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Duloxetine hydrochloride enteric-coated tablet and preparation method

A technology of duloxetine hydrochloride and loxetine enteric, which is applied in the field of duloxetine hydrochloride enteric-coated tablets and its preparation, can solve the problems of slow onset of action and difficulty in quickly reaching effective blood drug concentration, and reduce irritation , Long duration of drug effect, fast onset effect of the drug

Active Publication Date: 2013-06-05
HEBEI TIANCHENG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The drug has a matrix-type sustained-release function of intestinal erosion, but it is difficult for patients to quickly reach the effective blood concentration after taking the drug, resulting in slow onset of action

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] The preparation of embodiment 1 duloxetine hydrochloride enteric-coated tablets

[0033] (1) Immediate release layer formula:

[0034]

[0035] (2) Sustained release layer formula:

[0036]

[0037]

[0038] (3) Isolation gown formula:

[0039] Gastric soluble coating powder 50g

[0040] Appropriate amount of pure water

[0041] Coating weight gain 5%.

[0042] (4) Enteric coating formula:

[0043] Enteric coating powder 100g

[0044] Appropriate amount of pure water

[0045] Coating weight gain 10%.

[0046] Preparation Process:

[0047] (1) Pass duloxetine hydrochloride, low-substituted hydroxypropyl cellulose, lactose, microcrystalline cellulose and sodium carbonate in the immediate-release layer through a 100-mesh sieve, mix well, add pure water as a binder, and granulate , dried, granulated through a 20-mesh sieve, magnesium stearate was added to the dry granules, mixed evenly, and set aside;

[0048] (2) Pass the duloxetine hydrochloride, hydroxyp...

Embodiment 2

[0051] The preparation of embodiment 2 duloxetine hydrochloride enteric-coated tablets

[0052] (1) Immediate release layer formula:

[0053]

[0054]

[0055] (2) Sustained release layer formula:

[0056]

[0057] (3) Isolation gown formula:

[0058] Gastric soluble coating powder 50g

[0059] Appropriate amount of pure water

[0060] Coating weight gain 5%.

[0061] (4) Enteric coating formula:

[0062] Enteric coating powder 100g

[0063] Appropriate amount of pure water

[0064] Coating weight gain 10%.

[0065] Preparation Process:

[0066] (1) Pass duloxetine hydrochloride, crospovidone, lactose, microcrystalline cellulose and sodium carbonate in the immediate-release layer through a 100-mesh sieve, mix well, add pure water as a binder, granulate, and dry , through a 20-mesh sieve, add magnesium stearate to the dry granules, mix well, and set aside;

[0067] (2) Pass the duloxetine hydrochloride, hydroxypropyl methylcellulose K4M, starch and sodium car...

Embodiment 3

[0070] The preparation of embodiment 3 duloxetine hydrochloride enteric-coated tablets

[0071] (1) Immediate release layer formula:

[0072]

[0073] (2) Sustained release layer formula:

[0074]

[0075] (3) Isolation gown formula:

[0076] Gastric soluble coating powder 50g

[0077] Appropriate amount of pure water

[0078] Coating weight gain 5%.

[0079] (4) Enteric coating formula:

[0080] Enteric coating powder 100g

[0081] Appropriate amount of pure water

[0082] Coating weight gain 10%.

[0083] Preparation Process:

[0084] (1) Pass duloxetine hydrochloride, crospovidone, mannitol, microcrystalline cellulose and sodium carbonate in the immediate-release layer through a 100-mesh sieve, mix well, add pure water as a binder, and granulate, Drying, 20-mesh sieve and granulation, adding magnesium stearate to the dry granules, mixing, set aside;

[0085] (2) Pass the duloxetine hydrochloride, hydroxypropyl methylcellulose K4M, starch and sodium carbonate...

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Abstract

The invention discloses a duloxetine hydrochloride enteric-coated tablet and a preparation method, the enteric-coated tablet comprises a tablet core composed of a rapid-release layer and a slow-release layer, the tablet core is coated with a gastric solubility isolation coating, the gastric solubility isolation coating is coated with an enteric coating, wherein the slow-release layer contains 1 part of duloxetine hydrochloride, 0.5-2 parts of disintegrating agent, 1-6 parts of filler, 6-10 parts of sodium carbonate and 0.1-0.5 parts of magnesium stearate; the slow-release layer contains 3- 5 parts of duloxetine hydrochloride, 3-15 parts of filler, 8-20 parts of sodium carbonate and 0.2-1 part of magnesium stearate. The enteric-coated tablet has the advantages of fast onset time, long duration of pharmaceutical effect and high stability, and is suitable for industrial production.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a duloxetine hydrochloride enteric-coated tablet and a preparation method thereof. Background technique [0002] According to the report of the World Health Organization, depression has become the fourth largest disease in the world, and it is the second largest disease in the age group of 15 to 44 years old. It is estimated that by 2020, depression may become the second most common disease after heart disease, and may even cause 850 million people to have suicidal tendencies or die by suicide every year. [0003] Duloxetine hydroehloride is an antidepressant developed by Lilly Company. It is a serotonin and norepinephrine reuptake inhibitor (SNRI), which can inhibit the symptoms of pain in patients with depression. Common adverse reactions of duloxetine hydrochloride enteric-coated tablets include nausea, dry mouth, insomnia, drowsiness, constipa...

Claims

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Application Information

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IPC IPC(8): A61K9/28A61K31/381A61P25/24
Inventor 不公告发明人
Owner HEBEI TIANCHENG PHARMA
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