CO2017013305A2 - Composiciones farmacéuticas sólidas de dos capas para el tratamiento de vhc - Google Patents

Composiciones farmacéuticas sólidas de dos capas para el tratamiento de vhc

Info

Publication number
CO2017013305A2
CO2017013305A2 CONC2017/0013305A CO2017013305A CO2017013305A2 CO 2017013305 A2 CO2017013305 A2 CO 2017013305A2 CO 2017013305 A CO2017013305 A CO 2017013305A CO 2017013305 A2 CO2017013305 A2 CO 2017013305A2
Authority
CO
Colombia
Prior art keywords
solid
pharmaceutical compositions
hcv
compound
treatment
Prior art date
Application number
CONC2017/0013305A
Other languages
English (en)
Inventor
Nancy Sever
Ulrich Westedt
Ute Lander
Katrin Schneider
Benedikt Steitz
Thomas Mueller
Regina Reul
Constanze Obermiller
Adivaraha Jayasankar
Michael Simon
Yi Gao
Harald Hach
Samuel Kyeremateng
Katharina Asmus
Ping Tong
Donghua Zhu
Marius Naris
Colleen Garrett
Original Assignee
Abbvie Inc
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 Abbvie Inc filed Critical Abbvie Inc
Publication of CO2017013305A2 publication Critical patent/CO2017013305A2/es

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/06—Tripeptides
    • 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
    • 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
    • A61K31/41—Heterocyclic 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
    • A61K31/4164—1,3-Diazoles
    • A61K31/4184—1,3-Diazoles condensed with carbocyclic rings, e.g. benzimidazoles
    • 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
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445—Non condensed piperidines, e.g. piperocaine
    • A61K31/4523—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems
    • A61K31/454—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. pimozide, domperidone
    • 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
    • A61K31/498—Pyrazines or piperazines ortho- and peri-condensed with carbocyclic ring systems, e.g. quinoxaline, phenazine
    • 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
    • A61K31/4985—Pyrazines or piperazines ortho- or peri-condensed with heterocyclic ring systems
    • 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
    • A61K9/1682—Processes
    • A61K9/1688—Processes resulting in pure drug agglomerate optionally containing up to 5% of excipient
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
    • 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
    • A61K9/20—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
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Virology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Communicable Diseases (AREA)
  • General Chemical & Material Sciences (AREA)
  • Molecular Biology (AREA)
  • Organic Chemistry (AREA)
  • Oncology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

La presente invención presenta composiciones farmacéuticas sólidas que comprenden el Compuesto 1 y el Compuesto 2. En una realización, la composición farmacéutica sólida incluye (1) una primera capa que comprende 100 mg de Compuesto 1, así como un polímero hidrófilo farmacéuticamente aceptable y un tensioactivo farmacéuticamente aceptable, todos los cuales están formulados en dispersión sólida amorfa; y (2) una segunda capa que comprende 40 mg de Compuesto 2, así como un polímero hidrófilo farmacéuticamente aceptable y un tensioactivo farmacéuticamente aceptable, todos los cuales están formulados en una dispersión sólida amorfa.
CONC2017/0013305A 2015-06-26 2017-12-22 Composiciones farmacéuticas sólidas de dos capas para el tratamiento de vhc CO2017013305A2 (es)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201562185145P 2015-06-26 2015-06-26
US201562186154P 2015-06-29 2015-06-29
US201562193639P 2015-07-17 2015-07-17
US201662295309P 2016-02-15 2016-02-15
PCT/US2016/039266 WO2016210273A1 (en) 2015-06-26 2016-06-24 Solid pharmaceutical compositions for treating hcv

Publications (1)

Publication Number Publication Date
CO2017013305A2 true CO2017013305A2 (es) 2018-05-21

Family

ID=56409187

Family Applications (1)

Application Number Title Priority Date Filing Date
CONC2017/0013305A CO2017013305A2 (es) 2015-06-26 2017-12-22 Composiciones farmacéuticas sólidas de dos capas para el tratamiento de vhc

Country Status (24)

