MD4081G2 - Forme polimorfe de rifaximină, procedee de obţinere şi utilizare a acestora în calitate de preparate medicamentoase cu activitate antibiotică - Google Patents

Forme polimorfe de rifaximină, procedee de obţinere şi utilizare a acestora în calitate de preparate medicamentoase cu activitate antibiotică Download PDF

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Publication number
MD4081G2
MD4081G2 MDA20070265A MD20070265A MD4081G2 MD 4081 G2 MD4081 G2 MD 4081G2 MD A20070265 A MDA20070265 A MD A20070265A MD 20070265 A MD20070265 A MD 20070265A MD 4081 G2 MD4081 G2 MD 4081G2
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MD
Moldova
Prior art keywords
rifaximin
polymorphous
forms
processes
polymorphous forms
Prior art date
Application number
MDA20070265A
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English (en)
Russian (ru)
Other versions
MD4081F2 (ro
MD20070265A (ro
Inventor
Джузеппе Клавдио ВИСКОМИ
Мануэла Кампана
Донателла Конфортини
Мария Мириам Барбанти
Дарио Брага
Original Assignee
Alfa Wassermann S.P.A.
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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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(G2) "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)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oncology (AREA)
  • Communicable Diseases (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

Invenţia se referă la formele polimorfe de rifaximină, şi anume la formele δ şi ε.Forma polimorfă de rifaximină δ este caracterizată printr-un conţinut de apă de la 2,5% până la 6,0%, de preferinţă de la 3,0% până la 4,5%, şi o difractogramă pe pulbere cu raze X având vârfuri la valorile unghiurilor de difracţie 2Θ 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 polimorfă de rifaximină ε este caracterizată printr-o difractogramă pe pulbere cu raze X având vârfuri la valorile unghiurilor de difracţie 2Θ 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.Invenţia se referă de asemenea la procedee de obţinere a formelor polimorfe de rifaximină δ şi ε printr-un proces de cristalizare desfăşurat prin diluarea rifaximinei brute în alcool etilic şi precipitarea prin adăugarea apei la o anumită temperatură şi într-o perioadă prestabilită de timp cu uscarea ulterioară în condiţii de vid sau la o presiune atmosferică normală până la atingerea unui conţinut anumit de apă în produsul finit.Formele polimorfe de rifaximină obţinute pot fi utilizate în calitate de preparate medicamentoase cu acţiune antibiotică pentru administrare orală şi topică.
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 MD4081F2 (ro) 2010-12-31
MD4081G2 true MD4081G2 (ro) 2011-07-31

Family

ID=34934045

Family Applications (1)

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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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