Lurasidone medicine composition and preparation method thereof

Abstract

The invention discloses a lurasidone medicine composition and a preparation method thereof. Concretely, the lurasidone medicine composition disclosed by the invention comprises the lurasidone shown in the formula (I), polyhydroxy alcohol and water. The invention also relates to the application of the lurasidone medicine composition in preparing a medicine for psychosis, and a method for preparing the lurasidone medicine composition. The method comprises the following steps of: dissolving the lurasidone in a proper amount of polyhydroxy alcohol; adding water and optional other additives; and adding polyhydroxy alcohol until the total amount of the prescription is obtained; optionally sterilizing or removing bacteria of the liquid composition; and sealing and packing. The lurasidone medicine composition disclosed by the invention is suitable for old patients and patients uncooperative in taking medicines.

Description

Technical field The present invention relates to a novel lurasidone pharmaceutical composition, in particular to a lurasidone liquid pharmaceutical composition, and its preparation method. Background technique Lurasidone hydrochloride (Lurasidone HCl, in the present invention, the hydrochloride of the substance can be called Lurasidone) is a new type of atypical antipsychotic, October 28, 2010, the U.S. Food and Drug Administration ( FDA) approved it to be marketed under the trade name Latuda for the treatment of schizophrenia. It is a new type of antipsychotic drug with dual effects developed by Japan's Sumitomo Pharmaceutical Company. It has high affinity for both 5-HT2A receptor and dopamine D2 receptor. It has a significant effect on both the positive and negative symptoms of mental patients. Studies have reported that lurasidone can improve cognitive function. The recommended starting dose is 40 mg / d, the effective dose range is 40-120 mg / d, and the maximum recommended ...

AI Technical Summary

Problems solved by technology

However, since the solubility of lurasidone or its free form in water is less than a few micrograms per milliliter, it has been difficult to prepare aqueous preparations containing high concentrations of lurasidone or its free form

Also, to date, no method of solubilizing lurasidone and its free form is known.

In the case of using a solution-type preparation for parenteral administration such as injection, there are potential problems such as local irritation, hemolysis, neurotoxicity, etc. due to the difference in the organic solvent used, and therefore, the concentration of the organic solvent in the solution The type, dosage or content is limited, and therefore the type and amount of organic solvents need to be reduced