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Orally disintegrating tablet containing lurasidone and preparation method thereof

A technology of orally disintegrating tablets and lurasidone hydrochloride is applied to medical preparations containing active ingredients, medical preparations without active ingredients, and pharmaceutical formulas, which can solve problems such as poor dissolution in vitro and bad taste. Achieving good taste, avoiding false medication, and good dissolution rate in vitro

Active Publication Date: 2016-11-09
CHENGDU KANGHONG PHARMA GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0017] In order to solve the problems existing in the prior art, the present invention provides an orally disintegrating tablet containing lurasidone hydrochloride, which effectively solves the poor in vitro dissolution and bad taste of lurasidone hydrochloride orally disintegrating tablets The problem

Method used

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  • Orally disintegrating tablet containing lurasidone and preparation method thereof
  • Orally disintegrating tablet containing lurasidone and preparation method thereof
  • Orally disintegrating tablet containing lurasidone and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0056] Example 1 Fluidity detection of lurasidone hydrochloride

[0057] According to above-mentioned fluidity detection method, measure the fluidity of lurasidone hydrochloride, the result is as follows:

[0058] The angle of repose of D90≤250um powder is 39.7°;

[0059] The angle of repose of D90≤75um powder is greater than 60°, about 60-80°, and the reproducibility of the results is poor;

[0060] D90≤30um powder cannot pass through the funnel, and the angle of repose cannot be detected.

Embodiment 2

[0061] Example 2 Preparation of orally disintegrating tablets by wet granulation process

[0062] Lurasidone hydrochloride is a white or off-white powder with poor fluidity and a bitter taste, making it difficult to prepare orally disintegrating tablets with good mouthfeel. The contriver finds by a large number of tests surprisingly, when choosing pH-dependent solubility material such as acrylic resin E100, acrylic resin EPO as binding agent, lurasidone hydrochloride is granulated alone or with some auxiliary materials earlier, can well Solve the fluidity and bitterness of this product. And adopt conventional binder material, when as binder of the present invention such as povidone k30, hypromellose, ethyl cellulose, 70% ethanol, though can solve the problem of its fluidity difference, but Cannot effectively mask the bitter taste of disintegrating tablets.

[0063] This experiment adopts the prescription: lurasidone hydrochloride (D90≤75um) 26.7%, mannitol 53.0%, microcrysta...

Embodiment 3

[0069] Example 3 Preparation of orally disintegrating tablets by direct compression of powder

[0070] The powder direct compression method has the advantages of simple process, energy saving and time saving, and is conducive to continuous and automatic production. However, this process has higher requirements on the fluidity, compressibility and lubricity of the material. In order to meet the requirements of oral disintegration and improve compliance, the material must also have good disintegration or dissolution properties, as well as good taste. The challenge is: lurasidone hydrochloride API has poor fluidity and is difficult to dissolve in water, so a large number of fillers must be used to improve it, which may lead to the consequences of heavy tablets and a large number of tablets taken, which is different from The need to improve medication compliance in psychiatric patients is conflicting.

[0071] The inventor investigated the feasibility of directly compressing the...

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Abstract

The invention relates to an orally disintegrating tablet containing hydrochloric acid lurasidone and a preparation method thereof. The orally disintegrating tablet contains the hydrochloric acid lurasidone, a filling agent, a disintegrating agent, a flavoring agent and a lubricating agent; meanwhile, the grain diameter D90 of the hydrochloric acid lurasidone is controlled to be smaller than 75mum. The orally disintegrating tablet containing the hydrochloric acid lurasidone has good in-vitro dissolution and good mouthfeel. The orally disintegrating tablet has the advantages that the preparation process is simple; the industrialized mass production can be realized by ordinary pelletizing and tabletting equipment.

Description

[0001] This application is a divisional application with the application number CN201210241053.3, the application date is July 12, 2012, and the invention title is "an orally disintegrating tablet containing lurasidone and its preparation method". technical field [0002] The invention relates to the field of pharmaceutical preparations. Specifically relates to an orally disintegrating tablet containing lurasidone and a preparation method thereof. Background technique [0003] Schizophrenia (schizophrenia) is a common mental illness whose etiology has not been fully elucidated. It usually occurs in young adults, often with disturbances in perception, thinking, emotion, and behavior, and generally unconsciousness and mental retardation. The course of the disease is often protracted, accounting for more than half of the inpatients in the psychiatric department, and the final outcome is about half of the patients have mental disabilities, which brings a serious burden to the so...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/496A61K47/10A61P25/18
CPCA61K9/0056A61K9/2018A61K9/2095A61K31/496
Inventor 柯潇郑强
Owner CHENGDU KANGHONG PHARMA GRP
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