Memantine hydrochloride sustained release micro-pill tablets and preparation method thereof

A technology of memantine hydrochloride and sustained-release pellets, applied in pill delivery, microcapsules, nervous system diseases, etc., can solve the problems of uncontrollable release, difficult to mix uniformly, layering, etc., and achieve good compressibility, good Effect of Drug Content Uniformity

Active Publication Date: 2016-07-20
BEIJING UNIV OF CHEM TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] There are two main technical problems to be solved by the present invention: (1) the coating film of the sustained-release pellets is broken during tablet compression, resulting in faster drug release and uncontrollable release; (2) sustained-release pellets during tablet compression Due to the difference in size, shape and density between pills and other tablet excipients, it is not easy to mix evenly, and it is easy to produce stratification, which leads to the problem that the drug content uniformity of the tablet is unqualified

Method used

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  • Memantine hydrochloride sustained release micro-pill tablets and preparation method thereof
  • Memantine hydrochloride sustained release micro-pill tablets and preparation method thereof
  • Memantine hydrochloride sustained release micro-pill tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] The composition of self-protected multi-layer pellets is shown in the following table:

[0033]

[0034] Preparation:

[0035] Drug coating layer: dissolve memantine hydrochloride and PVPK30 in 50% ethanol solution to prepare drug solution containing adhesive. Put the sucrose ball core into the fluidized bed coating machine, use the bottom spray method to wrap the above drug solution on the surface of the ball core, the atomization pressure is controlled at 0.1MPa, and the ventilation volume is 50m 3 / h, material temperature 32-38 ℃. After the drug application is completed, the atomization pressure is turned off and the micropills are kept in a fluidized state for 15 minutes to prepare the micropills containing the drug layer for subsequent use.

[0036] Including slow-release layer: disperse Surelease in an appropriate amount of water to make an aqueous dispersion with a solid content of 15%, and stir for more than 15 minutes. Put the drug-containing pellets into...

Embodiment 2

[0042] The composition of self-protected multi-layer pellets is shown in the following table:

[0043]

[0044]

[0045] Preparation:

[0046] Drug coating layer: dissolve memantine hydrochloride and PVPK30 in 50% ethanol solution to prepare drug solution containing adhesive. Put the sucrose ball core into the fluidized bed coating machine, use the bottom spray method to wrap the above drug solution on the surface of the ball core, the atomization pressure is controlled at 0.15MPa, and the ventilation volume is 60m 3 / h, material temperature 32-37°C. After the drug application is completed, the atomization pressure is turned off to allow the micropills to continue to maintain the fluidized state for 10 minutes, and the micropills containing the drug layer are prepared for subsequent use.

[0047] Including slow-release layer: disperse Surelease in an appropriate amount of water to make an aqueous dispersion with a solid content of 15%, and stir for more than 15 minutes...

Embodiment 3

[0053] The lubricant in the protective layer of the self-protecting multi-layer pellets is selected from sodium stearate fumarate, and the composition of the pellets is shown in the table below.

[0054]

[0055] Preparation:

[0056] Drug coating layer: dissolve memantine hydrochloride and PVPK30 in 50% ethanol solution to prepare drug solution containing adhesive. Put the sucrose ball core into the fluidized bed coating machine, use the bottom spray method to wrap the above drug solution on the surface of the ball core, the atomization pressure is controlled at 0.1MPa, and the ventilation volume is 70m 3 / h, material temperature 34-39 ℃. After the drug application is completed, the atomization pressure is turned off to allow the micropills to continue to maintain the fluidized state for 30 minutes, so as to prepare the micropills containing the drug layer for subsequent use.

[0057] Including slow-release layer: disperse Surelease in an appropriate amount of water to m...

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Abstract

The invention provides memantine hydrochloride sustained release micro-pill tablets and a preparation method thereof. The memantine hydrochloride sustained release micro-pill tablets are prepared by directly pressing self-protected multi-layer micro-pills, and a filling agent, a disintegrating agent and other auxiliary tablet materials do not need to be added. The self-protected multi-layer micro-pill is composed of a pill core, a medicine layer, a sustained release layer, a protective layer and a compressible composite auxiliary material layer, can tolerate extrusion of a certain tabletting pressure, and contributes to keeping the integrity of a micro-pill sustained release coating and good sustained release properties of the medicine. The self-protected multi-layer micro-pill also has high compressibility, disintegration and lubricating property and can be directly pressed into tablets, and the prepared memantine hydrochloride sustained release micro-pill tablets have good drug content uniformity.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and relates to a memantine hydrochloride sustained-release pellet tablet and a preparation method thereof. Background technique [0002] Memantine hydrochloride is a low-medium affinity, non-competitive, strong voltage-dependent N-methyl-D-aspartate receptor antagonist, which can block over-opening receptors and effectively regulate excitatory transmitters , slows down the neurodegenerative process, and has a therapeutic effect on Alzheimer's disease without the side effects on the central nervous system that other N-methyl-D-aspartate receptors usually have. It is the first FDA-approved The medicine for treating moderate and severe senile dementia has good application prospect. [0003] Since Alzheimer's disease requires long-term medication, making memantine hydrochloride into a sustained-release preparation can reduce the number of doses, facilitate the application of pati...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K9/16A61K31/13A61P25/28
CPCA61K9/2095A61K9/5078A61K31/13
Inventor 赵会英武建宇涂贵平李媛
Owner BEIJING UNIV OF CHEM TECH
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