Broadband Acoustic Resonance Dissolution Spectroscopy (BARDS): a rapid test for enteric coating thickness and integrity of controlled release pellet formulations

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dc.contributor.authorDillon, Amy
dc.contributor.authorAlfarsi, Anas
dc.contributor.authorMcSweeney, Seán
dc.contributor.authorKrüse, Jacob
dc.contributor.authorGriffin, Brendan T.
dc.contributor.authorDevine, Ken J.
dc.contributor.authorSherry, Patricia
dc.contributor.authorHenken, Stephan
dc.contributor.authorFitzpatrick, Stephen
dc.contributor.authorFitzpatrick, Dara
dc.contributor.funderMinistry of Education, Saudi Arabia
dc.date.accessioned2018-04-18T12:12:18Z
dc.date.available2018-04-18T12:12:18Z
dc.date.issued2018-04-12
dc.date.updated2018-04-18T12:02:11Z
dc.description.abstractThere are no rapid dissolution based tests for determining coating thickness, integrity and drug concentration in controlled release pellets either during production or post-production. The manufacture of pellets requires several coating steps depending on the formulation. The sub-coating and enteric coating steps typically take up to six hours each followed by additional drying steps. Post production regulatory dissolution testing also takes up to six hours to determine if the batch can be released for commercial sale. The thickness of the enteric coating is a key factor that determines the release rate of the drug in the gastro-intestinal tract. Also, the amount of drug per unit mass decreases with increasing thickness of the enteric coating. In this study, the coating process is tracked from start to finish on an hourly basis by taking samples of pellets during production and testing those using BARDS (Broadband Acoustic Resonance Dissolution Spectroscopy). BARDS offers a rapid approach to characterising enteric coatings with measurements based on reproducible changes in the compressibility of a solvent due to the evolution of air during dissolution. This is monitored acoustically via associated changes in the frequency of induced acoustic resonances. A steady state acoustic lag time is associated with the disintegration of the enteric coatings in basic solution. This lag time is pH dependent and is indicative of the rate at which the coating layer dissolves. BARDS represents a possible future surrogate test for conventional USP dissolution testing as its data correlates directly with the thickness of the enteric coating, its integrity and also with the drug loading as validated by HPLC.en
dc.description.sponsorshipMinistry of Education, Saudi Arabia (Ph.D. funding)en
dc.description.statusPeer revieweden
dc.description.versionAccepted Versionen
dc.format.mimetypeapplication/pdfen
dc.identifier.citationAlfarsi, A., Dillon, A., McSweeney, S., Krüse, J., Griffin, B., Devine, K., Sherry, P., Henken, S., Fitzpatrick, S. and Fitzpatrick, D. (2018) ‘Broadband Acoustic Resonance Dissolution Spectroscopy (BARDS): a rapid test for enteric coating thickness and integrity of controlled release pellet formulations', International Journal of Pharmaceutics. doi:10.1016/j.ijpharm.2018.04.018en
dc.identifier.doi10.1016/j.ijpharm.2018.04.018
dc.identifier.issn0378-5173
dc.identifier.journaltitleInternational Journal of Pharmaceuticsen
dc.identifier.urihttps://hdl.handle.net/10468/5819
dc.language.isoenen
dc.publisherElsevier B.V.en
dc.rights© 2018, Elsevier B.V. All rights reserved. This manuscript version is made available under the CC-BY-NC-ND 4.0 license.en
dc.rights.urihttps://creativecommons.org/licenses/by-nc-nd/4.0/en
dc.subjectHypromelloseen
dc.subjectEnteric coated pelletsen
dc.subjectDissolutionen
dc.subjectBARDSen
dc.titleBroadband Acoustic Resonance Dissolution Spectroscopy (BARDS): a rapid test for enteric coating thickness and integrity of controlled release pellet formulationsen
dc.typeArticle (peer-reviewed)en
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