ae
`
`pe,aer?
`
`ae
`
`ra
`—ss
`
`Nee
`
`.oiCe
`F ‘| PaPaws
`
`FRESENIUS EXHIBIT 1013 Page 1 of 408
`
`FRESENIUS EXHIBIT 1013
`Page 1 of 408
`
`

`

`'iiif ■ - . . .
`
`Remington's
`Pharmaceutical
`Sciences
`
`18
`
`FRESENIUS EXHIBIT 1013
`Page 2 of 408
`
`

`

`18rn
`
`EDITION
`
`Remington's
`
`ALFONSO R GENNARO
`Editor, and Chairman
`of the Editorial Doord
`
`FRESENIUS EXHIBIT 1013
`Page 3 of 408
`
`

`

`Pharmaceutical
`
`Sciences
`
`1990
`
`MACK PUBLISHING COMPANY
`
`Easton, Pennsylvania 18042
`
`/
`
`FRESENIUS EXHIBIT 1013
`Page 4 of 408
`
`

`

`l~ntcrcd nccording io Aci of Congrc.,s, in tJ1e yoor 188/i by Joseph P Romington,
`in the Office of the Lilm1rinn ofCm1gre.,s, 11t Wttshiugton DC
`
`Copy1igbt 1889, 1894, J.905, 1907, 1917, by Josoph P Remington
`
`Copyright 1926, 1936, by Jo8eph P Remington ll:stnte
`
`Copyriffht 1948, 1961, by The Philadelphia College of Pharmacy a nd Science
`
`Copyright. © 1956, 1960, 1965, lll70, 1975, 1980, 1981.i, 1990, b.v The Philndelphlo College of
`Phormncy ond Science
`
`All Rich ts Reserved
`
`Librar_y of Congrcfis Calnlog Card No. 60-53334
`
`ISBN 0-912734-04-3
`
`'I'he use of ~tructural formulas from USAN and the USP Dictiona1-y of Drug Names is by
`permission of The USP Convention. 'rhe Conv,mtion is not rcspo11sible for an.Y inaccuracy
`contai11cd herein.
`
`N01'JCl,--This text is not intended to rt!present, nor shall ir. be interpreted to be, the equivalent
`of or o su~titute for the official. United States Pharmocopei<t (USP) and/or the National
`Pormulary (NP). In the event of any difference or discl'epa11ey between the curre11t o/ficial
`USP or NF stlt11dards of $tre11gth, quality, purity, pltckc,11ing and labeling for drugs and
`representations of them herein, the context and effect of the offici<1/ compendia $hall
`prevail.
`
`Printed in the United States of America by the Mach Printing Company, Easton, Pa1111sylvania
`
`FRESENIUS EXHIBIT 1013
`Page 5 of 408
`
`

`

`···T1-· --···-
`,
`
`Remington's Pharmaceutical Sciences ... a treatise on the theory
`and practice of the pharmaceutical sciences, with essential
`Information about phormoceurical and medicinal agents; also a guide
`to the professional responsibilities of the pharmacist as the
`drug-information specialist of the health team . .. A textbook
`and reference worh for pharmacists, physicians and other
`practitioners of the pharmaceutical and medical sciences.
`
`EDITOf\.S
`
`Alfonso R Gennaro, Chairman
`
`Thomas Medwick
`
`Grafton D Chose
`
`Ara Der Marderosian
`
`Stewart C Harvey
`
`Daniel A Hussar
`
`Edward G Ripple
`
`Joseph D Schwartz
`
`Ewart A Swinyord
`
`Gilbert L Zink
`
`AUTHORS
`
`The 109 chapters of this edition of Remington's Pharmaceutlcol
`Sciences were written by the editors, by members of rhe
`Editorial Doord, ond by other authors listed on pages ix to xi.
`
`Monogln9 Editor
`
`John E Hoover
`
`Edltotlol Assistant
`
`Donnie [kighom Packer
`
`Director
`
`Allen Misher 1905- 1990
`
`Eighteenth Edition-1990
`
`Published in the 170th year of the
`PHILADELPHIA COLLEGE OF PHARMACY AND SCIENCE
`
`FRESENIUS EXHIBIT 1013
`Page 6 of 408
`
`

