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Duloxetine hydrochloride controlled-release tablet and preparation method thereof

A technology for duloxetine hydrochloride and controlled-release tablets, which is applied in the direction of pharmaceutical formulas, medical preparations containing active ingredients, sugar-coated pills, etc., and can solve the problem that duloxetine hydrochloride enteric-coated preparations cannot be released at a constant rate and start to release and other problems, to achieve the effect of being suitable for industrial production, easy to operate, and simple in process

Active Publication Date: 2014-08-13
徐东
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The purpose of the present invention is to overcome the above-mentioned deficiencies in the prior art, provide a kind of enteric-coated duloxetine hydrochloride effective controlled-release tablet, solve the duloxetine hydrochloride enteric-coated preparation in the prior art can not be released at a constant rate, and osmotic pump The technical problem of the tablet starting to release the drug in the stomach, so that it can realize the intestinal controlled release of duloxetine hydrochloride, avoid the premature release of the drug in the stomach, which will affect the drug effect or cause side effects, and can maintain the blood drug for a long time concentration

Method used

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  • Duloxetine hydrochloride controlled-release tablet and preparation method thereof
  • Duloxetine hydrochloride controlled-release tablet and preparation method thereof
  • Duloxetine hydrochloride controlled-release tablet and preparation method thereof

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preparation example Construction

[0043] see figure 2 , figure 2 Show the schematic diagram of the preparation method of duloxetine hydrochloride controlled-release tablets in the embodiment of the present invention, including the following steps:

[0044] S01, weighing each formula component.

[0045] S02, preparing the tablet core: obtaining the above-mentioned granules of the drug-containing layer and the granules of the booster layer, and compressing the above-mentioned granules of the drug-containing layer and the granules of the booster layer to obtain a tablet core.

[0046] S03, coated with a semipermeable membrane: obtain the solution of the above semipermeable membrane, add the tablet core, coat the outer surface of the tablet core with a semipermeable membrane coating, and form a diaphragm between the drug-containing layer and the booster layer;

[0047] S04, punching: heat treatment, punching holes on the above-mentioned semi-permeable membrane to form through holes;

[0048] S05, coated enter...

Embodiment 1

[0070] The duloxetine hydrochloride controlled-release tablet of the present embodiment 1 has the following components in weight percentage:

[0071] Drug-containing layer composition:

[0072] Duloxetine hydrochloride 60mg, polyoxyethylene 50mg, sodium chloride 50mg, magnesium stearate 20mg, ethanol in proper amount;

[0073] Boost layer:

[0074] 250mg of polyoxyethylene, 30mg of sucrose, 20mg of magnesium stearate, appropriate amount of ethanol;

[0075] Semi-permeable membrane:

[0076] Cellulose acetate 80mg, polyethylene glycol 40mg, ethanol 5ml;

[0077] Enteric polymer film:

[0078] Eukit L30D-55 200mg, triethyl citrate 25mg, talcum powder 30mg;

[0079] The preparation method of duloxetine hydrochloride controlled release tablet of the present invention comprises the following steps:

[0080] S11, weighing each of the above formula components;

[0081] S12, preparation of tablet core:

[0082] 1. Obtain drug-containing layer particles:

[0083] (1) above-men...

Embodiment 2

[0107] The duloxetine hydrochloride controlled-release tablet of the present embodiment 2 has the following components in weight percentage:

[0108] Drug-containing layer composition:

[0109] Duloxetine hydrochloride 60mg, hypromellose 50mg, sucrose 50mg, sodium benzoate 20mg, appropriate amount of ethanol;

[0110] Boost layer:

[0111] Carbomer 250mg, mannose 30mg, talcum powder 20mg, ethanol amount;

[0112] Semi-permeable membrane:

[0113] Ethyl cellulose 80mg, hydroxypropyl cellulose 40mg, ethanol 5ml;

[0114] Enteric polymer film:

[0115] Eukit L100-55200mg, tributyl citrate 25mg, glyceryl monostearate 30mg;

[0116] The preparation method of duloxetine hydrochloride controlled release tablet of the present invention comprises the following steps:

[0117] S21, weighing each of the above formula components;

[0118] S22, preparation of tablet core:

[0119] 2. Obtain drug-containing layer particles:

[0120] (1) Sieve the above-mentioned duloxetine hydrochl...

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Abstract

The invention is applicable to the technical field of pharmacy and provides an enteric-soluble duloxetine hydrochloride controlled-release tablet. The duloxetine hydrochloride controlled-release tablet comprises a tablet core and a semipermeable membrane coated on the outer surface of the tablet core, wherein the tablet core comprises a drug-containing layer and a boosting layer which are adjacently arranged; a diaphragm is arranged between the drug-containing layer and the boosting layer; a through hole is formed in the semipermeable membrane; an enteric-soluble membrane is coated on the outer surface of the semipermeable membrane; the drug-containing layer comprises substances such as duloxetine hydrochloride, and the like. By compounding and adopting a double-layer osmotic pump and the enteric-soluble, medicines in the drug-containing layer are pushed to release from the through hole at a constant speed (namely zero-level release) by utilizing the stable swelling effect after the boosting layer absorbs water, so that the controlled release purpose is achieved; moreover, the enteric-soluble membrane is coated on the outer surface of the semipermeable membrane, so that intestinal tract controlled release of the acid-sensitive type duloxetine hydrochloride is realized. The preparation method of the duloxetine hydrochloride controlled-release tablet is simple in process, easy to operate and very suitable for industrial production.

Description

technical field [0001] The invention belongs to the technical field of chemical pharmacy, and in particular relates to a duloxetine hydrochloride controlled-release tablet and a preparation method thereof. Background technique [0002] Duloxetine Hydrochloride is a compound that has dual inhibitory effects on the uptake of 5-hydroxytryptamine (5-HT) and norepinephrine (NE). Existing research data have shown that the drug has a certain effect on depression, pain caused by diabetic peripheral neuropathy, and stress urinary incontinence. Because duloxetine hydrochloride is prone to produce naphthol in an acidic environment and has toxic and side effects on the human body, it is generally made into enteric-coated preparations. Although traditional duloxetine hydrochloride enteric-coated tablets can be released in the intestinal tract to avoid being decomposed by gastric acid, the drug release behavior is not controlled. It is a one-time release, which can only reach a higher b...

Claims

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Application Information

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IPC IPC(8): A61K9/28A61K9/24A61K31/381A61P25/24A61P25/02A61P13/00
Inventor 徐东沈楠
Owner 徐东
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