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Novel Olanzapine orally disintegrating tablet

An orally disintegrating tablet and olanzapine technology are applied in the field of preparation of the olanzapine orally disintegrating tablet, and can solve the problems of non-compliance, negative influence of treatment effect, poor treatment effect, etc., so as to cover bitter taste and improve treatment compliance. sex, improve taste

Active Publication Date: 2011-09-14
ZHEJIANG HUAHAI PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This results in poor or even non-compliant treatment, with considerable negative impact on therapeutic efficacy (H. Seager, 1998, J Pharm. Pharmacol. 50, 375-382)

Method used

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  • Novel Olanzapine orally disintegrating tablet
  • Novel Olanzapine orally disintegrating tablet
  • Novel Olanzapine orally disintegrating tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0168] (1) Production of olanzapine coated particles

[0169] In a fluidized bed coating granulator [produced by Chongqing Yingge (China), WBF-III type], load 1500 g of spherical granulated products (microcrystalline cellulose) with an average particle size of 106-212 μm and containing microcrystalline cellulose Cellulose CP 102 is manufactured by Asahi Chemical Co., Ltd (Japan). The air inlet temperature and material temperature are controlled at 50-70°C and 35-45°C respectively, and the atomization pressure is controlled at 1.5-2.5Bar. The olanzapine coating disperse phase is coated on the neutral core with the spray rate of 16g / min by spray coating process.When the olanzapine coating disperse phase of prescribed amount has been coated, stop this bottom spray coating operation, The resulting granules were then dried in a coating granulator to obtain approximately 1807 g of olanzapine coated granules.

[0170] Olanzapine coating phase:

[0171] Olanzapine (form II, particle...

Embodiment 2

[0209] (1) Production of olanzapine coated particles

[0210] In a fluidized bed coating granulator [produced by Chongqing Yingge (China), WBF-III type], load 1500g average particle diameter about 100 μm spray-dried mannitol spherical granules (mannitol 100SD, produced by Roquette (France) product) production. Control the air inlet temperature and material temperature at 50-70°C and about 35-45°C respectively, control the atomization pressure at 1.5-2.5Bar, and apply olanzapine at a spray rate of 20g / min by top spray coating process The dispersed phase is coated on a neutral core. The top spray coating operation was stopped when a prescribed amount of olanzapine-coated dispersed phase had been coated, and then the resulting granules were dried in a coating granulator to obtain about 2000 g of olanzapine-coated granules.

[0211] Olanzapine coating phase:

[0212] Olanzapine (form II, particle size D(V, 0.9)≤20μm) 500g

[0213] HPMC E5 PREM LV 85g

[0214] Purified water 1...

Embodiment 3

[0229] (1) Production of olanzapine coated particles

[0230] In a fluidized bed coating granulator [produced by Chongqing Yingge (China), WBF-III type], load 1200g average particle diameter about 100 μ m spray-dried mannitol spherical particles (mannitol 100SD, produced by Roquette (France) product) production. Control the air inlet temperature and material temperature at 50-70°C and about 35-45°C respectively, control the atomization pressure at 1.5-2.5Bar, and apply olanzapine at a spray rate of 19g / min by top spray coating process The dispersed phase is coated on a neutral core. The top spray coating operation was stopped when the prescribed amount of the olanzapine-coated dispersed phase had been coated, and then the resulting granules were dried in a coating granulator to obtain about 1300 g of olanzapine-coated granules.

[0231] Olanzapine coating phase:

[0232] Olanzapine (form II, particle size D(V, 0.9)≤20μm) 150g

[0233] PVP K30 25g

[0234] Purified water 4...

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Abstract

The invention relates to a novel Olanzapine orally disintegrating tablet. The tablet comprises (I) a stabilizing Olanzapine coating particulate and (II) an additive, wherein the stabilizing Olanzapine coating particulate contains: (i) a neutral core; (ii) an active layer surrounding the neutral core; and (iii) a protective layer surrounding the active layer. The invention also relates to a preparation method of the stabilizing Olanzapine coating particulate and the novel Olanzapine orally disintegrating tablet containing the stabilizing Olanzapine coating particulate.

Description

technical field [0001] The invention relates to an orally disintegrating tablet of olanzapine. The present invention also relates to a preparation method of the olanzapine orally disintegrating tablet. Background technique [0002] Oral Disintegration Technology [0003] Oral disintegration technology involves the technical field of oral immediate release preparations, mainly including: freeze-drying oral disintegration technology, wet particle molded tablet oral disintegration technology, blank high-performance excipient tablet oral disintegration technology, conventional tablet oral disintegration technology technology. [0004] Freeze-drying orally disintegrating technology is a drying method that pre-freezes the drug solution that needs to be dried into a solid, and then sublimates directly from the frozen state without melting into a liquid state under low temperature and low pressure conditions. Its main preparation process: the suspension of drug and matrix is ​​q...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/5513A61K47/38A61P25/18
Inventor 代孔恩魏方王红莲辛家华李巧霞彭俊清胡功允
Owner ZHEJIANG HUAHAI PHARMA CO LTD
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