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An Improved Method For Manufacture Of Ceftriaxone Sodium
Abstract: A process for prepartion of ceftriaxone sodium of formula(II), is disclosed the process comprising the steps of i 0 reacting a silylated compound of formula(III), with a 4-halo-2-methoxyimino-3-oxo-butyric acid derivative of formula (IV) wherein X and Y represent a halogen atom to give a compound of formula(V) ii) desilyating the compound of formula(V) wherein X is as defined herenabove to give the desilylated compound of formula(VI) iv) reacting the desilyated compound of formula (VI) with thiourea in a solvent system containing organic solvent and water, to obtain ceftriaxone of formula(I) iv) converttion the compound of formula (I) to the sodium salt(II). The process is charatectrised by i1) reacting a silyated compound of formula(III) with a 4-halo-2-methoxyimino-3-oxobutyric acid derivative of formula (IV) having a purity of at least 95% and containing di-and poly-brominated compounds less than 0.5% Wherein X and Y represent a halogen atome in the presence of an inert water-immiscible oranic sovent or mixtures thereof and in the presence of an acid scavenging agent at a temperature of between -10C to -60C to give a compound of dformula(V) ii) adding the solution of compound of formula (V) in the inert water-immiscible organic solvent mixtures thereof to a 1:1mixture of water and a water-miscible organic solvent and separation of the organic phase to provide a soluution compound of formula (VI) in the inert water-immiscible organic or mixtures thereof, iii0 reacting the solution of compound of formula (VI) in the inert water-immiscible organic solvent or mixture thereof with a solution of thiourea in water in the presence of an alkali metal containing inorganic base at a temperature of between 0 Cto + 10 C at a pH ranging betwwen 5.0 to 55 and separation of the organic layer to provide a solution of the alkali metal of ceftriaxone of formula (II1) in water M is an alkali metal iv) mixing the solution of the alkali metal salt of cefriaxone (II) wherein M is as defind hereinearline in water with a water-immiscibe organic solvent and a water-miscibe solvent and trating the solution thus obtained with an acid to a Ph of 3.6 to 4.0 and isloading the precipited ceftriaxone of formula (I) by filtration, v) reacting a solution of ceftriciaxone of formula (I) in water with an organic amine maintainging a pH of 5.4-+0.2 to produce a solution of the amine salt of ceffriaxone in water of formula(VII).
Notices, Deadlines & Correspondence
Patent Information
Applicants
LUPIN LIMITED
Inventors
1. DATTA DEBASHISH
2. DANTU MURALIKRISHNA
3. SHARMA POLLEPEDDI
4. MISHRA BRIJKISHORE
Specification
Documents
Application Documents
| # | Name | Date |
|---|---|---|
| 1 | 236101FORM-27-2010..pdf | 2024-02-29 |
| 1 | 967-MUM-2008-FORM 3(12-08-2008).pdf | 2008-08-12 |
| 2 | 967-mum-2003-abstract(granted)-(23-9-2009).pdf | 2018-08-09 |
| 2 | 967-MUM-2003-CORRESPONDENCE(12-08-2008.pdf | 2008-08-12 |
| 3 | 967-mum-2003-correspondence(ipo)-(23-10-2009).pdf | 2009-10-23 |
| 3 | 967-MUM-2003-CLAIMS(1-7-2009).pdf | 2018-08-09 |
| 4 | 967-MUM-2003-FORM 4-(18-11-2013).pdf | 2013-11-18 |
| 4 | 967-mum-2003-claims(complete)-(17-9-2003).pdf | 2018-08-09 |
| 5 | 967-MUM-2003-CORRESPONDENCE-(18-11-2013).pdf | 2013-11-18 |
