P
`
`“OF a 7
`
`|
`anAUOnes
`7 wien
`i ) Le oa
`ree
`~
`Va
`I
`Haine NCCuineal
`SGNelNew
`
`
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`MYLAN INST. EXHIBIT 1013 PAGE 1
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`

`

` MYLANINST. EXHIBIT 1013 PAGE 2
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`MYLAN INST. EXHIBIT 1013 PAGE 2
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`

`

` ALFONSO R GENNARO
`
`MYLANINST. EXHIBIT 1013 PAGE 3
`
`Edifer, and Chairman
`of the Editorial Boord
`
`MYLAN INST. EXHIBIT 1013 PAGE 3
`
`

`

`
`
`1990
`
`MACK PUBLISHING COMPANY
`
`Easton, Pennsylvania 18042
`
`MYLANINST. EXHIBIT 1013 PAGE 4
`
`
`
`MYLAN INST. EXHIBIT 1013 PAGE 4
`
`

`

`Entered according to Act of Congress, in the year 1B85 by Joseph P Remington,
`in the Office of the Librarian of Congress, at Washington DC
`Copyright. 1889, 1894, 1905, 1907, 1917, by Joseph P Remington
`Copyright 1926, 1936, by Joseph P
`Remington Estate
`sopyright 1948, 1951, by The Philadelphia College of Phazmnacy and Science
`Copyright © 1956, 1960, 1965, 1970, 1975, 1986, 1985, 1990, by The Philadelphia College of
`Pharmacy and Science
`
`All Rights Reserved
`
`Library of Congress Catalog Card Na, 60-53334
`ISBN 0-912734-04-3
`
`The use
`of structural formitas fram USAN and the USP Dictionary of Drug Namesis by
`permission of The USP Convention. The Conventionis not responsible for any inaccuracy
`contained herein.
`
`Novice-—This text is not intended to represent, nor shall it be interpreted to be, the equivalent
`of or a substitute for the official United States Pharmocapeia (USP} and/or the National
`or
`In the event of any difference
`discrepancy between the current official
`Formulary (NF).
`USPor NF standardsof strength, quality, purity, packaging and labeling for drugs and
`representations of then: herein, the context and effect of the official compendia shall
`prevail,
`
`Printed in the United States of America by the Mach Printing Company, Easton, Pennsylvania
`
`MYLANINST. EXHIBIT 1013 PAGE 5
`
`
`
`MYLAN INST. EXHIBIT 1013 PAGE 5
`
`

`

`Managing
`
`Editor
`
`Editorial Assistant
`
`John E Hoaver
`
`Bonnie
`
`Brigham
`
`Packer
`
`Director
`
`Allen Misher 14985-1990
`
`Eighteenth
`
`Edition— 1990
`
`Published in the 170th year of the
`PHILADELPHIA COLLEGE OF PHARMACY AND SCIENCE
`
`.. . a treotise on the theory
`Remington's Pharmaceutical Sciences
`of the pharmaceutical sciences, with essential
`and practice
`and medicinal agents; also a
`information about pharmaceutical
`guide
`as the
`fo the professional responsibilities of the pharmacist
`drug-information specialist of the health team... A fextbook
`and other
`and reference work for pharmacists, physicians
`and medical sciences.
`of the pharmaceutical
`practitioners
`
`EDITORS
`
`Alfonso R Gennaro, Chairman
`
`Grafton D Chase
`
`Ara Der Marderosian
`
`Stewart C Harvey
`Daniel A Hussar
`
`Thomas Medwick
`
`Edward G Rippie
`Joseph B Schwartz
`Ewart A Swinyard
`Gilbert L Zink
`
`AUTHORS
`
`The 109 chapters of this edition of
`Pharmaceutical
`Remington's
`Sciences were written by the editors, by members of the
`Editorial Board, and by other authorslisted on pages ix to xi.
`
`MYLANINST. EXHIBIT 1013 PAGE 6
`
`MYLAN INST. EXHIBIT 1013 PAGE 6
`
`

