EA201390310A1 - Фармацевтические композиции, содержащие рифаксимин, способы их получения и способ лечения кишечного заболевания - Google Patents

Фармацевтические композиции, содержащие рифаксимин, способы их получения и способ лечения кишечного заболевания

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Publication number
EA201390310A1
EA201390310A1 EA201390310A EA201390310A EA201390310A1 EA 201390310 A1 EA201390310 A1 EA 201390310A1 EA 201390310 A EA201390310 A EA 201390310A EA 201390310 A EA201390310 A EA 201390310A EA 201390310 A1 EA201390310 A1 EA 201390310A1
Authority
EA
Eurasian Patent Office
Prior art keywords
methods
receiving
pharmaceutical compositions
compositions containing
intestinal disease
Prior art date
Application number
EA201390310A
Other languages
English (en)
Other versions
EA027588B1 (ru
Inventor
Джузеппе Клаудио Вискоми
Паола Маффей
Джузеппе Боттони
Мария Гримальди
Original Assignee
Альфа Вассерманн С.П.А.
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.)
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Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=43737853&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=EA201390310(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Альфа Вассерманн С.П.А. filed Critical Альфа Вассерманн С.П.А.
Publication of EA201390310A1 publication Critical patent/EA201390310A1/ru
Publication of EA027588B1 publication Critical patent/EA027588B1/ru

Links

Classifications

    • 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
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • 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
    • 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
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • 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
    • 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
    • A61K9/1635—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
    • A61K9/14—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
    • 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
    • A61K9/2072—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
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • 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
    • 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
    • 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
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • 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
    • A61P1/12—Antidiarrhoeals
    • 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
    • A61P19/00—Drugs for skeletal disorders
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2121/00—Preparations for use in therapy
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Nitrogen And Oxygen Or Sulfur-Condensed Heterocyclic Ring Systems (AREA)
  • Medicinal Preparation (AREA)

Abstract

Объектом изобретения являются гастрорезистентные таблетки, содержащие рифаксимин, полученные с использованием гастрорезистентных микрогранул, отличающиеся тем, что они задерживают высвобождение рифаксимина при значениях pH от 1,5 до 4,0 и делают возможным его высвобождение при значениях pH от 5,0 до 7,5, способы их получения и их применение в лечении и предупреждении заболеваний, непосредственно или опосредовано обусловленных воспалительными заболеваниями кишечника.
EA201390310A 2010-09-22 2011-09-21 Таблетка для лечения болезни крона и ее применение для этой цели EA027588B1 (ru)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
ITBO20100567 2010-09-22
ITBO20100638 2010-10-22
ITBO2011A000012A IT1403847B1 (it) 2010-09-22 2011-01-19 Composizioni farmaceutiche comprendenti rifaximina e loro uso.
PCT/IB2011/054133 WO2012038898A1 (en) 2010-09-22 2011-09-21 Pharmaceutical formulations containing rifaximin, processes for their obtainment and method of treating intestinal disease

Publications (2)

Publication Number Publication Date
EA201390310A1 true EA201390310A1 (ru) 2013-11-29
EA027588B1 EA027588B1 (ru) 2017-08-31

Family

ID=43737853

Family Applications (1)

Application Number Title Priority Date Filing Date
EA201390310A EA027588B1 (ru) 2010-09-22 2011-09-21 Таблетка для лечения болезни крона и ее применение для этой цели

Country Status (31)

Country Link
US (4) US20120245192A1 (ru)
EP (1) EP2618819B1 (ru)
JP (1) JP5918242B2 (ru)
KR (2) KR20180001586A (ru)
CN (1) CN103118666A (ru)
AU (1) AU2011306444B2 (ru)
BR (1) BR112013007457A8 (ru)
CA (1) CA2809509C (ru)
CL (1) CL2013000677A1 (ru)
CO (1) CO6680695A2 (ru)
CY (1) CY1119746T1 (ru)
DK (1) DK2618819T3 (ru)
EA (1) EA027588B1 (ru)
ES (1) ES2649063T3 (ru)
HR (1) HRP20171734T1 (ru)
HU (1) HUE034620T2 (ru)
IL (1) IL271927A (ru)
IT (1) IT1403847B1 (ru)
LT (1) LT2618819T (ru)
ME (1) ME03044B (ru)
MX (1) MX349719B (ru)
NO (1) NO2618819T3 (ru)
PL (1) PL2618819T3 (ru)
PT (1) PT2618819T (ru)
RS (1) RS56708B1 (ru)
SG (2) SG188271A1 (ru)
SI (1) SI2618819T1 (ru)
TN (1) TN2013000073A1 (ru)
UA (1) UA110212C2 (ru)
WO (1) WO2012038898A1 (ru)
ZA (1) ZA201301391B (ru)

