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www.bjorl.org

Brazilian

Journal

of

OTORHINOLARYNGOLOGY

ORIGINAL

ARTICLE

New

Ringer’s

lactate

gel

formulation

on

nasal

comfort

and

humidification

Maura

Catafesta

das

Neves

a,∗

,

Fabrizio

Ricci

Romano

a,b

,

Samuel

Guerra

Filho

c aUniversidadedeSãoPaulo(USP),HospitalUniversitário(HU),SãoPaulo,SP,Brazil

bHospitalInfantilSabará,SãoPaulo,SP,Brazil

cAllergisaPesquisaDermato-CosméticaLtda,Campinas,SP,Brazil

Received29March2018;accepted4July2018 Availableonline8August2018

KEYWORDS Dryness; Nasalhydration; Nasalwash; Rhinitis; Nasalgel; Ringerlactate Abstract

Introduction:Theuseofsalineirrigationfornasalwashesisawellestablishedprocedurein thetreatmentofsinonasalinflammationandinfection.Inadditiontosalinesolutions,Ringer’s lactateisalsoanefficientoptionfornasalwashesandhumidification.

Objective:Toassessthecomfort,humidificationandtoleranceregardingstingingsensation, providedbysodiumchloridenasalgelattheconcentrationsof4.5mg/gand6.0mg/gthrough questionnairesansweredbythepatients.

Methods:Atotalof60patients,56females,agedbetween22and66yearsold(meanageof47) and4males,agedbetween36and66years(meanageof49),wereincludedinthestudyfora periodof17days(±2days)treatment.Thepatientsweremonitoredbyageneralpractitioner throughoutthestudyperiod.Theywereinstructedtoapplyeachproductinbothnostrilstwice adayduringa7-day period(±2days). Thepatients wereevaluatedprior totheuseofthe firstproductatvisit0(V0),after7daysoftreatment(±2days)atvisit1(V1),after3daysof productdiscontinuationatvisit2(V2)andafter7days(±2days)oftreatmentwiththesecond product,invisit3(V3).

Results:Asignificantdifference(5%significance)wasobservedregardingcomfortandstinging sensationbetweenthetwodifferentconcentrations;comfortwashigherandstingingwaslower withthe6.0mg/gconcentrationgel.Nodifferenceinhumidificationwasobservedbetweenthe twotreatments.

Conclusion:Ringer’slactateattheconcentrationof6.0mg/gwassuperiortothatat4.5mg/g forparameterscomfortandstingingsensation.Nostatisticaldifferencewasobservedbetween thetwoproductsregardingnasalhumidification.

© 2018 Associac¸˜ao Brasileira de Otorrinolaringologia e Cirurgia C´ervico-Facial. Published by Elsevier Editora Ltda. This is an open access article under the CC BY license (http:// creativecommons.org/licenses/by/4.0/).

Pleasecitethisarticleas:NevesMC,RomanoFR,GuerraFilhoS.NewRinger’slactategelformulationonnasalcomfortandhumidification. BrazJOtorhinolaryngol.2019;85:746---52.

Correspondingauthor.

E-mail:mauraneves@hotmail.com(M.C.Neves).

PeerReviewundertheresponsibilityofAssociac¸ãoBrasileiradeOtorrinolaringologiaeCirurgiaCérvico-Facial.

https://doi.org/10.1016/j.bjorl.2018.07.004

1808-8694/©2018Associac¸˜aoBrasileiradeOtorrinolaringologiaeCirurgiaC´ervico-Facial.PublishedbyElsevierEditoraLtda.Thisisanopen accessarticleundertheCCBYlicense(http://creativecommons.org/licenses/by/4.0/).

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PALAVRAS-CHAVE Ressecamento; Hidratac¸ãonasal; Lavagemnasal; Rinite;

Gelnasal; Ringerlactato

Novaformulac¸ãodeRingerlactatogelnoconfortoeumidificac¸ãonasal

Resumo

Introduc¸ão: Ousodesoluc¸õessalinasparalavagemnasalestáconsagradonotratamentode quadrosinflamatórioseinfecciososnasossinusais.Alémdassoluc¸õessalinas,oringerlactatoé umaimportanteopc¸ãotantoparalavagemquantoparaahidratac¸ãonasal.

Objetivo: Avaliaratolerabilidade(ardênciaeconforto)eumidificac¸ãodoprodutogelnasal cloretodesódio 4,5mg/gemrelac¸ãoao ringerlactato6,0mg/g,pormeiodequestionários respondidospelospacientes.

