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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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)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (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)
  • Diabetes (AREA)
  • Obesity (AREA)
  • Vascular Medicine (AREA)
  • Hematology (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 (https=)
EP (1) EP3383372B1 (https=)
JP (3) JP6952707B2 (https=)
KR (1) KR102841419B1 (https=)
CN (4) CN116637076A (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
BR112018015718A2 (pt) 2016-02-01 2019-01-08 Ironwood Pharmaceuticals Inc utilização de estimuladores de sgc para o tratamento de esteato-hepatite não alcoólica (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
WO2018009602A2 (en) * 2016-07-07 2018-01-11 Ironwood Pharmaceuticals, Inc. Novel processes for preparation of soluble guanylate cyclase stimulators
WO2019055859A1 (en) 2017-09-14 2019-03-21 Ironwood Pharmaceuticals, Inc. TREATMENT OF METABOLIC SYNDROME BY SGC STIMULATOR
MA71753A (fr) * 2018-01-10 2025-05-30 Cyclerion Therapeutics, Inc. Nouveaux procédés et intermédiaires pour la préparation de stimulateurs de guanylate cyclase soluble
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
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
US20240000769A1 (en) * 2020-12-18 2024-01-04 UCB Biopharma SRL Amorphous solid dispersions
US20240366596A1 (en) 2021-07-28 2024-11-07 Cyclerion Therapeutics, Inc. Treatment of hfpef in post-menopausal women with an sgc stimulator

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 (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ATE364374T1 (de) * 1997-08-11 2007-07-15 Pfizer Prod Inc Feste pharmazeutische dispersionen mit erhöhter bioverfügbarkeit
EP1027886B1 (en) * 1999-02-10 2008-07-09 Pfizer Products Inc. Pharmaceutical solid dispersions
EP2654726A1 (en) * 2011-03-08 2013-10-30 Zalicus Pharmaceuticals Ltd. Solid dispersion formulations and methods of use thereof
US9309235B2 (en) * 2012-09-18 2016-04-12 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

Patent 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

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
AU2016364976A1 (en) 2018-06-14
JP6952707B2 (ja) 2021-10-20
IL290338A (en) 2022-04-01
JP2022000464A (ja) 2022-01-04
IL259493B (en) 2022-03-01
CA3006746C (en) 2024-01-30
JP7641320B2 (ja) 2025-03-06
JP2023100851A (ja) 2023-07-19
MX2022001655A (es) 2022-03-11
US20240293324A1 (en) 2024-09-05
IL290338B1 (en) 2023-01-01
MX2022001656A (es) 2022-03-11
JP2019501216A (ja) 2019-01-17
CN116942616A (zh) 2023-10-27
US20190269619A1 (en) 2019-09-05
MX389961B (es) 2025-03-20
CN108883071A (zh) 2018-11-23
WO2017095697A1 (en) 2017-06-08
US20250017862A1 (en) 2025-01-16
EA201891315A1 (ru) 2018-12-28
JP7277534B2 (ja) 2023-05-19
KR20180086497A (ko) 2018-07-31
CA3006746A1 (en) 2017-06-08
US20250255821A1 (en) 2025-08-14
EP3383372B1 (en) 2023-11-01
CN116637077A (zh) 2023-08-25
CN116637076A (zh) 2023-08-25
KR102841419B1 (ko) 2025-08-01
EP3383372A1 (en) 2018-10-10
BR112018011154A2 (pt) 2018-11-21
BR112018011154B1 (pt) 2023-09-26
IL259493A (en) 2018-07-31
IL290338B2 (en) 2023-05-01

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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)