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Memantine hydrochloride oral-dissolving film preparation and preparation method and application of preparation

A technology of memantine hydrochloride and oral dissolving film, applied in the field of medicine, can solve the problems of not easy to dissolve quickly, large film thickness, poor patient compliance, etc., and achieve the effects of good taste, smooth surface, and improved patient compliance.

Active Publication Date: 2015-11-11
QILU PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At the same time, when the content of the raw material drug is less than 20%, the weight of a single film of 10mg specification will exceed 50mg, the thickness of the film is relatively large, it is not easy to dissolve quickly in the oral cavity, and the patient's compliance is poor

Method used

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  • Memantine hydrochloride oral-dissolving film preparation and preparation method and application of preparation
  • Memantine hydrochloride oral-dissolving film preparation and preparation method and application of preparation
  • Memantine hydrochloride oral-dissolving film preparation and preparation method and application of preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] In this example: 1) Anhydrous citric acid and sucralose are used as flavoring agents, which can effectively mask the bitterness and numbness; 2) The content of the main ingredient is 30%, and the prepared film has no ice flower-like dots on the surface; 3 ) The average particle size of the raw material is less than 12 μm, and the prepared film has a smooth surface without roughness; 4) The film-forming material adopts hypromellose, which has good film-forming properties; 5) Bright blue lake is used as a colorant, and the dosage is 0.1% , good appearance.

[0038] The prescription quantity is 600 tablets (specification 5mg) or 300 tablets (specification 10mg)

[0039] prescription:

[0040] Memantine hydrochloride: 3.0g (30%)

[0041] Hypromellose: 5.5g (55%)

[0042] Titanium dioxide: 0.3g (3%)

[0043] Glycerin: 0.7g (7%)

[0044] Anhydrous citric acid: 0.2g (2%)

[0045] Sucralose: 0.3g (3%)

[0046] Bright blue lake: 0.01g (0.1%)

[0047] Purified water: 25.0...

Embodiment 2

[0050] In the present embodiment, compared with embodiment 1: 1) increase strawberry essence as fragrance agent, consumption 2%, taste is good; 2) film-forming material adopts polyvinylpyrrolidone, consumption 52%, film-forming property is good; 3) bright The blue lake is used as a coloring agent, the dosage is 1%, and the appearance is good.

[0051] The prescription quantity is 600 tablets (specification 5mg) or 300 tablets (specification 10mg)

[0052] prescription:

[0053] Memantine hydrochloride: 3.0g (30%)

[0054] Polyvinylpyrrolidone: 5.2g (52%)

[0055] Titanium dioxide: 0.3g (3%)

[0056] Glycerin: 0.7g (7%)

[0057] Anhydrous citric acid: 0.2g (2%)

[0058] Sucralose: 0.3g (3%)

[0059] Bright blue lake: 0.1g (1%)

[0060] Strawberry essence: 0.2g (2%)

[0061] Purified water: 25.0g

[0062] Weigh 3.0g of memantine hydrochloride and add it into 25.0g of purified water, stir and disperse evenly, then weigh 0.2g of anhydrous citric acid, 0.3g of sucralose, 0...

Embodiment 3

[0064] In the present embodiment, compared with embodiment 2: 1) increase strawberry essence as aromatic agent, consumption 4%, taste is good; 2) film-forming material adopts polyoxyethylene, consumption 51%, film-forming property is good; 3) bright Blue starch is not added.

[0065] The prescription quantity is 600 tablets (specification 5mg) or 300 tablets (specification 10mg)

[0066] prescription:

[0067] Memantine hydrochloride: 3..0g (30%)

[0068] Polyoxyethylene: 5.1g (51%)

[0069] Titanium dioxide: 0.3g (3%)

[0070] Glycerin: 0.7g (7%)

[0071] Anhydrous citric acid: 0.2g (2%)

[0072] Sucralose: 0.3g (3%)

[0073] Strawberry essence: 0.4g (4%)

[0074] Purified water: 25.0g

[0075] Weigh 3.0g memantine hydrochloride and add it into 25.0g purified water, stir and disperse evenly, then weigh 0.2g anhydrous citric acid, 0.3g sucralose, 0.3g titanium dioxide, 0.7g glycerin, 0.4g strawberry essence, add purified In water, stir and disperse evenly, weigh 5.1g ...

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Abstract

The invention discloses a memantine hydrochloride oral-dissolving film preparation. The preparation shields a stimulated flavor and is good in appearance. The memantine hydrochloride oral-dissolving film preparation comprises, by weight, 30-50% of memantine hydrochloride, preferentially, 30-40% of memantine hydrochloride, 35-55% of macromolecule film-forming materials, 3.0-15% of flavor corrective, 2-20% of plasticizers and 0-5% of other auxiliary materials. The other auxiliary materials comprise one or two of pigment and flavoring agents. Through increasing the content of the raw material chemicals, selecting the appropriate flavor corrective and the film-forming materials and controlling the grain size of the raw material chemicals, the film preparation free of the stimulated flavor, smooth in surface, even in content of chemicals, high in disintegration speed and rapid in absorption is obtained; the film preparation is convenient to take and improves the compliance of a patient. The invention further provides a method of preparing the film preparation and an application of the film preparation in treating the Alzheimer disease.

Description

technical field [0001] The invention relates to a memantine hydrochloride mouth-dissolving film preparation with masked irritating taste and good appearance, belonging to the technical field of medicine. The invention also relates to a preparation method and application of a memantine hydrochloride orosoluble film preparation. Background technique [0002] Senile dementia (Alzheimer's disease) is one of the common diseases of the elderly, mainly manifested as memory loss and cognitive impairment, etc., and is a progressive neurodegenerative disorder. A large number of research data at home and abroad show that one out of every ten elderly people shows different degrees of dementia symptoms, which seriously affects people's health and quality of life. Alzheimer's disease has become the fourth killer of human beings after cardiovascular disease, cancer and stroke. At present, the etiology of this disease has not been fully elucidated, and it has always been a thorny problem i...

Claims

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Application Information

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IPC IPC(8): A61K9/70A61K31/13A61P25/28
Inventor 杨清敏李延志王栋海张明会张勇周志超
Owner QILU PHARMA
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