A comprehensive review of the Maillard reaction in solid pharmaceutical dosage forms: a focus on lactose

The Maillard reaction between lactose and amino-group-containing drugs poses a significant quality risk, directly affecting the stability and safety of pharmaceutical preparations. In generic drug development, controlling this reaction is a critical step in achieving consistency with the reference listed drug (RLD). Instead of simply avoiding lactose, a proactive strategy should be adopted early in development. Through compatibility assessment, mechanistic studies, and comprehensive control measures, this challenge can be transformed into an opportunity for formulation optimization and innovation, thereby advancing the development of high-quality solid dosage forms.