Quantifying Crystallinity of Amlodipine Maleate in Amorphous Solid Dispersions Produced by Fluidized Bed Granulation Using PAT Tools.

One of the main concerns with formulations containing amorphous solid dispersions (ASDs) is their physical stability. Stability can be compromised if a formulation contains any residual crystallinity of an active pharmaceutical ingredient (API) that could act as seeds for further crystallisation. This study presents four methods for crystalline amlodipine maleate quantification in ASD, which were developed using one Raman and three NIR process analysers.

Quantification of Amlodipine Maleate Content in Amorphous Solid Dispersions Produced by Fluidized Bed Granulation Using Process Analytical Technology Tools.

Active pharmaceutical ingredient (API) content is a critical quality attribute (CQA) of amorphous solid dispersions (ASDs) prepared by spraying a solution of APIs and polymers onto the excipients in fluid bed granulator. This study presents four methods for quantifying API content during ASD preparation. Raman and three near-infrared (NIR) process analysers were utilized to develop methods for API quantification.