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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

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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

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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

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Family Applications (1)

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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)

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