`

`Remington Historical I Biographical Dcta
`
`The followlng ls a record of rhe editors ond the dotes of publlcarlon of successive editions of this book, prior to the 13th
`Edition known os Reming1on's Prac1Jce of Pharmacy ond subsequently os Remington 's Phormoceutlcol Sciences.
`
`first Edition, 1886
`S9cond Edition, 1889
`Third Edition, 1897
`Fourth Edition, 1905
`
`Fifth Edition, 1907
`Sixth Edition, 1917
`
`Sevonth Edition, 1926
`
`Editors
`E Fullert on Cook
`Charles H LoWoll
`
`Eighth Edition, 19::16
`
`Ed/tors
`E Fullerton Cook
`Charles H Lo Woll
`
`Ninth Edition, 1948
`
`Tenth Edition. 1951
`
`EhPvenfh Edlflon, 1956
`
`Editors
`EricW Mortin
`E Fullerton Cook
`
`TWolffh Edition, 1961
`
`Editors
`Eric W Marlin
`E Fullerton Cook
`E Emerson Leuallen
`A rthu r Osol
`Linwood FTice
`Clarence T Van Meter
`
`Joseph P l\emlngton
`
`Thirteenth Edition, 1965
`
`Joseph P l\emlngron
`Assisted by
`E fullerron Cook
`
`Associate EdltorJ
`Ivor Griffi th
`Adley D Nichols
`Arthur Osol
`
`Editors
`E F ullerron Cook
`Eric W Morrin
`
`EdilO(J
`E Fullerton Cook
`Eric W Mortin
`
`Associate Editors
`E Emerson Leuollen
`Arthur Osol
`Linwood F Tice
`Clarence T Von Meter
`
`Assistant to the Editors
`John E Hoover
`
`Editor-In-Chief
`Eric W Martin
`Editors
`Grofron D Chase
`Herald P. Cox
`Richard A Deno
`A lfonso R Gennaro
`Stewart C Harvey
`
`Fourtc.-enth Edition, t970
`
`Choirmon. Editor/al Doard
`Anhui Osol
`Edlfors
`Grallon D Chose
`R !chard A DP.no
`Alfonso P. Gennaro
`Melvin R Gibson
`Scewart C Horv·ey
`
`Flffoonth Edition, 197 5
`
`Chairman, Ed/Jor/al Doord
`Arthur Osol
`Editors
`John T Anderson
`Cecil L Dendush
`Grafton D Chose
`Alfonso I\ Gennaro
`Melvin R Gibson
`
`Sixteenth Edition, 1980
`
`Chairman, Ed/101/a/ Doord
`Arrhur Osol
`Editors
`Grafron D Chose
`Alfonso P. Gennaro
`Melvin P. Gibson
`C 0oyd Gronberg
`Srewarr C Harvey
`
`Seventeenth Edition, 1985
`
`Chairman. Ed/tot/al Ooord
`Alfonso P. Gennaro
`Edito,s
`Grolton D Chase
`Aro Der Morderoslon
`Stewart Hervey
`Doniel A Hussar
`Thomas Medwick
`
`Managing Editor
`John E Hoover
`
`Robe rt E King
`E Emerson Leuollen
`Arthur Osol
`Eworl A Swlnyard
`Clarence T Von Meter
`
`Managing Editor
`John E Hoover
`
`Robert E King
`Alfred N Mortin
`Eworr A Swinyord
`Clore-nee T Von Meter
`Dernard Witlin
`
`Managing Editor
`John E Hoover
`
`C lloyd Gronberg
`Stewort C Harvey
`Robert E King
`Allred N Mortin
`Ewart A Swlnyord
`
`Robert E King
`Alfred N Mortin
`Ewart A 5wlnyord
`GIibert L Zink
`
`Edward G f\ipple
`Joseph D Schwottz
`Eworr A Swlnyord
`Gllberr I. Zink
`
`viii
`
`FRESENIUS EXHIBIT 1013
`Page 7 of 408
`
`

`

`Editorial Board Members and Editors
`
`Alfonso P. Gennaro, PhD / Phl/adelphla Co/Jege of Pharmacy or,d Science-Professor of
`Chemistry. Chairman of the Editorial Boord ond Editor, Remington's Phormoceuflcof
`Sciences. Coauthor, Chapter 22. Coeditor, Port 6, Pharmoceuflcol and Medicina l
`Agents.
`
`Grofton D Chose, PhD / Phl!ocle/phia College of Pharmacy and Science-Emeritus Professor of
`Chemlslfy, Editor, Port 5, Radioisotopes Jr, Phormacy and Medicine. Author, Chapters
`02 ond 00.
`
`Aro l>erMorderoslan, PhD / Phlladelphla College of Phormocy and Science- Professor of
`Phormocognosy. P.esearch Professor In Medicinal Chemistry. Editor, Port 1.
`Orientation. Author, Chapters 64, 74 and 96.
`
`Siewort C Horvey, PhD/ University of Utah School of Medicine-Professor of Phormocology.
`Edltorlal Boord Member. Editor, Parr 6. Phormoce utlcal and Medic/no/ Agents.
`Author, Choplers 05. 08. 40, 40 to 47, 49, 61 ond 62. Coauthor. Chapters 36, 41 and
`50.
`
`Doniel A Hussor, PhD / Philadelphia College of Pharmacy and Scle11ce-J\emlng1on Professor of
`Pharmacy. Edltorlal Boord Member. Editor, Parr 9, Phormaceurlcal Practice. Author,
`Chapters 100 and 102.
`
`Thomo, Medwlck, Phi> / Rutgers University-Professor and Chairman, Deportment of
`Phormoceutlcol Chemistry. Editorial Doard member. Editor, Port 0. Pharmaceutlcol
`Chemistry, and Port 4, Testing and Ano/ysls. Coauthor, Chapter 26.
`
`Edword G P.lpple, Phi> / University of M/Mesota College of Pharmacy- Professor of
`Pharmaceutics, Editorial Doard Member. Editor, Part 2. Pharmaceutics. Au1hor.
`Chapter 12. Coauthor. Chapter 68.
`
`Joieph I) Schwartz, Phi) / Phlladelphfa College of Pharmacy and Science-Linwood Tice
`Professor of Pharmaceutics. Editorial Board Member. Editor, Part 8, Pharmaceutical
`Preparations and Their Manufaclure. Coauthor, Chapters 88 ond 89.
`
`Ewart A Swlnyord, PhD / University of Utah- Professor Emeritus of Pharmacology, College of
`Pharmacy and School of Medicine. Edltorlal Doord member. Editor, Port 6,
`PharmoceuflcoJ and Medicinal Agents. Author, Chapters 09, 42, 48, 53 to 60, 63, 65
`and 70. Coauthor. Chapter 66.
`
`Gilbert L Zink, Phi>/ Phlladelphla College of Pharmacy and Science-Associate Professor of
`Olology, Editor, Part 7, 0/ologlco/ Products. Author, Chapter 71.
`
`FRESENIUS EXHIBIT 1013
`Page 8 of 408
`
`

