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Enteric coated table of duloxetine, and preparation method

A technology for enteric and coated tablets of duloxetine, which is applied in the field of enteric-coated oral coated tablets of duloxetine and the preparation thereof, can solve the problems that do not involve solid dispersion technology and solubilization methods.

Active Publication Date: 2008-01-23
SHANGHAI INST OF PHARMA IND CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

And in this patent, the inventor did not relate to the solid dispersion technology and solubilization method used in this patent

Method used

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  • Enteric coated table of duloxetine, and preparation method
  • Enteric coated table of duloxetine, and preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0055] Dissolve polyvinylpyrrolidone in an appropriate amount of ethanol solution, add the prescribed amount of duloxetine, add sucrose and lactose after it dissolves, stir and mix evenly, sieve, and dry in an oven to obtain duloxetine as a solid Dispersion, whole granules, mixed with prescribed amount of magnesium stearate and compressed into tablets to obtain plain tablet cores.

[0056] Preparation of the coating solution for the isolation layer: heat half of the prescribed amount of water to 70°C, pour in hypromellose, stir to disperse evenly and set aside. Add polyethylene glycol, talcum powder, and titanium dioxide to the other half of the water, use a high-shear homogenizer to homogenize for several minutes, and slowly pour the suspension into the hypromellose solution prepared in the previous step, slowly Stir at high speed for half an hour, and coat with a sugar pan under the continuous stirring of a magnetic stirrer.

[0057] Enteric-coating layer preparation...

Embodiment 2

0.63

[0062] Dissolve hypromellose in an appropriate amount of ethanol solution, add the prescribed amount of duloxetine, add sucrose and lactose after it dissolves, stir and mix evenly, sieve, and dry in an oven to obtain duloxetine The solid dispersion, the whole grain, mixed with the prescribed amount of micropowder silica gel, and then pressed into tablets to obtain plain tablet cores.

[0063] Preparation of the coating solution for the isolation layer: heat half of the prescribed amount of water to 70°C, pour in hypromellose, stir to disperse evenly and set aside. Add triethyl citrate, talc powder, and titanium dioxide to the other half of the water, homogenize with a high-shear homogenizer for several minutes, and slowly pour the suspension into the hypromellose solution prepared in the previous step , stirred at a slow speed for half an hour, and coated with a sugar pan under the continuous stirring of a magnetic stirrer.

[0064] Preparation of enteric laye...

Embodiment 3

[0068] Dissolve polyethylene glycol in an appropriate amount of ethanol solution, add the prescribed amount of duloxetine, add lactose and mannitol after it dissolves, stir and mix evenly, sieve, and dry in an oven to obtain duloxetine The solid dispersion, the whole grain, is mixed with the prescribed amount of talcum powder and compressed into tablets to obtain plain tablet cores.

[0069] Preparation of the coating solution for the isolation layer: dissolve polyvinylpyrrolidone in half of the prescribed amount of water. Add polyethylene glycol, talcum powder, and titanium dioxide to the other half of the water, and use a high-shear homogenizer to homogenize for several minutes. Slowly pour the suspension into the polyvinylpyrrolidone solution prepared in the previous step, and stir slowly For half an hour, coat with a icing pan under constant stirring with a magnetic stirrer.

[0070] Preparation of enteric layer coating solution: Weigh the required aqueous dispersi...

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Abstract

A coated enteric tablet of Duluoxiding and its preparing process are disclosed. It features that said Duluoxiding can be released only in small intestine, so resulting in high biologic utilization rate.

Description

technical field [0001] The invention relates to an oral preparation of duloxetine and its salts, in particular to an enteric-coated oral duloxetine tablet and a preparation method thereof. Background technique [0002] Depression is one of the leading causes of loss of work and life. As fatigue progresses, patients lose the ability to make decisions, function normally, or perform basic self-care activities. The acceleration of the pace of modern life and the increase of social pressure have brought great challenges to people's psychological endurance. According to the latest medical literature, about 12% of people suffer from depression, but the effective rate of antidepressants currently available clinically is less than 70%, and the onset time is generally more than 15 days, and some are difficult to tolerate Many patients lose confidence in treatment due to side effects (sexual dysfunction, severe gastrointestinal reactions). [0003] Duloxetine, chemically named (+)-N...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/381A61K9/28A61P25/24
Inventor 闻聪金方
Owner SHANGHAI INST OF PHARMA IND CO LTD
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