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A kind of fluoxetine hydrochloride dispersible tablet and preparation method thereof

A technology of fluoxetine hydrochloride and dispersible tablets, which is applied in the field of medicine, can solve the problems of poor dispersion uniformity of fluoxetine hydrochloride dispersible tablets and the inability of dispersible tablets to exert drug effect quickly, and achieves improvement of bioavailability and particle fineness. Appropriate, fast disintegration effect

Active Publication Date: 2020-01-31
SHANDONG LINUO KEFENG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the disintegration rate and dispersion uniformity of fluoxetine hydrochloride dispersible tablets prepared by traditional methods are unsatisfactory, resulting in the dispersible tablets not being able to exert their drug effect quickly

Method used

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  • A kind of fluoxetine hydrochloride dispersible tablet and preparation method thereof
  • A kind of fluoxetine hydrochloride dispersible tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] A fluoxetine hydrochloride dispersible tablet is made of the following components by weight: fluoxetine hydrochloride 223.5g, low-substituted hydroxypropyl cellulose 50g, microcrystalline cellulose 390g, sodium stearyl fumarate 10g, silicon dioxide 22.5g, mannitol 304g.

[0026] The preparation method of this fluoxetine hydrochloride dispersible tablet adopts the following steps:

[0027] (1) Material preparation: Weigh fluoxetine hydrochloride, low-substituted hydroxypropyl cellulose, microcrystalline cellulose, sodium stearyl fumarate, silicon dioxide, and mannitol by weight percentage, and mix silicon dioxide at a ratio of 1:8 Divide into two parts, 2.5g and 20g, respectively as the amount of internal addition and external addition, and set aside; add low-substituted hydroxypropyl cellulose to 15ml of 50°C hot water to swell, stir evenly, and set aside as an adhesive;

[0028] (2) Mixed granulation: get the fluoxetine hydrochloride taken by step (1) and the amount o...

Embodiment 2

[0032] A fluoxetine hydrochloride dispersible tablet is made of the following components by weight: fluoxetine hydrochloride 223.5g, low-substituted hydroxypropyl cellulose 60g, microcrystalline cellulose 300g, sodium stearyl fumarate 8g, silicon dioxide 22g, mannitol 400g.

[0033] The preparation method of this fluoxetine hydrochloride dispersible tablet adopts the following steps:

[0034] (1) Material preparation: Weigh fluoxetine hydrochloride, low-substituted hydroxypropyl cellulose, microcrystalline cellulose, sodium stearyl fumarate, silicon dioxide, and mannitol by weight percentage, and mix silicon dioxide at a ratio of 1:10 Divide into two parts, 2.0g and 20g, respectively as the amount of internal addition and external addition, and set aside; add low-substituted hydroxypropyl cellulose to 24ml of hot water at 60°C to swell, stir evenly, and use it as an adhesive for later use;

[0035](2) Mixed granulation: get the fluoxetine hydrochloride taken by step (1) and t...

Embodiment 3

[0039] A fluoxetine hydrochloride dispersible tablet is made of the following components by weight: fluoxetine hydrochloride 223.5g, low-substituted hydroxypropyl cellulose 40g, microcrystalline cellulose 490g, sodium stearyl fumarate 6g, silicon dioxide 19g, mannitol 220g.

[0040] The preparation method of this fluoxetine hydrochloride dispersible tablet adopts the following steps:

[0041] (1) Material preparation: Weigh fluoxetine hydrochloride, low-substituted hydroxypropyl cellulose, microcrystalline cellulose, sodium stearyl fumarate, silicon dioxide, and mannitol by weight percentage; Divide into two parts, 1.9g and 17.1g, respectively as the amount of internal addition and external addition, and set aside; add low-substituted hydroxypropyl cellulose to 14ml of hot water at 55°C to swell, stir evenly, and use it as an adhesive for later use;

[0042] (2) Mixing granulation: take the fluoxetine hydrochloride taken by step (1) and the amount of silicon dioxide, microcry...

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Abstract

The invention belongs to the technical field of medicine, and particularly discloses a fluoxetine hydrochloride dispersible tablet and a preparation method thereof. The fluoxetine hydrochloride dispersible tablet is made of the following components by weight percentage: 20-25% of fluoxetine hydrochloride, 3-10% of low-substituted hydroxypropyl cellulose, 30-50% of microcrystalline cellulose, stearin-rich Sodium maleate 0.2‑2%, silicon dioxide 1.5‑5% and mannitol 20‑45%. The fluoxetine hydrochloride dispersible tablet and the preparation method thereof have simple process operation, good repeatability, good compressibility of all raw and auxiliary materials, and are suitable for large-scale production technology. When the prepared fluoxetine hydrochloride dispersible tablet is dissolved in water, the dissolution rate reaches More than 95%, the active ingredient fluoxetine hydrochloride is evenly distributed in the pharmaceutical preparation, and the disintegration speed of the dispersible tablet in water is fast; the fineness of particles dispersed in the disintegrated product is suitable, which meets the requirements of the Chinese Pharmacopoeia.

Description

technical field [0001] The invention belongs to the technical field of medicines, in particular to a fluoxetine hydrochloride dispersible tablet and a preparation method thereof. Background technique [0002] The antidepressant effect of fluoxetine hydrochloride is based on the ability to selectively inhibit the uptake of serotonin by central nervous system neurons. Fluoxetine hydrochloride is particularly indicated for the treatment of depression and its related anxiety symptoms, as well as for the treatment of bulimia nervosa and obsessive-compulsive and behavioral disorders. Fluoxetine hydrochloride dispersible tablet is an oral solid pharmaceutical dosage form, which must be disintegrated completely and uniformly dispersed in water within 3 minutes. The dispersion uniformity test of the dispersible tablets is checked according to the disintegration time limit inspection method. During the inspection, the inner diameter of the stainless steel wire mesh is 710 μm, and the...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K47/38A61K47/26A61K47/14A61K47/04A61K31/138A61P25/24
CPCA61K9/2009A61K9/2013A61K9/2018A61K9/2054A61K9/2095A61K31/138
Inventor 王孝泉贾永涛陈昌尹琪乐杨建民
Owner SHANDONG LINUO KEFENG PHARMA
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