Lurasidone hydrochloride pharmaceutical composition and preparation method thereof

A technology of lurasidone hydrochloride and a composition is applied in the field of lurasidone hydrochloride pharmaceutical composition and preparation thereof, and can solve the problems of poor stability of nanosuspension, difficult to store for a long time, etc. The preparation process is simple and the effect of reducing the food effect

Pending Publication Date: 2022-05-27
CHANGZHOU HANSOH PHARM CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, it is a long-acting injection, not an oral preparation, and does not involve curing, reconstitution, etc. The stability of its nanosuspension is poor, and it is difficult to store for a long time

Method used

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  • Lurasidone hydrochloride pharmaceutical composition and preparation method thereof
  • Lurasidone hydrochloride pharmaceutical composition and preparation method thereof
  • Lurasidone hydrochloride pharmaceutical composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0133] Preparation of nanocrystal suspension: dissolve stabilizer hypromellose E5 and Tween 80 in water to prepare a stabilizer aqueous solution, add lurasidone hydrochloride, and stir well; the obtained lurasidone hydrochloride is suspended The liquid was added to the ball mill, and 0.3 mm zirconia beads were added, the peristaltic pump was turned on at 44 rpm, the grinding chamber speed was 10 m / s, and the lurasidone hydrochloride nanocrystal suspension was obtained by wet grinding for 4 h.

[0134]

[0135] Preparation of nanocrystal solidified product: take the lurasidone hydrochloride nanocrystal suspension obtained in the above steps, filter through a 300-mesh sieve, add redispersant sucrose and stir well, use filler lactose as a carrier, and filter through a fluidized bed Granulation to obtain a solidified product of lurasidone hydrochloride nanocrystals.

[0136]

[0137]

[0138] Nanocrystalline composition: take the obtained nanocrystalline solidified produc...

Embodiment 2

[0141] Preparation of nanocrystal suspension: dissolve stabilizer hypromellose E5 and Tween 80 in water to prepare a stabilizer aqueous solution, add lurasidone hydrochloride, and stir well; the obtained lurasidone hydrochloride is suspended The liquid was added to the ball mill, and 0.3 mm zirconia beads were added, the peristaltic pump was turned on at 22 rpm, the grinding chamber speed was 10 m / s, and the lurasidone hydrochloride nanocrystal suspension was obtained by wet grinding for 4 h.

[0142]

[0143] Nanocrystalline solids were prepared in a manner similar to that described in Example 1.

[0144]

[0145] Nanocrystalline compositions were prepared in a manner similar to that described in Example 1 .

[0146]

[0147]

Embodiment 3

[0149] Nanocrystal suspensions were prepared in a similar manner as described in Example 2.

[0150]

[0151] Nanocrystalline solids were prepared in a manner similar to that described in Example 1.

[0152]

[0153] Nanocrystalline compositions were prepared in a manner similar to that described in Example 1 .

[0154]

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PUM

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Abstract

The invention relates to a lurasidone hydrochloride pharmaceutical composition and a preparation method thereof. The present invention discloses a lurasidone hydrochloride pharmaceutical composition, which comprises lurasidone hydrochloride and a stabilizer, and the lurasidone hydrochloride is in a nanometer level. The lurasidone hydrochloride pharmaceutical composition prepared by the invention can be used for improving the solubility and bioavailability of the medicine and reducing the influence of food effect at the same time. The preparation method disclosed by the invention is simple to operate, relatively low in production cost and easy to realize industrial large-scale production.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a lurasidone hydrochloride pharmaceutical composition and a preparation method thereof. Background technique [0002] The chemical name of lurasidone hydrochloride is (3aR,4S,7R,7aS)-2-{(1R,2R)-2-[4-(1,2-benzisothiazol-3-yl)piperazine-1 -ylmethyl]cyclohexylmethyl}hexahydro-4,7-methylene-2H-isoindole-1,3-dione hydrochloride, is a new type of hydrochloride developed by Dainippon Sumitomo Pharmaceutical Co., Ltd. Second-generation antipsychotics. In October 2010, the US FDA approved lurasidone hydrochloride tablets Marketed for the treatment of schizophrenia. In June 2013, it was approved by the FDA for the treatment of bipolar depression. In March 2014, it was approved to be marketed in the European Union for the treatment of schizophrenia. In January 2019, it obtained the NMPA import drug registration license for the treatment of mentally ill patients. Lurasidone ...

Claims

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Application Information

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IPC IPC(8): A61K31/496A61K47/38A61K47/26A61K9/00A61K9/20A61K9/16A61K9/48A61P25/18
CPCA61K31/496A61K47/38A61K47/26A61K9/0053A61K9/2054A61K9/2018A61K9/2095A61K9/1652A61K9/1623A61K9/1682A61K9/4866A61K9/4858A61P25/18
Inventor 黄健伍定梅赵娜程周
Owner CHANGZHOU HANSOH PHARM CO LTD
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