In vivo investigation of (2-hydroxypropyl)-β-cyclodextrin-based formulation of spironolactone in aqueous solution for paediatric use

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dc.contributor.authorLopalco, Antonio
dc.contributor.authorManni, Annachiara
dc.contributor.authorKeeley, Alexander
dc.contributor.authorHaider, Shozeb
dc.contributor.authorLi, Wenliang
dc.contributor.authorLopedota, Angela
dc.contributor.authorAltomare, Cosimo Damiano
dc.contributor.authorDenora, Nunzio
dc.contributor.authorTuleu, Catherine
dc.date.accessioned2022-04-11T09:54:44Z
dc.date.available2022-04-11T09:54:44Z
dc.date.issued2022-04-03
dc.description.abstractSpironolactone (SPL), a potent anti-aldosterone steroidal drug used to treat several diseases in paediatric patients (e.g., hypertension, primary aldosteronism, Bartter’s syndrome, and congestive heart failure), is not available in child-friendly dosage forms, and spironolactone liquids have been reported to be unpalatable. Aiming to enhance SPL solubility in aqueous solution and overcome palatability, herein, the effects of (2-hydroxypropyl)-β-cyclodextrin (HP-β-CyD) were thoroughly investigated on solubilisation in water and on masking the unpleasant taste of SPL in vivo. Although the complexation of SPL with HP-β-CyD was demonstrated through phase solubility studies, Job’s plot, NMR and computational docking studies, our in vivo tests did not show significant effects on taste aversion. Our findings, on the one hand, suggest that the formation of an inclusion complex of SPL with HP-β-CyD itself is not necessarily a good indicator for an acceptable degree of palatability, whereas, on the other hand, they constitute the basis for investigating other cyclodextrin-based formulations of the poorly water-soluble steroidal drug, including solid dosage forms, such as spray-dried powders and orodispersible tablets.en_UK
dc.identifier.citationLopalco A, Manni A, Keeley A, et al., (2022) In vivo investigation of (2-hydroxypropyl)-β-cyclodextrin-based formulation of spironolactone in aqueous solution for paediatric use. Pharmaceutics, Volume 14, Issue 4, April 2022, Article number 780en_UK
dc.identifier.issn1999-4923
dc.identifier.urihttps://doi.org/10.3390/pharmaceutics14040780
dc.identifier.urihttp://dspace.lib.cranfield.ac.uk/handle/1826/17759
dc.language.isoenen_UK
dc.publisherMDPIen_UK
dc.rightsAttribution 4.0 International*
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/*
dc.subjectspironolactoneen_UK
dc.subjecthydroxypropyl-β-cyclodextrinen_UK
dc.subjectpalatabilityen_UK
dc.subjectcyclodextrin inclusionen_UK
dc.subjectphase solubility studyen_UK
dc.subjectbrief-access taste aversionen_UK
dc.subjecthuman taste panelen_UK
dc.subjectpaediatric formulationen_UK
dc.titleIn vivo investigation of (2-hydroxypropyl)-β-cyclodextrin-based formulation of spironolactone in aqueous solution for paediatric useen_UK
dc.typeArticleen_UK

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