JP7456933B2 - アムロジピン製剤 - Google Patents

アムロジピン製剤 Download PDF

Info

Publication number
JP7456933B2
JP7456933B2 JP2020554193A JP2020554193A JP7456933B2 JP 7456933 B2 JP7456933 B2 JP 7456933B2 JP 2020554193 A JP2020554193 A JP 2020554193A JP 2020554193 A JP2020554193 A JP 2020554193A JP 7456933 B2 JP7456933 B2 JP 7456933B2
Authority
JP
Japan
Prior art keywords
amlodipine
minutes
suspension
benzoate
preparing
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.)
Active
Application number
JP2020554193A
Other languages
English (en)
Japanese (ja)
Other versions
JP2021520367A5 (https=
JP2021520367A (ja
Inventor
ブラウアー,スコット
エル. モッシャー,ジェロルド
Original Assignee
シルバーゲイト ファーマシューティカルズ,インク.
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=68161047&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=JP7456933(B2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by シルバーゲイト ファーマシューティカルズ,インク. filed Critical シルバーゲイト ファーマシューティカルズ,インク.
Publication of JP2021520367A publication Critical patent/JP2021520367A/ja
Publication of JP2021520367A5 publication Critical patent/JP2021520367A5/ja
Application granted granted Critical
Publication of JP7456933B2 publication Critical patent/JP7456933B2/ja
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic 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
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445Non condensed piperidines, e.g. piperocaine
    • A61K31/451Non condensed piperidines, e.g. piperocaine having a carbocyclic group directly attached to the heterocyclic ring, e.g. glutethimide, meperidine, loperamide, phencyclidine, piminodine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/24Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38Cellulose; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Molecular Biology (AREA)
  • Inorganic Chemistry (AREA)
  • Biochemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Dispersion Chemistry (AREA)
  • Biophysics (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
JP2020554193A 2018-04-11 2019-04-11 アムロジピン製剤 Active JP7456933B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201862656188P 2018-04-11 2018-04-11
US62/656,188 2018-04-11
PCT/US2019/027044 WO2019200143A1 (en) 2018-04-11 2019-04-11 Amlodipine formulations

Publications (3)

Publication Number Publication Date
JP2021520367A JP2021520367A (ja) 2021-08-19
JP2021520367A5 JP2021520367A5 (https=) 2024-02-07
JP7456933B2 true JP7456933B2 (ja) 2024-03-27

Family

ID=68161047

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2020554193A Active JP7456933B2 (ja) 2018-04-11 2019-04-11 アムロジピン製剤

Country Status (6)

Country Link
US (6) US10799453B2 (https=)
EP (1) EP3773574A4 (https=)
JP (1) JP7456933B2 (https=)
CN (1) CN112334134A (https=)
CA (1) CA3096101A1 (https=)
WO (1) WO2019200143A1 (https=)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3960158B1 (en) 2016-10-07 2025-05-21 Silvergate Pharmaceuticals, Inc. Amlodipine formulations
WO2019200143A1 (en) 2018-04-11 2019-10-17 Silvergate Pharmaceuticals, Inc. Amlodipine formulations
CN112716903B (zh) * 2021-01-18 2023-03-21 广州一品红制药有限公司 一种氨氯地平干混悬剂及其制备方法
US11452690B1 (en) 2021-01-27 2022-09-27 ECI Pharmaceuticals, LLC Oral liquid compositions comprising amlodipine besylate and methods of using the same

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102018708A (zh) 2010-12-12 2011-04-20 林飞 包含氨氯地平和阿托伐他汀镁的药物组合物
CN102114017A (zh) 2011-01-05 2011-07-06 王定豪 包含氨氯地平和培哚普利的药物组合物及其应用