Método: Foramincluídos 60 pacientes, 56 mulheres (22-66anos; média: 47 anos) e quatro homens(36-66anos;média:49anos)foramincluídosnoestudode17dias(±2dias)de trata-mento. Ospacientesforamsupervisionadosporum clínico geraldurantetodooperíododo estudo.Ospacientesusaramosprodutos comuma borrifadaemcadanarinaduasvezes ao dia, durantesetedias(±2dias).Asformulac¸õesforamavaliadas antesdousodoprimeiro produtonavisita0(V0),apóssetedias(±2dias)detratamentonavisita1(V1),apóstrêsdias deinterrupc¸ãodoprimeirotratamentonavisita2(V2)eapóssetedias(±2dias)deusodo segundoprodutonavisita3(V3).

Resultados: Foiobservadadiferenc¸asignificanteparaoconfortodasviasnasais,(significância de5%),nacomparac¸ãoentreostratamentosnosatributosdeconfortoeardência.Oconforto dasviasnasaisfoisuperior eaardênciainferiorparaogelnasalringerlactato6,0mg/gem comparac¸ãoaogelcloretodesódio4,5mg/g.Nãofoiobservadadiferenc¸asignificanteparaa umidificac¸ãoentreostratamentos.

Conclusão:Ogelringerlactato6,0mg/gfoisuperioraoprodutogelcloretodesódio4,5mg/g nos quesitosconforto eardência.Nãofoi observadadiferenc¸aestatisticamentesignificante entreostratamentosemrelac¸ãoàumidificac¸ãodasviasnasais.

© 2018 Associac¸˜ao Brasileira de Otorrinolaringologia e Cirurgia C´ervico-Facial. Publicado por Elsevier Editora Ltda. Este ´e um artigo Open Access sob uma licenc¸a CC BY (http:// creativecommons.org/licenses/by/4.0/).

Introduction

Inflammatoryconditionsofthenose andparanasalsinuses arethemostprevalentgroupofdiseasesinthegeneral popu-lation.Allergicandnon-allergicrhinitis,aswellasacuteand chronicrhinosinusitis,resultinamarkeddecreaseinquality oflifeandgeneratesignificantlossesinlaborproductivity, leisureandsocialactivitiesingeneral.1

Nasal topical medications are extremely important in the treatment of inflammatory and infectious nasal and paranasalsinusdiseases,allowingactivesubstancestoreach thetargetedsiteinordertoexerttheirclinicallocalaction, minimizingthesystemiceffects.1

Themajorityofacuterespiratoryinfectionsareofviral etiology,oftenpresenting a self-limitingcourse.However, the associated symptoms (rhinorrhea, nasal obstruction, cough,painandfever)arefrequentlyareasonofhigh med-icationconsumption.2

Theuseofsalinesolutionfornasalhygienehasbeen rec-ommendedbymanyexpertsinrhinology,anditseffectmay begreaterthanjustthatofanadjuvanttreatment.1

Nasal lavage with isotonic saline (0.9% sodium chlo-ride) is recommended in respiratory infections aiming to help the mechanical removal of secretions and microor-ganisms in addition toincreasing nasal permeability. It is an easy-to-perform procedure with no relevant adverse clinical effects, well tolerated, and beneficial to the organism.2

Sodiumchloridenasalsprays,nasalgelsandRinger’s lac-tatenasalgelsarerecommendedtohelpthefluidificationof secretions.Theyactbydecreasingthemucusviscosity, pro-motingitsfluidizationand facilitatingitselimination,and areusuallyindicatedinanyconditionrelatedtodrynessof thenasalmucosa,suchaslowairhumidity,exposuretoair conditioningandpollution.

Currently, thenasal gel 4.5mg/g, that is highly effec-tivefornasalhydration,isalreadyavailableonthemarket.3

However,itsformulationisbasedonaglycoliccomponent (propyleneglycol)thatproducesanasalstingingsensation immediatelyafteritsapplication.3Aimingtoincreasenasal

comfortmaintainingthequalityofthehydration,anewgel formulationbased onRinger’slactate solutionwas devel-oped,whichresultedinaconcentrationof6.0mg/g,without theglycoliccomponent.4

Thisstudyaimstocomparethetolerability(stinging sen-sation and comfort) and the efficacy of nasal hydration betweensodiumchloridenasalgelat4.5mg/gandRinger’s lactatenasalgelat6.0mg/g.