Country Link
US (3) US20160375087A1 (es)
EP (1) EP3313378A1 (es)
JP (2) JP7162425B2 (es)
KR (1) KR102637828B1 (es)
CN (1) CN107920996A (es)
AU (1) AU2016283018C1 (es)
BR (1) BR112017028185A2 (es)
CA (1) CA2990855A1 (es)
CL (1) CL2017003350A1 (es)
CO (1) CO2017013305A2 (es)
CR (1) CR20180030A (es)
DO (1) DOP2017000314A (es)
EA (1) EA201890160A1 (es)
EC (1) ECSP18000689A (es)
HK (1) HK1250627A1 (es)
IL (1) IL256504B (es)
MX (1) MX2018000218A (es)
MY (1) MY192606A (es)
PE (1) PE20180488A1 (es)
PH (1) PH12017502426A1 (es)
RU (2) RU2018102809A (es)
SG (1) SG10202002899VA (es)
WO (1) WO2016210273A1 (es)
ZA (1) ZA201800533B (es)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20160375017A1 (en) 2015-06-26 2016-12-29 Abbvie Inc. Solid Pharmaceutical Compositions for Treating HCV
AU2016296709C1 (en) * 2015-07-17 2022-02-24 Abbvie Inc. Solid pharmaceutical compositions for treating HCV
GB202113944D0 (en) * 2021-09-29 2021-11-10 Univ Liverpool Injectable formulations

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6087386A (en) * 1996-06-24 2000-07-11 Merck & Co., Inc. Composition of enalapril and losartan
DE102004008804A1 (de) 2004-02-20 2005-09-08 Boehringer Ingelheim Pharma Gmbh & Co. Kg Mehrschichttablette
ES2300188B1 (es) 2006-05-24 2009-05-01 Ferrer Internacional, S.A. Comprimido bicapa para la prevencion de los accidentes cardiovasculares.
US8716454B2 (en) * 2009-06-11 2014-05-06 Abbvie Inc. Solid compositions
US9394279B2 (en) * 2009-06-11 2016-07-19 Abbvie Inc. Anti-viral compounds
EP2337781B1 (en) * 2009-06-11 2014-07-23 AbbVie Bahamas Ltd. Anti-viral compounds to treat hcv infection
CA2780939C (en) 2009-11-13 2018-06-12 Bristol-Myers Squibb Company Bilayer tablet formulations
NZ605440A (en) * 2010-06-10 2014-05-30 Abbvie Bahamas Ltd Solid compositions comprising an hcv inhibitor
JP5857053B2 (ja) 2010-09-21 2016-02-10 エナンタ ファーマシューティカルズ インコーポレイテッド 大環式プロリン由来ｈｃｖセリンプロテアーゼ阻害剤
DK2897611T3 (da) 2012-09-18 2019-11-04 Abbvie Inc Fremgangsmåder til behandling af hepatitis c
LT2968301T (lt) 2013-03-14 2017-05-25 Abbvie Inc. Dviejų antivirusinių vaistų derinys, skirtas hepatito c gydymui

Also Published As

Publication number Publication date
SG10202002899VA (en) 2020-05-28
AU2016283018A1 (en) 2018-01-25
US20190216882A1 (en) 2019-07-18
US20200282004A1 (en) 2020-09-10
DOP2017000314A (es) 2018-02-15
MY192606A (en) 2022-08-29
RU2021102950A (ru) 2021-03-01
MX2018000218A (es) 2018-03-08
PE20180488A1 (es) 2018-03-07
KR20180021840A (ko) 2018-03-05
PH12017502426A1 (en) 2018-07-02
IL256504B (en) 2021-09-30
AU2016283018B2 (en) 2021-10-07
US20160375087A1 (en) 2016-12-29
JP7162425B2 (ja) 2022-10-28
ECSP18000689A (es) 2018-03-31
KR102637828B1 (ko) 2024-02-20
CR20180030A (es) 2018-05-24
CN107920996A (zh) 2018-04-17
AU2016283018C1 (en) 2022-03-03
CL2017003350A1 (es) 2018-06-22
CA2990855A1 (en) 2016-12-29
ZA201800533B (en) 2018-12-19
JP2018518517A (ja) 2018-07-12
RU2018102809A (ru) 2019-07-29
RU2018102809A3 (es) 2019-12-10
EA201890160A1 (ru) 2018-06-29
IL256504A (en) 2018-02-28
EP3313378A1 (en) 2018-05-02
JP2022177014A (ja) 2022-11-30
HK1250627A1 (zh) 2019-01-11
BR112017028185A2 (pt) 2018-09-04
WO2016210273A1 (en) 2016-12-29

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