Topical Antimicrobials Industrial Applications in Consumer Products and Pharmaceuticals

434 Pages·2002·15.82 MB·English

by  Daryl S. Paulson

h a n d b o o k
o f t o p i c a l
a n t i m i c r o b i a l s
industrial applications
in consumer products
and pharmaceuticals
edited by
daryl s. paulson
BioScience Laboratories, Inc.
Bozeman, Montana, U.S.A.
Copyright 2003 by Marcel Dekker, Inc. All Rights Reserved.
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Copyright 2003 by Marcel Dekker, Inc. All Rights Reserved.
Preface
Over the years, topical antimicrobials have become commonly used to help re-
ducetheriskofinfectiousdisease.FromthehumblebeginningsofSemmelweis,
who showed that surgically associated infection could be significantly reduced
bysimplywashingone’shands,tothefastmicrobialkillsandlong-lastingeffects
ofcurrenttopicalantimicrobialproducts,theindustryhasprogressed.Thus,this
text should be viewed as a contribution to an ongoing effort.
The book has several parts. The first consists of three overviews of the
topicalantimicrobialindustry.Theseincludea philosophicalview fromtheedi-
tor, the perspectives of a Food and Drug Administration (FDA) officer, and a
discussion of healthcare industry regulations. Part II is devoted to describing
aspects of the specific antimicrobial compounds used as active drugs in topical
antimicrobial products. Thethird part addresses variousmedical applications of
antimicrobial formulations used as healthcare personnel handwashes, surgical
washes/scrubs,andpreoperativeskinpreparations,aswellasseveralnovelareas
ofapplication.Thefourthpart presentsdiscussionsofconcernsfacedbytopical
antimicrobial suppliers in assuring that the role of food handlers in infectious
disease transmission is reduced. Finally, Part V addresses specific testing con-
cerns, test methods,andthe appropriatenessof using certaintest methods toas-
sess the value of specific products.
Thisbookhastakenseveralyearstoproduce,andIthankthecontributing
authorsfortheirdedication,professionalism,andpersistenceinwritingtheirvari-
ouschapters.Idedicateittothefollowingscientistswhohavebeeninstrumental
in forming my views, and who have been guiding lights along the way. Carl
Bruch,Ph.D.,wasmymentoratSkylandScientificServices.ElaineLarson,R.N.,
Ph.D.,hasbeenaninspirationtomesincethebeginningofmycareerintheearly
Copyright 2003 by Marcel Dekker, Inc. All Rights Reserved.
iv Preface
1980s. Mary Bruch and Arthur Peterson, Ph.D., the creative minds behind the
‘‘glove juice’’ procedure used in surgical scrub and healthcare personnel hand-
wash evaluations,weremymotivationtoenterthis fieldand ultimatelylinkmi-
crobiologywithbiostatistics.Finally,AlbertSheldon,Ph.D.,hasalwaysbeenan
inspirationtomeinhisdiligencetoensurethatbusinessinterestsdonotoverride
good science.
I have been influenced by each of the chapter authors in this book and
appreciatetheircontributiontothefield.IamindebtedtothestaffatBioScience
Laboratories,Inc.,forkeepingthingsrunningasIwroteandcollectedthechap-
ters.IamparticularlyindebtedtoJohnMitchell,Ph.D.,forhishelpinassembling
thisbook.Additionally,IoweadebtofgratitudetoMs.TammyAnderson,who
providedvaluableassistanceinassemblingandretypingeverychapterforformat-
tingandediting.IalsothankthestaffatMarcelDekker,Inc.,particularlyMaria
Allegra and Brian Black.
Daryl S. Paulson
Copyright 2003 by Marcel Dekker, Inc. All Rights Reserved.
Contents
Preface
Contributors
Part 1 Overview
1 Introduction to Topical Antimicrobials and Their Applications
Daryl S. Paulson
2 Food and Drug Administration Perspective on Topical Antiseptic
Drug Product Development
Albert T. Sheldon, Jr.
3 Healthcare Continuum: A Model for the Classification and
Regulation of Topical Antimicrobial Products
George E. Fischler, Marc Shaffer, and Rhonda D. Jones
Part II Topical Antimicrobials
4 Clinical Applications of Povidone-Iodine as a Topical
Antimicrobial
Steven Ripa, Nancy Bruno, Robert F. Reder, Renate Casillis,
and Robert I. Roth
5 Quaternary Ammonium Compounds
Edward B. Walker
Copyright 2003 by Marcel Dekker, Inc. All Rights Reserved.
vi Contents
6 Chlorhexidine Gluconate
Daryl S. Paulson
7 Alcohols
Daryl S. Paulson
Part III Product Applications
8 Microorganisms and Disease
Daryl S. Paulson
9 Nosocomial Infection
Daryl S. Paulson
10 Postsurgery Infection
Daryl S. Paulson
11 Antimicrobial Body Washes
David W. Hobson and Lawton Anthony Seal
12 Some Aspects of Human Disease and Staphylococcus Species
Daryl S. Paulson
13 Full-Body Shower Wash: Efficacy Evaluation of a 4%
Chlorhexidine Gluconate
Daryl S. Paulson
14 Surgical Preparation and Site Access: Testing’s Stepchild
Mary Bruch
15 Brushless Surgical Scrubbing and Handwashing
David W. Hobson and Lawton Anthony Seal
16 Fundamental Steps in Designing a Healthcare Personnel
Handwash
Daryl S. Paulson
Part IV Food
