Zolpidem tartrate controlled-release double-layer tablet and preparation process of zolpidem tartrate controlled-release double-layer tablet

A zolpidem tartrate, double-layer tablet technology, applied to medical preparations containing active ingredients, pill delivery, organic active ingredients, etc., can solve the problem of slow onset of action and achieve the effect of improving bioavailability

Inactive Publication Date: 2012-07-25
李宁
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the slow onset of action and some of the above-mentioned side effects were also found during the use of the ordinary sustained-release matrix tablet of the drug.

Method used

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  • Zolpidem tartrate controlled-release double-layer tablet and preparation process of zolpidem tartrate controlled-release double-layer tablet
  • Zolpidem tartrate controlled-release double-layer tablet and preparation process of zolpidem tartrate controlled-release double-layer tablet
  • Zolpidem tartrate controlled-release double-layer tablet and preparation process of zolpidem tartrate controlled-release double-layer tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Firstly, Zolpidem Tartrate, lactose and microcrystalline cellulose (filler), croscarmellose sodium (disintegrant) and povidone (binder) were quickly released according to Table 1. The indicated amounts were accurately weighed and carefully added to the pot of the high-shear wet granulator. Before adding purified water, premix for 5 minutes at a set main knife speed of 150 rpm and a side knife speed of 1500 rpm. Then, increase the speed of the main knife to 250rpm and the speed of the side knife to 1800rpm, and add 400g of pre-weighed purified water through an atomizing nozzle at a speed of 25g / min into the same pot for wet granulation. . After the purified water is added, keep the main knife and side knife running, and continue to mix for 2 minutes. Stop granulation and transfer the Zolpidem Tartrate quick-release soft material to the fluidized bed dryer, and then use the fluidized bed to dry the soft material at 60°C until the water content of the granules is not high...

Embodiment 2

[0037] Firstly, Zolpidem Tartrate, lactose and microcrystalline cellulose (filler), croscarmellose sodium (disintegrant) and povidone (binder) are quickly released according to Table 2. The indicated amounts were accurately weighed and carefully added to the pot of the high-shear wet granulator. Before adding purified water, premix for 5 minutes at a set main knife speed of 150 rpm and a side knife speed of 1500 rpm. Then, increase the speed of the main knife to 250rpm and the speed of the side knife to 1800rpm, and add 400g of pre-weighed purified water through an atomizing nozzle at a speed of 25g / min into the same pot for wet granulation. . After the purified water is added, keep the main knife and side knife running, and continue to mix for 2 minutes. Stop granulation and transfer the Zolpidem Tartrate quick-release soft material to the fluidized bed dryer, and then use the fluidized bed to dry the soft material at 60°C until the water content of the granules is not highe...

Embodiment 3

[0041] Firstly, Zolpidem Tartrate, lactose and microcrystalline cellulose (filler), croscarmellose sodium (disintegrant) and povidone (binder) are quickly released according to Table 3. The indicated amounts were accurately weighed and carefully added to the pot of the high-shear wet granulator. Before adding purified water, premix for 5 minutes at a set main knife speed of 150 rpm and a side knife speed of 1500 rpm. Then, increase the speed of the main knife to 250rpm and the speed of the side knife to 1800rpm, and add 400g of pre-weighed purified water through an atomizing nozzle at a speed of 25g / min into the same pot for wet granulation. . After the purified water is added, keep the main knife and side knife running, and continue to mix for 2 minutes. Stop granulation and transfer the Zolpidem Tartrate quick-release soft material to the fluidized bed dryer, and then use the fluidized bed to dry the soft material at 60°C until the water content of the granules is not highe...

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Abstract

The invention discloses a zolpidem tartrate controlled-release double-layer tablet. The tablet comprises a zolpidem tartrate quick-release medicine releasing layer and a zolpidem tartrate controlled-release medicine releasing layer and shows the quick dissolving in 1h and the subsequent slow dissolving in 6h. In addition, the invention also discloses a preparation process of the zolpidem tartrate controlled-release double-layer tablet. The preparation process comprises the steps of 1) preparing zolpidem tartrate quick-release particles and zolpidem tartrate controlled-release particles through wet granulation process, and drying and straightening the particles; 2) respectively mixing the quick-release particles and the controlled-release particles with a flow aid and a lubricant in a mixer through a dry method; and 3) pressing the mixed zolpidem tartrate quick-release mixed particles and the controlled-release mixed particles into the zolpidem tartrate controlled-release double-layer tablet.

Description

technical field [0001] The present invention belongs to the preparation method of a kind of sustained-release double-layer tablet in the field of oral pharmaceutical preparations, and particularly relates to the preparation method of the hypnotic drug Zolpidem Tartrate (Zolpidem Tartrate) sustained-release double-layer tablet; The prepared zolpidem tartrate (Zolpidem Tartrate) sustained-release bilayer tablet and its in vitro dissolution rate. Background technique [0002] Zolpidem tartrate is a new generation of non-benzodiazepine hypnotic sedatives. Since the 1990s, due to its rapid oral absorption (the plasma concentration reaches the peak after 0.5-2 hours of administration) and rapid metabolism in the body (the elimination half-life is only 1.4-3.8 hours), and little or no accumulation, no production Residual reactions are superior to benzodiazepine hypnotic and sedative drugs (such as diazepam and diazepam), and there is a tendency to gradually replace traditional ben...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/24A61K31/437A61P25/20
Inventor 李宁宋明娜
Owner 李宁
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