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Duloxetine hydrochloride enteric-coated tablet and preparation method thereof

A technology of enteric and hydrochloric acid degree of loxetine, which is applied to pharmaceutical formulations, medical preparations with inactive ingredients, and medical preparations containing active ingredients, etc., can solve problems such as poor dissolution rate and achieve the effect of good dissolution rate.

Pending Publication Date: 2021-07-16
SHANGHAI ZHONGXI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The technical problem to be solved by the present invention is to provide a kind of duloxetine hydrochloride enteric-coated tablets in order to overcome the defect that the dissolution rate of duloxetine hydrochloride enteric-coated tablets in the prior art is not good in a phosphate buffer solution with a pH of 6.8 Dissolving tablet and preparation method thereof

Method used

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  • Duloxetine hydrochloride enteric-coated tablet and preparation method thereof
  • Duloxetine hydrochloride enteric-coated tablet and preparation method thereof
  • Duloxetine hydrochloride enteric-coated tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0083] The raw materials of duloxetine hydrochloride enteric-coated tablets are prepared according to the above table, and the preparation method is as follows:

[0084] (1) Preparation of tablet cores: The active ingredients and fillers were premixed by hand, passed through a 40-mesh sieve, poured into a fast stirring granulator, and premixed for 5 minutes with the stirring paddle turned on. Then turn on the flying knife at low speed and add purified water. The mass ratio of purified water to tablet core material is 1:5. After the purified water is added, turn on the flying knife at high speed and continue granulating for about 3-8 minutes. The material is dried in an oven at 50° C., and the drying is stopped when the moisture content is less than 1.0 wt%. Install a stainless steel sieve ring with a size of 1.2mm to 2.0mm for sizing, then add a lubricant and mix for 5 minutes, press into tablets, control the hardness to 4-10kg, the friability is less than 0.8%, and the weight...

Embodiment 2-3

[0088] The raw materials of duloxetine hydrochloride enteric-coated tablets are prepared according to the above table, and the preparation method is as follows:

[0089] (1) Preparation of tablet core: pretreatment: powder sucrose and pass through a 40-mesh sieve, and the remaining raw materials are passed through a 40-mesh sieve in turn. Wet granulation: ①Preparation of binder: Dissolve the binder in 70% (w / w) ethanol aqueous solution, and the mass ratio of the ethanol aqueous solution to the tablet core raw material is 1:18. ②Put the active ingredients and fillers into the tank mixer, mix for 10 minutes, pour in the binder evenly, and continue stirring for 3 to 5 minutes after pouring to make a soft material, and turn off the stirring. ③ Install a 20-mesh nylon net on the swing granulator, add the soft materials into the hopper in stages, and carry out the granulation operation. Collect the prepared wet granules into the stainless steel basin, and then evenly and appropriate...

Embodiment 4-7

[0093] The raw materials of duloxetine hydrochloride enteric-coated tablets were prepared according to the following table, and the preparation method was the same as in Example 1.

[0094]

[0095]

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Abstract

The invention discloses a duloxetine hydrochloride enteric-coated tablet and a preparation method thereof. The enteric-coated tablet comprises a tablet core, an isolating layer, and an enteric-coated layer; the tablet core comprises duloxetine hydrochloride, lactose, a lubricant and a non-lactose filler, and the mass percentages of the duloxetine hydrochloride, the lactose, the lubricant and the non-lactose filler in the tablet core are 7.7%-22.3%, 31.8%-56.7%, 0.3%-1.5% and supplemented to 100% respectively; the isolating layer comprises an adhesive, cane sugar and an anti-sticking agent, and the mass percentages of the adhesive, the cane sugar and the anti-sticking agent in the isolating layer are 20.0%-50.0%, 20.0%-50.0% and 10.0%-50.0% respectively; the enteric-coated layer comprises an enteric-coated material, an anti-sticking agent and a plasticizer, and the mass percentages of the enteric-coated material, the anti-sticking agent and the plasticizer in the enteric-coated layer are 60.0%-85.7%, 5.4%-30.0% and 5.0%-25% respectively; and the weight of the coating of the isolating layer is increased by 4-12%, and the weight of the coating of the enteric-coated layer is increased by 5.4-12%. The dissolution rate of the enteric-coated tablet in a buffer solution is better.

Description

technical field [0001] The invention relates to a duloxetine hydrochloride enteric-coated tablet and a preparation method thereof. Background technique [0002] Duloxetine Hydrochloride (DuloxetineHydrochloride, API) is an effective dual absorption inhibitor of serotonin and norepinephrine for the treatment of depression. The chemical name is: S-(+)-N-methyl-3 -(1-naphthyloxy)-3-(2-thienyl)-propylamine hydrochloride, its structural formula is: [0003] [0004] Duloxetine hydrochloride is white or off-white crystalline powder, which is soluble in ethanol and has a certain solubility in water. It is unstable under acidic conditions and easy to degrade. Therefore, it is suitable to be made into enteric-coated preparations to resist the damage of gastric juice to the drug. [0005] The original research uses a fluidized bed to prepare enteric-coated pellets and fill gelatin capsule capsules. In the United States, it was first approved for the treatment of major depressive ...

Claims

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Application Information

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IPC IPC(8): A61K9/36A61K9/32A61K31/381A61K47/26A61P25/22A61P25/24
CPCA61K9/2018A61K9/2846A61K9/2866A61K9/2886A61K31/381A61P25/22A61P25/24
Inventor 綦宁姣徐豪石海芹丁祎馨傅麟勇周敏丁云晖王菲李星旺王永
Owner SHANGHAI ZHONGXI PHARMA
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