Coating composition containing methyl cellulose, method for producing the same, and solid preparation

Patent metadata

Field	Value
Publication number	US-11021628-B2
Application number	US-201715450511-A
Country	US
Kind code	B2
Filing date	Mar 6, 2017
Priority date	Mar 9, 2016
Publication date	Jun 1, 2021
Grant date	Jun 1, 2021

Abstract

Regarding coating of fine particles or the like, provided are a coating composition containing methyl cellulose having small adhesiveness, resistance to generation of lumps, ability to form uniform coating, and ability to form a coating composition easily with water of normal temperature; a method for producing the coating composition; and a solid preparation. More specifically provided are a coating composition including methyl cellulose having such a viscosity that a viscosity at 20° C. of a 2% by weight aqueous solution of the methyl cellulose is 1 to 15 mPa·s and having such a dissolution start temperature that a dissolution start temperature of a 12% by weight aqueous liquid of the methyl cellulose is 10 to 25° C. and a solvent; a solid preparation obtained by coating of the coating composition; and the like.

First claim

The invention claimed is:

1. A coating composition comprising:
methyl cellulose having a viscosity that a viscosity at 20° C. is 1 to 15 mPa s, as determined in a 2% by weight aqueous solution of the methyl cellulose in water, and a dissolution start temperature of 10 to 25° C., as determined in a 12% by weight aqueous dispersion of the methyl cellulose in water; and
a solvent.

2. The coating composition according to claim 1 , wherein a 15% by weight aqueous solution of the methyl cellulose has a gelation temperature of 13 to 25° C.

3. The coating composition according to claim 1 , wherein the solvent is water or a mixed solvent of water and an alcohol.

4. The coating composition according to claim 2 , wherein the solvent is water or a mixed solvent of water and an alcohol.

5. A solid preparation comprising a drug substance or a core particle containing a drug, and a coating comprising the coating composition according to claim 1 .

6. A solid preparation comprising a drug substance or a core particle containing a drug, and a coating comprising the coating composition according to claim 2 .

7. A solid preparation comprising a drug substance or a core particle containing a drug, and a coating comprising the coating composition according to claim 3 .

8. The solid preparation according to claim 5 , wherein the solid preparation has an average particle size of 300 mm or less.

9. A method for producing a coating composition, the method comprising the steps of:
mixing a cellulose pulp and a first alkali metal hydroxide solution with stirring to obtain alkali cellulose;
reacting the alkali cellulose with a methylating agent to obtain a first reaction mixture;
mixing the first reaction mixture and a second alkali metal hydroxide solution with stirring and without further addition of any methylating agent to obtain a second reaction mixture;
isolating methyl cellulose from the second reaction mixture;
depolymerizing the methyl cellulose to obtain a depolymerized methyl cellulose; and
dissolving the depolymerized methyl cellulose in a solvent, wherein a ratio of a weight of a first alkali metal hydroxide in the first alkali metal hydroxide solution to a total weight of the first alkali metal hydroxide in the first alkali metal hydroxide solution and a second alkali metal hydroxide in the second alkali metal hydroxide solution is 50 to 86%.

Assignees

• Shinetsu Chemical Co

Inventors

• Maruyama Naosuke
• Yokosawa Takuya
• Kitamura Akira

Classifications

• A61K9/5047 Primary

  Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose · CPC title

• C08B11/02

  Alkyl or cycloalkyl ethers · CPC title

• C09D101/28 Primary

  Alkyl ethers · CPC title

• A61K47/38 Primary

  Cellulose; Derivatives thereof · CPC title

• C09D7/69

  Particle size larger than 1000 nm · CPC title