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Sustained-release tablet containing quetiapine fumarate and preparation method of sustained-release tablet

A technology for quetiapine fumarate and sustained-release tablets, which is applied to medical preparations containing active ingredients, medical preparations with non-active ingredients, and pharmaceutical formulas, and can solve complex processes, high energy consumption, and increased production. cost and other issues, to achieve the effect of simple preparation process and lower production cost

Active Publication Date: 2015-08-19
ZHEJIANG YONGNING PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The dissolution of the pH-dependent framework material used is affected by the pH of the gastrointestinal tract. Due to the large differences in the gastrointestinal tract environment between different individuals, especially between patients of different ages, this will inevitably lead to variability in the in vivo absorption of the preparation ; Due to its water-insoluble characteristics and the complexity of its preparation process, the sustained-release preparation based on wax materials also limits the use of this type of material
In the above disclosed patents, the wet granulation process or one-step granulation is used in the examples, the process is more complicated, the energy consumption is large, and the production cost is increased.

Method used

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  • Sustained-release tablet containing quetiapine fumarate and preparation method of sustained-release tablet
  • Sustained-release tablet containing quetiapine fumarate and preparation method of sustained-release tablet
  • Sustained-release tablet containing quetiapine fumarate and preparation method of sustained-release tablet

Examples

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Embodiment Construction

[0035] Below in conjunction with specific embodiment, further illustrate the present invention. It should be understood that these examples are only used to illustrate the present invention and are not intended to limit the scope of the present invention. All percentages, ratios, ratios, or parts are by weight unless otherwise indicated.

[0036]The sustained-release properties of the preparation in the examples of the present invention can be evaluated by in vitro dissolution methods. With reference to the first method of the second appendix X D of the Chinese Pharmacopoeia version in 2010, the device of the first method of the dissolution measurement method (Appendix X C) is adopted. 100 revolutions per minute, first use 750ml of hydrochloric acid solution (9→1000) as the solvent to release for 2 hours. Then add 250ml of 0.2mol / L sodium phosphate solution to the medium, adjust the pH to (6.8±0.05) with 2mol / ml hydrochloric acid solution or sodium hydroxide solution, and ope...

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Abstract

The invention provides a sustained-release tablet containing quetiapine fumarate. The sustained-release tablet comprises the following components according to weight percent: 12.5% to 60% of the quetiapine fumarate according to quetiapine, 10% to 40% of sustained-release material and other pharmaceutic adjuvants as the rest, wherein the sustained-release material is a composition of carbomer and hydroxyethyl cellulose. After being dosed, the sustained-release tablet can slowly and continuously release as required, so as to maintain the effective treatment concentration, thereby achieving a long-acting effect by dosing once a day. Additionally, according to the sustained-release tablet, a dry granulation tableting process is adopted, the preparation process is simple, large-scale industrial production is facilitated, and the production cost can be effectively reduced.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to a sustained-release tablet, in particular to a sustained-release tablet containing quetiapine fumarate and a preparation method thereof. Background technique [0002] Quetiapine (Thiazepine), namely 11-[4-[2(2-hydroxyethoxy)ethyl]-1-piperazinyl]dibenzo-[b,f][1,4]thiazepine Zazhuo is an atypical antipsychotic, which is a variety of neurotransmitter receptor antagonists in the brain. The antipsychotic mechanism may be mainly through blocking the central dopamine D 2 receptors and 5-HT receptors. It also has a blocking effect on histamine receptors and adrenergic receptors, and it has been used as a first-line drug for the treatment of schizophrenia in clinical practice abroad. [0003] The results of pharmacokinetic studies of common preparations of quetiapine show that it is rapidly absorbed after oral administration, and the plasma concentration reaches the peak in abou...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K47/38A61K47/32A61K31/554A61P25/18
Inventor 陈鑫叶天健洪亮王敏戈震
Owner ZHEJIANG YONGNING PHARMA
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