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Transdermal patch containing proton pump inhibitor drug and preparation method of transdermal patch

The technology of a proton pump inhibitor and a transdermal patch is applied to the transdermal patch containing a proton pump inhibitor drug and the preparation field thereof, and can solve the problem of easy occurrence of racemization, instability of esomeprazole salt, etc. problems, to achieve the effect of increasing compliance and compliance, reducing the frequency of administration, and high bioavailability

Inactive Publication Date: 2018-04-20
ZHENGZHOU TAIFENG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Esomeprazole salt is extremely unstable and easily degraded under acidic conditions; aqueous solution is prone to racemization at room temperature

Method used

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  • Transdermal patch containing proton pump inhibitor drug and preparation method of transdermal patch
  • Transdermal patch containing proton pump inhibitor drug and preparation method of transdermal patch
  • Transdermal patch containing proton pump inhibitor drug and preparation method of transdermal patch

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] A transdermal patch containing proton pump inhibitor medicine, the transdermal patch consists of a backing layer, a drug reservoir layer and an anti-adhesive layer from top to bottom; the material of the backing layer is non-woven fabric; the The above-mentioned anti-sticking layer is polyethylene film. The weight percentages of each component of the drug reservoir layer are shown in the table below.

[0042]

[0043] The preparation method of the above-mentioned transdermal patch containing proton pump inhibitor medicine, it comprises the steps:

[0044] 1) Dissolving the active ingredient esomeprazole sodium in the solution to obtain a drug-containing solution;

[0045] 2) Add stabilizer sodium hydroxide and transdermal absorption enhancer polyethylene glycol 400 to the drug store matrix acrylate pressure-sensitive adhesive 87-2287, and then add dispersant propylene glycol to adjust the viscosity of the glue to 1500cp at 25°C , stirred at a speed of 6000rpm for 2 h...

Embodiment 2

[0052] A transdermal patch containing proton pump inhibitor medicine, the transdermal patch is composed of a backing layer, a drug reservoir layer and an anti-adhesive layer from top to bottom; the material of the backing layer is woven cloth; the The anti-adhesive layer is polypropylene film. The weight percentages of each component of the drug reservoir layer are shown in the table below.

[0053]

[0054] Refer to Example 1 for the preparation method of the above-mentioned transdermal patch containing proton pump inhibitor drugs. The same method as mentioned above was used to carry out the in vitro transdermal experiment, and the experimental results are shown in figure 2 . Depend on figure 2 It can be seen that the esomeprazole sodium transdermal patch prepared in Example 2 has a good release through the skin of nude mice, and the drug release amount in 48h is 100.0%.

Embodiment 3

[0056] A transdermal patch containing proton pump inhibitor medicine, which is composed of a backing layer, a drug store layer and an anti-adhesive layer from top to bottom; the weight percentage of each component of the drug store layer is as follows Shown; Other with reference to embodiment 1.

[0057]

[0058] Refer to Example 1 for the preparation method of the above-mentioned transdermal patch containing proton pump inhibitor drugs. The same method as mentioned above was used to carry out the in vitro transdermal experiment, and the experimental results are shown in image 3 . Depend on image 3 It can be seen that the esomeprazole sodium transdermal patch prepared in Example 3 has a good release through the skin of nude mice, and the drug release amount in 48 hours is 94.6%.

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Abstract

The invention relates to a transdermal patch containing a proton pump inhibitor drug. The transdermal patch is characterized by mainly comprising a back lining layer, a drug library layer and an anti-sticking layer, wherein the drug library layer contains the following components in percentage by weight: 0.1%-40% of active components, 20%-90% of a drug library matrix, 1%-5% of a stabilizer, 1%-30%of a transdermal absorption enhancer and 0-20% of a dispersing agent. According to the transdermal patch, long-time continuous transdermal penetration of the drug can be effectively realized, a constant blood concentration can be maintained, and a preparation is high in transdermal absorption speed and transdermal absorbing capacity; and the transdermal patch has the characteristics of stability,high efficiency, relatively high pharmaceutical safety and the like.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, in particular to a transdermal patch containing proton pump inhibitors and a preparation method thereof. Background technique [0002] Reflux esophagitis (RE) is one of the most common gastrointestinal diseases. It is mainly an inflammatory lesion of the esophagus caused by the reflux of gastric and duodenal contents into the esophagus. That is, esophageal erosion and (or) esophageal ulcer. Reflux esophagitis can occur in people of any age, and the incidence in adults increases with age. The incidence is high in Western countries and low in Asia. This regional difference may be related to genetic and environmental factors. However, the global incidence has been on the rise in the past two decades. Middle-aged and elderly people, obesity, smoking, drinking, and high mental stress are high-risk groups for reflux esophagitis. The disease has an acute onset and a long period ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/70A61K31/4439A61P1/04
CPCA61K9/0014A61K9/7038A61K9/7053A61K9/7069A61K31/4439
Inventor 沙薇常新义吕艳歌朱新科李婷
Owner ZHENGZHOU TAIFENG PHARMA CO LTD
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