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Olanzapine orally-disintegrating tablet preparation and preparation method thereof

A technology for olanzapine orally disintegrating tablets, applied in the field of olanzapine orally disintegrating tablets and their preparation, can solve the problems of being unsuitable for long-term storage, transportation and use, unfavorable promotion and application, industrial large-scale production of splits, etc., and achieves improved biological utilization. The effect of speed, drug dissolution, and low cost

Active Publication Date: 2010-12-08
QILU PHARMA
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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 orally-disintegrating tablet preparation and preparation method thereof
  • Olanzapine orally-disintegrating tablet preparation and preparation method thereof
  • Olanzapine orally-disintegrating tablet preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] The prescription is:

[0048] Olanzapine (ADP) 5%

[0049] Mannitol 200SD 47.1%

[0050] Lactose (Tabllettose 80) 40.3%

[0051] Cross-linked polyvinylpyrrolidone (PVPP) 5%

[0052] Aspartan 0.6%

[0053] Orange flavor 0.5%

[0054] Magnesium Stearate 1.5%

[0055] Preparation: This dosage form can be produced by using conventional tablet pharmaceutical equipment and prepared by direct tableting process. The specific preparation method is as follows: grind the essence, aspartame and main drug separately and pass through an 80-mesh sieve, and the essence, aspartame and The main ingredients are mixed evenly; the cross-linked polyvinylpyrrolidone is passed through a 100-mesh sieve, and the mannitol and lactose are respectively passed through a 40-mesh sieve, respectively weighed according to the amount, and then added to the main ingredients mixed with essence and aspartam and mixed evenly, and then add the prescribed amount of Magnesium stearate, sieved and mixed, a...

Embodiment 2

[0057] The prescription is:

[0058] Olanzapine (ADP) 6.4%

[0059] Mannitol 200SD 38%

[0060] Lactose (Tab lettose 80) 38%

[0061] Microcrystalline Cellulose (MCC PH101) 10%

[0062] Cross-linked polyvinylpyrrolidone (PVPP) 5%

[0063] Aspartan 0.6%

[0064] Orange flavor 0.5%

[0065] Magnesium Stearate 1.5%

[0066] Preparation: This dosage form can be produced by using conventional tablet pharmaceutical equipment and prepared by direct tableting process. The specific preparation method is as follows: grind the essence, aspartame and main drug separately and pass through an 80-mesh sieve, and the essence, aspartame and The main ingredients are mixed evenly; the cross-linked polyvinylpyrrolidone is passed through a 100-mesh sieve, and the mannitol, lactose and microcrystalline cellulose are respectively passed through a 40-mesh sieve. Mix well, then add the prescribed amount of magnesium stearate, sieve and mix, and detect the intermediate content. After determinin...

Embodiment 3

[0068] The prescription is:

[0069] Olanzapine (ADP) 8%

[0070] Mannitol 200SD 38.44%

[0071] Lactose (Tabllettose 80) 32.96%

[0072] Microcrystalline Cellulose (MCC PH101) 8%

[0073] Low-substituted hydroxypropyl cellulose (L-HPC) 8%

[0074] Cross-linked polyvinylpyrrolidone (PVPP) 2%

[0075] Aspartan 0.6%

[0076] Orange flavor 0.5%

[0077] Magnesium Stearate 1.5%

[0078] Preparation: The dosage form can be produced by using conventional tablet pharmaceutical equipment and prepared by dry granulation and tabletting technology. The specific preparation method is as follows: the main drug, orange essence, aspartame, mannitol, lactose, microcrystalline cellulose, Low-substituted hydroxypropyl cellulose and cross-linked polyvinylpyrrolidone were respectively passed through a 100-mesh sieve, weighed according to the amount and added in sequence, sieved and mixed, pressed into tablets, and passed through a 18-mesh sieve for dry granulation. Then add the magnesium ...

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Abstract

The invention belongs to the technical field of medicines and relates to an olanzapine orally-disintegrating tablet preparation and a preparation method thereof. The orally-disintegrating tablet comprises the following components in weight percentage: 2.5%-10% of olanzapine, 35%-74% of mannitol, 10%-40% of lactose, 0-10% of dry adhesives, 2.0%-10% of disintegrating agents, 0.1%-6% of flavoring agents and 0.4%-3% of lubricants. A dry-method direct tablet compressing technology and a dry-compressing particle tablet compressing technology can be adopted in the preparation process. The invention aims to provide an olanzapine orally-disintegrating tablet having simple preparation process, low cost, convenient taking and rapid effect taking. After being orally taken, the olanzapine orally-disintegrating tablet is rapidly disintegrated and dispersed into fine particles or powder and is especially suitable for patients with dysphagia and psychopaths; as the preparation exists in a fine particle or powder form before arriving at gastrointestinal tracts, medicines have quickened dissolution, large distribution area in the gastrointestinal tracts and more adsorption points; and for indissoluble medicines, such as the olanzapine, the bioavailability of the indissoluble medicines can be improved.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to an orally disintegrating olanzapine tablet and a preparation method thereof. Background technique [0002] The chemical name of Olanzapine is 2-methyl-10-(4-methyl-1-piperazine)-4H-thieno[2,3-b][1,5]benzodiazepine It is used for the acute and maintenance treatment of schizophrenia and other psychosis with severe positive symptoms and / or negative symptoms, and can also alleviate the secondary affective symptoms of schizophrenia and related diseases. As a new type of antipsychotic drug, this product has the advantages of good long-term curative effect and few side effects, and has been highly recognized by clinicians. At present, the dosage forms abroad include ordinary tablets, orodispersible tablets, orally disintegrating tablets and intramuscular injections; piece. [0003] Dysphagia is a common side effect of antipsychotic drugs. Therefore, for patients ...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/551A61K47/26A61K47/36A61K47/38A61P25/18
Inventor 李伯涛王晶翼李长军于艳玲杨清敏李颖张明会
Owner QILU PHARMA
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