WO2005094800B1 - A co-precipitated cefepime composition and process for preparation thereof - Google Patents
A co-precipitated cefepime composition and process for preparation thereofInfo
- Publication number
- WO2005094800B1 WO2005094800B1 PCT/IN2005/000095 IN2005000095W WO2005094800B1 WO 2005094800 B1 WO2005094800 B1 WO 2005094800B1 IN 2005000095 W IN2005000095 W IN 2005000095W WO 2005094800 B1 WO2005094800 B1 WO 2005094800B1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- cefepime
- sterile
- process according
- pharmaceutically acceptable
- aqueous solution
- 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.)
- Ceased
Links
Abstract
The present invention provides a stable and sterile composition of Cefepime with a pharmaceutically acceptable non-toxic organic and inorganic base in high purity which exhibits good thermal stability which is obtained by co precipitation of composition containing non-sterile Cefepime and non-sterile pharmaceutically acceptable base. The method of preparing the co-precipitated composition of Cefepime with pharmaceutically acceptable non-toxic base comprises of, i) dissolving a composition containing mixture of non sterile Cefepime and a non sterile pharmaceutically acceptable non-toxic organic or inorganic base in water to obtain a clear aqueous solution having a pH in the range of 3.5-7 and ii) filtration of aqueous solution through 0.2 micron membrane filter and then adding the clear aqueous solution to a suitable an organic solvent followed by stirring, filtration and drying.
Claims
1. Λ co precipitation process to obtain amorphous pharmaceutical composition comprising of cefepime acid addition salt or solvates thereof and a pharmaceutically acceptable non-toxic organic base in the ratio of 1 :2 to 1 :5 comprising of:
(i) 'dissolving an admixture of cefepime acid addition salt or solvates thereof with pharmaceutically acceptable non toxic organic base in water to obtain a aqueous solution having a pH in the range of 3.5-7,
(ii) filtering the aqueous solution through 0.2 micron membrane filter to get clear solution,
(iii) adding the clear aqueous solution to a suitable organic solvent or adding suitable organic solvent to clear aqueous solution to cause precipitation, and
(iv) isolation of solid.
2. A process according to claim 1 wherein the cefepime used is acid addition salt or solvates thereof which are in amorphous or crystalline form.
3. A process according to claim 1 wherein the cefepime used in the admixture is sterile or non sterile. 14
4. A process according to claim 1 wherein a pharmaceutically acceptable non-toxic organic base in the admixture is sterile or non sterile.
5. Λ process according to claim 1 wherein a pharmaceutically acceptable non-toxic organic base in the admixture is selected from N-methylglucosamine, N- methylglucamine, L(+)lysine, L(+)arginine tris(hydroxymethyl) aminomethane, preferred base is 1-arginine.
6. A process according to claim 1 wherein the molar ratio of cefepime to base is in the range 1 :2 to 1 :3
7. A process according to claims 1 wherein the co precipitation is performed preferably at 20-4O0C, preferably at 25-3O0C.
8. A process according to claim 1 wherein the suitable organic solvent is water miscible solvent selected from methanol, ethanol and isopropanol, acetone, methyl ethyl ketone, tertrahydrofuran, 1,4-dioxane, acetonitrile, dimethylformamide and dimethyl acetamide, most preferably isopropanol.
9. A sterile pharmaceutical composition of cefepime and a pharmaceutically acceptable non-toxic organic base obtained by the process according to claim 1. 15
10. A pharmaceutical composition obtained by co precipitation according to claim 1 in the form of injectable solution.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IN393MU2004 | 2004-03-31 | ||
| IN393/MUM/2004 | 2004-03-31 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| WO2005094800A2 WO2005094800A2 (en) | 2005-10-13 |
| WO2005094800A3 WO2005094800A3 (en) | 2005-11-24 |
| WO2005094800B1 true WO2005094800B1 (en) | 2006-01-19 |
Family
ID=34973079
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/IN2005/000095 Ceased WO2005094800A2 (en) | 2004-03-31 | 2005-03-30 | A co-precipitated cefepime composition and process for preparation thereof |
Country Status (1)
| Country | Link |
|---|---|
| WO (1) | WO2005094800A2 (en) |
Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2006106529A1 (en) * | 2005-04-05 | 2006-10-12 | Lupin Limited | A co-spray dried composition of cefepime with base and process for preparation thereof |
| US20070038224A1 (en) * | 2005-07-28 | 2007-02-15 | Ethicon Endo-Surgery, Inc. | Electroactive polymer-based flexing access port |
| CA2713989A1 (en) * | 2008-03-04 | 2009-09-11 | Elan Pharma International Limited | Stable liquid formulations of anti-infective agents and adjusted anti-infective agent dosing regimens |
| CN112094281B (en) * | 2020-08-11 | 2021-07-30 | 华北制药河北华民药业有限责任公司 | Preparation method of cefepime hydrochloride for injection |
Family Cites Families (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3984403A (en) * | 1972-06-30 | 1976-10-05 | Takeda Chemical Industries, Ltd. | Arginine and lysine salts of acid cephalosporins |
| US4910301A (en) * | 1985-08-05 | 1990-03-20 | Bristol-Myers Company | Cefepime cephalosporin salts |
| US4808617A (en) * | 1985-12-18 | 1989-02-28 | Bristol-Myers Company | Lyophilized or precipitated cephalosporin zwitterion and salt combination |
-
2005
- 2005-03-30 WO PCT/IN2005/000095 patent/WO2005094800A2/en not_active Ceased
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