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  • 1.
    Abramson, Alex
    et al.
    MIT, Dept Chem Engn, Cambridge, MA 02139 USA.;MIT, David H Koch Inst Integrat Canc Res, Cambridge, MA 02139 USA..
    Caffarel-Salvador, Ester
    MIT, Dept Chem Engn, Cambridge, MA 02139 USA.;MIT, David H Koch Inst Integrat Canc Res, Cambridge, MA 02139 USA.;MIT, Inst Med Engn & Sci, 77 Massachusetts Ave, Cambridge, MA 02139 USA..
    Khang, Minsoo
    MIT, Dept Chem Engn, Cambridge, MA 02139 USA.;MIT, David H Koch Inst Integrat Canc Res, Cambridge, MA 02139 USA..
    Dellal, David
    MIT, Inst Med Engn & Sci, 77 Massachusetts Ave, Cambridge, MA 02139 USA..
    Silverstein, David
    MIT, Dept Chem Engn, Cambridge, MA 02139 USA.;MIT, David H Koch Inst Integrat Canc Res, Cambridge, MA 02139 USA..
    Gao, Yuan
    MIT, Dept Chem Engn, Cambridge, MA 02139 USA.;MIT, David H Koch Inst Integrat Canc Res, Cambridge, MA 02139 USA..
    Frederiksen, Morten Revsgaard
    Novo Nordisk AS, Global Res Technol, Global Drug Discovery & Device R&D, Copenhagen, Denmark..
    Vegge, Andreas
    Novo Nordisk AS, Global Res Technol, Global Drug Discovery & Device R&D, Copenhagen, Denmark..
    Hubalek, Frantisek
    Novo Nordisk AS, Global Res Technol, Global Drug Discovery & Device R&D, Copenhagen, Denmark..
    Water, Jorrit J.
    Novo Nordisk AS, Global Res Technol, Global Drug Discovery & Device R&D, Copenhagen, Denmark..
    Friderichsen, Anders V.
    Novo Nordisk AS, Global Res Technol, Global Drug Discovery & Device R&D, Copenhagen, Denmark..
    Fels, Johannes
    Novo Nordisk AS, Global Res Technol, Global Drug Discovery & Device R&D, Copenhagen, Denmark..
    Kirk, Rikke Kaae
    Novo Nordisk AS, Global Res Technol, Global Drug Discovery & Device R&D, Copenhagen, Denmark..
    Cleveland, Cody
    MIT, Dept Chem Engn, Cambridge, MA 02139 USA.;MIT, David H Koch Inst Integrat Canc Res, Cambridge, MA 02139 USA.;Novo Nordisk AS, Global Res Technol, Global Drug Discovery & Device R&D, Copenhagen, Denmark..
    Collins, Joy
    MIT, Dept Chem Engn, Cambridge, MA 02139 USA.;MIT, David H Koch Inst Integrat Canc Res, Cambridge, MA 02139 USA..
    Tamang, Siddartha
    MIT, Dept Chem Engn, Cambridge, MA 02139 USA.;MIT, David H Koch Inst Integrat Canc Res, Cambridge, MA 02139 USA..
    Hayward, Alison
    MIT, Dept Chem Engn, Cambridge, MA 02139 USA.;MIT, David H Koch Inst Integrat Canc Res, Cambridge, MA 02139 USA.;MIT, Div Comparat Med, Cambridge, MA 02139 USA..
    Landh, Tomas
    Novo Nordisk AS, Global Res Technol, Global Drug Discovery & Device R&D, Copenhagen, Denmark..
    Buckley, Stephen T.
    Novo Nordisk AS, Global Res Technol, Global Drug Discovery & Device R&D, Copenhagen, Denmark..
    Roxhed, Niclas
    KTH, School of Electrical Engineering and Computer Science (EECS), Micro and Nanosystems.
    Rahbek, Ulrik
    Novo Nordisk AS, Global Res Technol, Global Drug Discovery & Device R&D, Copenhagen, Denmark..
    Langer, Robert
    MIT, Dept Chem Engn, Cambridge, MA 02139 USA.;MIT, David H Koch Inst Integrat Canc Res, Cambridge, MA 02139 USA.;MIT, Inst Med Engn & Sci, 77 Massachusetts Ave, Cambridge, MA 02139 USA.;MIT, Media Lab, Cambridge, MA 02139 USA..
    Traverso, Giovanni
    MIT, Dept Chem Engn, Cambridge, MA 02139 USA.;MIT, David H Koch Inst Integrat Canc Res, Cambridge, MA 02139 USA.;MIT, Dept Mech Engn, Cambridge, MA 02139 USA.;Harvard Med Sch, Brigham & Womens Hosp, Div Gastroenterol, Boston, MA 02115 USA..
    An ingestible self-orienting system for oral delivery of macromolecules2019In: Science, ISSN 0036-8075, E-ISSN 1095-9203, Vol. 363, no 6427, p. 611-+Article in journal (Refereed)
    Abstract [en]

    Biomacromolecules have transformed our capacity to effectively treat diseases; however, their rapid degradation and poor absorption in the gastrointestinal (GI) tract generally limit their administration to parenteral routes. An oral biologic delivery system must aid in both localization and permeation to achieve systemic drug uptake. Inspired by the leopard tortoise's ability to passively reorient, we developed an ingestible self-orienting millimeter-scale applicator (SOMA) that autonomously positions itself to engage with GI tissue. It then deploys milliposts fabricated from active pharmaceutical ingredients directly through the gastric mucosa while avoiding perforation. We conducted in vivo studies in rats and swine that support the applicator's safety and, using insulin as a model drug, demonstrated that the SOMA delivers active pharmaceutical ingredient plasma levels comparable to those achieved with subcutaneous millipost administration.

  • 2.
    Abramson, Alex
    et al.
    MIT, Dept Chem Engn, Cambridge, MA 02139 USA.;MIT, David H Koch Inst Integrat Canc Res, 77 Massachusetts Ave, Cambridge, MA 02139 USA..
    Caffarel-Salvador, Ester
    MIT, Dept Chem Engn, Cambridge, MA 02139 USA.;MIT, David H Koch Inst Integrat Canc Res, 77 Massachusetts Ave, Cambridge, MA 02139 USA.;MIT, Inst Med Engn & Sci, 77 Massachusetts Ave, Cambridge, MA 02139 USA..
    Soares, Vance
    MIT, Dept Chem Engn, Cambridge, MA 02139 USA.;MIT, David H Koch Inst Integrat Canc Res, 77 Massachusetts Ave, Cambridge, MA 02139 USA..
    Minahan, Daniel
    MIT, Dept Chem Engn, Cambridge, MA 02139 USA.;MIT, David H Koch Inst Integrat Canc Res, 77 Massachusetts Ave, Cambridge, MA 02139 USA..
    Tian, Ryan Yu
    MIT, Dept Chem Engn, Cambridge, MA 02139 USA.;MIT, David H Koch Inst Integrat Canc Res, 77 Massachusetts Ave, Cambridge, MA 02139 USA..
    Lu, Xiaoya
    MIT, Dept Chem Engn, Cambridge, MA 02139 USA.;MIT, David H Koch Inst Integrat Canc Res, 77 Massachusetts Ave, Cambridge, MA 02139 USA..
    Dellal, David
    MIT, David H Koch Inst Integrat Canc Res, 77 Massachusetts Ave, Cambridge, MA 02139 USA.;MIT, Inst Med Engn & Sci, 77 Massachusetts Ave, Cambridge, MA 02139 USA..
    Gao, Yuan
    MIT, Dept Chem Engn, Cambridge, MA 02139 USA.;MIT, David H Koch Inst Integrat Canc Res, 77 Massachusetts Ave, Cambridge, MA 02139 USA..
    Kim, Soyoung
    MIT, Dept Chem Engn, Cambridge, MA 02139 USA.;MIT, David H Koch Inst Integrat Canc Res, 77 Massachusetts Ave, Cambridge, MA 02139 USA..
    Wainer, Jacob
    MIT, Dept Chem Engn, Cambridge, MA 02139 USA.;MIT, David H Koch Inst Integrat Canc Res, 77 Massachusetts Ave, Cambridge, MA 02139 USA..
    Collins, Joy
    MIT, Dept Chem Engn, Cambridge, MA 02139 USA.;MIT, David H Koch Inst Integrat Canc Res, 77 Massachusetts Ave, Cambridge, MA 02139 USA..
    Tamang, Siddartha
    MIT, Dept Chem Engn, Cambridge, MA 02139 USA.;MIT, David H Koch Inst Integrat Canc Res, 77 Massachusetts Ave, Cambridge, MA 02139 USA..
    Hayward, Alison
    MIT, Dept Chem Engn, Cambridge, MA 02139 USA.;MIT, David H Koch Inst Integrat Canc Res, 77 Massachusetts Ave, Cambridge, MA 02139 USA.;MIT, Div Comparat Med, Cambridge, MA 02139 USA..
    Yoshitake, Tadayuki
    MIT, Dept Elect Engn & Comp Sci, Cambridge, MA 02139 USA.;MIT, Elect Res Lab, Cambridge, MA 02139 USA..
    Lee, Hsiang-Chieh
    MIT, Dept Elect Engn & Comp Sci, Cambridge, MA 02139 USA.;MIT, Elect Res Lab, Cambridge, MA 02139 USA..
    Fujimoto, James
    MIT, Dept Elect Engn & Comp Sci, Cambridge, MA 02139 USA.;MIT, Elect Res Lab, Cambridge, MA 02139 USA..
    Fels, Johannes
    Global Drug Discovery, Global Res Technol, Malov, Denmark.;Novo Nordisk, Device R&D, Malov, Denmark..
    Frederiksen, Morten Revsgaard
    Global Drug Discovery, Global Res Technol, Malov, Denmark.;Novo Nordisk, Device R&D, Malov, Denmark..
    Rahbek, Ulrik
    Global Drug Discovery, Global Res Technol, Malov, Denmark.;Novo Nordisk, Device R&D, Malov, Denmark..
    Roxhed, Niclas
    KTH, School of Electrical Engineering and Computer Science (EECS), Micro and Nanosystems. MIT, Dept Chem Engn, Cambridge, MA 02139 USA.;MIT, David H Koch Inst Integrat Canc Res, 77 Massachusetts Ave, Cambridge, MA 02139 USA..
    Langer, Robert
    MIT, Dept Chem Engn, Cambridge, MA 02139 USA.;MIT, David H Koch Inst Integrat Canc Res, 77 Massachusetts Ave, Cambridge, MA 02139 USA.;MIT, Inst Med Engn & Sci, 77 Massachusetts Ave, Cambridge, MA 02139 USA.;MIT, Dept Mech Engn, Cambridge, MA 02139 USA.;MIT, Media Lab, Cambridge, MA 02139 USA..
    Traverso, Giovanni
    MIT, Dept Chem Engn, Cambridge, MA 02139 USA.;MIT, David H Koch Inst Integrat Canc Res, 77 Massachusetts Ave, Cambridge, MA 02139 USA.;MIT, Dept Mech Engn, Cambridge, MA 02139 USA.;Harvard Med Sch, Brigham & Womens Hosp, Div Gastroenterol, Boston, MA 02115 USA..
    A luminal unfolding microneedle injector for oral delivery of macromolecules2019In: Nature Medicine, ISSN 1078-8956, E-ISSN 1546-170X, Vol. 25, no 10, p. 1512-+Article in journal (Refereed)
    Abstract [en]

    Insulin and other injectable biologic drugs have transformed the treatment of patients suffering from diabetes(1,2), yet patients and healthcare providers often prefer to use and prescribe less effective orally dosed medications(3-5). Compared with subcutaneously administered drugs, oral formulations create less patient discomfort(4), show greater chemical stability at high temperatures(6), and do not generate biohazardous needle waste(7). An oral dosage form for biologic medications is ideal; however, macromolecule drugs are not readily absorbed into the bloodstream through the gastrointestinal tract(8). We developed an ingestible capsule, termed the luminal unfolding microneedle injector, which allows for the oral delivery of biologic drugs by rapidly propelling dissolvable drug-loaded microneedles into intestinal tissue using a set of unfolding arms. During ex vivo human and in vivo swine studies, the device consistently delivered the microneedles to the tissue without causing complete thickness perforations. Using insulin as a model drug, we showed that, when actuated, the luminal unfolding microneedle injector provided a faster pharmacokinetic uptake profile and a systemic uptake > 10% of that of a subcutaneous injection over a 4-h sampling period. With the ability to load a multitude of microneedle formulations, the device can serve as a platform to orally deliver therapeutic doses of macromolecule drugs.

1 - 2 of 2
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