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Medicinal preparations containing duloxetine hydrochloride and preparation method thereof

A technology for enteric-coated tablets containing duloxetine hydrochloride and its preparation, which can solve the problems of cumbersome operation methods, high equipment requirements, and poor reproducibility, and meet simple equipment requirements , good reproducibility and high yield

Active Publication Date: 2008-06-04
CSPC ZHONGQI PHARM TECH (SHIJIAZHUANG) CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The patent selects HPMCAS as the enteric material, which reduces or avoids the reaction with duloxetine hydrochloride, but the patent needs to be prepared in fluidized bed equipment or rotary table equipment during the preparation process, and in the preparation of the enteric coating layer, must Pay attention to the temperature of the nozzle and pipeline in the fluidized bed equipment to ensure the smooth passage of the enteric suspension without agglomeration. This operation method is cumbersome and has poor reproducibility. It requires high equipment and high cost.

Method used

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  • Medicinal preparations containing duloxetine hydrochloride and preparation method thereof
  • Medicinal preparations containing duloxetine hydrochloride and preparation method thereof
  • Medicinal preparations containing duloxetine hydrochloride and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0074] Example 1 Duloxetine Hydrochloride Enteric-Coated Tablets

[0075]

[0076]

[0077] Preparation:

[0078] (1) Grind and mix duloxetine hydrochloride with basic magnesium oxide, then fully mix with lactose, starch, croscarmellose sodium, and magnesium stearate, then add 5% polyvinylpyrrolidone 50% ethanol solution Made into soft materials, granulated, dried to obtain dry granules, compressed into tablets, and tablet cores were obtained;

[0079] (2) Place the prepared tablet cores in a coating pan, mix hydroxypropyl methylcellulose, micro silica gel, and triethyl citrate evenly, and prepare a coating solution with 85% ethanol solution. Coating method is carried out coating, bag isolation layer, tablet core weight gain is 8%;

[0080] (3) The above products are coated with an enteric coating layer, Eudragit L100, talcum powder, tributyl citrate, titanium dioxide, and color lake are mixed evenly, and an enteric coating solution is formulated with 85% ethanol solut...

Embodiment 2

[0081] Example 2 Duloxetine Hydrochloride Enteric-Coated Tablets

[0082]

[0083] Preparation:

[0084] (1) Grind and mix duloxetine hydrochloride with alkaline filler magnesium oxide, then fully mix with microcrystalline cellulose, dextrin, crospovidone, and stearic acid, then add 50% ethanol solution to make soft materials, granulated, dried to obtain dry granules, compressed into tablets, and tablet cores were obtained;

[0085] (2) Place the prepared tablet cores in a coating pan, mix hydroxypropyl cellulose, talcum powder, and triethyl citrate evenly, prepare a coating solution with 85% ethanol solution, and adopt a conventional coating The method is to carry out coating, wrap the isolation layer, and the weight gain of the tablet core is 7%;

[0086] (3) The above products are coated with an enteric coating layer, and the acrylic resin No. II, acrylic resin III, talcum powder, tributyl citrate, castor oil, titanium dioxide, and pigment are mixed evenly, and the ent...

Embodiment 3

[0087] Example 3 Duloxetine Hydrochloride Enteric-Coated Tablets

[0088]

[0089] Preparation:

[0090] (1) Grind and mix duloxetine hydrochloride with basic magnesium carbonate basic filler, then fully mix with microcrystalline cellulose, mannitol, crospovidone and magnesium stearate, and then add 5% polyethylene Pyrrolidone 50% ethanol solution is made into a soft material, granulated, dried to obtain dry granules, and compressed into tablets to obtain tablet cores;

[0091] (2) Place the prepared tablet cores in the coating pan, and use 85% ethanol solution to prepare the "Easy-Release Li" gastric-soluble coating solution, and use the conventional coating method to coat, wrap the isolation layer, and the tablet cores 5% weight gain;

[0092] (3) The above products are coated with an enteric coating layer, Eudragit L100-55, micropowder silica gel, Tween-80, triethyl citrate, and titanium dioxide are mixed evenly, and an enteric coating solution is prepared with 85% eth...

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Abstract

The invention relates to an enteric-coated tablet containing duloxetine hydrochloride and a preparation method thereof. The enteric-coated tablet of duloxetine hydrochloride consists of three parts: a tablet core, a gastric-coated isolation layer and an enteric-coated layer. The technical proposal of the invention can effectively avoid the cross reaction between the medicine and enteric coating material occurring during the releasing process of the medicine and affecting the release of the medicine; therefore, the stability of the medicine can be effectively improved. The preparation method is simple and is easy to be operated, which is suitable for industrialized production.

Description

technical field [0001] The invention relates to a pharmaceutical preparation containing duloxetine hydrochloride and a preparation method thereof, in particular to an enteric-coated tablet containing duloxetine hydrochloride and a preparation method thereof. technical background [0002] Duloxetine hydrochloride (Duloxetine hydrochloride), its chemical name is: S-(+)-N-methyl-3-(1-naphthyloxy)-3-(2-thienyl)-propylamine hydrochloride , whose structural formula is: [0003] [0004] Duloxetine hydrochloride is a dual absorption inhibitor of serotonin and norepinephrine developed by Eli Lilly (Elilly) and is a safe and effective antidepressant. It has the following advantages: ① It acts on two key neurotransmitters related to depression and improves physical symptoms such as general pain and gastrointestinal disturbances. ②It acts quickly and relieves various symptoms of depression, including muscle pain, abdominal cramps and headaches. ③It is effective for women's stress...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/28A61K31/381A61K47/02A61P25/24A61P25/04
Inventor 王金戌陈素锐杨丽英杨秋生孟程军容彦华陈玉洁
Owner CSPC ZHONGQI PHARM TECH (SHIJIAZHUANG) CO LTD
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