Phrmaceutical glossary

1. Bracketing:isthe designof a stabilityschedulesuchthatonlysamplesonthe extremesof certaindesign
factors (e.g.,strength,containersizeand/orfill) are testedatall time pointsasina full design.
Bronchodilators:Drugsthatopenup the bronchial tubeswithinthe lungswhenthe tubeshave become
narrowedbymuscle spasm.Bronchodilators ease breathingindiseasessuchasasthma.
Brittleness:The extenttowhichamaterial will breakwithoutundergoingsignificantelasticorplastic
deformation.
BulkDensity:The massperunitvolume of a material underspecifiedconditionsof pressure.
BulkProduct: Anyproductwhichhas completedall processingstagesupto,butnot including,final
packaging.
Burstingstrength:Pressure atwhicha filmorsheet(ofpaperorplastic,forexample) will burst.
Calibration:The demonstrationthataparticularinstrumentordevice producesresultswithinspecified
limitsbycomparisonwiththose producedbyareference ortraceable standardoveranappropriate
range of measurements.
Cap: The upperpart of a two piece capsule.Itisslightlylargerindiameterandshorterthanthe body.
Caplet:A tablet shapedlike acapsule toease swallowing.
Capping:A faultin tabletmaking.Incappingthe topof the tabletseparatesfromthe restof the tablet.
Cappingmaybe apparentas the tabletisejectedfromthe die,oroccur at some subsequentstage in
tabletprocessing,forexample duringcoatingorfriabilitytesting,orat any othertime whenthe tabletis
stressed.
Chipping:‘Chipping’isdefinedasthe breakingof tabletedges,while the tabletleavesthe pressor
duringsubsequenthandlingandcoatingoperations.
Cleanarea(cleanroom):Anarea(orroom) withdefinedenvironmental control of particulate and
microbial contamination,constructedandusedinsucha wayas to reduce the introduction,generation
and retentionof contaminantswithinthe area.
CleanHoldTime:The time fromthe endof a cleaningprocessuntil the equipmentisusedagain.
Coating:The processof applyingacoat to a tabletor otherdosage form.
Containerclosure system:The sumof packagingcomponentsthattogethercontainandprotectthe
dosage form.Thisincludesprimarypackagingcomponentsandsecondarypackagingcomponents,if the
latterare intendedtoprovide additional protectiontothe drugproduct
Combinationproduct:A drugproductwhichcontainsmore than one drug substance.
Compression:The processof reducingthe bulkvolume of amaterial byapplyingexternal force.

2. Contamination:The undesiredintroductionof impuritiesof achemical ormicrobiological nature,orof
foreignmatter,intooronto a raw material,intermediate,orAPIduringproduction,sampling,packaging
or repackaging,storage ortransport.
Critical Area:Areawhere sterilizedproducts orcontainers/closures are exposedtothe environment(i.e
asepticpreparationandfilling).
D Value : Decimal reductionvalue(forbiological indicators).Thetime inminutesrequired tosecure
inactivationof 90% (one log) of the testorganismsunderstatedexposure conditions.
Decongestants:Drugsthatreduce swellingof the mucousmembranes,that line the nose bycontracting
bloodvessels,thusrelievingnasal stuffiness.
Desiccant:A highlyhygroscopicsubstance usedtoabsorbmoisture inbottles,vials,blistersandother
packing.
Depyrogenation:A processusedtodestroyor remove pyrogens.
Deviation:Departure fromanapprovedinstructionorestablishedstandard.
Die:A circularmachine tool witha central cavityinwhichpowdersorgranular solidsare compactedin
to tabletbetweenthe upperandlowerpunchesof atabletpress.
Diluent:A componentof atabletor capsule,usuallypresenttoaddbulkto the dosage form.The most
commonlyuseddiluentsinclude lactose,microcrystallinecellulose andnative orpregelatinisedstarches.
Dibasiccalciumphosphate andmannitol are alsoused.
