RU2001118035A - ETHANOLATE OF AZITROMYCINE, THE PROCESS OF OBTAINING AND CONTAINING ITS PHARMACEUTICAL COMPOSITIONS - Google Patents

ETHANOLATE OF AZITROMYCINE, THE PROCESS OF OBTAINING AND CONTAINING ITS PHARMACEUTICAL COMPOSITIONS

Info

Publication number
RU2001118035A
RU2001118035A RU2001118035/14A RU2001118035A RU2001118035A RU 2001118035 A RU2001118035 A RU 2001118035A RU 2001118035/14 A RU2001118035/14 A RU 2001118035/14A RU 2001118035 A RU2001118035 A RU 2001118035A RU 2001118035 A RU2001118035 A RU 2001118035A
Authority
RU
Russia
Prior art keywords
ethanolate
azithromycin
suspension
specified
under item
Prior art date
Application number
RU2001118035/14A
Other languages
Russian (ru)
Other versions
RU2240124C2 (en
Inventor
Джудит Аронхиме
Клауди СИНГЕР
Original Assignee
Тева Фармасьютикал Индастриз Лтд.
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
Application filed by Тева Фармасьютикал Индастриз Лтд. filed Critical Тева Фармасьютикал Индастриз Лтд.
Publication of RU2001118035A publication Critical patent/RU2001118035A/en
Application granted granted Critical
Publication of RU2240124C2 publication Critical patent/RU2240124C2/en

Links

Claims (15)

1. Этанолят азитромицина, содержащий этанол в количестве от приблизительно 1,5 до приблизительно 3%.1. Azithromycin ethanolate containing ethanol in an amount of from about 1.5 to about 3%. 2. Этанолят по п. 1, содержащий воду в количестве от приблизительно 2 до приблизительно 4%. 2. Ethanolate under item 1, containing water in an amount of from about 2 to about 4%. 3. Этанолят по п. 2, отличающийся тем, что содержание воды в нем составляет от приблизительно 2,5 до приблизительно 3,5%. 3. Ethanolate under item 2, characterized in that the water content in it is from about 2.5 to about 3.5%. 4. Этанолят по п. 1, отличающийся тем, что содержание этанола в нем составляет от приблизительно 1,5 до приблизительно 2,5%. 4. Ethanolate under item 1, characterized in that the ethanol content in it is from about 1.5 to about 2.5%. 5. Этанолят по п. 4, отличающийся тем, что содержание воды в нем составляет от приблизительно 2 до приблизительно 4%. 5. Ethanolate under item 4, characterized in that the water content in it is from about 2 to about 4%. 6. Этанолят по п. 5, отличающийся тем, что содержание воды в нем составляет от приблизительно 1,5 до приблизительно 2,5%. 6. Ethanolate under item 5, characterized in that the water content in it is from about 1.5 to about 2.5%. 7. Этанолят азитромицина, характеризующийся тем, что его порошковая дифракционная рентгенограмма в основном имеет вид, изображенный на рис. 2. 7. Azithromycin ethanolate, characterized in that its powder X-ray diffraction pattern basically has the appearance shown in Fig. 2 8. Способ получения этанолята азитромицина 1, включающий следующие стадии:
растворения азитромицина в этаноле;
добавления к полученному раствору азитромицина воды так, чтобы началась кристаллизация указанного азитромицина и чтобы образовалась суспензия, и
выделения образовавшихся кристаллов азитромицина.8. A method of producing azithromycin 1 ethanolate, comprising the following steps:
dissolving azithromycin in ethanol;
adding water to the resulting solution of azithromycin so that crystallization of said azithromycin begins and so that a suspension is formed, and
the selection of the resulting crystals of azithromycin. 9. Способ по п. 8, включающий также стадию выдержки указанной суспензии в течение некоторого периода времени при температуре от приблизительно 30 до приблизительно 80oС.9. The method according to p. 8, including the stage of holding the specified suspension for a certain period of time at a temperature of from about 30 to about 80 o C. 10. Способ по п. 9, отличающийся тем, что к указанной суспензии добавляют воду, и эту суспензию в течение от приблизительно 1 ч до приблизительно 18 ч выдерживают при температуре от приблизительно 30 до приблизительно 80oС.10. The method according to p. 9, characterized in that water is added to this suspension, and this suspension is maintained at a temperature from about 30 to about 80 o C. for about 1 hour to about 18 hours. 11. Способ по п. 10, отличающийся тем, что до выделения кристаллов азитромицина указанную суспензию охлаждают до приблизительно 20oС.11. The method according to p. 10, characterized in that prior to the separation of crystals of azithromycin specified suspension is cooled to approximately 20 o C. 12. Способ по п. 8, отличающийся тем, что содержание этанола в указанном этаноляте составляет от приблизительно 1,5 до приблизительно 3%. 12. The method according to p. 8, characterized in that the ethanol content in the specified ethanolate is from about 1.5 to about 3%. 13. Способ по п. 12, отличающийся тем, что содержание воды в указанном этаноляте составляет от приблизительно 2 до приблизительно 4%. 13. The method according to p. 12, characterized in that the water content in the specified ethanolate is from about 2 to about 4%. 14. Способ по п. 8, отличающийся тем, что порошковая дифракционная рентгенограмма указанного этанолята азитромицина в основном имеет вид, изображенный на рис. 2. 14. The method according to p. 8, characterized in that the powder x-ray diffraction pattern of the specified ethanolate azithromycin basically has the form shown in Fig. 2 15. Фармацевтический состав, включающий терапевтически эффективное количество этанолята по п. 1 и фармацевтически приемлемый носитель. 15. A pharmaceutical composition comprising a therapeutically effective amount of ethanolate according to claim 1 and a pharmaceutically acceptable carrier.
RU2001118035/15A 1998-11-30 1999-11-30 Azithromycin ethanolate, process for preparing and pharmaceutical compositions comprising thereof RU2240124C2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US11029898P 1998-11-30 1998-11-30
US60/110298 1998-11-30

