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Duloxetine hydrochloride enteric micro-pellet capsule and preparation method thereof

A technology of duloxetine hydrochloride and loxetine pellets, which is applied in the field of preparation of duloxetine hydrochloride enteric-coated pellets, can solve the problem of difficult dissolution of preparations, rapid absorption, difficulty in dissolving duloxetine hydrochloride and Dispersion and other issues

Inactive Publication Date: 2015-03-18
TIANJIN INSTITUTE OF PHARMA RESEARCH +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] Although duloxetine hydrochloride has the above-mentioned good curative effect, because of its unique physical and chemical properties, especially its low solubility only slightly soluble in water, and easy to degrade in acid, it should be made into enteric-coated preparations, because the drug It is difficult to completely dissolve the prepared preparation due to the poor water solubility, and the main drug is easy to interact with some coating materials during the preparation, forming an insoluble or insoluble coating layer, which makes the main drug difficult to dissolve, which is easy to reduce its bioavailability
[0008] The raw material of duloxetine hydrochloride is needle-like crystal, which is hardly soluble in aqueous medium. When it is orally administered in the form of capsule or tablet, duloxetine hydrochloride which is not micronized is not easy to dissolve and disperse, so it cannot rapidly absorbed in the body

Method used

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  • Duloxetine hydrochloride enteric micro-pellet capsule and preparation method thereof
  • Duloxetine hydrochloride enteric micro-pellet capsule and preparation method thereof
  • Duloxetine hydrochloride enteric micro-pellet capsule and preparation method thereof

Examples

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Embodiment 1

[0063] This embodiment is used to illustrate the preparation method of duloxetine hydrochloride pellets in the present invention.

[0064] Example 1 illustrates the specific preparation process of duloxetine hydrochloride pellets in the present invention, and the final form of the duloxetine hydrochloride pellets is in the form of capsules.

[0065] (1) Preparation of drug-containing pellet core: SHK series wet granulator is used to feed 1000 pellets. The specific preparation process is as follows:

[0066] Mix duloxetine hydrochloride microparticles with sodium lauryl sulfate and sucrose, and pass through a 60-mesh sieve as component A for later use; microcrystalline cellulose PH101, lactose, crospovidone, hydroxypropyl cellulose, Mix talcum powder, etc., pass through a 60-mesh sieve as component B for later use, put component A and component B in a wet granulator and stir and mix for 5 minutes, then use ethanol-water solution to make a soft material, and then extrude and gra...

Embodiment 2

[0073] In this example, the single capsule contains 30 mg of duloxetine hydrochloride, and the dosages of main ingredients and various auxiliary materials in the single duloxetine hydrochloride enteric-coated capsule are listed below, wherein duloxetine hydrochloride is prepared by step (1). Duloxetine hydrochloride microparticles:

[0074]

[0075]

Embodiment 3

[0077] In this example, the single capsule contains 30 mg of duloxetine hydrochloride, and the dosages of main ingredients and various auxiliary materials in the single duloxetine hydrochloride enteric-coated capsule are listed below, wherein duloxetine hydrochloride is prepared by step (1). Duloxetine hydrochloride microparticles:

[0078]

[0079]

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Abstract

The invention provides a preparation method of a duloxetine hydrochloride enteric micro-pellet capsule. The preparation method comprises following steps: (1) performing air jet pulverization to duloxetine hydrochloride to obtain duloxetine hydrochloride micro-particles; (2) mixing the duloxetine hydrochloride micro-particles with a medicinal excipient and preparing duloxetine hydrochloride micro-pellets through an extrusive granulation technology; (3) wrapping the duloxetine hydrochloride micro-pellets with an isolating layer for reducing mutual influence between main drugs and an enteric coating material; and (4) wrapping the isolating layer on the duloxetine hydrochloride micro-pellets by an enteric coating layer for achieving the enteric effect.

Description

technical field [0001] The invention relates to a preparation method of duloxetine hydrochloride enteric-coated pellets, in particular to a preparation method of duloxetine hydrochloride drug-containing pellet core. Background technique [0002] Duloxetine Hydrochloride (Ruloxetine Hydrochloride, trade name Cymbalta) is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI). Its structural formula is as follows: [0003] [0004] The pharmacological mechanism of duloxetine hydrochloride is as follows: [0005] The exact mechanism of the antidepressant and central analgesic effects of duloxetine hydrochloride is not yet clear, but it is considered to be related to the enhancement of central nervous system serotonergic and noradrenergic functions. Preclinical studies have shown that duloxetine hydrochloride is a strong inhibitor of neuronal serotonin and norepinephrine reuptake, and its inhibitory effect on dopamine reuptake is relatively weak. The results o...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K9/16A61K31/381A61P25/24A61P25/04
Inventor 张晓东梁慧敏曹光蔡桂玲张铁英
Owner TIANJIN INSTITUTE OF PHARMA RESEARCH
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