`

`Historical / Biographical Dara
`
`Remington
`The following is a record of the editors and the dates of publication of successive editions of this book, prior to the f3th
`Edition known os
`Remington's Practice of Pharmacy and subsequently as Remington's Pharmaceutical Sciences.
`
`Joseph P Remington
`
`Joseph P Remington
`Assisted by
`E Fullerton Cook
`
`Associate Editors
`Ivor Griffith
`Adiey B Nichals
`Arthur Osol
`
`Editors
`E Fullerton Cook
`Eric W Martin
`
`Editors
`E Fullerton Cook
`Eric W Martin
`
`Associate Editors
`E Emerson Levallen
`Arthur Osol
`Linwood F Tice
`Clarence T Yon Meter
`
`Assistant to the Editors
`John E Hoover
`
`Firat Edition, 7866
`Second Edition, 1867
`Third Edition, 1897
`Fourth Edition, 1905
`
`Fifth Edition, 1907
`Sheth Edition, 1917
`
`Seventh Edition, 1926
`
`Edlfors
`E Fullerton Cook
`Charles H LaWall
`
`Eighth Edition, 1936
`
`Edlrors
`E Fuliertan Cook
`Charles H LaWall
`
`Ninth Edition, 1946
`
`Tenth Edition, 1957
`
`Elevensh Edition, 4954
`
`Editors
`Eric W Martin
`E Fullerton Coak
`
`Twelfth Edition, 1964
`
`Editors
`Eric W Martin
`E Fullerton Cack
`E Emersan Levailen
`Arthur Osol
`Linwood
`Tice
`Clarence T Yan Mefer
`
`Thirteenth Edition, 1965
`Editor-in-Chief
`Erle W Martin
`Editors
`Grafton D Chase
`Heraid & Cox
`Richard A Deno
`Alfonso R Gennaro
`Stewart C Harvey
`Fourfeenth Editlan, #970
`Chairmen, Editorial Board
`Arthur Osol
`Edifors
`Grafton D Chase
`Richard A Deno
`Alfonse R Gennaro
`Melvin A Gibson
`Stewart C Harvey
`Fifteenth Edition, 1975
`Chairman, Edltorlal Board
`Arthur Oso]
`Editors
`John T Anderson
`Cecil L Bendush
`Grafton D Chase
`Alfonso R Gennaro
`Melvin R Gibson
`
`Sixteenth Edition, 1960
`Chaitman, Editorial Board
`Arthur Osol
`Editors
`Grafton D Chase
`Alfonso R Gennaro
`Melvin R Gibson
`C Boyd Granberg
`Stewart C Harvey
`Seventeenth Edision, 1985
`Chairman, Editorial Board
`Alfonso A Gennaro
`Editors
`Grafton D Chase
`Ara Der Marderosian
`Stewart Harvey
`Daniet A Hussar
`Thomas Medwick
`
`Managing Editor
`John E Hoover
`
`Robert E King
`E Emerson Leuallen
`Arthur Osol
`Ewart A Swinyard
`Clarence T Van Meter
`
`Managing Editor
`John E Hoover
`
`Robert E King
`Alfred N Martin
`Ewart A Swinyard
`Clarence T Yan Meter
`Bernard Witlin
`
`Managing Editor
`John E Hoover
`
`C Boyd Granberg
`Stewart C Harvey
`Robert E King
`Alfred N Martin
`Ewart A Swinyard
`
`Robert E King
`Alfred N Martin
`Ewart A Swinyard
`Gilbert L Zink
`
`Edward G Ripple
`Joseph D Schwartz
`Ewart A Swinyard
`Gilbert |. Zink
`
`vill
`
`MYLANINST. EXHIBIT 1013 PAGE 7
`
`MYLAN INST. EXHIBIT 1013 PAGE 7
`
`

`

`
`
`Editorial Board Members and Editors
`
`Alfonso BR Gennaro, PhD / Philadelphia College of Pharmacy and Science--Professor of
`Chemistry. Chairman of the Editorial Board and Edites, Remington's Pharmaceutical
`Sciences. Caauthor, Chapter 22, Coeditor, Part 6, Pharmaceutical and Medicinal
`Agents,
`
`Grofton D Chose, PhD / Philadelphia College of Pharmacy and Science—Emeritus Professor of
`Chemistry, Edltor, Part 5, Radioisotopes in Pharmacy and Medicine. Author, Chapters
`32 and 33.
`
`Aro DerMorderasian, PhD / Philadelphia Callege of Pharmacy and Science—Professor of
`Pharmacognosy. Research Professor in Medicinal Chemistry. Editor, Part 1,
`Orfentation. Author, Chapters 64, 74 and 96,
`
`Stewart C Horvey, PhD / University of Utah School of Medicine—Professor of Pharmacology.
`Editorlal Board Member. Editor, Part 6, Pharmaceutical and Medicinal Agents.
`Author, Chapters 35, 38, 40, 43 to 47, 49, 64 ond 62. Coauthor, Chapters 36, 44 and
`50.
`
`Doniel A Hussar, PhD / Philadelphia College of Pharmacy and Science—Remington Professorof
`Pharmacy. Editorial Board Member. Editor, Part 9, Pharmaceutical Practice. Author.
`Chapters 400 and 102.
`
`Thomas Medwick, PhD / Rutgers University—Professor and Chairman, Department of
`Pharmaceutleal Chemistry. Editorial Board member. Editor, Part 3, Pharmaceutical
`Chemistry, and Part 4, Testing and Analysis. Coauthor, Chapter 26.
`
`of Pharmacy—Professor of
`Edword G Ripple, PhD / University of Minnesota
`College
`Pharmaceutics. Editorial Board Member, Editor, Part 2, Pharmaceutics. Author,
`Chapter 12. Coauthor, Chapter 66.
`
`Joseph D Schwartz, PhD / Philadelphia College of Pharmacy and Science-Linwood Tice
`Professor of Pharmaceutics. Editorial Board Member. Editar, Part 6, Pharmaceutical
`Preparations and Thelr Manufacture. Coauthor, Chapters 68 and 89,
`
`Ewart A Swinyord, PhD / University of UtahPrafessar Emeritus of Pharmacology, College of
`Pharmacy and Scheal of Medicine. Edlfarlal Board member. Editor, Part 6,
`Pharmaceutical and Medicinal Agents. Author, Chapters 99, 42, 48, 53 to 60, 63, 65
`and 70. Coauthor, Chapter 66.
`
`Gilbert L Zink, PAD / Philadelphia College of Pharmacy and Sclence—Assoclate Professor of
`Biology, Editor, Part 7, Biological Products. Author, Chapter 714.
`
`Ix
`
`MYLANINST. EXHIBIT 1013 PAGE 8
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`
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`MYLAN INST. EXHIBIT 1013 PAGE 8
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`

