Novel pregabalin crystal form and preparing method thereof

A pregabalin and crystal form technology, which is applied in the field of new crystal forms, can solve the problems of no public reports of pregabalin crystal forms, and achieve the effect of controllable product quality and good stability

Inactive Publication Date: 2007-05-16
CHONGQING PHARMA RES INST
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Relevant information disclosures include: world patents WO9638405, WO9640617, WO04054565, WO03066040, WO03061656, WO03020273...

Method used

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  • Novel pregabalin crystal form and preparing method thereof
  • Novel pregabalin crystal form and preparing method thereof
  • Novel pregabalin crystal form and preparing method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] Add 5 grams of pregabalin into a 250ml flask, add 90ml of isopropanol and 30ml of water, heat to 70-75°C to dissolve, filter while hot, cool to 0°C to crystallize, leave overnight, filter, wash with isopropanol, Vacuum-dry at 40°C for 12 hours to obtain the new crystal form of pregabalin.

Embodiment 2

[0043] Add 5 grams of pregabalin into a 250ml flask, add 100ml of acetonitrile and 50ml of water, and heat to 70-75°C to dissolve it. Filtrate while hot, cool to 0°C for crystallization, stand overnight, filter, wash with acetonitrile, and dry under vacuum at 40°C for 12 hours to obtain the new crystal form of pregabalin.

Embodiment 3

[0045] Add 5 grams of pregabalin to a 250ml flask, add 60ml of water and heat it to 70-75°C to dissolve it, slowly add 60ml of N,N-dimethylformamide dropwise, the solution just becomes turbid, cool down gradually, crystallize, and leave overnight , filtered, washed with N,N-dimethylformamide, and vacuum-dried at 40°C for 12 hours to obtain a new crystal form of pregabalin.

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Abstract

The invention discloses a (S)-(+)-3-aminomethyl-5-methyl hexanoic acid crystal (Pregabalin), which is characterized by the following: treating epilepsy, nervous pain and wide anxiety; possessing excellent stability; fitting for large scale of production; using Cu-Ka irradiation for Pregabalin; displaying feature peak at 9.6(2), 12.4(7.1), 18.5(4.8), 20.0(4.4) and 23.4(3.8) diffracted by X-ray powder at 2 thita and d value as crystal gap distance.

Description

Technical field: [0001] The invention relates to a new crystal form of a compound, in particular to a new crystal form of pregabalin, a composition containing it and a preparation method thereof. The crystal form is used to treat epilepsy and neuropathic pain drugs. Background technique: [0002] The chemical name of Pregabalin is (S)-(+)-3-aminomethyl-5-methylhexanoic acid. Pregabalin is a γ-amino acid (GABA) receptor antagonist, similar to Gabapentin, and also a 3-alkyl substitution of GABA, but compared with Gabapentin, this product has a lower dose and fewer medication times, Advantages such as small side effects. Clinical research for the treatment of epilepsy, neuropathic pain and other disorders such as anxiety and depression. Relevant information disclosures include: world patents WO9638405, WO9640617, WO04054565, WO03066040, WO03061656, WO03020273; Drugs of the Future1999, 24(8): 826-870. There is no public report about the crystal form of pregabalin in the existi...

Claims

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Application Information

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IPC IPC(8): C07C229/08C07C227/42A61K31/197A61P25/04A61P25/08
Inventor 颜伟伟张道林罗杰
Owner CHONGQING PHARMA RES INST
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