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Memantine hydrochloride sustained release preparation and preparing method thereof

A technology for memantine hydrochloride and sustained-release preparations, which is applied in pharmaceutical formulations, drug delivery, and amine active ingredients. The effect of simple equipment and controllable quality

Active Publication Date: 2014-05-28
GUANGZHOU NEWORLD PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] In the multi-unit dosage form, the sustained-release pellets are usually prepared by extrusion spheronization method or fluidized bed drug, and the film control is mostly realized by fluidized bed coating. The process is complicated and requires high experience of the operator. Large, many parameter settings
The particle size and weight of pellets can only be controlled within a certain range, so there are large differences within or between batches, and it is difficult to achieve accurate

Method used

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  • Memantine hydrochloride sustained release preparation and preparing method thereof
  • Memantine hydrochloride sustained release preparation and preparing method thereof
  • Memantine hydrochloride sustained release preparation and preparing method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] Tablet formulation: (made into 1000 tablets, each containing 28mg of memantine hydrochloride)

[0040]

[0041] The preparation method of the present embodiment memantine hydrochloride slow-release preparation comprises the steps:

[0042] (1) Memantine hydrochloride, skeleton material, diluent, lubricant, and binder are sieved separately, and then mixed evenly to obtain a mixed powder;

[0043] (2) Wet granulate the mixed powder and then press it with a 3mm punch to obtain tablet cores;

[0044] (3) Coat the tablet core with coating solution; the coating process parameters are: tablet bed weight 300g, coating pan rotation speed 5-35rpm, tablet bed temperature 25°C, coating solution inflow rate 4-5g / min, spray pressure 0.08-0.12MPa;

[0045] (4) Heat the coated finished product at 40°C for 12 hours to obtain memantine hydrochloride sustained-release mini-tablets;

[0046] (5) Put the memantine hydrochloride sustained-release mini tablets into hard capsules to obtai...

Embodiment 2

[0048] Tablet formula: (made into 1000 tablets, each containing 14mg of memantine hydrochloride)

[0049]

[0050]

[0051] The preparation method of the present embodiment memantine hydrochloride slow-release preparation comprises the steps:

[0052] (1) Memantine hydrochloride, skeleton material, diluent, lubricant, and binder are sieved separately, and then mixed evenly to obtain a mixed powder;

[0053] (2) Wet granulate the mixed powder and then press it with a 3mm punch to obtain tablet cores;

[0054] (3) Dissolve the coating material, porogen, and plasticizer in 95% ethanol solution to make a coating solution with a mass concentration of 7.5%, and add talcum powder to the above coating solution, stir evenly, To obtain a mixed coating solution;

[0055] (4) Coat the tablet core with the above mixed coating solution; the coating process parameters are: tablet bed weight 300g, coating pan speed 5-35rpm, tablet bed temperature 35°C, coating solution inflow rate 4- ...

Embodiment 3

[0059] Tablet formula: (make 1000 tablets, each tablet contains 7mg of memantine hydrochloride)

[0060]

[0061] The preparation method of the present embodiment memantine hydrochloride slow-release preparation comprises the steps:

[0062] (1) Memantine hydrochloride, skeleton material, diluent, lubricant, and binder are sieved separately, and then mixed evenly to obtain a mixed powder;

[0063] (2) Compress the mixed powder with a 2mm punch to obtain tablet cores;

[0064] (3) Dissolve the coating material, porogen, and plasticizer in 95% ethanol solution to make a coating solution with a mass concentration of 7.5%, and add talcum powder to the above coating solution, stir evenly, To obtain a mixed coating solution;

[0065] (4) Coat the tablet core with the above mixed coating solution; the coating process parameters are: tablet bed weight 300g, coating pan speed 5-35rpm, tablet bed temperature 50°C, coating solution inflow rate 4- 5g / min, spray pressure 0.08-0.12MPa...

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Abstract

The invention discloses a memantine hydrochloride sustained release preparation. The memantine hydrochloride sustained release preparation comprises a memantine hydrochloride sustained release mini-tablet formed by a tablet core and a coating film. The weight of the coating film is 0-30% of the weight of the tablet core. Equipment for producing the sustained release mini-tablet is simple and is similar to equipment for producing common tablets, besides changes of the diameter size of a punch, and therefore industrial production of the sustained release mini-tablet can be easily achieved. After process parameters of the mini-tablet are determined, the sizes of obtained tablets are largely the same, in-batch differences or differences among batches are almost nonexistent, and the quality is easy to control.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a sustained-release preparation of memantine hydrochloride and a preparation method thereof. Background technique [0002] Alzheimer's disease (AD) is a degenerative disease of the central nervous system and the most common type of senile dementia. The onset is 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 patients in my country, and it is estimat...

Claims

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Application Information

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IPC IPC(8): A61K9/52A61K9/22A61K31/13A61P25/28
Inventor 吴传斌章正赞李峰张观雄李革钟硕宇
Owner GUANGZHOU NEWORLD PHARMA CO LTD
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