`

`
`
`Authors
`
`The following contributors to the Eighteenth Edition of Remington's Pharmaceutical Sciences
`served as authors or coauthors. along with the editors and members of the Editorial Beard,
`of the 409 chopters of this book.
`
`Waumed M Abdou, PhD / Vice President, Worldwide Pharmaceuti-
`cal Technica! Operations, E R Squihb & Sons, Inc; Author of
`Chapter 30, Instrumental Methods of Analysis and Chapter
`31, Dissolutian.
`Anu B Amerson, PharmD / Professor, College of Pharmacy/Di-
`rector, Drug Information Center, Chandler Medical Center,
`University of Kentucky; Author of Chapter 108, Clinical Drug
`Literature.
`Woward C Ausel, PhD / Professor of Pharmacy and Dean, College
`of Pharmacy, University of Georgia; Author of Chapter 101,
`The Preseription.
`Kenneth E Avis, DSe / Mmeritus Professor, Pharmaceutics, Cal-
`lege of Pharmacy, University of Tennessee, Memphis; Author
`of Chapter 84, Parenteral Preparations.
`Leonard C Bailey, PhD / Associate Professor of Pharmaceutical
`Chemistry, Rutgers University College of Pharmacy; Author of
`Chapter 29, Chromatography,
`Lawrence H Bloek, PhD / Professor of Pharmaceutics, Duqnesne
`University School of Pharmacy; Author of Chapter 87, Med:-
`cated Applications.
`Joseph B Bogardus, PhD / Basic Pharmaceutics Research, Bris-
`tol-Myers Company; Coauthor of Chapter 18, Heaction Kineé-
`ies.
`Sanford Bolton, PhD / Chairman, Department of Pharmacy and
`Administrative Sciences, St John’s Universily; Author of Chap-
`ter 10, Statistics,
`John Bosso, Pharm{Professor of Clinical Pharmacy and Ad-
`junct Professor of Pediatrics, College of Pharmacy and School
`of Medicine, University of Utah, Coauthor of Chapter 34, Dis-
`eases: Mantfestations and Pathophysiology.
`B Sue Brizuela, MS / Assistant Professor of Information Science,
`Head of Public Services, Jaseph W England Library, Philadel-
`phia College of Pharmacy and Science; Coauthor of Chapter 7,
`Drug Information,
`Dale B Christensen, PhD / Associate Professor, Department of
`Pharmacy Practice, School of Pharmacy, University of Wash-
`ington; Coauthor of Chapter 11, Compuzer Setence.
`Sebastian G Ciancio, DDS / Profesaor and Chairman, Depart-
`mentof Periodontology, School of Dental Medicine, State Uni-
`versity of New York at Buffalo; Author of Chapter 109, Dental
`Services,
`Kenneth A Connors, PhD / Professor of Pharmaceutics, Schooi of
`Pharmacy, University of Wisconsin; Author of Chapter 14,
`Complex Formation.
`Authony J Cutie, PhD / Professor of Pharmaceutics, Arnold and
`Marie Schwartz College of Pharmacy and Health Sciences,
`LongIsland University; Cosuthor of Chapter 92, Aerosols.
`Anthony RK DiSante, PhD / Vice President, Drug Delivery Re-
`search and Development, The Upjohn Company; Author of
`Chapter 76, Bicevailability and Bicequivalency Testing.
`Clarence A Discher,* PhD / Professor Emeritus, Rutgers Univer-
`sity; Authorof Chapter 21, /norgantc Pharmaceutical Chemis-
`try.
`Clyde R Evskine, Jr, BSe / Vice President, Corporate Quality
`Audits and Services, SmithKline Beckman Corporation; Au-
`thor of Chapter 82, Quality Assurance and Contral,
`Lorraine D Evans, BS, H(ASCP) / Clinical Pathology, Bristol-
`Myers Company; Coauthor of Chapter 28, Clinieal Analysts.
`William E Faasest, BS, MBA / Assistant Professor, Departmentof
`Pharmacy Practice, Schoo! of Pharmacy, University of Wash-
`ington; Coauthor of Chapter 11, Computer Setence.
`Joseph L Fink JE, BS(Pharm), JD / Assistant Dean and Profes-
`sor, College of Pharmacy, University of Kentueky; Coauthor of
