3-yloxy)-l-aza-bicyclo-[2.2.2]octane for adminstration once daily, twice daily or thrice daily

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5747068A (en) * 1994-07-20 1998-05-05 Lilly S. A. Flouxetine pharmaceutical formulations
WO2012175522A1 (en) * 2011-06-21 2012-12-27 Novartis Ag Polymorphs of (s)-pyrrolidine-1,2-dicarboxylic acid 2-amide 1-({4-methyl-5-[2-(2,2,2-trifluoro-1,1-dimethyl-ethyl)-pyridin-4-yl]-thiazol-2-yl}-amide
WO2013144249A1 (en) * 2012-03-29 2013-10-03 Novartis Ag Pharmaceutical diagnostic
WO2013161823A1 (ja) * 2012-04-24 2013-10-31 第一三共株式会社 口腔内崩壊錠及びその製造方法

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RU2017114195A (ru) 2018-11-08
EP3200772A1 (en) 2017-08-09
RU2690685C2 (ru) 2019-06-05
MX2017004359A (es) 2017-06-23
CN112957334A (zh) 2021-06-15
JP6723229B2 (ja) 2020-07-15
EP3200772B1 (en) 2022-08-03
ES2929554T3 (es) 2022-11-30
KR20170056574A (ko) 2017-05-23
CA2962714A1 (en) 2016-04-07
EP4169508B1 (en) 2026-05-20
JP2017530143A (ja) 2017-10-12
US20220331305A1 (en) 2022-10-20
KR102486126B1 (ko) 2023-01-09
CN107106497A (zh) 2017-08-29
US20170296523A1 (en) 2017-10-19
EP4169508A1 (en) 2023-04-26
US20190314353A1 (en) 2019-10-17
WO2016051374A1 (en) 2016-04-07
AU2015326392B2 (en) 2018-10-04
BR112017004694A2 (pt) 2017-12-05
KR20230008913A (ko) 2023-01-16
PT3200772T (pt) 2022-10-19
AU2015326392A1 (en) 2017-03-09
PL3200772T3 (pl) 2022-12-19
KR102598782B1 (ko) 2023-11-07
CA2962714C (en) 2023-09-19
RU2017114195A3 (enExample) 2018-11-16

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