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Lurasidone hydrochloride orally disintegrating tablet and preparation method thereof

A technology of lurasidone hydrochloride orally disintegrating tablets and lurasidone hydrochloride, which is applied in the direction of pharmaceutical formulas, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., and can solve the problem of material growth and sugar substances Problems such as excessive intake

Inactive Publication Date: 2017-08-04
万全万特制药江苏有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The invention provides a powder coating technology that can improve the mouthfeel of lurasidone hydrochloride orally disintegrating tablets, and overcome the bitterness of lurasidone hydrochloride itself or the excessive intake of sugar substances caused by the use of too much corrective agent. raises questions about material growth, etc.

Method used

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  • Lurasidone hydrochloride orally disintegrating tablet and preparation method thereof
  • Lurasidone hydrochloride orally disintegrating tablet and preparation method thereof
  • Lurasidone hydrochloride orally disintegrating tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022]

[0023] Preparation

[0024] (1) Add a certain amount of acrylic resin E100 to an appropriate amount of ethanol (80%), use a high-shear homogenizer or colloid mill to fully homogenize for 10 minutes, and set aside;

[0025] (2) Weigh an appropriate amount of lurasidone hydrochloride powder and co-powder with mannitol, put it in a fluidized bed to make it fully fluidized, and then spray the coating solution at an appropriate speed for powder coating to obtain lurasidone hydrochloride Coated granules with ketone powder and mannitol powder, passed through a 0.5mm sieve after drying for later use;

[0026] (3) Add menthol passed through a 80-mesh sieve and mix well;

[0027] (4) Add microcrystalline cellulose passing through 80 mesh sieve and mix evenly, use pure water as wetting agent, granulate with 24 mesh sieve, dry in a 50°C oven with air blast, dry the moisture to 1-3%, pass the dried granules through Sieve with 24 meshes, weigh, calculate the yield, add microcr...

Embodiment 2

[0030]

[0031] Preparation

[0032] (1) Add a certain amount of behenic acid glyceride into an appropriate amount of ethanol (80%), use a high-shear homogenizer or a colloid mill to fully homogenize for 10 minutes, and set aside;

[0033] (2) Weigh an appropriate amount of lurasidone hydrochloride powder and co-powder with sorbitol, put it in a fluidized bed to make it fully fluidized, and then spray the coating solution at an appropriate speed for powder coating to obtain lurasidone hydrochloride Coated granules of ketone powder and sorbitol powder, passed through a 0.5mm sieve after drying for later use;

[0034] (3) Add menthol passed through a 80-mesh sieve and mix well;

[0035] (4) Add microcrystalline cellulose passing through 80 mesh sieve and mix evenly, use pure water as wetting agent, granulate with 24 mesh sieve, dry in a 50°C oven with air blast, dry the moisture to 1-3%, pass the dried granules through Sieve with 24 meshes, weigh, calculate the yield, add m...

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Abstract

The invention belongs to the field of pharmaceutic preparation and specifically relates to a lurasidone hydrochloride orally disintegrating tablet and a preparation method thereof. The orally disintegrating tablet is prepared according to the following steps: taking lurasidone hydrochloride as a raw material; taking filler, disintegrating agent, corrigent and lubricating agent as ingredients; using a coating material under a specific condition, adopting a specific preparation method for preparing and adopting a tablet press for tableting. The invention can solve the problem of the reducing drug dissolution in long-term storage process and the problem of the taste of the lurasidone hydrochloride orally disintegrating tablet.

Description

technical field [0001] The application belongs to the technical field of pharmaceutical preparations, and in particular relates to a lurasidone hydrochloride orally disintegrating tablet powder coating technology for masking taste and increasing drug stability and a preparation method thereof. Background technique [0002] Schizophrenia is a common mental illness whose etiology has not been fully elucidated. It usually occurs in young adults, often accompanied by obstacles in perception, thinking, emotion, and behavior, and generally unconsciousness and mental retardation. The course of the disease is often protracted and recurrent, and some patients suffer from mental activity decline and varying degrees of social function impairment, which brings serious burdens to the society, patients and their families. With the development of society and the increasing pressure of life, people's demand for antipsychotic drugs is increasing day by day. [0003] Atypical antipsychotic d...

Claims

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Application Information

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IPC IPC(8): A61K9/32A61K9/28A61K31/496A61K47/38A61P25/18
CPCA61K9/0056A61K9/2054A61K9/2081A61K9/2095A61K9/282A61K9/2846A61K31/496
Inventor 王少辰王宇杰
Owner 万全万特制药江苏有限公司
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