Pediatric Liquid Medicaments

Cariogenic Potential of Pediatric Liquid Medicaments

An in vitro Study
SubramaniamP*/NandanN**

Pediatric liquid medicaments (PLM) are popular and are easily accepted by both parents and children. They
are widely prescribed and easily available. However the sugar content and properties of these preparations
determines their cariogenic potential. Aims and Objectives: This study assessed the pH and viscosity of
pediatric liquid medicaments, type and concentration of sugars present in them and their effect on the
growth of Streptococcus mutans. Methodology: PLM included two each of the most commonly prescribed
analgesics, antibiotics, nutritional supplements, antitussive and antiepileptic preparations. The endogenous
pH was measured using a digital pH meter and the viscosity was measured using a digital Brookefield vis-
cometer. Analysis of sugars (sucrose, glucose and sorbitol) was performed using High Performance Liquid
Chromatography. The effect of PLM on Streptococcus mutans was done by ditch plate method. Results: The
pH of PLM ranged from 3.70 to 7.04 and viscosity varied from 307.33cP to 2408.33cP. Fifty percent of the
PLM contained sucrose, glucose and sorbitol, and sucrose was present in nine of the PLM. The antibiotic
preparations showed zones of inhibition against growth of streptococcus mutans. Conclusions: The physi-
cal properties of Pediatric Liquid Medicaments as well as the type and concentration of sugars present in
them can be indicative of their cariogenic potential.
Keywords: pediatric liquid medicaments, cariogenic, pH, viscosity, sucrose, streptococcus mutans.
JClinPediatrDent36(3):357362,2012

INTRODUCTION Although, the active ingredients in these medicines are

S
ystemic administration of drugs include oral, sublin-
gual,rectal,cutaneous,inhalation,nasalandparental
routes.Amongtheseroutes,theoralrouteistheoldest
and the most common mode of drug administration.
Pediatric liquid preparations are popular and are easily
acceptedbybothparentsandchildren.Syrupshavealong
history of use in pediatric medicine. They are widely
prescribed,andareeasilyavailable.Theiruseisusuallyfor
a short duration, but for some children it may be a daily
occurrence.
* Priya Subramaniam, MDS, Professor and Head, Department of
Pedodontics and Preventive Dentistry, the Oxford Dental College,
HospitalandResearchCentre,Bommanahalli,HosurRoad,Karnataka,
India.
** NandanN,BDSPGStudent,TheOxfordDentalCollege,Hospitaland
Research Centre, Bommanahalli, Hosur Road, Bangalore-560068,
Karnataka,India,DepartmentofPedodonticsandPreventiveDentistry,
the Oxford Dental College, Hospital and Research Centre,
Bommanahalli,HosurRoad,Karnataka,India.
Send all correspondence to: Dr. Priya Subramaniam, Department of
PedodonticsandPreventiveDentistry,TheOxfordDentalCollege,Hospital
and Research Centre, Bommanahalli, Hosur Road, Bangalore-560068,
Karnataka,India
necessaryforimprovementormaintenanceofhealth,some
oftheinactiveingredientsposearisktodentalhealth.1 The
AAPDcariesriskassessmenttool(CAT)stipulatesthatchil-
drenwithchronicconditionsandwhoaretakingmedicines
maybeathigherriskfordentaldiseases.2,3 Mostoftheseliq-
uidpreparationsaremadepalatableinordertogainpatient
compliance and are used extensively in children.4,5,6 The
inclusionofsugars,inchildrensmedicinesis,primarilyto
maskthelesspleasanttasteofactiveingredients.7 However
sugarsaddedtomedicinescanbefermentedbyoralbacteria
leadingtoacidformationandadropinintraoralpH.Only
fewstudiesprovideinformationabouttheconcentrationof
freesugarspresentinliquidmedicinesandtheyareusually
basedondruglabelsandoninformationfrompharmaceuti-
calindustries.8,9,10
Thereisgrowingconcernamongpediatricdentistsabout
the increased consumption of hidden sugars by children,
especially those who are chronically ill. It is important to
assess the cariogenic potential of commonly used PLM.
Hencethepurposeofthisstudywastoassesstheendoge-
nouspHandviscosityofpediatricliquidmedicaments,type
andconcentrationofsugarspresentinthemandtheireffect
onthegrowthofStreptococcus mutans

