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SI3845221T1 - Trdne oblike sofosbuvirja - Google Patents

Trdne oblike sofosbuvirja

Info

Publication number
SI3845221T1
SI3845221T1 SI201531985T SI201531985T SI3845221T1 SI 3845221 T1 SI3845221 T1 SI 3845221T1 SI 201531985 T SI201531985 T SI 201531985T SI 201531985 T SI201531985 T SI 201531985T SI 3845221 T1 SI3845221 T1 SI 3845221T1
Authority
SI
Slovenia
Prior art keywords
sofosbuvir
solid state
state forms
forms
solid
Prior art date
Application number
SI201531985T
Other languages
English (en)
Inventor
Wolfgang Albrecht
Judith Aronhime
Brijnath P. Chaurasia
Jens Geier
Richard Guserle
Julia Hrakovsky
Claudia Lauer
Ramkaran Prajapati
Vinod K. Kansal
Pavan V. KUMAR
Hans-Juergen Mika
Siva Rama Krishna Muppalla
Marina Ratkaj
Roman Safonov
Dirk Schenk
Naveen C. SRIVASTAV
Ralph Stefan
Ashish Tripathi
Original Assignee
Ratiopharm Gmbh
Teva Pharmaceuticals International Gmbh
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 Ratiopharm Gmbh, Teva Pharmaceuticals International Gmbh filed Critical Ratiopharm Gmbh
Publication of SI3845221T1 publication Critical patent/SI3845221T1/sl

Links

Classifications

    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07HSUGARS; DERIVATIVES THEREOF; NUCLEOSIDES; NUCLEOTIDES; NUCLEIC ACIDS
    • C07H19/00Compounds containing a hetero ring sharing one ring hetero atom with a saccharide radical; Nucleosides; Mononucleotides; Anhydro-derivatives thereof
    • C07H19/02Compounds containing a hetero ring sharing one ring hetero atom with a saccharide radical; Nucleosides; Mononucleotides; Anhydro-derivatives thereof sharing nitrogen
    • C07H19/04Heterocyclic radicals containing only nitrogen atoms as ring hetero atom
    • C07H19/06Pyrimidine radicals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/41641,3-Diazoles
    • A61K31/41841,3-Diazoles condensed with carbocyclic rings, e.g. benzimidazoles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7052Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
    • A61K31/706Compounds 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
    • A61K31/7064Compounds 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
    • A61K31/7068Compounds 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
    • A61K31/7072Compounds 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2009Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • A61P31/14Antivirals for RNA viruses
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07BGENERAL METHODS OF ORGANIC CHEMISTRY; APPARATUS THEREFOR
    • C07B2200/00Indexing scheme relating to specific properties of organic compounds
    • C07B2200/13Crystalline forms, e.g. polymorphs

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Biotechnology (AREA)
  • Engineering & Computer Science (AREA)
  • Genetics & Genomics (AREA)
  • Biochemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Virology (AREA)
  • Communicable Diseases (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oncology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Nitrogen Condensed Heterocyclic Rings (AREA)
  • Medicinal Preparation (AREA)
SI201531985T 2014-06-13 2015-06-12 Trdne oblike sofosbuvirja SI3845221T1 (sl)

Applications Claiming Priority (11)

Application Number Priority Date Filing Date Title
IN1610DE2014 2014-06-13
EP14002279 2014-07-03
EP14180278 2014-08-07
IN2268DE2014 2014-08-08
US201562119599P 2015-02-23 2015-02-23
US201562157043P 2015-05-05 2015-05-05
EP15167228 2015-05-11
EP15167683 2015-05-13
IN1348DE2015 2015-05-14
EP15169888 2015-05-29
EP20212270.1A EP3845221B1 (en) 2014-06-13 2015-06-12 Solid state forms of sofosbuvir

Publications (1)

Publication Number Publication Date
SI3845221T1 true SI3845221T1 (sl) 2024-03-29

Family

ID=54832933

Family Applications (3)

