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Donepezil oral disintegrating tablet and preparation method thereof

A technology of orally disintegrating tablets and donepezil, which is applied in the direction of pharmaceutical formulas, medical preparations with no active ingredients, medical preparations containing active ingredients, etc., can solve the problems of difficult control conditions and complicated processes, and achieve good stability, Good effect, reduce the effect of unstable factors

Inactive Publication Date: 2017-05-24
杭州新诺华医药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, those skilled in the art are well aware that when cyclodextrin inclusion is used to mask the taste, the conditions are not easy to control, and the final product must be verified by special means, such as X-diffraction, differential thermal analysis (DSO), etc., and the process is complicated.

Method used

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  • Donepezil oral disintegrating tablet and preparation method thereof
  • Donepezil oral disintegrating tablet and preparation method thereof
  • Donepezil oral disintegrating tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] prescription:

[0031]

[0032]

[0033] Preparation Process:

[0034] Heat glyceryl behenate to 70°C to dissolve, add donepezil to it and stir quickly evenly, after cooling, crush it through a 40-mesh sieve and mix evenly with mannitol and low-substituted hydroxypropyl cellulose, then add magnesium stearate and mix evenly , compressed into tablets.

Embodiment 2

[0036] prescription:

[0037]

[0038] Preparation Process:

[0039] Heat glyceryl behenate to 85°C to dissolve, add donepezil to it and stir quickly evenly, after cooling, pulverize through a 40-mesh sieve and mix evenly with microcrystalline cellulose, lactose, sodium starch glycolate, then add magnesium stearate and mix Evenly, pressed into pieces.

Embodiment 3

[0041] prescription:

[0042]

[0043]

[0044] Preparation Process:

[0045] Heat glyceryl behenate to 80°C to dissolve, add donepezil to it and stir quickly evenly, after cooling, pulverize through a 40-mesh sieve, mix evenly with microcrystalline cellulose, lactose, sodium starch glycolate, and micropowder silica gel, and press into tablets.

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Abstract

The invention provides a donepeziloral disintegrating tablet and a preparation method thereof. The donepeziloral disintegrating tablet comprises a docosanoic acid glycerol ester inclusion compound of donepezil, and an auxiliary material layer cladding the inclusion compound; the donepezil is included through a docosanoic acid glycerol ester, so that the contact of the donepezil with other auxiliary materials, air and moisture is reduced, and the degradation of the donepezil can be slowed down; meanwhile, during a preparation process, the donepezil does not contact with the moisture, so that the unstabilizing factor of quality is reduced; a mixing and tableting process is simple so as to be beneficial to improving industrial automation degree, the obtained donepeziloral disintegrating tablet has the characteristics that the stability is excellent, related substances and contents meet the requirement, and an effect of covering a bad taste is good.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a donepezil orally disintegrating tablet and a preparation method thereof. Background technique [0002] Alzheimer's disease (AD, commonly known as senile dementia) is a neurodegenerative disease with insidious onset and progressive development. Clinically, it is characterized by comprehensive dementia such as memory impairment, aphasia, apraxia, agnosia, impairment of visuospatial skills, executive dysfunction, and personality and behavior changes. The etiology is still unknown. With the aging population becoming more and more prominent, Alzheimer's disease has become a serious social public health problem, and its high morbidity and disability rate have become a major disease affecting human health. At present, the prevalence of dementia in the elderly over 65 years old in my country is as high as 10%. [0003] Donepezil is the second-generation cholinesterase inhib...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/445A61K47/54A61K47/69A61P25/28
CPCA61K31/445A61K9/2054A61K9/2059
Inventor 姚成志杨凯石建祥
Owner 杭州新诺华医药有限公司
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