JP2020203936A5 - - Google Patents
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- Publication number
- JP2020203936A5 JP2020203936A5 JP2020152967A JP2020152967A JP2020203936A5 JP 2020203936 A5 JP2020203936 A5 JP 2020203936A5 JP 2020152967 A JP2020152967 A JP 2020152967A JP 2020152967 A JP2020152967 A JP 2020152967A JP 2020203936 A5 JP2020203936 A5 JP 2020203936A5
- Authority
- JP
- Japan
- Prior art keywords
- crystalline polymorph
- ylmethyl
- biphenyl
- pharmaceutical
- heart failure
- 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
- FERIUCNNQQJTOY-UHFFFAOYSA-M Butyrate Chemical compound CCCC([O-])=O FERIUCNNQQJTOY-UHFFFAOYSA-M 0.000 claims description 5
- FERIUCNNQQJTOY-UHFFFAOYSA-N Butyric acid Natural products CCCC(O)=O FERIUCNNQQJTOY-UHFFFAOYSA-N 0.000 claims description 5
- RFTKDSUXTLVWOX-UHFFFAOYSA-N [Na].[Na].[Na].O Chemical compound [Na].[Na].[Na].O RFTKDSUXTLVWOX-UHFFFAOYSA-N 0.000 claims description 3
- 206010019280 Heart failures Diseases 0.000 claims 8
- 208000001647 Renal Insufficiency Diseases 0.000 claims 8
- 201000006370 kidney failure Diseases 0.000 claims 8
- 206010003658 Atrial Fibrillation Diseases 0.000 claims 7
- 238000004519 manufacturing process Methods 0.000 claims 6
- 206010002383 Angina Pectoris Diseases 0.000 claims 5
- 206010012601 diabetes mellitus Diseases 0.000 claims 5
- 201000010099 disease Diseases 0.000 claims 5
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 5
- 208000024891 symptom Diseases 0.000 claims 5
- 201000001320 Atherosclerosis Diseases 0.000 claims 4
- 206010007559 Cardiac failure congestive Diseases 0.000 claims 4
- 208000004248 Familial Primary Pulmonary Hypertension Diseases 0.000 claims 4
- 206010020772 Hypertension Diseases 0.000 claims 4
- 206010049694 Left Ventricular Dysfunction Diseases 0.000 claims 4
- 206010064911 Pulmonary arterial hypertension Diseases 0.000 claims 4
- 206010039808 Secondary aldosteronism Diseases 0.000 claims 4
- 206010042600 Supraventricular arrhythmias Diseases 0.000 claims 4
- 208000032594 Vascular Remodeling Diseases 0.000 claims 4
- 206010047281 Ventricular arrhythmia Diseases 0.000 claims 4
- 230000001969 hypertrophic effect Effects 0.000 claims 4
- 208000010125 myocardial infarction Diseases 0.000 claims 4
- 239000008194 pharmaceutical composition Substances 0.000 claims 4
- 201000008312 primary pulmonary hypertension Diseases 0.000 claims 4
- 208000037812 secondary pulmonary hypertension Diseases 0.000 claims 4
- 239000007787 solid Substances 0.000 claims 4
- 241000380490 Anguina Species 0.000 claims 3
- 206010003210 Arteriosclerosis Diseases 0.000 claims 3
- 208000032781 Diabetic cardiomyopathy Diseases 0.000 claims 3
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 claims 3
- YXFVVABEGXRONW-UHFFFAOYSA-N Toluene Chemical compound CC1=CC=CC=C1 YXFVVABEGXRONW-UHFFFAOYSA-N 0.000 claims 3
- 150000004945 aromatic hydrocarbons Chemical class 0.000 claims 3
- 208000011775 arteriosclerosis disease Diseases 0.000 claims 3
- 238000000634 powder X-ray diffraction Methods 0.000 claims 3
- 239000002904 solvent Substances 0.000 claims 3
- 102000003729 Neprilysin Human genes 0.000 claims 2
- 108090000028 Neprilysin Proteins 0.000 claims 2
- 239000013078 crystal Substances 0.000 claims 2
- 239000000945 filler Substances 0.000 claims 2
- 239000000314 lubricant Substances 0.000 claims 2
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims 2
- 238000002360 preparation method Methods 0.000 claims 2
- 230000005855 radiation Effects 0.000 claims 2
- HRXKRNGNAMMEHJ-UHFFFAOYSA-K trisodium citrate Chemical compound [Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O HRXKRNGNAMMEHJ-UHFFFAOYSA-K 0.000 claims 2
