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Overcoming challenges in pediatric formulation with a patient-centric design approach: a proof-of-concept study on the design of an oral solution of a bitter drug

2022Journal article Open access
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dc.contributor.authorOgbonna, John Dike N.
dc.contributor.authorCunha, Edite
dc.contributor.authorAttama, Anthony A.
dc.contributor.authorOfokansi, Kenneth C.
dc.contributor.authorFerreira, Helena
dc.contributor.authorPinto, Susana
dc.contributor.authorGomes, Joana
dc.contributor.authorMarx, Ítala
dc.contributor.authorPeres, António M.
dc.contributor.authorLobo, José Manuel Sousa
dc.contributor.authorAlmeida, Isabel F.
dc.date.accessioned2023-02-07T15:42:14Z
dc.date.available2023-02-07T15:42:14Z
dc.date.issued2022
dc.description.abstractDesigning oral formulations for children is very challenging, especially considering their peculiarities and preferences. The choice of excipients, dosing volume and palatability are key issues of pediatric oral liquid medicines. The purpose of the present study is to develop an oral pediatric solution of a model bitter drug (ranitidine) following a patient centric design process which includes the definition of a target product profile (TPP). To conclude on the matching of the developed solution to TPP, its chemical and microbiological stability was analyzed over 30 days (stored at 4 °C and room temperature). Simulation of use was accomplished by removing a sample with a syringe every day. Taste masking was assessed by an electronic tongue. The developed formulation relied on a simple taste masking strategy consisting in a mixture of sweeteners (sodium saccharine and aspartame) and 0.1% sodium chloride, which allowed a higher bitterness masking effectiveness in comparison with simple syrup. The ranitidine solution was stable for 30 days stored at 4 °C. However, differences were noted between the stability protocols (unopened recipient and in‐use stability) showing the contribution of the simulation of use to the formation of degradation products. Stock solution was subjected to acid and alkali hydrolysis, chemical oxidation, heat degradation and a photo degradation stability assessment. The developed pediatric solution matched the TPP in all dimensions, namely composition suitable for children, preparation and handling adapted to hospital pharmaceutical compounding and adequate stability and quality. According to the results, in‐use stability protocols should be preferred in the stability evaluation of pediatric formulations.pt_PT
dc.description.sponsorshipThis work was supported by national funds from FCT—Fundação para a Ciência e a Tecnologia, I.P., Portugal, in the scope of the project UIDP/04378/2020 and UIDB/04378/2020 of the Research Unit on Applied Molecular Biosciences—UCIBIO and the project LA/P/0140/2020 of the Associate Laboratory Institute for Health and Bioeconomy—i4HB. This research was also supported by and Federal Government of Nigeria NEEDS Assessment grant‐2018. The authors are grateful to FCT (Portugal) for financial support by national funds FCT/MCTES to CIMO (UIDB/00690/2020 and UIDP/00690/2020) and to the Associate Laboratory SusTEC (LA/P/0007/2020). Ítala M.G. Marx also acknowledges the Ph.D. research grant (SFRH/BD/137283/2018) provided by FCT.pt_PT
dc.description.versioninfo:eu-repo/semantics/publishedVersionpt_PT
dc.identifier.citationOgbonna, John Dike N.; Cunha, Edite; Attama, Anthony A.; Ofokansi, Kenneth C.; Ferreira, Helena; Pinto, Susana; Gomes, Joana; Marx, Ítala; Peres, António M.; Lobo, José Manuel Sousa; Almeida, Isabel F. (2022). Overcoming challenges in pediatric formulation with a patient-centric design approach: a proof-of-concept study on the design of an oral solution of a bitter drug. Pharmaceuticals. ISSN 1424-8247. 15:11, p. 1-14pt_PT
dc.identifier.doi10.3390/ph15111331pt_PT
dc.identifier.issn1424-8247
dc.identifier.urihttp://hdl.handle.net/10198/26777
dc.language.isoengpt_PT
dc.peerreviewedyespt_PT
dc.publisherMDPIpt_PT
dc.relationLA/P/0140/2020pt_PT
dc.relationApplied Molecular Biosciences Unit
dc.relationApplied Molecular Biosciences Unit
dc.relationLA/P/0007/2020pt_PT
dc.relationMountain Research Center
dc.relationMountain Research Center
dc.relationImprovement of olive oil flavor and bioactive composition by optimizing industrial extraction using taste sensor devices
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/pt_PT
dc.subjectPediatric medicinespt_PT
dc.subjectOral formulationspt_PT
dc.subjectBitterness maskingpt_PT
dc.subjectPatient centric designpt_PT
dc.subjectIn use stabilitypt_PT
dc.titleOvercoming challenges in pediatric formulation with a patient-centric design approach: a proof-of-concept study on the design of an oral solution of a bitter drugpt_PT
dc.typejournal article
dspace.entity.typePublication
oaire.awardTitleApplied Molecular Biosciences Unit
oaire.awardTitleApplied Molecular Biosciences Unit
oaire.awardTitleMountain Research Center
oaire.awardTitleMountain Research Center
oaire.awardTitleImprovement of olive oil flavor and bioactive composition by optimizing industrial extraction using taste sensor devices
oaire.awardURIinfo:eu-repo/grantAgreement/FCT/6817 - DCRRNI ID/UIDP%2F04378%2F2020/PT
oaire.awardURIinfo:eu-repo/grantAgreement/FCT/6817 - DCRRNI ID/UIDB%2F04378%2F2020/PT
oaire.awardURIinfo:eu-repo/grantAgreement/FCT/6817 - DCRRNI ID/UIDB%2F00690%2F2020/PT
oaire.awardURIinfo:eu-repo/grantAgreement/FCT/6817 - DCRRNI ID/UIDP%2F00690%2F2020/PT
oaire.awardURIinfo:eu-repo/grantAgreement/FCT/POR_NORTE/SFRH%2FBD%2F137283%2F2018/PT
oaire.citation.issue11pt_PT
oaire.citation.titlePharmaceuticalspt_PT
oaire.citation.volume15pt_PT
oaire.fundingStream6817 - DCRRNI ID
oaire.fundingStream6817 - DCRRNI ID
oaire.fundingStream6817 - DCRRNI ID
oaire.fundingStream6817 - DCRRNI ID
oaire.fundingStreamPOR_NORTE
person.familyNameMarx
person.familyNamePeres
person.givenNameÍtala
person.givenNameAntónio M.
person.identifier1676851
person.identifier107333
person.identifier.ciencia-id2717-C420-DEAE
person.identifier.ciencia-idCF16-5443-F420
person.identifier.orcid0000-0002-7049-2114
person.identifier.orcid0000-0001-6595-9165
person.identifier.ridGLV-5485-2022
person.identifier.ridI-8470-2012
person.identifier.scopus-author-id57191503603
person.identifier.scopus-author-id7102331969
project.funder.identifierhttp://doi.org/10.13039/501100001871
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project.funder.identifierhttp://doi.org/10.13039/501100001871
project.funder.identifierhttp://doi.org/10.13039/501100001871
project.funder.nameFundação para a Ciência e a Tecnologia
project.funder.nameFundação para a Ciência e a Tecnologia
project.funder.nameFundação para a Ciência e a Tecnologia
project.funder.nameFundação para a Ciência e a Tecnologia
project.funder.nameFundação para a Ciência e a Tecnologia
rcaap.rightsopenAccesspt_PT
rcaap.typearticlept_PT
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