Looking for breakthrough ideas for innovation challenges? Try Patsnap Eureka!

A sacubitril valsartan sodium pharmaceutical composition and preparation method thereof

A technology of sacubitril and sartan sodium, which is applied in directions such as drug combinations, pharmaceutical formulations, and active ingredients of heterocyclic compounds, can solve the problems of overall performance control of unfavorable products, poor reproducibility, unbalanced effects, etc., and achieves beneficial effects. The effect of large-scale industrial application, reduction of differences between wafers, and reduction of process costs

Inactive Publication Date: 2020-02-28
裴建梅
View PDF5 Cites 0 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] Based on the aforementioned prior art, other derived prior art solutions all adopt dry granulation technology, through the adjustment of excipients and process parameters, the stability of the product is improved, etc. However, there is still poor reproducibility between scale-up / scale-down Different specifications may require different production processes, which is not conducive to the overall performance control of the product, and may lead to uneven effects after medication

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • A sacubitril valsartan sodium pharmaceutical composition and preparation method thereof
  • A sacubitril valsartan sodium pharmaceutical composition and preparation method thereof
  • A sacubitril valsartan sodium pharmaceutical composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0057] A kind of sacubitril valsartan sodium pharmaceutical composition and preparation method thereof, comprising:

[0058]

[0059] (1) Add sacubitril-valsartan sodium and a small amount of acetone to make wet particles over 20 mesh, LCZ696:acetone=1:0.15g / mL;

[0060] (2) Pass the hydrophilic filler-sorbitol, the binder-hypromellose, and the disintegrant-croscarmellose sodium through a 80-mesh sieve, and add a small amount of acetone to make 20-mesh wet particles , the sum of the mass of hydrophilic filler, binder and disintegrant: acetone=1:0.5g / mL;

[0061] (3) Mix the wet granules of steps (1) and (2) evenly, granulate, then dry the granulated granules under reduced pressure at 30-40°C for 30 minutes, remove acetone, then add lubricant and mix well, Tablets were compressed according to the required specifications of the drug, coated with Opadry, and the weight was increased by 1%.

Embodiment 2

[0063] A kind of sacubitril valsartan sodium pharmaceutical composition and preparation method thereof, comprising:

[0064]

[0065] (1) Add sacubitril-valsartan sodium and a small amount of acetone to make wet particles over 20 mesh, LCZ696:acetone=1:0.15g / mL;

[0066] (2) Pass the hydrophilic filler-mannitol, the binder-hypromellose, and the disintegrant-cross-linked carboxymethyl starch sodium through a 80-mesh sieve, and add a small amount of acetone to make 20-mesh wet particles , the sum of the mass of hydrophilic filler, binder and disintegrant: acetone=1:0.5g / mL;

[0067] (3) Mix the wet granules of steps (1) and (2) evenly, granulate, then dry the granulated granules under reduced pressure at 30-40°C for 30 minutes, remove acetone, then add lubricant and mix well, Tablets were compressed according to the required specifications of the drug, coated with Opadry, and the weight was increased by 1%.

Embodiment 3

[0069] A kind of sacubitril valsartan sodium pharmaceutical composition and preparation method thereof, comprising:

[0070]

[0071] (1) Add sacubitril-valsartan sodium and a small amount of acetone to make wet particles over 20 mesh, LCZ696:acetone=1:0.15g / mL;

[0072] (2) Pass the hydrophilic filler-microcrystalline cellulose, the binder-hypromellose, and the disintegrant-croscarmellose sodium through a 80-mesh sieve, and add a small amount of acetone to make a 20-mesh sieve The sum of the mass of wet particles, hydrophilic filler, binder and disintegrant: acetone = 1: 0.5g / mL;

[0073] (3) Mix the wet granules of steps (1) and (2) evenly, granulate, then dry the granulated granules under reduced pressure at 30-40°C for 30 minutes, remove acetone, then add lubricant and mix well, Tablets were compressed according to the required specifications of the drug, coated with Opadry, and the weight was increased by 1%.

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

PUM

No PUM Login to View More

Abstract

The invention belongs to the technical field of pharmaceutical preparations, and particularly relates to a sacubitril valsartan sodium pharmaceutical composition and a preparation method of the sacubitril valsartan sodium pharmaceutical composition. The preparation method comprises the following steps: adopting a solvent individually granulated through a wet method by using acetone at the specificproportion as the raw material, then mixing and granulating, drying a granulated particle in combination with drying under reduced pressure at the lower temperature, the process with excellent repeatability is obtained when the scale is enlarged / reduced, and a drug is guaranteed not to be damaged in the preparation process. The stability and the uniformity of the obtained pharmaceutical preparation are excellent, and the pharmaceutical preparation is favorable for the excellent promotion of the drug to the treatment of congestive heart failure, high blood pressure and the like.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, in particular to a sacubitril-valsartan sodium pharmaceutical composition and a preparation method thereof. Background technique [0002] According to the "China Cardiovascular Disease Report 2013") statistics, there are about 290 million people with cardiovascular disease in my country, including about 4.5 million people with heart failure. Angiotensin-converting enzyme inhibitors (ACEI) are the first class of drugs that have been proven to reduce the mortality of patients with heart failure. They are also the drugs with the most evidence-based medical evidence. Pulley. [0003] Sacubitril-valsartan sodium, also known as LCZ696, is an anti-heart failure drug developed by Novartis with dual effects of angiotensin receptor blocking and neutral endopeptidase inhibition. Its structure (as follows) It was first disclosed in the patent WO2007056546A1. The results of published cl...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

Application Information

Patent Timeline
no application Login to View More
Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/41A61K47/26A61K47/38A61K47/36A61K47/08A61P9/12A61P9/04
CPCA61K31/41A61K47/08A61K47/26A61K47/36A61K47/38A61P9/04A61P9/12
Inventor 裴建梅
Owner 裴建梅
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Patsnap Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Patsnap Eureka Blog
Learn More
PatSnap group products

Browse by: Latest US Patents, China's latest patents, Technical Efficacy Thesaurus, Application Domain, Technology Topic, Popular Technical Reports.

© 2024 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap|About US| Contact US: help@patsnap.com