| 5 | 967-mum-2003-claims(granted)-(23-9-2009).pdf | 2018-08-09 |
| 6 | 967-MUM-2003_EXAMREPORT.pdf | 2018-08-09 |
| 6 | 967-MUM-2003-CORRESPONDENCE(1-7-2009).pdf | 2018-08-09 |
| 7 | 967-MUM-2003-POWER OF ATTORNEY(21-8-2008).pdf | 2018-08-09 |
| 7 | 967-MUM-2003-CORRESPONDENCE(15-9-2010).pdf | 2018-08-09 |
| 8 | 967-MUM-2003-OTHER DOCUMENT(1-7-2009).pdf | 2018-08-09 |
| 8 | 967-MUM-2003-CORRESPONDENCE(21-8-2008).pdf | 2018-08-09 |
| 9 | 967-mum-2003-correspondence(6-8-2007).pdf | 2018-08-09 |
| 9 | 967-mum-2003-form 3(17-9-2003).pdf | 2018-08-09 |
| 10 | 967-MUM-2003-DESCRIPTION(COMPLETE)-(1-7-2009).pdf | 2018-08-09 |
| 10 | 967-MUM-2003-FORM 3(1-7-2009).pdf | 2018-08-09 |
| 11 | 967-mum-2003-description(complete)-(17-9-2003).pdf | 2018-08-09 |
| 11 | 967-mum-2003-form 2(title page)-(granted)-(23-9-2009).pdf | 2018-08-09 |
| 12 | 967-mum-2003-description(granted)-(23-9-2009).pdf | 2018-08-09 |
| 12 | 967-mum-2003-form 2(title page)-(complete)-(17-9-2003).pdf | 2018-08-09 |
| 13 | 967-MUM-2003-FORM 1(1-12-2003).pdf | 2018-08-09 |
| 13 | 967-MUM-2003-FORM 2(TITLE PAGE)-(1-7-2009).pdf | 2018-08-09 |
| 14 | 967-mum-2003-form 1(17-9-2003).pdf | 2018-08-09 |
| 14 | 967-mum-2003-form 2(granted)-(23-9-2009).pdf | 2018-08-09 |
| 15 | 967-mum-2003-form 18(7-8-2007).pdf | 2018-08-09 |
| 15 | 967-mum-2003-form 2(complete)-(17-9-2003).pdf | 2018-08-09 |
| 16 | 967-mum-2003-form 2(1-7-2009).pdf | 2018-08-09 |
| 17 | 967-mum-2003-form 2(complete)-(17-9-2003).pdf | 2018-08-09 |
| 17 | 967-mum-2003-form 18(7-8-2007).pdf | 2018-08-09 |
| 18 | 967-mum-2003-form 2(granted)-(23-9-2009).pdf | 2018-08-09 |
| 18 | 967-mum-2003-form 1(17-9-2003).pdf | 2018-08-09 |
| 19 | 967-MUM-2003-FORM 1(1-12-2003).pdf | 2018-08-09 |
| 19 | 967-MUM-2003-FORM 2(TITLE PAGE)-(1-7-2009).pdf | 2018-08-09 |
| 20 | 967-mum-2003-description(granted)-(23-9-2009).pdf | 2018-08-09 |
| 20 | 967-mum-2003-form 2(title page)-(complete)-(17-9-2003).pdf | 2018-08-09 |
| 21 | 967-mum-2003-description(complete)-(17-9-2003).pdf | 2018-08-09 |
| 21 | 967-mum-2003-form 2(title page)-(granted)-(23-9-2009).pdf | 2018-08-09 |
| 22 | 967-MUM-2003-DESCRIPTION(COMPLETE)-(1-7-2009).pdf | 2018-08-09 |
| 22 | 967-MUM-2003-FORM 3(1-7-2009).pdf | 2018-08-09 |
| 23 | 967-mum-2003-correspondence(6-8-2007).pdf | 2018-08-09 |
| 23 | 967-mum-2003-form 3(17-9-2003).pdf | 2018-08-09 |
| 24 | 967-MUM-2003-OTHER DOCUMENT(1-7-2009).pdf | 2018-08-09 |
| 24 | 967-MUM-2003-CORRESPONDENCE(21-8-2008).pdf | 2018-08-09 |
| 25 | 967-MUM-2003-POWER OF ATTORNEY(21-8-2008).pdf | 2018-08-09 |
| 25 | 967-MUM-2003-CORRESPONDENCE(15-9-2010).pdf | 2018-08-09 |
| 26 | 967-MUM-2003_EXAMREPORT.pdf | 2018-08-09 |
| 26 | 967-MUM-2003-CORRESPONDENCE(1-7-2009).pdf | 2018-08-09 |
| 27 | 967-MUM-2003-CORRESPONDENCE-(18-11-2013).pdf | 2013-11-18 |
| 27 | 967-mum-2003-claims(granted)-(23-9-2009).pdf | 2018-08-09 |
| 28 | 967-MUM-2003-FORM 4-(18-11-2013).pdf | 2013-11-18 |
| 28 | 967-mum-2003-claims(complete)-(17-9-2003).pdf | 2018-08-09 |
| 29 | 967-mum-2003-correspondence(ipo)-(23-10-2009).pdf | 2009-10-23 |
| 29 | 967-MUM-2003-CLAIMS(1-7-2009).pdf | 2018-08-09 |
| 30 | 967-MUM-2003-CORRESPONDENCE(12-08-2008.pdf | 2008-08-12 |
| 30 | 967-mum-2003-abstract(granted)-(23-9-2009).pdf | 2018-08-09 |
| 31 | 236101FORM-27-2010..pdf | 2024-02-29 |
| 31 | 967-MUM-2008-FORM 3(12-08-2008).pdf | 2008-08-12 |