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Donepezil hydrochloride orally disintegrating tablet and preparation method thereof

A technology of donepezil hydrochloride and orally disintegrating tablets, which is applied in the fields of pharmaceutical formulas, medical preparations containing active ingredients, and pill delivery, which can solve patent infringement, limit the development process of orally disintegrating tablets, and increase the difficulty of developing orally disintegrating tablets And other issues

Inactive Publication Date: 2010-06-30
COSCI MED TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, the above two methods are relatively mature preparation methods of orally disintegrating tablets, but due to their particularity, they have relatively high requirements on process conditions and equipment, and the problem of patent infringement increases the difficulty of developing orally disintegrating tablets and limits the orally disintegrating tablets. The development process of films in my country

Method used

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  • Donepezil hydrochloride orally disintegrating tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] prescription:

[0033] Donepezil Hydrochloride

5g

Mannitol

100g

PVPP

5g

L-HPC

2g

aspartame

4g

microcrystalline cellulose

10g

Magnesium stearate

1g

production

1000 pieces

[0034] Preparation Process:

[0035] Mix microcrystalline cellulose, mannitol, and donepezil hydrochloride, make soft material with water, granulate with 30 mesh sieve, dry at 60°C, granulate with 20 mesh sieve, add other excipients except magnesium stearate, and mix evenly Then add magnesium stearate and mix evenly for tableting.

Embodiment 2

[0037] prescription:

[0038] Donepezil Hydrochloride

5g

Mannitol

100g

PVPP

5g

L-HPC

4g

aspartame

4g

Micropowder silica gel

15g

Magnesium stearate

1g

[0039] Donepezil Hydrochloride

5g

production

1000 pieces

[0040] Preparation Process:

[0041] Mix donepezil hydrochloride and micropowder silica gel through 80-mesh sieve for 3 times, add mannitol, make soft material with water, granulate with 30-mesh sieve, dry at 60°C, granulate with 20-mesh sieve, add PVPP, L-HPC, aspal Mix well, add magnesium stearate, mix and compress into tablets.

Embodiment 3

[0043] prescription:

[0044] Donepezil Hydrochloride

5g

Mannitol

140g

PVPP

6.7g

L-HPC

6.7g

aspartame

3.35g

Magnesium stearate

0.85g

production

1000 pieces

[0045] Preparation Process:

[0046] Through experiments on ethanol and water, it was found that the solubility of donepezil hydrochloride in hot water is greatly improved, and it does not precipitate after cooling, so hot water is used for dissolution.

[0047] Firstly, dissolve donepezil hydrochloride in 5ml of water, put it in a water bath at 60°C, and stir to make it fully dissolved, then granulate this solution with a soft material made of mannitol, granulate with a 30-mesh sieve, dry at 60°C, granulate with a 20-mesh sieve, add PVPP, Mix L-HPC and aspartame, add magnesium stearate, mix and compress into tablets.

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Abstract

The invention relates to a donepezil hydrochloride orally disintegrating tablet and a preparation method thereof, in particular to an orally disintegrating tablet taking donepezil hydrochloride as main medicine and a preparation method thereof. The donepezil hydrochloride orally disintegrating tablet can be used for treating Alzheimer's Association.

Description

technical field [0001] The invention relates to a donepezil hydrochloride orally disintegrating tablet and a preparation method thereof, in particular to an orally disintegrating tablet with donepezil hydrochloride as the main ingredient and a preparation method thereof. The donepezil hydrochloride orally disintegrating tablet can be used for treating Alzheimer's disease. Background technique [0002] Donepezil Hydrochloride (Donepezil Hydrochloride) is the second generation of cholinesterase inhibitor (AChEI) for the treatment of Alzheimer's disease. The content of acetylcholine in the synapses directly involved in neurotransmission is increased, which produces therapeutic effects and can improve learning disabilities. It has almost no inhibitory effect on acetylcholinesterase in the heart and intestines, so it has strong selectivity, long acting time, small side effects, and no liver Toxicity and other characteristics. It is an ideal drug for the treatment of Alzheimer's ...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/445A61P25/28
CPCA61K9/2054A61K9/2027A61K9/0056A61K31/445A61P25/28
Inventor 蒋海松王锦刚
Owner COSCI MED TECH CO LTD
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