Lurasidone orally disintegrating tablet

Abstract

The invention belongs to the field of pharmaceutical preparations and in particular relates to an orally disintegrating tablet containing lurasidone or a salt thereof and a preparation method thereof. The orally disintegrating tablet is a pharmaceutical composition containing the lurasidone or a pharmaceutically acceptable lurasidone acid addition salt and amorphous silicon dioxide, wherein the particle size range of the lurasidone or the salt thereof is 0.1-10 mu m, the using amount of the amorphous silicon dioxide is 1-30%, and the orally disintegrating tablet has effective storage life. The invention provides the lurasidone orally disintegrating tablet with convenient preparation process, low production cost and effective storage life and aims at providing the preparation containing the lurasidone or the pharmaceutical acceptable salt thereof, which has the advantages of convenience in administration, rapidness in absorption and high bioavailability, for patients.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to an orally disintegrating tablet containing lurasidone and a salt thereof and a preparation method thereof. Background technique [0002] Schizophrenia is a common mental illness. According to estimates by the World Health Organization, the lifetime prevalence rate of schizophrenia in the world is about 3.8‰-8.4‰. According to research in the United States, the lifetime prevalence rate is as high as 13‰; my country 1994 According to the annual survey data, the prevalence rate in urban areas is 7.11‰, and that in rural areas is 4.26‰. The etiology of schizophrenia is complex and has not yet been fully elucidated. It mostly occurs in young and middle-aged people, manifested as obstacles in perception, thinking, emotion, will, and other aspects. Mental activities are not coordinated with the surrounding environment and inner experience, and are divorced from reality. General...

AI Technical Summary

Problems solved by technology

Lurasidone preparations currently on the market only have ordinary tablets, which need to be swallowed with water, and dysphagia is one of the common adverse symptoms of patients with schizophrenia. Compliance, such as the new technology of lurasidone hydrochloride orally disintegrating tablets reported in patent CN201210589694.8

[0004] However, the above technology still has shortcomings: due to the special way of taking orally disintegrating tablets, it is required to disintegrate completely within 60s, otherwise it will cause discomfort to the user and reduce the compliance of the user, so the orally disintegrating tablet needs to Satisfies the characteristics of rapid disintegration, but also leads to the special sensitivity of orally disintegrating tablets to moisture or environmental humidity

After research, it was found that the commercially available tablets and lurasidone hydrochloride orally disintegrating tablets reported in patent CN201210589694.8 also have the problem of decreased dissolution rate after being placed under high humidity conditions

At the same time, due to the special sensitivity of orally disintegrating tablets to moisture or environmental humidity, even if strict control of product moisture and environmental humidity can delay the decline in the dissolution rate, the dissolution rate will still decline significantly after the accelerated test. It increases the cost of production and packaging, is not conducive to long-term storage of products, shortens the validity period of products, and causes waste of resources

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