Nanoparticle composition with reduced contaminant and production method thereof
Inventors
Tanaka, Hironori • OCHII, Yuya • Ibaraki, Tetsuharu
Assignees
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Publication Number
US-12285526-B2
Publication Date
2025-04-29
Expiration Date
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.
Core Innovation
The invention relates to a method for the production of fine particles via a grinding process using a bead mill. The method includes preparing a slurry comprising a material to be ground and a dispersion medium, adjusting the pH of the slurry to 6.5 to 9, and agitating the slurry and beads in the bead mill, or preparing a slurry comprising the material to be ground, beads and the dispersion medium before adjusting the pH to 6.5 to 9 and agitating in the bead mill.
The method is limited to grinding a pharmaceutical compound, where impurities caused by the grinding process are derived from the beads and/or the bead mill. The amount of the impurities is less than 50 ppm with respect to the weight of the material to be ground.
As disclosed, slurry pH significantly affects contamination derived from grinding media. Fine particles including microparticles and nanoparticles can be produced under the claimed pH-adjusted bead-mill wet-grinding conditions while mitigating impurities originating from zirconia-based beads, including zirconium (Zr), yttrium (Y), and aluminum (Al).
Claims Coverage
The document provides two independent claims. Both independent claims share the same core sequence of preparing a slurry, adjusting pH to 6.5 to 9, and agitating with beads in a bead mill, with additional limitations on impurity origin and an impurity amount of less than 50 ppm relative to the weight of the pharmaceutical compound.
Bead mill slurry with pH adjusted to 6.5 to 9 before or after adding beads
A method for the production of fine particles via a grinding process using a bead mill, comprising preparing a slurry comprising a material to be ground and a dispersion medium, adjusting the pH of the slurry to 6.5 to 9, and agitating the slurry and beads in the bead mill; or preparing a slurry comprising a material to be ground, beads and a dispersion medium, adjusting the pH of the slurry to 6.5 to 9, and agitating in the bead mill.
Impurity control derived from beads and or bead mill below 50 ppm for pharmaceutical compounds
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.
Reducing grinding-process impurities by slurry pH adjustment in a bead mill to 6.5 to 9
A method for reducing impurities caused by a grinding process using a bead mill, comprising preparing a slurry comprising a material to be ground and a dispersion medium, adjusting the pH of the slurry to 6.5 to 9, and agitating the slurry and beads in the bead mill; or preparing a slurry comprising a material to be ground, beads and a dispersion medium, adjusting the pH of the slurry to 6.5 to 9, and agitating in the bead mill.
Across both independent claims, the inventive core is the use of bead-mill grinding for pharmaceutical compounds where a slurry is adjusted to pH 6.5 to 9 and then agitated with beads to produce fine particles while keeping impurities originating from the beads and or bead mill below 50 ppm relative to the pharmaceutical compound.
Stated Advantages
Impurities caused by the grinding process are reduced or controlled to less than 50 ppm with respect to the weight of the pharmaceutical compound.
Documented Applications
Production of fine particles including microparticles and nanoparticles derived from a pharmaceutical compound using bead-mill wet-grinding with slurry pH adjustment.
Reducing impurities caused by bead-mill grinding of a pharmaceutical compound by adjusting slurry pH to 6.5 to 9.
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