Methods

Asingle-blind,comparative,monadic,sequential, random-ized clinical study with a wash-out period of 3 days was carriedoutinNovemberandDecember2014.

The enrolledsample consisted of patients with recom-mendationofnasalgelapplication,whomettheinclusion

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Table 1 Standardization of sample labels delivered to patients. Typeof product Product code Product lot Product validity Nasalgel 43329-01 LP247/14A 09/2016 Nasalgel 43329-02 14/0042 09/2016

criteria and none of the exclusion criteria. The selected patientsattendedthevisitsfortheevaluationsrequiredby thetrialandsignedthefreeinformedconsentform,inorder tobeincludedinthestudy.

The inclusion criteria comprised: participants of both genders;age>18years;adherencetothestudyprocedures andrequirements;attendancetotheclinicontheday(s)and timepreviouslydeterminedfortheevaluations,andwriting abilitytoprovidetheconsentformtotheirparticipation.

Exclusioncriteriaincluded:concomitantuseofanyother nasal medication; pregnancy or breastfeeding; diabetes; immunedeficiencydiseases;useofsystemiccorticosteroids orimmunosuppressantsinaperiodnotlargerthan2weeks beforethebeginningofthestudy;previousreactiontothe tested productcategory; other diseases andlicit or illicit medications that might directly could interfere with the studyorendangerthevolunteer’shealthandanyother pre-viouslyunmentionedconditionswhich,intheopinionofthe investigator,couldimpairthestudyevaluation.

The sample size wasdetermined based on the ANVISA guidetocosmeticproductstudies,5whichrequiresa

mini-mumnumberof30responsesforsafetystudies.Therefore, asampleof60patientswasestablished.Patientrecruitment wascarriedoutbyAllergisa, acompanywitha computer-izedandupdatedregistrysystemof individualsinterested inresearchesparticipation.

ThesponsorcompanyLibbsFarmacêuticaLTDAprovided the nasal gel samples to the researcher,3,4 which were

evaluatedinstandardized packagesidentifiedwithalabel indicatingonlythetypeofproduct,productcode,validity andsamplelotasshowninTable1.Thenameofthe prod-uct wasnot identified onthe sample labels of the study. Code43329-1correspondedtoRinger’slactatenasalgel,at 6.0mg/g,4whereascode43329-02correspondedtosodium

chloridenasalgel,at4.5mg/g.3

Studydesign

Patientswereassessedbyageneralpractitionerforinclusion andexclusioncriteriaandfor theirclinical status(history of diseases, allergies, blood pressure and general physi-calexamination)at visit0(V0).Approvedfemalepatients underwentalsotoaurinarypregnancytestonV0.

Aftergivingtheirinformedconsentandbeingincluded, thepatientsreceivedoneoftheproductstobeappliedto thenosefor7±2days(onesprayineachnostrilevery12h). Productprescriptionwasrandomized,sothatthepatients didnotknowwhichproducttheywereusing.

After7±2daysthepatientswereevaluatedatvisit1(V1) formonitoringtheonsetofanyadverseevents,answeringa questionnairetoevaluatetheproduct.

Table2 Scheduleofprocedure.

Stage V0 V1 V2 V3

Signatureoftermofinformedconsent X

Clinicalevaluation X X X X

Pregnancytest X X

Evaluationofefficacyandtolerability X X

Productdelivery X X

Productreturn X X

Aftera3-day intervalwithoutusing anyproduct(wash out), thepatients returnedfor visit 2(V2) toreceive the second producttobeusedfor7±2days.After7±2days thepatientsreturnedonvisit3(V3)forthefinalassessment (clinical examination and newpregnancy test, for female patients).Table2outlinesthevisitsandfollow-up.

Forthe analysisof the acceptabilityresults, the study considered patients with a minimum adherence of 80% regarding the frequency of use. As the prescription con-sistedoftwiceapplicationsadayfor7days,14applications were expected as the final result. Considering the mini-mum adherenceof 80% regarding the product application frequency,eachparticipantshouldhaveappliedatleast11 timestohavetheirevaluationsvalidandaccountedforthe finalstudyresults.

