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Film preparation containing donepezil-free base and method for producing same

A technology of donepezil and free base is applied in the field of film preparations containing donepezil free base and its preparation, and can solve the problems such as the inability to satisfy the film activity effect, performance and control, weight increase and the like

Active Publication Date: 2016-02-10
CTC BIO INC
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  • Abstract
  • Description
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AI Technical Summary

Problems solved by technology

As a result, the weight of various reagents loaded in the film will increase, or in order to load a high content of absorption mode regulator in a film of limited size, the content of donepezil hydrochloride and other additives will be limited, so it cannot meet the needs of the film. active effects, performance and handling

Method used

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  • Film preparation containing donepezil-free base and method for producing same

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preparation example Construction

[0037]

[0038] Film formulations containing donepezil free base were prepared as follows. A plasticizer, an additive, a sweetener, a surfactant, and a dispersant are added to purified water, followed by dissolution or dispersion by stirring, and donepezil free base is added thereto. Homogenization was then performed using a homogenizer (Ultraturrax T-25, IKA). A polymer was added thereto and homogenized again using the same homogenizer to obtain a polymer solution in which donepezil free base was dispersed. Flavoring is added to the polymer solution and mixed by stirring. Then, the resulting film formation was degassed under vacuum, cooled to room temperature, and then coated on a PE film with a suitable thickness. The coating was dried at 80°C to obtain a film formulation containing donepezil free base.

Embodiment 1-16

[0039]

[0040] Except for using the ingredients and their contents listed in Table 1, the above steps of "Preparation of Donepezil free base-containing film" were repeated to prepare a film. The prepared films were analyzed for the amount of donepezil free base in order to determine the dispersion stability. The results are expressed as relative standard deviation (RSD, %).

[0041] The RSD (%) of donepezil free base content was determined by cutting the prepared bulk film into samples of specified size and area. Then, in order to confirm the uniform dispersion of donepezil free base, each of the obtained samples was analyzed for the amount of donepezil free base present therein.

[0042] Table 1

[0043]

[0044] As shown in Table 1, the use of vinyl polymer-based compounds as dispersants provides excellent dispersion stability. Especially, when polyvinyl alcohol was used as the dispersant (Example 4), the best result, ie, the RSD (%) value was 0.4. Furthermore, the...

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Abstract

The present invention provides a method for producing a film which contains a tasteless donepezil-free base, has an appropriate size and thickness, has flexibility for providing stability when handled so as to not easily tear, and has a uniformly dispersed donepezil-free base. In addition, the present invention provides a film containing the donepezil-free base produced through the method.

Description

technical field [0001] The present invention relates to a thin film preparation for oral administration comprising donepezil free base as an active ingredient and a method for preparing the thin film preparation. [0002] This application claims the priority of Korean Patent Application No. 10-2013-0053355 filed in Korea on May 10, 2013, and the disclosure content of this patent application is hereby incorporated by reference in its entirety. Background technique [0003] Donepezil is a representative therapeutic agent among various commercially available agents for treating Alzheimer's disease, and a tablet formulation containing donepezil hydrochloride is commercially available. [0004] Some patients who need Alzheimer's treatment often refuse to take the medicine or feel uncomfortable swallowing or chewing the medicine. Therefore, when it is necessary to use an Alzheimer's disease therapeutic agent, it is preferable to use a film form generally called a "strip" in terms...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/70A61K31/445
CPCA61K9/006A61K9/7007A61K31/445A61P25/28A61K9/70A61K47/32
Inventor 全泓烈权度又李凤相朴秀晙车奉根金准基韩知姈吉明哲
Owner CTC BIO INC
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