Preparation method of donepezil oral fast dissolving film

Abstract

The invention belongs to the field of medicinal preparations, and particularly relates to a donepezil oral fast dissolving film, a preparation method and medical application thereof. The film comprises the following components by weight percent: 1-30% of donepezil, 40-90% of a film-forming material, 0-20% of a plasticizer, 2-6% of a saliva irritant, 2-6% of a corrigent and 0-5% of other auxiliary materials. According to the donepezil oral fast dissolving film, water is not needed during medicine taking, and the film can be quickly melted in the mouth, so that the phenomenon that patients with alzheimer's disease hide medicine in the mouth and spilt medicine is avoided, and the medication compliance of patients is improved; the basic remedy, obtained from the preparation method provided by the invention, of the dosage form is uniformly dispersed in the film-forming material; the finished product is good in appearance; the basic remedy can be quickly dissolved out, and is good in stability; the product dosage is accurate; the production process is free of flying dust, so that the problems related to labor protection and environmental pollution can be solved.

Description

technical field [0001] The invention belongs to the field of chemical pharmacy, and in particular relates to a donepezil hydrochloride oral instant film and a preparation method thereof. Background technique [0002] Alzheimer's disease 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. In the case of increasingly obvious aging, Alzheimer's disease (AD, commonly known as senile dementia) has become a serious social public health problem, and its high incidence 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%. Donepezil hydrochloride is a new generation of long-acting cholinesterase in...

AI Technical Summary

Problems solved by technology

However, those skilled in the art know that when using cyclodextrin inclusion complexation and solid dispersion technology to cover 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., the process is complicated

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