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Preparation method of sodium valproate sustained release tablet

A technology of sodium valproate and sustained-release tablets, which is applied in the field of medicine, can solve the problems of easy spherical shape, low moisture content, slow particle growth, etc., and achieve the effect of overcoming the consequences of collapsed bed.

Active Publication Date: 2021-08-27
YANGTAI PHARMA SHANDONG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

If the moisture content is too high, some powder will adhere to the inner wall of the pot, and the particles will easily adhere to each other to form a block, which will cause the bed to collapse seriously; if the moisture content is too low, the particles will grow slowly, resulting in too much powder
[0014] If fluidized bed granulation technology can be applied to the preparation process of sodium valproate sustained-release tablets, its granulation efficiency will be improved, and the patent "a sodium valproate sustained-release preparation and its preparation process and use" ( Application number: CN201610595004.8) provides a method for preparing sodium valproate sustained-release preparations using a fluidized granulator; yet it uses ethanol as a binder, and because of the extremely strong hygroscopicity of sodium valproate, water, anhydrous Ethanol and different concentrations of ethanol can easily induce the viscosity of sodium valproate, and the material will easily form a ball during granulation, resulting in the failure of granulation
The open patent and optimization based on the original research formula are difficult to solve the problem of difficult granulation

Method used

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  • Preparation method of sodium valproate sustained release tablet
  • Preparation method of sodium valproate sustained release tablet
  • Preparation method of sodium valproate sustained release tablet

Examples

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Effect test

preparation example Construction

[0076] The preparation process of the original trituration agent is as follows:

[0077] The raw and auxiliary materials in the tablet core are simply mixed, and tabletable granules can be obtained without the need for reagents and drying. The granules are compressed and finally coated. The environment does not require dehumidification. By repeating the method and simply mixing the raw and auxiliary materials, the particles have poor fluidity, and due to the large amount of fine powder and the strong hygroscopicity of sodium valproate, the sticking is serious during the tableting process.

[0078] (5), fluidized bed granulator

[0079] The structure of the fluidized bed granulator is as follows: Figure 5 As shown, it includes an air treatment system 1 , a pot body 2 , a spray gun 3 , a filter 4 , an exhaust gas treatment system 5 and a humidifier 6 . In the air treatment system 1, the controlled temperature and humidity entering the fluidized bed can be monitored, and the ...

Embodiment 1

[0082] Example 1: In order to demonstrate that this technology can be used for scale-up production, 100,000 pieces of products are produced in this example.

[0083] A preparation method of sodium valproate sustained-release tablet, comprising the steps:

[0084] 1. Adsorption

[0085] Pour valproic acid into silica, the mass ratio of valproic acid to silica is 4:1, stir to solidify into powder, and pass the powder through an 80-mesh sieve to obtain valproic acid adsorbate.

[0086] 2. Mix

[0087] Pour the hypromellose, sodium valproate, valproic acid adsorbate, ethyl cellulose and sodium saccharin into the wet granulator, set stirring at 150 rpm, cut the knife at 2000 rpm, and mix for 5 minutes to prepare a premix .

[0088] 3. Granulation

[0089] Pour the premix into the fluidized bed pot, turn off the heating, set the inlet air humidity to 70±5%, and fluidize for 126 minutes to form wet granules.

[0090] Pour the premix directly into the fluidized bed pot, turn off ...

Embodiment 2

[0099] Example 2: Using the same recipe as Example 1

[0100] The preparation process is as follows:

[0101] 1. Adsorption

[0102] Pour valproic acid into silica, the mass ratio of valproic acid to silica is 5:1, stir to solidify into powder, and pass the powder through an 80-mesh sieve to obtain valproic acid adsorbate.

[0103] 2. Mix

[0104] Pour the hypromellose, sodium valproate, valproic acid adsorbate, ethyl cellulose and sodium saccharin into the wet granulator, set stirring at 150 rpm, cut the knife at 2000 rpm, and mix for 5 minutes to prepare a premix .

[0105] 3. Granulation

[0106] Pour the premix directly into the fluidized bed pot, turn off the heating, and set the air volume to 600m 3 / h, the bag shaking interval is 30s, the bag shaking time is 15s, and the inlet air humidity is 90±5%. Granulate for 30 minutes to form wet granules.

[0107] 4. Dry

[0108] Set the inlet air temperature to 70°C, set the inlet air humidity to 40%, and the air volume to...

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Abstract

The invention discloses a preparation method of a sodium valproate sustained release tablet, and belongs to the technical field of medicines. The sodium valproate sustained-release tablet disclosed by the invention consists of active medicines, namely valproic acid, sodium valproate, a flavoring agent, a framework material, a retardant, a lubricant, an adsorbent and a gastric-soluble coating premix. According to the preparation method of the sodium valproate sustained release tablet, the problem that sodium valproate in the product is not beneficial to industrial production due to extremely high hygroscopicity is solved, the hygroscopicity characteristic of the sodium valproate is utilized, the humidity in a fluidized granulator is increased to form granules in the fluidization process, the prepared granules have good flowability and tabletability, and the prepared product has good stability, has good similarity between in-vitro dissolution and original dissolution curves, and is suitable for large-scale production.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a preparation method of a sodium valproate sustained-release tablet. Background technique [0002] Sodium valproate is white crystalline powder or granules; it has strong hygroscopicity. This product is easily soluble in water, easily soluble in methanol or ethanol, and almost insoluble in acetone. Chemical name: sodium 2-propyl valerate. [0003] Chemical Structure: [0004] [0005] Sodium valproate is an anti-seizure drug that is also used to treat mania. It can be used for epilepsy monotherapy or as an add-on therapy. For the treatment of generalized epilepsy: including absence seizures, myoclonic seizures, tonic-clonic seizures, atonic seizures and mixed seizures, special types of syndromes (West, Lennox-Gastaut syndrome), etc. For the treatment of partial epilepsy: Partial seizures, with or without generalized seizures. It can also be used to treat manic episodes ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/36A61K47/38A61K31/19A61K47/04A61P25/08A61P25/18
CPCA61K9/2866A61K9/2009A61K31/19A61P25/08A61P25/18
Inventor 王玉广孙迎基李洋张元元
Owner YANGTAI PHARMA SHANDONG
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