The efficacy (humidification) and tolerability (stinging sensation andcomfort)evaluation wasperformed through questionnaires answered by the patients. A visual analog scale(VAS)wasusedforeachitemasshowninFigs.1and2. TheinvestigatorshowedtheVASscaletoeachpatientand askedthemtoindicatethepointthatbestrepresentedeach assesseditem.Theinvestigatorverifiedthepointindicated bythepatientinthefigure,whichrangedfrom0(zero)to 10(ten)centimetersandnotedthecorrespondingvalue.In thisscale,thevalueof0(zero)representedthelowest effi-cacyperceivedatthetreatmentandthevalueof10(ten) representedthegreatestefficacy.

Allparticipantswhodidnotmeettheinclusion/exclusion criteria prior to the beginning of the study or that did not agreeparticipating beforeor after theinformed con-sentformsignaturewereconsideredas‘‘selectionfailure’’. Theseparticipantswerereplaced,andtheirdatawerenot considered in the finalreport. Therewasno replacement for thosewhowithdrewafterreceivingtheproductunder investigation.

Thisstudywascarriedoutaccordingtotheprinciplesof theHelsinkiDeclarationofOctober2008,andtheapplicable regulatoryrequestsincludingCNSResolutionNo.466/2012,6

andtheprinciplesofGoodClinicalPractices(Documentof theAmericasandICHE6:GoodClinicalPractice).7Thestudy

wasapprovedbytheinstitutionalresearchethicscommittee (CAAE:37042514.8.0000.5599).

Results

Atotalof60patientswhometalltheinclusionand exclu-sioncriteriawereenrolled,56werefemales,agedbetween 22and66years(mean:47years)andfourweremales,aged between36and66years(mean:49years).Ina complemen-tary study, a primary skin irritation potential of products

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0 1 2 3 4 5 6 7 8 9 10

MILD MODERATE SEVERE

VISUAL ANALOGUE SCALE

Figure1 Visualanalogscale---VAS(comfortandstinging).

0 1 2 3 4 5 6 7 8 9 10

For evaluation, the Visual Analog Scale will be used, according to the example below:

MILD MODERATE SEVERE

VISUAL ANALOGUE SCALE

Figure2 Visualanalogscale---VAS(humidification).

Table3 Mean,standarddeviationandresultofthecomparisonbetweentreatments.

Characteristic Ringer’slactatenasalgel6.0mg/g Sodiumchloridenasalgel4.5mg/g pvalue

Mean SD Mean SD

Comfort 8.6 1.7 7.7 2.1 0.003b

Stinging 0.2 1.0 1.5 2.7 <0.001c

Humidification 8.9 1.3 8.6 1.4 0.136

aSignificantatthe5%level(Wilcoxontest). b Significantatthe1%level.

c Significantatthe0.1%level.

(patchtest)wasevaluated.Inthisstudy,noneofthe parti-cipantsshowedclinicalsignsofskinirritationrelatedtothe productandthelatterdidnotinduceprimaryskinirritation processinthestudygroup.

Theresultsobtainedforeachassessedcharacteristicare showninTable3.

Asignificantdifferencewasobserved,withasignificance levelof5%,whencomparingthetreatmentsregardingthe characteristicsofcomfortandstingingsensation.The com-fortofnasalapplicationwassuperiorwithRinger’slactate nasalgel,at6.0mg/g4comparedtosodiumchloridenasal

gel,at4.5mg/g.3Thestingingsensationwaslowerforthe

treatment with Ringer’s lactate nasal gel, at 6.0mg/g,4

comparedwiththenasalgel,at4.5mg/g.3Nosignificant

dif-ferencewasobservedregardingnasalhumidification when comparingbothtreatments.

Fig.3 comparesthe dataobtainedregarding the sting-ing sensation for each tested product concentrations, on VAS scale. The stingingsensation was reportedas moder-atetosevereby15patientswhotestedthesodiumchloride nasalgel,4.5mg/g3 andmoderateforonly2patientswho

testedRinger’slactatenasalgel,at6.0mg/g.4Therewere

no reports of intense stinging sensation among patients thatusedRinger’slactategel atthe concentrationof6.0 mg/g.4

Thestingingsensationwasreportedasmildby58patients whotested for the concentration of 6.0mg/g4 andby 45

patientsthattestedfortheconcentrationof4.5mg/g3(Fig. 3).The stingingsensation wasreportedasZERO(included as mild in the VAS scale) by 57 patients (95%) tested for ringer’slactategel ata concentrationof6.0mg/g4 vs. 41

0 20 40 60 80 100

Intense Moderate Mild

Nasal gel 6.0mg/g 0 3.3 96.7

Nasal gel 4.5mg/g 8.3 16.7 75

%

STINGING

Figure 3 Stinging with nasal gel 6.0mg/g4×nasal gel

4.5mg/g.3

patients(68.3%)whotestedthesodiumchloridenasalgelat aconcentrationof4.5mg/g3(Fig.4).

