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Sustained-release suspension with lurasidone and preparation method of sustained-release suspension

A sustained-release suspension, lurasidone hydrochloride technology, applied in the field of sustained-release suspension composition containing lurasidone or its salt and its preparation, can solve bad mouthfeel, tablet swallowing difficulties, prolonged Solve problems such as the release time of lurasidone hydrochloride to achieve the effect of delaying drug release and improving compliance

Inactive Publication Date: 2015-10-21
AVENTIS PHARMA HAINAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The purpose of the present invention is to solve the problems existing in the prior art, providing a kind of oral sustained-release suspension containing lurasidone hydrochloride, which effectively prolongs the release time of lurasidone hydrochloride and avoids the rapid release preparation The peak and valley phenomenon of blood drug concentration improves the bad taste of the drug at the same time, and solves problems such as difficulty in swallowing tablets

Method used

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  • Sustained-release suspension with lurasidone and preparation method of sustained-release suspension

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-3

[0020] Prescription composition:

[0021] Name of raw material effect Example 1(g) Example 2(g) Example 3(g) lurasidone hydrochloride Main drug 2 4 6 Xylitol Water Soluble Excipients 2 4 6 twain D 0.05 0.1 0.15 polyacrylic resin RS Microcapsule coating material 2.5 5 7.5 triethyl citrate plasticizer 0.5 1 1.5 xanthan gum suspending agent 2 4 6 sucrose flavoring agent 2 4 6 Ethylparaben preservative 0.005 0.01 0.015 pure water dispersion medium up to 100ml up to 100ml up to 100ml

[0022] Preparation Process:

[0023] (1) Preparation of lurasidone hydrochloride suspension: add 0.5g Tween into 200ml pure water, stir well, then add 40g co-powder of lurasidone hydrochloride and xylitol (1:1), and disperse ;

[0024] (2) Preparation of lurasidone hydrochloride microcapsules: 25g of polyacrylic resin RS and 5g of triethyl citrate were dissolved in 500ml of ethanol with ...

Embodiment 4-6

[0027] Prescription composition:

[0028] Name of raw material effect Example 4(g) Example 5(g) Example 6(g) lurasidone hydrochloride Main drug 4 4 4 Xylitol Water Soluble Excipients 2 4 6 twain D 0.1 0.1 0.1 Ethyl cellulose Microcapsule coating material 2.5 5 7.5 Diethyl phthalate plasticizer 0.5 1 1.5 hypromellose suspending agent 4.5 4.5 4.5 sucrose flavoring agent 2 3 4 Sorbic acid preservative 0.01 0.01 0.01 pure water dispersion medium up to 100ml up to 100ml up to 100ml

[0029] Preparation Process:

[0030] According to the content of the invention, the preparation method of lurasidone hydrochloride sustained-release suspension is prepared, and ethanol is selected as the solvent of the microcapsule coating material. Attention should be paid to the calculation of the drug content in the microcapsules, and the corresponding microcapsules should be injected ac...

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Abstract

The invention belongs to the field of pharmaceutic preparations, and particularly relates to a sustained-release suspension composition with lurasidone or salt of the lurasidone and a preparation method of the sustained-release suspension composition. A sustained-release suspension comprises the lurasidone or the salt, capable of being medically accepted, of the lurasidone and a sustained-release micro-capsule coating material medicine composition. According to the preparation, the release time of lurasidone hydrochloride is effectively prolonged, and the blood concentration peak valley phenomenon caused by quick release preparations is avoided. The sustained-release suspension with the lurasidone is low in production cost and has the good taste and medicine release character, the preparation process of the sustained-release suspension with the lurasidone is convenient, and the aim of providing the preparation with the lurasidone or the salt, capable of being medically accepted, of the lurasidone for a patient is achieved, wherein the preparation is convenient to take, high in bioavailability and mild in medicine release.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a sustained-release suspension composition containing lurasidone or a salt thereof and a preparation method thereof. Background technique [0002] Lurasidone is an atypical antipsychotic drug with the chemical name N-[4-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]-(2R, 3R)-2,3-tetramethylene-butyl]-(1'R,2'S,3'R,4'S)-2,3-bicyclo[2,2,1]heptanediimide, which The chemical structural formula is as follows: [0003] [0004] The pharmaceutically acceptable salt of lurasidone is hydrochloride. In October 2010, the U.S. FDA approved the listing of Lurasidone Hydrochloride Tablets of Sumitomo Pharmaceutical Co., Ltd., Japan, with the trade name Latuda, once a day, for the first-line treatment of patients with schizophrenia. Lurasidone is a dopamine D2 / 5-HT2A receptor dual antagonist, which has significant curative effect on both positive and negative symptoms of psychotic p...

Claims

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Application Information

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IPC IPC(8): A61K9/10A61K31/496A61K47/32A61K47/34A61K47/38A61P25/18
Inventor 于红霞马莉
Owner AVENTIS PHARMA HAINAN
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