`Chapter 107, Laws Governing Pharmacy.
`
`*
`
`Deceased
`
`x
`
`Michael R Franklin, Ph/ Professor of Pharmacology, College of
`Pharmacy and School of Medicine, University of Utah; Author
`of Chapter 62, Enzymes.
`Ruta Freimanis, BS, RPh / Associate Secretary, United States
`Adopted Names Council; Coauthor of Chapter 24, Drug No-
`menelature-~ United States Adopted Names.
`James W Fyeston, MD, PhD / Professor and Chairman, Depart-
`ment of Medicine, University of Connecticut Health Center;
`Coauthor of Chapter 34, Diseases: Manifestations and Patho-
`physiology.
`Robert L Giles, BA / Vice President and General Manager, Gienn
`Beall Engineering Ine; Coauthor of Chapter80, Plastic Packag-
`ing Materials.
`Harold N Godwin, MS / Professor and Director of Pharmacy, The
`University of Kansas Medical Center; Author of Chapter 94,
`Institutional Patient Care,
`Frederick J Goldstein, PhD / Professor of Pharmacology, Phila-
`delphia Coiloge of Pharinacy and Science; Coauthor of Chapter
`69, Pharmacological Aspects of Substance Abuse.
`A Richard Goolkasian, BS, RPh/ Director of Ahimani and Profes-
`sional Affairs, Massachusetts College of Pharmacy and Allied
`Health Sciences; Author of Chapter 1, Seope.
`Gerald Hecht, PD / Director Process Development, Alcon Lab-
`oratories; Conuthar of Chapter 86, Ophthalmic Preparations.
`Judith Aesp, MS / Instructor in Information Science, Coordina-
`tor of Bibliographic Instruction, Jogeph W lengland Library,
`Philadelphia College of Pharmacyand Science; Coauthor of
`Chapter 7, Drug Information.
`Gregory J Highy, PhD / Director, American Institute of the Histo-
`ry of Pharmacy, Schooi of Pharmacy, University of Wisconsin-
`Madison; Author of Chapter 2, Zuolution af Pharmacy.
`Audrew 5 Katocks, Jr, PhD / Senior Research Pharmacologiat,
`American Cyanamid Company, Medical Research Division;
`Coauthor of Chapter 27, Mological Testing.
`Calvin G Knowlton, MDiv, RPh / Clinica! Associate Professor of
`Pharmacy, Philadelphia College of Pharmacy and Science; Au-
`thor of Chapter4, The Practice of Community Pharmacy.
`Richard W Knueppel, RPh / President, Knueppel Wome Health
`Care Center; Author of Chapter 104, Vealth Accessories.
`Warry B Kostenbauder, PhD / Associate Dean for Research, Col-
`lege of Pharmacy, University of Kentucky; Coauthor of Chap-
`ter 18, Reaction Kinetics.
`Richard L Kronenthal, PhD / Director of Research, Ethicon Inc;
`Author of Chapter 108, Surgical Supplies.
`Arthur J Lawrence, PhD, RPh / Office of the Assistant Secretary
`of Health, US Public Health Service; Author of Chapter 6,
`Pharmacists in Government,
`Eric J Lien, PhD /Profesaor of Pharmaey / Pharmaceutics and
`Biomedical Chemistry, Schoo! of Pharmacy, University of
`Southern California; Author of Chapter 13, Molecular Strue-
`ture, Properties and States of Motter,
`Mark A Longer, PhD / MCRResearch Fellow, Department of
`Biological Sciences, University of Keele; Coauthor of Chapter
`91, Sustained-Release Drug Delivery Systems.
`Werner Lowenthal, PhD / Professor of Pharmacy and Pharma-
`ceutics and Professor of Educational Development and Plan-
`ning, School of Pharmacy, Medical Callege of Virginia; Author
`of Chapter 9, Metrology and Calculation.
`Karen 2 Main, PhD / Physical Pharmacist, Pharmaceutical De-
`velopment Department, LCI Pharmaceuticals Group; Coauthor
`of Chapter 26, Analysts of Medicinals.
`Deane D Miller, PHD / Professor and Chairman, Division of Me-
`dicinal Chemistry and Pharmacognosy, College of Pharmacy,
`
`MYLANINST. EXHIBIT 1013 PAGE 9
`
`MYLAN INST. EXHIBIT 1013 PAGE 9
`
`

