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A facile system to evaluate in vitro drug release from dissolving microneedle arrays

The use of biological tissues in the in vitro assessments of dissolving (?) microneedle (MN) array mechanical strength and subsequent drug release profiles presents some fundamental difficulties, in part due to inherent variability of the biological tissues employed. As a result, these biological ma...

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Autores principales: Larrañeta, Eneko, Stewart, Sarah, Fallows, Steven J., Birkhäuer, Lena L., McCrudden, Maeliosa T.C., Woolfson, A. David, Donnelly, Ryan F.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier/North-Holland Biomedical Press 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4722988/
https://www.ncbi.nlm.nih.gov/pubmed/26621687
http://dx.doi.org/10.1016/j.ijpharm.2015.11.038
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author Larrañeta, Eneko
Stewart, Sarah
Fallows, Steven J.
Birkhäuer, Lena L.
McCrudden, Maeliosa T.C.
Woolfson, A. David
Donnelly, Ryan F.
author_facet Larrañeta, Eneko
Stewart, Sarah
Fallows, Steven J.
Birkhäuer, Lena L.
McCrudden, Maeliosa T.C.
Woolfson, A. David
Donnelly, Ryan F.
author_sort Larrañeta, Eneko
collection PubMed
description The use of biological tissues in the in vitro assessments of dissolving (?) microneedle (MN) array mechanical strength and subsequent drug release profiles presents some fundamental difficulties, in part due to inherent variability of the biological tissues employed. As a result, these biological materials are not appropriate for routine used in industrial formulation development or quality control (QC) tests. In the present work a facile system using Parafilm M(®) (PF) to test drug permeation performance using dissolving MN arrays is proposed. Dissolving MN arrays containing 196 needles (600 μm needle height) were inserted into a single layer of PF and a hermetic “pouch” was created including the array inside. The resulting system was placed in a dissolution bath and the release of model molecules was evaluated. Different MN formulations were tested using this novel setup, releasing between 40 and 180 μg of their cargos after 6 h. The proposed system is a more realistic approach for MN testing than the typical performance test described in the literature for conventional transdermal patches. Additionally, the use of PF membrane was tested either in the hermetic “pouch” and using Franz Cell methodology yielding comparable release curves. Microscopy was used in order to ascertain the insertion of the different MN arrays in the PF layer. The proposed system appears to be a good alternative to the use of Franz cells in order to compare different MN formulations. Given the increasing industrial interest in MN technology, the proposed system has potential as a standardised drug/active agent release test for quality control purposes.
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spelling pubmed-47229882016-02-18 A facile system to evaluate in vitro drug release from dissolving microneedle arrays Larrañeta, Eneko Stewart, Sarah Fallows, Steven J. Birkhäuer, Lena L. McCrudden, Maeliosa T.C. Woolfson, A. David Donnelly, Ryan F. Int J Pharm Article The use of biological tissues in the in vitro assessments of dissolving (?) microneedle (MN) array mechanical strength and subsequent drug release profiles presents some fundamental difficulties, in part due to inherent variability of the biological tissues employed. As a result, these biological materials are not appropriate for routine used in industrial formulation development or quality control (QC) tests. In the present work a facile system using Parafilm M(®) (PF) to test drug permeation performance using dissolving MN arrays is proposed. Dissolving MN arrays containing 196 needles (600 μm needle height) were inserted into a single layer of PF and a hermetic “pouch” was created including the array inside. The resulting system was placed in a dissolution bath and the release of model molecules was evaluated. Different MN formulations were tested using this novel setup, releasing between 40 and 180 μg of their cargos after 6 h. The proposed system is a more realistic approach for MN testing than the typical performance test described in the literature for conventional transdermal patches. Additionally, the use of PF membrane was tested either in the hermetic “pouch” and using Franz Cell methodology yielding comparable release curves. Microscopy was used in order to ascertain the insertion of the different MN arrays in the PF layer. The proposed system appears to be a good alternative to the use of Franz cells in order to compare different MN formulations. Given the increasing industrial interest in MN technology, the proposed system has potential as a standardised drug/active agent release test for quality control purposes. Elsevier/North-Holland Biomedical Press 2016-01-30 /pmc/articles/PMC4722988/ /pubmed/26621687 http://dx.doi.org/10.1016/j.ijpharm.2015.11.038 Text en © 2015 The Authors http://creativecommons.org/licenses/by/4.0/ This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Larrañeta, Eneko
Stewart, Sarah
Fallows, Steven J.
Birkhäuer, Lena L.
McCrudden, Maeliosa T.C.
Woolfson, A. David
Donnelly, Ryan F.
A facile system to evaluate in vitro drug release from dissolving microneedle arrays
title A facile system to evaluate in vitro drug release from dissolving microneedle arrays
title_full A facile system to evaluate in vitro drug release from dissolving microneedle arrays
title_fullStr A facile system to evaluate in vitro drug release from dissolving microneedle arrays
title_full_unstemmed A facile system to evaluate in vitro drug release from dissolving microneedle arrays
title_short A facile system to evaluate in vitro drug release from dissolving microneedle arrays
title_sort facile system to evaluate in vitro drug release from dissolving microneedle arrays
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4722988/
https://www.ncbi.nlm.nih.gov/pubmed/26621687
http://dx.doi.org/10.1016/j.ijpharm.2015.11.038
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