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Zolpidem tartrate oral spraying agent and preparation method thereof

A technology for zolpidem tartrate and oral spray, which is applied in the field of zolpidem tartrate preparations, can solve the problem of not producing a quick-acting effect on oral mucosa, and achieves the effects of avoiding the liver first-pass effect, being convenient to use, and having a wide distribution range.

Inactive Publication Date: 2010-07-21
SHANGHAI MODERN PHARMA ENG INVESTIGATION CENT
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This shows that the spray is mainly absorbed through the gastrointestinal tract after oral spray administration, and does not produce the quick-acting effect of oral mucosal administration.

Method used

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  • Zolpidem tartrate oral spraying agent and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] Formula: Zolpidem tartrate 5g

[0042] Citric acid 6g

[0043] Carbopol 971P 0.1g

[0044] Sodium caprate 0.5g

[0045] Aspartame 0.2g

[0046] Ethanol 20g

[0047] Menthol 0.4g

[0048] Tween 80 0.3g

[0049] Sodium bisulfite 0.15g

[0050] EDTA-2Na 0.2g

[0051] Sorbic acid 0.15g

[0052] Distilled water to 100ml

[0053] Preparation method: 0.1g of Carbopol 971P is dissolved in 70ml of distilled water, 6g of citric acid is added, 5g of Zolpidem tartrate is added, and the mixture is stirred to dissolve. Add 0.5g of sodium caprate, 0.2g of aspartame, 0.15g of sodium bisulfite, 0.2g of EDTA-2Na, and 0.15g of sorbic acid. After dissolving, add 20g of ethanol solution dissolving 0.4g of menthol and 0.3g of Tween, Mix well and add distilled water to make the volume to 100ml. The solution is passed through a 0.22μm microporous membrane and filled in a spray bottle with a metering valve.

Embodiment 2

[0055] Formula: Zolpidem tartrate 10g

[0056] Citric acid 8g

[0057] Hydroxypropyl methyl fiber HPMC E6 0.2g

[0058] Azone 0.8g

[0059] Ethanol 40g

[0060] Neotame 0.3g

[0061] Lecithin 0.2g

[0062] Menthol 0.5g

[0063] Sodium metabisulfite 0.2g

[0064] EDTA-2Na 0.2g

[0065] Benzoic acid 0.1g

[0066] Distilled water to 100ml

[0067] Preparation method: Dissolve 0.2g HPMC E6 in 50ml pure water, add 8g citric acid, add 30g ethanol and 10g Zolpidem tartrate after dissolution, and stir to dissolve. Add azone 0.8g, neotame 0.3g, sodium metabisulfite 0.25g, EDTA-2Na 0.2g, benzoic acid 0.1g, after dissolving, add 10g propylene glycol solution dissolving 0.5g menthol and 0.2g lecithin, mix well, add distilled water Make the volume to 100ml. The solution is passed through a 0.22μm microporous membrane and filled in a spray bottle with a metering valve.

Embodiment 3

[0069] Recipe: Zolpidem tartrate 1g

[0070] Propylene glycol 10g

[0071] Citric acid 2g

[0072] Chitin 0.2g

[0073] Caprylic acid capric acid polyethylene glycol glyceride 0.8g

[0074] Sucralose 0.3g

[0075] Menthol 0.4g

[0076] EDTA-2Na 0.2g

[0077] Methyl Paraben 0.1g

[0078] Distilled water to 100ml

[0079] Preparation method: Dissolve 0.2g of water-soluble chitin in 80ml of water, add 2g of citric acid and 1g of Zolpidem tartrate, stir to dissolve. Add 0.8 g of caprylic acid capric acid polyethylene glycol glyceride, 0.3 g of sucralose, 0.1 g of methyl paraben, and 0.2 g of EDTA-2Na. After dissolving, add 10 g of propylene glycol solution dissolving 0.4 g of menthol and mix well. Add distilled water to make the volume to 100ml. The solution is passed through a 0.22μm microporous membrane and filled in a spray bottle with a metering valve.

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Abstract

The invention discloses a zolpidem tartrate oral spraying agent and a preparation method thereof. The oral spraying agent uses water as a solvent and 100ml of oral spraying agent comprises 1 to 10g of zolpidem tartrate, 0.1 to 50g of solubilizer, 0.1 to 5g of sorbefacient, 0.01 to 5g of flavoring agent and 0.1 to 3g of antioxidant. After the zolpidem tartrate oral spraying agent is sprayed and taken by oral cavity or hypoglottis, the medicament is mainly absorbed through the oral cavity or sublingual mucosa to avoid first pass effect of liver and food influence; therefore, the medicament is absorbed more rapidly, takes effect more quickly, and has smaller individual difference; and the medicament has convenient use, is taken without water before bedtime, and is particularly suitable for patients who are incompliant to oral administration and injection. Due to wide distribution range of the medicament in oral mucosa after spraying and administration and the effect of the sorbefacient, the medicament is rapidly absorbed from the oral mucosa and has quick-acting effect.

Description

Technical field [0001] The invention relates to a Zolpidem tartrate preparation. technical background [0002] Zolpidem is a new generation of non-benzodiazepine hypnotics. It is an imidazopyridine drug. It has strong sedative and hypnotic effects, as well as slight anti-anxiety, muscle relaxation, and anticonvulsant effects. Its effect is related to specific central GABA receptors. Body activation. The drug usually induces sleep within 20-30 minutes after oral administration, which can reduce the number of early awakenings and improve the quality of sleep. It has a good effect on the symptoms of insomnia, such as difficulty falling asleep, easy awakening, dreaminess and early awakening. The sleep structure Not affected. The bioavailability of oral administration of Zolpidem is about 70%, but food has a great influence on the pharmacokinetics, and individual differences are large. [0003] Zolpidem is widely used in Europe, the United States and many other countries, and has a t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/12A61K31/437A61P25/20
Inventor 侯惠民王健陈芳夏怡然
Owner SHANGHAI MODERN PHARMA ENG INVESTIGATION CENT
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