Phone:+919844225624 MATERIALS AND METHOD

Fax:+9108025734656 The study was conducted on ten pediatric liquid medica-
E-mail:drpriyapedo@yahoo.com ments(PLM)ofdifferentpharmaceuticalcompanies.These

The Journal of Clinical Pediatric Dentistry Volume 36, Number 4/2012 357
Pediatric Liquid Medicaments
medicaments were selected based on a preliminary ques-
tionnairetypeofsurveyconductedtofindoutthemostcom-
monly prescribed preparations among pediatricians in
Bangalorecity,India.Asimilartypeofpreliminarysurvey
has been done in earlier studies.11,12 From the responses
obtained, two each of the most commonly prescribed and
available analgesics, antibiotics, nutritional supplements,
antitussivesandantiepilepticsyrupswereselected.
ThePediatricLiquidMedicaments(PLM)includedtwo
each of the most commonly prescribed analgesics, antibi-
otics, nutritional supplements, antitussive and antiepileptic
preparations(TableI).Thelabelsofeachmedicamentwere
examinedtogatherinformationontheircomposition.
Evaluation of pH 9,11,13 and Viscosity14
TheendogenouspHofeachPLMwasmeasuredusinga
digitalpHmeter(Methron,781pH/Ionmeter).Theviscos-
ity was measured in centipoises (cP) using a digital
Brookefield viscometer. Parameters for each medicament
wereevaluatedintriplicate.
Analysis of Type and Concentration of Sugars 9,12
Analysis of sugars (sucrose, glucose and sorbitol) was
performedusingHighPerformanceLiquidchromatography
(HPLC)(Agilent1100system,UK).FivemlofeachPLM
was pipetted into a 10ml volumetric flask, to which 2ml
of diluent was added and sonicated for 5 minutes.
Microdilutionsof1mlwerepassedthrougha0.45mmfilter
paperandthesupernatantwasusedforchromatography.All
sampleswerepreparedintriplicate.
The chromatographic conditions were maintained as
follows:
Column : 0.3 mm X 7.8 cation exchange
resincolumn
Flowrate : 0.5ml/minute
Injectionvolume : 20.0mL
Detector : RefractiveIndexDetector
Runtime : 85.0minutes
ColumnTemperature : 35C
Degassedwaterwasusedbothasthemobilephaseandas
adiluent.
Evaluation of Effect on Streptococcus Mutans15
TheeffectofPLMonStreptococcus mutans wasdoneby
ditchplatemethodasitissimpleandinexpensive.Freeze-
dried forms of Streptococcus mutans MTCC 497 was
obtained from Microbial Type Culture Collection,
Chandigarh,India.15
After preparationoftheinoculum,1mlofinoculumsus-
pensionwasaddedtosterilizedMuller-Hiltonagarmedium
andmixedthoroughly.About20mlwasthendispensedinto
sterilepetridishesandallowedtosolidify.Cylindricalcavi-
ties/wellswereboredinthemediaaftersolidificationusing
thesterileborer.
Two dilutions of each sample of PLM were prepared
usingsterilewatertogive1:2dilution(1mlofsample+1ml otherhealthychildrenwhotakemedicineinfrequentlyand
ofsterilewater)and1:10dilution(1mlofsample+9mlof
358
sterilewater).0.1mlofeachdilutedsamplewaspipettedinto
the prepared wells on the agar plate.The plates were then
kept at room temperature for 2-4 hours for pre-incubation
diffusion. The plates were then incubated for 24 hours at
30C-35C,followingwhichtheplateswereobservedfor
zonesofinhibitionand/orexhibition.Themaximumdiame-
ter of the zones was measured using digital vernier
calipers.16,17
ThedataobtainedwithregardtothepH,viscosity,type
and concentration of sugars and zone of inhibition/exhibi-
tionwithStreptococcus mutans weresubjectedtostatistical
analysis using Kruskal-Wallis test and Mann-Whitney test.
TheSPSSsoftwarewasalsousedforstatisticalanalysisof
data.
RESULTS
Among all the PLM, Gardenal showed the highest pH of
7.04, while a very low pH of 3.7 was seen withTaxim-O.
Visyneral Z was found to be most viscous (2408.3 cP)
whereas,MitsLinctusCodeinateCoshowedtheleastvis-
cosity(307.33cP).(Table1)
FiftypercentofPLMcontainedsucrose,glucoseandsor-
bitol. Sucrose was observed in 9 PLM and glucose in 7
PLM. The highest concentration of sucrose was seen in
Ibugesic (18.80 g%).The lowest concentration of sucrose,
glucose and sorbitol was seen in Mits Linctus Codeinate
Co. Taxim-O contained only sucrose, whereas Mox-Clav
containedbothsorbitolandsucrose(lowestconcentrationof
0.08g%).TheonlyPLMthatdidnotcontainsucroseorglu-
cosewasGardenal.However,ithadthehighestconcentra-
tionofsorbitol(25.97g%).(Table2)
Zones of inhibition were seen with Taxim-O and Mox-
Clav,atbothdilutions.OnlyZincovitshowedzonesofexhi-
bitionatboththedilutions.(Table3)
DISCUSSION
Pediatric medications and/or nutritional supplements are
commonly available as drops and syrups. Studies on pedi-
atricoralmedicationshaveprimarilyfocusedontheirero-
sivepotential.12,18 However,thecariogenicpotentialofthese
medicationsdependsonfactorssuchaspH,viscosity,sugar
content,highfrequencyofingestion,bedtimeconsumption
andreducedsalivaryflowcausedbytheuseofsomedrugs.
Manyparentsareawarethatsugarscausetoothdecaybut
commonly relate this solely to the consumption of sweets
and biscuits. They are often unaware of the hidden sugars
added to many foods and drinks including pediatric liquid
medicines.19,20 Oralliquidmedicationsseemtohavecompo-
sitionandpatternofrepetitiveapplicationthatmakesthem
particularly prone to the production of dental caries.21
Children on an average take medicine every eighth hourly
on a day or ten times in a week.The risk of dental caries
especially concerns chronically sick children, who require
longtermmedication22,23 andchildrenwhoreceivemedica-
tions frequently because of coughs and colds.9,19 However
forshortperiodsarealsoatarisk.
The Journal of Clinical Pediatric Dentistry Volume 36, Number 4/2012
 Pediatric Liquid Medicaments

