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

INTRODUCTION: Solid dosage forms face the risk of the Maillard reaction during development and storage. This reaction occurs between reducing excipients and amino-group-containing drugs, potentially leading to discoloration, impurity formation, and degradation of active ingredients, significantly impacting product quality and excipient selection. AREAS COVERED: Using lactose, a representative reducing excipient, as an example, this article systematically explores the mechanisms, influencing factors, control strategies, and potential applications of the Maillard reaction in solid dosage forms. It aims to provide theoretical support and practical guidance for formulation optimization, quality control, and…