DirectCompression:A meansof producingatabletwithoutgranulation.The active ingredientisblended
withexcipients,typicallyatleasta filler-binder,adisintegrantanda lubricantandthenthe blendis
compressedona tabletmachine.The filler-bindersare usuallyspecial gradesof excipients(forexample
spray driedlactose) exhibitinggoodflow andcompactionpropertiestoenablethe DCprocess.
DirtyHold time:The time fromthe endof product manufacturinguntil the beginningof the cleaning
process.
Disintegrant:Anexcipient thatfacilitatesthe disintegrationof atabletorotherdosage form incontact
withwateror gastro-intestinal fluid.Traditionallystarchwasused,butingeneral today’sformulations
utilise asocalledsuperdisintegrantsuchascroscarmellose sodiumorsodiumstarchglycolate.
Superdisintegrantsare typicallycross-linkedhydrophilicpolymersthatstronglyattractwater.The
presence of the crosslinksallowsswelling,butpreventsdissolutionof the polymerandgenerationof
highviscositygels.
Disintegration:The processbywhicha solidoral dosage formbreaksupin waterwhenmeasuredina
standardapparatus.

3. Dissolution:The processbywhichdrugdissolvesoutof adosage form andis made available for
absorptionfromthe gastro-intestinaltract. Invitromeasurementsare made ina range of apparatus
types.The requirementsfordifferenttypesof dosage formsare givenineachpharmacopoeia.
Diuretics:Drugsthat increase the quantityof urine producedbykidney.
Dosage form:A pharmaceutical producttype (e.g.,tablet,capsule,solution,cream) thatcontainsadrug
substance generally,butnotnecessarily,inassociationwithexcipients.
DOP Test:Dioctyl Phthalate testisatest whichusedtocheck the HEPA filterintegrity.
Drug product:The dosage forminthe final immediate packagingintendedformarketing.
Drug substance:The unformulateddrugsubstance thatmaysubsequentlybe formulatedwithexcipients
to produce the dosage form.
Dry granulation:A meansof granulation(size enlargement) of apowderusingacompactionstep
followedbymilling.The mostcommonmeansof drygranulationinpharmaceutical industryisroller
compaction,althoughthe olderprocessof sluggingisstillsometimesused.Anhydrouslactoseisthe
mostsuitable formof lactose forthese processesbecause ittendstoretaincompactabilityafterthe dry
granulationprocess.
Endotoxin:A pyrogen(eg:lipopolysaccharide)derivedfromthe cell wallof gramnegative bacteria.
Endotoxincanleadto reactionsinpatientsreceiving injectionsrangingfromfevertodeath.
EntericCoat: A delayedrelease coating,usuallydesignedtodelayrelease of the drugfromthe dosage
formuntil ithas reachedan area of the gastro-intestinal tractof a specifiedpH.Methacrylicacid
copolymersare verycommonlyused.
Excipient:A componentof adrug productotherthan the API,that isintentionallyaddedtothe dosage
formto enable processingintopatientfriendlymedicines,tocontrol the rate at whichthe APIdissolves
fromthe dosage form,toaid drug stabilityandotherreasons.Forsolidoral dosage forms,mainclasses
of excipientsinclude diluentsorfiller-binders,disintegrants,glidants,lubricants,coatingmaterials,and
stabilisingagents.
Exotoxin:Anexotoxinisatoxinsecretedbybacteria.Anexotoxincancause damage tothe host by
destroyingcellsordisruptingnormal cellularmetabolism.Theyare highlypotentandcancause major
damage to the host.Exotoxinsmaybe secreted,or,similar toendotoxins,maybe releasedduringlysisof
the cell.
Expectorant:Drugsthat stimulate the flow of salivaandpromotescoughingtoeliminatephlegmfrom
the respiratorytract.
Finishedproduct:Finishedproductisaproductthat has undergone all stagesof production,including
packaginginits final containerandlabelling.

4. FixedDose Combination(FDC):FixedDose Combinations(FDCs) refertoproductscontainingtwoor
more active ingredientsusedforaparticularindication(s).
Flashing:Small extrusionsthatappeararoundtabletperipherywhere the bandmeetsthe cups.It
usuallyflakesoff duringhandling,dedustingorcoating.
