Process for Preparation of Copolymer-1 Used in the Treatment of Multiple Sclerosis
BACKGROUND Out of the many processes available today for synthesis of Copolymer- 1, no process provides control over the specific molecular weight (m. wt.) especially since the m.wt of 22KDa and above is considered toxic and without residual levels of acids. TECHNOLOGY DESCRIPTION A novel process using readily available raw materials, for the synthesis of Copolymer-1 and its pharmaceutically acceptable salts is described here. The process uses a polymer bound catalyst as an initiator (which requires 10X less catalyst concentration than conventional systems). The resulting polymer has a narrow molecular weight distribution, with m.wt can be tailored to be in the range of 8- 19KDa. Copolymer-1 could be injected subcutaneously, intra-peritoneally, intravenously, intramuscularly for the treatment MS.
Sector: Fluid systems and components for general use
Country: India
Area of Application: · Copolymer-1 is used for treatment of MS · Suggested application in the treatment of non-autoimmune neurodegenerative disorders such as glaucoma, acute CNS injuries, Alzheimer’s disease* *Kipnis, J. and Schwartz, M., Dual action of glatiramer acetate (Cop-1) in the treatment of CNS autoimmune and neurodegenerative disorders, TRENDS in Molecular Medicine , Vol.8, 2002, Pg. 319-323
Keywords: multiple sclerosis, copolymer 1, injectable, polymer-bound catalyst
Advantages: · A simple, cost-effective process using easily available raw materials · Yields a product with high degree of purity (without requiring additional steps of separation, purification etc.) · Molecular weight can be tailored to be in the range of 8-19KDa (hence overcoming toxicity issues; m. wt of over 20 KDa are known to be toxic)- with excellent control over the m. wt distribution · High purity levels - almost no acid residues (less than 1%)
Environmental aspects:
Development Status: Laboratory Model
Legal Protection: Patent
Technical specifications:
Transfer Terms: Technology Licensing
Target Countries:
Estimated cost (US$):
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Contact Person: National Chemical Laboratory, CSIR
Address: A208, PAML Building, National Chemical Laboratory Dr Homi Bhabha Road,
City: Pune
Country: India
Zip/Pin Code: 411007
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