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Transdermal tobacco alkaloid reservoir patch

A tobacco alkaloid and patch technology, which is applied in drug combination, neurological diseases, sheet delivery, etc., can solve the problems of low comfort, leakage of nicotine or nicotine derivatives, large patch size, etc., to achieve large dose, The effect of low leakage and high comfort

Inactive Publication Date: 2010-07-28
费廷药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Especially with matrix patches, the large size and lack of flexibility of the patch may make the corners of the patch more prone to peeling away from the user's skin, resulting in nicotine evaporating into the environment without entering the user's skin
[0007] To overcome the lack of adhesiveness of the patch, manufacturers of matrix-based patches have added higher amounts of adhesive, which in turn causes greater irritation to the user
[0008] The problem with the use of reservoir patches for delivering nicotine is that reservoir patches may be less comfortable than matrix patches because they are less comfortable than the corresponding matrix patches. Harder and more uncomfortable
[0010] Another big problem with reservoir patches is that they are more prone to leakage from the patch, and in the event of a leak, naturally more nicotine is wasted than with matrix and binder-in-drug transdermal patches, In matrix and drug-in-adhesive transdermal patches, nicotine is bound to, for example, a gel or other flux-controlling substance
[0011] More specifically, it has been proven that this problem is severe when using nicotine or nicotine derivatives, which is due to the high volatility of nicotine or nicotine derivatives, leakage occurs even at very low pressure, nicotine or nicotine derivatives can also escape from the reservoir through this small leak

Method used

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  • Transdermal tobacco alkaloid reservoir patch
  • Transdermal tobacco alkaloid reservoir patch
  • Transdermal tobacco alkaloid reservoir patch

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0206] Prepare the above-mentioned reservoir type patch with the backing layer, film and adhesive, the patch release area of ​​the reservoir type patch is 3.2 cm 2 , containing 20mg of nicotine mixed with 170mg of gelling agent in the reservoir. In this case, the obtained patch had a ratio of tobacco alkaloid content to patch release area of ​​6.25 mg / cm 2 .

[0207] Patches having such a ratio of nicotine in the reservoir to patch release area have proven to be satisfactory.

Embodiment 2

[0209] Prepare multiple patches with the same release area (9.52cm 2 ), the data are listed in Table 1.

[0210] Table 1

[0211]

[0212] All patches A-I have proved to be satisfactory in terms of nicotine delivery and adhesion on the body. The flow rate in Table 1 is calculated by the nicotine released per unit patch release area per unit time, rather than the total nicotine content per unit patch release area per unit time. Therefore, this reflects the actual amount released, i.e., for patch A, the flow rate is 15mg / 16h*cm 2 =0.10mg / h*cm 2 .

Embodiment 3

[0214] A series of reservoir patches with higher ratios were prepared as in Example 1. The ratios in this series consist of the following ratios: approximately 10 mg / cm 2 , 20mg / cm 2 , 40mg / cm 2 、60mg / cm 2 , 80mg / cm 2 , 100mg / cm 2 . Ratio values ​​up to 100mg / cm have been demonstrated 2 The patch is satisfactory.

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Abstract

The invention relates to a tobacco alkaloid patch (10; 41; 42; 43; 51; 52; 53; 54) for transdermal administration of a tobacco alkaloid, said patch comprising an impermeable backing (11) and a membrane (14) which defines a reservoir (12) there between, said membrane being permeable to and in contact with said tobacco alkaloid, said tobacco alkaloid being mixed with a viscous flowable gel, said impermeable backing and said membrane being at least partly joined by a sealing and wherein the amount of said tobacco alkaloid is above 10 mg.

Description

technical field [0001] The present invention relates to a reservoir-type transdermal patch according to claim 1 . Background technique [0002] The present invention relates to a reservoir type transdermal patch, more specifically, the present invention relates to a nicotine transdermal patch. Nicotine patches are usually used to maintain a constant or relatively constant amount of nicotine or corresponding tobacco alkaloids in the user's blood, thereby avoiding addiction to nicotine. [0003] Transdermal devices capable of releasing various physiologically active substances are known, and transdermal devices in the form of reservoir-type patches are disclosed in, for example, U.S. Patent No. 5,254,346, and matrix-type patches are disclosed in U.S. Patent No. 6,165,497. . These devices generally consist of an impermeable liner, a drug or physiologically active substance reservoir, a release-controlling membrane and an adhesive layer sealed together in a specific manner, re...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/70A61K31/465
CPCA61K9/7084A61K9/7092A61P25/34
Inventor J·克鲁泽F·约尔特
Owner 费廷药业股份有限公司
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