- 102000008873 Angiotensin II receptor Human genes 0.000 claims 1
- 108050000824 Angiotensin II receptor Proteins 0.000 claims 1
- 206010003662 Atrial flutter Diseases 0.000 claims 1
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims 1
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 claims 1
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims 1
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims 1
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical group O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims 1
- 230000001476 alcoholic effect Effects 0.000 claims 1
- 150000001298 alcohols Chemical class 0.000 claims 1
- 239000002775 capsule Substances 0.000 claims 1
- 239000003795 chemical substances by application Substances 0.000 claims 1
- 229940075614 colloidal silicon dioxide Drugs 0.000 claims 1
- FPAFDBFIGPHWGO-UHFFFAOYSA-N dioxosilane;oxomagnesium;hydrate Chemical group O.[Mg]=O.[Mg]=O.[Mg]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O FPAFDBFIGPHWGO-UHFFFAOYSA-N 0.000 claims 1
- 239000007884 disintegrant Substances 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 239000003937 drug carrier Substances 0.000 claims 1
- 230000000694 effects Effects 0.000 claims 1
- 230000005713 exacerbation Effects 0.000 claims 1
- 239000001863 hydroxypropyl cellulose Substances 0.000 claims 1
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 claims 1
- 235000019359 magnesium stearate Nutrition 0.000 claims 1
- 229940016286 microcrystalline cellulose Drugs 0.000 claims 1
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims 1
- 239000008108 microcrystalline cellulose Substances 0.000 claims 1
- 239000008177 pharmaceutical agent Substances 0.000 claims 1
- 239000000546 pharmaceutical excipient Substances 0.000 claims 1
- 239000000825 pharmaceutical preparation Substances 0.000 claims 1
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims 1
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims 1
- 229940069328 povidone Drugs 0.000 claims 1
- 239000002244 precipitate Substances 0.000 claims 1
- 238000003756 stirring Methods 0.000 claims 1
- 125000004299 tetrazol-5-yl group Chemical group [H]N1N=NC(*)=N1 0.000 description 1
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201462089225P | 2014-12-08 | 2014-12-08 | |
| US62/089,225 | 2014-12-08 |
Related Parent Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2018127088A Division JP2018168180A (ja) | 2014-12-08 | 2018-07-03 | バルサルタンおよびａｈｕ−３７７を含む三ナトリウム塩超分子複合体の新規な結晶形及びその製造方法 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JP2020203936A JP2020203936A (ja) | 2020-12-24 |
| JP2020203936A5 true JP2020203936A5 (enExample) | 2021-02-12 |
Family
ID=55582176
Family Applications (3)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2017530598A Pending JP2017537120A (ja) | 2014-12-08 | 2015-12-08 | バルサルタンおよびａｈｕ−３７７を含む三ナトリウム塩超分子複合体の新規な結晶形及びその製造方法 |
| JP2018127088A Pending JP2018168180A (ja) | 2014-12-08 | 2018-07-03 | バルサルタンおよびａｈｕ−３７７を含む三ナトリウム塩超分子複合体の新規な結晶形及びその製造方法 |
| JP2020152967A Pending JP2020203936A (ja) | 2014-12-08 | 2020-09-11 | バルサルタンおよびａｈｕ−３７７を含む三ナトリウム塩超分子複合体の新規な結晶形及びその製造方法 |
Family Applications Before (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2017530598A Pending JP2017537120A (ja) | 2014-12-08 | 2015-12-08 | バルサルタンおよびａｈｕ−３７７を含む三ナトリウム塩超分子複合体の新規な結晶形及びその製造方法 |
| JP2018127088A Pending JP2018168180A (ja) | 2014-12-08 | 2018-07-03 | バルサルタンおよびａｈｕ−３７７を含む三ナトリウム塩超分子複合体の新規な結晶形及びその製造方法 |
Country Status (16)
| Country | Link |
|---|---|
