Sarfaraz K. Niazi - Handbook of Pharmaceutical Manufacturing Formulations Series, Second Edition, Volume 5_ Over-the-Counter Products (2009).pdf

1、S a r f a r a z K.N i a z iPharmaceutical Scientist,Inc.Deerfield,Illinois,USAV O L U M E F I V ESecond EditionHandbook of Pharmaceutical Manufacturing FormulationsOver-the-Counter ProductsNiazi_978-1420081282_TP.indd 25/27/09 4:31:11 PMSPHSPHIHBK039-fmIHBK039-Niazi-FMMay 27,20090:25Char Count=Handb

2、ook ofPharmaceutical Manufacturing FormulationsSecond EditionVolume SeriesSarfaraz K.NiaziVolume 1Handbook of Pharmaceutical Manufacturing Formulations:Compressed Solid ProductsVolume 2Handbook of Pharmaceutical Manufacturing Formulations:Uncompressed Solid ProductsVolume 3Handbook of Pharmaceutical

3、 Manufacturing Formulations:Liquid ProductsVolume 4Handbook of Pharmaceutical Manufacturing Formulations:Semisolid ProductsVolume 5Handbook of Pharmaceutical Manufacturing Formulations:Over-the-Counter ProductsVolume 6Handbook of Pharmaceutical Manufacturing Formulations:Sterile ProductsSPHSPHIHBK03

4、9-fmIHBK039-Niazi-FMMay 27,20090:25Char Count=Informa Healthcare USA,Inc.52 Vanderbilt AvenueNew York,NY 10017C?2009 by Informa Healthcare USA,Inc.Informa Healthcare is an Informa businessNo claim to original U.S.Government worksPrinted in the United States of America on acid-free paper10 9 8 7 6 5

5、4 3 2 1International Standard Book Number-10:1-4200-8116-0(Volume 1;Hardcover)International Standard Book Number-13:978-1-4200-8116-9(Volume 1:Hardcover)International Standard Book Number-10:1-4200-8118-7(Volume 2;Hardcover)International Standard Book Number-13:978-1-4200-8118-3(Volume 2;Hardcover)I

6、nternational Standard Book Number-10:1-4200-8123-3(Volume 3;Hardcover)International Standard Book Number-13:978-1-4200-8123-7(Volume 3;Hardcover)International Standard Book Number-10:1-4200-8126-8(Volume 4;Hardcover)International Standard Book Number-13:978-1-4200-8126-8(Volume 4;Hardcover)Internati

7、onal Standard Book Number-10:1-4200-8128-4(Volume 5;Hardcover)International Standard Book Number-13:978-1-4200-8128-2(Volume 5;Hardcover)International Standard Book Number-10:1-4200-8130-6(Volume 6;Hardcover)International Standard Book Number-13:978-1-4200-8130-5(Volume 6;Hardcover)This book contain

8、s information obtained from authentic and highly regarded sources.Reprinted ma-terial is quoted with permission,and sources are indicated.A wide variety of references are listed.Reasonable efforts have been made to publish reliable data and information,but the author and thepublisher cannot assume r

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10、n storage or retrieval system,without written permission from thepublishers.For permission to photocopy or use material electronically from this work,please (http:/ contact the Copyright Clearance Center,Inc.(CCC)222 Rosewood Drive,Danvers,MA 01923,978-750-8400.CCC is a not-for-profit organizationth

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12、n and explanation without intent to infringe.Library of Congress Cataloging-in-Publication DataNiazi,Sarfaraz,1949Handbook of pharmaceutical manufacturing formulations/Sarfaraz K.Niazi.2nd ed.p.;cm.Includes bibliographical references and index.ISBN-13:978-1-4200-8106-0(set)(hardcover:alk.paper)ISBN-

13、10:1-4200-8106-3(set)(hardcover:alk.paper)ISBN-13:978-1-4200-8116-9(v.1)(hardcover:alk.paper)ISBN-10:1-4200-8116-0(v.1)(hardcover:alk.paper)etc.1.DrugsDosage formsHandbooks,manuals,etc.I.Title.DNLM:1.Drug CompoundingHandbooks.2.Dosage FormsHandbooks.3.Formularies as TopicHandbooks.4.Technology,Pharm

14、aceuticalHandbooks.QV 735 N577h 2009RS200.N53 2009615?.19dc222009009979For Corporate Sales and Reprint Permission call 212-520-2700 or write to:Sales Department,52 Vanderbilt Avenue,16th floor,New York,NY 10017.Visit the Informa Web site and the Informa Healthcare Web site SPHSPHIHBK039-fmIHBK039-Ni

15、azi-FMMay 27,20090:25Char Count=to the memory of Dean Allen I.WhiteSPHSPHIHBK039-fmIHBK039-Niazi-FMMay 27,20090:25Char Count=Preface to the SeriesSecond EditionThe science and the art of pharmaceutical formulation keepsevolving as new materials,methods,and machines becomereadilyavailabletoproducemor

