Quality by Design (QbD) based process optimisation to develop functionalised particles with modified release properties using novel dry particle coating technique.

ABSTRACT: Quality by Design (QbD), a current trend employed to develop and optimise various critical pharmaceutical processes, is a systematic approach based on the ethos that quality should be designed into the product itself, not just end tested after manufacture. The present work details a step-wise application of QbD principles to optimise process parameters for production of particles with modified functionalities, using dry particle coating technology. Initial risk assessment identified speed, air pressure, processing time and batch size (independent factors) as having high-to-medium impact on the dry coating process. A design of experiments (DOE) using MODDE software employed a D-optimal design to determine the effect of variations in these factors on identified responses (content uniformity,

SUBMITTER: Dahmash EZ 

PROVIDER: S-EPMC6211725 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature