Considerations in the sterile manufacture of polymeric microneedle arrays

Drug Delivery and Translational Research
Maelíosa T C McCruddenRyan F Donnelly

Abstract

We describe, for the first time, considerations in the sterile manufacture of polymeric microneedle arrays. Microneedles (MN) made from dissolving polymeric matrices and loaded with the model drugs ovalbumin (OVA) and ibuprofen sodium and hydrogel-forming MN composed of "super-swelling" polymers and their corresponding lyophilised wafer drug reservoirs loaded with OVA and ibuprofen sodium were prepared aseptically or sterilised using commonly employed sterilisation techniques. Moist and dry heat sterilisation, understandably, damaged all devices, leaving aseptic production and gamma sterilisation as the only viable options. No measureable bioburden was detected in any of the prepared devices, and endotoxin levels were always below the US Food & Drug Administration limits (20 endotoxin units/device). Hydrogel-forming MN were unaffected by gamma irradiation (25 kGy) in terms of their physical properties or capabilities in delivering OVA and ibuprofen sodium across excised neonatal porcine skin in vitro. However, OVA content in dissolving MN (down from approximately 101.1 % recovery to approximately 58.3 % recovery) and lyophilised wafer-type drug reservoirs (down from approximately 99.7 % recovery to approximately 60.1 % recovery...Continue Reading

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Citations

Feb 26, 2016·Pharmaceutical Research·Eneko LarrañetaRyan F Donnelly
Jul 1, 2015·Drug Delivery and Translational Research·Joanne McCaffreyHelen O McCarthy
Apr 15, 2016·Therapeutic Delivery·Helen L QuinnRyan F Donnelly
May 29, 2015·Bioconjugate Chemistry·Ellen M Cahill, Eoin D O'Cearbhaill
Jun 12, 2016·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Ji-Yeon KimJung-Hwan Park
Jun 11, 2016·Journal of Drug Targeting·Hye-Rin JeongJung-Hwan Park
Dec 31, 2017·Drug Delivery and Translational Research·Tamara N TarboxRobert O Williams
Sep 12, 2018·Expert Opinion on Drug Delivery·Aoife M RodgersRyan F Donnelly
Jun 5, 2019·Pharmaceutics·Mahdi RoohnikanDavide Brambilla
May 30, 2015·Drug Delivery and Translational Research·Rebecca E M LuttonRyan F Donnelly
Jul 19, 2017·Pharmaceutical Research·M LeoneG Kersten
Mar 25, 2020·Drug Development and Industrial Pharmacy·Honnavar Parthasarathy SwathiHagalavadi Nanjappa Shivakumar
Oct 7, 2017·Sports Medicine - Open·Martin Anthony Christopher ManoukianCharles DeMesa
Jul 28, 2020·Micromachines·Hye-Rin JeongJung-Hwan Park
Feb 28, 2020·Drug Delivery and Translational Research·Rehan Al-KasasbehRyan F Donnelly
Aug 2, 2019·Science Translational Medicine·Won-Gyu BaeHoon Eui Jeong
Aug 3, 2020·Drug Delivery and Translational Research·Vahid AlimardaniMohammad Ashfaq
Feb 8, 2019·Therapeutic Delivery·Carlos GamazoRyan F Donnelly
Nov 27, 2020·Macromolecular Bioscience·Joseph G TurnerHannah S Leese
Jan 4, 2021·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Suman PahalPraveen Kumar Vemula
Jan 17, 2021·Drug Delivery and Translational Research·Emma McAlisterRyan F Donnelly
Sep 7, 2020·International Journal of Pharmaceutics·Akmal H SabriMaria Marlow
Mar 3, 2021·Journal of Materials Chemistry. B, Materials for Biology and Medicine·Miguel Angel Lopez-RamirezJoseph Wang
Aug 28, 2020·Biomedicine & Pharmacotherapy = Biomédecine & Pharmacothérapie·Xiao ZhuLiao Cui
Apr 9, 2021·Advanced Drug Delivery Reviews·Alejandro J ParedesRyan F Donnelly
Apr 20, 2021·Advanced Healthcare Materials·Jiaobing Tu, Wei Gao
Jun 11, 2021·Advanced Drug Delivery Reviews·Emma McAlisterRyan F Donnelly
Jun 15, 2021·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Praveen K Srivastava, Hetal P Thakkar
Aug 1, 2021·Journal of Materials Science. Materials in Medicine·Rupali S Bhadale, Vaishali Y Londhe
Jul 13, 2018·Molecular Pharmaceutics·Aaron J CourtenayRyan F Donnelly

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