AU2015319831B2 - Crystalline forms of trisodium supramolecular complex comprising valsartan and AHU-377 and methods thereof - Google Patents

Crystalline forms of trisodium supramolecular complex comprising valsartan and AHU-377 and methods thereof Download PDF

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AU2015319831B2
AU2015319831B2 AU2015319831A AU2015319831A AU2015319831B2 AU 2015319831 B2 AU2015319831 B2 AU 2015319831B2 AU 2015319831 A AU2015319831 A AU 2015319831A AU 2015319831 A AU2015319831 A AU 2015319831A AU 2015319831 B2 AU2015319831 B2 AU 2015319831B2
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crystalline form
ray powder
biphenyl
ylmethyl
diffraction pattern
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AU2015319831A1 (en
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Minhua Chen
Jiaoyang LI
Pixu Li
Peng Wang
Chaohui YANG
Xiaoyu Zhang
Yanfeng Zhang
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SUZHOU PENGXU PHARMATECH Co Ltd
Crystal Pharmatech Co Ltd
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SUZHOU PENGXU PHARMATECH CO Ltd
Crystal Pharmatech Co Ltd
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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D257/00—Heterocyclic compounds containing rings having four nitrogen atoms as the only ring hetero atoms
    • C07D257/02—Heterocyclic compounds containing rings having four nitrogen atoms as the only ring hetero atoms not condensed with other rings
    • C07D257/04—Five-membered rings
    • 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
    • A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/22—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
    • A61K31/225—Polycarboxylic acids
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • 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
    • A61P13/12—Drugs for disorders of the urinary system of the kidneys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/06—Antihyperlipidemics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/38—Drugs for disorders of the endocrine system of the suprarenal hormones
    • A61P5/42—Drugs for disorders of the endocrine system of the suprarenal hormones for decreasing, blocking or antagonising the activity of mineralocorticosteroids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/04—Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/06—Antiarrhythmics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/12—Antihypertensives
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C233/00—Carboxylic acid amides
    • C07C233/01—Carboxylic acid amides having carbon atoms of carboxamide groups bound to hydrogen atoms or to acyclic carbon atoms
    • C07C233/45—Carboxylic acid amides having carbon atoms of carboxamide groups bound to hydrogen atoms or to acyclic carbon atoms having the nitrogen atom of at least one of the carboxamide groups bound to a carbon atom of a hydrocarbon radical substituted by carboxyl groups
    • C07C233/46—Carboxylic acid amides having carbon atoms of carboxamide groups bound to hydrogen atoms or to acyclic carbon atoms having the nitrogen atom of at least one of the carboxamide groups bound to a carbon atom of a hydrocarbon radical substituted by carboxyl groups with the substituted hydrocarbon radical bound to the nitrogen atom of the carboxamide group by an acyclic carbon atom
    • C07C233/47—Carboxylic acid amides having carbon atoms of carboxamide groups bound to hydrogen atoms or to acyclic carbon atoms having the nitrogen atom of at least one of the carboxamide groups bound to a carbon atom of a hydrocarbon radical substituted by carboxyl groups with the substituted hydrocarbon radical bound to the nitrogen atom of the carboxamide group by an acyclic carbon atom having the carbon atom of the carboxamide group bound to a hydrogen atom or to a carbon atom of an acyclic saturated carbon skeleton
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07B—GENERAL METHODS OF ORGANIC CHEMISTRY; APPARATUS THEREFOR
    • C07B2200/00—Indexing scheme relating to specific properties of organic compounds
    • C07B2200/13—Crystalline forms, e.g. polymorphs

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Diabetes (AREA)
  • Epidemiology (AREA)
  • Emergency Medicine (AREA)
  • Endocrinology (AREA)
  • Obesity (AREA)
  • Urology & Nephrology (AREA)
  • Hematology (AREA)
  • Hospice & Palliative Care (AREA)
  • Vascular Medicine (AREA)
  • Pulmonology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
AU2015319831A 2014-12-08 2015-12-08 Crystalline forms of trisodium supramolecular complex comprising valsartan and AHU-377 and methods thereof Active AU2015319831B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201462089225P 2014-12-08 2014-12-08
US62/089,225 2014-12-08
PCT/US2015/064432 WO2016049663A1 (en) 2014-12-08 2015-12-08 Crystalline forms of trisodium supramolecular complex comprising valsartan and ahu-377 and methods thereof

