Memantine oral film agent and preparation method thereof

A technology of oral film and memantine, which is applied in the field of pharmaceutical preparations to achieve the effects of easy portability, good drug efficacy, and improved drug compliance

Active Publication Date: 2014-05-21
CHONGQING PHARMA RES INST
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Memantine dosage forms administered orally, currently on the market in China are only ordinary tablets (10mg / tablet), oral liquid (120ml:240mg), ordinary tablets In the absence of water, it is not convenient for patients to take, and it is not easy to take for children and elderly patients.
Oral solution is inconvenient to carry, and it is difficult to administer special drugs to elderly patients with dementia

Method used

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  • Memantine oral film agent and preparation method thereof
  • Memantine oral film agent and preparation method thereof
  • Memantine oral film agent and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Memantine Hydrochloride 20.01g

[0033] HPMC 15 20.03g

[0034] HPC 25.01g

[0035] Sodium alginate 1.02g

[0036] PEG400 20.01g

[0037] Microcrystalline Cellulose 14.02g

[0038] Preparation Process:

[0039] Weigh 20.01g (20%) memantine hydrochloride and add it into 500m purified water, stir to dissolve it; add 20.03g (20%) HPMC 15, 25.10g (25%) HPC, 1.02g (1%) alginic acid under stirring Sodium, stir to form a translucent viscous liquid; add 20.01g (20%) PEG400, 14.02g (14%) microcrystalline cellulose under stirring, stir to form a viscous liquid of memantine hydrochloride, and then stir to remove air bubbles; finally Cast the non-bubble memantine hydrochloride viscous liquid on the mold, dry it at 40-60°C, take it out after 20 minutes, cool it, cut it into the desired shape and size, and obtain the memantine hydrochloride oral film.

[0040] Embodiment 2-4

Embodiment 2～4

[0042]

[0043] Preparation process: with embodiment 1

[0044] Embodiment 5-8

Embodiment 5～8

[0046]

[0047] Preparation Process:

[0048] With embodiment 1, difference is that amylopectin needs earlier hot water bath to be made into the liquid of 0.2g / ml.

[0049] Examples 9-12

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Abstract

The invention relates to a memantine oral film agent and a preparation method thereof. The memantine oral film agent is prepared from the following ingredients in weight percentage: 1-25% of memantine hydrochloride, 18-90% of pharmaceutical high polymer materials and 5-60% of additive, wherein the pharmaceutical high polymer materials include hydroxy propyl cellulose and at least one another medicinal polymer film-forming material. The memantine oral film agent is good in exterior appearance, high in disintegration speed and good in flexibility; the instant oral film is used for treating moderate and serious Alzheimer's diseases, is convenient to take, and can improve the taking compliance of children and senile patients.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a memantine oral film and a preparation method thereof. technical background: [0002] Memantine is a novel, low-moderate affinity, voltage-dependent, noncompetitive NMDA receptor antagonist. It has a good curative effect on vascular dementia and Alzheimer's dementia, becoming the first drug for the treatment of moderate to severe senile dementia with low incidence of side effects. It was first developed by Merz Company in Germany and introduced Akatinol Memantine in Germany in 1984. ? The trade name is listed and sold, and conventional tablets, capsules, and oral liquid are arranged. And in February 2002 and October 2003, it was approved to go on the market in Europe and the United States. [0003] Orally administered memantine dosage forms are currently on the market in China only as ordinary tablets (10mg / tablet) and oral liquids (120ml: 240mg). Ordin...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/70A61K31/13A61K47/38A61K47/36A61P25/28
Inventor 张涛李璐张雁翎王立邓杰
Owner CHONGQING PHARMA RES INST
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