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Quetiapine fmarate dispersible tablets and preparation method thereof

A technology of quetiapine fumarate and quinoline fumarate, which is applied in the field of quetiapine fumarate dispersible tablet preparation and preparation thereof, can solve the problem that ordinary tablets are inconvenient to take, unsuitable for difficulty in swallowing, and low in bioavailability It can quickly disintegrate and mask the bad taste of the drug, expand the scope of clinical use, and achieve the effect of high bioavailability.

Inactive Publication Date: 2009-04-29
张宏宇
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] 1. Ordinary tablets disintegrate slowly, resulting in slow drug absorption and low bioavailability;
[0005] 2. Ordinary tablets are inconvenient to take and need to be swallowed with water. They are not suitable for those with dysphagia (especially elderly and children)

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0013] Embodiment 1, raw material ratio: 50 parts of quetiapine fumarate, 15 parts of crospovidone, 15 parts of microcrystalline cellulose, 15 parts of mannitol, 3 parts of aspartame, 2 parts of micropowdered silica gel, hard Magnesium fatty acid 1 part, cool alcohol 1 part.

[0014] Preparation method: take quetiapine fumarate and pulverize, sieve, and set aside; take microcrystalline cellulose and mannitol, sieve, set aside; take quetiapine fumarate, 50% (weight) of crospovidone, Mix microcrystalline cellulose, mannitol, and aspartame, add 10% povidone ethanol solution to the obtained mixture to make a soft material, granulate through a 20-mesh sieve, dry, granulate with a 16-mesh sieve, add the remaining auxiliary materials, Mix evenly, measure the drug content, calculate the tablet weight, compress the tablet, and you get it.

[0015] The obtained dispersible tablets have the following characteristics:

[0016] 1. Dispersibility inspection: Disintegrate completely within...

Embodiment 2

[0018] Embodiment 2, raw material ratio: 200 parts of quetiapine fumarate, 100 parts of croscarmellose sodium, 300 parts of microcrystalline cellulose, 200 parts of maltodextrin, aspartame 50 parts, micronized silica gel 50 parts, magnesium stearate 20 parts.

[0019] Preparation method: The preparation method of the above quetiapine fumarate dispersible tablets: take quetiapine fumarate and pulverize, sieve, and set aside; take microcrystalline cellulose and maltodextrin, sieve, set aside; take all raw and auxiliary materials and mix well , measure the drug content, calculate the weight of the tablet, and compress the tablet.

[0020] The obtained dispersible tablets have the following characteristics:

[0021] Dispersibility check: all disintegrated within 3 minutes and passed through No. 2 sieve.

[0022] Dissolution test: in compliance with the regulations.

Embodiment 3

[0023] Embodiment 3, raw material ratio: 120 parts of quetiapine fumarate as quetiapine, 12 parts of sodium starch glycolate, 20 parts of crospovidone, 40 parts of microcrystalline cellulose, 20 parts of starch, aspirin Patan 6 parts, micronized silica gel 4 parts, magnesium stearate 2 parts, orange juice essence 2 parts.

[0024] Preparation method: The preparation method of the above quetiapine fumarate dispersible tablets: take quetiapine fumarate and pulverize, sieve, and set aside; take microcrystalline cellulose and starch, sieve, set aside; take each raw material and mix, measure The content of the drug is calculated, the weight of the tablet is calculated, and the tablet is pressed to obtain the product.

[0025] The obtained dispersible tablets have the following characteristics:

[0026] 1. Dispersibility inspection: Disintegrate completely within 3 minutes and pass through No. 2 sieve.

[0027] 2. Dissolution test: the dissolution rate is not less than 80% within ...

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PUM

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Abstract

The invention discloses a quetiapine fumarate dispersible tablet preparation and a preparation method thereof. The quetiapine fumarate dispersible tablet preparation is prepared by the following materials according to weight part: 1 part to 300 parts of quetiapine fumarate (calculated by quetiapine), 2 parts to 400 parts of disintegrating agent, 5 parts to 900 parts of filling agent, 0 part to 100 parts of flow agent and 0.2 part to 50 parts of lubricant. The quetiapine fumarate dispersible tablet preparation has the following advantages: 1. the preparation can rapidly disintegrate and conceal the disagreeable taste of drugs; 2. the preparation can be taken by being dispersed in water, also can be swallowed, chewed and sucked, and is convenient to be taken; and 3. the preparation has fast absorption and high biological availability.

Description

technical field [0001] The invention relates to a pharmaceutical preparation and a preparation method thereof, in particular to a quetiapine fumarate dispersible tablet preparation and a preparation method thereof. Background technique [0002] Quetiapine fumarate, 11-{4-[2-(2-(hydroxyethoxy)ethyl-1-piperazine])dibenzo[b,f][1,4]thiazepine Zhuo}·1 / 2 fumarate is an atypical antipsychotic. Quetiapine fumarate is a diphenoxazepine drug, similar in structure to clozapine and olanzapine, and is an antagonist of multiple neurotransmitter receptors in the brain. Preclinical pharmacology studies have shown that quetiapine fumarate has similar pharmacological characteristics to clozapine, that is, it has a balanced regulation effect on 5HTergic and DAergic neural pathways, and is a 5HT / D2 receptor blocker. The drug has a greater affinity for 5HT2A than D2 receptors, and its pharmacological characteristics of selectively acting on the limbic system can explain its therapeutic effect ...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/554A61P25/18
Inventor 张宏宇杜军戴庆华
Owner 张宏宇
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