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Memantine hydrochloride slow-release pellet preparation and preparation method thereof

A technology of memantine hydrochloride and sustained-release pellets, which is applied in the direction of bulk delivery, active ingredients of amines, nervous system diseases, etc., can solve the problems of sudden release risks and safety hazards of sustained-release tablets, and achieve long-lasting and stable drug effects. Increased safety and good fluidity

Inactive Publication Date: 2013-12-04
HANGZHOU SHARPLY PHARM R&D INSTIT +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although the sustained-release tablets can achieve the effect of stabilizing the blood drug concentration, there is a risk of sudden release in the sustained-release tablets, which poses a certain safety hazard

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Embodiment 1: Preparation of memantine hydrochloride sustained-release pellets

[0021] Prescription: weight of raw and auxiliary materials (g)

[0022] Blank core 799

[0023] Memantine Hydrochloride 56

[0024] Hypromellose 110

[0025] Talc powder 25

[0026] Polyethylene glycol 10

[0027] 95% ethanol in appropriate amount.

[0028] Preparation method: 1) Dissolve hypromellose in 95% ethanol, and at the same time dissolve memantine hydrochloride and polyethylene glycol in 95% ethanol and add it;

[0029] 2) Put the blank pellet core in the coating machine, spray the drug sustained-release composite layer solution prepared in step 1) on the blank pellet core after preheating, and control the air inlet temperature at 40°C to prepare drug-containing pellets;

[0030] 3) Dry the drug-containing pellets obtained in step 2) in a hot air circulation oven at 60°C to 70°C for 2 hours to obtain sustained-release pellets; , to obtain sustained-release pellets.

[0031] ...

Embodiment 2

[0033] prescription

[0034] Raw materials Weight (g)

[0035] Blank core 789

[0036] Memantine Hydrochloride 56

[0037] Stearic acid 120

[0038] Povidone 10

[0039] Talc powder 25

[0040] 95% ethanol in appropriate amount.

[0041] Preparation Process:

[0042] (1) Fully dissolve the stearic acid, memantine hydrochloride and povidone in the prescription with 95% ethanol, and stir evenly;

[0043] （2） Put the blank pellet core in the coating machine, spray the drug sustained-release composite layer solution prepared in step (1) on the blank pellet core after preheating, and control the air inlet temperature at 40°C to prepare drug-containing pellets;

[0044] (3) Dry the drug-containing pellets obtained in step (2) in a hot air circulation oven at 60°C to 70°C for 2 hours to obtain sustained-release pellets;

[0045] The sustained-release pellets are packed into hollow capsules to obtain memantine hydrochloride sustained-release pellets capsules.

Embodiment 3

[0047] prescription

[0048] Raw materials Weight (g)

[0049] Blank core 799

[0050] Memantine Hydrochloride 56

[0051] Acrylic resin (Utech NE30D) 110

[0052] Triethyl citrate 5

[0053] 95% ethanol appropriate amount

[0054] Preparation Process:

[0055] (1) Fully dissolve the stearic acid, memantine hydrochloride and povidone in the prescription with 95% ethanol, and stir well.

[0056] (2) Put the blank pellet core in the storage tank of the fluidized boiling coating machine, pass hot air from the bottom to make it in a fluidized state, and spray the drug sustained-release compound solution in step (1) through the bottom Spray in so the solution is sprayed onto blank pellet cores and allowed to dry.

[0057](3) The working parameters of the fluidized boiling coating machine are: the air supply temperature is set to 35~60°C; the fan frequency is set to 40~50hZ; the nozzle atomization pressure is 1.5~3.0bar.

[0058] The sustained-release pellets are packed into...

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Abstract

The invention relates to a memantine hydrochloride slow-release pellet preparation and a preparation method thereof. The memantine hydrochloride slow-release pellet preparation comprises a blank pellet core as a nuclear parent and memantine hydrochloride medicine slow-release composite layer wrapped as an outer layer. The preparation is characterized in that the blank pellet core and the memantine hydrochloride medicine slow-release composite layer are in the weight ratio of 2-6:1; the memantine hydrochloride medicine slow-release composite layer contains 10-40% of memantine hydrochloride, 50-70% of a slow-release material and 0.1-20% of other accessories. The slow-release pellet prepared by the invention has high roundness and good fluidity, can obtain high yield during wrapping of medicine and the slow release material, and has good reappearance. The simple preparation technology of the slow-release pellet is not restrained by place or equipment and suitable for industrialized production.

Description

technical field [0001] The invention relates to a pharmaceutical preparation, in particular to a memantine hydrochloride sustained-release pellet preparation for treating Alzheimer's disease and a preparation method thereof. Background technique [0002] With the aging of the world's population and the improvement of people's living standards, the average life expectancy is also extended. In 2002, the elderly over the age of 60 accounted for 20% of the world's total population. By 2050, the number of elderly people It is expected to reach 21% of the world's total population. With the aging of the world's population, senile dementia has become the primary problem of human health, and the incidence rate is increasing year by year with the progress of population aging. At present, the number of sick people in the world has exceeded 18 million, and the number of sick people in my country is about 6 million, which is the country with the largest number of sick people in the worl...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K31/13A61P25/28
Inventor 范敏华王美红刘华
Owner HANGZHOU SHARPLY PHARM R&D INSTIT
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