Application Number Title Priority Date Filing Date
SI201530663T SI3154526T1 (sl) 2014-06-13 2015-06-12 Trdne oblike sofosbuvira
SI201531513T SI3524234T1 (sl) 2014-06-13 2015-06-12 Trdne oblike sofosbuvira
SI201531985T SI3845221T1 (sl) 2014-06-13 2015-06-12 Trdne oblike sofosbuvirja

Family Applications Before (2)

Application Number Title Priority Date Filing Date
SI201530663T SI3154526T1 (sl) 2014-06-13 2015-06-12 Trdne oblike sofosbuvira
SI201531513T SI3524234T1 (sl) 2014-06-13 2015-06-12 Trdne oblike sofosbuvira

Country Status (6)

Country Link
US (1) US10214553B2 (sl)
EP (3) EP3845221B1 (sl)
CA (1) CA2988393C (sl)
ES (1) ES2971478T3 (sl)
SI (3) SI3154526T1 (sl)
WO (2) WO2015191945A2 (sl)

Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CZ2015443A3 (cs) * 2015-06-26 2017-01-04 Zentiva, K.S. Farmaceutická formulace sofosbuviru
CN107710050A (zh) 2015-06-30 2018-02-16 3M创新有限公司 照明器
EP3430023A1 (en) 2016-03-17 2019-01-23 Mylan Laboratories, Limited Polymorphic forms of sofosbuvir
CN106220639A (zh) * 2016-07-22 2016-12-14 上海众强药业有限公司 一种维帕他韦中间体新晶型
CZ2016553A3 (cs) * 2016-09-09 2018-03-21 Zentiva, K.S. Pevná farmaceutická dávková forma obsahující sofosbuvir
CN106432253B (zh) * 2016-09-21 2019-06-14 上海众强药业有限公司 一种维帕他韦新晶型及其制备方法
RU2656228C9 (ru) * 2017-06-13 2019-04-16 Олег Ростиславович Михайлов Слабозакристаллизованная β-модификация (S)-изопропил 2-((S)-(((2R,3R,4R,5R)-5-(2,4-диоксо-3,4-дигидропиримидин-(2Н)-ил)-4-фтор-3-гидрокси-4-метилтетрагидрофуран-2-ил)метокси)-(фенокси)фосфориламино)пропаноата, способ её получения и фармацевтическая композиция на её основе
WO2019025600A1 (en) 2017-08-03 2019-02-07 Sandoz Ag SOFOSBUVIR HYDRATE
CN110693887B (zh) * 2019-05-17 2022-06-17 歌礼药业(浙江)有限公司 包含索磷布韦和拉维达韦的片剂及其制备方法
CN111773192B (zh) * 2020-08-18 2024-08-02 福建广生堂药业股份有限公司 一种索磷布韦片剂及其制备方法
CN115368310B (zh) 2021-05-18 2025-06-27 奥库菲尔医药公司 合成甲磺酸酚妥拉明的方法

