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Polymorphic form of rasagiline mesylate

A technology of rasagiline mesylate and mesylate, which is applied in the field of polymorphic forms of rasagiline mesylate, and can solve the problems of undisclosed issues

Inactive Publication Date: 2011-08-10
GENERICS UK LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The prior art does not disclose satisfactory methods for the removal of dipropargylaminoindan and mesylateaminoindan impurities

Method used

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  • Polymorphic form of rasagiline mesylate
  • Polymorphic form of rasagiline mesylate
  • Polymorphic form of rasagiline mesylate

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] Rasagiline mesylate (1 eq) was placed in acetonitrile (4 vol) and heated to 55°C for 20-30 minutes until a clear solution was obtained. The solution was cooled to 25°C for 30 minutes and filtered. The solid product was dried under vacuum at 25-30°C for 2 hours. XRPD and DSC analysis data confirmed that the obtained product was a crystalline form of rasagiline mesylate.

Embodiment 2

[0051] Rasagiline mesylate (1 eq) was placed in THF (20 vol) and heated to 66°C for 20-30 minutes. Obtain a slurry. The slurry was cooled to 25°C for 30 minutes and filtered. The solid product was dried under vacuum at 25-30°C for 2 hours. XRPD and DSC analysis data confirmed that the obtained product was a crystalline form of rasagiline mesylate.

Embodiment 3

[0053] Rasagiline mesylate (1 eq) was dissolved in 1-butanol (3 vol) and heated to 55°C for 20-30 minutes until a clear solution was obtained. The solution was cooled to 25°C for 30 minutes and filtered. The solid product was dried under vacuum at 25-30°C for 2 hours. XRPD and DSC analysis data confirmed that the obtained product was a crystalline form of rasagiline mesylate.

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Abstract

The present invention relates to a novel crystalline form of rasagiline mesylate and a pure form of rasagiline mesylate and processes for their preparation. Further, the invention relates to pharmaceutical compositions comprising said forms and use of said compositions in the treatment of patients suffering from Parkinson's Disease, dementia, Alzheimer's Disease, depression, hyperactive syndrome, stroke, brain ischemia, neurotrauma, schizophrenia and multiple sclerosis.

Description

technical field [0001] The present invention relates to a new crystalline form (crystal form) of rasagiline mesylate and a pure form of rasagiline mesylate and their preparation methods. Furthermore, the present invention also relates to pharmaceutical compositions comprising said forms and said compositions in the treatment of Parkinson's disease, dementia, Alzheimer's disease, depression, hyperactivity syndrome, stroke, cerebral ischemia, Use in patients with neurotrauma, schizophrenia, and multiple sclerosis. Background technique [0002] Rasagiline, represented by structural formula (1) and having the chemical name 1-(R)-(2-propynylamino)indan, is a selective and potent irreversible inhibitor of monoamine oxidase type B (MAO-B) . Currently, rasagiline is marketed as a mesylate salt for the treatment of Parkinson's disease as a monotherapy and as an adjunct to levodopa. Rasagiline is also used to treat dementia, Alzheimer's disease, depression, ADHD, stroke, cerebral i...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07C211/42C07C309/04A61P25/16A61K31/135
CPCC07C309/04C07B2200/13C07C2102/08C07C211/42A61P3/12A61P9/10A61P25/00A61P25/14A61P25/16A61P25/18A61P25/24A61P25/28C07C2602/08
Inventor 维纳亚克·戈雷宾杜·马诺杰库马桑迪普·索娜瓦内达塔特雷·科卡内辛德帕尔·汤克
Owner GENERICS UK LTD
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