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Olanzapine oral disintegration tablet and preparation method thereof

A technology of orally disintegrating tablets and olanzapine, applied in the field of pharmaceutical preparations, can solve the problems of small lumps falling, unsuitable for long-term storage, transportation and use, and high cost

Inactive Publication Date: 2012-08-15
BEIJING MEDISAN TECH +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Mannitol is used as a filler to prepare orally disintegrating tablets. The taste and appearance are good. However, when the friability is measured, small lumps tend to fall off. Although the measured friability is qualified, it is still too high and is not suitable for long-term storage. Transportation and use, and the cost of its processing is also high, which is not conducive to wide promotion and application; when lactose is used alone as a filler, the industrial production will appear fragmentation

Method used

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  • Olanzapine oral disintegration tablet and preparation method thereof
  • Olanzapine oral disintegration tablet and preparation method thereof
  • Olanzapine oral disintegration tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0065] Embodiment 1: the preparation of olanzapine orally disintegrating tablet (5mg / tablet)

[0066] formula:

[0067]

[0068] making process:

[0069] 1) Take the prescribed amount of olanzapine and pass through a 120-mesh sieve, and anhydrous calcium hydrogen phosphate, aspartame, and crospovidone respectively pass through a 80-mesh sieve;

[0070] 2) Olanzapine, aspartame, yellow ferric oxide and mannitol are mixed uniformly in equal increments;

[0071] 3) Add anhydrous calcium hydrogen phosphate and crospovidone to the mixture in step 2, and mix well;

[0072] 4) Add magnesium stearate and micronized silica gel to the mixture obtained in step 3, and mix well. Select a suitable tablet press and punching die to compress the tablets, each tablet contains 5 mg of olanzapine, inspect, pack, and obtain the finished product.

Embodiment 2

[0073] Embodiment 2: the preparation of olanzapine orally disintegrating tablet (10mg / tablet)

[0074] formula:

[0075]

[0076] making process:

[0077] 1) Take the prescribed amount of olanzapine and pass through a 120-mesh sieve, and anhydrous calcium hydrogen phosphate, aspartame, and crospovidone respectively pass through a 80-mesh sieve;

[0078] 2) Olanzapine, aspartame, yellow ferric oxide and mannitol are mixed uniformly in equal increments;

[0079] 3) Add anhydrous calcium hydrogen phosphate and crospovidone to the mixture in step 2, and mix well;

[0080] 4) Add magnesium stearate and micronized silica gel to the mixture obtained in step 3, and mix well. Select a suitable tablet press and punching die to compress the tablets, each tablet contains 10 mg of olanzapine, inspect, pack, and obtain the finished product.

Embodiment 3

[0081] Embodiment 3: the preparation of olanzapine orally disintegrating tablet (15mg / tablet)

[0082] formula:

[0083]

[0084]

[0085] making process:

[0086] 1) Take the prescribed amount of olanzapine and pass through a 120-mesh sieve, and anhydrous calcium hydrogen phosphate, aspartame, and crospovidone respectively pass through a 80-mesh sieve;

[0087] 2) Olanzapine, aspartame, yellow ferric oxide and mannitol are mixed uniformly in equal increments;

[0088] 3) Add anhydrous calcium hydrogen phosphate and crospovidone to the mixture in step 2, and mix well;

[0089] 4) Add magnesium stearate and micronized silica gel to the mixture obtained in step 3, and mix well. Select a suitable tablet press and punching die to compress tablets, inspect and pack, and the finished product is obtained.

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Abstract

The present invention relates to an olanzapine oral disintegration tablet and a preparation method thereof. The olanzapine oral disintegration tablet comprises: olanzapine, mannitol, and calcium hydrogen phosphate. The olanzapine oral disintegration tablet uses the olanzapine as the raw material, comprises one or more pharmaceutically acceptable excipients and is prepared by a direct compression. The olanzapine oral disintegration tablet can be quickly disintegrated in vitro, and quickly and uniformly disintegrated and dispersed, and is slightly sweet and tastes good. The olanzapine oral disintegration tablet is conveniently taken, and is especially suitable for the patients with emergency in dysphagia or special environment such as the elderly, children, and coma patient. The olanzapine oral disintegration tablet has the advantages of simple preparation process and low cost, and is suitable for industrialized production.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to an olanzapine orally disintegrating tablet preparation and a preparation method thereof. Background technique [0002] The chemical name of Olanzapine is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b][1,5]benzodiazepine Zhuo is used for the acute and maintenance treatment of schizophrenia and other mental illnesses with severe positive and / or negative symptoms, and can also alleviate the secondary affective symptoms of schizophrenia and related diseases. [0003] Olanzapine is a non-traditional antipsychotic drug developed by Eli Lilly and Company for short-term and long-term treatment of schizophrenia. It was launched in Europe and the United States in 1996, and in China in 1999. In 2003, it was listed as a first-line drug by the guidelines for the prevention and treatment of schizophrenia in China. According to the conclusions of the "Clinical Investigation o...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/5513A61K47/10A61K47/02A61P25/18
Inventor 刘津爱刘颖慧王明新王爱玲
Owner BEIJING MEDISAN TECH
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