Lurasidone hydrochloride oral preparation and preparing method of lurasidone hydrochloride oral preparation

Abstract

The invention provides a lurasidone hydrochloride oral preparation and a preparing method of the lurasidone hydrochloride oral preparation. The lurasidone hydrochloride oral preparation comprises lurasidone hydrochloride accounting for 20 to 45 weight percent of the oral preparation and cellulose derivatives accounting for 5 to 30 weight percent of the oral preparation, wherein the cellulose derivatives are a mixture of low-substituted hydroxypropyl cellulose and croscarmellose sodium. The lurasidone hydrochloride oral preparation has the advantages that the low-substituted hydroxypropyl cellulose and the croscarmellose sodium are simultaneously used as disintegrating agents, so that lurasidone hydrochloride tablets can be fast dissolved out, even when the content of active ingredients in the preparation is changed, the dissolution characteristics are also identical to the reference preparation, and the in-batch differences are small. In addition, according to the raw material processing mode, the raw material yield is higher, and the loss is less.

Description

technical field [0001] The invention belongs to the technical field of medicines, in particular to a lurasidone hydrochloride oral preparation and a preparation method thereof. Background technique [0002] Lurasidone (lurasidone) is a kind of atypical antipsychotic drug developed by Japan's Sumitomo Pharmaceutical Company, which has been marketed in the United States in the form of film-coated tablets (20mg, 40mg, 80mg, 120mg / tablet). On October 28, 2010, the U.S. Food and Drug Administration (FDA) approved Latuda (lurasidone hydrochloride) for the treatment of schizophrenia; on June 28, 2013, two new indications approved by FDA, One as monotherapy and the other as adjunctive drug therapy to lithium or sodium valproate for major depressive episodes associated with bipolar I disorder in adult patients. [0003] Lurasidone was significantly more effective than placebo in patients with schizophrenia. Lurasidone has no gender, age, and race differences in the treatment of sch...

AI Technical Summary

Problems solved by technology

However, since lurasidone is a poorly soluble drug, sufficient immediate release and solubility cannot be obtained under many prescription preparation conditions

[0006] At present, in order to solve the above problems, some researchers micronize the raw materials to control the particle size of the raw materials in the preparation process of lurasidone hydrochloride preparations, and then mix and granulate them with other auxiliary materials to achieve lurasidone hydrochloride tablets. Better dissolution rate in the dissolution medium, but we found in the experiment that the raw material has a large static electricity after the raw material is micronized, and the loss is relatively large during the raw material processing process

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