`

`Authors
`
`The following contributors to the Eightee nth Edition of Remington's Phormoce-urlcol Sciences
`served os authors or coauthors. a long w ith the editors and membe rs of the Editorlol Doord,
`of the 109 ch opters of t h is book.
`
`Hu med M Abdon, PhD / Vico President, Worldwide Pharmnceuti(cid:173)
`ca.l Tochnical Oporations, E R Squibb & Sons, Inc; Author of
`Chapter 30, lnstrum•mt<JI Methods of A11alysis and Chapter
`31, Dissolution.
`Auu B Amerson, PbarmD / P rofossor, College of P harmacy/Di(cid:173)
`rector, Dn1g lnformntion Center, Chandler Medical Ccmtm·,
`UnivC!rsity of Kentucky; Autho1· of Chapter 103, Clinical DruJJ
`l,iteratu.re.
`Howard CA ueol, PhD / P rofessor of Pharmacy and D ean, Cc>llcge
`of Phal'mncy, University of Gl.\orgia; Author of Chaptr.r 101,
`The Prescription.
`Ke11J1oth E Avis, DSo /l~meritus Profe~sor, Pharmaceutics, Col•
`lege of Pharmacy, University of T ennessee, Memphis; AutJwr
`of Chapter 84, Pare11temt Preparations.
`L eonard C Bailey, PhD / Associate Profossor of Phormaceuticat
`Ch~millf.ry, Rutgers University College of Pharmacy; Author of
`Chapter 29, C/iromat.ography .
`La\Vrence H Blo<.'-k, PhD / Profos$or of Phnrmat<"t1t.ic1;, n\1qnc,~nn
`UniverAity School of Pbnrm11cy; Authnr of Chopccr 87, Medi(cid:173)
`cated Applications.
`Joecph B Bog11rdu6, PhD/ 13osic Ph11rm11ceutics Rcscnrch, Bris ..
`tol-Mycrs Company; Conut.hor of Chopt.er 18, Reaction l{inet•
`ics.
`Sanford Bolton, PhD/ Chairman, Deportment of Pharmacy and
`Administrative Sciences, St John's University; Author of Chnp(cid:173)
`tcr 10, Swtist:ics.
`Jolin Bosso, Phar,uD / Professor of Clinical Pharmacy and Ad(cid:173)
`junct Professor of Pediot.rics, College of Ph11rm11cy 1111d School
`of Med icine, University of Utah; Coauthor of Chapter 34, Dis(cid:173)
`eases: Monifestations and Pat hophysiology.
`B Sue Dri1.uelo, MS/ Assi&tont Professor of Information Science,
`Heed of Public Service~, Joseph W England Library, Philodcl(cid:173)
`phi11 Coll ego of Pharm11cy and Science; Coauthor of Chapter 7,
`Dr ug lnformalicm .
`Da le B Christeu8cn, PhD / A~socintc Prolcssor, Department of
`Pharmacy Prncticc, Sch<>ol of Phormncy, University of W nsh•
`ingto11; Coouthor ofChllf)ter I.I, Computer Science.
`Sebnstiau G Cianc io, DDS / Professor and Chairn)llll, Deport(cid:173)
`ment of Periodontology, School of Den to.I M edicine, St.ate Uni•
`vereitv of New York at Buffolo; Author of Chapter 109, Dental
`Servi;es.
`Kenueth A Connors, PhD / Professor of Pharmaceutics, School of
`Pluumacy, Uni versity of Wisconsin; Author of Chapter 14,
`Comple.~ Formation.
`Antbony J Cutio, Ph D / ProflJllsor of Phormnccutic~, Arnold and
`Marie Schwart.z Coller:e of Pharmocy and Health Sciences,
`Long Island Uuiversity; Co11uthor of Chapter 92, A erosols.
`Ant)1ony R DiSnnto, PIID / Vice President, Drug Delivery Re(cid:173)
`scu ch 1111d Development, The Upjohn Company; Author of
`Chapter 76, Bioauailabt'.lity and Bioequiualenr.y Testing.
`Cla1·cnce A Discher,• PltD / Pi-ofessor E1neritua, Rutgers Univer(cid:173)
`sity; Author of Chapter 21, Inorganic Pliarmaceutical Chemis(cid:173)
`try.
`Clyde R Erskine, Jr, BSe /Vicc President, Corporate Quality
`Audits and Services, Smithl{line Beckman Corporation; Au(cid:173)
`tJ,or of Chapter 82, Quality Assurance and Control.
`LorrAinc D Evans, DS, H(ASCP) / Clinical Pathology, 13ristol(cid:173)
`Myers Company; Coauthor of Ch11pL~r 28, Clinical Analysis.
`William E Fnesctt, BS, MBA / Assist ant Professor, Depart.Mont of
`Pharmacy P1·actice, School of Pharmucy, University of Wnsh(cid:173)
`ingt.on; Coaut,hor of Clrnpt er 11, Computer .Sci encl'.
`Joseph L Ffok IIJ, DS(Pharm), JD/ Assistant Deau nnd P rofes(cid:173)
`sor, College of P harmacy, University of Kentueky; Coaut hor of
