Lurasidone hydrochloride orally disintegrating tablet and preparation method thereof

Abstract

The invention provides a lurasidone hydrochloride orally disintegrating tablet containing indissolvable drugs. The lurasidone hydrochloride orally disintegrating tablet comprises 8%-24% of lurasidone hydrochloride, 8%-48% of a carrier, 0.8%-4% of adhesive, 24%-76.2% of filler, 4%-10% of a disintegrating agent, 2%-6% of flavoring agent and 1%-4% of a lubricating agent. The lurasidone hydrochloride orally disintegrating tablet can be disintegrated quickly, and convenience is provided for medicine taking of patients particularly like the aged, children, coma patients and the patients who cannot take water conveniently. Moreover, the dissolving-out rate can reach 85% or above within 5 minutes. In addition, the lurasidone hydrochloride orally disintegrating tablet can be disintegrated and absorbed quickly in the oral cavity, so that the bioavailability is greatly improved. Operation is easy in production technology, the production cost is low, and the lurasidone hydrochloride orally disintegrating tablet is suitable for industrial mass production.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to a lurasidone hydrochloride orally disintegrating tablet and a preparation method thereof. Background technique [0002] Schizophrenia (schizophrenia) is a psychiatric disease. It is a persistent and usually chronic major mental illness. It is the most serious type of mental illness. Environmental disharmony is the most common type of mental illness, and it usually occurs in young and middle-aged people, which in turn affects behavior and emotion. The main symptom of schizophrenia is considered to be a fragmentation of basic thinking structures and cognition. This dissociation creates thought-form disorders and leads to an inability to distinguish between inner and outer experience. People with schizophrenia may report hallucinations themselves, or others may find that their performance is affected by hallucinations. Patients may also express overtly delusional beliefs....

AI Technical Summary

Problems solved by technology

[0007] However, lurasidone hydrochloride is a poorly soluble drug, which is slightly soluble in methanol, slightly soluble in ethanol, and very slightly soluble in acetone. This solubility property limits the dissolution and disintegration of its preparations. The original research company Japan's Sumitomo Pharmaceutical Co., Ltd. disclosed in a patent (CN101184489B) an oral preparation with lurasidone hydrochloride as an active ingredient, but its dosage form still belongs to an ordinary tablet, which does not have the characteristics of rapid disintegration in the oral cavity, and it dissolves in 10 minutes. The dissolution rate is about 70-80%, and the dissolution rate in 15 minutes is about 80-90%. However, it can be seen from the dissolution curve that the dissolution rate in 5 minutes is only about 50%, and the effect of rapid dissolution cannot be achieved.

A Chinese patent (CN103054824A) discloses a lurasidone hydrochloride orally disintegrating tablet preparation and its preparation method, which uses wet granulation and tabletting after ultrafine pulverization of the raw material drug and hydrophilic excipients to achieve rapid dissolution The purpose of this method is that the operation process is complicated, the process is relatively backward, and the preparation cost is high. Only 15 minutes of dissolution can make the dissolution rate reach about 90%, which cannot be rapidly dissolved, and the dissolution will be significantly reduced under high humidity conditions.

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