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Composition for covering flavor and preparation of containing the composition

A technique for donepezil hydrochloride and its composition, which is applied in the field of taste-masking compositions of donepezil hydrochloride and preparations containing the composition, and can solve the problems of high dosage, high requirements for packaging and storage conditions, and high process conditions

Inactive Publication Date: 2006-07-05
ZHEJIANG WANBANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In this method, the amount of gelatin is relatively high, generally 1 times the amount of the drug, which is not conducive to the forming and dispersibility of the tablet. Therefore, the process conditions and equipment requirements are relatively high during production, and because the hardness of the product is low, it is difficult for packaging. and storage conditions are also very high

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] ① Preparation of donepezil hydrochloride taste-masking composition:

[0026] Donepezil Hydrochloride

[0027] Preparation process: Weigh donepezil hydrochloride, mannitol, sucralose, gelatin and xanthan gum according to the above prescription, mix them evenly, dissolve them in water, and spin dry them with a rotary thin film evaporator at 50°C to 70°C. The resulting dried product is passed through an 80-mesh sieve for subsequent use.

[0028] Donepezil hydrochloride taste masking composition

[0029] Preparation process: Weigh the taste-masking composition of donepezil hydrochloride according to the prescription, mix with auxiliary materials, granulate with water, add magnesium stearate after drying, mix and tablet.

Embodiment 2

[0031] Donepezil Hydrochloride

[0032] Preparation process: Weigh donepezil hydrochloride, mannitol, sucralose, gelatin and xanthan gum according to the above prescription, mix evenly, dissolve in water, and spray dry at 180°C to obtain the product.

[0033] Donepezil hydrochloride taste masking composition

[0034] Preparation process: according to the prescription, the donepezil hydrochloride composition is weighed and mixed with auxiliary materials, 5% povidone aqueous solution is granulated, after drying, it is mixed with talcum powder and compressed into tablets.

Embodiment 3

[0036] Donepezil Hydrochloride

[0037] Preparation process: Weigh donepezil hydrochloride, mannitol, sucralose, gelatin and xanthan gum according to the above prescription, mix evenly, dissolve in water, and spray dry at 180°C to obtain the product.

[0038] Donepezil hydrochloride taste masking composition

[0039] Preparation process: Weigh the taste-masking composition of donepezil hydrochloride according to the prescription, mix with auxiliary materials, granulate with water, add magnesium stearate after drying, mix and tablet.

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PUM

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Abstract

A taste-masking composition for donepezil hydrochloride is prepared from mannitol, trichlorosucrose, gelatin and xanthan gum. It can be mixed with donepezil for masking the irritative taste of donepezil, and can be used to prepare the oral disintegrating tablet.

Description

technical field [0001] The invention relates to a taste-masking composition of donepezil hydrochloride and an orally disintegrating tablet prepared by using the composition. Background technique [0002] Donepezil hydrochloride is a specific reversible acetylcholinesterase inhibitor, and its indication is the treatment of mild or moderate Alzheimer's dementia symptoms. A large number of animal test data show that the drug has little other effects except the pharmacological effect of cholinergic nerve stimulation. In the reverse mutation experiment of bacterial Ames or the forward mutation experiment of mouse lymphoma in vitro, donepezil hydrochloride was not found to have a teratogenic effect; in the long-term carcinogenicity study of rats and rabbits, it was shown that donepezil hydrochloride had no carcinogenic effect. [0003] In order to ensure the effect of taking medicine for patients with Alzheimer's dementia, a drug is prepared that is placed on the tongue without t...

Claims

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Application Information

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IPC IPC(8): A61K31/445A61K47/42A61K47/10A61P25/28
Inventor 廖娟李颖寰
Owner ZHEJIANG WANBANG PHARMA
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