Family Cites Families (41)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DK161312C (da) 1982-03-11 1991-12-09 Pfizer Analogifremgangsmaade til fremstilling af 2-aminoalkoxymethyl-4-phenyl-6-methyl-1,4-dihydropyridin-3,5-dicarboxylsyreestere eller syreadditionssalte deraf samt phthalimidoderivater til anvendelse som udgangsmateriale ved fremgangsmaaden
GB8608335D0 (en) 1986-04-04 1986-05-08 Pfizer Ltd Pharmaceutically acceptable salts
US6057344A (en) 1991-11-26 2000-05-02 Sepracor, Inc. Methods for treating hypertension, and angina using optically pure (-) amlodipine
US6333342B1 (en) 1998-11-04 2001-12-25 Isotechnika, Inc Methods of pharmacological treatment using S(−) amlodipine
CN1100038C (zh) 2000-02-21 2003-01-29 张喜田 氨氯地平对映体的拆分
PL362660A1 (en) 2000-12-29 2004-11-02 Pfizer Limited Process for making amlodipine maleate
WO2002053540A1 (en) 2000-12-29 2002-07-11 Pfizer Limited Aspartate derivative of amlodipine as calcium channel antagonist
AT5874U1 (de) 2000-12-29 2003-01-27 Bioorg Bv Pharmazeutische zubereitungen enthaltend amlodipinmaleat
EP1309557B9 (en) 2000-12-29 2006-11-15 Pfizer Limited Amlodipine hemimaleate
MXPA03005882A (es) 2000-12-29 2005-04-19 Pfizer Ltd Derivado amida de amlodipina.
EP1309556B1 (en) 2000-12-29 2004-11-24 Pfizer Limited Amlodipine fumarate
US6653481B2 (en) 2000-12-29 2003-11-25 Synthon Bv Process for making amlodipine
CA2433193C (en) 2000-12-29 2006-01-31 Pfizer Limited Amide derivative of amlodipine
US6680334B2 (en) 2001-08-28 2004-01-20 Pfizer Inc Crystalline material
IL161448A0 (en) 2001-10-24 2004-09-27 Sepracor Inc Method of resolving amlodipine racemate
KR100496436B1 (ko) 2002-07-30 2005-06-20 씨제이 주식회사 암로디핀의 유기산염
KR100538641B1 (ko) 2002-07-30 2005-12-22 씨제이 주식회사 암로디핀의 유기산염
KR100467669B1 (ko) 2002-08-21 2005-01-24 씨제이 주식회사 암로디핀의 유기산염
AU2003253460A1 (en) 2002-09-19 2004-04-08 Cj Corporation Crystalline organic acid salt of amlodipine
CA2559670A1 (en) 2003-04-14 2004-10-28 Gabor Pragai Stable amlodipine maleate formulations
WO2005079772A2 (en) 2004-02-18 2005-09-01 Sepracor Inc. Combination of (s)-amlodipine and an ace inhibitor, and methods for reducing hypertension
US20060030602A1 (en) * 2004-03-16 2006-02-09 Sepracor Inc. (S)-amlodipine malate
WO2005099699A1 (en) 2004-04-07 2005-10-27 Sepracor Inc. Combination of (s)-amlodipine and a beta-blocker, and methods for reducing hypertension
WO2006059217A1 (en) 2004-12-01 2006-06-08 Ranbaxy Laboratories Limited Stable solid dosage forms of amlodipine besylate and processes for their preparation
EP1831166B1 (en) 2004-12-02 2010-10-20 SK Chemicals, Co., Ltd. Optical resolution method of amlodipine
GT200600371A (es) 2005-08-17 2007-03-21 Formas de dosis sólidas de valsartan y amlodipina y método para hacer las mismas
US8158146B2 (en) 2005-09-28 2012-04-17 Teva Pharmaceutical Industries Ltd. Stable combinations of amlodipine besylate and benazepril hydrochloride
CN101522174A (zh) 2006-05-10 2009-09-02 赢创德固赛有限责任公司 辊压热解制备的二氧化硅在药物组合物中的应用
CA2655596C (en) * 2006-06-27 2011-10-25 Biovail Laboratories International Srl Multiparticulate osmotic delivery system
DK2200588T3 (da) 2007-09-25 2019-07-01 Solubest Ltd Sammensætninger, som omfatter lipofile aktive forbindelser, og fremgangsmåde til fremstilling deraf
CN101416966B (zh) 2007-10-22 2010-11-10 鲁南制药集团股份有限公司 一种治疗高血压的药物组合物
KR20100052262A (ko) 2008-11-10 2010-05-19 (주)아모레퍼시픽 난용성 약물의 나노입자를 포함하는 분말의 제조방법, 그에의해 제조된 분말 및 이를 포함하는 약학적 조성물
CN102256604A (zh) * 2008-12-17 2011-11-23 株式会社医药处方 稳定的氨氯地平含水口服制剂
CN101843615A (zh) 2010-06-25 2010-09-29 包丽昕 含有缬沙坦和苯磺酸氨氯地平的分散片及其制备方法
CN102370965A (zh) 2010-08-11 2012-03-14 南京先宇科技有限公司 一种含有左旋氨氯地平药学上可接受的盐与培哚普利药学上可接受的盐的药物组合物
CN102746215A (zh) * 2011-04-18 2012-10-24 张兆勇 一种制备高纯度盐酸贝尼地平的方法
WO2013191668A1 (en) * 2012-06-22 2013-12-27 Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi Compositions preventing hypertension comprising soluplus
US20140024723A1 (en) 2012-07-17 2014-01-23 Dow Global Technologies Llc Composition comprising an organic liquid diluent and a specific hydroxypropyl methylcellulose
GB2529605B (en) * 2014-06-03 2018-03-21 Essential Pharmaceuticals Ltd Pharmaceutical composition
EP3960158B1 (en) 2016-10-07 2025-05-21 Silvergate Pharmaceuticals, Inc. Amlodipine formulations
WO2019200143A1 (en) 2018-04-11 2019-10-17 Silvergate Pharmaceuticals, Inc. Amlodipine formulations

