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Orally disintegrating tablets containing aripiprazole and preparation method of orally disintegrating tablets

An orally disintegrating tablet and aripiprazole technology, which is applied to the orally disintegrating tablet of aripiprazole and the field of preparation thereof, can solve the problems that the overall stability of the preparation is not significantly improved, and the patient's medication experience is affected, and the medication experience can be achieved. Improvement, good mouthfeel acceptance, long-term dissolution improvement effect

Active Publication Date: 2019-06-11
CHENGDU KANGHONG PHARMA GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] To sum up, microcrystalline cellulose is often used as one of the main fillers in the prescriptions of powder direct compression technology in the prior art, although microcrystalline cellulose can improve the fluidity, compressibility, As well as improving the disintegration performance of the tablet, but the overall stability of the formulation in the aripiprazole orally disintegrating tablet formulation has not been significantly improved, especially the stability of the formulation after long-term storage, which is particularly important for the drug during storage. It is very important to maintain the proper curative effect for a long time and try not to produce related substances with toxic and side effects
In addition, the high content of microcrystalline cellulose will bring a very obvious grainy feeling to the orally disintegrating tablet, which will affect the patient's medication experience

Method used

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  • Orally disintegrating tablets containing aripiprazole and preparation method of orally disintegrating tablets
  • Orally disintegrating tablets containing aripiprazole and preparation method of orally disintegrating tablets
  • Orally disintegrating tablets containing aripiprazole and preparation method of orally disintegrating tablets

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Experimental program
Comparison scheme
Effect test

Embodiment 1

100

[0073] Preparation:

[0074] (1) Take the prescribed amount of aripiprazole, mannitol, silicified microcrystalline cellulose, croscarmellose sodium, silicon dioxide, and sucralose and mix them in a three-dimensional mixer for 20 minutes;

[0075] (2) Add the magnesium stearate of the prescribed amount to the mixed granules prepared in step (1), mix for 5 minutes, and tablet to obtain.

Embodiment 2

100

[0078] Preparation:

[0079] (1) Take the prescription amount of aripiprazole, lactose, silicified microcrystalline cellulose, croscarmellose sodium, silicon dioxide, and aspartame and mix them in a three-dimensional mixer for 20 minutes;

[0080] (2) Add the magnesium stearate of the prescribed amount to the mixed granules prepared in step (1), mix for 5 minutes, and tablet to obtain.

Embodiment 3

[0082]

[0083]

[0084] Preparation:

[0085] (1) Take the prescribed amount of aripiprazole, starch lactose, silicified microcrystalline cellulose, croscarmellose sodium, silicon dioxide, and acesulfonate potassium and mix them in a three-dimensional mixer for 20 minutes;

[0086] (2) Add the magnesium stearate of the prescribed amount to the mixed granules prepared in step (1), mix for 5 minutes, and tablet to obtain.

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Abstract

The invention provides orally disintegrating tablets containing aripiprazole and a preparation method of the orally disintegrating tablets. The orally disintegrating tablets comprise the components ofaripiprazole as the active component, silicified microcrystalline cellulose, croscarmellose sodium, silicon dioxide, a stuffing agent, a corrigent and a lubricant. Based on a formula, the orally disintegrating tablets are prepared by a powder vertical compression technology. The orally disintegrating tablets have good mouth feel and good long-term stability, so that the validity and the safety ofdrugs are guaranteed.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, specifically an orally disintegrating tablet of aripiprazole and a preparation method thereof. Background technique [0002] Schizophrenia (schizophrenia) is a kind of mental illness, which is persistent and chronic, and is the most common type of mental illness characterized by the division of basic personality, thinking, emotion and behavior, and the incoordination between mental activities and the environment. The onset occurs in the prime of life, which in turn affects behavior and emotion. The main symptom of schizophrenia is considered to be a fragmentation of basic thinking structures and cognition. This dissociation creates thought-form disorders and leads to an inability to distinguish between inner and outer experience. People with schizophrenia may report hallucinations themselves, or others may find that their performance is affected by hallucinations. Patients may also e...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K47/38A61K47/04A61K31/496A61P25/18
Inventor 柯潇郑强陈开军张启余刘浪
Owner CHENGDU KANGHONG PHARMA GRP
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