AU2015239018A1 - Solid composition comprising amorphous sofosbuvir - Google Patents

Solid composition comprising amorphous sofosbuvir Download PDF

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Publication number
AU2015239018A1
AU2015239018A1 AU2015239018A AU2015239018A AU2015239018A1 AU 2015239018 A1 AU2015239018 A1 AU 2015239018A1 AU 2015239018 A AU2015239018 A AU 2015239018A AU 2015239018 A AU2015239018 A AU 2015239018A AU 2015239018 A1 AU2015239018 A1 AU 2015239018A1
Authority
AU
Australia
Prior art keywords
weight
sofosbuvir
solid composition
matrix compound
solid
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.)
Abandoned
Application number
AU2015239018A
Other languages
English (en)
Inventor
Nolwenn Martin
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Sandoz AG
Original Assignee
Sandoz AG
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 Sandoz AG filed Critical Sandoz AG
Publication of AU2015239018A1 publication Critical patent/AU2015239018A1/en
Abandoned legal-status Critical Current

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Classifications

    • 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
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7052—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
    • A61K31/706—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom
    • A61K31/7064—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines
    • A61K31/7068—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines having oxo groups directly attached to the pyrimidine ring, e.g. cytidine, cytidylic acid
    • A61K31/7072—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines having oxo groups directly attached to the pyrimidine ring, e.g. cytidine, cytidylic acid having two oxo groups directly attached to the pyrimidine ring, e.g. uridine, uridylic acid, thymidine, zidovudine
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/143—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with inorganic compounds
    • 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
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
    • 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
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/14—Antivirals for RNA viruses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07F—ACYCLIC, CARBOCYCLIC OR HETEROCYCLIC COMPOUNDS CONTAINING ELEMENTS OTHER THAN CARBON, HYDROGEN, HALOGEN, OXYGEN, NITROGEN, SULFUR, SELENIUM OR TELLURIUM
    • C07F9/00—Compounds containing elements of Groups 5 or 15 of the Periodic Table
    • C07F9/02—Phosphorus compounds
    • C07F9/06—Phosphorus compounds without P—C bonds
    • C07F9/22—Amides of acids of phosphorus
    • C07F9/222—Amides of phosphoric acids
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07F—ACYCLIC, CARBOCYCLIC OR HETEROCYCLIC COMPOUNDS CONTAINING ELEMENTS OTHER THAN CARBON, HYDROGEN, HALOGEN, OXYGEN, NITROGEN, SULFUR, SELENIUM OR TELLURIUM
    • C07F9/00—Compounds containing elements of Groups 5 or 15 of the Periodic Table
    • C07F9/02—Phosphorus compounds
    • C07F9/547—Heterocyclic compounds, e.g. containing phosphorus as a ring hetero atom
    • C07F9/6558—Heterocyclic compounds, e.g. containing phosphorus as a ring hetero atom containing at least two different or differently substituted hetero rings neither condensed among themselves nor condensed with a common carbocyclic ring or ring system
    • C07F9/65586—Heterocyclic compounds, e.g. containing phosphorus as a ring hetero atom containing at least two different or differently substituted hetero rings neither condensed among themselves nor condensed with a common carbocyclic ring or ring system at least one of the hetero rings does not contain nitrogen as ring hetero atom
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07H—SUGARS; DERIVATIVES THEREOF; NUCLEOSIDES; NUCLEOTIDES; NUCLEIC ACIDS
    • C07H1/00—Processes for the preparation of sugar derivatives
    • C07H1/06—Separation; Purification
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07H—SUGARS; DERIVATIVES THEREOF; NUCLEOSIDES; NUCLEOTIDES; NUCLEIC ACIDS
    • C07H19/00—Compounds containing a hetero ring sharing one ring hetero atom with a saccharide radical; Nucleosides; Mononucleotides; Anhydro-derivatives thereof
    • C07H19/02—Compounds containing a hetero ring sharing one ring hetero atom with a saccharide radical; Nucleosides; Mononucleotides; Anhydro-derivatives thereof sharing nitrogen
    • C07H19/04—Heterocyclic radicals containing only nitrogen atoms as ring hetero atom
    • C07H19/06—Pyrimidine radicals
    • C07H19/10—Pyrimidine radicals with the saccharide radical esterified by phosphoric or polyphosphoric acids

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Molecular Biology (AREA)
  • Epidemiology (AREA)
  • Biochemistry (AREA)
  • Genetics & Genomics (AREA)
  • Biotechnology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Inorganic Chemistry (AREA)
  • Virology (AREA)
  • Oncology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Communicable Diseases (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
AU2015239018A 2014-04-03 2015-04-02 Solid composition comprising amorphous sofosbuvir Abandoned AU2015239018A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP14163434.5 2014-04-03
EP14163434 2014-04-03
PCT/EP2015/057411 WO2015150561A2 (en) 2014-04-03 2015-04-02 Solid composition comprising amorphous sofosbuvir

