MX2019009842A - Composicion solida que comprende sofosbuvir amorfo. - Google Patents

Composicion solida que comprende sofosbuvir amorfo.

Info

Publication number
MX2019009842A
MX2019009842A MX2019009842A MX2019009842A MX2019009842A MX 2019009842 A MX2019009842 A MX 2019009842A MX 2019009842 A MX2019009842 A MX 2019009842A MX 2019009842 A MX2019009842 A MX 2019009842A MX 2019009842 A MX2019009842 A MX 2019009842A
Authority
MX
Mexico
Prior art keywords
sofosbuvir
solid composition
weight
amorphous sofosbuvir
matrix compound
Prior art date
Application number
MX2019009842A
Other languages
English (en)
Inventor
Martin Nolwenn
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 MX2019009842A publication Critical patent/MX2019009842A/es

Links

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)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Molecular Biology (AREA)
  • Epidemiology (AREA)
  • Biochemistry (AREA)
  • Genetics & Genomics (AREA)
  • Biotechnology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Inorganic Chemistry (AREA)
  • Virology (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

Una composición sólida, la cual comprende sofosbuvir y cuando menos un compuesto de matriz farmacéuticamente aceptable, en donde cuando menos el 99 por ciento en peso del sofosbuvir comprendido en la composición está presente en una forma amorfa, cuando menos el 99 por ciento en peso de la composición sólida consiste en el sofosbuvir y el cuando menos un compuesto de matriz, y en donde la composición sólida contiene el sofosbuvir en una cantidad de cuando menos el 55 por ciento en peso, basándose en el peso combinado del sofosbuvir y el cuando menos un compuesto de matriz.
MX2019009842A 2014-04-03 2016-09-30 Composicion solida que comprende sofosbuvir amorfo. MX2019009842A (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP14163434 2014-04-03

Publications (1)

Publication Number Publication Date
MX2019009842A true MX2019009842A (es) 2019-10-22

Family

ID=50397065

Family Applications (2)

Application Number Title Priority Date Filing Date
MX2016012934A MX2016012934A (es) 2014-04-03 2015-04-02 Composicion solida que comprende sofosbuvir amorfo.
MX2019009842A MX2019009842A (es) 2014-04-03 2016-09-30 Composicion solida que comprende sofosbuvir amorfo.

Family Applications Before (1)

Application Number Title Priority Date Filing Date
MX2016012934A MX2016012934A (es) 2014-04-03 2015-04-02 Composicion solida que comprende sofosbuvir amorfo.

Country Status (10)

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

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015189386A1 (en) 2014-06-13 2015-12-17 Teva Pharmaceuticals International Gmbh Composition with a high drug load 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
CN108136033A (zh) * 2015-10-07 2018-06-08 桑多斯股份公司 包含无定形索非布韦的固体药物组合物
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
MX2019001771A (es) * 2016-08-12 2019-11-18 Sandoz Ag Composición farmacéutica sólida que comprende el sofosbuvir amorfo.
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
CA3114751A1 (en) 2018-10-05 2020-04-09 Fuji Chemical Industries 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
DE60038162T2 (de) * 1999-12-08 2009-02-26 Pharmacia Corp. Celecoxib in festkörperform mit erhöhter bioverfügbarkeit
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
TWI576352B (zh) 2009-05-20 2017-04-01 基利法瑪席特有限責任公司 核苷磷醯胺
AU2011235112B2 (en) 2010-03-31 2015-07-09 Gilead Pharmasset Llc Nucleoside phosphoramidates
EP2907505A3 (en) * 2011-12-29 2015-12-30 Abbvie Inc. Solid compositions comprising an HCV inhibitor
CN104093819A (zh) * 2011-12-30 2014-10-08 雪佛龙美国公司 液体中去除重金属的工艺、方法和系统
NZ716840A (en) * 2013-08-27 2017-06-30 Gilead Pharmasset Llc Combination formulation of two antiviral compounds

Also Published As

Publication number Publication date
EP3125868A2 (en) 2017-02-08
US10493089B2 (en) 2019-12-03
RU2016142819A3 (es) 2018-05-10
CN106163529A (zh) 2016-11-23
KR20160142342A (ko) 2016-12-12
CA2943574A1 (en) 2015-10-08
RU2016142819A (ru) 2018-05-10
US20170100422A1 (en) 2017-04-13
WO2015150561A2 (en) 2015-10-08
JP2017512811A (ja) 2017-05-25
US20190381085A1 (en) 2019-12-19
AU2015239018A1 (en) 2016-10-13
WO2015150561A3 (en) 2016-01-28
MX2016012934A (es) 2016-12-07

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