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Pain relieving bilayer controlled-release tablet and preparation method thereof

A controlled-release tablet, double-layer technology, applied in non-central analgesics, pharmaceutical formulas, medical preparations containing active ingredients, etc., can solve problems such as tablet splitting, achieve difficult separation, maintain therapeutic effect, and tightly bond Effect

Active Publication Date: 2014-03-26
越洋医药(广州)开发有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] In the above-mentioned technology, since the double-layer tablet is generally compressed by layer I and layer II, it will lead to unfavorable results such as tablet splitting during transportation and storage.

Method used

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  • Pain relieving bilayer controlled-release tablet and preparation method thereof
  • Pain relieving bilayer controlled-release tablet and preparation method thereof
  • Pain relieving bilayer controlled-release tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] The prescription of the double-layer controlled-release tablet of the present embodiment is as shown in Table 1. Its preparation method is as follows:

[0048] 1. Preparation of sustained-release granules:

[0049] (1) Weigh the prescription amount of zolpidem tartrate that has passed through a 60-mesh sieve, mix well with hypromellose K100LV, K4M, and lactose, and then add half of the prescription amount of silicon dioxide and magnesium stearate . Transfer the mixed material to the wet granulator;

[0050] (2) Prepare an ethanol solution with a concentration of 70% to make soft materials from the mixture in step 1;

[0051] (3) Sizing the prepared soft material with a 24-mesh sieve;

[0052] (4) Dry and sieve the particles

[0053] (5) Obtaining sustained-release granules for forming a sustained-release layer.

[0054] 2. Preparation of immediate-release granules:

[0055] (1) Mix the prescribed amount of zolpidem tartrate, lactose, microcrystalline cellulose, a...

Embodiment 2

[0069] The prescription of the double-layer controlled-release tablet of the present embodiment is as shown in Table 1. Its preparation method is as follows:

[0070] 1. Preparation of sustained-release granules:

[0071] (1) Weigh the prescription amount of zolpidem tartrate that has passed through a 60-mesh sieve, mix well with hypromellose K100LV, K4M, and lactose, and then add half of the prescription amount of silicon dioxide and magnesium stearate . Transfer the mixed material to the wet granulator;

[0072] (2) Prepare an ethanol solution with a concentration of 75% to make soft materials from the mixture in step 1;

[0073] (3) Sizing the prepared soft material with a 24-mesh sieve;

[0074] (4) Dry and sieve the particles

[0075] (5) Obtaining sustained-release granules for forming a sustained-release layer.

[0076] 2. Preparation of immediate-release granules:

[0077] (1) Mix the prescribed amount of zolpidem tartrate, lactose, microcrystalline cellulose, h...

Embodiment 3

[0089] The prescription of the double-layer controlled-release tablet of the present embodiment is as shown in Table 1. Its preparation method is as follows:

[0090] 1. Preparation of sustained-release granules:

[0091] (1) Weigh the prescribed amount of zopiclone that has passed through a 60-mesh sieve, mix well with hypromellose K100LV, K4M, and lactose, and then add half of the prescribed amount of silicon dioxide and magnesium stearate. Transfer the mixed material to the wet granulator;

[0092] (2) Prepare an ethanol solution with a concentration of 80% to make soft materials from the mixture in step 1;

[0093] (3) Sizing the prepared soft material with a 24-mesh sieve;

[0094] (4) Dry and sieve the particles

[0095] (5) Obtaining sustained-release granules for forming a sustained-release layer.

[0096] 2. Preparation of immediate-release granules:

[0097] (1) Mix the prescribed amount of zopiclone, lactose, microcrystalline cellulose, hydroxypropyl cellulose...

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Abstract

The invention provides a pain relieving bilayer controlled-release tablet which comprises a quick release layer and a slow release layer, wherein holes are formed in the slow release layer; the holes are filled with quick release particles; the quick release layer and the quick release particles consist of pain relieving drugs and pharmaceutical adjuvant; the slow release layer consists of pain relieving drugs, slow release materials and pharmaceutical adjuvant. The pain relieving bilayer controlled-release tablet has the following technical effects: 1) the bilayer tablet has better physical stability than a common bilayer tablet, so that the storage and the transportation are convenient; 2) the disintegration time limit of the quick release layer of the bilayer controlled-release tablet is 10-30 seconds through the detection of the dissolving experiment; the slow release layer presents the zero-level release mode; the medicine taking effectiveness and safety of patients are largely improved. In the preparation process of the bilayer tablet, the quick release particles are filled in the holes. The quick disintegration of the quick release layer after the medicine taking is guaranteed through the drug release mode of combining the quick release with the slow release, so that the blood concentration can quickly achieve the range of a therapeutic window; the slow release layer is slowly released in a longer time period to continuously maintain the treatment effect; the toxic or side effects are effectively controlled.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to an analgesic double-layer controlled-release tablet and a preparation method thereof. Background technique [0002] Oral solid preparations represented by tablets are the most convenient and safest way of drug delivery, and have always occupied the main and dominant position in the clinical application, marketing and research and development of drugs. At present, by changing the tablet preparation method to ensure that the drug maintains the stable structure of the double-layer tablet during the shelf life and regulates drug release to achieve drug synergism and toxicity reduction, it has become the most demanded and practical new preparation technology in the pharmaceutical industry. Double-layer tablet is a new biphasic drug release system with double-layer structure developed on the basis of osmotic pump controlled release tablet, and its structure varies with the de...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/24A61K9/36A61K45/00A61P29/00
Inventor 闻晓光
Owner 越洋医药(广州)开发有限公司
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