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Menantine hydrochloride slow-release capsules and preparation method thereof

A technology of memantine hydrochloride and sustained-release capsules, which is applied in the fields of pharmaceutical formulations, drug delivery, and inorganic non-active ingredients. Problems, to achieve great application value, simple and easy production method, and improve the effect of curative effect

Pending Publication Date: 2019-06-07
杭州和康药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But this product releases in the scope within 24 hours, and the consistency of the release degree of 12 hours and reference preparation (original research drug preparation) is low, and the release degree of reference preparation reaches more than 85% in 12 small tests
[0008] It can be seen from the above that the memantine preparation of the above-mentioned patent is far from the Memantine hydrochloride sustained-release capsule NamendaXR jointly developed by Forest Lab and Merz in terms of drug consistency. Currently, there is no sustained-release memantine hydrochloride that meets the requirements in the market. Capsules NamendaXR generic drug formulation

Method used

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  • Menantine hydrochloride slow-release capsules and preparation method thereof
  • Menantine hydrochloride slow-release capsules and preparation method thereof
  • Menantine hydrochloride slow-release capsules and preparation method thereof

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Effect test

preparation example Construction

[0066] The preparation method of above-mentioned memantine hydrochloride sustained-release capsules, comprises the following steps:

[0067] 1) Add binder to ethanol aqueous solution and stir until dissolving, then add memantine hydrochloride and stir until dissolving to obtain the drug coating solution, the ratio of memantine hydrochloride in the drug coating solution is 5-20wt% (preferably 8-15wt%).

[0068] 2) Install the B-type air distribution plate, pour the blank pellet core, start the machine to preheat the blank pellet core, and start spraying when the temperature of the blank pellet core reaches 35-40°C, the temperature control range of the blank pellet core is 35-40°C; After the coating solution is sprayed, turn off the spraying, turn off the heating, continue drying for 5-10 minutes, turn off the air inlet, and discharge the material to prepare the drug-coated pellets.

[0069] 3) Add ethanol, slow-release materials, plasticizers, and porogens in sequence in the c...

Embodiment 1

16.4

[0074] Add 15kg of 95% ethanol and 10kg of purified water into a 50L liquid mixing tank and stir for 5 minutes to prepare 25kg of ethanol solution (dissolving agent), add hydroxypropyl methylcellulose (1.6kg) and stir until dissolved, then add 2.8kg of raw materials and stir to dissolve for 10 minutes .

[0075] Install the B-type air distribution plate, adjust the spray angle of the spray gun, pour in the blank core, and start the machine to preheat the blank core. When the temperature of the blank pellet core reaches 36°C, start spraying, and the material temperature control range is 35-40°C. After spraying the drug-coating solution, turn off the spraying, turn off the heating, continue drying for 8 minutes, turn off the air inlet, and discharge the material to prepare the drug-based pellets.

[0076] name

Unit dosage mg

%%

Batch prescription (kg)

Shangyao pellets

164

82.95

16.4

Ethyl cellulose

14

7.08

...

Embodiment 2

16.8

[0082] Add 16kg of 95% ethanol and 9kg of purified water into a 50L liquid mixing tank and stir for 5min to prepare 25kg of ethanol solution (dissolving agent). Add hydroxypropylmethylcellulose E5 (1.5kg) and stir until dissolved, then add 2.8kg of raw materials and stir to dissolve for 10 minutes.

[0083] Install the B-type air distribution plate, adjust the spray angle of the spray gun, pour in the blank core, and start the machine to preheat the blank core. When the temperature of the blank pellet core reaches 35°C, start spraying, and the temperature control range of the blank pellet core is 35-39°C. After spraying the drug-coating solution, turn off the spraying, turn off the heating, continue drying for 5 minutes, turn off the air inlet, and discharge the material to obtain the drug-based pellets.

[0084] name

Unit dosage mg

%%

Batch prescription (kg)

Shangyao pellets

168

92.97

16.8

Ethyl cellulose

5

...

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Abstract

The invention relates to the field of pharmacy, and discloses menantine hydrochloride slow-release capsules and a preparation method thereof. The menantine hydrochloride slow-release capsules comprisecapsules and menantine hydrochloride slow-release mini-pills, wherein the menantine hydrochloride slow-release mini-pills sequentially comprise a hollow pill core, a main medicine layer and a slow-release coating layer from inner part to outer part; the main medicine layer comprises menantine hydrochloride and an adhesion agent; the slow-release coating layer comprises a slow-release material, anantisticking agent, a pore-forming agent and a plastifier; the slow-release material is an alcohol-soluble material; and the menantine hydrochloride slow-release capsules comprise the following raw materials in parts by weight of 100-150 parts of the hollow pill cores, 28 parts of the menantine hydrochloride, 11-17 parts of the adhesion agent, 5-14 parts of the slow-release material, 4-10.1 partsof the antisticking agent, 2.5-6.5 parts of the pore-forming agent and 1.2-3.1 parts of the plastifier. The menantine hydrochloride slow-release capsules and original developed medicines can keep high consistency in medicine effects, and the release curve of the menantine hydrochloride slow-release capsules has high capacity of resisting disturbance for ethanol.

Description

technical field [0001] The invention relates to the field of pharmacy, in particular to a memantine hydrochloride sustained-release capsule 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. An irreversible progressive disorder of brain cell (neuron) deterioration that results in loss of cognitive function, primary memory, judgment and reasoning, motor coordination, and pattern recognition. In advanced stages of the disease, all memory and intellectual function may be lost. People with Alzheimer's disease have problems with memory, judgment, and thinking, making it difficult to work or participate in daily life. It is associated with senile dementia, the mental decline (loss of intelligence) associated with old age. Senile dementia is defined as two main types: Alzheimer's type caused by generalized wasting disease and caused by vascul...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/62A61K31/13A61K47/02A61P25/28
Inventor 沈一杰高庆丰陈晶
Owner 杭州和康药业有限公司
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