发明名称 THE PROCESS FOR MANUFACTURING OF CLEAR LIQUID PHARMACEUTICAL COMPOSITION OF AZITHROMYCIN
摘要 <p>Azithromycin is a macrolide antibiotic used for treating infections. This is available in a solid oral dosage form. It is desirable to have a clear liquid formulaiton also for treating severe infections by intravenous administration of the drug. Currently, it is not possible to manufacture liquid preparation which is ready to use. As it is not soluble in water or other known solvents, for this purpose, it is being marketed as lyophilized preparation which is reconstituted prior to use. According to present invention, it is found that it is soluble in water at pH 5.0. The change in pH can be obtained by adding citric acid in a desired concentration. However, this solution is not stable, and precipitates are seen over the time. According to the present invention, this solution is stabilized by addition of sodium salts like sodium hydroxide, thereby changing its pH from 5.0 to 7.0. The solution so prepared remains clear and is stable for a longer period.</p>
申请公布号 WO2002007736(A1) 申请公布日期 2002.01.31
申请号 IB2001001313 申请日期 2001.07.23
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