Donepezil hydrochloride orally disintegrating tablet and preparation method thereof

A technology of donepezil hydrochloride and oral disintegrating tablets, which is applied in the directions of pharmaceutical formulations, medical preparations of inactive ingredients, and pill delivery, etc., can solve the problem of poor compliance of the elderly with dementia, delaying the best time for treatment, and inconvenience in use. and other problems, to achieve the effect of alleviating gastrointestinal discomfort, less adverse reactions, and no unpleasant taste

Inactive Publication Date: 2011-05-04
SHANDONG FANGMING PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, although donepezil hydrochloride has oral dosage forms of tablets and capsules, it is not very convenient for the elderly, bedridden patients and patients with swallowing dysfunction. Many elderly people with weak swallowing ability are unwilling to take these drugs. Routine solid dosage forms, and complain of difficulty swallowing or esophagus obstruction, while chewable tablets are also not suitable for elderly people with poor chewing ability
As far as powders or granules are concerned, in addition to their difficulty in swallowing, they are also easy to stay in the mouth, resulting in an unpleasant feeling in the mouth. At the same time, drinking water is required when taking the above oral preparations, especially for dementia elderly people who are more compliant. Difference
These dosage forms cannot be considered as the most suitable dosage forms for the treatment of AD due to the difficulties in taking the medicine
In addition, the bitter taste and bad smell of many oral medicines are often unacceptable, causing some patients to refuse treatment in order to avoid taking the medicine, delaying the best time for treatment

Method used

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  • Donepezil hydrochloride orally disintegrating tablet and preparation method thereof
  • Donepezil hydrochloride orally disintegrating tablet and preparation method thereof
  • Donepezil hydrochloride orally disintegrating tablet and preparation method thereof

Examples

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Effect test

Embodiment 1

[0031] The orally disintegrating tablet of donepezil hydrochloride includes main ingredients and auxiliary materials, and is characterized in that it is prepared according to the following weight percentages: main ingredients 2.5%, auxiliary materials 97.5%.

[0032] The orally disintegrating tablet of the present invention is prepared from the following raw materials in weight ratio:

[0033]

[0034]

[0035] Among them, mannitol and microcrystalline cellulose are fillers; hydroxypropyl cellulose, crospovidone and sodium starch glycolate are disintegrants; citric acid and sodium bicarbonate are effervescent agents; magnesium stearate is Lubricants; Sodium saccharin, fruit flavors are flavoring agents.

[0036] The preparation method of donepezil hydrochloride orally disintegrating tablets of the present invention comprises the steps of pulverizing raw materials, weighing and mixing, and tableting, and is characterized in that the specific process steps are as follows: ...

example 2

[0044] The orally disintegrating tablet of donepezil hydrochloride includes main ingredients and auxiliary materials, and is characterized in that it is prepared according to the following weight percentages: main ingredients 2.5%, auxiliary materials 97.5%.

[0045]

[0046] Among them, mannitol and microcrystalline cellulose are fillers; hydroxypropyl cellulose, crospovidone and sodium starch glycolate are disintegrants; citric acid and sodium bicarbonate are effervescent agents; magnesium stearate is Lubricants; Sodium saccharin, fruit flavors are flavoring agents.

[0047] The preparation method of the orally disintegrating cetirizine hydrochloride tablet of the present invention comprises pulverizing raw materials, weighing and mixing, granulating and tabletting, and is characterized in that the specific process steps are as follows:

[0048] Step 1: Grinding donepezil hydrochloride and the above-mentioned various auxiliary materials respectively, then passing through ...

example 3

[0057] The orally disintegrating tablet of donepezil hydrochloride comprises main ingredients and auxiliary materials, and is characterized in that it is formulated according to the following weight percentages: 5% of main ingredients and 95% of auxiliary materials.

[0058]

[0059] Among them, mannitol and microcrystalline cellulose are fillers; hydroxypropyl cellulose, crospovidone and sodium starch glycolate are disintegrants; citric acid and sodium bicarbonate are effervescent agents; magnesium stearate is Lubricants; Sodium saccharin, fruit flavors are flavoring agents.

[0060] The preparation method of the donepezil hydrochloride orally disintegrating tablet of the present invention comprises pulverizing raw materials, weighing and mixing, granulating and tableting, and is characterized in that the specific process steps are as follows:

[0061] Step 1: Grinding donepezil hydrochloride and the above-mentioned various auxiliary materials respectively, then passing th...

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Abstract

The invention discloses a donepezil hydrochloride orally disintegrating tablet. The main medicine of the donepezil hydrochloride orally disintegrating tablet is donepezil hydrochloride; and the auxiliary medicines of the donepezil hydrochloride orally disintegrating tablet comprise mannitol, microcrystalline cellulose, hyprolose, crospovidone, sodium bicarbonate, citric acid, soluble saccharin, carboxymethyl starch sodium, magnesium stearate and essence. The invention can preferably treat the low-degree or moderate-degree alzheimer type dementia, can preferably improve the cognitive dysfunction, the mental and behavioral abnormalities and the daily self-care ability of the patient who suffers from the alzheimer type dementia (AD), can alleviate the dementia degree, is convenient to take, can fast disintegrate, and is convenient for the old or the patient who has medication obstacles or is hard to take water.

Description

Technical field: [0001] The invention relates to an oral pharmaceutical preparation for treating mild or moderate Alzheimer's dementia and a preparation method thereof, in particular to an orally disintegrating tablet of donepezil hydrochloride which can rapidly disintegrate, release and mask bad taste and its preparation method. Background technique: [0002] In the prior art, clinical studies have shown that donepezil hydrochloride is a drug that has a good therapeutic effect on mild or moderate Alzheimer's dementia, and can better improve cognitive dysfunction and abnormal mental behavior in AD patients. and daily life self-care ability, reduce the degree of dementia, and less adverse reactions, high safety, good tolerance. [0003] At present, although donepezil hydrochloride has oral dosage forms of tablets and capsules, it is not very convenient for the elderly, bedridden patients and patients with swallowing dysfunction. Many elderly people with weak swallowing abili...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/445A61K47/38A61P25/28
Inventor 王飞龙孟爱红范兴山吴双俊
Owner SHANDONG FANGMING PHARMACEUTICAL CO LTD
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