MODERN PHARMACEUTICAL EXCIPIENTS AND THEIR IMPACT ON DRUG QUALITY

Abstract

The quality of a medicinal product is defined as a reproducible set of critical
quality attributes that ensure identity, strength, purity, and performance throughout the
shelf life and use conditions. A clear example is the replacement of lactose with mannitol
in moisture-sensitive formulations to reduce Maillard-type reactivity with amine-containing
APIs. Quantitatively, excipients typically constitute about 80-99% of the mass of many
solid oral dosage forms, meaning their variability can dominate batch-to-batch performance.
From a scientific standpoint, this repositions excipient selection as a primary design variable
within quality-by-design logic, where material attributes are linked to process parameters
and final performance