MD4081F2 - Forme polimorfe de rifaximina, procedee de obtinere si utilizare a acestora in calitate de preparate medicamentoase cu activitate antibiotica - Google Patents

Forme polimorfe de rifaximina, procedee de obtinere si utilizare a acestora in calitate de preparate medicamentoase cu activitate antibiotica Download PDF

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Publication number
MD4081F2
MD4081F2 MDA20070265A MD20070265A MD4081F2 MD 4081 F2 MD4081 F2 MD 4081F2 MD A20070265 A MDA20070265 A MD A20070265A MD 20070265 A MD20070265 A MD 20070265A MD 4081 F2 MD4081 F2 MD 4081F2
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MD
Moldova
Prior art keywords
rifaximin
polymorphous
forms
delta
epsilon
Prior art date
Application number
MDA20070265A
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English (en)
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MD20070265A (ro
MD4081G2 (ro
Inventor
Giuseppe Claudio Viscomi
Manuela Campana
Donatella Confortini
Maria Miriam Barbanti
Dario Braga
Original Assignee
Alfa Wassermann S.P.A.
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Publication date
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=34934045&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=MD4081(F2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Alfa Wassermann S.P.A. filed Critical Alfa Wassermann S.P.A.
Publication of MD20070265A publication Critical patent/MD20070265A/ro
Publication of MD4081F2 publication Critical patent/MD4081F2/ro
Publication of MD4081G2 publication Critical patent/MD4081G2/ro

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    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D491/00—Heterocyclic compounds containing in the condensed ring system both one or more rings having oxygen atoms as the only ring hetero atoms and one or more rings having nitrogen atoms as the only ring hetero atoms, not provided for by groups C07D451/00 - C07D459/00, C07D463/00, C07D477/00 or C07D489/00
    • C07D491/22—Heterocyclic compounds containing in the condensed ring system both one or more rings having oxygen atoms as the only ring hetero atoms and one or more rings having nitrogen atoms as the only ring hetero atoms, not provided for by groups C07D451/00 - C07D459/00, C07D463/00, C07D477/00 or C07D489/00 in which the condensed system contains four or more hetero rings
    • 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
    • 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
    • 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
    • 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
    • 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
    • C07D499/00—Heterocyclic compounds containing 4-thia-1-azabicyclo [3.2.0] heptane ring systems, i.e. compounds containing a ring system of the formula:, e.g. penicillins, penems; Such ring systems being further condensed, e.g. 2,3-condensed with an oxygen-, nitrogen- or sulfur-containing hetero ring
    • C07D499/21—Heterocyclic compounds containing 4-thia-1-azabicyclo [3.2.0] heptane ring systems, i.e. compounds containing a ring system of the formula:, e.g. penicillins, penems; Such ring systems being further condensed, e.g. 2,3-condensed with an oxygen-, nitrogen- or sulfur-containing hetero ring with a nitrogen atom directly attached in position 6 and a carbon atom having three bonds to hetero atoms with at the most one bond to halogen, e.g. an ester or nitrile radical, directly attached in position 2
    • C07D499/44—Compounds with an amino radical acylated by carboxylic acids, attached in position 6
    • C07D499/48—Compounds with an amino radical acylated by carboxylic acids, attached in position 6 with a carbon chain, substituted by hetero atoms or by carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals, attached to the carboxamido radical
    • C07D499/58—Compounds with an amino radical acylated by carboxylic acids, attached in position 6 with a carbon chain, substituted by hetero atoms or by carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals, attached to the carboxamido radical substituted in alpha-position to the carboxamido radical
    • C07D499/64—Compounds with an amino radical acylated by carboxylic acids, attached in position 6 with a carbon chain, substituted by hetero atoms or by carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals, attached to the carboxamido radical substituted in alpha-position to the carboxamido radical by nitrogen atoms
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07B—GENERAL METHODS OF ORGANIC CHEMISTRY; APPARATUS THEREFOR
    • C07B2200/00—Indexing scheme relating to specific properties of organic compounds
    • C07B2200/13—Crystalline forms, e.g. polymorphs

