DE69921192T2 - Ethanolate des azithromycin, herstllungsverfahren und deren pharmazeutische zusammenstellungen - Google Patents

Ethanolate des azithromycin, herstllungsverfahren und deren pharmazeutische zusammenstellungen Download PDF

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Publication number
DE69921192T2
DE69921192T2 DE69921192T DE69921192T DE69921192T2 DE 69921192 T2 DE69921192 T2 DE 69921192T2 DE 69921192 T DE69921192 T DE 69921192T DE 69921192 T DE69921192 T DE 69921192T DE 69921192 T2 DE69921192 T2 DE 69921192T2
Authority
DE
Germany
Prior art keywords
azithromycin
ethanolate
suspension
water
ethanol
Prior art date
Legal status (The legal status 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 status listed.)
Expired - Fee Related
Application number
DE69921192T
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German (de)
English (en)
Other versions
DE69921192D1 (de
Inventor
Claude Singer
Judith Aronhime
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Teva Pharmaceutical Industries Ltd
Original Assignee
Teva Pharmaceutical Industries 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
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=22332273&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=DE69921192(T2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Teva Pharmaceutical Industries Ltd filed Critical Teva Pharmaceutical Industries Ltd
Publication of DE69921192D1 publication Critical patent/DE69921192D1/de
Application granted granted Critical
Publication of DE69921192T2 publication Critical patent/DE69921192T2/de
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07H—SUGARS; DERIVATIVES THEREOF; NUCLEOSIDES; NUCLEOTIDES; NUCLEIC ACIDS
    • C07H17/00—Compounds containing heterocyclic radicals directly attached to hetero atoms of saccharide radicals
    • C07H17/04—Heterocyclic radicals containing only oxygen as ring hetero atoms
    • C07H17/08—Hetero rings containing eight or more ring members, e.g. erythromycins
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P33/00—Antiparasitic agents
    • A61P33/02—Antiprotozoals, e.g. for leishmaniasis, trichomoniasis, toxoplasmosis
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07H—SUGARS; DERIVATIVES THEREOF; NUCLEOSIDES; NUCLEOTIDES; NUCLEIC ACIDS
    • C07H1/00—Processes for the preparation of sugar derivatives
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07H—SUGARS; DERIVATIVES THEREOF; NUCLEOSIDES; NUCLEOTIDES; NUCLEIC ACIDS
    • C07H17/00—Compounds containing heterocyclic radicals directly attached to hetero atoms of saccharide radicals

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  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biochemistry (AREA)
  • Biotechnology (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Veterinary Medicine (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Saccharide Compounds (AREA)
DE69921192T 1998-11-30 1999-11-30 Ethanolate des azithromycin, herstllungsverfahren und deren pharmazeutische zusammenstellungen Expired - Fee Related DE69921192T2 (de)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US11029898P 1998-11-30 1998-11-30
US110298P 1998-11-30
PCT/US1999/028368 WO2000032203A1 (en) 1998-11-30 1999-11-30 Ethanolate of azithromycin, process for manufacture, and pharmaceutical compositions thereof

Publications (2)

Publication Number Publication Date
DE69921192D1 DE69921192D1 (de) 2004-11-18
DE69921192T2 true DE69921192T2 (de) 2006-02-16

Family

ID=22332273

Family Applications (1)

Application Number Title Priority Date Filing Date
DE69921192T Expired - Fee Related DE69921192T2 (de) 1998-11-30 1999-11-30 Ethanolate des azithromycin, herstllungsverfahren und deren pharmazeutische zusammenstellungen

Country Status (26)

Country Link
US (1) US6365574B2 (https=)
EP (2) EP1152765B1 (https=)
JP (1) JP2002531409A (https=)
KR (1) KR100603226B1 (https=)
CN (2) CN100339384C (https=)
AP (1) AP1709A (https=)
AT (1) ATE279200T1 (https=)
AU (1) AU768219B2 (https=)
BG (1) BG105547A (https=)
CA (1) CA2352562A1 (https=)
CZ (1) CZ20011886A3 (https=)
DE (1) DE69921192T2 (https=)
DK (1) DK1152765T3 (https=)
ES (1) ES2229804T3 (https=)
HK (1) HK1043725B (https=)
HU (1) HUP0104241A3 (https=)
IL (1) IL143376A0 (https=)
LV (1) LV12735B (https=)
NZ (1) NZ512496A (https=)
PL (1) PL197894B1 (https=)
PT (1) PT1152765E (https=)
RO (1) RO121408B1 (https=)
RU (1) RU2240124C2 (https=)
SI (1) SI20639A (https=)
WO (1) WO2000032203A1 (https=)
ZA (1) ZA200104312B (https=)

