A PROCESS FOR ISOLATION OF ROMIDEPSIN FROM FERMENTATION BROTH AND PREPARATION OF CRYSTALS OF ROMIDEPSIN

Title:

A PROCESS FOR ISOLATION OF ROMIDEPSIN FROM FERMENTATION BROTH AND PREPARATION OF CRYSTALS OF ROMIDEPSIN

Document Type and Number:

WIPO Patent Application WO/2015/136548

Kind Code:

A4

Abstract:

The present invention describes a process for isolation of romidepsin from fermentation broth and preparation of crystals of romidepsin. The process of the invention includes fewer purification steps and provides romidepsin having purity of greater than 99.5% area by HPLC. The process of the invention involves simple purification steps and hence, does not require multiple chromatographic purification steps to achieve desired quality of romidepsin. The process is advantageous over reported processes in terms of 99.5 % pure yield, fast process, less expensive and less cumbersome as multiple chromatographic purification is not necessary to achieve desired quality. The process for the preparation of crystals of romidepsin provides advantages like simple steps and involves use of single solvent. The process is advantageous in terms of time, cost, and simplicity.

Inventors:

VAID ANKUR SUDHIR (IN)
DHIMAN ANAND MAHADEV (IN)
SHARMA TRAUNKANT PARSHURAM (IN)

Application Number:

PCT/IN2015/000113

Publication Date:

March 31, 2016

Filing Date:

March 02, 2015

Export Citation:

Click for automatic bibliography generation Help

Assignee:

CONCORD BIOTECH LTD (IN)

International Classes:

A61K38/07; C07K11/02; C12P21/04

Attorney, Agent or Firm:

ACHARYA, Rajeshkumar H. et al. (Advocates•Patent & Trademarks AttorneysHK Avenue, 19, Swastik Society,,Navrangpura, Ahmedabad 9, IN)

Download PDF:

View/Download PDF PDF Help

Claims:

AMENDED CLAIMS

received by the International Bureau on 25 Jan 2016(25.01.2016)

We claim:

1. A process for the isolation of romidepsin from fermentation broth which comprises, a) extracting the fermentation broth with an organic solvent and evaporating the solvent to obtain a residue; b) treating the residue obtained in step a) with an organic solvent selected from a ketone or a nitrile solvent; c) evaporating the solvent to obtain a residue;

[Original claim 3. specification page no. 8, lines 9-101

d) subjecting the residue obtained in step c) to silica gel column chromatography; wherein silica gel of 60-120 mesh or 230-400 mesh; wherein mobile phase is selected from acetone-heptane, ethyl acetate- cyclohexane and dichloromethane-hexan;

[Original claim 2 and 4, specification page no. 5. lines 2-71

e) treating the product of step d) with an organic solvent; and

0 crystallizing the product obtained in step e).

2. (Deleted)

3. (Deleted)

4. (Deleted)

5. The process according to claim 1, wherein romidepsin is obtained with a purity of 99.5% or more by area.

6. A single solvent process for the preparation of crystals of romidcpsin which comprises, a) dissolving romidepsin in a solvent either a chlorinated hydrocarbon or an ester to obtain a solution; fOriginal claim 7. specification page no. 7. lines 6-91

b) initiating precipitation of romidepsin by allowing the solution to stand at a temperature lower than 25° C or evaporating the solution to the reduced volume; fOriginal claim 8. specification page no. 7. lines 11-141

c) recovering crystals of romidepsin.

7. (Deleted)

8. (Deleted)

Previous Patent: A SYSTEM FOR ALERTING AND PREVENTING LEAKAGE OF COMBUSTIBLE GASES AND REPORTING AND MONITORING GAS L...

Next Patent: A SURGICAL CORRUGATED TUBE DRAIN