CY1113068T1 - Φαρμακευτικες συνθεσεις ριφαξιμινης - Google Patents

Φαρμακευτικες συνθεσεις ριφαξιμινης

Info

Publication number
CY1113068T1
CY1113068T1 CY20121100760T CY121100760T CY1113068T1 CY 1113068 T1 CY1113068 T1 CY 1113068T1 CY 20121100760 T CY20121100760 T CY 20121100760T CY 121100760 T CY121100760 T CY 121100760T CY 1113068 T1 CY1113068 T1 CY 1113068T1
Authority
CY
Cyprus
Prior art keywords
pharmaceutically acceptable
rifaximine
rifaximin
polymorph
enantiomer
Prior art date
Application number
CY20121100760T
Other languages
English (en)
Inventor
Harshal Anil Jahagirdar
Rajesh Kulkarni
Shirishkumar Kulkarni
Original Assignee
Lupin 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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=40091777&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CY1113068(T1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Lupin Ltd. filed Critical Lupin Ltd.
Publication of CY1113068T1 publication Critical patent/CY1113068T1/el

Links

Classifications

    • 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
    • A61K31/435Heterocyclic 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
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0065Forms with gastric retention, e.g. floating on gastric juice, adhering to gastric mucosa, expanding to prevent passage through the pylorus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1652Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, 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
    • 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
    • A61K9/2072Pills, 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
    • A61K9/2086Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • 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
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/284Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A61K9/2846Poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04Drugs 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/12Antidiarrhoeals
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Landscapes

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

Abstract

Φαρμακευτική σύνθεση περιλαμβάνουσα θεραπευτικώς αποτελεσματική ποσότητα ριφαξιμίνης ή φαρμακευτικώς αποδεκτού άλατος ή εναντιομερούς ή πολυμόρφου αυτής, φαρμακευτικώς αποδεκτό έκδοχο(α) και παράγοντα(ες) ελέγχου απελευθέρωσης. Φαρμακευτική σύνθεση ριφαξιμίνης που περιλαμβάνει: τουλάχιστον δύο ολότητες όπου μια ολότητα είναι άμεσης απελευθέρωσης ή ταχείας απελευθέρωσης και η άλλη είναι ελεγχόμενης απελευθέρωσης. Η φαρμακευτική σύνθεση στην μορφή δισκίου πολλαπλής στοιβάδας περιλαμβάνει, τουλάχιστον μια στοιβάδα περιλαμβάνουσα θεραπευτικώς αποτελεσματική ποσότητα ριφαξιμίνης ή φαρμακευτικώς αποδεκτού άλατος ή εναντιομερούς ή πολύμορφου αυτής, φαρμακευτικώς αποδεκτό έκδοχο(α), η εν λόγω δε στοιβάδα παρέχει ελεγχομένη απελευθέρωση ριφαξιμίνης και τουλάχιστον μια στοιβάδα η οποία παρέχει αυξημένο χρόνο παραμονής της μορφής δοσολογίας στην γαστρεντερική οδό. Η φαρμακοτεχνική μορφή περιλαμβάνει ριφαξιμίνη έχουσα in vitro προφίλ διαλυτοποίησης, όπου περίπου 70% ριφαξιμίνης απελευθερώνεται περίπου σε 24 ώρες. Η σύνθεση περιλαμβάνει θεραπευτικώς αποτελεσματική ποσότητα ριφαξιμίνης ή φαρμακευτικώς αποδεκτού άλατος(ων) ή εναντιομερούς(ων) ή πολύμορφου(ων) αυτής, έναν ή περισσότερους παράγοντα(ες) ελέγχου απελευθέρωσης και φαρμακευτικώς αποδεκτό έκδοχο(α) προκαλώντας εκρίζωση παθογόνου.
CY20121100760T 2007-07-06 2012-08-23 Φαρμακευτικες συνθεσεις ριφαξιμινης CY1113068T1 (el)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IN968KO2007 2007-07-06
EP08252158 2008-06-23
EP08252198.0A EP2011486B2 (en) 2007-07-06 2008-06-26 Pharmaceutical compositions of rifaximin

Publications (1)

Publication Number Publication Date
CY1113068T1 true CY1113068T1 (el) 2016-04-13

Family

ID=40091777

Family Applications (1)

Application Number Title Priority Date Filing Date
CY20121100760T CY1113068T1 (el) 2007-07-06 2012-08-23 Φαρμακευτικες συνθεσεις ριφαξιμινης

Country Status (8)

Country Link
EP (4) EP3714878B1 (el)
CY (1) CY1113068T1 (el)
DK (1) DK2011486T3 (el)
ES (3) ES2798253T3 (el)
HR (1) HRP20120665T1 (el)
PL (1) PL2011486T5 (el)
PT (1) PT2011486E (el)
SI (1) SI2011486T1 (el)

