EA033370B1 - Составы рифаксимина и их применение - Google Patents

Составы рифаксимина и их применение

Info

Publication number
EA033370B1
EA033370B1 EA201370018A EA201370018A EA033370B1 EA 033370 B1 EA033370 B1 EA 033370B1 EA 201370018 A EA201370018 A EA 201370018A EA 201370018 A EA201370018 A EA 201370018A EA 033370 B1 EA033370 B1 EA 033370B1
Authority
EA
Eurasian Patent Office
Prior art keywords
rifaximin
hpmc
grade
hydroxypropyl methylcellulose
acetate succinate
Prior art date
Application number
EA201370018A
Other languages
English (en)
Other versions
EA201370018A1 (ru
Inventor
Jon Selbo
Jing Teng
Mohammed A Kabir
Pam Golden
Original Assignee
Salix Pharmaceuticals Ltd
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 Salix Pharmaceuticals Ltd filed Critical Salix Pharmaceuticals Ltd
Publication of EA201370018A1 publication Critical patent/EA201370018A1/ru
Publication of EA033370B1 publication Critical patent/EA033370B1/ru

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
    • A61K31/33—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
    • A61K31/4353—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 ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/437—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 ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a five-membered ring having nitrogen as a ring hetero atom, e.g. indolizine, beta-carboline
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • 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
    • A61K9/10—Dispersions; Emulsions
    • 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
    • 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
    • A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, 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
    • A61K9/14—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
    • 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
    • A61K9/205—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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—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
    • 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
    • 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
    • A61P31/04—Antibacterial agents
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D498/00—Heterocyclic compounds containing in the condensed system at least one hetero ring having nitrogen and oxygen atoms as the only ring hetero atoms
    • C07D498/22—Heterocyclic compounds containing in the condensed system at least one hetero ring having nitrogen and oxygen atoms as the only ring hetero atoms in which the condensed system contains four or more hetero rings

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Dispersion Chemistry (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Nitrogen And Oxygen Or Sulfur-Condensed Heterocyclic Ring Systems (AREA)
  • Medicinal Preparation (AREA)
  • Agricultural Chemicals And Associated Chemicals (AREA)
  • Compositions Of Macromolecular Compounds (AREA)

Abstract

Изобретение относится к новым твердым дисперсным формам рифаксимина, содержащим рифаксимин и фталат гидроксипропилметилцеллюлозы (НРМС-Р) 55, ацетатсукцинат гидроксипропилметилцеллюлозы (HPMC-AS) HG, ацетатсукцинат гидроксипропилметилцеллюлозы (HPMC-AS) MG или полиметакрилат (Eudragit® L100-55), микрогранулам и фармацевтическим композициям их содержащим, а также к их применению для профилактики или лечения бактериальной инфекции.
EA201370018A 2010-07-12 2011-07-12 Составы рифаксимина и их применение EA033370B1 (ru)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US36360910P 2010-07-12 2010-07-12
US41905610P 2010-12-02 2010-12-02
PCT/US2011/043769 WO2012009388A1 (en) 2010-07-12 2011-07-12 Formulations of rifaximin and uses thereof

Publications (2)

Publication Number Publication Date
EA201370018A1 EA201370018A1 (ru) 2013-09-30
EA033370B1 true EA033370B1 (ru) 2019-10-31

Family

ID=45469785

Family Applications (1)

Application Number Title Priority Date Filing Date
EA201370018A EA033370B1 (ru) 2010-07-12 2011-07-12 Составы рифаксимина и их применение

Country Status (26)