Table 1. Mean pH and Viscosity of Paediatric Liquid Medicaments

PLM PRINCIPAL TRADE NAME PHARMACEUTICAL pH Viscosity( cP)

INGREDIENT COMPANY MeanSD MeanSD
Analgesic Paracetomol Calpol Glaxo Smithkline 6.080.04 2040.0010.00
Pharmaceuticals Limited
Analgesic Ibuprofen Ibugesic CIPLA Ltd. 4.570.02 1800.0020.00
Antibiotic Cefixime Taxim- O Alkem Laboratories Ltd 3.700.06 1620.0020.00

Antibiotic Amoxicillin and potassium Mox Clav Rexcel (A division of Ranbaxy 6.010.01* 1396.6715.28
clavulanate Laboratories Limited)

Antitussive Codeine phosphate Mits Linctus Vivimed Labs Ltd 5.020.01 307.333.06
Chlorpheniramine maleate Codeinate Co
Antitussive Dextramethorphan Chericof Sobrex Pharmaceuticals 4.660.01 1755.005.00
Hydrobromide,Chlor- Company (for Ranbaxy
pheniramine maleate, Laboratories Limited)
Phenylephrine hydrochloride
Nutritional Multivitamins Visyneral Z Crest healthcare (P) Ltd 3.810.01 2408.332.89*
supplement

