Chemistry of protein stabilization by trehalose.
1994
Colaco C.A.L.S. | Smith C.J.S. | Sen S. | Roser D.H. | Newman Y. | Ring S. | Roser B.J.
Carbohydrates are widely used to stabilise dried protein and peptide drugs. Several sugars can prevent damage to proteins during drying, but the products often have a short shelf life at ambient temperatures. There is increasing evidence to suggest that this is due to a progressive chemical reaction between the reducing carbonyl groups of the sugars and the amino groups of proteins, the so-called Maillard reaction. The rational choice of an excipient for pharmaceutical use must thus consider not only the avoidance of desiccation damage but also subsequent degradative chemistries on storage. We present data from comparative studies on the long term stability of a variety of proteins, including enzymes and therapeutic peptides, dried using various carbohydrate excipients, which establish the superiority of the simple disaccharide trehalose as a stabilising excipient. These observations illustrate the chemical stability of trehalose and document the protein degradation observed in samples dried using other carbohydrates.
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