`Chapter 107, Laws Govemi11p, l'harmacy.
`
`Michno IR Fl·cmklin, l'J1D / Professor of Pharmncology, College of
`Ph11rmacy and School of Medicine, University of Utah; Author
`of Chapter 62, Enzymes.
`Rutn Frcimnnits, DS, RPh / Aij~ociatc Secretary, United Stlltc~
`Adopted N nmes Council; Co111.1t hor c,f Ch11J)ter 24, Dru,: No(cid:173)
`menclature- United Stute., Adopted Numl!.~.
`JnmCII W Fl'ceton, MD, PbD / Profes$or ond Chairman, Deplll't•
`men L of Medicine, Univarnity of Connecticut Health Center;
`Coauthor of Chapter 34, Diseases: Manifesta tionsandPatlio(cid:173)
`phy,iology.
`Rohol't L GiJOH, BA / Vice Prosident and Gc11ero l Mannr,<ir, Glmm
`Beall Engiueerillg Inc; Coauthor of Cheptc,· 80, Plc1.~tic Packac•
`ing Moteri'als.
`Hnrold N Godwin, MS / ProfeSlior and Director of Pharmacy, The
`University of I<11ns11s Mcclicnl Cent.er; Author of Cllll.ptc,r 94,
`l 11stit11tionlll Patient Care.
`Frederick J GolclHtoin, Pl1D / Professor of Phnrmucology, Philo(cid:173)
`dolphia Coiloi:e of Ph:mn:,cy and Science; Conuthor ofChnpt<!r
`69, Plw rmacological As peel& of Substa11ee Abuse.
`A Richard Goolkn11inu, BS, RPh / Dfrector of Alumni and Prof es•
`sionnl Affairs, MaSliachusctt.s College of Ph11r111acy and Allied
`Health Sciences; Author of Chapter 1, ScopP..
`Gei·a hi Hecht, PhD / Director Procc.>ss Development, Alcon Lab•
`oratorir-~; Conuthor of Chnpter 86, Ophthalmic Prr.pnrations.
`Judith A Hc1111, MS / Instructor in Information Sciencll, Coordina(cid:173)
`tor of Bibliographic Instruction, Joseph W England Lihrnry,
`Philadelphia College of Pharmacy ond Science; Coauthor of
`Chapter 7, Drue lnformc,tion.
`Grcgo1-y J Higby, PhD / Director, American Institute of the H isto(cid:173)
`ry of Phormucy, School of Phann11cy, University of Wisconsin(cid:173)
`Modison; Au thor ofChaptnr 2, Evolution of Pharmacy.
`Andrew S ICatocks, Jr, PhD / Senior Research P ht1rmHCOlogist,
`Amcricnn Cynnomid Company, Medico! Rascorch Division;
`Coa\lthor of Chapter 27, Diologicc,l 1'esti11g.
`Colvin H l{nowlton, MDiv, RPh / .Clinical Associate Profos.qor of
`Pharmacy, Philndelphia College o f P harmacy and Science; Au(cid:173)
`t.hor of Chnpt er ,t, The Pmctice of Community Pharmacy.
`Richard W l{nueppel, RPh / President, l(nueppel Horne Heall;h
`Core Center; Author of Chapter 101, liealth Acce.~sories.
`Hai-ry 13 Kostenboude r, PhD / Associate Dean for Research, Col(cid:173)
`lege of Phormecy, University of Kent uc ky; Coauthor of Chap•
`tcr 18, Renction l(in.etics.
`Uiohord L l{roncnthnl, PbD / Direct.or of l<eOOArch, l~thicon Inc;
`Author of Chapter 105, Surgicnl Supplies.
`A1·thur J Lo w1·cnce, PhD, RPh / Office of the Assistant Secretary
`of I·foolth, US Public lfonlth Service; Author of Chapter 6,
`Pharmacists in Govemment.
`Eric J Lien, PhD / Profo~sor of Pharmacy / Pharmaceutics and
`Biomedical Chemiatry, School of Pharmncy, University of
`Southern Californ ia; Author of Chnptcr 18, Molccufctr Struc(cid:173)
`ture, Properties and S t ates <>f Motter.
`Mark A l,o:ugcr, PhD / MCR Research Fellow, Department of
`Biologkol Scfonces, U11iversity of l{ecle; Coauthor of Chapter
`91 , Sustai11ed-llelease Dmg Delivery Systems-
`Werner Lowcuthol, PhD/ Professor of Pharmacy nnd Phorma(cid:173)
`coutics ond Profosaor of Educotionol Development and Plon(cid:173)
`ning, School of Ph11rmacy, Medical College of Virginia; Aut hor
`ofChapte1· 9, Metrology and Colculation.
`K1tren B Mnin, PhD / Physical Pharmacist, Phormaceuticol De(cid:173)
`velopment Department, ICJ PharmnccuLicnleGroup; Coauthor
`of Chapter 26, Analysis of Medici11als.
`Dunne D Miller, Phi) / Professor nnd Chairman, Division of Me(cid:173)
`dicinal Chemistry 1111d Phnrmacognosy, Coliogc of Phai-mncy,
`
`• DecC118etl
`
`X
`
`FRESENIUS EXHIBIT 1013
`Page 9 of 408
`
`