Fluid-beddryer(FBD):A device thatdriespowderusingmechanical force and/orairflow toevaluate and
aerate it,increasinginterstitialparticle spacing anddrivingoff moisture.
Fluidbedgranulation:The processof spraying solutionontoaeratedpowderstoformgranules.
Formulation:Aningredientormixture of specificingredients;thatis,drugsubstancesandexcipientsin
specificamounts,definingagivenproduct.
Friabilty:A measure of the resistance toabrasionandbreakage of tabletsduringastandardisedtest
involvingtumblingtabletsinarotatingdrum.Detailsof the equipmentandtestprotocol are foundin all
mainpharmacopoeia.A limitof notmore than 1% weightlossisgenerallytakentobe a satisfactory
measure of friability.
GenericDrug: A drug for whichthe patentsprotectingthe originatorproducthave expired(ormaybe
challenged).Genericproductsare pharmaceuticallyequivalenttoa reference listeddrug(same drug
substance,same route of administration,same dosage formandsame strengths) andare also
therapeuticallyequivalent(typicallybioequivalentfororal soliddosage forms).
Glidants:Glidantsare execipientsusedtopromote powderflowbyreducinginterparticle frictionand
cohesion.These are usedincombinationwithlubricantsastheyhave noabilitytoreduce die wall
friction(ex:talc).
Granulation:Granulationisthe processin whichprimarypowderparticlesare made toadhere toform
larger,multi particle entitiescalledgranules.Granulationprocessisaninevitablestepintablet
manufacturingasit improvesflow propertyandcompressibilityof powdermassintendedfor
compression.
Growth PromotionTest:Testperformedtodemonstratethe abilityof the microbial mediatosupport
microbial growth.
HEPA Filter:High efficiencyparticulate airfilterwithminimum0.3micronparticle retainingefficiencyof
99.97%.
Hygroscopicity:A material’sabilitytoabsorbmoisture fromitssurroundings.
ICH: International Conference onHarmonization.
Impurity: Anycomponentof the newdrugsubstance thatis notthe chemical entitydefinedasthe new
drug substance.

5. Laxatives:Laxatives(purgatives,aperients)are foods,compoundsand/ordrugsthatfacilitate orincrease
bowel movements.Theyare mostoftenusedtotreatconstipation.
LD50: The dose of a material whichresultsin50% mortalityinananimal test.
Lubricant:An excipientthatisusedintabletandcapsule formulationstoallow ejectionof the
compressedtabletfromthe die,orthe capsule plugfromthe dosator.Lubricantsalsoact as anti-
adherentstopreventstickingof the tablettothe tabletpunchesduringcompression .
Lyophilization:A processbywhichmaterial israpidlyfrozenanddehydratedunderhighvacuum.
Matrixing:The designof a stabilityschedule suchthata selectedsubsetof the total numberof possible
samplesforall factorcombinationsistestedata specifiedtime point.Atasubsequenttime point,
anothersubsetof samplesforall factorcombinationsistested.The designassumesthatthe stabilityof
each subsetof samplestestedrepresentsthe stabilityof all samplesata giventime point.The
differencesinthe samplesforthe same drugproductshouldbe identifiedas,forexample,covering
differentbatches,differentstrengths,differentsizesof the same containerclosure system, and,possibly
insome cases,differentcontainer closure systems.
Milling:The processof de-agglomeratingorreducingthe particle size of powdersmanuallyorby
machine.
ModifiedRelease:Dosage formswhosedrug-release characteristicsof time course and/orlocationare
chosento accomplishtherapeuticorconvenience objectivesnotofferedbyconventionaldosage forms
such as a solutionoran immediate releasedosage form.Modifiedrelease solidoral dosage forms
include bothdelayedandextendedreleasedrugproducts.
Mottling:‘Mottling’isthe term usedto describe anunequal distributionof colourona tablet,withlight
or dark spotsstandingoutin an otherwise uniformsurface.
