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Novel polycrystal product of sertraline hydrochloride, and composition comprising same and new method for preparing same and non-formed anticle

A technology of sertraline hydrochloride and its crystal form, which is applied to new polymorphs of sertraline hydrochloride and compositions containing them, and can solve problems such as failure to obtain crystal form II of sertraline hydrochloride

Inactive Publication Date: 2007-01-10
TEVA PHARMA IND LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

By the method of preparing sertraline hydrochloride crystalline form II described in the '699 patent, we were not able to obtain sertraline hydrochloride crystalline form II

Method used

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  • Novel polycrystal product of sertraline hydrochloride, and composition comprising same and new method for preparing same and non-formed anticle
  • Novel polycrystal product of sertraline hydrochloride, and composition comprising same and new method for preparing same and non-formed anticle
  • Novel polycrystal product of sertraline hydrochloride, and composition comprising same and new method for preparing same and non-formed anticle

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preparation example Construction

[0053] According to the method for preparing sertraline hydrochloride crystal form II described in the '699 patent, we cannot obtain sertraline hydrochloride crystal form II. Therefore, obviously neither the '699 patent nor the '518 patent discloses a useful method for preparing sertraline hydrochloride.

[0054] The invention also relates to a new method for preparing sertraline hydrochloride crystal form II through granulation. In the conversion of sertraline hydrochloride crystal form V to sertraline hydrochloride crystal form II, sertraline hydrochloride crystal form V is mixed with a small amount of ethanol or methanol. Stirring the mixture of sertraline hydrochloride crystal form V and ethanol or methanol for a period of at least several hours to several days, preferably about 2 days, promotes the conversion of crystal form V to crystal form II. Then the Sertraline Hydrochloride crystal form II was separated by filtration.

[0055] The present invention also provides a new m...

Embodiment 1

[0141] Preparation of Sertraline

[0142] Sertraline mandelate was prepared according to the method of US Patent No. 5,248,699. Sertraline mandelic acid (5 g) was stirred with 50 mL ethyl acetate at room temperature. The aqueous sodium hydroxide solution was added dropwise until sertraline mandelate was completely neutralized. Separate phases, organic phase passes MgSO 4 Dry and filter. The solvent was separated under reduced pressure to obtain an oil of sertraline base (3.2 g).

Embodiment 2

[0144] Preparation of Sertraline Hydrochloride Ethanolate Crystal Form VI by Re-beating Crystal Form I

[0145] Sertraline hydrochloride crystal form I (1 g) and absolute ethanol (20 mL) were stirred at room temperature for 24 hours. The mixture was filtered to obtain sertraline hydrochloride ethanolate form VI.

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Abstract

The invention discloses a method for synthesizing crystal II of sertraline-hydrochloride. According to the invention, the crystal II of sertraline-hydrochloride can be synthesized directly with the sertraline alkali or serraline-mandelic acid. It can also be synthesized from the solvent system of sertraline-hydrochloride solvate and hydrate crystal and the crystallization solvate. It also discloses the components of crystal II containing sertraline-hydrochloride and the use of these drugs.

Description

[0001] This application is a divisional application with an application number of 01823948.X and an application date of December 13, 2001. [0002] Cross reference of related applications [0003] This application corresponds to the U.S. Patent Application Serial No. 09 / 575,634 filed on May 22, 2000 and the serial number 09 / 586,842 filed on June 5, 2000. The U.S. Serial No. 09 / 575,634 filed on May 22, 2000 The application claims the priority of the U.S. Provisional Application Serial No. 60 / 182,159 filed on February 14, 2000. The US application serial number 09 / 586,842 filed on June 5, 2000 is a partial serial application of the US application serial number 09 / 448,985 filed on November 24, 1999, and the US provisional application number filed on August 9, 1999 is required. Priority of 60 / 147,888. The content of each of the above applications is hereby incorporated by reference. Invention field [0004] The present invention relates to a new cryst...

Claims

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Application Information

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IPC IPC(8): C07C209/82C07C211/42
Inventor E·施瓦茨T·尼丹A·利伯曼M·门德洛维奇J·阿伦希姆C·辛格E·瓦尔德曼
Owner TEVA PHARMA IND LTD
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