Data-Driven Modeling of the Spray Drying Process. Process Monitoring and Prediction of the Particle Size in Pharmaceutical Production.

ABSTRACT: Spray drying is used in the pharmaceutical industry for particle engineering of amorphous solid dispersions (ASDs). The particle size of the spray-dried (SD) powders is one of their key attributes due to its impact on the downstream processes and the drug product's functional properties. Offline and inline laser diffraction methods can be used to estimate the product's particle size; however, the final release of these ASDs is based on offline instruments. This paper presents a novel data-driven modeling approach for predicting the particle size of SD products. The model-based characterization of the process and the product's particle size, as a critical quality attribute, follows the quality by design principles. The resulting model can be used for online process monitoring, reducing the

SUBMITTER: Munoz Lopez CA 

PROVIDER: S-EPMC11191099 | biostudies-literature | 2024 Jun

REPOSITORIES: biostudies-literature