Publications (2)

Publication Number Publication Date
RU2001118035A true RU2001118035A (en) 2003-04-20
RU2240124C2 RU2240124C2 (en) 2004-11-20

Family

ID=22332273

Family Applications (1)

Application Number Title Priority Date Filing Date
RU2001118035/15A RU2240124C2 (en) 1998-11-30 1999-11-30 Azithromycin ethanolate, process for preparing and pharmaceutical compositions comprising thereof

Country Status (26)

Country Link
US (1) US6365574B2 (en)
EP (2) EP1152765B1 (en)
JP (1) JP2002531409A (en)
KR (1) KR100603226B1 (en)
CN (2) CN1273142C (en)
AP (1) AP1709A (en)
AT (1) ATE279200T1 (en)
AU (1) AU768219B2 (en)
BG (1) BG105547A (en)
CA (1) CA2352562A1 (en)
CZ (1) CZ20011886A3 (en)
DE (1) DE69921192T2 (en)
DK (1) DK1152765T3 (en)
ES (1) ES2229804T3 (en)
HK (1) HK1043725B (en)
HU (1) HUP0104241A3 (en)
IL (1) IL143376A0 (en)
LV (1) LV12735B (en)
NZ (1) NZ512496A (en)
PL (1) PL197894B1 (en)
PT (1) PT1152765E (en)
RO (1) RO121408B1 (en)
RU (1) RU2240124C2 (en)
SI (1) SI20639A (en)
WO (1) WO2000032203A1 (en)
ZA (1) ZA200104312B (en)

Families Citing this family (36)