Regardingthecomfort,Ringer’slactategelat6.0mg/g4

providedintensecomfortfor47patients(78.3%)and mod-erate for 13 patients, (21.7%) while the concentration of 4.5mg/g3 provided intensecomfortfor 36 (60%)patients,

moderate for 22 (36.7%) and mild for 2 patients (3.3%) (Fig.5).

Regardinghumidification,theconcentrationof6.0mg/g4

ofRinger’slactategel providedintensehumidification for 48 (80%) patients and moderate for 13 (20%), while the concentrationof4.5mg/g3ofthesodiumchloridenasalgel

providedintensehumidificationfor47(78.4%)andmoderate for13patients(21.6%),asshowninFig.6.

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0 1 2 Nasal gel 6.0mg/g 95 1.7 0 Nasal gel 4.5mg/g 68.3 5 1.7 0 20 40 60 80 100 % MILD STINGING

Figure4 DivisionofmildstingingreportsforRinger’slactate nasalgel6.0mg/g4×sodiumchloridenasalgel4.5mg/g.3

0 10 20 30 40 50

Intense Moderate Mild

Nasal gel 6.0mg/ml 47 13 0

Nasal gel 4.5 mg/ml 36 22 2

N

COMFORT

Figure 5 Comfort with nasal gel 6.0mg/g4×nasal gel

4.5mg/g.3 0 10 20 30 40 50 Intense o

Moderate Mild Zero

Nasal gel 6.0 mg/g 48 12 0 0

Nasal gel 4.5mg/g 47 13 0 0

N

HUMIDIFICATION

Figure 6 Humidification with Ringer’s lactate nasal Gel 6.0mg/g4×sodiumchloridenasalgel4.5mg/g.3

Fig.7comparestheresultsobtainedforeach character-isticevaluatedforeachnasalgelconcentration.

Discussion

Theuseofisotonicsalinesolutionsfornasalcleaningiswell disseminated and clinically established for more than 70 yearsasa practical, effective andwell tolerated method ofpromotingwell-beingandnasalphysiologymaintenance.8

Thesesolutionsarerecommendedascomplementary ther-apy in cases of acute and chronic rhinosinusitis, rhinitis, post-nasal drip, septum perforation and postoperative care.9,10

COMFORT

% PATIENTS WITH INCREASE % PATIENTS WITH NO DIFFERENCE % PATIENTS WITH DECREASE

STINGING HUMIDIFICATION 20 30 50 3.3 31.7 65 38% 20% 42%

Figure7 Percentageofparticipantswithincrease,no differ-enceandwithreductionofcharacteristicsduringthetreatment withRinger’slactatenasalgel6.0mg/g4×nasalgel4.5mg/g.3

Theiractionmechanisminvolvesthemechanicalremoval of mucus, crusts and nasopharyngeal secretion and alter-ation of the viscoelastic characteristics of the mucus (hydrating it through osmotic gradient and altering the bonds between glycoproteins), which facilitates the mucociliaryclearance.11

Thereisnoclearevidenceintheliteratureofwhichtype ofsalinesolutionisthemostappropriateforthisfunction. However,thestudyofBoek8showedthatnasalRinger’s

lac-tateisotonicsolutionismoreappropriatethanothernasal salinesolutions.

Accordingtotheliterature,every100mLofringer’s lac-tatesolutioncontains600mgofsodiumchloride,310mgof sodiumlactate,30mgof potassium chlorideand 20mg of calcium chloride dihydrate.12---14 This formulationprovides

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itsmetabolizationintobicarbonate.Moreover,ringer’s lac-tatesolutionhaspotassiumandcalciumatconcentrations thataresimilartotheionizedconcentrationsfoundin nor-mal blood plasma. To maintain electrical neutrality, the solutionhaslowersodiumlevelthanthatfoundinisotonic salinesolutionorplasma.Thecombinationofallsaltsresults inanosmolaritysimilartheblood,whichmakesthissolution isotonic,withameanpHof6.75(6.0---7.5).12---14

Ringer’slactatenasalgelhasaconcentrationof6mg/g due to the predominant presence of sodium chloride in its composition in solid form (expressed in mg/g) and becomes isotonic with the presence of other ions in its formulation.

