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Asenapine maleate oral instant membrane and making method thereof

A technology of asenapine maleate and oral instant film, which is applied in the field of atypical psychiatric drug asenapine oral instant film and its preparation, which can solve the problems that affect the treatment of diseases and cannot play a role , to achieve convenient packaging and transportation, improved compliance, and low cost

Inactive Publication Date: 2014-08-27
AVENTIS PHARMA HAINAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, conventional tablets and capsules often cannot play a role, which affects the treatment of diseases.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] Prescription quantity 2000 tablets (5mg specification) or 1000 tablets (10mg specification)

[0044] Prescription:

[0045] Asenapine Maleate 10g

[0046] Hyaluronic Acid 1.0g

[0047] Hypromellose E15LV 50g

[0048] Propylene glycol 12g

[0049] Sucralose 0.64g

[0050] Medical absolute ethanol 200g

[0051] Distilled water 200g

[0052] Preparation:

[0053] Step 1: Weigh 1.0g of hyaluronic acid, 50g of hypromellose E5LV and 12g of propylene glycol, put them in an appropriate container, add 200g of distilled water and 200g of absolute ethanol into the container, and stir until the solution is uniform;

[0054] Step 2: Weigh 10g of asenapine maleate, put it into the glue solution in step 1, and continue to stir until it dissolves uniformly;

[0055] Step 3: Weigh 0.64g of three-filtered sucrose, add it to the glue solution in step 2, stir until it is completely dissolved, and leave it in vacuum for 6 hours to degas; scrape the degassed glue solution on the plas...

Embodiment 2

[0057] Prescription quantity 2000 tablets (5mg specification) or 1000 tablets (10mg specification)

[0058] prescription:

[0059] Asenapine Maleate 10g

[0060] Hyaluronic Acid 1.6g

[0061] Hypromellose E5LV 60g

[0062] Glycerin 10g

[0063] Sucralose 0.5g

[0064] Peppermint Oil 0.5g

[0065] Medical absolute ethanol 200g

[0066] Distilled water 200g

[0067] Preparation:

[0068] Step 1: Weigh 60g of hypromellose E5LV and 1.6g of hyaluronic acid, put them in an appropriate container, add 200ml of medical absolute ethanol and 200ml of distilled water, heat to 60°C, work overtime until completely dissolved, and cool to room temperature; ;

[0069] Step 2: Weigh 10g of asenapine maleate and 10g of glycerol, put them into the glue solution in step 1, and continue to stir until the solution is uniform;

[0070] Step 3: Weigh 0.5g of three-filter sucrose and 0.5g of peppermint oil, add to the glue in step 2, stir until it is completely dissolved, and leave it in vacu...

Embodiment 3

[0072] Prescription quantity 2000 tablets (5mg specification) or 1000 tablets (10mg specification)

[0073] prescription:

[0074] Asenapine Maleate 10g

[0075] Hyaluronic Acid 1.0g

[0076] Polyvinyl alcohol 60g

[0077] Propylene glycol 12g

[0078] Sucralose 0.5g

[0079] Orange flavor 0.5g

[0080] Medical absolute ethanol 200g

[0081] Distilled water 200g

[0082] Preparation:

[0083] Step 1: Weigh 60g of polyvinyl alcohol and 1.0g of hyaluronic acid, put them in an appropriate container, add 200ml of medical absolute ethanol and 200ml of distilled water, heat to 60°C, work overtime until completely dissolved, and cool to room temperature;

[0084] Step 2: Weigh 10g of asenapine maleate and 12g of propylene glycol, put them into the glue solution in step 1, and continue to stir until the solution is uniform;

[0085] Step 3: Weigh 0.5g of three-filtered sucrose and 0.5g of orange flavor, add to the glue in step 2, stir until it is completely dissolved, and lea...

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Abstract

The invention relates to an Asenapine maleate oral instant membrane used for treating adult schizophrenia, chronic severe brain dysfunction and type I bipolar disorder, and a making method thereof. The above dosage form has the advantages of convenient administration, administration without water, rapid dissolving in the oral cavity, restriction or complete prevention of the removal of a medicine by a schizophrenia patient, and improvement of the compliance f the patient. The main drug content of the dosage form made through the making method can reach the unit dosage of Asenapine maleate, and the dosage form has the characteristics of drug loading uniformity, good appearance and good stability. In the production process, the technology is simple, the cost is low, and almost no dust is generated.

Description

technical field [0001] The invention relates to a chemical medicine and a preparation method thereof, in particular to an atypical psychiatric drug asenapine maleate oral instant film and a preparation method thereof. Background technique [0002] With the rapid development of society, people's work and life pressure is increasing, leading to an increase in mental illness. According to statistics, the ranking of mental illness in the total burden of disease in my country has surpassed diseases such as cardiovascular and cerebrovascular diseases, respiratory system and malignant tumors, and jumped to the top of the list. The number of people suffering from various mental diseases in my country accounts for about 7.7% of the total population. [0003] Schizophrenia is a persistent, often chronic, major mental illness and is the most serious of the mental illnesses. According to statistics, the number of schizophrenic patients in the world is as high as 24 million, and there ...

Claims

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Application Information

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IPC IPC(8): A61K9/70A61K31/407A61K47/38A61K47/36A61K47/32A61P25/18A61P25/00A61P25/24
Inventor 刘二军宋雪梅郭夏
Owner AVENTIS PHARMA HAINAN
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