PVP: A Critical Review Of The Kinetics And Toxicology Of Polyvinylprrolidone (Povidone) PDF
Preview PVP: A Critical Review Of The Kinetics And Toxicology Of Polyvinylprrolidone (Povidone)
s i t Í I ■il J PVP A Critical Review of the Kinetics and Toxicology of Polyvinylpyrrolidone (Povidone) i • Walter Reppe (1892-1969) PVP A Critical Review of the Kinetics and Toxicology of Polyvinylpyrrolidone (Povidone) B. V. Robinson F. M. Sullivan Department of Pharmacology and Toxicology United Medical and Dental Schools Guy’s Hospital University of London London J. F. Borzelleca Department of Pharmacoiogy and Toxicology Medical College of Virginia Richmond, Virginia S. L. Schwartz Department of Pharmacology Georgetown School of Medicine Washington, D.C. CRC Press Taylor h Francis Group Boca Raton London New York CRC Press is an imprint of the Taylor & Francis Croup, an informa business Library of Congress Cataloging-in-Publication Data PVP: a critical review of the kinetics and toxicology of polyvinylpyr rolidone (povidone) Includes bibliographical references 1. Povidone—Pharmacokinetics. 2. Povidone— Toxicology. I. Robinson, B.V. (Brian V.) [DNLM: 1. Povidone- pharmacokinetics. 2. Povidone—toxicity. WH 450 P994] RM666.P822P96 1990 615'.7 89-13515 ISBN 0-87371-288-9 COPYRIGHT © 1990 by LEWIS PUBLISHERS, INC. ALL RIGHTS RESERVED Neither this book nor any part may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photo copying, microfilming, and recording, or by any information storage and retrieval system, without permission in writing from the publisher. LEWIS PUBLISHERS, INC. 121 South Main Street, Chelsea, Michigan 48118 Preface The new era of synthetic polymer chemistry opened by Wal ter Reppe in the 1930s led to the synthesis of polyvinyl pyrrolidone (PVP), which was patented in 1939. The physi cal, chemical, and physiological properties of this synthetic polymer are the keys to its very widespread use in medicine, pharmaceuticals, cosmetics, foods, printing inks, textiles, and many more diverse applications. In recent years, the general interest in reassessing the safety of chemicals used in foods, drugs, and cosmetics has led to the réévaluation and reaffirmation of the safety of PVP by the Joint Expert Committee on Food Additives (JECFA) of the World Health Organization (WHO). Along with others, the authors of this book became involved in collecting and reassessing the information, published and unpublished, on the absorption, distribution, storage, and excretion of PVP and in its toxicological evaluation. As 1989 is the 50th anni versary of the invention of PVP, it seemed appropriate to assemble at this time both the published and the unpub lished data that have accumulated over the last 50 years, to critically review it, and to assess the safety of PVP as judged by present-day criteria. In performing this task, extensive literature reviews were carried out, covering the period from 1939 to 1989. The most recent toxicological investigations have been carried out by the two major world manufacturers of PVP, BASF Aktienge sellschaft in Ludwigshafen, Federal Republic of Germany, and GAF Chemicals Corporation in Wayne, New Jersey, Vi POLYVINYLPYRROLIDONE USA, for submission to regulatory authorities and to WHO. Most of this work is unpublished. We have been fortunate in being given access to all of these data and so are able to publish for the first time critiques of much of this invaluable material. The very earliest use of PVP in medicine was dur ing World War 11 when a 3.5% solution of PVP was infused into patients as a synthetic blood plasma volume expander. This use recognized such valuable properties of PVP as water solubility, viscosity, and osmotic activity and demon strated that the material appeared to be biologically inert and safe. The toxicity of PVP, extensively studied in a variety of species including humans and other primates, is of extremely low order. In Chapters 1 and 2 the reader is introduced to PVP, its uses, and its synthesis and properties. We have been assisted in the preparation of this material by both BASF and GAF, who supplied the details of the determination of the K-values of the different PVP polymers and the molecular weight distributions of representative batches of these polymers. Chapter 3 is a discussion of movement of large molecules across membranes and forms a basis for Chapter 4, which discusses the absorption of PVP following various routes of administration. The excretion and metabolism of PVP are reviewed in Chapter 5, followed by a discussion on the dis tribution and storage of the material in Chapter 6. Chapter 7 reviews the storage of PVP in humans. Chapter 8 presents a review of the functional conse quences of PVP uptake, with particular emphasis on the reti culoendothelial and immune systems. Chapter 9 is a broad review of the toxicological studies performed on PVP, includ ing acute, subchronic, chronic, reproductive, mutagenicity, and carcinogenicity studies. Each chapter ends with a sum mary of the main findings. In addition, there is a final, over all summary and conclusions. We have also prepared an Appendix, listing the key stud ies, with references, on the absorption, renal elimination, distribution, acute toxicity, subchronic toxicity, chronic toxic PREFACE vil ity, teratogenicity, mutagenicity, and carcinogenicity of PVP. The Appendix summarizes in list form the major toxico- kinetic and toxicological studies that have been conducted on PVP, giving the species used, the experimental methods employed, the molecular weight of PVP or its K-value, the observations made, and the source of the information.
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