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AU2015319831A1 AU2015319831A1 (en) 2017-07-20
AU2015319831B2 true AU2015319831B2 (en) 2019-02-14

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US (2) US9957240B2 (enExample)
EP (2) EP3443960A1 (enExample)
JP (3) JP2017537120A (enExample)
CN (3) CN110938042B (enExample)
AU (1) AU2015319831B2 (enExample)
CA (1) CA2970192C (enExample)
DK (1) DK3229799T3 (enExample)
ES (1) ES2706948T3 (enExample)
HU (1) HUE043014T2 (enExample)
IL (2) IL252740A0 (enExample)
MX (1) MX383336B (enExample)
PL (1) PL3229799T3 (enExample)
PT (1) PT3229799T (enExample)
SI (1) SI3229799T1 (enExample)
TR (1) TR201900360T4 (enExample)
WO (1) WO2016049663A1 (enExample)

Families Citing this family (22)

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AR057882A1 (es) 2005-11-09 2007-12-26 Novartis Ag Compuestos de accion doble de bloqueadores del receptor de angiotensina e inhibidores de endopeptidasa neutra
WO2016037552A1 (zh) * 2014-09-09 2016-03-17 上海翰森生物医药科技有限公司 结晶型ARB-NEPi复合物及其制备方法和应用
AU2015319831B2 (en) 2014-12-08 2019-02-14 Crystal Pharmatech Co., Ltd. Crystalline forms of trisodium supramolecular complex comprising valsartan and AHU-377 and methods thereof
EP3307720A1 (en) * 2015-06-12 2018-04-18 Teva Pharmaceuticals International GmbH Solid state forms of trisodium valsartan: sacubitril
CN105037289B (zh) * 2015-07-17 2017-08-22 华东理工大学 血管紧张素受体拮抗剂和中性内肽酶抑制剂超分子复合体的新晶型
WO2017012600A1 (en) * 2015-07-20 2017-01-26 Zentiva, K.S. A pharmaceutical composition containing valsartan and sacubitril and methods for preparation and stabilization thereof
CN106854187B (zh) * 2015-12-08 2020-04-14 苏州晶云药物科技股份有限公司 一种ahu-377和缬沙坦三钠盐共晶水合物晶型ii的制备方法
CN106905253B (zh) * 2015-12-23 2020-01-03 正大天晴药业集团股份有限公司 一种超分子复合物的结晶
CN105753733B (zh) * 2016-04-15 2019-06-18 苏州晶云药物科技股份有限公司 Ahu377的晶型及其制备方法与用途
US10683260B2 (en) * 2016-09-07 2020-06-16 Nanjing Noratech Pharmaceuticals Co., Ltd. Crystalline form of sacubitril sodium salt
US10857132B2 (en) 2016-10-10 2020-12-08 Laurus Labs Limited Stable amorphous form of sacubitril valsartan trisodium complex and processes for preparation thereof
CN110713465A (zh) * 2017-01-03 2020-01-21 上海博志研新药物技术有限公司 ARB-NEPi复合物、晶型、制备方法及应用
CN108299323A (zh) * 2017-01-11 2018-07-20 上海迪赛诺药业股份有限公司 一种抗心衰共晶化合物的新晶型
WO2018178295A1 (en) 2017-03-31 2018-10-04 Alfred E. Tiefenbacher (Gmbh & Co. Kg) Stable hot-melt extrudate containing valsartan and sacubitril
WO2019073062A1 (en) 2017-10-13 2019-04-18 Alfred E. Tiefenbacher (Gmbh & Co. Kg) TABLET CONTAINING VALSARTAN AND SACUBITRIL
WO2019239432A1 (en) 2018-06-14 2019-12-19 Cipla Limited Trisodium sacubitril valsartan complex and hot-melt extruded pharmaceutical composition comprising thereof
KR20210032437A (ko) 2018-08-23 2021-03-24 노파르티스 아게 심부전의 치료를 위한 신규한 약제학적 용도
WO2020039394A1 (en) 2018-08-24 2020-02-27 Novartis Ag New drug combinations
CN111253330B (zh) * 2020-02-29 2023-01-24 广州白云山天心制药股份有限公司 沙坦类药物的新晶型及其制备方法和用途
KR102858594B1 (ko) * 2020-10-08 2025-09-11 한미약품 주식회사 사쿠비트릴 및 발사르탄 나트륨염을 포함하는 경구용 고형제제
CN115745904A (zh) * 2022-09-29 2023-03-07 浙江美诺华药物化学有限公司 一种沙库巴曲缬沙坦钠共晶物的制备方法
CN118141930A (zh) * 2024-03-26 2024-06-07 迪沙药业集团有限公司 沙坦类药物组合物及其制备方法