Families Citing this family (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2522895T3 (es) 2005-03-03 2014-11-19 Alfa Wassermann S.P.A. Nuevas formas polimorfas de rifaximina, procedimientos para su producción y uso de las mismas en preparados medicinales
ITBO20050123A1 (it) 2005-03-07 2005-06-06 Alfa Wassermann Spa Formulazioni farmaceutiche gastroresistenti contenenti rifaximina
ITMI20061692A1 (it) 2006-09-05 2008-03-06 Alfa Wassermann Spa Uso di polioli per ottenere forme polimorfe stabili di rifaximina
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.
WO2014091432A1 (en) * 2012-12-12 2014-06-19 Ranbaxy Laboratories Limited Pharmaceutical compositions of rifaximin
PT2983647T (pt) * 2013-04-12 2020-11-09 Alfasigma Spa Administração de aine e composições, métodos e sistemas relacionados
CN103340856A (zh) * 2013-07-09 2013-10-09 荣港生技医药科技（北京）有限公司 一种利福昔明药物组合物及其制备方法
US20160206564A1 (en) * 2013-09-27 2016-07-21 Ira Milton Trachtman Compositions and methods for treatment and prophylaxis of gastrointestinal diseases
WO2015173697A1 (en) 2014-05-12 2015-11-19 Alfa Wassermann S.P.A. New solvated crystal form of rifaximin, production, compositions and uses thereof
JP6608193B2 (ja) * 2014-06-27 2019-11-20 花王株式会社 固形状組成物
WO2016063289A2 (en) * 2014-10-22 2016-04-28 Strides Arcolab Limited Pharmaceutical tablet compositions comprising rifaximin
EP4137132A1 (en) 2016-09-30 2023-02-22 Salix Pharmaceuticals, Inc. Solid dispersion forms of rifaximin
MX2018010065A (es) 2017-04-26 2019-02-07 Sandoz Ag Forma de dosificacion oral que comprende rifaximina en forma beta.
MX2021002686A (es) 2018-09-06 2021-08-11 Fachhochschule Nordwestschweiz Formulacion controlada de liberacion de farmacos.
JP2022548788A (ja) * 2019-09-24 2022-11-21 バウシュ ヘルス アイルランド リミテッド リファキシミン液体製剤

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ITMI20032144A1 (it) * 2003-11-07 2005-05-08 Alfa Wassermann Spa Forme polimorfe di rifaximina, processi per ottenerle e
US7902206B2 (en) 2003-11-07 2011-03-08 Alfa Wassermann, S.P.A. Polymorphic forms α, β and γ of rifaximin
US20080262024A1 (en) 2003-11-07 2008-10-23 Giuseppe Claudio Viscomi Rifaximin compositions and method of use
US7906542B2 (en) * 2004-11-04 2011-03-15 Alfa Wassermann, S.P.A. Pharmaceutical compositions comprising polymorphic forms α, β, and γ of rifaximin
ES2522895T3 (es) 2005-03-03 2014-11-19 Alfa Wassermann S.P.A. Nuevas formas polimorfas de rifaximina, procedimientos para su producción y uso de las mismas en preparados medicinales
ITBO20050123A1 (it) * 2005-03-07 2005-06-06 Alfa Wassermann Spa Formulazioni farmaceutiche gastroresistenti contenenti rifaximina
ITMI20061692A1 (it) * 2006-09-05 2008-03-06 Alfa Wassermann Spa Uso di polioli per ottenere forme polimorfe stabili di rifaximina
WO2008035108A1 (en) 2006-09-21 2008-03-27 Ray Mason Engine assemblies
ITMI20071241A1 (it) 2007-06-20 2008-12-21 Solmag S P A Processo per la preparazione di rifaximina amorfa e rifaximina amorfa cosi' ottenuta
AU2008273699A1 (en) * 2007-07-06 2009-01-15 Lupin Limited Pharmaceutical compositions of rifaximin
US7709634B2 (en) 2007-09-20 2010-05-04 Apotex Pharmachem Inc. Amorphous form of rifaximin and processes for its preparation
CN104650114A (zh) 2008-02-25 2015-05-27 萨利克斯药品有限公司 利福昔明的多种形式及其用途

Also Published As

Publication number Publication date
AU2011306444A1 (en) 2013-03-21
EP2618819B1 (en) 2017-11-01
MX2013003243A (es) 2013-05-22
CL2013000677A1 (es) 2013-07-19
KR20130106400A (ko) 2013-09-27
DK2618819T3 (en) 2017-12-11
US20170071916A1 (en) 2017-03-16
US20120245192A1 (en) 2012-09-27
IL271927A (en) 2020-02-27
NO2618819T3 (ru) 2018-03-31
LT2618819T (lt) 2018-02-26
ME03044B (me) 2018-10-20
MX349719B (es) 2017-08-09
JP2013537900A (ja) 2013-10-07
ES2649063T3 (es) 2018-01-09
IT1403847B1 (it) 2013-11-08
WO2012038898A1 (en) 2012-03-29
AU2011306444B2 (en) 2015-04-23
SG188271A1 (en) 2013-04-30
HUE034620T2 (en) 2018-02-28
RS56708B1 (sr) 2018-03-30
US20150080421A1 (en) 2015-03-19
UA110212C2 (ru) 2015-12-10
PL2618819T3 (pl) 2018-01-31
CA2809509A1 (en) 2012-03-29
SI2618819T1 (en) 2018-01-31
BR112013007457A8 (pt) 2017-12-26
US20210244714A1 (en) 2021-08-12
SG10201507869UA (en) 2015-10-29
ITBO20110012A1 (it) 2012-03-23
BR112013007457A2 (pt) 2016-07-12
PT2618819T (pt) 2017-12-11
EP2618819A1 (en) 2013-07-31
CY1119746T1 (el) 2018-06-27
CN103118666A (zh) 2013-05-22
KR102049253B1 (ko) 2019-11-28
KR20180001586A (ko) 2018-01-04
HRP20171734T1 (hr) 2018-01-26
ZA201301391B (en) 2014-04-30
EA027588B1 (ru) 2017-08-31
JP5918242B2 (ja) 2016-05-18
TN2013000073A1 (en) 2014-06-25
CA2809509C (en) 2016-04-26
CO6680695A2 (es) 2013-05-31

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