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Quick-release amisulpride drug composition and preparation method thereof

A technology of amisulpride and its composition, which is applied in the field of immediate-release amisulpride pharmaceutical composition and its preparation, can solve the problems that the amisulpride drug cannot dissolve quickly and take effect quickly, and achieve the benefits of effectiveness and safety High stability, excellent stability, and simple process

Inactive Publication Date: 2017-08-18
SHENZHEN FONCOO PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] In order to solve the problem that the amisulpride medicine in the prior art cannot be dissolved quickly and take effect quickly, the present invention provides an immediate-release amisulpride pharmaceutical composition and a preparation method thereof

Method used

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  • Quick-release amisulpride drug composition and preparation method thereof
  • Quick-release amisulpride drug composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] unit (mg)

[0037] inner layer

[0038] Micronized amisulpride 100.0;

[0039] Polyvinylpyrrolidone 80.0;

[0040] Lactose 116.0;

[0041] Sodium Lauryl Sulfate 2.0.

[0042] outer layer

[0043] Cross-linked polyvinylpyrrolidone 92.0;

[0044] Microcrystalline cellulose 145.0;

[0045] Sodium stearyl fumarate 5.5;

[0046] Colloidal silicon dioxide 3.5;

[0047] Sweetener 1.0.

[0048] Preparation steps:

[0049] (a) preparing a suspension of micronized form of amisulpride with a particle size of less than 60 μm in an aqueous solution of polyvinylpyrrolidone and polyvinylpyrrolidone;

[0050] (b), apply the suspension obtained in step (a) to lactose, and compress into tablets;

[0051] (c) Coating the thus obtained tablet with an appropriate amount of outer layer material dissolved in aqueous ethanol, with a weight gain of 2%.

Embodiment 2

[0053] unit (mg)

[0054] inner layer

[0055] Micronized amisulpride 100.0;

[0056] Polyvinylpyrrolidone 90.0;

[0057] Lactose 106.0;

[0058] Sodium Lauryl Sulfate 2.0.

[0059] outer layer

[0060] Cross-linked polyvinylpyrrolidone 92.0;

[0061] Microcrystalline cellulose 145.0;

[0062] Sodium stearyl fumarate 5.5;

[0063] Colloidal silicon dioxide 3.5;

[0064] Sweetener 1.0.

[0065] Preparation steps:

[0066] (a) preparing a suspension of micronized form of amisulpride with a particle size of less than 60 μm in an aqueous solution of polyvinylpyrrolidone and polyvinylpyrrolidone;

[0067] (b), apply the suspension obtained in step (a) to lactose, and compress into tablets;

[0068] (c) Coating the thus obtained tablet with an appropriate amount of outer layer material dissolved in aqueous ethanol, with a weight gain of 2%.

Embodiment 3

[0070] unit (mg)

[0071] inner layer

[0072] Micronized amisulpride 100.0;

[0073] Polyvinylpyrrolidone 90.0;

[0074] Lactose 96.0;

[0075] Sodium Lauryl Sulfate 1.0.

[0076] outer layer

[0077] Cross-linked polyvinylpyrrolidone 92.0;

[0078] Microcrystalline cellulose 145.0;

[0079] Sodium stearyl fumarate 5.5;

[0080] Colloidal silicon dioxide 3.5;

[0081] Sweetener 1.0.

[0082] Preparation steps:

[0083] (a) preparing a suspension of micronized form of amisulpride with a particle size of less than 60 μm in an aqueous solution of polyvinylpyrrolidone and polyvinylpyrrolidone;

[0084](b), apply the suspension obtained in step (a) to lactose, and compress into tablets;

[0085] (c) Coating the thus obtained tablet with an appropriate amount of outer layer material dissolved in aqueous ethanol, with a weight gain of 2%.

[0086] Table 1. The solubility results of different embodiments and reference substances in water

[0087]

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Abstract

The invention discloses a quick-release amisulpride drug composition and a preparation method thereof. The composition comprises: (a) at least one inner layer: formed by at least one layer of inert water-soluble holder of a coating comprising micro-powdered amisulpride, hydrophilic polymer and a surfactant; and (b) an outer layer: one or more outer layers, comprising a sweetening agent. The composition is good in solution effect, excellent in quality stability, simple in process, beneficial in industrialization, and capable of sufficiently ensuring the drug application effectiveness and safety.

Description

technical field [0001] The invention belongs to the field of amisulpride pharmaceutical preparations, and relates to an immediate-release amisulpride pharmaceutical composition and a preparation method thereof. Background technique [0002] Amisulpride is a selective dopamine D2 and D3 receptor antagonist developed by Sanofi for the treatment of psychiatric disorders, especially with positive symptoms (eg delirium, hallucinations, cognitive impairment) and / or Acute or chronic schizophrenia with or negative symptoms (such as: slow response, apathy and social ability withdrawal), also includes psychopaths with negative symptoms, and its chemical structure is as follows: [0003] [0004] Amisulpride is an atypical antipsychotic drug indicated for the treatment of paranoid progressive schizophrenia, acute delusional psychosis, and also for the treatment of deficit states in schizophrenia, residual psychotic evolution, and accompanying There is a sluggish inhibition state. ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/36A61K47/32A61K47/26A61K47/38A61K31/40A61P25/18
CPCA61K9/2018A61K9/2027A61K9/2081A61K9/2866A61K31/40
Inventor 贾文强王秋成闫鹏
Owner SHENZHEN FONCOO PHARMACEUTICAL CO LTD
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