Galenics of Insulin The Physico-chemical and Pharmaceutical Aspe

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 qualit

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Galenics of Insulin The Physico-chemical and Pharmaceutical Aspects of Insulin and Insulin Preparations

With the Collaboration of B. Skelbaek-Pedersen L. Langkjaer U. Damgaard H. Ege S. Havelund L.G. Heding K.H. J0rgensen 1. Lykkeberg 1. Markussen M. Pingel E. Rasmussen

With 34 Figures and 20 Tables

Springer-Verlag Berlin Heidelberg GmbH

M. Se. Novo Research Institute Novo Alle 2880 Bagsvaerd, Denmark

JENS BRANGE,

This work is subject to copyright. AII rights are reserved, whether the whole or part of the material is concerned, specifically the rights of translation, reprinting, reuse of iIIustrations, recitation, broadcasting, reproduction on microfilms or in other ways, and storage in data banks. Duplication of this publication or parts thereof is only permitted under the provisions of the German Copyright Law of September 9, 1965, in its version of June 24, 1985, and a copyright fee must always be paid. Violations fali under the prosecution act of the German Copyright Law. ISBN 978-3-662-02528-4 ISBN 978-3-662-02526-0 (eBook) DOI 10.1007/978-3-662-02526-0

© Springer-Verlag Berlin Heidelberg 1987 Originally published by Springer-Verlag Berlin Heidelberg New York in 1987. The use of registered names, trademarks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use. Actrapid Lente Neusulin Semilente Humulin Mixtard NovoPen Semitard lnitard Monotard Optisulin Ultralente Insulatard Neulente Protaphane Ultratard Lentard Neuphane Rapitard Velosulin Product liability: The publisher can give no guarantee for information about drug dosage and application thereof contained in this book. In every individual case the respective user must check its accuracy by consulting other pharmaceuticalliterature. 2127/3130-543210

Foreword

Galenical pharmacy or galenics is the science dealing with the production 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 development 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 semisynthetical