* 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
CA2245398C (en) 1998-08-21 2002-01-29 Apotex Inc. Azithromycin monohydrate isopropanol clathrate and methods for the manufacture thereof
ES2229804T3 (en) * 1998-11-30 2005-04-16 Teva Pharmaceutical Industries Ltd. AZITHROMYCIN ETHANOLATE, PROCEDURE FOR MANUFACTURING AND PHARMACEUTICAL COMPOSITIONS CONTAINING IT.
AU2002221895A1 (en) * 2000-11-27 2002-06-03 Biochemie S.A. Macrolide solvates
RU2279439C2 (en) * 2000-11-27 2006-07-10 Сандоз Аг Azithromycin monohydrate and method for its preparing
KR100431431B1 (en) * 2001-04-25 2004-05-14 한미약품 주식회사 Clathrate of azithromycin hydrate with 1,2-propyleneglycol, methods for the manufacture thereof, and pharmaceutical compositions thereof
DK1390377T3 (en) * 2001-05-22 2006-06-19 Pfizer Prod Inc New crystal form of azithromycin
SI1390377T1 (en) 2001-05-22 2006-06-30 Pfizer Prod Inc New crystal form of azithromycin
US6861413B2 (en) 2001-05-22 2005-03-01 Pfizer Inc. Stable non-dihydrate azithromycin oral suspensions
US20080149521A9 (en) * 2001-10-18 2008-06-26 Michael Pesachovich Methods of stabilizing azithromycin
EP1541134A3 (en) * 2001-10-18 2007-06-06 Teva Pharmaceutical Industries Limited Stabilized azithromycin compositions
ATE428403T1 (en) 2001-10-18 2009-05-15 Teva Pharma STABILIZED AZITHROMYCIN COMPOSITIONS
CA2469246A1 (en) * 2001-12-21 2003-07-03 Pfizer Products Inc. Directly compressible formulations of azithromycin
MXPA04003027A (en) * 2001-12-21 2004-07-05 Pfizer Prod Inc Methods for wet granulating azithromycin.
AU2003201146B2 (en) * 2002-02-01 2008-04-17 Pfizer Products Inc. Dry granulated formulations of azithromycin
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
WO2005053652A1 (en) 2003-12-04 2005-06-16 Pfizer Products Inc. Multiparticulate crystalline drug compositions containing a poloxamer and a glyceride
WO2005053651A1 (en) * 2003-12-04 2005-06-16 Pfizer Products Inc. Multiparticulate compositions with improved stability
ES2600577T3 (en) * 2003-12-04 2017-02-09 Bend Research, Inc. Spray-solidification process using an extruder to prepare multiparticulate compositions of crystalline drugs
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 (en) * 2003-12-04 2008-07-15 Pfizer Prod Inc METHOD FOR PRODUCING PHARMACEUTICAL MULTIPARTICLE PRODUCTS
RU2006119453A (en) * 2003-12-04 2007-12-20 Пфайзер Продактс Инк. (Us) PRODUCTION OF MEDICINES ASITROMYCIN WITH A LARGE NUMBER OF PARTICLES BASED ON THE APPLICATION OF LIQUIDS OF METHODS
US7943585B2 (en) 2003-12-22 2011-05-17 Sandoz, Inc. Extended release antibiotic composition
US20060116336A1 (en) * 2004-03-17 2006-06-01 American Pharmaceutical Partners, Inc. Lyophilized azithromycin formulation
US7468428B2 (en) * 2004-03-17 2008-12-23 App Pharmaceuticals, Llc Lyophilized azithromycin formulation
US7683162B2 (en) * 2004-08-30 2010-03-23 Taro Pharmaceutical Industries Limited Process of preparing a crystalline azithromycin monohydrate
JP2008524318A (en) * 2004-12-21 2008-07-10 ファイザー・プロダクツ・インク Stable azithromycin non-dihydrate oral suspension
US20060198895A1 (en) * 2005-03-07 2006-09-07 Kotliar Eleonora M Azithromycin powder for oral suspension compositions
US20120058936A1 (en) 2009-03-13 2012-03-08 Assistance Publique - Hopitaux De Paris Compositions and methods for elimination of gram negative bacteria
EP3366326A1 (en) * 2009-04-17 2018-08-29 Micell Technologies, Inc. Stents having controlled elution
WO2013088274A1 (en) 2011-12-14 2013-06-20 Wockhardt Limited Anhydrous amorphous azithromycin composition free of azithromycin dihydrate
CN103983730B (en) * 2014-06-11 2015-09-30 北京市药品检验所 Determination of foreign matter method in azithromycin or its preparation