Nutritional Multivitamins and minerals Zincovit Apex laboratories private 3.840.02 708.332.89*
supplement limited

Antiepileptic Phenobarbitone Gardenal Nic.Piramal 7.040.03 1455.005.00

Antiepileptic Phenytoin Eptoin Knoll pharma 5.070.03 800.005.00

*P= 0.001; P0.05 significant

The increase of prescribed medicine intake and of self- areboughtoverthecounterwithoutprescriptionand17%of

medicationindevelopedcountriesexposesagrowingnum- childrenaregivenanon-prescriptioncoughmedicine.26
ber of children to medication caries, which can be Theerosivepotentialofanacidisbasedonthreeproper-
considered a public health problem.19 The most common ties:(1) the concentration of H+ ions (endogenous pH); (2)
Over-The-Counter(OTC)preparationsgiventochildrenare amountofacidavailable(titratableacidity);and(3)relative
analgesics, cough medicines and vitamins.24,25 It has been
reportedthateverydayupto60%ofthepopulationofdevel- Table 3. Effect of Paediatric Liquid Medicaments on growth of
oped countries take some form of medicine, of which half Streptococcus mutans
PEDIATRIC ZONE OF INHIBITION AND/OR
LIQUID EXHIBITION WITH STREPTOCOCCUS
Table 2. Concentration of Sugars in Paeditric Liquid Medicaments MEDICAMENTS MUTANS
and Effect on growth of Streptococcus Mutans
1:2 dilution 1:10 dilution
PEDIATRIC CONCENTRATION OF SUCROSE, Mean SD Mean SD
LIQUID GLUCOSE AND SORBITOL (in mm) (in mm)
MEDICAMENTS (g%)
Calpol Nil Nil
Sucrose Glucose Sorbitol
MeanSD MeanSD MeanSD Ibugesic Nil Nil

Calpol 7.940.02 0.840.01* 0.700.01* Taxim-O 37.680.21 29.560.04

(inhibition) (inhibition)
Ibugesic 18.80.02* 1.710.01 0.830.02*
Mox-Clav 48.521.66 43.740.25**
Taxim-O 13.590.05 0.000.00* 0.000.0 (inhibition) (inhibition)
Mox-Clav 0.080.0.0* 0.000.01 4.680.01 Mits Linctus Nil Nil
Codeinate Co
Mits Linctus 7.090.06 0.790.03 0.600.01
Chericof Nil Nil
Codeinate Co
Chericof 17.550.31 1.710.01 0.000.0 Visyneral Z Nil Nil

Visyneral Z 8.110.07 5.490.04 0.000.00 Zincovit 11.800.58 14.57 0.13

(exhibition) (exhibition)
Zincovit 16.090.08 2.020.03 2.910.74
Gardenal Nil Nil
Gardenal 00.00* 0.000.00 25.970.55
Eptoin Nil Nil
Eptoin 16.670.02 2.130.02 3.900.01
**Z= -2.121; Z0 .05 significant
*P=0.001;P0.05 significant **P =0.034; P0 .05 significant

