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Aripiprazole composition microcrystalline orally disintegrating tablets and preparation method thereof

A technology of orally disintegrating tablets and aripiprazole, which is applied in the field of orally disintegrating tablets containing aripiprazole composition microcrystals and its preparation, can solve the problems that cannot reflect the advantages of fast dissolution of orally disintegrating tablets, Achieve good taste, improve compliance, and improve dissolution rate

Active Publication Date: 2013-09-11
QILU PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The aripiprazole orally disintegrating tablet involved in this invention uses a large amount of microcrystalline cellulose and micropowder silica gel, and the use of insoluble excipients causes discomfort in the oral cavity after disintegration; at the same time, because aripiprazole is insoluble Drug, the dissolution rate of the orally disintegrating tablet obtained in CN1709256A is lower than that of the original drug Aripiprazole ordinary tablet (trade name: Anlufan), which cannot reflect the advantage of fast dissolution of the orally disintegrating tablet

Method used

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  • Aripiprazole composition microcrystalline orally disintegrating tablets and preparation method thereof
  • Aripiprazole composition microcrystalline orally disintegrating tablets and preparation method thereof
  • Aripiprazole composition microcrystalline orally disintegrating tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0053] Example 1. The orally disintegrating tablet of microcrystalline aripiprazole composition consists of:

[0054]

[0055] Preparation:

[0056]Mix the microcrystalline aripiprazole composition with lactose passed through a 40-mesh sieve to prepare mixture A; mannitol, optimized microcrystalline cellulose, crospovidone, sweet orange essence, and aspartame were passed through a 40-mesh sieve respectively After sieving, mix uniformly to obtain mixture B, mix mixture A and mixture B uniformly in equal increments, add magnesium stearate, mix uniformly, and press into tablets to obtain.

Embodiment 2

[0057] Example 2. The orally disintegrating tablet of microcrystalline aripiprazole composition consists of:

[0058]

[0059] Preparation:

[0060] Mix the microcrystalline aripiprazole composition with mannitol passing through a 40-mesh sieve to prepare mixture A; microcrystalline cellulose, low-substituted hydroxypropyl cellulose, croscarmellose sodium, micropowder silica gel, strawberry essence and aspartame were respectively passed through a 40-mesh sieve and mixed uniformly to obtain a mixture B. After the mixture A and the mixture B were uniformly mixed in equal amounts, magnesium stearate was added, mixed uniformly, and then compressed into tablets to obtain the product.

Embodiment 3

[0061] Example 3. Aripiprazole composition The composition of microcrystalline orally disintegrating tablets by mass is:

[0062]

[0063] Preparation:

[0064] Mix the microcrystalline aripiprazole composition with mannitol passing through a 40-mesh sieve to prepare mixture A; optimize microcrystalline cellulose, crospovidone, sweet orange essence, and aspartame after passing through a 40-mesh sieve Mix uniformly to prepare mixture B, mix mixture A and mixture B uniformly by adding equal amounts, add micropowder silica gel and magnesium stearate, mix uniformly, and press into tablets to obtain.

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Abstract

The invention relates to aripiprazole composition microcrystalline orally disintegrating tablets and a preparation method thereof. The aripiprazole composition microcrystalline orally disintegrating tablets mainly consist of aripiprazole lactose composition crystallites, a filling agent, a disintegrating agent, a corrigent and a lubricant, wherein the granularity of the aripiprazole lactose composition crystallite is less than 30 microns. The preparation method comprises the steps of: evenly mixing all the components of the aripiprazole orally disintegrating tablets, and then directly tabletting the mixture or granulating and tabletting the mixture by a wet method. The crystallites obtained by common micronization of an aripiprazole lactose composition is higher in dissolution rate compared with crystallites obtained by separate micronization of aripiprazole, meanwhile, the crystal form of the aripiprazole in the composition crystallites is not changed, and thus the content uniformity of the orally disintegrating tablets is higher. The hardness of the aripiprazole orally disintegrating tablets is 5kg-8kg, and the disintegration time limit is shorter than 30s, so that the tablets are prevented from being crushed during transportation, and are convenient to take.

Description

[0001] This application is a divisional application of application number 201010145059.1. technical field [0002] The invention belongs to the field of pharmaceutical preparations, and in particular relates to an orally disintegrating tablet containing aripiprazole composition microcrystals and a preparation method thereof. Background technique [0003] Schizophrenia is a severely disabling mental illness. Its symptoms are mainly positive symptoms (such as delusions, hallucinations, thinking disorders, hostility and suspicion) and weird behaviors, negative symptoms (such as slow response, apathy, poor speech, etc.) Cognitive symptoms caused by impaired reasoning and reasoning ability, and some patients may also have affective symptoms (especially depression). [0004] Aripiprazole is a poorly soluble drug with a solubility of about 7.8g / L in water and its chemical name is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy Base]-3,4-dihydroquinolinone, which is a quinolone ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/496A61K47/26A61P25/18
Inventor 王晶翼李长军王婧璨杨清敏李颖张明会
Owner QILU PHARMA CO LTD
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