AU2016364976B2 - Solid dispersions comprising a sGC stimulator - Google Patents

Solid dispersions comprising a sGC stimulator Download PDF

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Publication number
AU2016364976B2
AU2016364976B2 AU2016364976A AU2016364976A AU2016364976B2 AU 2016364976 B2 AU2016364976 B2 AU 2016364976B2 AU 2016364976 A AU2016364976 A AU 2016364976A AU 2016364976 A AU2016364976 A AU 2016364976A AU 2016364976 B2 AU2016364976 B2 AU 2016364976B2
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AU
Australia
Prior art keywords
compound
dispersion
disease
solid dispersion
disorder
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AU2016364976A
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AU2016364976A1 (en
Inventor
Craig Anthony DUNBAR
Ahmad Hashash
Vasu SETHURAMAN
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Cyclerion Therapeutics Inc
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Cyclerion Therapeutics Inc
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Publication of AU2016364976A1 publication Critical patent/AU2016364976A1/en
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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
    • A61K9/20—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
    • 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
    • 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)
  • 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)
AU2016364976A 2015-11-30 2016-11-22 Solid dispersions comprising a sGC stimulator Active AU2016364976B2 (en)

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
AU2016364976A1 AU2016364976A1 (en) 2018-06-14
AU2016364976B2 true AU2016364976B2 (en) 2022-08-25

Family

ID=57590822

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2016364976A Active AU2016364976B2 (en) 2015-11-30 2016-11-22 Solid dispersions comprising a sGC stimulator

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

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014144100A2 (en) * 2013-03-15 2014-09-18 Takashi Nakai Sgc stimulators

Family Cites Families (7)

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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
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

Patent Citations (1)

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Publication number Priority date Publication date Assignee Title
WO2014144100A2 (en) * 2013-03-15 2014-09-18 Takashi Nakai Sgc stimulators

Non-Patent Citations (4)

* Cited by examiner, † Cited by third party
Title
BROADHEAD J. et al., "The Spray Drying of Pharmaceuticals", DRUG DEVELOPMENT AND INDUSTRIAL PHARMACY, (1992), vol. 18, no. 11/12, pages 1169 - 1206 *
FRIESEN D. T. et al., "Hydroxypropyl Methylcellulose Acetate Succinate-Based Spray-Dried Dispersions: An Overview", MOLECULAR PHARMACEUTICS, (2008), vol. 5, no. 6, pages 1003 - 1019 *
LEUNER C. et al., "Improving drug solubility for oral delivery using solid dispersions", EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS, ELSEVIER SCIENCE PUBLISHERS B.V., (2000), vol. 50, no. 1, pages 47 - 60 *
TIWARI R. et al., "Solid dispersions: An overview to modify bioavailability of poorly water soluble drugs", INTERNATIONAL JOURNAL OF PHARMTECH RESEARCH, SHPINX KNOWLEDGE HOUSE, (2009), vol. 1, no. 4, pages 1338 - 1349 *

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
JP6952707B2 (ja) 2021-10-20
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
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

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PC1 Assignment before grant (sect. 113)

Owner name: CYCLERION THERAPEUTICS, INC.

Free format text: FORMER APPLICANT(S): IRONWOOD PHARMACEUTICALS, INC.

FGA Letters patent sealed or granted (standard patent)