Nonviable:A termusedinreference toparticulates,whichare notcapable of living,growingor
developingandfunctioningsuccessfully–“unable todivide”
Overage : Increasedcontentof drugsubstance,usuallydue tolossof potencyonstorage.
OverFill:Increasedvolume of drugproductto account forlossduringdelivery.
Overthe counterdrugs (OTC):A drug product that issafe and effective foruse withoutaprescription.
Pharmacopoea:Pharmacopoeiaisa bookor encyclopediaof DrugsStandards,theirformulas,Methods
for makingmedicinalpreparationsandotherrelatedinformation'swhichispublishedunderthe
jurisdictionof governmentbody.
Picking:A imperfectioncausedbypowdersstickingtoa punch surface duringtabletting.
Placebo:A productwhichstimulatesthe marketable productbuthasno active ingredientpresent.

6. PolymorphicForms: Differentcrystalline formsof the same drugsubstance.These caninclude hydration
products(alsoknownas pseudo-polymorphs) andamorphousforms.
Precision:The precisionof ananalytical procedure expressesthe closenessof agreement(degree of
scatter) betweenaseriesof measurementsobtainedfrommultiplesamplingof the same homogeneous
sample underthe prescribedconditions.Precisionmaybe consideredatthree levels:repeatability,
intermediate precisionandreproducibility.Precision shouldbe investigatedusinghomogeneous,
authenticsamples.
Probiotics:Probioticsare live microorganismsormicrobial mixturesadministeredtoimprove the
patient'smicrobial balance,particularlythe environmentof the gastrointestinal tractandthe
vagina.Probioticshave demonstratedanabilitytopreventandtreatsome infections.Probioticscanbe
bacteria,mouldsoryeast.Commonlyusedbacterial strainsare Lactobacillus&
Bifidobacterium.CommonlyusedyeaststrainisSaccharomycesboulardii.
Pyrogen:Substance whichinducesfebrilereactionsinapatient.
QualityAssurance (QA):The sumtotal of the organisedarrangementsmade withthe objectof ensuring
that all APIsare of the qualityrequiredfortheirintendeduse andthatqualitysystemsare maintained.
QualificationThreshold:A limitabove (>) whichanimpurityshouldbe qualified.
QualityRiskManagement:A systematicprocessforthe assessment,control,communication,andreview
of riskstothe qualityof the drugproduct across the productlifecycle.
QualitySystem:The sumof all aspectsof a systemthatimplementsqualitypolicyandensuresthat
qualityobjectivesare met.
Raw Material:A general termusedtodenote startingmaterials,reagents,andsolventsintendedforuse
inthe productionof intermediatesorAPIs.
Relative humidity:The ratioof the actual watervapour pressure of the airto the saturatedwater
vapourpressure of the air at the same temperature expressedasapercentage.More simplyput,itis
the ratio of the massof moisture inthe air,relative tothe massat 100% moisture saturation,ata given
temperature.
Saturatedsteam:Steamwhose temperature,atanygivenpressure,correspondstothatof the
vaporisationcurve of water.
Screening:The processof reducingagglomerates,sortingparticlesbysize andremovingoversized
particlesandcontaminantsusingawovenmetal screenorperforatedplate.
Semi-permeablecontainers:Containersthatallow the passage of solvent,usuallywater,while
preventingsolute loss.Examplesof semi-permeablecontainersincludeplasticbagsandsemi-rigid,low-
densitypolyethylene (LDPE) pouchesforlarge volume parenterals(LVPs),andLDPEampoules,bottles,
and vials.

7. Shelf life :The time periodduringwhichadrug productis expectedtoremainwithinthe approvedshelf
life specification,providedthatitisstoredunderthe conditionsdefinedonthe containerlabel.
Slugging:A formof drygranulation,somewhatsimilartorollercompaction. Inslugginghowevera
powderblendisfirstcompressedona tabletmachine andthe resulting,usuallylarge,tablets(slugs) are
milled,optionallyreblendedwithmore excipients,andrecompressedintotablets.Alternativelythe
milledslugsare sometimes filledintocapsules.