16、ereliable,stable,andrelease-controlled formulations.At the same time,globalization ofsourcing of raw and finished pharmaceuticals brings chal-lenges to regulatory authorities and results in more frequentrevisions to the current good manufacturing practices,regu-latory approval dossier requirements,a

17、nd the growing needfor cost optimization.Since the publication of the first editionof this book,a lot has changed in all of these areas of impor-tance to pharmaceutical manufacturers.The second editionbuilds on the dynamic nature of the science and art of for-mulations and provides an evermore usefu

18、l handbook thatshould be highly welcomed by the industry,the regulatoryauthorities,as well as the teaching institutions.The first edition of this book was a great success as itbrought under one umbrella the myriad of choices availableto formulators.The readers were very responsive and com-municatedw

19、ithmefrequentlypointingouttotheweaknessesaswellasthestrengthsofthebook.Thesecondeditiontotallyrevised attempts to achieve these by making major changesto the text,some of which include:1.Complete,revised errors corrected and subject matterreorganized for easy reference.Whereas this series hassix vol

20、umes differentiated on the basis of the type ofdosage form and a separate inclusion of the U.S.OTCproducts,ideally the entire collection is needed to ben-efit from the myriad of topics relating to formulations,regulatory compliance,and dossier preparation.2.Total number of pages is increased from 16

21、84 to 2726.3.Total number of formulations is expanded by about 30%with many newly approved formulations.4.Novel formulations are now provided for a variety ofdrugs;these data are collected from the massive intellec-tual property data and suggest toward the future trendof formulations.While some of t

22、hese formulations maynot have been approved in the United States or Europe,these do provide additional choices,particularly for theNDA preparation.As always,it is the responsibility ofthe manufacturer to assure that the intellectual propertyrights are not violated.5.A significant change in this edit

23、ion is the inclusion ofcommercial products;while most of this informationis culled out from the open source such as the FOIA(http:/www.fda.gov/foi/default.htm),I have made at-tempts to reconstruct the critical portions of it basedon what I call the generally acceptable standards.Thedrug companies ar

24、e advised to assure that any intellec-tual property rights are not violated and this applies toall information contained in this book.The freedom ofinformation act(FOIA)is an extremely useful conduitfor reliable information and manufacturers are stronglyurged to make use of this information.Whereas

25、this in-formation is provided free of charge,the process of ob-taining the information may be cumbersome,in whichcase,commercial sources of these databases can proveuseful,particularly for the non-U.S.companies.6.Also included are the new Good Manufacturing Guide-lines(2007)withamendments(2008)forth

26、eUnitedStatesand similar updates for European Union and WHO;it isstrongly urged that the companies discontinue using allold documents as there are significant changes in the re-vised form,and many of them are likely to reduce thecost of GMP compliance.7.Details on design of clean rooms is a new entr

27、y that willbe of great use to sterile product manufacturers;whereasthe design and flow of personnel and material flow is ofcritical nature,regulatory agencies view these differentlyand the manufacturer is advised always to comply withmost stringent requirements.8.Addition of a self-auditing template

28、 in each volume ofthe series.While the cGMP compliance is a complex is-sueandtherequirementsdiversifiedacrosstheglobe,thebasic compliance remains universal.I have chosen theEuropean Union guidelines(as these are more in tunewith the ICH)to prepare a self-audit module that I rec-ommend that every man

29、ufacturer adopt as a routine toassure GMP compliance.In most instances reading thetemplate by those responsible for compliance with keepthem sensitive to the needs of GMP.9.OTC products cross-referenced in other volumes whereappropriate.This was necessary since the regulatory au-thorities worldwide

30、define this class of drug differently.It is important to iterate that regardless of the prescrip-tion or the OTC status of a product,the requirements forcompliance with the cGMP apply equally.10.OTCmonographstatusisanewsectionaddedtotheOTCvolumeandthisshouldallowmanufacturerstochoseap-propriate form

31、ulations that may not require a filing withthe regulatory agencies;it is important to iterate that anapproved OTC monograph includes details of formula-tionincludingthetypesandquantitiesofactivedrugandexcipients,labeling,and presentation.To qualify the ex-emption,the manufacturer must comply with th

32、e mono-graph in its entirety.However,subtle modifications thatare merely cosmetic in nature and where there is an evi-dence that the modification will not affect the safety andefficacy of the products can be made but require priorapproval of the regulatory agencies and generally theseapprovals are g

33、ranted.11.Expanded discussion on critical factors in the manufac-turing of formulations provided;from basic shortcutsto smart modifications now extend to all dosage forms.Pharmaceutical compounding is one of the oldest pro-fessions and whereas the art of formulations has beenvSPHSPHIHBK039-fmIHBK039-Niazi-FMMay 27,20090:25Char Count=viPreface to the SeriesSecond Editionrelegated to more objective