A luminal unfolding microneedle injector for oral delivery of macromolecules.
Journal
Nature medicine
ISSN: 1546-170X
Titre abrégé: Nat Med
Pays: United States
ID NLM: 9502015
Informations de publication
Date de publication:
10 2019
10 2019
Historique:
received:
20
12
2018
accepted:
28
08
2019
pubmed:
9
10
2019
medline:
22
1
2020
entrez:
9
10
2019
Statut:
ppublish
Résumé
Insulin and other injectable biologic drugs have transformed the treatment of patients suffering from diabetes
Identifiants
pubmed: 31591601
doi: 10.1038/s41591-019-0598-9
pii: 10.1038/s41591-019-0598-9
pmc: PMC7218658
mid: NIHMS1565011
doi:
Substances chimiques
Insulin
0
Types de publication
Journal Article
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, Non-P.H.S.
Langues
eng
Sous-ensembles de citation
IM
Pagination
1512-1518Subventions
Organisme : NCI NIH HHS
ID : R01 CA075289
Pays : United States
Organisme : NIBIB NIH HHS
ID : R01 EB000244
Pays : United States
Organisme : NIBIB NIH HHS
ID : R37 EB000244
Pays : United States
Organisme : Foundation for the National Institutes of Health (Foundation for the National Institutes of Health, Inc.)
ID : R01-CA075289-21
Pays : International
Références
Turner, R. C., Cull, C. A., Frighi, V. & Holman, R. R. Glycemic control with diet, sulfonylurea, metformin, or insulin in patients with type 2 diabetes mellitus: progressive requirement for multiple therapies (UKPDS 49). J. Am. Med. Assoc. 281, 2005–2012 (1999).
doi: 10.1001/jama.281.21.2005
Pratley, R. E. et al. Liraglutide versus sitagliptin for patients with type 2 diabetes who did not have adequate glycaemic control with metformin: a 26-week, randomised, parallel-group, open-label trial. Lancet 375, 1447–1456 (2010).
doi: 10.1016/S0140-6736(10)60307-8
Korytkowski, M. When oral agents fail: practical barriers to starting insulin. Int. J. Obes. 26, S18–S24 (2002).
doi: 10.1038/sj.ijo.0802173
Boye, K. S. et al. Utilities and disutilities for attributes of injectable treatments for type 2 diabetes. Eur. J. Heal. Econ. 12, 219–230 (2011).
doi: 10.1007/s10198-010-0224-8
Calvert, M. J., McManus, R. J. & Freemantle, N. Management of type 2 diabetes with multiple oral hypoglycaemic agents or insulin in primary care: retrospective cohort study. Br. J. Gen. Pract. 57, 455–460 (2007).
pubmed: 17550670
pmcid: 2078170
Cleland, J. & Langer, R. in Formulation and Delivery of Proteins and Peptides (eds. Cleland, J. L. & Langer, R.) 1–19 (American Chemical Society, 1994).
Dallel, N., Kacem, M., Nabouli, R. M. & El May, M. Disposal of insulin syringes by diabetic patients. Report of 100 patients.Tunis. Med. 83, 390–392 (2005).
pubmed: 16220694
Anselmo, A. C., Gokarn, Y. & Mitragotri, S. Non-invasive delivery strategies for biologics. Nat. Rev. Drug Discov. 18, 19–40 (2018).
doi: 10.1038/nrd.2018.183
Harrison, G. A. Insulin in alcoholic solution by the mouth. Br. Med. J. 2, 1204–1205 (1923).
doi: 10.1136/bmj.2.3286.1204
Abramson, A. et al. An ingestible self-orienting system for oral delivery of macromolecules. Science 363, 611–615 (2019).
doi: 10.1126/science.aau2277
Traverso, G. et al. Microneedles for drug delivery via the gastrointestinal tract. J. Pharm. Sci. 104, 362–367 (2015).
doi: 10.1002/jps.24182
Scudellari, M. Shot to the Gut: “Robotic” Pill Sails Through Human Safety Study. https://spectrum.ieee.org/the-human-os/biomedical/devices/shot-to-the-gut-robotic-pill-sails-through-human-safety-study (accessed 25 September 2019).