Country Link
US (4) US20120077835A1 (ru)
EP (2) EP3750526A1 (ru)
JP (1) JP5943915B2 (ru)
KR (1) KR101887004B1 (ru)
CN (1) CN103228662B (ru)
AU (1) AU2011279261B2 (ru)
BR (1) BR112013000802B1 (ru)
CA (1) CA2804635C (ru)
CR (1) CR20130033A (ru)
DK (1) DK2593463T3 (ru)
EA (1) EA033370B1 (ru)
ES (1) ES2801678T3 (ru)
GE (1) GEP20227342B (ru)
HU (1) HUE049986T2 (ru)
IL (1) IL223725B (ru)
LT (1) LT2593463T (ru)
MX (1) MX345697B (ru)
MY (1) MY165086A (ru)
NZ (1) NZ605232A (ru)
PL (1) PL2593463T3 (ru)
PT (1) PT2593463T (ru)
SG (2) SG186981A1 (ru)
SI (1) SI2593463T1 (ru)
TN (1) TN2012000611A1 (ru)
WO (2) WO2012009388A1 (ru)
ZA (1) ZA201300193B (ru)

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DK1698630T3 (da) 2005-03-03 2014-12-08 Alfa Wassermann Spa Nye polymorfe former af rifaximin, fremgangsmåde for deres fremstilling og anvendelse deraf i de medicinske præparater
ITBO20050123A1 (it) 2005-03-07 2005-06-06 Alfa Wassermann Spa Formulazioni farmaceutiche gastroresistenti contenenti rifaximina
US9018684B2 (en) 2009-11-23 2015-04-28 California Institute Of Technology Chemical sensing and/or measuring devices and methods
IT1398550B1 (it) 2010-03-05 2013-03-01 Alfa Wassermann Spa Formulazioni comprendenti rifaximina utili per ottenere un effetto prolungato nel tempo
ITBO20110461A1 (it) 2011-07-29 2013-01-30 Alfa Wassermann Spa Composizioni farmaceutiche comprendenti rifaximina, processi per la loro preparazione e loro uso nel trattamento di infezioni vaginali.
AU2012332211B2 (en) * 2011-11-02 2016-11-24 Salix Pharmaceuticals, Ltd. Methods for treating irritable bowel syndrome (IBS) and infections
AU2013212008A1 (en) 2012-01-25 2014-07-10 Alfa Wassermann S.P.A. Rifaximin derivative and uses thereof
ITBO20120368A1 (it) 2012-07-06 2014-01-07 Alfa Wassermann Spa Composizioni comprendenti rifaximina e amminoacidi, cristalli di rifaximina derivanti da tali composizioni e loro uso.
EP2757135B1 (en) 2013-01-18 2017-11-29 3M Innovative Properties Company Method of bonding parts to a vehicle by an acrylic foam tape
EP3065788A1 (en) * 2013-11-08 2016-09-14 Tyrx, Inc. Antimicrobial compositions and methods for preventing infection in surgical incision sites
CA2947962C (en) 2014-05-04 2024-01-16 Salix Pharmaceuticals, Inc. Ibs microbiota and uses thereof
ES2742106T3 (es) 2014-05-12 2020-02-13 Alfasigma Spa Nueva forma de cristal solvatado de rifaximina, producción, composiciones y usos de la misma
JP7024248B2 (ja) * 2016-09-01 2022-02-24 大正製薬株式会社 固形製剤
WO2018064472A1 (en) * 2016-09-30 2018-04-05 Salix Pharmaceuticals, Ltd. Solid dispersion forms of rifaximin
CN110621305A (zh) * 2017-07-24 2019-12-27 爱科思华制药研发有限责任公司 高载药量药物组合物
CN109453165B (zh) * 2018-10-16 2021-02-05 丹诺医药(苏州）有限公司 一种利福霉素-硝基咪唑偶联分子的固体分散体及其应用
CN109453166B (zh) * 2018-10-16 2021-03-12 丹诺医药(苏州）有限公司 一种利福霉素-喹嗪酮偶联分子的固体分散体及其应用
WO2020198136A1 (en) * 2019-03-22 2020-10-01 New York Medical College Use of rifaximin on circulating aged neutrophils in sickle cell disease
US20220378758A1 (en) 2019-09-24 2022-12-01 Bausch Health Ireland Limited Rifaximin liquid formulations
US20230141118A1 (en) * 2020-04-13 2023-05-11 Bausch Health Ireland Limited Methods of using solid dispersions of rifaximin for the treatment of sickle cell disease
CA3184054A1 (en) 2020-06-26 2021-12-30 Jacob Cole Targeted release rifaximin compositions
WO2022090490A1 (en) 2020-10-29 2022-05-05 Bausch Health Ireland Limited Rifaximin liquid formulations for use in the treatment of sickle cell disease
CN114366717B (zh) * 2022-01-11 2023-06-09 四川农业大学 一种基于egcg纳米粒的肠溶固体分散体颗粒、制备方法及其应用