Publications (1)

Publication Number Publication Date
AU2015239018A1 true AU2015239018A1 (en) 2016-10-13

Family

ID=50397065

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2015239018A Abandoned AU2015239018A1 (en) 2014-04-03 2015-04-02 Solid composition comprising amorphous sofosbuvir

Country Status (10)

Country Link
US (2) US10493089B2 (enExample)
EP (1) EP3125868A2 (enExample)
JP (1) JP2017512811A (enExample)
KR (1) KR20160142342A (enExample)
CN (1) CN106163529A (enExample)
AU (1) AU2015239018A1 (enExample)
CA (1) CA2943574A1 (enExample)
MX (2) MX2016012934A (enExample)
RU (1) RU2016142819A (enExample)
WO (1) WO2015150561A2 (enExample)

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10214553B2 (en) 2014-06-13 2019-02-26 Teva Pharmaceuticals International Gmbh Solid state forms of sofosbuvir
WO2016038542A2 (en) * 2014-09-10 2016-03-17 Mylan Laboratories Limited Polymorphic forms of sofosbuvir
CZ2015443A3 (cs) * 2015-06-26 2017-01-04 Zentiva, K.S. Farmaceutická formulace sofosbuviru
EP3359199A1 (en) * 2015-10-07 2018-08-15 Sandoz AG Solid pharmaceutical composition comprising amorphous sofosbuvir
CZ2016257A3 (cs) * 2016-05-05 2017-11-15 Zentiva, K.S. Amorfní forma sofosbuviru, způsob její přípravy a její stabilizace
CN106083963A (zh) * 2016-06-08 2016-11-09 上海现代制药海门有限公司 一种索非布韦晶型6的制备方法
BR112019002729A2 (pt) * 2016-08-12 2019-05-14 Sandoz Ag composição farmacêutica sólida e processo para preparar uma composição farmacêutica sólida
CZ2016553A3 (cs) 2016-09-09 2018-03-21 Zentiva, K.S. Pevná farmaceutická dávková forma obsahující sofosbuvir
WO2018078536A1 (en) 2016-10-26 2018-05-03 Lupin Limited Stable solid dispersion of sofosbuvir and process for preparation thereof
CN108210509A (zh) * 2016-12-13 2018-06-29 南京圣和药业股份有限公司 新的核苷氨基磷酸脂化合物的组合物及其制备方法
RU2659693C1 (ru) * 2017-06-30 2018-07-03 Общество с ограниченной ответственностью "Изварино Фарма" Фармацевтическая композиция, обладающая активностью против ВИЧ-инфекции
WO2019134971A1 (en) * 2018-01-04 2019-07-11 Sandoz Ag Encapsulated particles comprising a pharmaceutically active ingredient
EP3862318A4 (en) 2018-10-05 2022-06-15 Fuji Chemical Industry Co., Ltd. Porous silica particle composition
CN111040010A (zh) * 2019-12-23 2020-04-21 上海红蓝医药科技有限公司 一种索非布韦中间体的合成方法

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
NZ513964A (en) * 1999-12-08 2004-01-30 Pharmacia Corp Solid-state form of celecoxib having enhanced bioavailability
CN1200262C (zh) 2003-01-10 2005-05-04 清华大学 测量粉末吸附气体量的方法和设备
WO2010017965A2 (en) 2008-08-11 2010-02-18 Merck Serono S.A. SOLID LIPID MICROCAPSULES CONTAINING hGH
TWI598358B (zh) 2009-05-20 2017-09-11 基利法瑪席特有限責任公司 核苷磷醯胺
JP2013527145A (ja) 2010-03-31 2013-06-27 ギリード・ファーマセット・エルエルシー リン含有活性化剤の立体選択的合成
EP2907505A3 (en) * 2011-12-29 2015-12-30 Abbvie Inc. Solid compositions comprising an HCV inhibitor
BR112014016319A8 (pt) * 2011-12-30 2017-07-04 Chevron Usa Inc processo, método, e sistema para remover metais pesados de fluidos
EP3650014B1 (en) * 2013-08-27 2021-10-06 Gilead Pharmasset LLC Combination formulation of two antiviral compounds

Also Published As

Publication number Publication date
WO2015150561A3 (en) 2016-01-28
MX2016012934A (es) 2016-12-07
US10493089B2 (en) 2019-12-03
EP3125868A2 (en) 2017-02-08
RU2016142819A (ru) 2018-05-10
MX2019009842A (es) 2019-10-22
US20170100422A1 (en) 2017-04-13
US20190381085A1 (en) 2019-12-19
KR20160142342A (ko) 2016-12-12
CN106163529A (zh) 2016-11-23
JP2017512811A (ja) 2017-05-25
RU2016142819A3 (enExample) 2018-05-10
WO2015150561A2 (en) 2015-10-08
CA2943574A1 (en) 2015-10-08

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MK4 Application lapsed section 142(2)(d) - no continuation fee paid for the application