Lurasidone sublingual tablet and preparation method thereof

Abstract

The invention discloses a sublingual tablet containing lurasidone hydrochloride or salt thereof and a preparation method of the sublingual tablet. The sublingual tablet is prepared from the following raw materials in parts by mass: 4 to 8 parts of lurasidone or a salt thereof, 2 to 6 parts of sorbitol, 4 to 8 parts of mannitol, 0.5 to 1.5 parts of polyvinylpolypyrrolidone, 0.1 to 0.5 part of hydroxy propyl cellulose, 0.1 to 0.2 part of aspartame and 0.1 to 0.2 part of magnesium stearate, wherein the particle size range of the lurasidone or the salt thereof is 0.1 to 10 microns. The sublingual tablet disclosed by the invention is convenient in preparation process, high in drug content, high in disintegration speed, good in permeable membrane absorption and good in in-vitro dissolution and taste, and a preparation containing lurasidone or salt thereof, which is convenient to take, quick to absorb and high in bioavailability, can be provided for patients.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a lurasidone sublingual tablet and a preparation method thereof. Background technique [0002] Schizophrenia (schizophrenia) is a common mental disease whose etiology has not been fully elucidated. It usually occurs in young adults, and often has obstacles in perception, thinking, emotion, and behavior, and generally unconsciousness and intellectual disabilities. The course of the disease is protracted and recurrent, and some patients suffer from mental activity decline and varying degrees of social function impairment, accounting for more than half of the inpatients in the psychiatric department, and about half of the patients in the final outcome are mentally disabled, which brings serious harm to the society, patients and their families. burden. [0003] Lurasidone hydrochloride is a new antipsychotic drug with dual effects developed by Sumitomo Pharmace...

AI Technical Summary

Problems solved by technology

[0008] Lurasidone ordinary tablets have the following disadvantages, they need to be swallowed with water, and the disintegration speed is slow, and the onset time is long

However, patients with schizophrenia generally have dysphagia and poor compliance, and it is difficult to achieve the effect of drug treatment. Therefore, it is necessary to develop a new type of drug that can disintegrate in the oral cavity without water or swallow, and can be well absorbed through the membrane under the tongue. tablet

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