Families Citing this family (37)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
HRP20020231A2 (en) * 2002-03-18 2003-12-31 Pliva D D ISOSTRUCTURAL PSEUDOPOLYMORPHS OF 9-DEOXO-9a-AZA-9a-METHYL-9a-HOMOERYTHROMYCIN A
TW546302B (en) * 1998-05-08 2003-08-11 Biochemie Sa Improvements in macrolide production
US6245903B1 (en) 1998-08-21 2001-06-12 Apotex, Inc. Azithromycin monohydrate isopropanol clathrate and methods for the manufacture thereof
AU768219B2 (en) * 1998-11-30 2003-12-04 Teva Pharmaceutical Industries Ltd. Ethanolate of azithromycin, process for manufacture, and pharmaceutical compositions thereof
CN100341886C (zh) * 2000-11-27 2007-10-10 桑多斯股份公司 大环内酯类化合物的溶剂化物
EE05200B1 (et) * 2000-11-27 2009-08-17 Biochemie S.A. Asitromtsiin monohdraadina, selle valmistamismeetod ja selle kasutamine ravimkoostises
KR100431431B1 (ko) * 2001-04-25 2004-05-14 한미약품 주식회사 아지트로마이신 수화물의 1,2-프로필렌글리콜 내포화합물,그의 제조방법 및 그의 약학적 조성물
DK1390377T3 (da) * 2001-05-22 2006-06-19 Pfizer Prod Inc Ny krystalform af azithromycin
EP1652851A1 (en) 2001-05-22 2006-05-03 Pfizer Products Inc. New crystal form of Azithromycin
US6861413B2 (en) * 2001-05-22 2005-03-01 Pfizer Inc. Stable non-dihydrate azithromycin oral suspensions
EP1541134A3 (en) * 2001-10-18 2007-06-06 Teva Pharmaceutical Industries Limited Stabilized azithromycin compositions
US20080149521A9 (en) * 2001-10-18 2008-06-26 Michael Pesachovich Methods of stabilizing azithromycin
EP1446010B1 (en) * 2001-10-18 2009-04-15 Teva Pharmaceutical Industries Ltd. Stabilized azithromycin compositions
PL371259A1 (pl) * 2001-12-21 2005-06-13 Pfizer Products Inc. Bezpośrednio sprasowywalne preparaty azytromycyny
AU2002353316A1 (en) * 2001-12-21 2003-07-09 Pfizer Products Inc. Methods for wet granulating azithromycin
BR0307331A (pt) * 2002-02-01 2004-12-07 Pfizer Prod Inc Formulações granuladas a seco de azitromicina
HRP20020614A2 (en) 2002-07-22 2004-06-30 PLIVA-ISTRAŽIVAČKI INSTITUT d.o.o. Rhombic pseudopolymorph of 9-deoxo-9a-aza-9a-methyl-9a-homoerythromycin a
US20050013835A1 (en) * 2003-07-15 2005-01-20 Pfizer Inc. Stable non-dihydrate azithromycin oral suspensions
US20050101547A1 (en) * 2003-11-06 2005-05-12 Sadatrezaei Mohsen Stabilized azithromycin composition
BRPI0416534A (pt) * 2003-12-04 2007-01-09 Pfizer Prod Inc composições multiparticuladas com estabilidade melhorada
WO2005053639A2 (en) * 2003-12-04 2005-06-16 Pfizer Products Inc. Controlled release multiparticulates formed with dissolution enhancers
US6984403B2 (en) * 2003-12-04 2006-01-10 Pfizer Inc. Azithromycin dosage forms with reduced side effects
ATE399536T1 (de) * 2003-12-04 2008-07-15 Pfizer Prod Inc Verfahren zur herstellung von pharmazeutischen multiteilchenförmigen produkten
EP1694304A2 (en) * 2003-12-04 2006-08-30 Pfizer Products Inc. Azithromycin multiparticulate dosage forms by liquid-based processes
WO2005053652A1 (en) 2003-12-04 2005-06-16 Pfizer Products Inc. Multiparticulate crystalline drug compositions containing a poloxamer and a glyceride
CA2549225A1 (en) * 2003-12-04 2005-06-16 Pfizer Products Inc. Spray-congeal process using an extruder for preparing multiparticulate crystalline drug compositions containing preferably a poloxamer and a glyceride
US7943585B2 (en) 2003-12-22 2011-05-17 Sandoz, Inc. Extended release antibiotic composition
US7468428B2 (en) * 2004-03-17 2008-12-23 App Pharmaceuticals, Llc Lyophilized azithromycin formulation
US20060116336A1 (en) * 2004-03-17 2006-06-01 American Pharmaceutical Partners, Inc. Lyophilized azithromycin formulation
US7683162B2 (en) * 2004-08-30 2010-03-23 Taro Pharmaceutical Industries Limited Process of preparing a crystalline azithromycin monohydrate
US20100048498A1 (en) * 2004-12-21 2010-02-25 Johnson Barbara A Stable non-dihydrate azithromycin oral suspensions
US20060198895A1 (en) * 2005-03-07 2006-09-07 Kotliar Eleonora M Azithromycin powder for oral suspension compositions
US20090318375A1 (en) * 2005-06-08 2009-12-24 Hanmi Pharm Co., Ltd Crystalline Azithromycin L-Malate Monohydrate and Pharmaceutical Composition Containing Same
CA2754604A1 (en) 2009-03-13 2010-09-16 Da Volterra Compositions and methods for elimination of gram-negative bacteria
WO2010121187A2 (en) * 2009-04-17 2010-10-21 Micell Techologies, Inc. Stents having controlled elution
WO2013088274A1 (en) 2011-12-14 2013-06-20 Wockhardt Limited Anhydrous amorphous azithromycin composition free of azithromycin dihydrate
CN103983730B (zh) * 2014-06-11 2015-09-30 北京市药品检验所 阿奇霉素或其制剂中的杂质检查方法