`

`
`
`The Ohio State University; Author of Chapter 25, Structure-
`Activity Relationship and Drug Design.
`Michael Montagne, PHD / Associate Professor of Pharmacy Ad-
`ministration, Philadelphia College of Pharmacy and Science;
`Coauthor of Chapter 3, Ethics and Authorof Chapter 99, Drug
`Education.
`John D Multing, PhD / Consultant; Coauthor of Chapter 86, Oph-
`thalmic Preparations.
`Maven J Myers, Ph/ Professor of Pharmacy Adminiatration,
`Philadelphia College of Pharmacy and Science; Coauthor of
`Chapter3, Zihics.
`J G Nairn, PhD / Professor of Pharmacy, Faculty of Pharmacy,
`University of Toronto; Author of Chapter 83, Setudions, mul-
`sions, Suspensions and lfxtracts.
`Paul J Niebergall, PhD / Professor of Pharmaceutical and Sci-
`ences / Director, Pharmaceutical Development Center, Medi-
`cal University of South Carolina; Author of Chapter 17, fonie
`Solutions and Electrolytic Equilibria.
`Rohert E O'Connor, PhD / Merck Frosst Canada, Inc; Coauthorof
`Chapter 88, Pawders.
`Melanie O’NeiE/ Becton Dickinson & Company; Coauthor of
`Chapter 78, Sterilization.
`Richard W Pecina, PhD / President, Richard W Pecina & Asso-
`ciates; Coauthor of Chapter 80, Plastic Packaging Materials,
`Garnet E Peck, PhD / Professor of Industrial Pharmacy/ Director
`of the Industrial Pharmacy Laboratory, Purdue University;
`Author of Chapter 77, Separation.
`G Briggs Phillips, PhD / Becton Dickinson & Company; Coauthor
`of Chapter 7B, Sterilization.
`Nicholas G Popovich, PhD / Associate Professor of Pharmacy
`Practice, School of Pharmacy and Pharmacal Sciences, Purdue
`University; Author of Chapter 93, Ambulatory Patient Care,
`Stuart C Porter, PhD / Vice President, Research and Develop-
`ment, Colorcon; Author of Chapter 90, Coating of Pharmaceu-
`tical Dosage Forms.
`Galen Radebaugh, Pht) / Director of Pharmaceutics, Parke-Davis
`Pharmaceutical Research Division, Warner-Lambert Compa-
`ny; Coauthor of Chapter 75, Preformulation.
`Paul L Ranolli, PhD / Assistant Professor of Pharmacy Adminis-
`tration, Philadelphia College of Pharmacy and Science; Author
`of Chapter 98, Patient Communication,
`Lonia J Ravin, PhD / Departmentof Pharmaceutics, Research and
`Development, Smith Kline & French Laboratories; Coauthor of
`Chapter 75, Preformulation.
`Jack W Reich, PAD / Vice President Regulatory Affairs, Gensia
`Pharmaceuticals, lic; Author of Chapter 8, Research.
`James W Richards, MBA / Professor of Pharmacy Administra-
`tion, College of Pharmacy, University of Michigan; Author of
`Chapter 108, Community Pharmacy Economics and Manage-
`ment.
`Jack Robbins, PhD / Director, Pharmacy Affairs, Schering Lah-
`oratories; Author of Chapter 5, Oppertunities for Pharmacists
`In the Pharmaceutical Industry.
`Joseph R Robinson, PhD / Professor of Pharmacy, School of
`Pharmacy, University of Wisconsin; Coauthor of Chapter 91,
`Susiained-Release Drug Delivery Systems.
`Frank Roia, PhD / Professor of Biology, Philadelphia College of
`Pharmacy and Science; Author of Chapter 72, Jinmunizing
`Agents and Diagnostic Skin Antigens.
`Douglas E Rollins, MD, PhD / Associate Profesaor of Medicine
`and Pharmacology, School of Medicine and College of Pharma-
`cy, University of Utah; Author of Chapter87, Clinical Pharma-
`cokinetics.
`G Vietor Rossi, PAD / Vice Presidont of Academic Affairs / Pro-
`fessor of Pharmacology, Philadelphia College of Pharmacy and
`Science; Coauthorof Chapter 27, Biological Testing and Coau-
`thor of Chapter 69,
`Rdward Rudnic, PhD / Director, Formulation Development,
`Research; Coauthor of Chapter 89, Oral Solid Dosage
`CORMS,
`Fohoring
`Donald O Schiffman, PhD /Secretary, United States Adopted
`
`Names Couneil; Coauthor of Chapter 24, Drug Nomencla-
`ture-—United States Adapted Names.
`Hang Schott, PhD / Professor of Pharmaceutics and Colloid
