A major challenge confronting the pharmaceutical scientist working with protein formulation is the instability during processing, storage and use of the protein drug. This book reviews stability aspects encountered since the pioneering isolation of insulin in 1921. An introductory chapter, treating insulin purity and stability in historical perspective, is followed by a chapter with a description of the structure of insulin. The main part of the book is a comprehensive review of the literature dealing with stability of insulin in pharmaceutical formulation, including biological stability and the physical and chemical decomposition of insulin. The physical stability (i.e. the tendency of insulin to form insoluble fibrils) is reviewed as are methods to stabilize insulin for long-term use in infusion pumps. The book will be of interest to research and clinical pharmacologists involved with insulin and other protein-based drug substances.

Galenical pharmacy or galenics is the science dealing with the pro duction of drug substances from raw materials, the purity of such substances, their formulation into pharmaceutical preparations with the desired effects and safety in use, and the quality control, stability and storage of the preparations. The field has taken its name from the Greek physician Galen (131-201 A.D.), who had a profound influence on medicine for many centuries because he collected and systematized the medicinal knowledge of his time. The discovery of insulin is attributed to Banting and Best who, in 1921, prepared an extract of the pancreas of the fetal calf and showed that the extract was capable of reducing the blood sugar level of a diabetic dog. This outstanding discovery gave rise to the rapid develop ment of the manufacture of insulin of bovine and porcine origin. By 1925, two Danish manufacturers of insulin preparations were established; both have since been in the forefront ofthe development of insulin preparations, the latest achievement being the marketing of human insulin by Novo in 1982. The development of highly purified human insulin produced semisynthetically from porcine insulin or by DNA recombinant methods are significant contributions to safe and efficient insulin therapy. Insulin is a protein which is destroyed in the gastrointestinal tract."