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US20080095754A1 (en) * 2006-10-18 2008-04-24 Burke Susan E Ophthalmic compositions comprising diglycine
US20090011020A1 (en) * 2005-03-07 2009-01-08 Alfa Wassermann S.P.A. Gastroresistant Pharmaceutical Formulations Containing Rifaximin
WO2009108730A2 (en) * 2008-02-25 2009-09-03 Salix Pharmaceuticals, Ltd. Forms of rifaximin and uses thereof
US20100174064A1 (en) * 2008-02-25 2010-07-08 Salix Pharmaceuticals, Ltd. Forms of rifaximin and uses thereof

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US20090011020A1 (en) * 2005-03-07 2009-01-08 Alfa Wassermann S.P.A. Gastroresistant Pharmaceutical Formulations Containing Rifaximin
US20080095754A1 (en) * 2006-10-18 2008-04-24 Burke Susan E Ophthalmic compositions comprising diglycine
WO2009108730A2 (en) * 2008-02-25 2009-09-03 Salix Pharmaceuticals, Ltd. Forms of rifaximin and uses thereof
US20100174064A1 (en) * 2008-02-25 2010-07-08 Salix Pharmaceuticals, Ltd. Forms of rifaximin and uses thereof

Also Published As

Publication number Publication date
BR112013000802B1 (pt) 2021-08-31
ZA201300193B (en) 2019-07-31
BR112013000802A2 (pt) 2016-05-24
CN103228662B (zh) 2016-08-10
MY165086A (en) 2018-02-28
GEP20227342B (en) 2022-01-25
JP5943915B2 (ja) 2016-07-05
US20120077835A1 (en) 2012-03-29
KR20130098300A (ko) 2013-09-04
EP2593463A1 (en) 2013-05-22
EP3750526A1 (en) 2020-12-16
EP2593463A4 (en) 2014-04-23
US9737610B2 (en) 2017-08-22
CA2804635C (en) 2019-09-10
US20170333562A1 (en) 2017-11-23
DK2593463T3 (da) 2020-08-10
KR101887004B1 (ko) 2018-08-09
SG10201505484RA (en) 2015-09-29
WO2012009388A1 (en) 2012-01-19
MX2013000522A (es) 2013-05-01
CR20130033A (es) 2013-04-29
SG186981A1 (en) 2013-02-28
PL2593463T3 (pl) 2020-11-02
US20200397904A1 (en) 2020-12-24
CA2804635A1 (en) 2012-01-19
PT2593463T (pt) 2020-09-17
US20150133482A1 (en) 2015-05-14
AU2011279261A1 (en) 2013-01-17
MX345697B (es) 2017-02-13
LT2593463T (lt) 2020-08-25
NZ605232A (en) 2015-09-25
CN103228662A (zh) 2013-07-31
SI2593463T1 (sl) 2020-10-30
EP2593463B1 (en) 2020-05-06
WO2012009387A1 (en) 2012-01-19
EA201370018A1 (ru) 2013-09-30
IL223725B (en) 2020-03-31
AU2011279261B2 (en) 2016-03-31
ES2801678T3 (es) 2021-01-12
JP2013532633A (ja) 2013-08-19
HUE049986T2 (hu) 2020-11-30
TN2012000611A1 (en) 2014-04-01

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MM4A Lapse of a eurasian patent due to non-payment of renewal fees within the time limit in the following designated state(s)

Designated state(s): AM AZ BY KZ KG MD TJ TM RU