Fast-release lurasidone hydrochloride tablet and preparation process thereof

Abstract

The invention relates to a lurasidone hydrochloride tablet which is used for treating severe depression related to bipolar I disorder of pediatric patients and can realize rapid and complete drug release and a preparation process of the lurasidone hydrochloride tablet. The drug and a part of diluent are dissolved in a mixed solvent of an organic solvent and water, then the drug and the part of diluent are mixed with remaining auxiliary materials at a high speed, dried, granulated and tableted to obtain the lurasidone hydrochloride tablet. Compared with the prior art, the lurasidone hydrochloride tablet is simple in preparation process, low in energy consumption, rapid to release and good in release repeatability, and the preparation is stable after accelerated test.

Description

technical field [0001] The invention relates to the field of pharmacy, in particular to a lurasidone hydrochloride tablet capable of rapid and complete drug release for treating severe depression associated with bipolar I disorder in pediatric patients and a preparation process thereof. Background technique [0002] Lurasidone Hydrochloride is an atypical antipsychotic drug developed by Sumitomo, Japan. It was approved by the FDA for the first-line treatment of schizophrenia on October 28, 2010. The trade name is Latuda, and the preparation form is a tablet. As of August 2019, there were 44 records about the drug in the US Orange Book; in addition, on January 3, 2019, the drug was approved by the FDA for the treatment of major depression associated with bipolar I disorder in pediatric patients. It can be seen that even after nearly 9 years of listing, the drug still has great potential in the subdivision of psychiatric diseases. At present, Sumitomo Pharmaceutical (Suzhou)...

AI Technical Summary

Problems solved by technology

However, compared with the above-mentioned pulverization and sieving method, micronization consumes more energy and is more dangerous, and the powder fluidity is poor, which limits the use of wet granulation, and the steps are cumbersome

In addition, the above-mentioned patents only paid attention to the dissolution of the preparation, but did not pay attention to the preparation stability of lurasidone hydrochloride

[0004] In order to overcome the drawbacks of the existing process, which are cumbersome and high energy consumption, and improve the release speed and release degree of lurasidone hydrochloride preparations, the invention provides a fast-release lurasidone hydrochloride tablet, which is compatible with Compared with the prior art, the preparation process of the tablet is very simple, and the release reproducibility of the preparation is good, and the chemical stability of the preparation is good

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