`

`Tho Ohio State University; Author of Chaptcl' 25, Structure(cid:173)
`Activity Relationship nml Vrug [)esi1111,
`Miduuil Mnntagnc, PhD / Associnte P rofessor of Phorm11cy Ad(cid:173)
`ministration, Phil11dclphin College of Pharmacy ond Science;
`Conut,hor of Chapter 3, Etlrics 11nd Author of Chapter 99, lll'li/1
`Education.
`,Yohu D Mullins, PhD/ Consultant; Conuthor of Chnpter 86, Opli•
`t.ha!mic Prepara t.ions.
`Mnvcn ,J Myers, Phi) / Profes:ior of Pharmacy Administ.ration,
`Philndclphia College of Pharmacy and Science; Coauthor of
`Chapter 3, Ethics.
`J G Nnirn, PhD/ Profossor of Phannncy, Faculty of Pharmacy,
`University of'J'oronl-0; Author of Chapter 83, S0l1ttion6, Emt,l•
`sions, Suspem1ions a11d l?,ctract6.
`Puul J NfobcJ.'gnll, PhD / Pmfessor of Pharmacouticol ond Sci(cid:173)
`ences/ Director, Pharmaceutical Dcvolopmeut Center, Medi(cid:173)
`cal University of South Cnrolinn; Author of Cha1>tcr 17, Ionic
`SolutWtM and Elactrolytic Equilibria.
`Rohcr t E O'Con11or, PhD / Merck Frosst Cnnada, Inc; Coauthor of
`Chapter 88, Pawders.
`Melnnlo O'Neill / Becton Dickinson & Com pony; Coauthor of
`Chapter 78, Sterilization,
`Richnrd W Pecina, PhD / Pre11idellt, Richard W Pecina & Asso(cid:173)
`r.iatea; Coauthor of Chnpter 80, Pla6tic Pachagi,11.1 Material,,.
`Gnrnot E Pock, PhD/ Professor of lndustriRI Phnrmacy / Director
`of the Industrial Pharmacy Lnhorutory, Purdue Univcrait.v;
`AutJ1or of Chapter '17, S1iparatitm.
`G Briggs Phillivs, PhD / Bocto11 Dickinson&, Company; C<>outhor
`of Chapter 78, Stcrilizntio11.
`Nicbohts G Popovich, PhD / Ail!!ociate Professor of Pharmncy
`Practice, School of Plu1rm11cy ond Pharmacal Sciences, Purdue
`University; Author of Chapte.i· 93, Ambulatory Patient Cnrll,
`Stunrt C Porter, PhD / Vice President, Rcseai-ch 1111d Develop•
`mcnt, Colorcon; Author of Chapte.r 90, Coating of Pharmoccu•
`tir.al Dosage Forms.
`Galon Jladebaugh, PhD / Director o{Phannaceutics, Parke-Dnvia
`P harmo,-eutical Research Division, Wnrner-Lnmberl Compa(cid:173)
`ny; Coauthor of Chnptcr 76, Pre/or111u.lation.
`Pnul L Rnnolli, PhD/ Assistant P rofe!l8or of Pharmacy Adminis(cid:173)
`trntfon, l'hilodelphin College o{ Phnrmocy and Science; Author
`of Chapter 98, Patient Communication.
`Louie J Ilnvi», PhD / Depertmontof Phorm11ceutics, Research 1111d
`Development, Smith Kline & French Labor11torfo11; Con11t.hor of
`Chapter 76, Prefomwlation.
`Jnek W Roicl1, PhD / Vice Pl'esident Regulatory Affairs, Gen11in
`Pharmaceuticals, Inc; Author of Chnpter 8, Research.
`Jaine& W Ric ha rd&, MBA / Professor of Pharmacy Ad rninistrn•
`tion, College of Pharmacy, Univeraity of Michigan; Author of
`Chapter 108. Community Pharmacy Economics and Manage•
`ment.
`Jack Robbins, PhD/ Direct.or, Pharmncy Affairs, Schering I,&h•
`oratories; Author of Cha11tcr 6, Opportunities for Pharmacists
`in the Pharmaceutical lnd1t6try.
`Joseph R Robinson, PhD/ Professor of Pharmacy, School of
`Pharmacy, llniveraity of Wisconsin; Coauthor of Chapter 91,
`Sustained-Release Drug l)clivcr.Y Syttl'ms.
`Frnnk Roin, PhD / Professor of Biology, Philadelphia College of
`Pharmacy end Science; Author of Chapter 72, Tmmuni:i:i11~
`A.cents and Diagnostic Shin Antigens.
`Douglus E Rollins, MD, PhD / Associate Pro!eS11or of Medicine
`and Pharmacology, School of Medicine end College of Ph(mna(cid:173)
`cy, University of Utah; Author of Chapter 37, Clinical Plw~ma(cid:173)
`coliinctics.
`G Victor RoHsi, PhD/ Victl Presidont of Academic Affairs/ Pro(cid:173)
`fessor of Plmrmocology, Philndolphia College of Pharmacy and
`Scionce; Coauthor of Chapter 27, Biolooical Testiric ond Coau(cid:173)
`thor of Chapter 69,
`Edwar<l lludnio, PhD/ Director, Fol'nrnlntion Devclopm<Jnt,
`Schllring l«:senrch; CoouthOI' of Cha1>tcr 89, Or(1/ Solid D1MC1fle
`Forms.
`Donnl<l O Sr.biffmon, PhD /Secrcuiry, United States AdoJ)t(ld
`
`Names Council; Coauthor of Chapter 24, Drnn Nome11cla•
`l1tre- United Stat.es Adapted. Name.<.