Vllasaliu, D., Thanou, M., Stolnik, S. & Fowler, R. Recent advances in oral delivery of biologics: nanomedicine and physical modes of delivery. Expert Opin. Drug Deliv. 15, 759–770 (2018).
doi: 10.1080/17425247.2018.1504017
Davies, M. et al. Effect of oral semaglutide compared with placebo and subcutaneous semaglutide on glycemic control in patients with type 2 diabetes. J. Am. Med. Assoc. 318, 1460–1470 (2017).
doi: 10.1001/jama.2017.14752
Banerjee, A. et al. Ionic liquids for oral insulin delivery. Proc. Natl Acad. Sci. USA 115, 7296–7301 (2018).
doi: 10.1073/pnas.1722338115
Mathiowitz, E. et al. Biologically erodable microspheres as potential oral drug delivery systems. Nature 386, 410–414 (1997).
doi: 10.1038/386410a0
Pridgen, E. M., Alexis, F. & Farokhzad, O. C. Polymeric nanoparticle drug delivery technologies for oral delivery applications. Expert Opin. Drug Deliv. 12, 1459–1473 (2015).
doi: 10.1517/17425247.2015.1018175
Banerjee, A., Wong, J., Gogoi, R., Brown, T. & Mitragotri, S. Intestinal micropatches for oral insulin delivery. J. Drug Target. 25, 608–615 (2017).
doi: 10.1080/1061186X.2017.1300664
Mitragotri, S., Burke, P. A. & Langer, R. Overcoming the challenges in administering biopharmaceuticals: formulation and delivery strategies. Nat. Rev. Drug Discov. 13, 655–672 (2014).
doi: 10.1038/nrd4363
Bass, D. M., Prevo, M. & Waxman, D. S. Gastrointestinal safety of an extended-release, nondeformable, oral dosage form (OROS): a retrospective study. Drug Saf. 25, 1021–1033 (2002).
doi: 10.2165/00002018-200225140-00004
Coffey, J. W., Meliga, S. C., Corrie, S. R. & Kendall, M. A. F. Dynamic application of microprojection arrays to skin induces circulating protein extravasation for enhanced biomarker capture and detection. Biomaterials 84, 130–143 (2016).
doi: 10.1016/j.biomaterials.2016.01.015
Gatto, N. M. et al. Risk of perforation after colonoscopy and sigmoidoscopy: a population-based study. J. Natl Cancer Inst. 95, 230–236 (2003).
doi: 10.1093/jnci/95.3.230
Podolsky, D. K. Healing the epithelium: solving the problem from two sides. J. Gastroenterol. 32, 122–126 (1997).
doi: 10.1007/BF01213309
Classen, M., Tytgat, G. & Lightdale, C. Gastroenterological Endoscopy (Thieme, 2010).
Velitchkov, N. G., Grigorov, G. I., Losanoff, J. E. & Kjossev, K. T. Ingested foreign bodies of the gastrointestinal tract: retrospective analysis of 542 cases. World J. Surg. 20, 1001–1005 (1996).
doi: 10.1007/s002689900152
Sandler, R. S., Stewart, W. F., Liberman, J. N., Ricci, J. A. & Zorich, N. L. Abdominal pain, bloating, and diarrhea in the United States. Dig. Dis. Sci. 45, 1166–1171 (2000).
doi: 10.1023/A:1005554103531
Bass, D. M., Prevo, M. & Waxman, D. S. Gastrointestinal safety of an extended-release, nondeformable, oral dosage form (OROS: a retrospective study). Drug Saf. 25, 1021–1033 (2002).
doi: 10.2165/00002018-200225140-00004
Iddan, G., Meron, G., Glukhovsky, A. & Swain, P. Wireless capsule endoscopy. Nature 405, 417 (2000).
doi: 10.1038/35013140
Hellmig, S. et al. Gastric emptying time of fluids and solids in healthy subjects determined by
doi: 10.1111/j.1440-1746.2006.04449.x
Wang, Y. R., Fisher, R. S. & Parkman, H. P. Gastroparesis-related hospitalizations in the United States: trends, characteristics, and outcomes, 1995–2004. Am. J. Gastroenterol. 103, 313–322 (2008).
doi: 10.1111/j.1572-0241.2007.01658.x
Snoeck, V. et al. Gastrointestinal transit time of nondisintegrating radio-opaque pellets in suckling and recently weaned piglets. J. Control. Release 94, 143–153 (2004).
doi: 10.1016/j.jconrel.2003.09.015
Cole, E. T. et al. Enteric coated HPMC capsules designed to achieve intestinal targeting. Int. J. Pharm. 231, 83–95 (2002).
doi: 10.1016/S0378-5173(01)00871-7
Ye, Y., Yu, J., Wen, D. & Kahkoska, A. R. Polymeric microneedles for transdermal protein delivery. Adv. Drug Deliv. Rev. 127, 106–118 (2018).
doi: 10.1016/j.addr.2018.01.015
Van Meer, L. et al. Injection site reactions after subcutaneous oligonucleotide therapy. Br. J. Clin. Pharmacol. 82, 340–351 (2016).
doi: 10.1111/bcp.12961
Fallingborg, J. Intraluminal pH of the human gastrointestinal tract. Dan. Med. Bull. 46, 183–196 (1999).
pubmed: 10421978