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dc.creatorIlić, Tanja
dc.creatorPantelić, Ivana
dc.creatorLunter, Dominique
dc.creatorDodević, Sanela
dc.creatorMarković, Bojan
dc.creatorRanković, Dragana
dc.creatorDaniels, Rolf
dc.creatorSavić, Snežana
dc.date.accessioned2019-09-02T11:58:06Z
dc.date.available2019-09-02T11:58:06Z
dc.date.issued2017
dc.identifier.issn0378-5173
dc.identifier.urihttp://farfar.pharmacy.bg.ac.rs/handle/123456789/2826
dc.description.abstractThis work aimed to prove the ability of "ready-to-use" topical vehicles based on alkyl polyglucoside-mixed emulsifier (with/without co-solvent modifications) to replace the conventionally used pharmacopoeial bases (e.g., non-ionic hydrophilic cream) in compounding practice. For this purpose, considering the regulatory efforts to establish alternative, scientifically valid methods for evaluating therapeutic equivalence of topical semisolids, we performed a comparative assessment of microstructure, selected critical quality attributes (CQAs) and in vitro/in vivo product performances, by utilizing aceclofenac as a model drug. The differences in composition between investigated samples have imposed remarkable variances in monitored CQAs (particularly in the amount of aceclofenac dissolved, rheological properties and water distribution mode), reflecting the distinct differences in microstructure formed, as partially observed by polarization microscopy and confocal Raman spectral imaging. Although not fully indicative of the in vivo performances, in vitro release data (vertical diffusion vs. immersion cells) proved the microstructure peculiarities, asserting the rheological properties as decisive factor for obtained liberation profiles. Contrary, in vitro permeation results obtained using pig ear epidermis correlated well with in vivo dermatopharmacokinetic data and distinguished unequivocally between tested formulations, emphasizing the importance of skin/vehicle interactions. In summary, suggested multi-faceted approach can provide adequate proof on topical semisolids therapeutic equivalence or lack thereof.en
dc.publisherElsevier Science BV, Amsterdam
dc.relationinfo:eu-repo/grantAgreement/MESTD/Technological Development (TD or TR)/34031/RS//
dc.relationFederal Republic of Germany
dc.rightsrestrictedAccess
dc.sourceInternational Journal of Pharmaceutics
dc.subjectMicrostructureen
dc.subjectCritical quality attributesen
dc.subjectIn vitro releaseen
dc.subjectIn vitro skin permeationen
dc.subjectIn vivo tape strippingen
dc.subjectIn vitro-in vivo correlationen
dc.titleCritical quality attributes, in vitro release and correlated in vitro skin permeation-in vivo tape stripping collective data for demonstrating therapeutic (non) equivalence of topical semisolids: A case study of "ready-to-use" vehiclesen
dc.typearticle
dc.rights.licenseARR
dcterms.abstractПантелић, Ивана; Марковић, Бојан; Додевић, Санела; Ранковић, Драгана; Даниелс, Ролф; Лунтер, Доминиqуе; Савић, Снежана; Илић, Тања;
dc.citation.volume528
dc.citation.issue1-2
dc.citation.spage253
dc.citation.epage267
dc.citation.other528(1-2): 253-267
dc.citation.rankM21
dc.identifier.wos000408007600023
dc.identifier.doi10.1016/j.ijpharm.2017.06.018
dc.identifier.pmid28602800
dc.identifier.scopus2-s2.0-85020633157
dc.identifier.rcubconv_3923
dc.type.versionpublishedVersion


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