17 Handwashing, Gloving, and Disease Transmission by the Food
Preparer
Daryl S. Paulson
18 Handwashing and Gloving for Food Protection: Examination of
the Evidence
Eleanor J. Fendler, Michael J. Dolan, and Ronald A. Williams
Copyright 2003 by Marcel Dekker, Inc. All Rights Reserved.
Contents vii
19 Handwashing and Gloving for Food Protection: Effectiveness
Eleanor J. Fendler, Michael J. Dolan, Ronald A. Williams,
Daryl S. Paulson
20 A Suggested Method for Evaluating Foodhandler/Processor
Handwash Formulations
Daryl S. Paulson
Part V Consumer Products
21 Appropriateness of the Healthcare Personnel Handwash Test in
Assessing Efficacy of Consumer Handwashing Products
Bruce H. Keswick, Kathy F. Wiandt, and Ward L. Billhimer
22 Development of Methods to Evaluate Efficacy of Handwashing
Products for Consumers
Bruce H. Keswick, Kathy F. Wiandt, and Ward L. Billhimer
23 Importance of Skin Care Attributes in Developing Topical
Antimicrobials
Daryl S. Paulson
Part VI Testing Methods
24 A Guide for Validation of Neutralizer Systems Used in Topical
Antimicrobial Efficacy Evaluations
Christopher M. Beausoleil
25 Testing Methodology of Preoperative Skin Preparation and
Surgical Scrub as Over-the-Counter Drugs
David K. Jeng
26 Skin Sampling Techniques
Barry Michaels
27 The Need and Methods for Assessing the Activity of Topical
Agents Against Viruses
Shamim A. Ansari and Syed A. Sattar
Copyright 2003 by Marcel Dekker, Inc. All Rights Reserved.
Contributors
Shamin A. Ansari Colgate-Palmolive Company, Piscataway, New Jersey,
U.S.A.
Christopher M. Beausoleil BioScience Laboratories, Inc., Bozeman, Mon-
tana, U.S.A.
WardL.Billhimer TheProcter&GambleCompany,Cincinnati,Ohio,U.S.A.
Mary Bruch Micro-Reg, Inc., Hamilton, Virginia, U.S.A.
Nancy Bruno Purdue Pharma, Stamford, Connecticut, U.S.A.
Renate Cassillis Purdue Pharma, Stamford, Connecticut, U.S.A.
Michael J. Dolan GoJo Industries, Akron, Ohio, U.S.A.
Eleanor J. Fendler GoJo Industries, Akron, Ohio, U.S.A.
George E. Fischler The Dial Corporation, Scottsdale, Arizona, U.S.A.
DavidW.Hobson,Ph.D. ChrysalisBiotechnology,Inc.,SanAntonio,Texas,
U.S.A.
David K. Jeng, Sc.D. Allegiance Healthcare Corporation, A Cardinal Health
Company, McGraw Park, Illinois, U.S.A.
Copyright 2003 by Marcel Dekker, Inc. All Rights Reserved.
x Contributors
Rhonda D. Jones Scientific & Regulatory Consultants, Inc., Columbia, Indi-
ana, U.S.A.
BruceH.Keswick TheProcter&GambleCompany,Cincinnati,Ohio,U.S.A.
Barry Michaels Georgia-Pacific Corporation, Palatka, Florida, U.S.A.
Daryl S. Paulson, Ph.D. BioScience Laboratories, Inc., Bozeman, Montana,
U.S.A.
Robert F. Reder Purdue Pharma, Stamford, Connecticut, U.S.A.
Steven Ripa Purdue Pharma, Stamford, Connecticut, U.S.A.
Robert I. Roth The Weinberg Group, Inc., Washington, D.C., U.S.A.
Syed A. Sattar University of Ottawa, Ottawa, Canada
Lawton Anthony Seal, Ph.D. Healthpoint, Ltd., San Antonio, Texas, U.S.A.
Marc Shaffer Clinical Research Laboratories, Inc., Piscataway, New Jersey,
U.S.A.
Albert T. Sheldon, Jr., Ph.D. Food and Drug Administration, Rockville,
Maryland, U.S.A.
Edward B. Walker, Ph.D. Weber State University, Ogden, Utah, U.S.A.
KathyF.Wiandt TheProcter&Gamble Company,Cincinnati,Ohio, U.S.A.
Ronald A. Williams GoJo Industries, Akron, Ohio, U.S.A.
Copyright 2003 by Marcel Dekker, Inc. All Rights Reserved.
1
Introduction to Topical
Antimicrobials and Their
Applications
Daryl S. Paulson
BioScience Laboratories,Inc.,Bozeman,Montana
I. DEVELOPING EFFECTIVE TOPICAL ANTIMICROBIALS
The intenselevelsofcompetition presentinthetopicalantimicrobialmarket, as
wellastheever-tighteningU.S.FoodandDrugAdministration’s(FDA)product
performance standards, demand that antimicrobial manufacturers produce prod-
uctsthatmeetmarketrequirements[1].Presentmarketrequirementsarenotjust
antimicrobial effectiveness; they also include low skin irritation potential, ease
of use, aesthetically pleasing, and various other ‘‘soft’’ attributes. If these have
beenaddressed, theproductmore than likelyhasbeendeveloped withadequate
care.Buttoooftenmanufacturersignoreimportantfactorsandmerelygetaprod-
uct to market to compete with those of competitors. In the end, this approach
oftenfails;theproductneverreallyisacceptedinthemarket[2].Becausethegoal
istointroduceproductsintothemarketthatwillbesuccessful,manufacturersare
urged to develop products from a multidimensional perspective. At least four
factors should be addressed: societal, cultural, personal objective, and personal
subjective to address human requirements. Let us look at this multidimensional
perspective in greater detail.
A. Societal Requirements
Societal requirementsinclude conforming to regulating agencies standards such
astheFDA,theFederalTradeCommission(FTC),andtheEnvironmentalProtec-
Copyright 2003 by Marcel Dekker, Inc. All Rights Reserved.