Family Cites Families (30)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7964580B2 (en) 2007-03-30 2011-06-21 Pharmasset, Inc. Nucleoside phosphoramidate prodrugs
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
US8618076B2 (en) 2009-05-20 2013-12-31 Gilead Pharmasset Llc Nucleoside phosphoramidates
ES2437933T3 (es) * 2010-01-28 2014-01-15 F. Hoffmann-La Roche Ag 4'-azido-nucleósidos como compuestos anti-VHC
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
TW201136945A (en) 2010-03-31 2011-11-01 Pharmasset Inc Purine nucleoside phosphoramidate
AU2012346217B2 (en) * 2011-11-29 2016-02-04 Gilead Sciences, Inc. Compositions and methods for treating hepatitis C virus
US8889159B2 (en) * 2011-11-29 2014-11-18 Gilead Pharmasset Llc Compositions and methods for treating hepatitis C virus
KR20150027155A (ko) 2012-07-03 2015-03-11 브리스톨-마이어스 스큅 컴퍼니 바이러스 감염의 치료를 위한 뉴클레오시드 화합물의 부분입체이성질체적으로 풍부한 포스포르아미데이트 유도체의 제조 방법
KR20200060782A (ko) 2013-01-31 2020-06-01 길리애드 파마셋 엘엘씨 두 항바이러스 화합물의 병용 제형물
US10100075B2 (en) 2013-12-23 2018-10-16 Mylan Laboratories Limited Process for the preparation of sofosbuvir
TW201609785A (zh) 2013-12-23 2016-03-16 吉李德製藥公司 固體型之抗病毒化合物
WO2015126995A1 (en) * 2014-02-20 2015-08-27 Ratiopharm Gmbh Solid state forms of sofosbuvir
US20170080008A1 (en) 2014-03-05 2017-03-23 Galenicum Health S.L. Stable pharmaceutical compositions of sofosbuvir
CN106163529A (zh) 2014-04-03 2016-11-23 桑多斯股份公司 包含无定形索非布韦的固体组合物
CZ2014502A3 (cs) 2014-07-17 2016-01-27 Zentiva, K.S. Nová forma sofosbuviru a způsob její přípravy
JP2017522343A (ja) 2014-07-31 2017-08-10 サンド・アクチエンゲゼルシヤフト ホスホルアミデート類の合成
TW201609709A (zh) 2014-08-01 2016-03-16 Hc製藥公司 呈晶形之索非布弗(Sofosbuvir)及其製備方法
CN104130302B (zh) 2014-08-08 2017-02-15 乳源东阳光药业有限公司 一种核苷药物的晶型及其制备方法
WO2016023906A1 (en) 2014-08-13 2016-02-18 Sandoz Ag A crystalline form of sofosbuvir
WO2016023905A1 (en) 2014-08-13 2016-02-18 Sandoz Ag New and efficient process for the preparation of crystalline form 6 of sofosbuvir
WO2016035006A1 (en) 2014-09-01 2016-03-10 Dr. Reddy’S Laboratories Limited Novel nucleotide analogs, process for the preparation of sofosbuvir and its analogs, novel forms of sofosbuvir and solid dispersion of sofosbuvir
WO2016038542A2 (en) 2014-09-10 2016-03-17 Mylan Laboratories Limited Polymorphic forms of sofosbuvir
WO2016055576A1 (en) 2014-10-08 2016-04-14 Sandoz Ag High drug load tablets comprising sofosbuvir
CN104277088A (zh) 2014-10-29 2015-01-14 汤律进 索菲布韦单晶m及其制备方法和用途
CN106046088B (zh) 2014-11-07 2018-05-15 南京旗昌医药科技有限公司 索氟布韦的晶型h3及其制备方法
WO2016097173A1 (en) 2014-12-17 2016-06-23 Sandoz Ag A process for preparing a crystalline form of sofosbuvir
WO2016156512A1 (en) 2015-04-01 2016-10-06 Sandoz Ag A process for preparing a crystalline form of sofosbuvir
WO2016189443A2 (en) 2015-05-23 2016-12-01 Virupaksha Organics Limited Solid forms of nucleoside phosphoramidate
EP3430023A1 (en) 2016-03-17 2019-01-23 Mylan Laboratories, Limited Polymorphic forms of sofosbuvir

Also Published As

Publication number Publication date
EP3524234B1 (en) 2020-12-09
EP3845221A1 (en) 2021-07-07
EP3154526B1 (en) 2019-03-06
CA2988393C (en) 2023-08-22
WO2015189386A1 (en) 2015-12-17
SI3524234T1 (sl) 2021-05-31
EP3154526A2 (en) 2017-04-19
EP3845221B1 (en) 2023-12-13
SI3154526T1 (sl) 2019-08-30
ES2971478T3 (es) 2024-06-05
US10214553B2 (en) 2019-02-26
WO2015191945A2 (en) 2015-12-17
CA2988393A1 (en) 2015-12-17
WO2015191945A3 (en) 2016-04-07
EP3524234A1 (en) 2019-08-14
US20170137453A1 (en) 2017-05-18

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