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Hypnotic double-layer controlled release tablet and preparation method thereof

A controlled-release tablet, double-layer technology, applied in the direction of pharmaceutical formulations, medical preparations containing active ingredients, pill delivery, etc., can solve problems such as tablet splitting, achieve difficult separation, good physical stability, improve effectiveness and safety effect

Active Publication Date: 2014-04-02
OVERSEAS PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0013] 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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  • Hypnotic double-layer controlled release tablet and preparation method thereof
  • Hypnotic double-layer controlled release tablet and preparation method thereof
  • Hypnotic double-layer controlled release tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] 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:

[0049] 1. Preparation of sustained-release granules:

[0050] ① Weigh the Zolpidem Tartrate that has passed the 60-mesh sieve and mix it with Hypromellose K100LV, K4M and lactose monohydrate, then add half of the prescription amount of silicon dioxide and magnesium stearate . Transfer the mixed material to the wet granulator;

[0051] ② Prepare an ethanol solution with a concentration of 70% to make soft materials from the mixture in step 1;

[0052] ③Sizing the prepared soft material with a 24-mesh sieve;

[0053] ④ dry and sieve the particles;

[0054] ⑤ Obtaining sustained-release granules for forming a sustained-release layer.

[0055] 2. Preparation of immediate-release granules:

[0056] ① Mix the prescribed amount of zolpidem tartrate, lactose, microcrystalline cellulose, and povidone through a 60-mesh sie...

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

[0073] ③Sizing 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, hydroxypropyl cel...

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] ①Weigh 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 a soft material from the mixture in step 1;

[0093] ③Sizing 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] ①Mix the prescription amount of zopiclone, lactose, microcrystalline cellulose, hydroxypropyl cellulose-HF, and so...

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Abstract

The invention provides a hypnotic double-layer controlled release tablet, comprising a rapid-release layer and a slow-release layer, wherein the rapid-release layer is provided with pores which are filled with rapid-release particles; the rapid-release layer and the rapid-release particles are composed of hypnotic drug and pharmaceutical excipients; the slow-release layer is composed of a hypnotic drug, a slow-release material and pharmaceutical excipients. The hypnotic double-layer controlled release tablet has the following technical effects that 1) the physical stability of the double-layer tablet provided by the invention is better than that of the common double-layer table, which is advantageous for storage and transportation, and 2) a dissolution test detects that the disintegration time limit of the rapid-release layer of the double-layer tablet provided by the invention ranges from 20 seconds to 30 seconds; and the slow-release layer is in a zero-order release pattern, and therefore the effectiveness and safety of medication for a patient are greatly improved. In the preparation process of the double-layer tablet, the rapid-release particles fill in the pores. The drug release pattern of combined rapid release and slow release guarantees that the rapid-release layer is disintegrated rapidly after the drug is taken; as a result, the blood concentration is capable of quickly reaching the therapeutic window range; the slow-release layer is slowly released so that the therapeutic action is maintained for a long period of time and toxic and side effects are effectively controlled.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a sleeping-type 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...

Claims

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Application Information

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IPC IPC(8): A61K9/28A61K9/22A61K31/5517A61K31/5513A61K31/4985A61K31/4375A61K31/437A61K31/519A61P25/20
Inventor 闻晓光
Owner OVERSEAS PHARMA
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