`Chemistry, School of Pharmacy, Temple University; Coauthor
`of Chapter 19, Disperse Sysiems and Author of Chapter 20,
`Rheology.
`John J Sciarra, PhD / President, Retail Drug Institute / Professor
`of Industrial Pharmacy, Arnold and Marie Schwartz College of
`Pharmacy and Health Sciences, Long Island University; Coau-
`thor of Chapter 92, Aerosals.
`John B Shinkai, PhD / Emeritus Professor of Pharmaceutical
`Chemistry, Ruigers University, College of Pharmacy; Coauthor
`af Chapter 22, Organie Pharmacettical Chemistry.
`E Richard Shough, PhD / Associate Dean and Professor, Univer-
`sity of Oklahoma Health Sciences Center, College of Pharinacy;
`Author of Chapter 73, Allergenic Extracts.
`Frederick P Sicgel, PhD / Professor of Pharmaceutics, College of
`Pharmacy, University of Ulinois; Author of Chapter 79, Tonict-
`ty, Osmoticity, Osmolality and Osmolarity.
`Larry M Simonsmcier, BS(Pharm}, JD/ Associate Dean and
`Professor, College of Pharmacy, Washington State University;
`Coauthor of Chapter 107, Laws Governing Pharmaey.
`Robert D Smyth, PhD / Vice President, Pharmaceutical Deyelup-
`ment, Bristol-Myers Company; Coauthor of Chapter 28, Clint-
`eal Analysis,
`Thomas C Snader, PharmD / Consultant Pharmacist; Author of
`Chapter 95, Long-Term Care Facilities.
`Theodore D Sokoloski, PhD / Professor of Pharmacy, College of
`Pharmacy, The Ohio State University; Author of Chapter 16,
`Solutions and Phase Equilibria.
`Robert B Stewart, MS / Professor and Chairman, Department of
`Pharmacy Practice, College of Pharmacy, University of Mori-
`da; Author of Chapter 67, Adverse Drug Reactions.
`dames Swarbrick, DSc, PhD / Professor nnd Chairman, Division
`of Pharmaceutics, School of Pharmacy, University of North
`Carolina at Chapel Hill; Coauthor of Chapter £9, Disperse
`Systems.
`Anthony R Temple, MD / Director, Regulatory and Modical Af-
`fairs, McNeil Consumer Products Company / Adjunct Asso-
`ciate Professor,Departmentof Pediatrics, University of Penn-
`sylvania School of Medicine / Lecturer, Philadelphia College of
`Pharmacy and Science; Authorof Chapter 106, Paison Contral,
`John P Tischio, PhD / Principle Scientist, Immunohiology Re-
`search Institute; Author of Chapter 68, Pharmacogenetics.
`Salvatere J Turco, PharmD / Professor of Pharmacy, Temple
`University School of Pharmacy; Author of Chapter85, Jnirace-
`nous Admixtures.
`EHzabeth B Vadas, PhD / Merck Frosst Canada, Inc; Author of
`Chapter81, Stability of Pharmaceutical Products.
`Ernestine Vandorveen, PhD / National Institute on
`Drug Abuse,
`ADAMHBHA; Coauthor of Chapter 51, Vitamins and Other Nu-
`trients,
`John E Vanderveen, PRD / Division of Nutrition, Food and Drug
`Administration; Coauthor of Chapter 51, Vitamins and Other
`Nutrients.
`Vincont S Venturella, PhD / Section Manager, Pharmaceutical
`Research, Anaquesi, Div of BOC; Author of Chapter 23, Natu-
`ral Products.
`Albert I Wertheimer, PhD / Professor and Director, Department
`of Graduate Studies in Social and Adiministrative Pharmacy,
`College of Pharmacy, University of Minnesota; Author of
`Chapter 97, The Patient: Behaoioral Determinanis.
`Assistant Professor, College of
`Timothy S Wicdmann, PhD
`Pharmacy, University of Minnesota; Author of Chapter 16,
`Thermodynamics.
`C Dean Withrow, PhD / Associate Professar of Pharmacology,
`School of Medicine, University of Utah; Coauther of Chapter
`36, Basie Pharmacokinetics, Coauthor of Chapter 41, Cardio-
`vaseular Drugs and Coauthor of Chapter 60, Hormones.
`George Zografi, PhD / Professor, School of Pharmacy, University
`of Wisconsin; Coauthor of Chapter 19, Disperse Systems.
`
`xi
`
`MYLANINST. EXHIBIT 1013 PAGE 10
`
`
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`MYLAN INST. EXHIBIT 1013 PAGE 10
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`

