Varied Bulk Powder Properties of Micro-Sized API within Size Specifications as a Result of Particle Engineering Methods.

ABSTRACT: Micronized particles are commonly used to improve the content uniformity (CU), dissolution performance, and bioavailability of active pharmaceutical ingredients (API). Different particle engineering routes have been developed to prepare micron-sized API in a specific size range to deliver desirable biopharmaceutical performance. However, such API particles still risk varying bulk powder properties critical to successful manufacturing of quality drug products due to different particle shapes, size distribution, and surface energetics, arising from the anisotropy of API crystals. In this work, we systematically investigated key bulk properties of 10 different batches of Odanacatib prepared through either jet milling or fast precipitation, all of which meet the particle size specification est

SUBMITTER: Wang Z 

PROVIDER: S-EPMC9500803 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature