JP6952707B2 - sGC刺激薬を含んでなる固体分散剤 - Google Patents

sGC刺激薬を含んでなる固体分散剤 Download PDF

Info

Publication number
JP6952707B2
JP6952707B2 JP2018547255A JP2018547255A JP6952707B2 JP 6952707 B2 JP6952707 B2 JP 6952707B2 JP 2018547255 A JP2018547255 A JP 2018547255A JP 2018547255 A JP2018547255 A JP 2018547255A JP 6952707 B2 JP6952707 B2 JP 6952707B2
Authority
JP
Japan
Prior art keywords
compound
dispersant
solid
disease
disorder
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
JP2018547255A
Other languages
English (en)
Japanese (ja)
Other versions
JP2019501216A5 (enExample
JP2019501216A (ja
Inventor
ダンバー,クレイグ・アンソニー
セスラマン,バス
ハシャシュ,アフマド
Original Assignee
サイクレリオン・セラピューティクス,インコーポレーテッド
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
Application filed by サイクレリオン・セラピューティクス,インコーポレーテッド filed Critical サイクレリオン・セラピューティクス,インコーポレーテッド
Publication of JP2019501216A publication Critical patent/JP2019501216A/ja
Publication of JP2019501216A5 publication Critical patent/JP2019501216A5/ja
Priority to JP2021157646A priority Critical patent/JP7277534B2/ja
Application granted granted Critical
Publication of JP6952707B2 publication Critical patent/JP6952707B2/ja
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Images

Classifications

    • 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
    • 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
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/506—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further heterocyclic rings
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • 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
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • 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
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • 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
    • 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
    • A61P9/10—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

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Urology & Nephrology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Ophthalmology & Optometry (AREA)
  • Hospice & Palliative Care (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Vascular Medicine (AREA)
  • Pulmonology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Plural Heterocyclic Compounds (AREA)
JP2018547255A 2015-11-30 2016-11-22 sGC刺激薬を含んでなる固体分散剤 Active JP6952707B2 (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2021157646A JP7277534B2 (ja) 2015-11-30 2021-09-28 sGC刺激薬を含んでなる固体分散剤

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201562260910P 2015-11-30 2015-11-30
US62/260,910 2015-11-30
US201662359440P 2016-07-07 2016-07-07
US62/359,440 2016-07-07
PCT/US2016/063312 WO2017095697A1 (en) 2015-11-30 2016-11-22 Solid dispersions comprising a sgc stimulator

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2021157646A Division JP7277534B2 (ja) 2015-11-30 2021-09-28 sGC刺激薬を含んでなる固体分散剤

Publications (3)

Publication Number Publication Date
JP2019501216A JP2019501216A (ja) 2019-01-17
JP2019501216A5 JP2019501216A5 (enExample) 2020-01-09
JP6952707B2 true JP6952707B2 (ja) 2021-10-20

Family

ID=57590822

Family Applications (3)

Application Number Title Priority Date Filing Date
JP2018547255A Active JP6952707B2 (ja) 2015-11-30 2016-11-22 sGC刺激薬を含んでなる固体分散剤
JP2021157646A Active JP7277534B2 (ja) 2015-11-30 2021-09-28 sGC刺激薬を含んでなる固体分散剤
JP2023076655A Active JP7641320B2 (ja) 2015-11-30 2023-05-08 sGC刺激薬を含んでなる固体分散剤

Family Applications After (2)

Application Number Title Priority Date Filing Date
JP2021157646A Active JP7277534B2 (ja) 2015-11-30 2021-09-28 sGC刺激薬を含んでなる固体分散剤
JP2023076655A Active JP7641320B2 (ja) 2015-11-30 2023-05-08 sGC刺激薬を含んでなる固体分散剤

Country Status (12)

