Fluidised bed granulation of two APIs: QbD approach and development of a NIR in-line monitoring method.

ABSTRACT: The study focused on the fluid-bed granulation process of a product with two active pharmaceutical ingredients, intended for coated tablets preparation and further transfer to industrial scale. The work aimed to prove that an accurate control of the critical granulation parameters can level the input material variability and offer a user-friendly process control strategy. Moreover, an in-line Near-Infrared monitoring method was developed, which offered a real time overview of the moisture level along the granulation process, thus a reliable supervision and control process analytical technology (PAT) tool. The experimental design's results showed that the use of apparently interchangeable active pharmaceutical ingredients (APIs) and filler sorts that comply with pharmacopoeial specification

SUBMITTER: Gavan A 

PROVIDER: S-EPMC7486511 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature