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Vilazodone hydrochloride composition and preparation method thereof

A technology of vilazodone hydrochloride and a composition is applied in the directions of pharmaceutical combinations, pharmaceutical formulations, medical preparations of inactive ingredients, etc. Effectiveness in Solving Dissolution Problems

Active Publication Date: 2019-06-11
JIANGSU SIMCERE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] One of the objects of the present invention is to provide a vilazodone hydrochloride composition to solve the problems of poor solubility and low bioavailability in vivo of other crystal forms except vilazodone hydrochloride crystal form IV, and improve the dissolution rate in vitro and in vivo bioavailability

Method used

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  • Vilazodone hydrochloride composition and preparation method thereof
  • Vilazodone hydrochloride composition and preparation method thereof
  • Vilazodone hydrochloride composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Table 1 Vilazodone hydrochloride tablet / capsule preparation

[0032]

[0033] Preparation process: vilazodone hydrochloride is crushed to a particle size of 5 μm, mixed evenly with other excipients in the prescription, directly compressed into tablets or powdered and directly filled into capsules.

Embodiment 2

[0035] Table 2 Vilazodone hydrochloride tablet / capsule preparation

[0036]

[0037] Preparation process: Vilazodone hydrochloride is crushed to a particle size of 5 μm, mixed evenly with other excipients in the prescription except silicon dioxide and magnesium stearate, added with an aqueous solution of polysorbate 80 to granulate, dried and granulated, and then added with two Silicon oxide and magnesium stearate are mixed and compressed into tablets.

Embodiment 3

[0039] Table 3 Vilazodone hydrochloride tablet / capsule preparation

[0040]

[0041] Preparation process: vilazodone hydrochloride is mixed with lactose and beta-cyclodextrin, crushed to a particle size of 20 μm, mixed evenly with other excipients in the prescription, directly compressed into tablets or powdered into capsules.

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PUM

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Abstract

The invention relates to a vilazodone hydrochloride composition and a preparation method thereof. The composition includes vilazodone hydrochloride, a microcarrier and pharmaceutically acceptable excipients for an oral solid preparation. The preparation method is as below: mixing and crushing vilazodone hydrochloride and the microcarrier, and evenly mixing the mixture with pharmaceutically acceptable excipients for oral solid preparation. The obtained composition preparation has greatly improved dissolution in vitro, and in vivo bioavailability reaching bioequivalence to VIIBRYD.

Description

technical field [0001] The invention relates to a pharmaceutical composition containing vilazodone hydrochloride and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] With the development of society and the mental and psychological pressure brought by the fast pace, the incidence of depression has increased significantly. Depression includes unipolar depression (i.e. major depression and psychotic depression), adjustment disorder, minor depression, seasonal affective disorder, bipolar disorder, etc. Major depressive disorder is also called major depressive disorder Symptoms include: depressed mood, decreased interest in daily activities, significant weight or appetite loss, insomnia or hypersomnia, restlessness / pacing (psychomotor agitation), fatigue or excessive sleepiness, feelings of guilt or self-deprecation , Suicidal thoughts. After the onset, it will affect the patient's work, sleep, study, diet and recreationa...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/496A61K47/38A61P25/24
Inventor 嵇元欣李玲任晋生王青松刘春晖许向阳
Owner JIANGSU SIMCERE PHARMA
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