BR112018011154B1 - Dispersões sólidas compreendendo um estimulador de sgc - Google Patents

Dispersões sólidas compreendendo um estimulador de sgc Download PDF

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Publication number
BR112018011154B1
BR112018011154B1 BR112018011154-6A BR112018011154A BR112018011154B1 BR 112018011154 B1 BR112018011154 B1 BR 112018011154B1 BR 112018011154 A BR112018011154 A BR 112018011154A BR 112018011154 B1 BR112018011154 B1 BR 112018011154B1
Authority
BR
Brazil
Prior art keywords
compound
solid dispersion
disease
dispersion
disorder
Prior art date
Application number
BR112018011154-6A
Other languages
English (en)
Portuguese (pt)
Other versions
BR112018011154A2 (pt
Inventor
Dunbar Craig Anthony
Sethuraman Vasu
Hashash Ahmad
Original Assignee
Cyclerion Therapeutics, Inc
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 Cyclerion Therapeutics, Inc filed Critical Cyclerion Therapeutics, Inc
Publication of BR112018011154A2 publication Critical patent/BR112018011154A2/pt
Publication of BR112018011154B1 publication Critical patent/BR112018011154B1/pt

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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
    • A61K9/14—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
    • A61K9/205—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
    • A61K9/20—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)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Urology & Nephrology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Hospice & Palliative Care (AREA)
  • Ophthalmology & Optometry (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Vascular Medicine (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Pulmonology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Plural Heterocyclic Compounds (AREA)
BR112018011154-6A 2015-11-30 2016-11-22 Dispersões sólidas compreendendo um estimulador de sgc BR112018011154B1 (pt)

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

Publications (2)

Publication Number Publication Date
BR112018011154A2 BR112018011154A2 (pt) 2018-11-21
BR112018011154B1 true BR112018011154B1 (pt) 2023-09-26

Family

ID=57590822

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112018011154-6A BR112018011154B1 (pt) 2015-11-30 2016-11-22 Dispersões sólidas compreendendo um estimulador de sgc

Country Status (12)

Country Link
US (4) US20190269619A1 (https=)
EP (1) EP3383372B1 (https=)
JP (3) JP6952707B2 (https=)
KR (1) KR102841419B1 (https=)
CN (4) CN116942616A (https=)
AU (1) AU2016364976B2 (https=)
BR (1) BR112018011154B1 (https=)
CA (1) CA3006746C (https=)
EA (1) EA201891315A1 (https=)
IL (2) IL259493B (https=)
MX (3) MX389961B (https=)
WO (1) WO2017095697A1 (https=)

Families Citing this family (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2017216429B2 (en) * 2016-02-01 2022-10-06 Cyclerion Therapeutics, Inc. Use of sGC stimulators for the treatment of Nonalcoholic Steatohepatitis (NASH)
CN109563077B (zh) 2016-07-07 2026-03-10 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新方法
CN109563086B (zh) 2016-07-07 2023-05-23 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
WO2019055859A1 (en) 2017-09-14 2019-03-21 Ironwood Pharmaceuticals, Inc. TREATMENT OF METABOLIC SYNDROME BY SGC STIMULATOR
WO2019161534A1 (en) * 2018-02-22 2019-08-29 Ironwood Pharmaceuticals, Inc. Novel processes and intermediates for preparation of soluble guanylate cyclase stimulators
US11274096B2 (en) * 2018-01-10 2022-03-15 Cyclerion Therapeutics, Inc. Processes and intermediates for the 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
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
KR102755855B1 (ko) * 2018-07-30 2025-01-15 가부시키가이샤 리코 입자의 제조 방법, 및 이 방법에 의해 제조된 입자 및 의약
CA3149182A1 (en) * 2019-09-23 2021-04-01 Bionomics Limited Therapeutic formulations and uses thereof
WO2021086967A1 (en) 2019-10-29 2021-05-06 Cyclerion Therapeutics, Inc. Treatment of diabetic nephropathy with an sgc stimulator
WO2022129267A1 (en) * 2020-12-18 2022-06-23 UCB Biopharma SRL Amorphous solid dispersions
WO2023009710A1 (en) 2021-07-28 2023-02-02 Cyclerion Therapeutics, Inc. Treatment of hfpef in post-menopausal women with an sgc stimulator