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
YU43006B (en) 1981-03-06 1989-02-28 Pliva Pharm & Chem Works Process for preparing n-methyl-11-aza-10-deoxo-10-dihydro erythromycin 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
WO1989000576A1 (en) * 1987-07-09 1989-01-26 Pfizer Inc. Azithromycin dihydrate
WO1989002271A1 (en) * 1987-09-10 1989-03-23 Pfizer Azithromycin and derivatives as antiprotozoal agents
CN1093370A (en) * 1993-12-10 1994-10-12 北京市集才药物研究所 A kind of new azido erythromycin crystal and preparation method thereof
CN1161971A (en) * 1997-01-03 1997-10-15 石家庄制药集团有限公司 Azimycin crystal and preparation method thereof
CA2245398C (en) * 1998-08-21 2002-01-29 Apotex Inc. Azithromycin monohydrate isopropanol clathrate and methods for the manufacture thereof
ES2229804T3 (en) * 1998-11-30 2005-04-16 Teva Pharmaceutical Industries Ltd. AZITHROMYCIN ETHANOLATE, PROCEDURE FOR MANUFACTURING AND PHARMACEUTICAL COMPOSITIONS CONTAINING IT.
KR100491183B1 (en) * 2001-03-21 2005-05-25 한미약품 주식회사 Process of preparing azithromycin and crystalline 9-deoxo-9a-aza-9a-homoerythromycin a hydrate used therein
DK1390377T3 (en) * 2001-05-22 2006-06-19 Pfizer Prod Inc New crystal form of azithromycin

Similar Documents

Publication Publication Date Title
RU2001118035A (en) ETHANOLATE OF AZITROMYCINE, THE PROCESS OF OBTAINING AND CONTAINING ITS PHARMACEUTICAL COMPOSITIONS
BG105547A (en) Ethanolate of azithromycin, process for manufacture, and pharmaceutical compositions thereof
CA2191647C (en) Process improvement in the synthesis of n-[3-(3-cyanopyrazolo[1,5-a]pyrimidin-7-yl)phenyl]-n-ethylacetamide
SK391091A3 (en) Crystalline paroxetine hydrochloride hemihydrate, pharmacuetical composition containing the same and its use
JP3726291B2 (en) Benzoxazine compound having stable crystal structure and process for producing the same
MXPA00002956A (en) Oral compositions of levosimendan.
MA23892A1 (en) NEW CRYSTALLINE FORM OF METHANESULFONIC ACID SALT OF ACID 7- (1X, 5X, 6X) -6-AMINO-3 - AZABICYCLO (3.1.0) HEX -3-YL) -6- FLUORO -1- (2, 4 - DIFLUOROPHENYL) -1, 4- DIHYDRO -4-OXO - 1, 8 - NAPHTYRIDINE -3- CARBOXYLIC ANHYDROUS, PROCESS FOR ITS PREPARATION AND COMPOSITION CONTAINING IT
JP2007536210A (en) Crystalline form of (6R) -L-erythro-tetrahydrobiopterin dihydrochloride
HU217118B (en) Process for producing 4-(di-n-propyl)-amino-6-(amino-carbonyl)-1,2,3,4,5-tetrahydro-benz[c,d]indole hippurate and pharmaceutical compositions containing this compound
FR2577941B1 (en) AMORPHOUS AL-BASED ALLOYS CONTAINING ESSENTIALLY NI AND / OR FE AND SI AND PROCESS FOR OBTAINING SAME
HU905314D0 (en) Process for the production of a table crystallizing in the monoclinic system, which contains light-, heat-, and moisture- sensitive active agents
MY126071A (en) Crystalline form ii of cabergoline.
JP2009108079A (en) Preparation method of enantiomerically enriched n-acylazetidine-2-carboxylic acid
KR102090912B1 (en) The edoxaban a novel crystalline form and the manufacturing method thereof
HUT68190A (en) Process for producing ergoline derivatives of serotoninergic activity
CA2120874E (en) Form of form 1 ranitidine
PE20010209A1 (en) POLYMORPHES OF AN AZOBICYCLE CITRATE [2,2,2] OCTAN-3-AMINE AND ITS PHARMACEUTICAL COMPOSITIONS
NO994263L (en) Process of crystallization of lactitol
JPS5373507A (en) Crystallization of pentaerythritol
US5670671A (en) Process for the production of an improved form of form 1 ranitidine
RU2008121240A (en) METHOD FOR PRODUCING PURIFIED CRYSTAL CCI-779
JPS55167266A (en) Recovery of alpha-l-aspartyl-l-phenylalanine lower alkyl ester
JPS5657750A (en) Separation of l-phenylalanine
HUT58347A (en) Process for producing cristalline h-arg-lys-asp-oh abd h-arg-lys-asp-val-oh of high purity
EA044465B1 (en) METHODS FOR PURIFICATION OF ISOVUCONAZONIUM SULPHATE