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US 2026/0241307 A1Published application
Process for making drug crystals of desired size distribution and morphology
AssigneeEupraxia Pharmaceuticals Inc.
InventorsAzadeh GOUDARZI, Troy LOSS, Michael GAINES, Gina STETSKO, Amanda MALONE
Life of this patent
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Abstract
Provided herein includes a process for forming drug crystals of narrow size distribution and desire dimensions and morphology, the process includes a recrystallization step followed by a resizing step.
Claims11
A process for providing crystals of fluticasone propionate of desired size distribution and morphology, the process comprising:
- providing recrystallized columnar crystals of fluticasone propionate having aspect ratios of larger than 1 and less than 20, the aspect ratio of each recrystallized columnar crystal being the ratio of a longest dimension along a lengthwise axis relative to a shortest dimension of a transverse plane perpendicular to the lengthwise axis, wherein at least 90% by mass of the recrystallized columnar crystals have the shortest dimensions in the range of 50-250 microns;
- and
- sizing the recrystallized columnar crystals to provide a collection of sized crystals having target dimensions, wherein, no more than 10% of the collection of the sized crystals by mass are less than 30 microns, wherein the sizing includes segmenting at least a portion of the recrystallized columnar crystals along the respective lengthwise axes while retaining the dimensions of the transverse plane perpendicular to the lengthwise axis.
Dependencies are inferred from the claim text.