Country Link
US (4) US20190269619A1 (enExample)
EP (1) EP3383372B1 (enExample)
JP (3) JP6952707B2 (enExample)
KR (1) KR102841419B1 (enExample)
CN (4) CN116637077A (enExample)
AU (1) AU2016364976B2 (enExample)
BR (1) BR112018011154B1 (enExample)
CA (1) CA3006746C (enExample)
EA (1) EA201891315A1 (enExample)
IL (2) IL259493B (enExample)
MX (3) MX389961B (enExample)
WO (1) WO2017095697A1 (enExample)

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11357777B2 (en) 2016-02-01 2022-06-14 Cyclerion Therapeutics, Inc. Use of sGC stimulators for the treatment of nonalcoholic steatohepatitis (NASH)
EA201990236A1 (ru) 2016-07-07 2019-08-30 Сайклерион Терапьютикс, Инк. Новые способы получения стимуляторов растворимой гуанилатциклазы
KR102487872B1 (ko) * 2016-07-07 2023-01-12 사이클리온 테라퓨틱스, 인크. 가용성 구아닐레이트 시클라제 자극제의 신규 제조 방법
WO2019055859A1 (en) 2017-09-14 2019-03-21 Ironwood Pharmaceuticals, Inc. TREATMENT OF METABOLIC SYNDROME BY SGC STIMULATOR
CN111902410B (zh) * 2018-01-10 2024-04-19 赛克里翁治疗有限公司 用于制备可溶性鸟苷酸环化酶刺激剂的方法及中间物
WO2019161534A1 (en) * 2018-02-22 2019-08-29 Ironwood Pharmaceuticals, Inc. Novel processes and intermediates for preparation of soluble guanylate cyclase stimulators
WO2019172420A1 (ja) * 2018-03-09 2019-09-12 協和発酵キリン株式会社 医薬組成物
EP3829644A4 (en) * 2018-07-30 2022-05-04 Ricoh Company, Ltd. PROCESS FOR MANUFACTURING PARTICLES AND PARTICLE AND MEDICATION MANUFACTURED BY THE PROCESS
JP7503781B2 (ja) * 2018-07-30 2024-06-21 株式会社リコー 粒子の製造方法、並びに、それにより製造された粒子及び医薬
JP7634525B2 (ja) * 2019-09-23 2025-02-21 バイオノミクス リミテッド 治療用製剤およびその使用
CN115175683A (zh) 2019-10-29 2022-10-11 赛克里翁治疗有限公司 用sGC刺激剂治疗糖尿病性肾病
CN116685308A (zh) * 2020-12-18 2023-09-01 Ucb生物制药有限责任公司 无定形固体分散体
EP4376843A1 (en) 2021-07-28 2024-06-05 Cyclerion Therapeutics, Inc. Treatment of hfpef in post-menopausal women with an sgc stimulator
WO2026035689A1 (en) * 2024-08-06 2026-02-12 Catalyst Pharmaceuticals, Inc. Vamorolone solid oral dosage forms

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PT901786E (pt) * 1997-08-11 2007-08-07 Pfizer Prod Inc Disperções farmacêuticas sólidas com biodisponibilidade melhorada
ES2307482T3 (es) * 1999-02-10 2008-12-01 Pfizer Products Inc. Dispersiones farmaceuticas solidas.
WO2012122279A1 (en) * 2011-03-08 2012-09-13 Zalicus Pharmaceuticals Ltd. Solid dispersion formulations and methods of use thereof
CA2861804C (en) * 2011-12-27 2021-10-26 Ironwood Pharmaceuticals, Inc. 2-benzyl,3(pyrimidin-2-yl)substituted pyrazoles useful as sgc stimulators
WO2014047111A1 (en) * 2012-09-18 2014-03-27 Ironwood Pharmaceuticals, Inc. Sgc stimulators
ES2911276T3 (es) * 2013-03-15 2022-05-18 Cyclerion Therapeutics Inc Estimuladores de sGC
WO2015106268A1 (en) * 2014-01-13 2015-07-16 Ironwood Pharmaceuticals, Inc. USE OF sGC STIMULATORS FOR THE TREATMENT OF NEUROMUSCULAR DISORDERS
EP3194382B1 (en) * 2014-09-17 2021-09-08 Cyclerion Therapeutics, Inc. Pyrazole derivatives as sgc stimulators