Families Citing this family (30)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7902206B2 (en) 2003-11-07 2011-03-08 Alfa Wassermann, S.P.A. Polymorphic forms α, β and γ of rifaximin
ITMI20032144A1 (it) 2003-11-07 2005-05-08 Alfa Wassermann Spa Forme polimorfe di rifaximina, processi per ottenerle e
US7906542B2 (en) 2004-11-04 2011-03-15 Alfa Wassermann, S.P.A. Pharmaceutical compositions comprising polymorphic forms α, β, and γ of rifaximin
PL1698630T3 (pl) 2005-03-03 2014-12-31 Alfasigma Spa Nowe postacie polimorficzne rifaksyminy,sposoby ich wytwarzania i ich zastosowanie w preparatach leczniczych
ITBO20050123A1 (it) 2005-03-07 2005-06-06 Alfa Wassermann Spa Formulazioni farmaceutiche gastroresistenti contenenti rifaximina
EP3620153A1 (en) * 2007-07-06 2020-03-11 Lupin Limited Pharmaceutical compositions for gastrointestinal drug delivery
ES2972135T3 (es) 2008-10-02 2024-06-11 Salix Pharmaceuticals Inc Tratamiento de encefalopatía hepática usando rifaximina
US7928115B2 (en) 2008-10-02 2011-04-19 Salix Pharmaceuticals, Ltd. Methods of treating travelers diarrhea and hepatic encephalopathy
US20110035232A1 (en) 2008-10-02 2011-02-10 Salix Pharmaceuticals, Ltd. Methods of treating hepatic encephalopathy
AU2010260089B2 (en) * 2009-06-15 2015-05-14 Salix Pharmaceuticals, Inc. Modulation of systemic exposure to rifaximin
CN102665693A (zh) * 2009-10-27 2012-09-12 鲁平有限公司 利福昔明固体分散体
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
AU2011279261B2 (en) * 2010-07-12 2016-03-31 Salix Pharmaceuticals, Ltd. Formulations of rifaximin and uses thereof
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.
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.
US20150238425A1 (en) 2012-08-28 2015-08-27 Dsm Sinochem Pharmaceuticals Netherlands B.V. Mini-tablets
ES2621557T3 (es) * 2014-03-31 2017-07-04 Euticals S.P.A. Mezcla polimórfica de rifaximina y su uso para la preparación de formulaciones sólidas
CA2940601C (en) 2014-05-12 2021-08-24 Alfa Wassermann S.P.A. New solvated crystal form of rifaximin, production, compositions and uses thereof
WO2018064472A1 (en) 2016-09-30 2018-04-05 Salix Pharmaceuticals, Ltd. Solid dispersion forms of rifaximin
EP3416627B9 (en) 2017-04-26 2020-04-22 Sandoz AG Oral dosage form comprising rifaximin in form beta
US11129862B2 (en) 2017-08-30 2021-09-28 Johnson & Johnson Consumer Inc. Ophthalmic compositions
CN108658673A (zh) * 2018-06-27 2018-10-16 安徽瑞然生物药肥科技有限公司 一种用于缓释肥料的包膜材料及其制备方法
CN109021187B (zh) * 2018-08-24 2019-09-06 中山大学 玉米醇溶蛋白-聚磺基甜菜碱两亲性缀合物及其制备方法与应用
CN109663150B (zh) * 2018-12-29 2022-01-14 广州贝奥吉因生物科技股份有限公司 一种心肌修复水凝胶材料及其制备方法
WO2020208140A1 (en) 2019-04-12 2020-10-15 Sandoz Ag Rifaximin-containing granules
EP4034091A1 (en) * 2019-09-24 2022-08-03 Bausch Health Ireland Limited Rifaximin liquid formulations
CN111317824B (zh) * 2020-02-29 2022-04-12 复旦大学 一种载多肽药物的口服纳米制剂及其制备方法
JP2023531268A (ja) * 2020-06-26 2023-07-21 バウシュ ヘルス アイルランド リミテッド 標的化放出リファキシミン組成物
WO2023067485A1 (en) * 2021-10-19 2023-04-27 Zydus Lifesciences Limited Pharmaceutical combinations

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IT1253711B (it) * 1991-12-17 1995-08-23 Alfa Wassermann Spa Formulazioni farmaceutiche vaginali contenenti rifaximin e loro uso nel trattamento delle infezioni vaginali
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ITBO20050123A1 (it) * 2005-03-07 2005-06-06 Alfa Wassermann Spa Formulazioni farmaceutiche gastroresistenti contenenti rifaximina

Also Published As

Publication number Publication date
ES2389358T5 (es) 2016-01-19
ES2798253T3 (es) 2020-12-10
DK2011486T3 (da) 2012-09-03
EP2420226B1 (en) 2020-03-04
EP2011486B1 (en) 2012-05-23
EP3714878B1 (en) 2022-01-19
EP2837378A1 (en) 2015-02-18
ES2905795T3 (es) 2022-04-12
ES2389358T3 (es) 2012-10-25
EP2011486A1 (en) 2009-01-07
EP2011486B2 (en) 2015-08-12
PL2011486T3 (pl) 2013-01-31
HRP20120665T1 (hr) 2012-10-31
PT2011486E (pt) 2012-08-24
SI2011486T1 (sl) 2012-10-30
EP3714878A1 (en) 2020-09-30
PL2011486T5 (pl) 2016-09-30
EP2420226A1 (en) 2012-02-22

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