Lurasidone hydrochloride crystal form as well as preparation method and application thereof

A lurasidone hydrochloride crystal and a technology for lurasidone hydrochloride, which are applied in the field of lurasidone hydrochloride crystal forms, can solve problems such as poor drug formability, and achieve the effects of stable crystal form and good repeatability

Inactive Publication Date: 2014-09-03
JIANGSU HANSOH PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the formability of the drug in the formulation involved in this patent is relatively poor

Method used

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  • Lurasidone hydrochloride crystal form as well as preparation method and application thereof
  • Lurasidone hydrochloride crystal form as well as preparation method and application thereof
  • Lurasidone hydrochloride crystal form as well as preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] Add lurasidone hydrochloride (3.54g) and ethanol (290ml) into a reaction flask, stir and heat to reflux, cool to 25°C naturally after completely dissolving, stir and crystallize overnight, filter, and dry to obtain a solid. It has been confirmed that its XRD characteristic pattern is as follows: figure 1 shown.

Embodiment 2

[0019] Add lurasidone hydrochloride (4.45g) and methanol (60ml) into the reaction flask, stir and heat to reflux, cool to 25°C naturally after completely dissolving, stir and crystallize for 2 hours, filter, and dry to obtain a solid. Its structure was confirmed by XRD.

Embodiment 3

[0021] Add lurasidone hydrochloride (4.5g) and methanol (90ml) into the reaction flask, stir and heat to reflux, add isopropanol (180ml) dropwise after completely dissolved, the solution becomes cloudy, naturally cool to 25°C, stir and crystallize 1 hour, filtered and dried to obtain a solid. Its structure was confirmed by XRD.

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PUM

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Abstract

The invention relates to a lurasidone hydrochloride crystal form as well as a preparation method and application thereof. Specifically, the invention discloses a lurasidone hydrochloride crystal form, and a preparation method, a pharmaceutical composition and a pharmaceutical purpose thereof. An XRD characteristic peak of the lurasidone hydrochloride crystal form is as shown in figure I. The lurasidone hydrochloride crystal form provided by the invention is stable in character, good in repeatability and suitable for drug development.

Description

technical field [0001] The invention relates to a crystal form of lurasidone hydrochloride, its preparation method, its pharmaceutical composition and its pharmaceutical use. Background technique [0002] Lurasidone hydrochloride, a dopamine D 2 / 5-HT 2A Receptor dual antagonists, belonging to atypical antipsychotic drugs, used in the first-line treatment of patients with schizophrenia, its chemical name is N-[4-[4-(1,2-benzisothiazol-3-yl)-1 -piperazinyl]-(2R,3R)-2,3-tetramethylene-butyl]-(1'R,2'S,3'R,4'S)-2,3-bicyclo[2,2,1 ] Heptane diimide hydrochloride, its chemical structural formula is as follows: [0003] [0004] WO2002 / 024166 discloses a tablet containing lurasidone hydrochloride, the auxiliary material is a water-soluble excipient (lactose or mannitol), an internal disintegrant, a water-soluble binder, an external disintegrant and a lubricant. The tablet has the same dissolution characteristics when the content of lurasidone hydrochloride is 5-40 mg, and whe...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D417/12A61K31/496A61P25/18
CPCC07D417/12
Inventor 袁阜平杜祖银李孝壁赵军军
Owner JIANGSU HANSOH PHARMA CO LTD
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