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Packaging body of edaravone solid dispersion or preparation thereof

A technology of solid dispersion and edaravone is applied in the packaging of edaravone solid dispersion or its preparation, and in the field of packaging to improve the stability of edaravone solid dispersion or its preparation, and can solve the problem of total impurities. Increased content, no edaravone solid dispersion or its formulation stability packaging method, affecting stability and product quality, etc.

Pending Publication Date: 2022-04-05
SUZHOU AUZONE BIOLOGICAL TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, it has been recently found that the pure crystalline form of Edaravone is relatively stable under high temperature, high humidity and light conditions. The total impurity content increases significantly under high temperature, high humidity and light conditions, which seriously affects its stability and product quality.
[0004] Although there are many packaging materials to choose from on the market, there is no packaging method aimed at improving the stability of Edaravone solid dispersion or its preparations

Method used

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  • Packaging body of edaravone solid dispersion or preparation thereof
  • Packaging body of edaravone solid dispersion or preparation thereof
  • Packaging body of edaravone solid dispersion or preparation thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Dissolve 5 g of Edaravone and 25 g of Soluplus in 173 ml (about 136.7 g) of methanol, and prepare a solid dispersion (ASD) by spray drying and vacuum drying.

Embodiment 2

[0039] Dissolve 30g of Edaravone and 150g of Soluplus in 1038ml (about 820g) of methanol, and prepare a solid dispersion by spray drying and vacuum drying. The auxiliary materials used for granulation include 190g of microcrystalline cellulose and 100g of mannitol , 10g sodium carboxymethyl starch, 2.5g silicon dioxide, 2.5g magnesium stearate, mixed, dry powder granulation; additional auxiliary materials for tableting include 12.5g sodium carboxymethyl starch and 2.5g magnesium stearate, Blending and tableting to make 1000 tablets, each weighing 500mg, packaged in HDPE bottles, HDPE bottles + deoxidizer KD-20, OxyVanish TM bottle + Deoxidizer KD-20, PET / AL / PE aluminum foil bag + deoxidizer KD-20.

Embodiment 3

[0041] Dissolve 30g of Edaravone and 150g of Soluplus in 1038ml (about 820g) of methanol, and prepare a solid dispersion by spray drying and vacuum drying. Sodium hydrogen, 160g mannitol, 128g crospovidone, 16g sodium carboxymethyl starch, 4g magnesium stearate, mixed, dry powder granulation; additional excipients for tableting include 32g crospovidone, 24g carboxy Sodium methyl starch and 8g magnesium stearate, mixed together, compressed into 1000 tablets, each weighing 800mg, in PET / AL / PE aluminum foil bag + deoxidizer KD-20 for packing.

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Abstract

The invention belongs to the field of pharmacy, and particularly discloses a packaging body of an edaravone solid dispersion or a preparation thereof, and the packaging body comprises a packaging container with a light shielding or shading effect and a bagged deoxidizer in addition to the solid dispersion or the preparation thereof. The invention also discloses a packaging method for improving the stability of the edaravone solid dispersion or the preparation thereof. The method is helpful for reducing the impurity content of the edaravone solid dispersion preparation during the storage period and improving the stability and quality of the product.

Description

technical field [0001] The invention belongs to the field of pharmacy, and in particular relates to a packaging body of an Edaravone solid dispersion or a preparation thereof, and a packaging method for improving the stability of the Edaravone solid dispersion or a preparation thereof. Background technique [0002] Edaravone (Edaravone), whose trade name is Radicut, is a kind of anti-oxidative stress drug developed by Mitsubishi Tanabe Pharmaceutical Company of Japan. Listed for acute stroke and amyotrophic lateral sclerosis (AIS). It was launched in the United States in May 2017 for the treatment of amyotrophic lateral sclerosis (AIS), and it is the second FDA-approved drug for the treatment of amyotrophic lateral sclerosis (AIS). [0003] Compared with injections, oral preparations can increase patient dependence on medication and have lower production costs, so they are usually the preferred dosage form for drug development. However, the bioavailability of oral edaravon...

Claims

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Application Information

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IPC IPC(8): A61K31/4152A61K9/00A61K47/32A61P25/28B65D81/26
Inventor 周意
Owner SUZHOU AUZONE BIOLOGICAL TECH CO LTD
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