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Stable particular pharmaceutical composition of solifenacin or salt thereof

A technology of solifenacin and composition, applied in the field of stable granular pharmaceutical composition of solifenacin or its salt

Inactive Publication Date: 2011-07-06
ASTELLAS PHARMA INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012]On the other hand, Solifenacin and its salts are known to have very high solubility to various solvents and have very strong bitter taste and astringent properties

Method used

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  • Stable particular pharmaceutical composition of solifenacin or salt thereof
  • Stable particular pharmaceutical composition of solifenacin or salt thereof
  • Stable particular pharmaceutical composition of solifenacin or salt thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0092] Example 2

[0093] The granular composition obtained in Example 1 was humidified at 25° C. and 75% RH for 12 hours, further dried at 30° C. and 40% RH for 3 hours, and crystallized to obtain the granular composition of the present invention.

Embodiment 2

[0095] Using PEG6000 as a binder, the material obtained by coating solifenacin succinate on crystalline cellulose core particles

Embodiment 3

[0097] Example 4

[0098] The granular composition obtained in Example 3 was humidified at 25° C. and 75% RH for 12 hours, further dried at 30° C. and 40% RH for 3 hours, and crystallized to obtain the granular composition of the present invention.

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PUM

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Abstract

A solid pharmaceutical preparation of solifenacin or a salt thereof, the preparation being stable and inhibited from decomposing with time when supplied to clinical fields. In a pharmaceutical preparation containing solifenacin or a salt thereof, the compound in an amorphous form was revealed to be causative of cardinal-drug decomposition with time. The composition for a solid pharmaceutical preparation of solifenacin or a salt thereof contains solifenacin or its salt each in a crystalline form, and the content of the compound in an amorphous form in the composition is within the range which exerts no influence on product stability. Also provided are: a process for producing the composition; and a medicinal composition for solid pharmaceutical preparations which contains solifenacin and an amorphization inhibitor.

Description

technical field [0001] The present invention relates to a stable granular pharmaceutical composition formed by using solifenacin or its salt and a specific binder and a manufacturing method thereof, an orally disintegrating tablet containing the granular pharmaceutical composition, and the granular medicine Method of stabilizing the composition. Background technique [0002] Solifenacin is shown in the following structural formula (I): [0003] [chemical formula 1] [0004] [0005] Structural formula (I) [0006] It is chemically known as 1-phenyl-1,2,3,4-tetrahydro-2-isoquinolinecarboxylic acid (1R,3'R)-quinuclidinyl ester. [0007] It has been reported that a series of quinucidine derivatives including solifenacin or its salts have no effect on muscarine M 3 Receptors have excellent selective antagonism and are useful in urinary disorders (e.g. neurogenic urinary frequency, neurogenic bladder, nocturia, unstable bladder, bladder contractures and chronic cysti...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/4725A61K9/14A61K47/26A61K47/32A61K47/34A61K47/36A61K47/38
CPCA61K31/4725A61K9/0056A61K9/1676A61P11/00A61P11/06A61P13/00A61P13/06A61K9/16A61K31/439A61K47/26A61K47/38
Inventor 梅岛启之大井宏志斋藤胜实武谷佑子
Owner ASTELLAS PHARMA INC
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