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Low-substituted hydroxypropylcellulose powder and method for producing the same

A hydroxypropyl cellulose, low-substitution technology, applied in the field of low-substituted hydroxypropyl cellulose, can solve the problems of weak compressibility, reduced fiber part weight, reduced compressibility, etc., and achieve excellent compressibility and excellent swelling Performance, the effect of excellent disintegration

Active Publication Date: 2008-02-13
SHIN ETSU CHEM IND CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] Solid preparations in the fields of pharmaceuticals, foods, etc., preparations prepared only from main ingredients have the following problems: when the drug is administered, the effect of the drug cannot be fully exerted because sufficient disintegration is not obtained, and due to its weak compressibility So that the shape of the tablet or granule prepared therefrom cannot be maintained
In addition, pulverization requires application of high energy for a short period of time, so the throughput and production efficiency of this method are low
[0011] In addition, the low-substituted hydroxypropyl cellulose prepared by the above method has the following problems: when dissolving with a smaller amount of partial neutralization in order to improve the fluidity of the powder, the amount of the fiber part decreases, and thus the compressibility decreases
[0018] Japanese Patent Application Unexamined Publication No. 7-324101 / 1995 describes a low-substituted hydroxypropyl cellulose having an angle of repose of 45° or less and a swelling volume growth rate of 100% or greater, but the low-substituted hydroxypropyl cellulose Propyl cellulose has very low compressibility

Method used

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  • Low-substituted hydroxypropylcellulose powder and method for producing the same
  • Low-substituted hydroxypropylcellulose powder and method for producing the same

Examples

Experimental program
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Effect test

Embodiment 1

[0085] First, 806g of powdery slurry (750g in anhydrous state) was added to a 10L internal stirring reaction device, 303g of sodium hydroxide aqueous solution (26wt%) was added to the reaction device, and then mixed at 45°C for 30 minutes Produce alkaline cellulose, wherein the weight ratio of sodium hydroxide and anhydrous cellulose is 0.105. Nitrogen purging was then carried out, 123 g of propylene oxide (0.164 parts by weight relative to cellulose) was added to the resultant, and then the mixture was reacted for 1.5 hours in a jacket at a temperature of 60° C., thereby obtaining 1232 g of hydroxypropyl fibers Crude reaction product of a prime with a molar substitution of hydroxypropoxy per anhydroglucose unit of 0.28. The etherification reaction rate was 61.4%.

[0086] Then, 236 g of acetic acid (50 wt %) was added to the above-mentioned 10 L internal stirring type reaction apparatus and mixed to perform a neutralization reaction. The neutralized product was washed in ho...

Embodiment 2

[0110] First, 806g of powdered slurry (750g in anhydrous state) was added to a 10L internal stirring reaction device, 504g of sodium hydroxide aqueous solution (26wt%) was added to the reaction device, and then mixed at 45°C for 30 minutes Produce alkaline cellulose, wherein the weight ratio of sodium hydroxide and anhydrous cellulose is 0.175. Nitrogen purging was then carried out, 143 g of propylene oxide (0.190 parts by weight relative to cellulose) was added to the resultant, and the mixture was reacted for 1.5 hours in a jacket at a temperature of 60° C., thereby obtaining 1453 g of hydroxypropyl fibers Crude reaction product of a prime with a molar substitution of hydroxypropoxy per anhydroglucose unit of 0.29. The etherification reaction rate was 53.6%.

[0111] Then, 394 g of acetic acid (50% by weight) was added to and mixed with the above-mentioned 10 L internal stirring type reaction apparatus to perform a neutralization reaction. The neutralized product was washe...

Embodiment 3

[0115] First, 806g of powdery slurry (750g in anhydrous state) was added to a 10L internal stirring reaction device, 808g of sodium hydroxide aqueous solution (26wt%) was added to the reaction device, and then mixed at 45°C for 30 minutes Generate alkaline cellulose, wherein the weight ratio of sodium hydroxide and anhydrous cellulose is 0.280. Nitrogen purging was then carried out, 173 g of propylene oxide (0.230 parts by weight relative to cellulose) was added to the resultant, and then the mixture was reacted for 1.5 hours in a jacket at a temperature of 60° C., thereby obtaining 1787 g of hydroxypropyl fibers Crude reaction product of a prime with a molar substitution of hydroxypropoxy per anhydroglucose unit of 0.30. The etherification reaction rate was 46.4%.

[0116] Then, 629 g of acetic acid (50 wt %) was added to and mixed with the above-mentioned 10 L internal stirring type reaction apparatus, and a neutralization reaction was performed. The neutralized product wa...

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Abstract

Provided are a solid dosage form comprising an enteric solid dispersion that allows a drug in the preparation to be rapidly dissolved without compromising the solubility of the solid dispersion, and a method for producing the same. More specifically, provided is a solid dosage form comprising an enteric solid dispersion comprising a poorly soluble drug, an enteric polymer and a disintegrant, wherein the disintegrant is low-substituted hydroxypropylcellulose having an average particle size of 10 to 100 [mu]m and a specific surface area measured by BET method of at least 1.0 m 2 / g. Moreover, provided is a method for producing a solid dosage form comprising an enteric solid dispersion, the method comprising steps of: spraying an enteric polymer solution in which a poorly soluble drug has been dispersed or dissolved, on a powder of low-substituted hydroxypropylcellulose having an average particle size of 10 to 100 [mu] m and a specific surface area measured by BET method of at least 1.0 m 2 / g and serving as a disintegrant; and granulating the resultant; and drying.

Description

technical field [0001] The invention relates to low-substituted hydroxypropyl cellulose, which is added to provide disintegration or compressibility when preparations are prepared in fields such as medicine and food. Specifically, the present invention particularly relates to low-substituted hydroxypropyl cellulose having excellent compressibility and disintegration properties. Background technique [0002] Solid preparations in the fields of pharmaceuticals, foods, etc., preparations prepared only from main ingredients have the following problems: when the drug is administered, the effect of the drug cannot be fully exerted because sufficient disintegration is not obtained, and due to its weak compressibility The shape of the tablet or granule thus prepared cannot be maintained. In this case, it can be improved by adding disintegrants such as low-substituted hydroxypropyl cellulose, calcium salt of carmellose, croscarmellose sodium, cross-linked polyvinylpyrrolidone or car...

Claims

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Application Information

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IPC IPC(8): C08B11/08C08B11/20
Inventor 丸山直亮梅泽宏
Owner SHIN ETSU CHEM IND CO LTD
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