Module 3 2019

Maillard Reaction

• Reaction between reducing sugars (carbohydrates) and amines first reported by French scientist Louis Maillard in 1912

• Maillard reaction of lactose and fluoxetine HCl

Fluoxetine – 2 o amine

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• Maillard reaction with lactose under pharmaceutically relevant conditions

• This finding should be considered during the selection of excipients and stability protocols for drugs

Journal of Pharmaceutical Sciences Vol. 87, No. 1, January 1998

The Organisation for Professionals in Regulatory Affairs