Various Pharmaceutical Lactose Grades in a Provocative Maillard Environment

Maillard reaction is a long known chemical, non-enzymatic reaction cascade, caused by the reaction of an amine with a reactive carbonyl group, typically a reducing sugar. An incredibly complex pathway leads finally to brown or dark colored, polymeric end products with defined taste and texture (Hodge,1953). The reaction is largely driven by its chemical and physical environment, effects of e.g. metals, pH, pressure, temperature, and water activity have been extensively discussed elsewhere (Nursten,2005). In nutrition industry this is of utmost functional importance and technological significance. However, in pharmaceutical practice such an outcome is unwanted due to pharmacological reasons when APIs are inactivated, or when the appearance of a dosage form is compromised. Lactose, one of the most frequently used pharmaceutical carriers in inhaled and oral dosage forms, is such a reducing sugar and therefore Maillard behavior can be of prime importance.