`llnne Schott, PhD / Profes.sor of Pharmaceutics and Colloid
`Chemistry, &:hool of Pharmncy, •rem pie University; Coauthor
`of Chapter 19, Disperse Syst.ems and Author of Chapter 20,
`Rheology.
`John J Sciarra, PhD / Presid1mi, lkt4il Dnir, InstitutCl / Professor
`of Ind ustrial Ph11rm11cy, Arnold and Marie Schwnrll'- College of
`Pl111r1nacy and Hcnlih Sciences, Long Island University; Coau••
`thor of Chapter 92, Aerosols.
`,Joh n H Shiukai, PhD / Emeritus ProfoBSor of Phnrmor.<?uticul
`Chemistry, Rutgers Univeuit.y, College of Pharmacy; Coauihm·
`<1f Chapter 22, Organic Pharmar.e11tic11i Chemfatry.
`E Richud Shough, PhD / As.~ociote D01111 and Professor, Univ,:,r.
`sity ofOklahomo HcQ(th Scienc.eaCenter, College of l'hnrme.cy;
`At1lhor of Chapter 73, Allergenic Ext.mets.
`Jtr-cdcrick P Siegel, PhD / J>rofC.<;Bor of Pharmnccutics, College of
`Pba.rmocy, Uni,•ereit.y of Illinois; Aut.hor of Choptcr '19, To11ici(cid:173)
`t)', Osmoticity, Osmo/ality and Osmolal'ity.
`Lorry M Silnonsmoior, BS(Pharm), JD / Associate Dean and
`Professor, College of Phormacy, Wnshington State Univcn,ity;
`Coauthor of Chapter 107. Laws Govemi1111 Ph(lrrnacy.
`ltobort D Smyth, PhD / Vier l' r(l~itlcnt, Ph€ll'lnnce11tic11l Develop(cid:173)
`ment, Bristol-Myers C<>mpany; CoRuthor of Chupter 28, Clini•
`col Analysis.
`1'homns C Snadcr, PhurmD / Consultant. Phnr1nocist; Author of
`Chapter 95, Long-1'arm Care Facilities.
`Theodore D Sokoloski, PhD / ProfCll~or of Phurmncy, College of
`Pharmacy, The Ohio Sit1te Univer$ity; Author of Chapter 16,
`Solut:ions and Phase Equilibria.
`Robert B Stewart, MS/ Professor ond Chnirmen, Deportment of
`P harmncy Practice, CollcBe of Phnrm11cy. University of Plori(cid:173)
`dn; Author of Chapter 6?, Adverse Drug Reactions.
`Jnmes S wa1·brick, DSc, PhD / Professor nnd Chairman, Division
`of Pharmaceutics, School of Phar1nocy, University of North
`Carolina nt Chapel Hill; Co11uthor of Chapter 19, Disperse
`Systems.
`Anthony R Temple, MD/ Dircc:tor, Hegulntory mid .Modicnl Af.
`fairs, McNeil Consumer Product:s Compnny / Adjunct As~o(cid:173)
`cint,Cl Profcs~or, Dopnrlment. of Pediatrics, University of Penn·
`sylv1111io School of Mediciuc / Lecturer, Philadelphia College of
`P harmacy and Science; Author of Chapter lOG, Pai8on Control.
`John P Tiechio, PhD / Principll! Scienti$L, lmmunohiology He(cid:173)
`search lnatituto; Author of Chnpter GB, Phcmnacogenetic.~.
`Sulvatore J Turco, PharmD / Professor of Pharmacy, Temple
`l111iversity School of P hurmucy; Auth<>r of Chapter 85,Jnt.raoe•
`nous Admi.xtures.
`Elizo.bot.h D Vndo&, PhD/ Merck Frosst Canada, Jnc; At1thor of
`Chuptcr 81, Stability CJ{ Pharmaceutical Proditcts.
`EmeBliuc Vandorvoen, PhD / Nntionol lnstitute on Drng Abuse,
`ADAMHA; Coauthor of Chnpl.er 61, Vitamins n11d Otlwr Nu(cid:173)
`trient:,,
`John E Virndcr vcen, PhD / Division of Nutrition, Food nnd Drug
`Admit1is l.rntion; Cont1thor of Ch11pter 51, Vitamins and Other
`Nutrient.~.
`Viucont S Venturella, PhD / Se<:t.ion Mauagcr, Pharmnce\lticnl
`Rescord1, Anoqucat, Div of BOC; Author of Chapter 23, Nntu(cid:173)
`ral Products.
`Albert. I Werthei1Ucr, PhD / Profc~sor and Diroctor, Dcp11rtmcnt
`of Graduate Studies in Socinl nnd Administrative Pharmacy,
`College of Phnrmacy, Univen;ily of Minncsotu; Author of
`Chapter 97, Tho Poticnt: Behaoiora/ Uctcm1inants.
`Timothy S Wicdmuun, PhD / Attsistont Professor, Collo~e of
`Pharmacy, University of Minnesota; Author of ChflJ>lcr 16,
`'l'lu:m11ody11amics.
`C Denn Withrow, Pl1D / AsROcinte PrnfeSRor of Phnrmacology,
`8chool of Medicine, Univcraity of Utah; Coauthor of Chapter
`36, Basic Phormacol,i11et.ics, Coimthor of Chapter 41, Catdio(cid:173)
`uasvu.lur Drugs ond Coauthor of Chapter 60, Jformo11es .
`George Zogrnfi, PhD/ Professor, School of Phnrmncy, University
`of Wisconsin; Coat1thor of ChnJ>te1· 19, Disperse Systems.
`
`xi
`
`FRESENIUS EXHIBIT 1013
`Page 10 of 408
`
`

