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Zaleplon oral-cavity administration system or composition and preparation method thereof

A zaleplon and oral technology, applied in the field of medicine, can solve the problems of not being able to effectively avoid the first-pass effect of the liver, drug absorption speed and bioavailability, so as to avoid the first-pass effect of the liver, avoid the effect of the digestive tract, and fast effect

Active Publication Date: 2011-10-26
BEIJING HUMANWELL JUNWEI PHARM TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, there has been a patent report on Zaleplon instant oral tablets (patent number: 00129669.8). Although it has improved in terms of drug compliance, it is mainly absorbed through the gastrointestinal tract and cannot effectively avoid the first-pass effect of the liver. Absorption rate and bioavailability are both affected

Method used

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  • Zaleplon oral-cavity administration system or composition and preparation method thereof
  • Zaleplon oral-cavity administration system or composition and preparation method thereof
  • Zaleplon oral-cavity administration system or composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Embodiment 1 zaleplon spray

[0038] Prescription ingredient dosage

[0039] Zaleplon 2.5g

[0040] Propylene glycol 50ml

[0041] Ethylparaben 0.05g

[0042] Menthol 0.1g

[0043] Mannitol 0.5g

[0044] Distilled water to 100ml

[0045] Preparation method: Accurately weigh the above-mentioned amount of zaleplon, ethylparaben, menthol, and mannitol, mix well, add the above-mentioned amount of propylene glycol, add water to 100ml, and ultrasonically or vibrate at 40°C until dissolved. The 0.45um microporous filter membrane is used to obtain the Zaleplon sublingual spray solution, which is then dispensed into the spray device.

Embodiment 2

[0046] Embodiment 2 zaleplon spray

[0047] Prescription ingredient dosage

[0048] Zaleplon 2.5g

[0049] Glycerol 50ml

[0050] Ethylparaben 0.05g

[0051] Menthol 0.1g

[0052] Mannitol 0.5g

[0053] Distilled water to 100ml

[0054] Preparation method: Accurately weigh the above-mentioned amount of zaleplon, ethylparaben, menthol, and mannitol, mix well, add the above-mentioned amount of glycerol, add water to 100ml, and ultrasonically or vibrate at 40°C until dissolved , Pass through a 0.45um microporous membrane to obtain zaleplon sublingual spray liquid, and then pack it into a spray device.

Embodiment 3

[0055] Example 3 Zaleplon spray

[0056] Prescription ingredient dosage

[0057] Zaleplon 2.5g

[0058] Macrogol 400 50ml

[0059] Ethylparaben 0.05g

[0060] Menthol 0.1g

[0061] Sorbitol 0.5g

[0062] Distilled water to 100ml

[0063] Preparation method: Accurately weigh the above-mentioned amount of zaleplon, ethylparaben, menthol, and sorbitol, mix well, add the above-mentioned amount of polyethylene glycol 400, add water to 100ml, and ultrasonically or vibrate at 40°C Until it dissolves, pass through a 0.45um microporous membrane to obtain the zaleplon sublingual spray liquid, and then pack it into a spray device.

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Abstract

The invention relates to a zaleplon oral administration preparation which belongs to the pharmacy field. The zaleplon oral administration preparation consists of active component zaleplon and medically acceptable auxiliary material. Every 100ml of the preparation contains 1 to 10g of zaleplon. The zaleplon oral administration preparation has the advantages that the zaleplon is preferred as the active component in a sublingual administration system; the system or combination feeds drugs by a spray form; the zaleplon oral administration preparation can avoid gastral action and liver first-pass effect and has the advantages of fast effect, high bioavailability, exact curative effect, convenient usage, adjustable dose according to the requirement and good adaptability; the zaleplon oral administration preparation is particularly fit for the elderly and the patient inconvenient for swallowing; the zaleplon oral administration preparation has the advantages of simple and feasible preparation technology and fit for the industrialized production, etc.

Description

technical field [0001] The invention relates to a zaleplon oral drug delivery system or composition and a preparation method thereof, belonging to the field of medicine. Background technique [0002] Insomnia is a very common problem in our country and even in the whole world. Epidemiological investigations show that the incidence of insomnia in adults is about 30-35%, especially in women and the elderly. At the same time, due to the continuous acceleration of the pace of life and the continuous increase of life pressure, many young people have also become victims of insomnia, and insomnia is showing a younger trend. There are as many as 700 million adults in my country, and 120 million elderly people. According to this calculation, there should be hundreds of millions of people in my country suffering from insomnia. Improper treatment of insomnia is not only a medical problem, but also a serious social and family problem. [0003] Drug therapy, especially the application ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/519A61K9/00A61K9/107A61K9/12A61K9/16A61P25/20
Inventor 高永良郭艳芳李劲彤
Owner BEIJING HUMANWELL JUNWEI PHARM TECH CO LTD
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