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

Abstract

Inventia se refera la formele polimorfe de rifaximina, si anume la formele Delta si Epsilon.Forma polimorfa de rifaximina Delta este caracterizata printr-un continut de apa de la 2,5% pana la 6,0%, de preferinta de la 3,0% pana la 4,5%, si o difractograma pe pulbere cu raze X avand varfuri la valorile unghiurilor de difractie 2Theta 5,7°±0,2, 6,7°±0,2, 7,1°±0,2, 8,0°±0,2, 8,7°±0,2, 10,4°±0,2, 10,8°±0,2, 11,3°±0,2, 12,1°±0,2, 17,0°±0,2, 17,3°±0,2, 17,5°±0,2, 18,5°±0,2, 18,8°±0,2, 19,1°±0,2, 21,0°±0,2, 21,5°±0,2.Forma polimorfa de rifaximina Epsilon.este caracterizata printr-o difractograma pe pulbere cu raze X avand varfuri la valorile unghiurilor de difractie 2Theta 7,0°±0,2, 7,3°±0,2, 8,2°±0,2, 8,7°±0,2, 10,3°±0,2, 11,1°±0,2, 11,7°±0,2, 12,4°±0,2, 14,5°±0,2, 16,3°±0,2, 17,2°±0,2, 18,0°±0,2, 19,4°±0,2.Inventia se refera de asemenea la procedee de obtinere a formelor polimorfe de rifaximina Delta si Epsilon. printr-un proces de cristalizare desfasurat prin diluarea rifaximinei brute in alcool etilic si precipitarea prin adaugarea apei la o anumita temperatura si intr-o perioada prestabilita de timp cu uscarea ulterioara in conditii de vid sau la o presiune atmosferica normala pana la atingerea unui continut anumit de apa in produsul finit. Formele polimorfe de rifaximina obtinute pot fi utilizate in calitate de preparate medicamentoase cu actiune antibiotica pentru administrare orala si topica.
MDA20070265A 2005-03-03 2006-02-27 Forme polimorfe de rifaximină, procedee de obţinere şi utilizare a acestora în calitate de preparate medicamentoase cu activitate antibiotică MD4081G2 (ro)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP05004695.2A EP1698630B1 (en) 2005-03-03 2005-03-03 New polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations
PCT/EP2006/001755 WO2006094662A1 (en) 2005-03-03 2006-02-27 New polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal

Publications (3)

Publication Number Publication Date
MD20070265A MD20070265A (ro) 2008-05-31
MD4081F2 true MD4081F2 (ro) 2010-12-31
MD4081G2 MD4081G2 (ro) 2011-07-31

Family

ID=34934045

Family Applications (1)

Application Number Title Priority Date Filing Date
MDA20070265A MD4081G2 (ro) 2005-03-03 2006-02-27 Forme polimorfe de rifaximină, procedee de obţinere şi utilizare a acestora în calitate de preparate medicamentoase cu activitate antibiotică

Country Status (27)

Country Link
US (9) US8193196B2 (ro)
EP (1) EP1698630B1 (ro)
JP (2) JP5737825B2 (ro)
KR (1) KR100885755B1 (ro)
CN (1) CN1900077B (ro)
AU (1) AU2006222312B8 (ro)
BR (1) BRPI0608073A8 (ro)
CA (1) CA2594789C (ro)
DK (1) DK1698630T3 (ro)
ES (1) ES2522895T3 (ro)
HR (1) HRP20070433B1 (ro)
IL (1) IL184694A0 (ro)
MA (1) MA29345B1 (ro)
MD (1) MD4081G2 (ro)
ME (1) ME00272B (ro)
MX (1) MX2007010742A (ro)
NO (1) NO342197B1 (ro)
NZ (1) NZ556737A (ro)
PL (1) PL1698630T3 (ro)
PT (1) PT1698630E (ro)
RS (1) RS54570B1 (ro)
RU (1) RU2397985C2 (ro)
SI (1) SI1698630T1 (ro)
TN (1) TNSN07292A1 (ro)
UA (1) UA89809C2 (ro)
WO (1) WO2006094662A1 (ro)
ZA (1) ZA200707397B (ro)

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