Memantine hydrochloride/donepezil slow-release resin composition and preparation method thereof

Abstract

The invention belongs to the field of pharmacy, and concretely relates to a memantine hydrochloride/donepezil slow-release resin composition and a preparation method thereof. The composition is composed of drug-loaded resin and a dressing layer, and the drug-loaded resin comprises the following raw auxiliary materials by weight percentage: 10-60% of memantine hydrochloride, 5-30% of donepezil, 20-70% of cation resin, 5-50% of an impregnating agent and the pharmaceutically acceptable auxiliary materials. The preparation method comprises the following steps: 1) preparing the cation resin; 2) preparing a drug-loaded solution; 3) preparing the drug-loaded resin; and 4) preparing slow-release resin. The composition has the characteristic of strong medication compliance for patients with moderate and severe alzheimer-type dementia, and can prepare a dry suspension and suspension with a corrigent, a suspending agent and a lubricant, the composition is convenient for administration by the patient, only one time administration is required for each day, administration frequency and administration dosage are reduced, patient compliance is increased, and the medicine combination effect of the medicine can be performed by using the technical advantage of the dosage form.

Description

technical field [0001] The invention belongs to the field of pharmacy, and in particular relates to a memantine hydrochloride / donepezil hydrochloride slow-release resin composition and a preparation method thereof. Background technique [0002] Alzheimer's disease is a chronic progressive mental decline disease characterized clinically by memory loss, cognitive dysfunction, and abnormal mental behavior. Studies have shown that with age, the incidence of the disease shows an upward trend, and the incidence rate of the elderly over 80 years old reaches 20%. In 2015, there were 46.8 million people with Alzheimer's disease in the world, and it is expected to reach 74.7 million in 2030 and 131.5 million in 2050. In 2015, there were 9.9 million new cases, and an average of one person was diagnosed with Alzheimer's disease every 3 seconds. Among them, most of the new cases will appear in low- and middle-income countries: in 2015, 58% of the world's Alzheimer's patients lived in t...

AI Technical Summary

Problems solved by technology

The dosage forms of memantine hydrochloride currently on the market are mainly tablets, oral solutions, and sustained-release capsules; the dosage forms of donepezil hydrochloride on the domestic market are mainly tablets, capsules, and orally disintegrating tablets. Patients with Alzheimer's dementia are characterized by reduced cognitive ability and dysphagia. If donepezil hydrochloride and memantine hydrochloride are taken once a day and memantine hydrochloride twice a day, the frequency and dosage of the medication are high, and it is difficult to ensure patient compliance , and increased the burden on the accompanying staff

[0007] At present, memantine hydrochloride / donepezil hydrochloride sustained-release capsules are newly launched in foreign countries. The filling contents are memantine hydrochloride sustained-release pellets and donepezil hydrochloride granules. They are capsules, which are inconvenient for patients with dysphagia.

[0008] In addition, in general, the pellets or granules produced by the fluidized bed have a large particle size, a bad taste, and a gritty feel. They are not suitable for the preparation of dry suspensions and suspensions, and can only be filled to prepare capsules. Poor drug compliance of patients; the spray drying method produces smaller particle size, which is suitable for the preparation of dry suspensions and suspensions, but the drug loading and encapsulation efficiency are low

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