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Duloxetine enteric coated tiny pill capsule, and preparation method

A technology of duloxetine intestine and loxetine intestine, which is applied in the directions of bulk delivery, nervous system diseases, active ingredients of heterocyclic compounds, etc., can solve the problems that do not involve solid dispersion technology and so on.

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

In this patent, the inventor also did not relate to the solid dispersion technology used in this patent

Method used

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  • Duloxetine enteric coated tiny pill capsule, and preparation method
  • Duloxetine enteric coated tiny pill capsule, and preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

0.02

[0062] Dissolve polyvinylpyrrolidone in an appropriate amount of ethanol solution, add duloxetine in the prescribed amount, add sucrose and sodium bisulfite after it dissolves, add talcum powder after it dissolves, and stir to obtain the main drug layer coating solution. Under the continuous stirring of the magnetic stirrer, the coating operation was carried out using a fluidized bed, and the coating was completed and fluidized and dried at 45° C. for several minutes.

[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 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 flui...

Embodiment 2

[0068] Dissolving hydroxypropyl β-cyclodextrin in an appropriate amount of ethanol solution, adding duloxetine in the prescribed amount, adding lactose after dissolving, adding talcum powder after dissolving, and stirring to obtain the coating solution of the main drug layer. Under the continuous stirring of the magnetic stirrer, the coating operation was carried out using a fluidized bed, and the coating was completed and fluidized and dried at 45° C. for several minutes.

[0069] 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 fluidized bed unde...

Embodiment 3

1.80

[0075] Dissolve polyethylene glycol in an appropriate amount of ethanol solution, add duloxetine in the prescribed amount, add lactose and mannitol after it dissolves, stir until it dissolves, add talcum powder, and obtain the coating solution of the main drug layer. Coating was carried out in a fluidized bed under continuous stirring with a magnetic stirrer.

[0076] 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, under the continuous stirring of the magnetic stirrer, the coating was carried out in a fluidized bed.

[0077] Preparation of enteric layer coating solution: Weigh the requ...

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Abstract

An enteric micropill (microsoftgel) of Duluoxiting and its preparing process are disclosed. Said micropill is composed of an empty core pill and a coated external layer consisting of a principal medicine layer, an isolating layer and an enteric layer. It features that its principal medicine can be quickly released only in small intestine.

Description

technical field [0001] The invention relates to an oral preparation of duloxetine and its salts, in particular to a duloxetine enteric-coated pellet capsule 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 (+)...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/38A61K9/16A61P25/24
Inventor 金方闻聪
Owner SHANGHAI INST OF PHARMA IND CO LTD
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