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102018708A (zh) 2010-12-12 2011-04-20 林飞 包含氨氯地平和阿托伐他汀镁的药物组合物
CN102114017A (zh) 2011-01-05 2011-07-06 王定豪 包含氨氯地平和培哚普利的药物组合物及其应用

Non-Patent Citations (6)

* Cited by examiner, † Cited by third party
Title
International Journal of Toxicology,2016年,Vol.35, No.2,pp.95-178
J Am Pharm Assoc,1999年,Vol.39,pp.375-377
Journal of Pharmaceutical and Biomedical Analysis,2016年,Vol.118,pp.105-112
Pharm Technol Hosp Pharm,2018年03月,Vol.3, No.1,pp.31-37
PLoS ONE,2016年,Vol.11, No.10,e0164577, pp.1-12
The Canadian Journal of Hospital Pharmacy,2016年,Vol.69, No.4,pp. 327-329

Also Published As

Publication number Publication date
US20210308049A1 (en) 2021-10-07
CN112334134A (zh) 2021-02-05
WO2019200143A1 (en) 2019-10-17
US11484498B2 (en) 2022-11-01
US20220401363A1 (en) 2022-12-22
EP3773574A4 (en) 2022-03-02
US11918685B2 (en) 2024-03-05
US20230338287A1 (en) 2023-10-26
US20190314279A1 (en) 2019-10-17
CA3096101A1 (en) 2019-10-17
US20240252433A1 (en) 2024-08-01
EP3773574A1 (en) 2021-02-17
US12383498B2 (en) 2025-08-12
US20210023003A1 (en) 2021-01-28
US11471409B2 (en) 2022-10-18
JP2021520367A (ja) 2021-08-19
US11701326B2 (en) 2023-07-18
US10799453B2 (en) 2020-10-13

Similar Documents

Publication Publication Date Title
US12128083B2 (en) Lisinopril formulations
US12336984B2 (en) Amlodipine formulations
US12383498B2 (en) Amlodipine formulations
WO2022115681A2 (en) Methods and compositions for oral pilocarpine liquid
HK1258803B (en) Lisinopril formulations

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20220411

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20220411

A977 Report on retrieval

Free format text: JAPANESE INTERMEDIATE CODE: A971007

Effective date: 20230228

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20230301

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20230529

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20230731

RD02 Notification of acceptance of power of attorney

Free format text: JAPANESE INTERMEDIATE CODE: A7422

Effective date: 20230927

RD04 Notification of resignation of power of attorney

Free format text: JAPANESE INTERMEDIATE CODE: A7424

Effective date: 20230927

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A821

Effective date: 20230927

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20231030

A524 Written submission of copy of amendment under article 19 pct

Free format text: JAPANESE INTERMEDIATE CODE: A524

Effective date: 20240129

TRDD Decision of grant or rejection written
A01 Written decision to grant a patent or to grant a registration (utility model)

Free format text: JAPANESE INTERMEDIATE CODE: A01

Effective date: 20240219

A61 First payment of annual fees (during grant procedure)

Free format text: JAPANESE INTERMEDIATE CODE: A61

Effective date: 20240314

R150 Certificate of patent or registration of utility model

Ref document number: 7456933

Country of ref document: JP

Free format text: JAPANESE INTERMEDIATE CODE: R150