The Journal of Clinical Pediatric Dentistry Volume 36, Number 4/2012 359
Pediatric Liquid Medicaments
strengthoftheacidoreasewithwhichtheacidwillgiveup
freeH+ ions(pKa).27 Theexactcontributionofvariousacidic
componentsofmedicinesinerodingenamelisunclear,espe-
ciallyin vivo.14 Ourstudydidnotaimtoanalyzetheextentto
whicheachPLMmightcauseerosion.Ratheritfocusedonly
oninherentcharacteristicsthatcouldinfluencedentalcaries.
Hence only the endogenous pH of the PLM was assessed
usingadigitalpHmeter,whichismoreaccurateandefficient
thanaconventionalelectrodepHmeter.9,11,18 ThepHof70%
ofPLMwasbelow5.5,thatissimilartothatofaBrazilian
study.9 ThepHofPLMshowedawiderangeof3.70to7.04,
which is in accordance with earlier studies.9,18 However, in
anotherstudythatusedapHelectrodemeter,higherpHval-
ueswerereportedforallPLM.1
However,itisnotjustthepH,thatisimportant,butrather
the titratable acidity. The greater the buffering capacity of
theliquid,thelongeritwilltakeforthesalivatoneutralize
theacid.9,28
Decreasedsalivationandlackofmasticatorymovements
during the night increase the cariogenic potential of medi-
cines.19 Sugar-containing analgesics are given at night to
relievepainandanight-timecoughmaybesoothenedbya
coughsyrup,soastohelpthechildsleep.Veryoftenthelast
daily dose of antibiotic syrup may be given at bedtime.
These viscous syrup medicines with prolonged oral clear-
ance can constitute a risk to dental health.29 Information
about the relation between viscosity and dissolution of the
dentalhardtissuesisrareinliterature.Inourstudyviscosity
varied from 307 cP to 2408 cP. Neves et al reported that
the viscosity of PLM in their study ranged between 4.7 to
412.3cP.9
An unrecognized and significant supply of cariogenic
carbohydratesisintheformofsugar-containingliquidoral
medicines. Medicines intended for pediatric use have a
meansugarcontentofapproximately50%andsyrupscon-
tain10%to80%sucrose,mostcommonlyabout55%.The
sugar content of 24 liquid medicines frequently prescribed
for infants and young children showed a range of 29.4-
61.2%.30
Barring the sugar free medicines, we observed that the
drug labels only provided information on the presence or
absenceofsugarsinthesyrupmedicines,rarelymentioning
thetypeofsugarpresent.Asimilarfindingwasalsoreported
in PLM available in Brazil.31 High Performance Liquid
Chromatography (HPLC) used in our study,9,12 enables the
discrimination of individual sugars present in the syrup as
wellasitsconcentrationwithremarkableaccuracy.12Studies
have concluded that although Paper Chromatography (PC)
andThinLayerChromatography(TLC)ofsugarsarehigh
speed and require simple instrumentation their results are
limitedandcanonlybeusedasareferenceaboutconstituent
mono-oroligosaccharidesidentification.32
Theselectionofsugarsforanalysiswasbasedonthefre-
quencyoftheirinclusioninPLM.Sucrose,followedbyglu-
cose, are the commonly added bulking and sweetening
agentspresentinalmostallPLM.Fructoseisnotusedfre-
quentlyinmostpreparations.Amongthesugarsubstitutes,
360
sorbitoliscommonlyused.
The percentage of pediatric medicines with sucrose in
theircompositionsvariesfrom0%to58.30%.9,33 Pomorico
et al reported that sucrose present in 7 of the 10 samples
studiedrangedbetween5to54g%.18 Anotherstudydetected
sucrosein10ofthe23samplesinvestigated,withconcen-
trations ranging from 11.36 g% to 85.99 g%.9 The other
sugarthathasbeencommonlyidentifiedinpediatricmedi-
cines is glucose. Brazilian studies have reported the pres-
ence of glucose in several PLM, with the range varying
between2.10g%and40.19g%.9,12,18 Inourstudy,7PLMhad
glucoserangingfrom0.84g%to5.49g%.
Presentlyanumberofproductsforinfantsandchildren
includingPLM/medicineshavebeenformulatedusingsugar
substitutes.Although some parents are aware of the avail-
abilityofsugar-freemedicines,theyaremorelikelytopur-
chase sugar-containing medicines that are prescribed by
most practitioners or use medicaments that are recom-
mendedbypharmacists.
Polyalcohols such as sorbitol and xylitol are important
sugar substitutes since they are not efficient substrates for
plaquebacteriaandthereforeproduceonlyaminimalplaque
pHdrop.Polyolsaresugarderivativesinwhichthereactive
aldehyde or keto groups have been reduced to hydroxyl
groups.Themetabolismofpolyalcoholsisrelatedtothatof
sugars:theyareoxidizedtoeitherketoseoranaldosegroup.
Inourstudy,sorbitolwasdetectedin7PLM,withthesor-
bitolcontentrangingupto26%.Thiswasinaccordancewith
reportsonPLMinBrazil.11,18 However,Neveset al foundthe
sorbitolcontentofPLMtorangefrom5.39%to46.09%.14
Masters suggested that the large number of antibiotics
prescribedassyrupstothechildreninhisstudymayhave
contributed to the observed reduction in dental caries,
althoughthiseffectdisappearedafter4yearsofage.34 Other
researchershaveclaimedthatantibacterialsyrupmedication
is associated with a significant decline in dental caries.35
Although zones of inhibition were expected with both
antibiotic PLM, we wanted to know which one was more
effectiveagainststreptococcusmutans.Thezoneofinhibi-
tionwassignificantlygreaterwithMox-Clavincomparison
toTaxim-O.ThiscouldalsobeduetothehigherpHofMox-
Clavanditsnegligiblesucrosecontent.Althoughantibiotics
areantimicrobialinnature,theiruseoverlongtermcannot
beignored.Thesepreparationsarealsoofconcernduetothe
sweetenerspresent.
A zone of exhibition was seen with Zincovit probably
because nutritional supplements contain constituents that
can promote growth of microorganisms. This preparation
hadalow pHandahighercontentofsucrose.Thepresence
of sodium selenite equivalent to 10 mcg of selenium in
Zincovit could have also contributed to the promotion of
Streptococcus mutans growth.36 Although,theothermedica-
mentsstudiedshowedneitherzoneofinhibitionnorexhibi-
tion their other properties should be considered for
ascertainingtheircariogenicpotential.
Pharmaceutical preparations with acidic pH and high
sugarcontentshaveapotentialforincreasingdentalcaries
The Journal of Clinical Pediatric Dentistry Volume 36, Number 4/2012

