Preparation method of LCZ696 sustained release matrix tablet for treatment of heart failure

A technology for slow-release skeletons and skeleton materials, which can be applied to medical preparations without active ingredients, medical preparations containing active ingredients, and pharmaceutical formulas, etc. The effect of stable drug concentration and slow drug release

Active Publication Date: 2016-07-13
SHANDONG ACADEMY OF PHARMACEUTICAL SCIENCES
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

This new type of medicine called lczainide has several technical benefits that make it easier for people who take them up too long or have trouble remembering how they took their drugs over time. It's also easy to use because there will always stay with its effect even if taken again later due to changes made by other factors such as eatings on foodstuffs.

Problems solved by technology

This patented technical solution described in this patents relates to developing new drugs called LCzainide, specifically target cardiovascular systems like those caused by weakened hearts due to various causes including stroke. However these treatments have drawbacks because they require frequent administration over several days even if only one person takes them daily. There is currently no effective way to administer these agents without causing adverse events during sleep periods.

Method used

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  • Preparation method of LCZ696 sustained release matrix tablet for treatment of heart failure
  • Preparation method of LCZ696 sustained release matrix tablet for treatment of heart failure
  • Preparation method of LCZ696 sustained release matrix tablet for treatment of heart failure

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Experimental program
Comparison scheme
Effect test

Embodiment 1

4

[0031] Preparation process: Raw and auxiliary materials are passed through 80-mesh sieve respectively, and the LCZ696 raw material is weighed according to the prescription and mixed with hypromellose K15M, and then mixed evenly with mannitol, micronized silica gel, talcum powder, and magnesium stearate, and the whole powder is directly pressed piece.

[0032] For the release test, the release rate of the sample was measured according to the first method of the release rate of the four general rules of the Chinese Pharmacopoeia 2015 edition. With 900ml of buffer salt of pH6.8 as solvent, 100 revolutions of rotating speed, sampling in 1, 4 and 8 hours, measure the release rate of sample, the result is as follows:

[0033] time

Embodiment 2

2

[0036] Preparation process: Raw and auxiliary materials are passed through 80-mesh sieve respectively, and the LCZ696 raw material is weighed according to the prescription and mixed with hypromellose K15M, and then mixed evenly with mannitol, micronized silica gel, talcum powder, and magnesium stearate, and the whole powder is directly pressed piece.

[0037] For the release test, the release rate of the sample was measured according to the first method of the release rate of the four general rules of the Chinese Pharmacopoeia 2015 edition. With 900ml of buffer salt of pH6.8 as solvent, 100 revolutions of rotating speed, sampling in 1, 4 and 8 hours, measure the release rate of sample, the result is as follows:

[0038] time

Embodiment 3

4

[0041] Preparation process: The raw and auxiliary materials are passed through 80-mesh sieve respectively, and the raw materials of LCZ696 and hypromellose K15M are weighed according to the prescription, mixed evenly, and then mixed evenly with mannitol, micronized silica gel, talcum powder, and magnesium stearate, and the whole powder is directly Tablet.

[0042] For the release test, the release rate of the sample was measured according to the first method of the release rate of the four general rules of the Chinese Pharmacopoeia 2015 edition. With 900ml of buffer salt of pH6.8 as solvent, 100 revolutions of rotating speed, sampling in 1, 4 and 8 hours, measure the release rate of sample, the result is as follows:

[0043] time

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Abstract

The invention provides a preparation method of an LCZ696 sustained release matrix tablet. The specific prescription of the LCZ696 sustained release tablet comprises (g/g): 40% of a main drug, 10%-20% of a matrix material, 30%-40% of a diluent, and 5%-10% of a lubricant. The preparation method consists of: sieving the raw and auxiliary materials by a 80-mesh sieve respectively for standby use, firstly mixing the main drug with the matrix material evenly, then adding the diluent and the lubricant and mixing the materials evenly, and performing all powder direct compression, thus obtaining the LCZ696 sustained release matrix tablet. The sustained release tablet is used for medication once every 24h, and the number of medication times is reduced. After oral taking, drugs are released slowly, the blood concentration is stable, and peak valley phenomenon is not generated. Also, the toxic and side effects of drugs are reduced.

Description

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Claims

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Application Information

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Owner SHANDONG ACADEMY OF PHARMACEUTICAL SCIENCES
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