Development of a Semi-Mechanistic Modeling Framework for Wet Bead Milling of Pharmaceutical Nanosuspensions.

ABSTRACT: This study aimed to develop a practical semi-mechanistic modeling framework to predict particle size evolution during wet bead milling of pharmaceutical nanosuspensions over a wide range of process conditions and milling scales. The model incorporates process parameters, formulation parameters, and equipment-specific parameters such as rotor speed, bead type, bead size, bead loading, active pharmaceutical ingredient (API) mass, temperature, API loading, maximum bead volume, blade diameter, distance between blade and wall, and an efficiency parameter. The characteristic particle size quantiles, i.e., x₁₀, x₅₀, and x₉₀, were transformed to obtain a linear relationship with time, while the general functional form of the apparent breakage r

SUBMITTER: Clancy DJ 

PROVIDER: S-EPMC10974034 | biostudies-literature | 2024 Mar

REPOSITORIES: biostudies-literature