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A kind of oral gel and preparation method thereof

A gel and oral technology, applied in the field of pharmaceutical preparations, can solve the problems of long drug onset time and failure to achieve therapeutic blood drug concentration, and achieve the effect of reducing degradation effects

Inactive Publication Date: 2016-09-14
SHANDONG UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] However, judging from the above listed preparations, no matter whether it is an orally disintegrating tablet, a sublingual tablet, or a dispersible tablet for immediate release, or a capsule or tablet for ordinary release, or a sustained release tablet for slow release, the onset time of the drug is different. Relatively long, did not achieve effective therapeutic blood concentration quickly

Method used

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  • A kind of oral gel and preparation method thereof
  • A kind of oral gel and preparation method thereof
  • A kind of oral gel and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Embodiment 1: Preparation of Zolpidem Tartrate Oral Gel

[0032] prescription:

[0033] product name

effect

Dosage (unit: g)

zolpidem tartrate

Main drug

0.5

Tween 80

Solubilizers

1.0

Poly(N-isopropylacrylamide)

gel matrix

3.0

sodium bicarbonate

pH regulator

1.0

Sodium carbonate

pH regulator

0.2

orange flavor

flavoring agent

0.5

benzoic acid

preservative

0.25

Ethylparaben

preservative

0.01

Propylparaben

preservative

0.01

water

solvent

Add to 100ml

[0034] Preparation:

[0035] Take a 200ml beaker, add about 70ml of purified water, then add 1g of Tween 80, and dissolve it under slight stirring, then add 0.5g of zolpidem tartrate, and stir to dissolve it. Then add sodium bicarbonate, sodium carbonate, orange flavor, benzoic acid, ethylparaben, propylparaben to dissolve; while stirring, slowly add poly-N-isopr...

Embodiment 2

[0036] Embodiment 2: Preparation of Zolpidem Tartrate Oral Gel

[0037] prescription:

[0038] product name

effect

Dosage (unit: g)

zolpidem tartrate

Main drug

0.5

Sodium dodecyl sulfate

Solubilizers

0.35

Polyallylamine-poly-N-isopropylacrylamide copolymer

gel matrix

17.0

sodium bicarbonate

pH regulator

4.2

Sodium carbonate

pH regulator

0.5

lemon flavor

essence

3.0

benzoic acid

preservative

0.20

Benzalkonium Bromide

preservative

0.20

water

solvent

Add to 100ml

[0039] Preparation:

[0040] Take a 200ml beaker, add about 70ml of purified water, then add 0.35g of sodium lauryl sulfate, and dissolve it under slight stirring, then add 0.5g of zolpidem tartrate, and stir to dissolve it. Then add sodium bicarbonate, sodium carbonate, lemon flavor, benzoic acid, and benzalkonium bromide to dissolve; under stirring, slowly add polyall...

Embodiment 3

[0041] Embodiment 3: the preparation of zolpidem tartrate oral gel

[0042] prescription:

[0043]

[0044]

[0045] Preparation method: Take a 200ml beaker, add about 70ml of purified water, then quantitatively add 8g of poloxamer and 0.1g of Tween, dissolve it under slight stirring, then add 0.5g of zolpidem tartrate, stir to dissolve it. Add sodium bicarbonate, sodium carbonate, apple flavor, benzoic acid, and benzalkonium chloride in turn to dissolve them; under stirring, slowly add polybutylmethacrylate-polyN-isopropylacrylamide copolymer, Make it more evenly dispersed, cover the mouth of the beaker with plastic wrap, place the beaker in a refrigerator at 8°C, cool for 1 day, take it out, stir it in a water bath (the temperature should not exceed 20°C) for about 10 minutes, pour it into a measuring cylinder, and use Make up to 100ml with purified water, then transfer to the beaker again, stir for about 5 minutes to make it evenly mixed, pour the gel into a special ...

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Abstract

The invention discloses an oral cavity gel. The oral cavity gel is prepared by taking water or a water solution containing 0.1 to 5% of ethanol by volume as a solvent, and comprises following ingredients: 0.5g / 100ml of zolpidem tartrate, 0.3 to 10g / 100ml of a solubilizer, 1 to 20g / 100ml of a gel substrate, 0.5 to 5g / 100ml of a pH conditioning agent, 0.01 to 2g / 100ml of a flavoring agent, and 0.01 to 0.5g / 100ml of a preservative. pH value of the oral cavity gel ranges from 7.4 to 8.0. The invention also discloses a preparation method of the oral cavity gel. The oral cavity gel is capable of achieving effects of zolpidem tartrate rapidly via solubilizing, temperature-sensitive controlling, and membrane permeating promoting, and realizing long-acting sustained release drug delivery.

Description

technical field [0001] The invention relates to a gel for oral cavity and a preparation method thereof, in particular to zolpidem tartrate oral gel and a preparation process thereof, belonging to the technical field of pharmaceutical preparations. Background technique [0002] Zolpidem Tartrate (Zolpidem Tartrate) is the third generation of non-benzodiazepine sedative hypnotics, which belongs to the replacement product of benzodiazepines. Its chemical structure is as follows: [0003] [0004] It was successfully developed by the French Sandelabo Pharmaceutical Company (now belonging to Sanofi-Aventis), and it was first launched in France in 1987. It was approved by the US FDA in December 1992 and is now available in more than 100 countries and regions. listed. Currently, the dosage forms on the market include tablets, capsules, sustained-release tablets, orally disintegrating tablets, dispersible tablets, oral sprays, sublingual tablets and other preparations. Such for...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/437A61K47/02A61K47/34A61K47/32A61K9/06A61P25/20
Inventor 翟光喜汪洋
Owner SHANDONG UNIV