Two-phase release preparation containing zolpidem or salt of zolpidem and preparation method thereof

A technology for zolpidem and immediate-release preparations, which is applied in the field of preparation of biphasic release preparations, can solve the problems such as the inability of drugs to reach an effective drug concentration, difficulty in falling asleep without a therapeutic effect, affecting normal work and life, and the like, so as to improve biological efficiency. Utilization, avoid aging problems, reduce the effect of individual differences

Active Publication Date: 2012-07-11
吉林天衡药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, continuous dosing with sustained-release formulations, especially at times when patients would be sleeping peacefully, is unnecessary
After 3-4 hours, it is often at a loss to wake up early because the drug has been released and the effective drug concentration cannot be reached
At the same time, due to the long release time of sustained-release preparations and the individual differences of patients, it is difficult to effectively control a reasonable blood drug concentration level, resulting in symptoms such as dizziness in most patients the next morning,...

Method used

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  • Two-phase release preparation containing zolpidem or salt of zolpidem and preparation method thereof
  • Two-phase release preparation containing zolpidem or salt of zolpidem and preparation method thereof
  • Two-phase release preparation containing zolpidem or salt of zolpidem and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Example 1: Biphasic Release Tablets Containing 10 mg Zolpidem Tartrate

[0022] Ordinary drug-containing immediate-release powder:

[0023] prescription:

[0024]

[0025] Process: mix the prescribed amount of zolpidem tartrate, lactose / starch mixture, microcrystalline cellulose PH102, polyethylene glycol 4000, and sodium carboxymethyl starch, add the prescribed amount of magnesium stearate, mix evenly, and obtain .

[0026] Enteric-coated immediate-release pellets

[0027] Ball core

[0028]

[0029] Enteric coating

[0030]

[0031] Process: mix the prescribed amount of zolpidem tartrate, microcrystalline cellulose PH101, low-substituted hydroxypropyl cellulose, and sucrose evenly, add 10% starch slurry to make a soft material, extrude and spheronize, and make an immediate-release pellet core, sausage Dissolving coating, coating weight gain 10-15%.

[0032] Mix the prepared quick-release granules and enteric-coated granules evenly, and press into tablet...

Embodiment 2

[0037] Example 2: Biphasic release tablet containing 12.5 mg zolpidem tartrate

[0038] Ordinary medicated immediate release powder

[0039]

[0040] Process: mix the prescribed amount of zolpidem tartrate, mannitol, microcrystalline cellulose PH200, and croscarmellose sodium, add the prescribed amount of calcium stearate, mix evenly, and obtain the product.

[0041] Enteric-coated immediate-release pellets

[0042] Ball core

[0043]

[0044] Enteric coating

[0045]

[0046] Process: Mix the prescription amount of zolpidem tartrate, microcrystalline cellulose PH101, low-substituted hydroxypropyl cellulose, and lactose evenly, add 0.1% carboxymethyl cellulose sodium soft material, extrude (35rpm) and spheronize (600rpm ), made into quick-release ball cores, enteric-coated, and the weight of the coating increased by 25-30%.

[0047] Mix the prepared quick-release granules and enteric-coated granules evenly, and press into tablets to obtain.

[0048]Adopt Chinese ...

Embodiment 3

[0052] Example 3: Biphasic Release Tablet Containing 12.5 mg Zolpidem Tartrate

[0053] Ordinary drug-containing immediate-release powder:

[0054]

[0055] Process: mix the prescription amount of zolpidem tartrate, lactose, microcrystalline cellulose PH102, and sodium carboxymethyl starch evenly, add the prescription amount of magnesium stearate, mix evenly, and get ready.

[0056] Enteric-coated immediate-release pellets:

[0057]

[0058] Enteric coating:

[0059]

[0060] Process: mix the prescription amount of zolpidem tartrate, microcrystalline cellulose PH101, crospovidone, and ethyl methyl cellulose evenly, add 10% pregelatinized starch slurry to make a soft material, extrude and spheronize, and make Immediate release pellet core, enteric coating, coating weight gain 15-25%.

[0061] Mix the prepared quick-release granules and enteric-coated granules evenly, and press into tablets to obtain.

[0062] Adopt Chinese Pharmacopoeia (2010 Edition) Appendix II I...

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PUM

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Abstract

The invention discloses a two-phase release preparation containing zolpidem or salt of zolpidem, which is characterized by comprising a normal medicine-containing fast release preparation and enteric fast release preparation and being suitable for respectively releasing zolpidem or salt of zolpidem in two preset periods of time. More than 90% dose of the normal medicine-containing fast release preparation is released within 30 minutes in 0.01M of hydrochloric acid buffer solution at 37 DEG C, and more than 90% dose of the enteric fast release preparation is released within 30 minutes in phosphate buffer solution of 6.8 potential of hydrogen (pH) at 37 DEG C. The two-phase release preparation containing zolpidem or salt of zolpidem is specific to the sleep characteristics of a patient with sleep difficulties and early waking, and has effects on patients with both sleeping difficulties and early waking simultaneously.

Description

technical field [0001] The invention relates to a biphasic release preparation of zolpidem or a salt thereof, and also relates to a preparation method of the biphasic release preparation of zolpidem or a salt thereof. Background technique [0002] Insomnia is a common sleep disorder, which is caused by various reasons, such as difficulty in falling asleep, shallow sleep or too short sleep frequency, early awakening and insufficient sleep time or poor quality. Common causes of insomnia mainly include environmental factors, individual factors, physical factors, mental factors, emotional factors and so on. Among them, early awakening refers to the phenomenon of waking up 2-3 hours or more earlier than the normal situation more than four times a week, and cannot fall back to sleep again. People with insomnia often have trouble falling asleep and waking up early at the same time. The effective action time of most sleeping pills is generally 4-6 hours. Taking the medicine before...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61K9/22A61K9/14A61K9/52A61K31/437A61P25/20A61P25/22A61P21/02A61P25/08
Inventor 刘光权吴燕张福成姜庆伟黄翠玲李冬梅
Owner 吉林天衡药业有限公司
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