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Lurasidone solid dispersion and preparation method thereof

A technology of solid dispersion and lurasidone, which is applied in the field of medicine, can solve problems such as refusal to eat, delayed patient's condition, and low bioavailability

Active Publication Date: 2022-01-11
SUNSHINE LAKE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] However, the bioavailability of lurasidone tablets currently on the market is low, and it must be taken with food at the same time. -The area under the curve (AUC) decreased by 3 times and 2 times respectively, even so the bioavailability is only 9%-19%
However, the medication requirements of this drug are relatively strict for patients with schizophrenia and depression. They usually do not strictly count calories when eating normally, and some patients may have symptoms of refusal to eat or loss of appetite. If they do not eat enough Taking medicine with food may lead to a decrease in the bioavailability of the drug, affecting the curative effect and delaying the patient's condition

Method used

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  • Lurasidone solid dispersion and preparation method thereof
  • Lurasidone solid dispersion and preparation method thereof
  • Lurasidone solid dispersion and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0100] The specific prescription is shown in Table 7.

[0101] Table 7

[0102]

[0103] Weigh the components contained in the hot-melt process according to the prescription shown in Table 7, mix them thoroughly and add them to the powder feeder of the hot-melt extruder. ℃, 165℃, 165℃, 165℃, 160℃, the screw speed is set to 30rpm, hot-melt extrusion, the extruded product is cooled and crushed, the crushed material passes through a 60-mesh sieve, and the additive microcrystal is added according to the prescription The cellulose is mixed, and the resulting mixture is filled into capsules.

Embodiment 2

[0105] According to the prescription and preparation process of Example 1, the obtained granules are finally poured into the shell of enteric-coated capsules.

Embodiment 3

[0107] The specific prescription is shown in Table 8.

[0108] Table 8

[0109]

[0110]

[0111] Weigh the components contained in the hot-melt process according to the prescription shown in Table 8, mix them thoroughly and add them to the powder feeder of the hot-melt extruder. ℃, 170℃, 170℃, 170℃, 165℃, the screw speed is set to 30rpm, hot-melt extrusion, the extrudate is cooled and crushed, the crushed material passes through a 60-mesh screen, and the additive microcrystal is added according to the prescription Cellulose, mixed, filled with capsules.

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Abstract

The present invention proposes a lurasidone solid dispersion and a preparation method thereof, the method comprising: melting a mixture containing lurasidone, a medicinal hot-melt carrier, and optionally adding an acid regulator and a plasticizer processing in order to obtain said solid dispersion, wherein said lurasidone is in free base form. The lurasidone solid dispersion obtained by the preparation method according to the embodiment of the present invention has the characteristics of high dissolution rate (dissolution rate can reach 30%-70%) in neutral medium (eg, pH 6.0). The bioavailability of the lurasidone solid dispersion in the embodiment of the present invention is significantly improved, and the food effect is significantly reduced; it overcomes the excessive medication restrictions in the prior art, and avoids the reduction or even ineffectiveness of the curative effect caused by improper medication for patients , To ensure the normal performance of the drug effect, thus increasing the flexibility and compliance of patients taking medicine.

Description

[0001] priority information [0002] This application claims the priority and rights of the patent application No. 201710009826.8 filed with the State Intellectual Property Office of China on January 06, 2017, and is hereby incorporated by reference in its entirety. technical field [0003] The invention relates to the field of medicine, in particular, the invention relates to a lurasidone solid dispersion, a method for preparing the lurasidone solid dispersion, a pharmaceutical composition, a drug combination and the use of the pharmaceutical composition in preparing medicine. Background technique [0004] Lurasidone hydrochloride is a kind of atypical antipsychotic drug, and on October 28, 2010, the U.S. Food and Drug Administration (FDA) approved the listing of lurasidone hydrochloride tablets of Sumitomo Pharmaceutical Co., Ltd., Japan, with trade name Latuda, specifications There are 20mg, 40mg, 60mg, 80mg, and 120mg / tablet respectively for the treatment of schizophreni...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K31/496A61K47/32A61K47/38A61P25/18
CPCA61K31/496A61P25/18A61K9/2054A61K9/4833A61K9/4858A61K9/4866A61K9/4891
Inventor 许玉珍田宁黄心游劲松黄芳芳
Owner SUNSHINE LAKE PHARM CO LTD