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Olanzapine oral instant membrane

An oral instant film and olanzapine technology, which is applied in drug combinations, nervous system diseases, organic active ingredients, etc., can solve problems such as inconvenient administration, and achieve the effect of improving compliance and uniform drug loading

Active Publication Date: 2013-02-13
JIANGSU HANSOH PHARMA CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Specifically, it is to provide a pharmaceutical dosage form that can dissolve quickly in the oral cavity, to overcome the problems such as the inconvenient administration of olanzapine as a tablet

Method used

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  • Olanzapine oral instant membrane
  • Olanzapine oral instant membrane
  • Olanzapine oral instant membrane

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] The prescription quantity is 2000 tablets (specification 5mg) or 1000 tablets (specification 10mg)

[0041]

[0042]

[0043] *Remove during drawdown drying.

[0044] Process:

[0045] Weigh 20g of mannitol, put it in an appropriate container, and add 200g of ethanol / water solution (ethanol:water=1:4). After stirring until completely dissolved, add 10 g of olanzapine, stir evenly, add 30 g of polyoxyethylene, stir evenly, add 0.5 g of sucralose. Shear at high speed (10000rpm) for 2 minutes, repeat 5 times, and let it stand under vacuum for 8 hours to remove air bubbles, and then get the gel for scraping. Apply this glue solution to the plastic film, and dry it at a temperature between 75°C and 80°C. Then the film agent obtained by scraping is peeled off from the plastic film, cut and packaged to obtain the film agent.

Embodiment 2

[0047] The prescription quantity is 2000 tablets (specification 5mg) or 1000 tablets (specification 10mg)

[0048]

[0049] Process:

[0050] 1) Weigh 20g of mannitol, put it in an appropriate container, and add 50g of ethanol / water solution (ethanol:water=1:4). After stirring until completely dissolved, add 10 g of olanzapine, stir evenly, and record it as A.

[0051] 2) Weigh 30g of hypromellose, put it in an appropriate container, add 160g of distilled water at 85°C-95°C, stir evenly, cool until completely dissolved, and obtain glue B.

[0052] 3) Add glue B to A, and add 0.5 g of sucralose. Shear at high speed (10000rpm) for 2 minutes, repeat 5 times, and let it stand under vacuum for 8 hours to remove air bubbles, and then get the gel for scraping. Apply this glue solution to the plastic film, and dry it at a temperature between 75°C and 80°C. Then the film agent obtained by scraping is peeled off from the plastic film, cut and packaged, and the film agent can be obt...

Embodiment 3

[0054] The prescription quantity is 2000 tablets (specification 5mg) or 1000 tablets (specification 10mg)

[0055]

[0056] Process:

[0057] 1) Weigh 20g of mannitol, put it in an appropriate container, and add 50g of ethanol / water solution (ethanol: water = 1:4). After stirring until completely dissolved, add 10 g of olanzapine, stir evenly, and record it as A.

[0058] 2) Weigh 30g of hydroxypropyl cellulose, put it in an appropriate container, and add 160g of distilled water. Stir for more than 2 hours until the glue is uniform, and glue B is obtained.

[0059] 3) Add glue B to A, and add 0.5g of sucralose. Shear at high speed (10000rpm) for 2 minutes, repeat 5 times, and let it stand under vacuum for 8 hours to remove air bubbles, and then get the gel for scraping. Apply this glue solution to the plastic film, and dry it at a temperature between 75°C and 80°C. Then the film agent obtained by scraping is peeled off from the plastic film, cut and packaged to obtain ...

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Abstract

The present invention belongs to the field of pharmaceutical preparations, particularly relates to an olanzapine oral instant membrane agent, a preparation method and pharmaceutical uses thereof. The membrane agent comprises the following components, by weight, 1-30% of olanzapine, 40-90% of a polymer membrane forming material, 0-40% of a plasticizer, 0-30% of a flavoring agent, and 0-5% of otherauxiliary agents. The olanzapine oral instant membrane agent has the following characteristics that: no water is required during administration, the olanzapine oral instant membrane agent can rapidlymelt in mouth, phenomena of drug hiding in mouth and drug spitting of schizophrenia patients can be avoided, and patient medication compliance is easily improved. With the preparation method, the main drug of the olanzapine oral instant membrane agent has characteristics of good dispersing effect in a hydrophilic matrix glue liquid, good finished product appearance, rapid dissolution and good stability. In addition, characteristics of accurate product dose and no dust flying during a production process are provided, and problems of labor protection and environmental pollution can be solved.

Description

technical field [0001] The invention belongs to the field of chemical pharmacy, and in particular relates to an olanzapine oral instant film and a preparation method thereof. Background technique [0002] Due to the rapid development of society and development, while people are under increasing pressure from work and life, mental illnesses are gradually increasing. According to statistics, mental illness has jumped to the first place in the ranking of the total burden of disease in my country, surpassing diseases such as cardiovascular and cerebrovascular diseases, respiratory system and malignant tumors. The number of mentally ill patients in my country is more than 100 million yuan. [0003] Schizophrenia is a persistent, often chronic, major mental illness and is the most serious of the mental illnesses. WHO estimates that the lifetime prevalence rate of schizophrenia is 3.8‰-8.4‰, and the lifetime prevalence rate in the United States is as high as 1.3%. The epidemiolog...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/70A61K31/5513A61K47/32A61K47/34A61K47/36A61K47/38A61P25/18A61P25/22A61P25/24
CPCA61K31/5513A61K9/70A61K9/006A61K31/551A61P25/18A61P25/22A61P25/24
Inventor 吴玉霞李子敬张欣
Owner JIANGSU HANSOH PHARMA CO LTD
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