Dimethyl fumarate enteric-coated pellets and preparation method thereof

A technology of enteric and enteric-coated pellets of dimethyl fumarate, which is used in pharmaceutical formulations, medical preparations containing active ingredients, organic active ingredients, etc., to achieve the effects of less gastrointestinal irritation, complete release, and reduced irritation

Active Publication Date: 2015-10-14
SHANGHAI HUILUN BIOLOGICAL TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

And its 1h release in pH 6.8 buffer is less than 30%

Method used

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  • Dimethyl fumarate enteric-coated pellets and preparation method thereof
  • Dimethyl fumarate enteric-coated pellets and preparation method thereof
  • Dimethyl fumarate enteric-coated pellets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] Composition of dimethyl fumarate enteric-coated pellets and capsules:

[0043]

[0044]

[0045] Preparation Process:

[0046] (1) Weigh the crushed and sieved dimethyl fumarate, sucrose, and other auxiliary materials (sodium carboxymethyl starch, talcum powder) and mix them in a wet granulator.

[0047] (2) Mix ethanol / water evenly (50%). The hydroxypropyl cellulose is dissolved in the above solution, and the hydroxypropyl cellulose ethanol solution is configured as a binder.

[0048] (3) Turn on the centrifugal granulator, add a blank pellet core (0.6-0.7mm in particle size), add the above-mentioned mixed raw and auxiliary material powder to the hopper of the centrifugal granulator, and slowly spray the binder into the centrifugal granulator at the same time, After the ball core is slightly wet, turn on the hopper stirring motor to convey the powder into the centrifugal granulator.

[0049] (4) After powder infusion, take out the upper pills, place them in an o...

Embodiment 2

[0055] Composition of dimethyl fumarate enteric-coated pellets:

[0056]

[0057]

[0058] Preparation Process:

[0059] (1) Weigh the crushed and sieved dimethyl fumarate, sucrose or starch, and other auxiliary materials (sodium carboxymethyl starch, talcum powder) and mix them in a wet granulator.

[0060] (2) Mix ethanol / water evenly (50%). The hydroxypropyl cellulose is dissolved in the above solution, and the hydroxypropyl cellulose ethanol solution is configured as a binder.

[0061] (3) Turn on the centrifugal granulator, add blank pellet cores (particle size 0.3mm-0.4mm), add the above-mentioned mixed raw and auxiliary material powder into the hopper of the centrifugal granulator, and slowly spray the adhesive into the centrifugal granulator , after the ball core is slightly wet, turn on the hopper stirring motor to convey the powder into the centrifugal granulator.

[0062] (4) After powder infusion, take out the upper pills, place them in an oven to dry at 4...

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Abstract

The invention discloses dimethyl fumarate enteric-coated pellets and a preparation method thereof. Each enteric-coated pellet comprises a blank pellet core, an active drug layer wrapping the blank pellet core, an isolating layer, an inner layer enteric-coated coating layer and an outer layer enteric-coated coating layer from inside to outside. The enteric-coated pellets are simple in process, complete in release, good in reproducibility, small in gastrointestinal tract irritation, safe and effective.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to dimethyl fumarate enteric-coated pellets and a preparation method thereof. Background technique [0002] Dimethyl fumarate is used for the oral treatment of severe psoriasis and has immunomodulatory effects. It has been approved and developed abroad for the treatment of multiple sclerosis. However, there is a strong gastrointestinal reaction when the drug is administered orally. [0003] Patent application CN1323206A discloses pharmaceutical preparations in the form of microtablets or pills containing one or more dialkyl fumarates (including dimethyl fumarate). The invention prepares alkyl hydrogen fumarate and dialkyl fumarate and suitable auxiliary materials into pill size or microtablet with an average diameter of 300-2000 microns, and optionally fills them in capsules or sachets to obtain Oral pharmaceutical preparations. Since the same dose of enteri...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K9/48A61K31/225A61P17/06
Inventor 雷伯开秦继红
Owner SHANGHAI HUILUN BIOLOGICAL TECH CO LTD
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