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Oral lurasidone suspension and preparation method thereof

The technology of an oral suspension and lurasidone, which is applied in the field of oral suspension containing lurasidone or its salt and its preparation, can solve the problems that patients' symptoms cannot be alleviated, and achieve good taste and simple preparation method , the effect of easy dosage

Inactive Publication Date: 2015-05-13
AVENTIS PHARMA HAINAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Despite the remarkable achievements in the treatment of schizophrenia in recent years, 30% of patients still have no remission of symptoms, and 60% of recovered patients will relapse for some reason within 2 years

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] ingredient name Dosage (g / 100mL) lurasidone hydrochloride 0.25 hypromellose 0.5 Polysorbate 80 0.05 citric acid 0.2 sodium citrate 0.05 Ethylparaben 0.05 Mannitol 10 strawberry flavor 0.5 purified water Add to 100mL

[0028] Preparation:

[0029] (1) Take 50mL of purified water and heat it to 80~90℃, add ethylparaben and stir to dissolve;

[0030] (2) Add citric acid, sodium citrate, mannitol, and strawberry essence to the ethylparaben solution prepared in step (1), stir to dissolve, and set aside;

[0031] (3) Under magnetic stirring, add hypromellose to the solution prepared in step (2), disperse it evenly, and prepare a uniform suspension system;

[0032] (4) Mix 20mL of purified water and polysorbate 80 evenly to prepare a dispersion;

[0033] (5) Mix the micronized lurasidone hydrochloride and the dispersion prepared in step (4) evenly, add it to the suspension system obtained in step (3), add ...

Embodiment 2

[0035] ingredient name Dosage (g / 100mL) lurasidone hydrochloride 0.5 xanthan gum 0.3 colloidal silica 1.0 Polysorbate 80 0.25 citric acid 0.2 sodium citrate 0.05 Ethylparaben 0.05 xylitol 20 strawberry flavor 0.5 purified water Add to 100mL

[0036] Preparation:

[0037] (1) Take 50mL of purified water and heat it to 80~90℃, add ethylparaben and stir to dissolve;

[0038] (2) Add citric acid, sodium citrate, xylitol, and strawberry essence to the ethylparaben solution prepared in step (1), stir to dissolve, and set aside;

[0039] (3) Under magnetic stirring, add xanthan gum and colloidal silica to the solution prepared in step (2), disperse them evenly, and prepare a uniform suspension system;

[0040] (4) Mix 20mL of purified water and polysorbate 80 evenly to prepare a dispersion;

[0041] (5) Mix the micronized lurasidone hydrochloride and the dispersion prepared in step (4) evenly, add it to the...

Embodiment 3

[0043] ingredient name Dosage (g / 100mL) lurasidone hydrochloride 1.0 Sodium carboxymethyl cellulose 3.0 Poloxamer 188 1.0 citric acid 0.2 sodium citrate 0.1 sodium benzoate 0.2 xylitol 30 orange flavor 1.0 purified water Add to 100mL

[0044] Preparation:

[0045] (1) Take 50mL of purified water, add sodium benzoate, stir to dissolve;

[0046] (2) Add citric acid, sodium citrate, xylitol, and orange flavor to the sodium benzoate solution prepared in step (1), stir to dissolve, and set aside;

[0047] (3) Under magnetic stirring, add sodium carboxymethylcellulose into the solution prepared in step (2), disperse it evenly, and prepare a uniform suspension system;

[0048] (4) Mix 20mL of purified water and Poloxamer 188 evenly to prepare a dispersion;

[0049] (5) Mix the micronized lurasidone hydrochloride and the dispersion prepared in step (4) evenly, add it to the suspension system obtained in step (3), ...

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Abstract

The invention discloses an oral lurasidone suspension and a preparation method thereof. The lurasidone suspension is a pharmaceutical composition which comprises lurasidone or salt thereof, a suspending aid, a wetting agent, a pH regulator, a preservative, a sweetening agent and a corrigent, wherein the particle size range of the lurasidone or salt thereof is 0.1-20 microns. The prepared oral suspension has the characteristics of being stable in quality and favorable in taste, facilitates dose distribution, and is beneficial to the acceptance of schizophrenia patients, simple in preparation method and suitable for industrial production.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to an oral suspension containing lurasidone or a salt thereof and a preparation method thereof. Background technique [0002] Schizophrenia (schizophrenia) is a group of severe mental illnesses of unknown etiology. Currently, the number of patients worldwide is as high as 24 million. Patients often lose the ability to live independently and have a high suicide rate when they attack. In addition, they are also accompanied by obesity, high blood pressure, diabetes and cardiovascular disease, etc. Although remarkable achievements have been made in the treatment of schizophrenia in recent years, 30% of patients still cannot relieve their symptoms, and 60% of those who recover will relapse for some reason within 2 years. With the increasing pressure of modern society, there are more and more patients with schizophrenia, and the market is also growing. [0003] Lurasidone (luras...

Claims

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Application Information

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IPC IPC(8): A61K9/10A61K31/496A61P25/18
Inventor 石娟刁媛媛马苏峰
Owner AVENTIS PHARMA HAINAN
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