THE PROCESS FOR MANUFACTURING OF CLEAR LIQUID PHARMACEUTICAL COMPOSITION OF AZITHROMYCIN

Application 687/MUM/2000 published 2006-03-03, filed 2000-07-24
Azithromycin is a macrolide antibiotic used for treating infections. This is available ln a solid oral dosage form. It is desirable to have a clear liquid formulation 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 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. Drawing: NIL Total Pages: 7. Fig. Nil

Applicant

CADILA PHARMACEUTICALS LIMITED,
IRM HOUSE, OFF C.G, ROAD, NAVRANGPURA, AHMEDABAD-380009, GUJARAT, INDIA

Inventor

1. MR. SHRIDHAR KRISHNAMURTHY GUMUDAVELLI 2. DR. BAKULESH MAFATLAL KHAMAR

International Info

Classification: A61K31/00