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2287971T3 (es) * 1997-08-11 2007-12-16 Pfizer Products Inc. Dispersiones farmaceuticas solidas con biodisponibilidad incrementada.
ATE400252T1 (de) * 1999-02-10 2008-07-15 Pfizer Prod Inc Pharmazeutische feste dispersionen
US8591944B2 (en) * 2011-03-08 2013-11-26 Zalicus Pharmaceuticals Ltd. Solid dispersion formulations and methods of use thereof
WO2014047111A1 (en) * 2012-09-18 2014-03-27 Ironwood Pharmaceuticals, Inc. Sgc stimulators
EA033168B1 (ru) * 2013-03-15 2019-09-30 Сайклерион Терапьютикс, Инк. СТИМУЛЯТОРЫ sGC
EP3094327A1 (en) * 2014-01-13 2016-11-23 Ironwood Pharmaceuticals, Inc. USE OF sGC STIMULATORS FOR THE TREATMENT OF NEUROMUSCULAR DISORDERS

Also Published As

Publication number Publication date
BR112018011154A2 (pt) 2018-11-21
JP2023100851A (ja) 2023-07-19
JP2019501216A (ja) 2019-01-17
IL290338B2 (en) 2023-05-01
EA201891315A1 (ru) 2018-12-28
MX2022001655A (es) 2022-03-11
WO2017095697A1 (en) 2017-06-08
IL259493B (en) 2022-03-01
US20190269619A1 (en) 2019-09-05
US20250255821A1 (en) 2025-08-14
EP3383372B1 (en) 2023-11-01
JP7641320B2 (ja) 2025-03-06
CN116637077A (zh) 2023-08-25
CA3006746C (en) 2024-01-30
IL290338B1 (en) 2023-01-01
AU2016364976A1 (en) 2018-06-14
CN108883071A (zh) 2018-11-23
KR20180086497A (ko) 2018-07-31
MX2022001656A (es) 2022-03-11
EP3383372A1 (en) 2018-10-10
JP6952707B2 (ja) 2021-10-20
CN116637076A (zh) 2023-08-25
AU2016364976B2 (en) 2022-08-25
KR102841419B1 (ko) 2025-08-01
JP2022000464A (ja) 2022-01-04
IL259493A (en) 2018-07-31
US20240293324A1 (en) 2024-09-05
CN116942616A (zh) 2023-10-27
MX389961B (es) 2025-03-20
JP7277534B2 (ja) 2023-05-19
CA3006746A1 (en) 2017-06-08
US20250017862A1 (en) 2025-01-16
IL290338A (en) 2022-04-01

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Legal Events

Date Code Title Description
B25A Requested transfer of rights approved

Owner name: CYCLERION THERAPEUTICS, INC. (US)

B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]

Free format text: DE ACORDO COM O ARTIGO 229-C DA LEI NO 10196/2001, QUE MODIFICOU A LEI NO 9279/96, A CONCESSAO DA PATENTE ESTA CONDICIONADA A ANUENCIA PREVIA DA ANVISA. CONSIDERANDO A APROVACAO DOS TERMOS DO PARECER NO 337/PGF/EA/2010, BEM COMO A PORTARIA INTERMINISTERIAL NO 1065 DE 24/05/2012, ENCAMINHA-SE O PRESENTE PEDIDO PARA AS PROVIDENCIAS CABIVEIS.

B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]
B06U Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]
B350 Update of information on the portal [chapter 15.35 patent gazette]
B09A Decision: intention to grant [chapter 9.1 patent gazette]
B16A Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]

Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 22/11/2016, OBSERVADAS AS CONDICOES LEGAIS