whenusedseveraltimeseachdayoverlongperiodsoftime.
Ithasbeenshownthatchildrenaged3-7yearshavelarger
variations and slower salivary sugar clearances and also
lower salivary flow rates than older children and adults.37
Primaryteethareknowntobelessmineralizedthanperma-
nentteethandsincetheirenamelsurfaceisnotasmatureas
thatofpermanentteeth,theyaremoretodentalcariesand
erosion.
Parentsshouldbeinformedaboutthepresenceofhidden
sugarsinmedicines.Itcanberecommendedthatallsugar
containing medicines particularly for paediatric use should
belabelledwiththetypeofsweeteneranditsconcentration.
Whenever possible, paediatric dentists should take the
responsibilityofinformingpediatriciansabouttheprofileof
theroutinelyprescribedmedications.
Thisin vitro studywaslimitedtoasmallnumberofPLM
andcouldhaveassesseddifferentsugarspresentineachof
them. In vivo studies using the same PLM could further
relate the effect of composition and properties of these
preparations on the primary dentition and/or oral environ-
ment.
CONCLUSIONS
1. Thecoughsyrup,Chericofcanberegardedcariogenic
becauseofitsacidicandviscousnature,togetherwith
its high sucrose content. This preparation can be
potentially harmful on night-time administration
and/or when frequently given to children in-between
theregularprescribeddoses.
2. Withregardtodentalhealth,Mox-clavappearstobe
less detrimental due to its relatively higher pH, sor-
bitolcontent,negligibleamountsofothersugarsand
higherinhibitionofStreptococcus mutans growth.
3. Zincovit can be considered to be the PLM with the
most cariogenic potential due to its acidic pH, high
viscosity and promotion of Streptococcus mutans
growth.
4. For long term use in children with convulsive disor-
ders,GardenalwouldbelesscariogenicasithasapH
ofabove7andapartfromsorbitol,itdoesnotcontain
any other sugar. The other anticonvulsant Eptoin,
though less viscous was acidic and had a very high
sucrosecontent.
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The Journal of Clinical Pediatric Dentistry Volume 36, Number 4/2012