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Cariprazine pharmaceutical composition and preparation method thereof

The technology of cariprazine and composition is applied in the field of cariprazine pharmaceutical composition and preparation thereof, which can solve the problems of difficult purification of cariprazine, patent protection of cariprazine, high impurity content, and high bioavailability. The effect of stability, product quality and fast dissolution

Inactive Publication Date: 2017-05-24
TIANJIN HANKANG PHARMA BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] In the actual production process, the applicant found that there were problems in the preparation process of cariprazine, such as difficult purification, high impurity content, crystal form protected by patents, and certain moisture absorption and weight gain.

Method used

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  • Cariprazine pharmaceutical composition and preparation method thereof
  • Cariprazine pharmaceutical composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] The described cariprazine pharmaceutical composition of every 1000, its formula consists of:

[0049] Cariprazine 5g

[0050] Hydroxypropyl Cellulose 20g

[0051] Lactose 75g

[0052] Microcrystalline Cellulose 30g

[0053] Magnesium Stearate 2g.

[0054] Preparation Process:

[0055] 1) Preparation: dry microcrystalline cellulose, lactose, and magnesium stearate at 80°C for 4 hours, and set aside

[0056] 2) Put the prescribed amount of hydroxypropyl cellulose and cariprazine in a container, mix well, grind until the particle size is 80±10um, and set aside;

[0057] 3) Mix item 2) with the prescribed amount of microcrystalline cellulose and magnesium stearate evenly;

[0058] 4) Tablet compression: adjust the appropriate hardness and tablet weight, and perform tablet compression;

[0059] 5) Packing: packed by aluminum-plastic blister packing machine;

[0060] 6) Storage.

Embodiment 2

[0062] The described cariprazine pharmaceutical composition of every 1000, its formula consists of:

[0063] Cariprazine 3.5g

[0064] Hydroxypropyl Cellulose 14g

[0065] Lactose 52.5g

[0066] Microcrystalline Cellulose 45g

[0067] Magnesium Stearate 2g.

[0068] Preparation process: with embodiment 1.

Embodiment 3

[0070] The described cariprazine pharmaceutical composition of every 1000, its formula consists of:

[0071] Cariprazine 12g

[0072] Hydroxypropyl Cellulose 48g

[0073] Lactose 180g

[0074] Microcrystalline Cellulose 72g

[0075] Magnesium Stearate 2g.

[0076] Preparation process: with embodiment 1.

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Abstract

The invention discloses a cariprazine pharmaceutical composition with high bioavailability. The cariprazine pharmaceutical composition with high bioavailability is composed of cariprazine, hydroxy propyl cellulose, lactose, microcrystalline cellulose and magnesium stearate, and is characterized in that weight ratio of cariprazine to hydroxy propyl cellulose to lactose is 1:4:15. The cariprazine pharmaceutical composition has good stability, has more obvious advantages in enhancing of product yield, cost reduction, industrialization realization and better application in clinic. By the preparation method, dissolubility can be effectively enhanced, and bioavailability is obviously improved. The pharmaceutical composition of the invention can be used for treating schizophrenia.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a cariprazine pharmaceutical composition and a preparation method thereof. Background technique [0002] Schizophrenia is a lifelong disabling mental disorder, of which the reported worldwide incidence is about 1%. The disorder usually manifests during adolescence or young adulthood; the main symptoms fall into three categories: positive symptoms, such as delusions and hallucinations; negative symptoms, such as an inability to drive and social withdrawal; and cognitive symptoms, such as attention and memory There is a problem. They lead to social and occupational sexual dysfunction, with inescapable implications for the victimized individual's place of existence within the family and wider society. In addition to psychotic symptoms, patients with schizophrenia are at greater risk for medical comorbidities than the general population. [0003] Symptoms of schizophr...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/495A61K47/38A61P25/18
CPCA61K31/495A61K9/2054
Inventor 严洁王志凤
Owner TIANJIN HANKANG PHARMA BIOTECH
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