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A Novel Non Column Chromatographic Process To Reduce N Formyl N Deacetyl Thiocolchicoside And Obtain High Purity Pharmacopoeial Grade 3 O (ß D Glucopyranosyl) 3 O Demethyl Thiocolchicine From Colchicoside.
Abstract: A novel process is invented to prepare 3-0-(ß-D-glucopyranosyl)-3-0-demethyl thiocolchicine (thiocolchicoside) of higher purity Pharmacopoeial grade from a naturally isolated colchicoside, obtained from Gloriosa superba seed. The key phases of present invention for preparing thiocolchicoside involves: (1) Semi-synthetic reaction of colchicoside of natural source with methyl mercaptide sodium salt to introduce thiomethyl group at specified time, temperature and pH to obtain thiocolchicoside in high yield with a low colchicoside content in the reaction. (2) To monitor and control, as defined in the Pharmacopoeia, at a selective pH and temperature the content of N-formyl-N-deacetyl thiocolchicoside that is formed from N-formyl-N-deacetyl colchicoside which is present originally within the source material colchicoside. 3) To obtain thiocolchicoside with low N-formyl-N-deacetyl thiocolchicoside impurity in reaction itself. 4) A selective crystallization and separation to produce 3-0-(ß-D-glucopyranosyl)-3-0-demethyl thiocolchicine having impurities N-deacetyl-N-formyl thiocolchicoside 0.35%, colchicoside below 0.2% and other unknown single impurity less than 0.1%.
Notices, Deadlines & Correspondence
Patent Information
Applicants
BHARTIA, UMA SHANKAR
INDIA GLYCOLS LIMITED (ENNATURE BIOPHARMA DIVISION)
Inventors
1. BHARTIA, UMA SHANKAR
2. KANDPAL, JAI BALLABH
Specification
Documents
Orders
| Section | Controller | Decision Date |
|---|---|---|
| Decision us 15 | Monika Yadav | 2022-01-23 |
| 15 | Monika Yadav | 2023-01-23 |
Application Documents
| # | Name | Date |
|---|---|---|
| 1 | 1450-del-2011-Form-1 (28-11-2011).pdf | 2011-11-28 |
| 2 | 1450-del-2011-Correspondence others-(28-11-2011).pdf | 2011-11-28 |
| 3 | 1450-del-2011-GPA.pdf | 2012-01-25 |
| 4 | 1450-del-2011-Form-5.pdf | 2012-01-25 |
| 5 | 1450-del-2011-Form-2.pdf | 2012-01-25 |
| 6 | 1450-del-2011-Form-1.pdf | 2012-01-25 |
| 7 | 1450-del-2011-Drawings.pdf | 2012-01-25 |
| 8 | 1450-del-2011-Description (Complete).pdf | 2012-01-25 |
| 9 | 1450-del-2011-Correspondence Others.pdf | 2012-01-25 |
| 10 | 1450-del-2011-Claims.pdf | 2012-01-25 |
| 11 | 1450-del-2011-Abstract.pdf | 2012-01-25 |
| 12 | 1450-DEL-2011-FER.pdf | 2019-06-25 |
| 13 | 1450-DEL-2011-OTHERS [24-12-2019(online)].pdf | 2019-12-24 |
| 14 | 1450-DEL-2011-FER_SER_REPLY [24-12-2019(online)].pdf | 2019-12-24 |
| 15 | 1450-DEL-2011-CLAIMS [24-12-2019(online)].pdf | 2019-12-24 |
| 16 | 1450-DEL-2011-US(14)-HearingNotice-(HearingDate-29-07-2020).pdf | 2020-07-07 |
| 17 | 1450-DEL-2011-Written submissions and relevant documents [12-08-2020(online)].pdf | 2020-08-12 |
| 18 | 1450-DEL-2011-NBA INTIMATION TO APPLICANT COMPLY WITH REQUIREMENT-15-06-2023.pdf | 2023-06-15 |
| 19 | 1450-DEL-2011-US(14)-ExtendedHearingNotice-(HearingDate-28-11-2023).pdf | 2023-10-23 |
| 20 | 1450-DEL-2011-RELEVANT DOCUMENTS [28-11-2023(online)].pdf | 2023-11-28 |
| 21 | 1450-DEL-2011-POA [28-11-2023(online)].pdf | 2023-11-28 |
| 22 | 1450-DEL-2011-FORM 13 [28-11-2023(online)].pdf | 2023-11-28 |
| 23 | 1450-DEL-2011-Written submissions and relevant documents [29-11-2023(online)].pdf | 2023-11-29 |
| 24 | 1450-DEL-2011-NBA Approval Submission [29-11-2023(online)].pdf | 2023-11-29 |
| 25 | 1450-DEL-2011-PatentCertificate05-12-2023.pdf | 2023-12-05 |
| 26 | 1450-DEL-2011-IntimationOfGrant05-12-2023.pdf | 2023-12-05 |
Search Strategy
| 1 | 1450_21-06-2019.pdf |