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Dimethyl fumarate-containing enteric slow-release pellet

A technology of dimethyl fumarate and sustained-release pellets, which is applied in the direction of medical preparations containing active ingredients, medical preparations with non-active ingredients, organic active ingredients, etc., and can solve the problem of sustained release of dimethyl fumarate Issues such as the successful production of capsule declaration

Inactive Publication Date: 2014-09-10
AVENTIS PHARMA HAINAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] At present, dimethyl fumarate is mainly used as a preservative, and no domestic company has successfully applied for the production of dimethyl fumarate sustained-release capsules

Method used

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  • Dimethyl fumarate-containing enteric slow-release pellet
  • Dimethyl fumarate-containing enteric slow-release pellet
  • Dimethyl fumarate-containing enteric slow-release pellet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0012] Ball core prescription:

[0013]

[0014] Enteric control layer coating solution prescription:

[0015]

[0016] Prescription of coating solution for sustained-release regulating layer:

[0017]

Embodiment 2

[0019] Ball core prescription:

[0020]

[0021] Enteric control layer coating solution prescription:

[0022]

[0023] Prescription of coating solution for sustained-release regulating layer:

[0024]

Embodiment 3

[0026] Ball core prescription:

[0027]

[0028] Enteric control layer coating solution prescription:

[0029]

[0030] Prescription of coating solution for sustained-release regulating layer:

[0031]

[0032] Preparation Process:

[0033] Take by weighing each component in the ball core prescription and put it into a planetary mixer and mix evenly, add the binder of the recipe amount and mix evenly, add 50% ethanol (mass fraction) solution of 10% PVP k30 to make soft material, prepare the The soft material is added to the extrusion spheronizer for pellet core preparation; the pellets are dried in a fluidized bed at 40°C, and the sized pellets are coated with a slow-release control layer at the bottom of the fluidized bed, and the weight gain meets the requirements, and then dried Enteric layer coating is carried out after the moisture content is qualified, the weight gain reaches the requirement, and the pellets are filled with capsules after being dried to the qu...

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PUM

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Abstract

The invention relates to a dimethyl fumarate-containing enteric slow-release pellet for treating multiple sclerosis. The dimethyl fumarate-containing enteric slow-release pellet is characterized in that the pellet is subjected to coating, one layer gives play to enteric effect, and one layer gives play to slow-release effect, so that the pellet is controlled to slowly release active substances according to a certain rate after arriving at intestinal tracts.

Description

technical field [0001] The invention relates to a pharmaceutical preparation of dimethyl fumarate enteric-coated sustained-release pellets for treating multiple sclerosis. After reaching the intestinal tract, the active substance is slowly released at a certain rate. Background technique [0002] Dimethyl fumarate enteric-coated sustained-release capsules are a drug used to treat multiple sclerosis (MS). Biogen Idec's Tecfidera (dimethyl fumarate extended-release capsules) has been approved by the FDA for the treatment of multiple sclerosis. [0003] Multiple sclerosis (MS) is a disease of the central nervous system. The typical development process is chronic or intermittent. The impact on the body can develop from minor physical troubles to major loss of major functions. Dimethyl Fumarate Enteric-Coated Sustained-Release Capsules Take a New Approach to MS Treatment - By Activating the Nuclear Factor (erythroid-derived)-2-Like Pathway, This Pathway Confers the Cells in the...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K9/52A61K47/38A61K47/34A61K47/32A61K31/225
Inventor 莫永俊郭夏宋雪梅
Owner AVENTIS PHARMA HAINAN
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