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JP3796763B2 (ja) * 1994-04-01 2006-07-12 東ソー株式会社 結晶形２，２−ビス（３，５−ジブロモ−４−ジブロモプロポキシフェニル）プロパン及びその製造方法
EP1467728B1 (en) * 2002-01-17 2007-08-22 Novartis AG Pharmaceutical compositions comprising valsartan and nep inhibitors
AR057882A1 (es) 2005-11-09 2007-12-26 Novartis Ag Compuestos de accion doble de bloqueadores del receptor de angiotensina e inhibidores de endopeptidasa neutra
FR2897060B1 (fr) * 2006-02-08 2008-07-25 Sanofi Aventis Sa Le monohydrate de rimonabant, son procede de preparation et les compositions pharmaceutiques en contenant
US7994238B2 (en) * 2007-09-04 2011-08-09 General Electric Company Article and associated method
DK2217205T3 (en) 2007-11-06 2015-05-11 Novartis Ag DOUBLE-ACTING PHARMACEUTICAL COMPOSITIONS BASED ON SUPER STRUCTURES OF ANGIOTENSINRECEPTORANTAGONIST / blocker (ARB) AND NEUTRAL endopeptidase (NEP) INHIBITOR
MA34483B1 (fr) 2010-08-24 2013-08-01 Novartis Ag Traitement de l'hypertension et/ou prévention ou traitement de l'insuffisance cardiaque l'insuffisance cardiaque chez un mammifère recevant une therapie anticoagulante
JP5809367B2 (ja) * 2013-04-24 2015-11-10 あすか製薬株式会社 レボノルゲストレルの結晶多形α及びその製造方法
AU2015319831B2 (en) 2014-12-08 2019-02-14 Crystal Pharmatech Co., Ltd. Crystalline forms of trisodium supramolecular complex comprising valsartan and AHU-377 and methods thereof
CN104860894B (zh) * 2015-06-10 2017-05-17 北京博全健医药科技有限公司 一种抗心衰药lcz696的制备方法
EP3307720A1 (en) 2015-06-12 2018-04-18 Teva Pharmaceuticals International GmbH Solid state forms of trisodium valsartan: sacubitril
CN105037289B (zh) * 2015-07-17 2017-08-22 华东理工大学 血管紧张素受体拮抗剂和中性内肽酶抑制剂超分子复合体的新晶型
CN106854187B (zh) * 2015-12-08 2020-04-14 苏州晶云药物科技股份有限公司 一种ahu-377和缬沙坦三钠盐共晶水合物晶型ii的制备方法

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US9957240B2 (en) 2018-05-01
CN105873586A (zh) 2016-08-17
EP3229799A1 (en) 2017-10-18
CA2970192A1 (en) 2016-03-31
US10508087B2 (en) 2019-12-17
HUE043014T2 (hu) 2019-07-29
CN105873586B (zh) 2019-09-13
CN110938042B (zh) 2022-12-13
EP3229799B1 (en) 2018-10-17
PT3229799T (pt) 2019-01-29
US20170362189A1 (en) 2017-12-21
IL276233B1 (en) 2023-03-01
CN110938042A (zh) 2020-03-31
JP2017537120A (ja) 2017-12-14
PL3229799T3 (pl) 2019-05-31
CN110922366A (zh) 2020-03-27
EP3443960A1 (en) 2019-02-20
IL252740A0 (en) 2017-08-31
US20180201589A1 (en) 2018-07-19
CA2970192C (en) 2020-08-04
JP2018168180A (ja) 2018-11-01
MX383336B (es) 2025-03-11
MX2017007426A (es) 2018-04-20
DK3229799T3 (en) 2019-02-11
JP2020203936A (ja) 2020-12-24
SI3229799T1 (sl) 2019-03-29
IL276233B2 (en) 2023-07-01
AU2015319831A1 (en) 2017-07-20
ES2706948T3 (es) 2019-04-01
TR201900360T4 (tr) 2019-02-21
EP3229799A4 (en) 2017-10-18
WO2016049663A1 (en) 2016-03-31
CN110922366B (zh) 2023-02-03
IL276233A (en) 2020-09-30

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