`

`Pr•fac:e to the first Edition
`
`1'h(i rapid and substantial progress mnde in Pharmacy
`within the last decade has created a necessity for a work
`tl'cating of the imf>l'oved nppnrntus, the revised prnc:e:;ses,
`and the recently introduced 1>1·eparations of the age.
`The vast. ndvanc<~S m11de in theoretical and applied chem•
`istry aud physics have much t.o do with the develoJ)meut of
`1>harmaceutical science, and these have been reflected in all
`the revised editions of the Pharmacopoeias which have been
`recently published. When the autbor was elected in 1874 to
`the chair of Theory and Practice of Pharmacy in the P hila(cid:173)
`delphia College of Pharmacy, the outlines of study which
`had been so c/ll·cfully 1>rep11red for the classes by his eminent
`predcr.essora, Professor William Procter, Jr, and Professor
`gdward Porrish, were found to be uoi strictly in accord,
`either ht their 11rrongement. of the subjects or in thefr mclbod
`of trentment. Deiiiring to preserve t,he dist,inct.ivc char/lC:(cid:173)
`teristics of each, an effort was at. once made t.o frame a
`system which should embody the ir valuable foat:ures, cm(cid:173)
`brnc<i new subjects, and still retnin that harmony of plan and
`proper sequence which nrc absolutely t:ssent.inl U) t.he suc(cid:173)
`cess of 11ny system.
`The st.ricUy 11lph11betic11l clt1ssificntion of subjects which is
`now universally adopted by phartnocopoeias and dispensa-
`1.ories, although admirable in works of refel'ence, presents 011
`effectual stumbling block to the acquisition of pharmaceuti(cid:173)
`cal knowledge through systemntic study; the vru,t accumula(cid:173)
`tion of facts collected under each head being arranged lexi(cid:173)
`cally, they necessarily have no connection with one another,
`and thus the saving c>f Jnhor r.ffected by considel'ing similar
`groups toge.the1·, and tJie value of the associntion of kindred
`subjects, are lost to I.he student ln the method of grnuping
`the subjects which is herein adopted, the consta nt aim has
`been to arrange t he latt.er in such a manner that the render
`shall be gradually led from the considel'lltion of elementary
`subjects to those which involve more advanced knowledge,
`whilst the groups themselves are so placed as to follow one
`another in a natural sequence.
`The work is divided into s ix parts. Port I is devoted to
`detailed descriptions of apparatus and definitions and com(cid:173)
`ments on general pharmaceutical processes.
`The Official Prepnrot.ions alone arc considernd in Part IL
`Due weight and prominence are thus given to tlrn Pharmaco(cid:173)
`poeia, t.he National authority, which is now so thoroughly
`recognized.
`In order t.o suit the e<mvenience of pharmacists who prefer
`to weigh solids and measure liquids, the official formulas are
`expressed, in addition to purts by weight, in avoirdupois
`weight and opothecal'ies' measure. These equivalents are
`
`pl'int.ed in bold type near the margin, and arr11ngecl so as to
`fit them for quick and accurate reference.
`Part [II treats of Inorganic Chemical Substances. Prece(cid:173)
`dence is of course given to official preparation in these. 1'he
`descriptiom;, solubilities, and tests for identity and impuri(cid:173)
`ties of each substance arc 3ystmnatically tabulated under it:s
`proper title. It is confidently believed that by this method
`of arrangement the valuable descriptive features of the
`Pharmacopoeia will be more proinineuily developed, ready
`reference facilitated, nnd close study of the details rendered
`easy. Each chemical operation is nccompnnied by equa(cid:173)
`tions, whilst the reactio n is, in addition, cx1>lained in words.
`'l'he Carbon Compounds, or Organic Chemical Sub(cid:173)
`stances, are considered in Port JV. Thes(i are naturally
`grouped according to the physical and medical propert:ies of
`their principal cou5(.ituents, beginning wiLh simple bodies
`like cellulin, gum, etc, and progrnssing t:o the mos!. highly
`organized alkaloids, etc.
`Part V is de,•oted to Extemporaneous Pharmacy. Core
`has been talcen to treat. of the 1m1ctice which would be best
`adapted for t he needs of the many phat'mocists who conduct
`operations upon a moderate scale, rather than for those of
`the few who manage very large establishments. Jn this, as
`well as in other parts of the work, operations are i\lustrnted
`which nre conducted by mam1factul'i11g pharmncis~.
`Part VI contnins a formulary of Pharmaceutical Prepnra(cid:173)
`tions which hove 11ot bee11 recognized by the Pharmacopoeia.
`The recipes selected ore chiefly those which have been here(cid:173)
`tofore rather difficult of access to most pharmacists, yot such
`as are likely to he in request. Many private formulas are
`embraced in the collection; and such of the preparations of
`the old Pharmacopoeias ns have not been included in the
`new edition, but are still in use, have been inserted.
`In conclusion, the author ventures to exprnss the hope
`that the work will prove an efficient help to the pharmaceu(cid:173)
`tical student as well as to t.he pharmacist and ihe physician.
`Although the labor has been mainly performed amidst the
`harassing cares of active professional duties, and perfection
`is known to be unatiainnblc, no pains have been spal'cd to
`discover and correct errors and omissions in the text. The
`nuthor'a warmest acknowledgments, are tendered to Mr AB
`'I'aylor, Mr ,Joseph McCrecry, and Mr George M Smith for
`their valuable asi;istance in rnyising the proof sheets, and to
`the latter ei;pecially for his work 011 the index.
`'l'he outline
`illustrations, by Mr Jolm Collins, we1·c drawn either from t he
`actual o bjects or from photogra1>hs taken by the author.
`
`Philadelphia, Oct"ber, 1885
`
`xii
`
`FRESENIUS EXHIBIT 1013
`Page 11 of 408
`
`