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SI8110592A8 (en) 1981-03-06 1996-06-30 Pliva Pharm & Chem Works Process for preparing of n-methyl-11-aza-10-deoxo-10-dihydroerythromycine a and derivatives thereof
US4474768A (en) * 1982-07-19 1984-10-02 Pfizer Inc. N-Methyl 11-aza-10-deoxo-10-dihydro-erytromycin A, intermediates therefor
RO107257B1 (ro) * 1987-07-09 1993-10-30 Pfizer Procedeu de obtinere a unui dihidrat de azitromicina, cristalin
WO1989002271A1 (en) * 1987-09-10 1989-03-23 Pfizer Azithromycin and derivatives as antiprotozoal agents
CN1093370A (zh) * 1993-12-10 1994-10-12 北京市集才药物研究所 一种新的阿齐红霉素结晶及其制备方法
CN1161971A (zh) * 1997-01-03 1997-10-15 石家庄制药集团有限公司 一种阿齐霉素结晶及其制备方法
US6245903B1 (en) * 1998-08-21 2001-06-12 Apotex, Inc. Azithromycin monohydrate isopropanol clathrate and methods for the manufacture thereof
AU768219B2 (en) * 1998-11-30 2003-12-04 Teva Pharmaceutical Industries Ltd. Ethanolate of azithromycin, process for manufacture, and pharmaceutical compositions thereof
KR100491183B1 (ko) * 2001-03-21 2005-05-25 한미약품 주식회사 아지트로마이신의 제조방법 및 이 방법에 사용되는9-데옥소-9에이-아자-9에이-호모에리트로마이신 에이의결정성 수화물
DK1390377T3 (da) * 2001-05-22 2006-06-19 Pfizer Prod Inc Ny krystalform af azithromycin

Also Published As

Publication number Publication date
HUP0104241A3 (en) 2003-12-29
CN1737008A (zh) 2006-02-22
WO2000032203A1 (en) 2000-06-08
JP2002531409A (ja) 2002-09-24
CN1273142C (zh) 2006-09-06
PT1152765E (pt) 2004-12-31
KR20010099806A (ko) 2001-11-09
EP1152765A4 (en) 2002-07-17
US20020007049A1 (en) 2002-01-17
NZ512496A (en) 2003-02-28
EP1484062A1 (en) 2004-12-08
HK1043725A1 (en) 2002-09-27
SI20639A (sl) 2002-02-28
CN1334735A (zh) 2002-02-06
IL143376A0 (en) 2002-04-21
US6365574B2 (en) 2002-04-02
AP2001002183A0 (en) 2001-06-30
PL347971A1 (en) 2002-05-06
CA2352562A1 (en) 2000-06-08
AU3106500A (en) 2000-06-19
CN100339384C (zh) 2007-09-26
LV12735B (en) 2002-03-20
ATE279200T1 (de) 2004-10-15
EP1152765A1 (en) 2001-11-14
DK1152765T3 (da) 2005-01-31
KR100603226B1 (ko) 2006-08-28
ZA200104312B (en) 2001-11-28
DE69921192D1 (de) 2004-11-18
LV12735A (en) 2001-10-20
RU2240124C2 (ru) 2004-11-20
HK1043725B (en) 2005-05-06
HUP0104241A2 (hu) 2002-03-28
CZ20011886A3 (cs) 2001-10-17
EP1152765B1 (en) 2004-10-13
BG105547A (en) 2001-12-31
AU768219B2 (en) 2003-12-04
PL197894B1 (pl) 2008-05-30
AP1709A (en) 2007-02-27
RO121408B1 (ro) 2007-05-30
ES2229804T3 (es) 2005-04-16

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8364 No opposition during term of opposition
8339 Ceased/non-payment of the annual fee