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Paroxetine enteric sustained-release composition

A composition and enteric-coated technology, which is applied in the direction of drug combination, non-active ingredients of polymer compounds, medical preparations of non-active ingredients, etc., can solve the problems of large individual differences and environmental factors, and reduce the dosage and frequency, quality control, and the effect of reducing drug withdrawal reactions

Inactive Publication Date: 2009-02-25
珠海天翼医药技术开发有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The drug release behavior of this preparation mainly depends on the hydration of polycarbophil calcium into a gel after encountering water, so it is greatly affected by internal environmental factors and individual differences are also large

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] Example 1: Drug-containing pellets %w / w

[0045] Sugar 30.0

[0046] Mannitol 2.0

[0047] Paroxetine hydrochloride 17.0

[0048] Starch 21.0

[0049] Dextrin 24.0

[0050] Hypromellose 6.0

[0051] Total 100.0

[0052] Sugar, mannitol and other materials are made into blank ball cores, hypromellose is used as a binder, paroxetine hydrochloride, starch, dextrin and other powders are evenly mixed, and wrapped around the blank ball cores to make drug-containing pellets , and then dried at 50°C.

Embodiment 2

[0053] Example 2: Drug-containing pellets %w / w

[0054] Blank core 33.0

[0055] Paroxetine hydrochloride 58.0

[0056] Sodium Alginate 9.0

[0057] Total 100.0

[0058] Using sodium alginate as a binder, paroxetine was wrapped on the blank pellet core to make drug-containing pellets, and then dried at 40°C.

Embodiment 3

[0059] Example 3: Drug-containing pellets %w / w

[0060] Blank core 32.6

[0061] Paroxetine hydrochloride 16.9

[0062] Starch 44.6

[0063] PVP-K30 5.9

[0064] Total 100.0

[0065] Using PVP-K30 as a binder, mix paroxetine hydrochloride, starch, dextrin and other powders evenly, wrap them on blank pellet cores to make drug-containing pellets, and then dry them at 40°C.

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Abstract

The invention relates to a medicament containing selective 5-hydroxytryptamine reuptake inhibitor which mainly refers to a composition taking paroxetine or a pharmaceutically acceptable salt of the paroxetine as main curing integrant, in particular to an intestinal-dissolved sustained-release composition slowly released by passing through stomach via oral taking. The medicament comprises four layers, namely, a drug pellet containing the paroxetine as an active integrant, a sustained-release layer coating on the exterior layer of the drug pellet and presenting sustained-release function, an isolated layer and an intestinal-dissolved layer, wherein, the weight ratio of paroxetine, adjuvant, the sustained-release layer and the intestinal-dissolved layer is 0.5- 5.0: 3-30: 0.5-3.0: 0.8-3.0. The drug preferentially selects a pellet, and can reduce a side effect due to the use of a common sustained-release preparation and individual difference caused by an internal environment factor.

Description

Technical field: [0001] The invention relates to a medicine containing a selective serotonin reuptake inhibitor, mainly refers to a composition with paroxetine as the main therapeutic component, specifically refers to an enteric-coated slow-release drug that is slowly released after oral administration through the stomach. release composition. Background technique: [0002] As a selective serotonin reuptake inhibitor (SSRI), paroxetine is currently used worldwide for the treatment and / or prevention of depression. [0003] Adverse reactions such as nausea and vomiting caused by the regular-release formulation of paroxetine can be greatly reduced by its delayed and (or) slow-release formulation. Patent No. ZL 03149046.8 granted to GlaxoSmithKline (GSK) discloses a controlled-release and delayed-release formulation of paroxetine. The formulation of this patent can reduce side effects due to constant-release formulations. In the preparation, its main structural feature is a co...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4525A61K9/16A61K47/32A61K47/34A61K47/36A61K47/38A61K47/40A61P25/24A61K47/10
Inventor 张晓明麦耀权吴苑燕曾万溪蒋晓萌黄金龙
Owner 珠海天翼医药技术开发有限公司
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