This evidencewasconfirmedbyother investigators15---18

whencomparingaringer’slactatesolutionwitha0.9%saline solution,demonstratinga statisticallysignificant improve-ment in mucociliary clearance with the ringer’s lactate solutioncomparedtoothersalinesolutions.

Ringer’slactatesolution12---14showsevidenceofbeingan

excellentnasalhumectant,possiblybecauseitcausesless irritatingeffectsontherespiratorymucosa,evenwhen com-paredto the‘‘physiological’’ 0.9% NaClsaline solutionin experimental19andclinicalstudies.17,20,21Asalimitationof

the present study, we should mention the enrollment of femaleparticipantsinthestudysamplesincethemenstrual cycleperiodwasnotevaluated.

Azzam16 emphasizes that although the isotonic saline

solutionisrecommendedforrepeateduseseveraltimes a dayandthatisveryimportantforthemechanicalremoval of crusts and secretions and nasal lavage, its hydrating power is verylimited andtransitory.The current concept of nasal humidification, according to Azzam,16 should be

directedtothepharmaceuticalformof‘‘gel’’,whichallows alongerperiodofproductadhesiontothenasalmucosa,22

andhavebeenconsideredsafeandeffectiveinseveral clin-icalstudies.18,23,24

Thetestedproductscompriseawidelymarketed formu-lation(sodium chloridenasal spray, at a concentrationof 4.5mg/g3andanewformulation(Ringer’slactatenasalgel,

ataconcentrationof6.0mg/g).4

Twoimportantmodificationsintheformulation differen-tiate thenasal gelat 4.5mg/g3 fromthe Ringer’slactate

nasal gel at 6.0mg/g.4 First, the presence of more ions

in the Ringer’s lactate solution is the base of the nasal gelat aconcentrationof 6.0mg/g,4 which confersunique

propertiestothisformula.Furthermore,propyleneglycol, whichprovidesthegelconsistencyforthenasalgelformula at4.5mg/g3 wasremoved fromthenasalgelat 6.0mg/g,

andreplacedbyhydroxyethylcellulose(HEC).4HEC25,26isa

semi-syntheticviscoelasticpolymerderivedfromthe water-solublecellulose polysaccharide withaosmotic potential, currently used in ophthalmologic products,26 in oral

cap-sulesandtablets,25 tostabilizeliposolubledrug solutions,

asaplasmaexpander,asahemostaticagentandassurface hydratingagent.23,25

Inclinicalstudies,theuseofHECasavehiclefornasal solutionshasbeenreportedasverysafe.Severalpublished studieshaveshownthatnasalsolutionswiththiscomponent donothavesignificantsideeffects.15Thissuitabilityhas

pro-motedgreater comfort, minimizing the stingingsensation thatis frequently experiencedwiththe previous formula-tion.

The results showed greater tolerability when using Ringer’slactategelat6.0mg/g4whencomparedtothe

cur-rently marketed nasal gel at 4.5mg/g3 providing greater

comfortand lower incidence of stinging sensation, which were statistically significant. Approximately 95% of the patientsreportednostingingsensation whenapplyingthe nasalgelataconcentrationof6.0mg/g4whencomparedto

68%ofthepatientsusingthenasalgelataconcentrationof 4.5mg/g.3Moreover,thepatientsshowedthesame

percep-tionofnasalhydrationwithbothproductsusedinthisstudy, whichindicatessimilarefficacybetweentheformulations.

The currently marketedformulationhas multiple clini-caluses,includingpostoperativenasalsurgery,15inaddition

toseveralclinicalconditionssuchasrhinitis,sinusitis,use of continuous positive air pressure (CPAP), among other mucosaldrynessconditions.3,16,24 Anew formulation

with-outtheglycoliccomponent(responsibleforsomestinging) andbasedonringer’slactatesolutionwillprovidegreater comfortandhydrationmanyclinicalconditions.4,16,17,20

Conclusion

Ringer’slactategelisanalternativefornasalhumidification byconferringnasalcomfortwithhighleveloftoleranceand minimalstingingsensation.Ringer’slactategelformulation at6.0mg/g4 wassignificantlysuperior tothat at4.5mg/g

sodiumchloride nasal gel formulation3 regarding comfort

andstinging, while the humidification sensation was high forbothconcentrations.

Conflicts

of

interest

Theauthorsdeclarenoconflictsofinterest.

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