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Matrix type sustained-release preparation

A technology for drugs and dementia, applied in pharmaceutical formulations, drug delivery, active ingredients of heterocyclic compounds, etc., to achieve the effect of low burden

Inactive Publication Date: 2007-12-19
EISIA R&D MANAGEMENT CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] However, since sustained-release formulations now contain sustained-release matrices and other additives not included in conventional, fast-dissolving tablets, care must be taken that the stability of the drug is not compromised

Method used

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  • Matrix type sustained-release preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0082] Add an appropriate amount of purified water and mix with 300 mg of donepezil hydrochloride (Eisai Co. Ltd.), 375 mg of ethyl cellulose (Ethocel 10FP, Dow Chemical Company), 1500 mg of Eudragit L100-55 (Röhm GmbH & Co. KG) and 795 mg of lactose were mixed, and the mixture was heated and dried in a constant temperature room. 30 mg of magnesium stearate (Mallinckrodt Baker, Inc.) was added and mixed with the dry granules. 200 mg of this mixture was taken and tableted with Autograph AG5000A (Shimazu Corporation) to obtain tablets with a diameter of 8 mm containing 20 mg of donepezil hydrochloride.

Embodiment 2

[0084] Add an appropriate amount of purified water and mix with 20 mg of donepezil hydrochloride (Eisai Co. Ltd.), 500 mg of Eudragit L100-55 (Rhm GmbH & Co. KG), 1000 mg of lactose and 500 mg of ethylcellulose (Ethocel 10FP, Dow Chemical Company) were mixed, and the mixture was heated and dried in a constant temperature dryer to obtain granules containing donepezil hydrochloride in an amount of about 1% of the total weight of the granules.

Embodiment 3

[0086]20 mg of citric acid was dissolved in an appropriate amount of purified water and mixed with 20 mg of donepezil hydrochloride (Eisai Co. Ltd.), 500 mg of Eudragit L100-55 (Rhm GmbH & Co. KG), 1000 mg of lactose and 500 mg of Ethyl cellulose (Ethocel 10FP, Dow Chemical Company) was mixed, and the mixture was heated and dried in a constant temperature dryer to obtain granules containing about 1% of donepezil hydrochloride based on the total weight of the granules.

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Abstract

The present invention provides a method for stabilizing an anti-dementia drug in a pharmaceutical composition containing the anti-dementia drug and a high molecular weight basic substance by adding a high molecular weight acidic substance to said pharmaceutical composition. Further, the present invention provides a pharmaceutical composition containing an anti-dementia drug and a high molecular basic substance in which a high molecular weight acidic substance is contained for stabilizing the anti-dementia drug. Furthermore, the present invention provides a method for manufacturing a pharmaceutical composition which comprises steps wherein a solution or suspension containing a high molecular weight acidic substance is added to a mixture of an anti-dementia drug and a high molecular weight basic substance for the sake of stabilizing the anti-dementia drug.

Description

technical field [0001] The present invention relates to the stabilization of an anti-dementia drug in a composition comprising the anti-dementia drug. More specifically, the present invention relates to stabilizing an anti-dementia drug in a pharmaceutical composition having a sustained-release property and comprising an anti-dementia drug having a tertiary amino group. Background technique [0002] In recent years, care for dementia including senile dementia, Alzheimer's dementia, etc. has become a social problem, and many therapeutic drugs have been developed. Among them, donepezil, which is available as hydrochloride in the form of tablets or capsules, has been observed to be very useful as a therapeutic drug in mild and moderate Alzheimer's type dementia due to its acetylcholinesterase inhibitory activity . Recently, tablets disintegrating in the oral cavity have been sold to patients with glossopharyngeal difficulties, and transdermal administration by ointment formul...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/30A61K9/14A61K9/22A61K9/54A61K31/445A61K47/10A61K47/26A61K47/32
Inventor 植木洋祐铃木康之藤冈贤
Owner EISIA R&D MANAGEMENT CO LTD
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