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Sustained-release tablet containing trazodone hydrochloride and preparation method of sustained-release tablet

A technology of trazodone hydrochloride and trazodone acid, which is applied in the field of medicine, can solve the problems of insufficient 24-hour release, unfavorable industrialization promotion of sustained and controlled release drugs, and difficult realization of preparation process requirements, etc.

Active Publication Date: 2016-07-13
SHENZHEN FONCOO PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The hydroxypropyl distarchate powder phosphoester used is currently not available in domestic pharmaceutical grade, and this excipient is protected by patents. In addition, the release of this marketed product is relatively low in the intestinal environment above pH 6.8, 24h The release is not thorough enough, in order to avoid possible accumulation, there is still room for improvement
[0009] CN102935074A provides a method for preparing a trazodone hydrochloride osmotic pump controlled-release tablet disclosed by Chengdu Kanghong Pharmaceutical Group Co., Ltd. The controlled-release tablet consists of three parts: a tablet core, a semipermeable membrane coating and a drug release hole. The preparation process is relatively complicated, and the preparation process requires high equipment equipment and performance. At the same time, the accuracy required by the preparation process is difficult for industrialization. The quality of the drug is relatively uneven and the reproducibility is poor, which is not conducive to slow control Industrialization of drug release

Method used

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  • Sustained-release tablet containing trazodone hydrochloride and preparation method of sustained-release tablet
  • Sustained-release tablet containing trazodone hydrochloride and preparation method of sustained-release tablet
  • Sustained-release tablet containing trazodone hydrochloride and preparation method of sustained-release tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] prescription

[0048]

[0049] Preparation Process:

[0050] Weigh the prescribed amount of trazodone hydrochloride, hypromellose K100M, and direct-pressed lactose for pre-mixing, then add silicon dioxide and magnesium stearate and mix evenly.

[0051] Tablet.

[0052] Coating: Take the prescribed amount of colored film coating agent to prepare a 10% full water coating solution for coating.

Embodiment 2

[0054] prescription

[0055]

[0056]

[0057] Preparation Process:

[0058] Weigh the prescribed amount of trazodone hydrochloride, hypromellose K100M, and direct-pressed lactose for pre-mixing, then add silicon dioxide and magnesium stearate and mix evenly.

[0059] Tablet.

[0060] Coating: Take the prescribed amount of colored film coating agent to prepare a 10% full water coating solution for coating.

Embodiment 3

[0062] prescription

[0063]

[0064]

[0065] Preparation Process:

[0066] Weigh the prescription amount of trazodone hydrochloride, hypromellose (K100M) and lactose for pre-mixing, then add 80% ethanol solution binder to carry out wet 30 mesh granulation, dry at 55±5°C, and then carry out 30 mesh whole grains. Add silicon dioxide and magnesium stearate and mix well.

[0067] Tablet.

[0068] Coating: Take the prescribed amount of colored film coating agent to prepare a 10% full water coating solution for coating.

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Abstract

The invention discloses a sustained-release tablet containing trazodone hydrochloride and a preparation method of the sustained-release tablet. The sustained-release tablet is prepared from, in percentage by weight of the whole tablet, 15%-65% of trazodone hydrochloride, 30%-85% of a sustained-release framework and 0.1%-10% of other medical auxiliaries, wherein the sustained-release framework is prepared from high-viscosity hydroxypropyl methylcellulose and water-soluble filler in the weight ratio being 1: (0.3-1.2), and other medical auxiliaries comprise a flow aid and a lubricating agent. Through matched use of high-viscosity hydroxypropyl methylcellulose and the water-soluble filler, the microporous sustained-release framework is formed; the prepared sustained-release tablet containing trazodone hydrochloride can effectively control the release speed of trazodone hydrochloride and can completely release trazodone hydrochloride contained in a sustained release tablet core within certain time, so that water-soluble trazodone hydrochloride is easily stabilized and effectively released, plasma concentration is prevented from fluctuating substantially, the prescription is simple, and the process is simple and convenient.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a sustained-release tablet containing trazodone hydrochloride and a preparation method thereof. Background technique [0002] Trazodone is a new synthetic triazole pyridine antidepressant, which belongs to 5-hydroxytryptamine (5-HT) receptor blocker and reuptake inhibitor, and has obvious central sedative effect and slight muscle relaxation. effect. [0003] Trazodone hydrochloride is white to off-white crystal or crystalline powder; it is not stable enough when exposed to light. Its chemical name is 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]-1,2,4-triazolo[4,3-a]pyridine-3( 2H)-Kone monohydrochloride, the structural formula is as follows. [0004] [0005] Trazodone hydrochloride is a 5-hydroxytryptamine (5-HT) receptor blocker and a reuptake inhibitor. It was first listed in Italy in 1972. It is a highly effective and safe antidepressant drug and has been used in man...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K31/496A61K47/38A61K47/26A61P25/24
CPCA61K9/0002A61K9/2018A61K9/2054A61K31/496
Inventor 黄伟棠王秋成林虹
Owner SHENZHEN FONCOO PHARMACEUTICAL CO LTD
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