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Aripiprazole pharmaceutic preparation and preparation method thereof

A technology for aripiprazole and pharmaceutical preparations, applied in the field of aripiprazole pharmaceutical preparations and their preparation, can solve the problems of large pollution and loss, potential safety hazards, complicated operations, etc. The effect of serious pollution

Active Publication Date: 2013-01-02
SHANGHAI ZHONGXI PHARMACEUTICAL CO LTD
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The technical problem to be solved by the present invention is to provide a non-safe Hidden danger, simple and convenient operation, low pollution loss, low cost, good process controllability, and a method for obtaining an aripiprazole pharmaceutical preparation with excellent dissolution characteristics, stability, and lower content of related substances, and the method manufactured product

Method used

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  • Aripiprazole pharmaceutic preparation and preparation method thereof
  • Aripiprazole pharmaceutic preparation and preparation method thereof
  • Aripiprazole pharmaceutic preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 11

[0054] Example 11 Aripiprazole tablet (10mg / tablet) formula and preparation method (unit: gram)

[0055]

Embodiment 12

[0056] Example 12 Aripiprazole tablet (5mg / tablet) formula and preparation method (unit: gram)

[0057]

Embodiment 13

[0058] Example 13 Aripiprazole tablet (10mg / tablet) formula and preparation method (unit: gram)

[0059]

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Abstract

The invention provides a preparation method of an aripiprazole pharmaceutic preparation, which comprises the following steps: dissolving aripiprazole in an acidic solution containing an acidifying agent to prepare a drug-containing acidic solution; then performing wet granulation or preparing a suspension by the drug-containing acidic solution, an alkalizer and an auxiliary material to obtain the aripiprazole pharmaceutic preparation; the auxiliary material comprises an anti-oxidant. The invention also provides an aripiprazole pharmaceutic preparation prepared by the method. The aripiprazole pharmaceutic preparation obtained by the preparation method of the invention has significantly reduced amounts of related materials, good dissolution property and stability, high bioavailability, less individual difference, and improved wetability and content uniformity of drugs which are difficult to dissolve. The method of the invention is simple in operation, and low in cost, requires no special equipment, and is easily applicable to industrial production; especially, the method eliminates the effect of raw material forms on preparation quality, and avoids defects of severe pollution, great loss, and severe potential safety hazard caused by aripiprazole pretreatment.

Description

technical field [0001] The invention relates to an aripiprazole pharmaceutical preparation and a preparation method thereof. Background technique [0002] Aripiprazole chemical name 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydro-2(1 hydrogen)-quinolin Linone, a quinolinone derivative, was approved by the US FDA in November 2002 for the treatment of schizophrenia. [0003] Aripiprazole is an insoluble drug in water, and only by making it reach a certain fineness can the prepared preparation be dissolved rapidly to ensure the absorption rate and bioavailability. If the aripiprazole is mechanically pulverized by a universal pulverizer, the particle size generally can only reach about 100 microns, and the dissolution characteristics of the prepared preparation are not ideal yet. In addition, the use of mechanical crushing also has defects such as a lot of dust, environmental pollution and large loss. Moreover, the drug activity of aripiprazole is relatively hi...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/10A61K9/16A61K9/20A61K9/48A61K31/496A61P25/18
CPCA61K9/2009A61K31/496A61K31/517A61K47/02A61K9/1611A61J3/02A61K9/0095A61K9/2027A61K9/10A61K9/16A61K9/48A61K9/20A61K9/1635A61P25/18
Inventor 郑斯骥刘潇怡傅麟勇谭波周敏
Owner SHANGHAI ZHONGXI PHARMACEUTICAL CO LTD
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