Nanoparticle composition with reduced contaminant and production method thereof

Patent metadata

Field	Value
Publication number	US-12285526-B2
Application number	US-202017434883-A
Country	US
Kind code	B2
Filing date	Feb 28, 2020
Priority date	Mar 1, 2019
Publication date	Apr 29, 2025
Grant date	Apr 29, 2025

Abstract

A method for the production of the present disclosure comprises: a) a step of agitating a mixture containing a material to be ground, beads and a dispersion medium in a bead mill; and b) a step of adjusting the pH of the mixture.
This method reduces a contamination caused by grinding process using a bead mill.

First claim

The invention claimed is:

1. A method for the production of fine particles via a grinding process using a bead mill,
wherein the method comprises:
a) a step of preparing a slurry comprising a material to be ground and a dispersion medium,
b) a step of adjusting the pH of the slurry prepared in the step a) to 6.5 to 9, and
c) a step of agitating the slurry prepared in the step b) and beads in the bead mill; or

wherein the method comprises:
a′) a step of preparing a slurry comprising a material to be ground, beads and a dispersion medium,
b′) a step of adjusting the pH of the slurry prepared in the step a′) to 6.5 to 9, and
c′) a step of agitating the slurry prepared in the step b′) in the bead mill;
wherein the material to be ground is a pharmaceutical compound, wherein impurities caused by the grinding process are derived from the beads and/or the bead mill, and wherein an amount of the impurities is less than 50 ppm with respect to the weight of the material to be ground.

2. The method according to claim 1 , wherein the dispersion medium comprises at least one selected from the group consisting of sodium linear alkylbenzene sulfonate, monoalkyl phosphate, sodium lauryl sulfate, cellulose polymer and vinyl polymer.

3. The method according to claim 1 , wherein the dispersion medium comprises polyvinylpyrrolidone.

4. The method according to claim 1 , wherein the dispersion medium comprises sodium lauryl sulfate.

5. The method according to claim 1 , wherein the dispersion medium comprises polyvinylpyrrolidone and sodium lauryl sulfate.

6. The method according to claim 1 , wherein the step b) of adjusting the pH of the slurry prepared in the step a) to 6.5 to 9 comprises adding an acidic substance or a basic substance to the slurry, or
wherein the step b′) of adjusting the pH of the slurry prepared in the step a′) to 6.5 to 9 comprises adding an acidic substance or a basic substance to the slurry.

7. The method according to claim 1 , wherein the beads are zirconia beads.

8. The method according to claim 1 , wherein the beads comprise zirconium, yttrium and aluminum.

9. The method according to claim 1 , wherein the impurities are at least one selected from the group consisting of zirconium, yttrium and aluminum.

10. The production method according to claim 1 , wherein the fine particles are microparticles.

11. The production method according to claim 1 , wherein the fine particles are nanoparticles.

12. Fine particles obtained by the method according to claim 1 .

13. The fine particles according to claim 12 , which are microparticles.

14. The fine particles according to claim 12 , which are nanoparticles.

15. The fine particles according to claim 12 , wherein the fine particles comprise at least one kind of impurities selected from the group consisting of zirconium, yttrium and aluminum, and the amount of the impurities is 0.0001 ppm or more and less than 50 ppm.

16. A pharmaceutical composition comprising the fine particles according to claim 12 .

17. A method for reducing impurities caused by a grinding process using a bead mill,
wherein the method comprises:
a) a step of preparing a slurry comprising a material to be ground and a dispersion medium,
b) a step of adjusting the pH of the slurry prepared in the step a) to 6.5 to 9, and
c) a step of agitating the slurry prepared in the step b) and beads in the bead mill; or

wherein the method comprises:
a′) a step of preparing a slurry comprising a material to be ground, beads and a dispersion medium,
b′) a step of adjusting the pH of the slurry prepared in the step a′) to 6.5 to 9, and
c′) a step of agitating the slurry prepared in the step b′) in the bead mill;
wherein the material to be ground is a pharmaceutical compound, wherein impurities caused by the grinding process are derived from the beads and/or the bead mill, and wherein an amount of the impurities is less than 50 ppm with respect to the weight of the material to be ground.

Assignees

• Shionogi & Co
• Hiroshima Metal & Machinery Co Ltd

Inventors

• Tanaka Hironori
• Ochii Yuya
• Ibaraki Tetsuharu

Classifications

• B82Y40/00

  Manufacture or treatment of nanostructures · CPC title

• B82Y5/00

  Nanobiotechnology or nanomedicine, e.g. protein engineering or drug delivery · CPC title

• B02C17/20

  Disintegrating members · CPC title

• A61K9/14 Primary

  Particulate form, e.g. powders, {Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles (microspheres A61K9/16; microcapsules A61K9/50; nanocapsules, nanoparticles of the matrix type A61K9/51)} · CPC title

• A61K9/146

  with organic macromolecular compounds · CPC title