| 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)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| SI3229799T1 (sl) | 2014-12-08 | 2019-03-29 | Crystal Pharmatech Co., Ltd. | Kristalinične oblike trinatrijevega supramolekularnega kompleksa, ki obsega valsartan in AHU-377, ter njihovi postopki |
| EP3828175A1 (en) * | 2015-06-12 | 2021-06-02 | 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 |
| EP3522886A4 (en) | 2016-10-10 | 2020-02-19 | Laurus Labs Limited | STABLE AMORPHE FORM OF THE SACUBITRIL VALSARTAN TRINATRIUM COMPLEX AND METHOD FOR THE PRODUCTION THEREOF |
| CN111592500A (zh) * | 2017-01-03 | 2020-08-28 | 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 |
| US20200276129A1 (en) | 2017-10-13 | 2020-09-03 | 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 |
| CA3110152A1 (en) | 2018-08-23 | 2020-02-27 | Novartis Ag | New pharmaceutical use for the treatment of heart failure |
| 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 |
Family Cites Families (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| PL212318B1 (pl) * | 2002-01-17 | 2012-09-28 | Novartis Ag | Kompozycja farmaceutyczna zawierajaca walsartan oraz inhibitor obojetnej endopeptydazy (NEP) oraz zestaw zawierajacy te kompozycje |
| 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 |
| PL2295035T3 (pl) | 2007-11-06 | 2016-11-30 | Podwójne działanie kompozycji farmaceutycznych opartych na superstrukturach antagonisty/blokera receptora angiotensyny (arb) oraz inhibitora obojętnej endopeptydazy (nep) | |
| KR101864865B1 (ko) * | 2010-08-24 | 2018-06-05 | 노파르티스 아게 | 항응고제 요법을 받고 있는 포유동물에서의 고혈압의 치료 및／또는 심부전의 예방 또는 치료 |
| 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 |
| SI3229799T1 (sl) | 2014-12-08 | 2019-03-29 | Crystal Pharmatech Co., Ltd. | Kristalinične oblike trinatrijevega supramolekularnega kompleksa, ki obsega valsartan in AHU-377, ter njihovi postopki |
| 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 |
| EP3828175A1 (en) | 2015-06-12 | 2021-06-02 | 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 |
-
2015
- 2015-12-08 SI SI201530569T patent/SI3229799T1/sl unknown
- 2015-12-08 JP JP2017530598A patent/JP2017537120A/ja active Pending
- 2015-12-08 EP EP18192712.0A patent/EP3443960A1/en not_active Withdrawn
- 2015-12-08 EP EP15843405.0A patent/EP3229799B1/en not_active Revoked
- 2015-12-08 MX MX2017007426A patent/MX383336B/es unknown
- 2015-12-08 ES ES15843405T patent/ES2706948T3/es active Active
- 2015-12-08 US US15/528,153 patent/US9957240B2/en active Active
- 2015-12-08 CN CN201910761992.2A patent/CN110938042B/zh active Active
- 2015-12-08 WO PCT/US2015/064432 patent/WO2016049663A1/en not_active Ceased
- 2015-12-08 HU HUE15843405A patent/HUE043014T2/hu unknown
- 2015-12-08 PL PL15843405T patent/PL3229799T3/pl unknown
- 2015-12-08 TR TR2019/00360T patent/TR201900360T4/tr unknown
- 2015-12-08 PT PT15843405T patent/PT3229799T/pt unknown
- 2015-12-08 CA CA2970192A patent/CA2970192C/en active Active
- 2015-12-08 DK DK15843405.0T patent/DK3229799T3/en active
- 2015-12-08 CN CN201580002782.5A patent/CN105873586B/zh active Active
- 2015-12-08 AU AU2015319831A patent/AU2015319831B2/en active Active
- 2015-12-08 CN CN201910761979.7A patent/CN110922366B/zh active Active
-
2017
- 2017-06-07 IL IL252740A patent/IL252740A0/en unknown
-
2018
- 2018-03-18 US US15/924,250 patent/US10508087B2/en active Active
- 2018-07-03 JP JP2018127088A patent/JP2018168180A/ja active Pending
-
2020
- 2020-07-22 IL IL276233A patent/IL276233B2/en unknown
- 2020-09-11 JP JP2020152967A patent/JP2020203936A/ja active Pending
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