Also Published As

Publication number Publication date
IL290338B1 (en) 2023-01-01
IL290338B2 (en) 2023-05-01
EP3383372A1 (en) 2018-10-10
US20240293324A1 (en) 2024-09-05
US20250255821A1 (en) 2025-08-14
WO2017095697A1 (en) 2017-06-08
MX389961B (es) 2025-03-20
CN116637077A (zh) 2023-08-25
KR20180086497A (ko) 2018-07-31
JP2022000464A (ja) 2022-01-04
JP7277534B2 (ja) 2023-05-19
CA3006746A1 (en) 2017-06-08
JP7641320B2 (ja) 2025-03-06
MX2022001656A (es) 2022-03-11
EA201891315A1 (ru) 2018-12-28
JP2019501216A (ja) 2019-01-17
AU2016364976A1 (en) 2018-06-14
CN108883071A (zh) 2018-11-23
KR102841419B1 (ko) 2025-08-01
CA3006746C (en) 2024-01-30
US20250017862A1 (en) 2025-01-16
IL259493B (en) 2022-03-01
CN116942616A (zh) 2023-10-27
AU2016364976B2 (en) 2022-08-25
BR112018011154B1 (pt) 2023-09-26
CN116637076A (zh) 2023-08-25
EP3383372B1 (en) 2023-11-01
MX2022001655A (es) 2022-03-11
IL259493A (en) 2018-07-31
JP2023100851A (ja) 2023-07-19
BR112018011154A2 (pt) 2018-11-21
IL290338A (en) 2022-04-01
US20190269619A1 (en) 2019-09-05

Similar Documents

Publication Publication Date Title
JP7641320B2 (ja) sGC刺激薬を含んでなる固体分散剤
TWI810243B (zh) 用於治療囊腫纖化症之醫藥組合物
TWI719349B (zh) Cftr調節劑之結晶形式及組合物
JP5017115B2 (ja) 4−(4−(3−(4−クロロ−3−トリフルオロメチルフェニル)ウレイド)−3−フルオロフェノキシ)ピリジン−2−カルボン酸を含んでなる過剰増殖性疾患の治療のための新規薬剤組成物
KR102606253B1 (ko) 2-(tert-부틸아미노)-4-((1r,3r,4r)-3-하이드록시-4-메틸사이클로헥실아미노)-피리미딘-5-카복사마이드의 제형
WO2001095912A1 (fr) Compositions permettant de reguler la plage et/ou la vitesse de liberation du ph
TW201924682A (zh) 包含血漿激肽釋放酶抑制劑之劑型
JP6524119B2 (ja) 治療活性化合物の医薬組成物
HK1261747B (en) Solid dispersions comprising a sgc stimulator
HK1261747A1 (en) Solid dispersions comprising a sgc stimulator
RU2822220C2 (ru) Фармацевтические композиции для лечения муковисцидоза
EA043018B1 (ru) Твердые дисперсии, содержащие стимулятор sgc, для применения в качестве лекарственного средства
LUST ANDRES LUST

Legal Events

Date Code Title Description
A711 Notification of change in applicant

Free format text: JAPANESE INTERMEDIATE CODE: A711

Effective date: 20190710

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20191121

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20191121

A977 Report on retrieval

Free format text: JAPANESE INTERMEDIATE CODE: A971007

Effective date: 20200924

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20201001

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20201224

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20210301

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20210401

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A821

Effective date: 20210401

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: 20210830

A61 First payment of annual fees (during grant procedure)

Free format text: JAPANESE INTERMEDIATE CODE: A61

Effective date: 20210928

R150 Certificate of patent or registration of utility model

Ref document number: 6952707

Country of ref document: JP

Free format text: JAPANESE INTERMEDIATE CODE: R150

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250