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Solid preparation containing alkyl cellulose and production method thereof

A solid preparation, methyl cellulose technology, applied in the field of solid preparations, to achieve high tablet hardness, high formability, and reduced production of fine powder

Active Publication Date: 2021-11-12
SHIN ETSU CHEM IND CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, this method generally requires larger amounts of additives than wet granulation to ensure formability

Method used

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  • Solid preparation containing alkyl cellulose and production method thereof
  • Solid preparation containing alkyl cellulose and production method thereof
  • Solid preparation containing alkyl cellulose and production method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0106] Wood pulp having an intrinsic viscosity of 1,400 ml / g was pulverized using a pulverizer to obtain cellulose pulp powder. An amount of cellulose pulp powder corresponding to 6.0 kg of cellulose was placed in an internally stirred pressure-resistant reactor with a jacket. The reactor was evacuated and purged with nitrogen to completely remove oxygen from the reactor. Then, the internal temperature of the reactor was adjusted to 55° C. with its internal stirring, and 49% by weight aqueous sodium hydroxide solution was used as the first alkali metal hydroxide solution at 12.04 [mol / mol hr] at an addition rate in such an amount that the molar ratio of the first sodium hydroxide to the cellulose (first sodium hydroxide / cellulose) becomes 3.01 to obtain alkaline cellulose.

[0107] Then 2.4 kg of dimethyl ether was added to the reactor, and the internal temperature of the reactor was controlled so as to maintain the internal temperature at 60°C. After the addition of dimethy...

Embodiment 2

[0133] The desired pulverized low-degree-of-polymerization methylcellulose was obtained in the same manner as in Example 1, except that the low-polymerization-degree methylcellulose obtained in Example 1 was used in an air flow impact mill Jet Mill ( Labo JetMill, manufactured by Nippon Kinetic Manufacturing Co., Ltd.) was pulverized under the following conditions: 0.35 MPa grinding pressure, 20 mm classification zone clearance and large louver size. Powder physical properties of pulverized low-polymerization degree methylcellulose, and tablet physical properties of tablets produced therefrom by dry direct compression in the same manner as in Example 1 are shown in Table 1.

Embodiment 3

[0135] The desired pulverized low degree of polymerization methylcellulose was obtained in the same manner as in Example 2, except that a grinding pressure of 0.45 MPa, a clearance of the classification zone of 35 mm and a large skylight size were used as the air flow impact mill JetMill crushing conditions. Powder physical properties of pulverized low-polymerization degree methylcellulose, and tablet physical properties of tablets produced therefrom by dry direct compression in the same manner as in Example 1 are shown in Table 1.

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Abstract

Provided are a solid preparation containing an alkyl cellulose that provides excellent formability and disintegration even in a small amount, and a production method thereof. Specifically, there is provided a solid preparation comprising alkyl cellulose having a value of 0.5 to 10.0 m as measured by the BET method. 2 A specific surface area per g and a dissolution initiation temperature of 5 to 27° C.; and a method for producing a solid preparation comprising the steps of mixing cellulose pulp and a first alkali metal hydroxide solution using agitation to obtain an alkali alkaline cellulose, reacting the alkaline cellulose with an alkylating agent to obtain a first reaction mixture, mixing the first reaction mixture with a second alkali metal hydroxide solution using stirring and without further adding any alkyl oxidizing agent to obtain a second reaction mixture, and pulverize the alkylcellulose separated from the second reaction mixture to obtain alkylcellulose.

Description

technical field [0001] The present invention relates to solid formulations containing alkyl cellulose in the field of pharmaceutical products, food and health food, wherein the alkyl cellulose provides high formability and good disintegratability; and a method for producing the solid formulation. Background technique [0002] In the field of pharmaceutical products, food and health food, methods for producing solid preparations, especially tablets, include dry direct compression, in which the mixture of drug and additives is directly compressed; dry granulation compression, in which where the drug and additive mixture is subjected to roller compression (dry granulation), followed by disintegration and tabletting; and wet granulation compression, where the drug and additive mixture is combined with a binder solution or a suitable solvent such as water It is granulated, and the resulting granules are dried and then compressed into tablets. Wet granulation tableting involves ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K47/38A61K9/20A23L29/00C08B11/02C08B1/08
CPCA61K9/2054C08B1/08C08B11/02A61K31/167A61K47/38C11D3/225C11D17/0073A61K9/2072A61K9/2095
Inventor 横泽拓也丸山直亮北村彰
Owner SHIN ETSU CHEM IND CO LTD
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