`

`
`
`Preface to the First Edition
`
`The rapid and substantial progress made in Pharmacy
`within the last. decade has created a
`necessity for a work
`treating of the improved apparatus, the revised processes,
`and the recently introduced preparations of the age.
`The vast. advances made in theoretical and applied chem-
`istry and physics have much to do with the development of
`pharmaceutical science, and these have been reflected in all
`the revised editions of the Pharmacopoeias which have been
`recently published. When the author was elected in 1874 to
`the chair of Theory and Practice of Pharmacyin the Phila-
`delphia College of Pharmacy, the outlines of study which
`had beenso
`carefully prepared for the classes by his eminent
`predecessors, Professor William Procter, Jr, and Professor
`were found to be not strictly in accord,
`kedward Parrish,
`or in their method
`either in their arrangementofthe subjects
`to preserve the distinctive charac-
`of treatment. Desiring
`teristics of each, an effort was at once made to frame a
`system which should embody their valuable features, em-
`andstill retain that harmonyof plan and
`brace new
`subjects,
`absolutely essential to the suc-
`proper sequence which are
`cess of any system.
`The strictly alphabetical classification of subjects whichis
`now universally adopled by pharmacopoeias and dispensa-
`an
`tories, although admirable in works of reference, presents
`effectual sturabling block to the acquisition of pharmaceuti-
`cal knowledge through syslematic study; the vast accumula-
`tion of facts collected under each head being arranged lexi-
`cally, they necessarily have no connection with one another,
`and thus the saving of labor effected by considering similar
`groups together, and the valueof the association of kindred
`are lost to the student.
`In the method of grouping
`subjects,
`the subjects which is herein adopted, the constant aim has
`been to arrange the latter in such a mannerthat the reader
`shall be gradually led from the consideration of elementary
`subjects to those which involve more advanced knowledge,
`as to follow one
`whilst the groups themselves are so
`placed
`anotherin a natural sequence.
`The work is divided into six parts. Part I is devoted to
`detailed descriptions of apparatus and definitions and com-
`ments on
`general pharmaceutical processes.
`The Official Preparations alone are considered in Part II.
`are thus given
`to the Pharmaco-
`Due weight and prominence
`poeia, the National authority, which is now so
`thoroughly
`recognized.
`in orderto suit the convenience of pharmacists whoprefer
`liquids, the official formulas are
`to weighsolids and measure
`in avoirdupois
`expressed, in addition to parts by weight,
`are
`measure. These equivalents
`weight and apothecaries’
`4
`
`near the margin, and arrangedso as to
`printed in bold type
`fit themfor quick and accurate reference.
`Part IH treats of Inorganic Chemical Substances. Prece-
`denceis of course
`to official preparation inthese. The
`given
`descriptions, solubilities, and tests for identity and impuri-
`ties of each substance are
`systematically tabulated underits
`It is confidently believed that by this method
`propertitle.
`of arrangement the valuable descriptive features of the
`Pharmacopoeia will be more
`prominently developed, ready
`referencefacilitated, and close study of the details rendered
`easy. Each chemical operation is accompanied by equa-
`tions, whilst the reactionis, in addition, explained in words.
`or
`The Carbon Compounds,
`Organic Chemical Sub-
`stances, are considered in Part TV. These are
`naturally
`grouped according to ihe physical and medical properties of
`their principal constituents, beginning with simple bedies
`to the most highly
`like cellulin, gum, etc, and progressing
`organized alkaloids, ete.
`Part V is devoted to
`xtemporaneous Pharmacy. Care
`has been takento treat of the practice which would be best
`adapted for the needs of the many pharmacists who conduct.
`operations upon a moderate seale, rather than for those of
`In this, as
`the few who manage verylarge establishments.
`well as in other parts of the work, operations
`are illustrated
`which are conducted by manufacturing pharmacists.
`Part VI contains a
`formulary of Pharmaceutical Prepara-
`tions which have not been recognized by the Pharmacopoeia.
`The recipes selected are
`chiefly those which have heen here-
`tofore rather difficult of acceas to most
`pharmacists, yet such
`as are
`likely to be in request. Many private formulas are
`embraced in the collection; and such of the preparations of
`as have not been included in the
`the old Pharmacopoeias
`new edition, but are still in use, have been inserted.
`In conclusion, the author ventures 10 express the hope
`that the work will prove anefficient help lo the pharmaceu-
`tical student as well as to the pharmacist and the physician.
`Although the laber has been mainly performed amidstthe
`cares of active professional duties, and perfection
`harassing
`no
`is known to be unattainable,
`pains have been spared to
`discover and correct errors and omissions in the text. The
`aulhor’s warmest acknowledgments, are tendered to Mr AB
`Taylor, Mr Joseph McCreery, and Mr George M Smith for
`their valuable assistance in revising the proof sheets, and to
`the latter especially for his work on the index. The outline
`were drawneither from the
`illustrations, by My John Collins,
`or from photographs taken by the author.
`actual objects
`JPR,
`Philadelphia, October, [885
`
`xii
`
`MYLANINST. EXHIBIT 1013 PAGE11
`
`
`
`MYLAN INST. EXHIBIT 1013 PAGE 11
`
`

