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Sacubitril valsartan sodium sustained release tablets and preparation method thereof

A technology of sacubitrilvaler and sustained-release tablets, which is applied in the direction of pharmaceutical formulas, medical preparations containing no active ingredients, medical preparations containing active ingredients, etc., and can solve problems such as poor patient compliance and fluctuations in blood drug concentration. Achieve sustained and effective heart failure, improve compliance, and be easy to operate and control

Active Publication Date: 2021-04-13
南京康川济医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] At present, the domestic sales of sacubitril and valsartan sodium preparations are only regular tablets (50mg, 100mg, 200mg) from Novartis, which require daily administration 2 times, it is easy to cause fluctuations in blood drug concentration, and the patient's compliance is poor

Method used

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  • Sacubitril valsartan sodium sustained release tablets and preparation method thereof
  • Sacubitril valsartan sodium sustained release tablets and preparation method thereof
  • Sacubitril valsartan sodium sustained release tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0054] (1) Core layer (per piece):

[0055]

[0056]

[0057] (2) The composition of the film coating solution:

[0058] Opadry 00F220009-CN 19mg

[0059] Embodiment 1 and embodiment 3 - the sacubitril valsartan sodium sustained-release tablet preparation process of embodiment 16:

[0060] (1) Weigh the raw and auxiliary materials according to the prescription amount, and mix them uniformly according to the equal-volume incremental method to obtain the premixed powder. Add an appropriate amount of soft material made of absolute ethanol to it, pass through a 20-mesh sieve to granulate, dry at 40°C for 2 hours, and pass through a 20-mesh sieve for granulation. Add the prescribed amount of lubricant and mix well;

[0061] (2) Tablet pressing: use a special-shaped die with a size of 19.5mm×9.6mm, and control the hardness to 8-10kg;

[0062] (3) Film coating: Opadry 00F220009-CN is used to coat the above-mentioned tablet cores with a weight gain of 2%.

[0063] Embodimen...

Embodiment 2

[0066] (1) Core layer (per piece):

[0067]

[0068]

[0069] (2) The composition of the film coating solution:

[0070] Opadry 00F220009-CN 19mg

[0071] The sacubitril valsartan sodium sustained-release tablet preparation technology of embodiment 2:

[0072] (1) Weigh the raw and auxiliary materials according to the prescription amount, and mix them uniformly according to the equal-volume incremental method to obtain the premixed powder. The premixed powder is then prepared into granules using a dry granulator. Add the prescribed amount of lubricant and mix well;

[0073] (2) Tablet pressing: use a special-shaped die with a size of 19.5mm×9.6mm, and control the hardness to 8-10kg;

[0074] (3) Film coating: Opadry 00F220009-CN is used to coat the above-mentioned tablet cores with a weight gain of 2%.

[0075] The sacubitril-valsartan sodium sustained-release tablet release rate of embodiment 1 sees figure 1 . The sacubitril-valsartan sodium sustained-release tab...

Embodiment 3

[0077] (1) Core layer (per piece):

[0078]

[0079] (2) The composition of the film coating solution:

[0080] Opadry 00F220009-CN 19mg

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Abstract

The invention belongs to the field of pharmaceutical preparations, and provides sacubitril valsartan sodium sustained release tablets and a preparation method thereof. The sacubitril valsartan sodium sustained release tablets provided by the invention contain sacubitril valsartan sodium, a sustained release material, a filler and other pharmaceutic adjuvants. In the sacubitril valsartan sodium sustained release tablets, the sacubitril valsartan sodium accounts for 30%-65% of the weight of tablet cores, the sustained release material accounts for 15%-40% of the weight of the tablet cores, the filler accounts for 8%-50% of the weight of the tablet cores, and a lubricant accounts for 0.1%-8% of the weight of the tablet cores. A film coating material accounts for 0-10% of the total weight of the tablets. The invention also discloses a preparation method of the sacubitril valsartan sodium sustained release tablets, and the sacubitril valsartan sodium sustained release tablets prepared by the method have the characteristics of sustained release, and is beneficial to maintaining long-term efficient plasma concentration in vivo and improving the treatment effect.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a sacubitril-valsartan sodium sustained-release tablet and a preparation method thereof. Background technique [0002] Heart failure (HF) is a syndrome of changes in cardiac function caused by myocardial injury, and it is the end-stage manifestation of all cardiovascular diseases, and its treatment effect has been unsatisfactory. Epidemiological surveys show that the prevalence of chronic HF in adults in my country is 1.61%, and the in-hospital mortality rate accounts for 40% of the cardiovascular in-hospital mortality rate, which is higher than the overall cardiovascular disease mortality rate. About 50% of HF patients are diagnosed 5 Death within a year is equivalent to the death rate of malignant tumors. Clinically, the treatment of chronic heart failure should not only improve the patient's symptoms and improve the quality of life, but also combine the mechanism of ...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K9/36A61K47/38A61K47/36A61K47/32A61K47/10A61K31/41A61K31/216A61P9/04
CPCA61K9/2095A61K9/2054A61K9/205A61K9/2027A61K9/2031A61K9/2866A61K31/41A61K31/216A61P9/04
Inventor 陈金脱朱春莉冯婧劼
Owner 南京康川济医药科技有限公司