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

Divalproex sodium sustained release tablet

A technology of sodium divalproex and sustained-release tablets, which is applied in the directions of anhydride/acid/halide active ingredients, medical preparations of non-active ingredients, and pill delivery, etc., can solve problems such as increase in tablet weight and related substances, and achieve The effect of uniform sample content, avoiding large fluctuations and ensuring safety

Active Publication Date: 2017-08-11
CHENGDU KANGHONG PHARMA GRP
View PDF4 Cites 2 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] In order to solve the problem of particle cohesion and content uniformity in the tablet caused by moisture absorption in the wet granulation process of divalproex sodium, and avoid the increase of a series of tablet weights and related substances caused by a large number of different types of excipients and other problems, the applicant has obtained a slow-release tablet that can solve the above-mentioned problems through a large number of experimental studies. At the same time, the slow-release tablet is prepared by firstly preparing a soft material with a hydrophilic skeleton material and a diluent with a wetting agent, and then adding dipropylene glycol Sodium valerate is prepared together with the above-mentioned soft materials into soft materials containing medicine, then granulated, mixed with glidants after drying, and then compressed into tablets

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
  • Divalproex sodium sustained release tablet
  • Divalproex sodium sustained release tablet
  • Divalproex sodium sustained release tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] Example 1 Preparation of divalproex sodium granules by two granulation processes

[0043] 1. The weight percentage of each component

[0044]

[0045] 2. Experimental method

[0046] (1) process granulation method of the present invention prepares divalproex sodium granules

[0047] a) Pulverize divalproex sodium and pass through a 100-mesh sieve;

[0048] b) mixing hydroxypropyl methylcellulose, microcrystalline cellulose and lactose to obtain a uniformly dispersed mixed material;

[0049] c) Adding an appropriate amount of ethanol to the homogeneously mixed material prepared in step b) under the stirring condition of the wet mixing granulator, the amount of ethanol added is 150-300 mL per 1 kg of material to obtain a wet and soft material;

[0050] d) Add the divalproex sodium prepared in step a) to the wet soft material prepared in step c) under the stirring condition of the wet mixing granulator, and continue to mix the materials with the wet mixing granulator, ...

Embodiment 2

[0074] prescription:

[0075]

[0076]

[0077] Process: prepare wet granules according to the process in Example 1, dry the wet granules at 50°C for 1 hour, sieve the granules with a 24 mesh sieve, mix them evenly with 3.0% silicon dioxide by weight, and press them into tablets. The die size is 1.9 cm ×0.91cm (oval shape), tablet weight 1000mg, pressure 130-150N.

[0078] Get the dried granules prepared in the above process, adopt the sieving rate method in Example 1 to measure the sieving rate by 24 mesh sieves, the result is 99.24%. Get each 6 of divalproex sodium sustained-release tablets made above, adopt the method in embodiment 1 to measure the content of divalproex sodium in every tablet, the results are as follows:

[0079]

Embodiment 3

[0081] prescription:

[0082]

[0083] Process: Prepare wet granules according to the process in Example 1, dry the wet granules at 60°C for 1 hour, sieve the granules with a 20-mesh sieve, mix them evenly with 2.0% silicon dioxide by weight, and press them into tablets. The die size is 1.9 cm ×0.91cm (oval shape), tablet weight 1000mg, pressure 120-135N.

[0084] Get the dried granules prepared in the above process, adopt the sieving rate method in Example 1 to measure the sieving rate by 20 mesh sieves, and the result is 100%. Get each 6 of divalproex sodium sustained-release tablets made above, adopt the method in embodiment 1 to measure the content of divalproex sodium in every tablet, the results are as follows:

[0085]

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 discloses a divalproex sodium sustained release tablet. A process comprises the following steps: S1, preparing an auxiliary soft material; and S2, preparing a medicine-containing soft material, and preparing particles. The obtained particles are even and orderly in appearance, no sticky micelles are formed, the particles are moderate in size and have good mobility and compressibility, and the contents of the active ingredients are uniform, so that the quality of the medicine is stable and controllable. The divalproex sodium sustained release tablet prepared by adopting the particles has good in-vitro release, the release curve has high similarity with that of a post-market drug product, and the medicine can be effectively controlled to slowly release within 24h.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a divalproex sodium sustained-release tablet. Background technique [0002] Epilepsy is a chronic brain disease, the essence is abnormal discharge, and has recurrent seizures. According to WHO statistics, there are 50 million epilepsy patients in the world, and there are more than 8 million epilepsy patients in China, with a lifetime prevalence rate of 0.7%, and about 400,000 new cases each year. Divalproex sodium (divalproex sodium) can regulate the balance of nerve excitation and inhibition by increasing the level of γ-aminobutyric acid (GABA) and other mechanisms, so as to effectively control epileptic seizures, have broad-spectrum anti-epileptic effects and treat various neurological diseases , can be used for various types of epilepsy patients. Because of its milder gastrointestinal side effects and fewer drug interactions, it has become the first-line drug of ch...

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
IPC IPC(8): A61K9/22A61K47/38A61K47/26A61K31/20A61P25/08
CPCA61K9/0002A61K9/2018A61K9/2054A61K9/2095A61K31/20
Inventor 柯潇郑强徐熊良陈永建
Owner CHENGDU KANGHONG PHARMA GRP
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