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Donepezil-containing transdermal delivery system and process for preparing the same

A technology of donepezil and adhesive, which is applied in the field of transdermal drug delivery system, can solve problems such as difficulties, reduced adhesion strength, complex production process, etc., and achieve the effect of ensuring stability and inhibiting burst release effect

Inactive Publication Date: 2014-11-12
SK CHEM CO LTD
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, if the content of donepezil is increased in conventional transdermal drug delivery systems, donepezil is precipitated out of the formulation, thereby causing problems such as decreased adhesion strength
In addition, in the case of a transdermal drug delivery system with a three-layer structure for the purpose of controlling the release rate of donepezil, its production process becomes complicated and difficult; and there is a disadvantage of low economic efficiency
[0005] In addition, even if a transdermal drug delivery system having a long action time is designed by completely dissolving donepezil with a conventional solubilizing agent such as a surfactant, a rapid release dumping effect occurs during its use

Method used

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  • Donepezil-containing transdermal delivery system and process for preparing the same
  • Donepezil-containing transdermal delivery system and process for preparing the same
  • Donepezil-containing transdermal delivery system and process for preparing the same

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preparation example Construction

[0031] The present invention also provides a preparation method for a transdermal drug delivery system, the preparation method comprising (a) the step of dissolving an acrylic adhesive in a solution containing donepezil or a pharmaceutically acceptable salt thereof and polyvinylpyrrolidone; (b) a step of applying the solution obtained in step (a) to a film, followed by drying, to form a drug-containing matrix layer; and (c) forming a drug-containing matrix layer comprising a drug-containing matrix layer obtained in step (b). Steps for an adhesive layer of an acrylic adhesive or a silicone-based adhesive.

[0032] In step (a), the solution containing donepezil or its pharmaceutically acceptable salt and polyvinylpyrrolidone can be obtained by mixing a mixture of donepezil or its pharmaceutically acceptable salt and ethyl acetate with an ethanol solution of polyvinylpyrrolidone mixed.

[0033] Step (b) may be performed by coating the solution obtained in step (a) onto a membran...

Embodiment 1

[0037] Example 1: Evaluation of polymers

[0038] Preliminary experiments were performed to evaluate the compatibility between various polymers and adhesives. The effect on the solubility of donepezil base of polymers found to be relatively well compatible through preliminary experiments was evaluated. That is, donepezil (1 g) and ethyl acetate (1 g) were mixed with each other. In separate containers, other polymers (0.2 g each), i.e., polyvinylpyrrolidone (PVP K17, BASF), Eudragit TM E100 (Degussa) and Plastoid TM B (Evonik Industries AG) was dissolved in ethanol (0.8 g), which was then added to a mixed solution of donepezil and ethyl acetate, respectively. In the case of 1-1 (no polymer was added), ethanol (1.0 g) was added to the mixed solution of donepezil and ethyl acetate. Each solution was stirred for 2 h, and then the appearance of each solution was observed, the results are shown in Table 1 below.

[0039] Table 1

[0040]

[0041] From the results in Table...

Embodiment 2

[0042] Example 2: Evaluation of Formulations Based on Molecular Weight of Polyvinylpyrrolidone

[0043] The effect of the molecular weight of polyvinylpyrrolidone on the formulation of transdermal drug delivery systems was evaluated. According to the components in Table 2 below (in the case of 2-1, only ethanol (1 g) was added), a solution containing donepezil base and polyvinylpyrrolidone was prepared according to the procedure of Example 1. The acrylic binder was added to the solution, which was then homogenized. Each of the resulting solutions was coated onto a silicone-coated PET film. The resulting individual films were dried in a 70°C oven for 15 minutes and then laminated to a backing film. Evaluate the possibility of formulation. In Table 2, as the polyethylene pyrrolidone; and Durotak 87-235A (Henkel) was used as the acrylic adhesive.

[0044] Table 2

[0045]

[0046]

[0047] Solution 2-1, which did not contain polymer, could not be coated because its vi...

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Abstract

The present invention relates to a percutaneous absorption preparation such as one provided in the form of a patch, and to a method for preparing same, wherein the percutaneous absorption preparation has a double-layer structure including an adhesive layer and a matrix layer containing a drug which is formulated with an adhesive after completely dissolving donepezil using a specific polymer. According to the present invention, the percutaneous absorption preparation does not exhibit the eduction of donepezil within the preparation, and can release donepezil at a constant rate for a long time, as well as prevent the release dumping phenomenon that occurs in a percutaneous absorption preparation having a single-layer structure.

Description

technical field [0001] The invention relates to a transdermal drug delivery system containing donepezil and a preparation method thereof. More specifically, the present invention relates to a transdermal drug delivery system (for example, in the form of a patch) having a bilayer structure comprising a drug-containing matrix layer and an adhesive layer, wherein the drug-containing matrix layer It is obtained by completely dissolving donepezil with a specific polymer and then formulating it together with an adhesive; and relates to a preparation method thereof. Background technique [0002] Donepezil (donepezil) or its salt, its chemical name is 2-[(1-benzyl-4-piperidinyl)methyl]-5,6-dimethoxyindan-1-one (2-[( 1-benzyl-4-piperidinyl)methyl]-5,6-dimethoxyindan-1-one), is an acetylcholinesterase inhibitor used as a therapeutic drug for the treatment of dementia. [0003] Dementia occurs mainly in older people. Older adults often have difficulty swallowing, and many patients w...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/70A61K31/445
CPCA61K9/7069A61K9/7053A61K9/7061A61K31/445A61K9/7084A61P25/28A61K9/70
Inventor 任钟燮黄用渊尹愿老朴如瞋金慧敏吴畯教金薰泽李峰镛
Owner SK CHEM CO LTD
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