Memantine hydrochloride sustained-release pellet and preparation method thereof

A technology of memantine hydrochloride and sustained-release pellets, applied in the direction of pharmaceutical formulations, microcapsules, medical preparations of non-active ingredients, etc., to achieve the effect of ensuring stability and complete release

Pending Publication Date: 2018-03-09
JIANGSU SIMCERE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Patent CN103417491 protects the preparation of memantine hydrochloride pellets, which mainly protects the process of the blank pellet core and the memantine hydrochloride drug compound layer wrapped in the outer layer, but this patent has the same risk of burst release as patent CN103181914

Method used

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  • Memantine hydrochloride sustained-release pellet and preparation method thereof
  • Memantine hydrochloride sustained-release pellet and preparation method thereof
  • Memantine hydrochloride sustained-release pellet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Embodiment 1: Preparation of memantine sustained-release pellets

[0027]

[0028] Preparation of drug-containing pellets: use 1600g of 50% ethanol aqueous solution as the drug dispersion medium, add 70g of polyvinylpyrrolidone, then disperse 280g of memantine hydrochloride and 50g of talc in the polyvinylpyrrolidone solution to obtain a suspension; adopt a fluidized bed Bottom spraying method, at a temperature of 30-40°C, spray the drug-on-drug suspension onto the blank pellet core to obtain drug-containing pellets.

[0029] Sustained-release pellet preparation: take 1260g 95% ethanol aqueous solution as the dispersion medium of the sustained-release layer, add 2g oleic acid, 2g triglyceride, then add 20g polyethylene glycol, stir until dissolved and then add 116g ethyl cellulose to obtain the sustained-release pellet. release layer suspension; using the fluidized bed bottom spray method, spray the sustained release layer suspension onto the drug-containing pellets ...

Embodiment 2

[0030] Embodiment 2: Preparation of memantine sustained-release layer pellets

[0031]

[0032]

[0033] Preparation of drug-containing pellets: preparation of drug-containing pellets in the same manner as in Example 1.

[0034] Preparation of sustained-release pellets: Add 373g of water to 560g of Surelease aqueous dispersion, and stir to obtain a sustained-release layer suspension; use the fluidized bed bottom spray method, mix the prepared sustained-release layer at a temperature of 40-50°C The suspension is sprayed onto the drug-containing pellets to obtain sustained-release layer pellets; the pellets are dried on-line in a fluidized bed at 40-60°C for 0.5-2 hours; the content is measured, and the pellets are filled into corresponding capsules to obtain the product.

Embodiment 3

[0035] Embodiment 3: Preparation of memantine sustained-release pellets

[0036]

[0037] Preparation of drug-containing pellets: preparation of drug-containing pellets in the same manner as in Example 1.

[0038] Preparation of extended-release pellets:

[0039] Sustained-release layer pellet 1: take 630g 95% ethanol aqueous solution as the dispersion medium of the sustained-release layer, add 1g oleic acid, 1g triglyceride, then add 10g polyethylene glycol, stir until dissolved, then add 58g ethyl cellulose to obtain Slow release layer suspension. Using a fluidized bed bottom spraying method, spray the prepared sustained-release layer suspension onto drug-containing pellets at a temperature of 30-40°C to obtain sustained-release layer pellets 1;

[0040] Sustained-release layer pellets 2: Add 187g of water to 280g of Surelease aqueous dispersion, and stir to obtain a sustained-release layer suspension; the prepared sustained-release layer is sprayed at the temperature o...

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Abstract

The invention relates to a memantine hydrochloride sustained-release pellet and a preparation method thereof. The memantine hydrochloride sustained-release pellet sequentially comprises a blank pelletcore, a drug-containing layer containing memantine hydrochloride and a sustained-release coating layer from inside to outside, and is characterized in that the sustained-release coating layer comprises a first layer of ethyl cellulose coating layer and a second layer of Surelease coating layer. The sustained-release pellet provided by the invention has the advantages of round appearance, uniformparticle size, good fluidity, no burst release phenomenon, complete drug release and good stability.

Description

technical field [0001] The invention relates to a memantine sustained-release pellet and a preparation method thereof, belonging to the technical field of pharmacy. Background technique [0002] Alzheimer's disease (Alzheimer's Disease, AD) is a degenerative disease of the central nervous system, the most common type of senile dementia, an irreversible progressive disorder of brain cell (neuron) deterioration, onset Insidious, the course of the disease is chronic and progressive, and the incidence rate increases with age. The clinical manifestations are cognitive decline, abnormal mental behavior, and decreased ability of daily living. Studies have found that the pathogenesis of AD is related to central cholinergic damage and excitatory amino acid toxicity. According to the data released by WHO in April 2012, there are nearly 35.6 million AD patients in the world, and the number is expected to double (65.7 million) by 2030 and triple by 2050. There are about 6 million AD ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/52A61K47/38A61K31/13A61P25/28
CPCA61K9/0002A61K9/5042A61K31/13
Inventor 周萍王悦彭涛李晓强
Owner JIANGSU SIMCERE PHARMA
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