Specification:A listof tests,referencestoanalytical procedures,andappropriate acceptance criteria
whichare numerical limits,ranges,orothercriteriaforthe testsdescribed.Itestablishesthe setof
criteriato whicha drug substance ordrug productshouldconformto be consideredacceptableforits
intendeduse.
Specificity:Specificityisthe abilitytoassessunequivocallythe analyteinthe presence of components
whichmay be expectedtobe present.
Identification: to ensure the identityof ananalyte.
PurityTests: to ensure thatall the analytical proceduresperformedallow an accurate
statementof the contentof impuritiesof ananalyte,i.e.relatedsubstancestest,heavymetals,residual
solventscontent,etc.
Assay(contentorpotency):toprovide anexactresultwhichallowsanaccurate statement onthe
contentor potencyof the analyte ina sample.
Spore:A bacterial formhighlyresistanttoadverse conditions.
Stability:Abilityof amaterial tomaintaina statedpropertyvalue withinspecifiedlimitsforaspecified
periodof time,whenstoredunderspecifiedconditions.
Standardoperatingprocedure (SOP) :Anauthorizedwrittenprocedure,givinginstructionsfor
performingoperations,notnecessarilyspecifictoagivenproductor material,butof a more general
nature,(e.g.equipmentoperation,maintenance andcleaning,validation,cleaningof premisesand
environmental control,samplingandinspection).
Sterile:Free of anyviable organisms(Absence of life).
Sterilization:A processusedtorenderaproduct free of viable organismswithaspecifiedprobability.
Supplement:A supplementisanapplicationtoallow acompanytomake changesin a productthat
alreadyhasan approvednewdrug application(NDA)
Surfactant:A substance thatdecreasesthe surface tensionof aliquid.
Sustainedrelease:A methodof drugdeliverybywhichAPIreleaseoccursoveranextendedperiodafter
administration.The methodreducesdosingfrequencycomparedtoatraditional methodsuchas
immediate release.

8. Teratogenicity:The occurrence of structural malformationsinadevelopingfoetuswhenasubstance is
administeredduringpregnancy.
Tincture:A medicine consistingof anextractinalcohol solution.
Twininng:The bondingof tabletswithlarge,flatsurfacesduringthe coatingprocess.
Uniformityof dosage Forms:A measure of the degree of uniformityof the amountof active substance in
individualdosage units(forexample individualtabletsorcapsules).Foruncoatedtablets,filmcoated
tabletsandhard capsulescontainingatleast25mg of drug substance andthe drug substance isat least
25% of the dosage form,thenvariationinweightmaybe usedas a measure of uniformity.
Validation:A documentedprogramthatprovidesahighdegree of assurance thata specificprocess,
method,orsystemwill consistentlyproduce aresultmeetingpre-determinedacceptance criteria.
ValidationMasterPlan(VMP) - Validationmasterplanisahigh-leveldocumentwhichestablishesan
umbrellavalidationplanforthe entire project,andisusedasguidance bythe projectteamforresource
and technical planning
Viable:Capable of living
Viscosity:The measurementof a materialsresistance toflow.
Water forInjection(WFI):Water,whichisintendedforuse inthe preparationsof parenteral
solutions.WFIisproducedbydistillationora purificationprocessthatisequivalentorsuperiorto
distillationinthe removal of chemicalsandmicroorganisms.
Wet Granulation:A meansof granulationof powdersusingwaterorotherliquidtoagglomerate
powdersintogranules,anddryingthe granules.The processfixesAPIandexcipientsintoagranular
formthat helpstopreventsegregationof the components,thataidsflow of there powders,andallows
the incorporationof binderstoimprove compactability.
Yield, Expected:The quantityof material orthe percentage of theoretical yieldanticipatedatany
appropriate phase of productionbasedonpreviouslaboratory,pilotscale,ormanufacturingdata.
Yield,Theoretical:The quantitythatwouldbe producedatanyappropriate phase of production,based
uponthe quantityof material tobe used,inthe absence of anylossor error in actual production.
Z- Value:The numberof degreesof temperature change necessarytochange the D-value byfactorof
10.