`

` Preface to the Eighteenth
`
`Edition
`
`to
`In anticipation of setting forth this Preface and prior
`more
`on paper (or
`accurately, the word
`gathering thoughts
`processor!), this Editor paused to reread the preface to the
`first edition of Remington, published in 1885. Since it ap-
`pears on the preceding page of this book it is recommended
`as suitable today
`highly. The first paragraph would he just
`as penned by Professor Remington 105 years ago.
`one and the pharma-
`Each decade transcendsthe previous
`ceutical and health sciences are not laggards.
`Ivery revi-
`new
`sion of Remington has encompassed
`viewpoints, ideas,
`were inconceivable
`doctrines or
`principles which, perhaps,
`It is a tribute to the authors and
`for the previous edition.
`editors that they have kept abreast of the burgeoning litera-
`ture in their respective fields of expertise.
`Change not withstanding, the organization of this edition
`is similarto its immediate predecessors, being divided inte 9
`Parts, each subdivided into several. chapters. Every chapter
`has been culled, revised and rewritten to update the material
`presented.
`are
`Two new chapters
`evident; Biotechnology and Drugs
`(Chapter 74) and Drug Education (Chapter 99), Three
`ofthe previous edition, which embraced Interfacial
`chapters
`and Particle Phenomena and Colloidal and Coarse Disper-
`sions have been winnowed and combined intoa
`single chap-
`ter entitled, Disperse Systems (Chapter 19).
`The current revision contains an additional 21 pages. A
`large amount of space {about 19 pages) gleaned from the
`review and condensation process, coupled with the extra
`pages, have been devoted primarily to expanding the con-
`tents of Part 6, Pharmaceutical and Medicinal Agents and
`Part 9, Pharmaceutical Practice.
`Excessive duplication of text is the bane of any editor
`dealing with a multitude of authors. While some
`duplica-
`tion in the discussion of rudimentary concepts is beneficial,
`there has been a
`special effort to cross-reference and elimi-
`nate unnecessary repetition. Space is at such a
`premium
`that it is hoped the reader will not be offended by being
`diverted to a different section of the text in order to obtain
`supplementary information.
`Photographs which depicted the typical] “black box” have
`been eliminated almost completely and replaced by line
`or schematic diagrams whichare instructive rather
`drawings
`than picturesque.
`Most of the drug monographs have been revamped not
`a
`as a meansof updating, but to gain
`degree of uniformi-
`only
`ty. All structural formulas are now in the standard USAN
`form. Duplication of chemical names has been minimized
`and the inclusion of trade names increased. No attempt has
`been madeto ferret out every trade name
`by which a preduct
`is known, and only the most commonare mentioned. The
`standard format for the major monographs is: Official
`Name, chemical name
`(CAS——inverted}, trade name(s} and
`manufacturer(s), structural formula, CAS (Chemical Ab-
`stracts System} registry numher (in brackets), molecular
`formula and formula weight (in parenthesis), This is fol-
`lowed by the method of preparation (or a reference if the
`method is lengthy), physical description, solubility, uses,
`dose and dosage forms.
`The number of authors remains at 97, however, 36 new
`as contributors to Remington. As the
`authors have joined
`credentials of the new authors touch upon many areas of
`pharmacy, every section of the book has been invigorated by
`the incorporation of updated and fresh concepts.
`
`primarily responsible for the production of a com-
`As one
`prehensive text devoted to the science and practice of phar-
`macy, the wisdom of Dr Erie Martin, editer of the 13th
`an Editorial Board to share the enor-
`Edition, in creating
`mous
`burden, has been evident constantly. Each of the
`section editors labored diligently to complywiththelogistics
`a smooth flow of manuscripts and proofs.
`of maintaining
`Also, each section editor doubled as an authoror coauthorof
`one or more chapters.
`EL would be remiss not to extend
`special mentionto this group of dedicated people.
`Four memhers of the [ditorial Board are
`serving for the
`first time after having been authors for several editions. Dr
`Ara DerMarderosian of PCP&S, Editorfor Part 1, Dr Daniel
`Hussar, also of PCP&S, Part 9; Dr Edward Rippie of the
`University of Minnesota, Part 2; and Dr Joseph Schwarta of
`PCP&S, Part 8, Bach of the new membersliterally “jumped
`into the fray,” gave much of their precious time and have
`become “blooded” membersof the staff.
`The stalwarts of the Editorial Board surviving thetrihula-
`tions of one or more
`previous editions of this work demand
`singular attention. Dr Grafton Chase of PCP&S for Part. 5,
`Radioisotopes in Pharmacy & Medicine, Dr Thomas Med-
`wick of Rutgers University for Part 3, Pharmacettical
`Chemistry and Part 4, Testing and Analysis; and Dr Gilbert
`@ink of PCP&S for Part 7, Biological Products,
`Two dauntless, prolific contributors claim special recogni-
`tion. Drs Stewart Harvey and Ewart Swinyard, both of the
`University of Utah, have served on the Editorial Board for
`twenty and twenty-five years respectively. They bear the
`burden of Part 6, Pharmaceutical & Medicinal Agents,
`over one-third of the book. Their diligence
`which comprises
`and meticulous attention to detail has eased the task of this
`over the past several decades has
`Editor. Ourrelationship
`been one of exceptional pleasure.
`The Mack Publishing Company, through Messers Paul
`Mack an