`

`Preface to the Eighteenth Edition
`
`In anticipation of setting forth thi8 Prcfo.ce and prior to
`gathering thoughts on paper (or more accurately, lhe word
`processor!), t h is Edi1,c>1· paused t.o reread the preface to t-he
`first edition of Remington, published in 1885. Since it ap (cid:173)
`p0nrs on the pi-eceding page of this book it is recommended
`highly. The first pa1·agraph would he just as suitable today
`as penned by Pl'ofessor Remington 105 years ago.
`Each decade transcends the previous one and the pharma(cid:173)
`ceutical and health sciences are not laggards. Every revi•
`aion of Remington has encompassed new viewpoints, ideas,
`doctrines or prillciples which, perhaps, were inconceivable
`for the previous edition. It ie a tribute to the authors and
`editors that they have kept abreast of the burgeoning litera(cid:173)
`ture in their respective fields of expertise,
`Change not withstanding, the organfaation of this edit ion
`is similar to its immediate predecessors, being divided into 9
`Parts, each subdivided into several.chapters. Every chapter
`has berm culled, revised and rewritten to update the mRteriBI
`presented.
`Two new chapters are evident; Biotechnology and Drugs
`(Chapter 74) and Dmg J,;ducalion (Chapter 99).
`'Phree
`chapters of the previous edition, which embraced Inter/ acial
`arid Particle Phenomena and Colloida l and Coarse Dispcr(cid:173)
`-~ion.~ have been winnowed and combined int.o a single chap(cid:173)
`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(cid:173)
`tents of Part 6, Pharmaceutical and Medicinal Agents ond
`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 t he discussion of rudimentary concepts is beneficial,
`there has been a special effort to cross-reference and elimi(cid:173)
`nate unnecessary repetition. Space is at such a premium
`that it is hoped the reader wiil not be offended by being
`diverted to a different section of the text in order to obtain
`supplementary information.
`Photographs which depicted the typical "blacli box" have
`been eliminated almost completely and replaced by line
`drawings or schematic diagram1, which ore instructive rather
`than picturesque.
`Most of the drug monographs have been revamped not
`only as a means of updating, but to gain a degree of uniformi(cid:173)
`ty, All structural fol'mulas are now in thci standard USAN
`form. Duplication of chemical names haa been minimized
`and the inclusion of trade names increased, No attempt has
`been made to ferret. out every trade name by which a product
`is known, and only the most common are mentioned. The
`standard format for the major monographs is: Official
`Name, chemical name (CAS-inverted), trade name(s) and
`manufacturer(s), iJtJ·uctural formula, CAS (Chemical. Ab·
`stracts System) registry numher (in brackets), molecular
`formula and formula weight (in parenthesis). This is fol(cid:173)
`lowed by the method of preparation (or a reference if the
`method is lengthy), physical description, solubility, uses,
`dose and dosage form8.
`T he number of authors remains at 97, however, 3H new
`authors have joined as contributors to Remington. Aa the
`credentials of the new authors touch upon many areas of
`pharmacy, eve1·y section of the book has been invigorated by
`the incol'poration of updated and fresh concepts.
`
`As one pl'imnrily rcsponsihle fo1· the production of a com(cid:173)
`prehensive text devoted to the 1,1cience and p l'actice of phar•
`macy, the wisdom of Dr H:ric