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Pessaries containing Nanostructured Lipid Carriers (NLC) for prolonged vaginal delivery of progesterone

2020Journal article Restricted access
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dc.contributor.authorCorreia, A.
dc.contributor.authorCosta, C.P.
dc.contributor.authorSilva, V.
dc.contributor.authorSilva, R.
dc.contributor.authorLobo, J.M. Sousa
dc.contributor.authorSilva, Ana Catarina
dc.date.accessioned2021-04-28T13:46:19Z
dc.date.available2021-04-28T13:46:19Z
dc.date.issued2020
dc.description.abstractProgesterone (PRG) plays a crucial role in the female reproductive system, being the vaginal route the most adequate for its administration, as this drug has an extensive hepatic first pass effect. Nonetheless, vaginal PRG dosage forms originate immediate drug release and requires repeated administrations, which is unpleasant. Thereby, it is necessary to develop alternative delivery systems for prolonged vaginal release of PRG. The objective of this work was the development of pessaries for the prolonged vaginal delivery of PRG. Studies began with the preparation of an aqueous dispersion of PRG-loaded NLC (NLC_PRG), followed by the evaluation of its biocompatibility in human immortalized keratinocytes (HaCat cells), using three different methods (neutral red uptake, resazurin reduction and sulforhodamine B assays). Finally, the NLC_PRG was incorporated into pessaries, which were further characterized according to the European Pharmacopoeia to assess their suitability to prolong PRG release through the vaginal route. The results showed that, after preparation, 90% of the NLC_PRG had sizes equal or lower than 315.60 ± 0.01 nm, and an EE of 96.42 ± 0.00%. All the assays used to assess the biocompatibility of NLC_PRG showed the absence of cytotoxicity towards HaCaT cells for concentrations up to 10 μg/mL. In all cytotoxicity assays, a cytotoxic effect was only observed for concentrations equal or higher than 25 μg/mL, which provides high confidence in the obtained results. The outcomes of this study suggest the suitability of using pessaries containing PRG-loaded NLC for sustained drug release, which is an innovative therapeutic strategy and constitutes a promising alternative for the vaginal use of PRG. However, further ex vivo and in vivo studies are needed to fully clarify the pharmacokinetic and toxicological profile before reaching the clinical use.pt_PT
dc.description.versioninfo:eu-repo/semantics/publishedVersionpt_PT
dc.identifier.doi10.1016/j.ejps.2020.105475pt_PT
dc.identifier.eissn1879-0720
dc.identifier.issn0928-0987
dc.identifier.urihttp://hdl.handle.net/10284/9818
dc.language.isoengpt_PT
dc.peerreviewedyespt_PT
dc.publisherElsevierpt_PT
dc.subjectNanostructured lipid carrierspt_PT
dc.subjectProgesteronept_PT
dc.subjectPessariespt_PT
dc.subjectVaginal deliverypt_PT
dc.titlePessaries containing Nanostructured Lipid Carriers (NLC) for prolonged vaginal delivery of progesteronept_PT
dc.typejournal article
dspace.entity.typePublication
oaire.citation.endPage9pt_PT
oaire.citation.startPage1pt_PT
oaire.citation.titleEuropean Journal of Pharmaceutical Sciencespt_PT
oaire.citation.volume153pt_PT
person.familyNameSilva
person.givenNameAna Catarina
person.identifier953153
person.identifier.ciencia-id5C1D-ED22-0D64
person.identifier.orcid0000-0001-6923-0232
person.identifier.ridF-1875-2017
person.identifier.scopus-author-id57028697500
rcaap.rightsrestrictedAccesspt_PT
rcaap.typearticlept_PT
relation.isAuthorOfPublication67e7f707-32ec-444a-a20d-a17f8e6e7c21
relation.isAuthorOfPublication.latestForDiscovery67e7f707-32ec-444a-a20d-a17f8e6e7c21

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