2018
DOI: 10.1016/j.jconrel.2018.08.042
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Preparation, properties and challenges of the microneedles-based insulin delivery system

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Cited by 111 publications
(63 citation statements)
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References 150 publications
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“…Demonstration of pharmacokinetic equivalence will be a central part of the approval pathway. Additionally, a number of novel devices targeting minimally invasive insulin delivery at high precision will require in vivo validation studies with accurate insulin quantification [20], especially in view of the new Medical Device Regulation coming into force in May 2021 in Europe [21]. Despite the many clinical benefits of IDeg and hence increasing popularity, the underlying complex biochemical structure poses challenges to its measurement.…”
Section: Discussionmentioning
confidence: 99%
“…Demonstration of pharmacokinetic equivalence will be a central part of the approval pathway. Additionally, a number of novel devices targeting minimally invasive insulin delivery at high precision will require in vivo validation studies with accurate insulin quantification [20], especially in view of the new Medical Device Regulation coming into force in May 2021 in Europe [21]. Despite the many clinical benefits of IDeg and hence increasing popularity, the underlying complex biochemical structure poses challenges to its measurement.…”
Section: Discussionmentioning
confidence: 99%
“…[47,48] Different research groups recently published the effects of MNs on dermatological problems such as scars and keloids. [54] Finally, the most relevant paper published in the field describes the results of a phase 1 clinical trial study on human vaccination against influenza. Exhaustive reviews on dermatological studies involving humans can also be found in the recent literature.…”
Section: Translational Challengesmentioning
confidence: 99%
“…[51][52][53] MN-based insulin delivery systems are reviewed in the paper of Chen et al, which reports on the full chain from the materials to the commercial devices available on the market. [54] Finally, the most relevant paper published in the field describes the results of a phase 1 clinical trial study on human vaccination against influenza. [55] One hundred patients were enrolled in the experiment, and the results demonstrated that the use of dissolvable MN patches for the influenza vaccination was well tolerated and generated robust antibody responses.…”
Section: Translational Challengesmentioning
confidence: 99%
“…In this sense, advanced biomedical technology will comprise implantable MEMS devices of proven biocompatibility (Voskerician et al, 2003), to carefully release drugs into the body from micro-chambers hosted in the device, eliminating the need for injections or needles (Grayson et al, 2004;Vasudev and Bhansali, 2013). The delivery of antibiotics, anti-inflammatories and analgesics is one such promising application, as also is the delivery of chemotherapy drugs or even hormones as the archetypical insulin (Shawgo et al, 2002;Chen et al, 2018). It is to note that these investigations could be enhanced by the incorporation of stimuli sensitive and/or targeted nanocarriers (Couvreur, 2013;Gonzalo et al, 2013;Jhaveri and Torchilin, 2014;das Neves et al, 2015;Kumar et al, 2018) within MEMS devices and the use of microfluidic organ-on-a-chip platforms for testing these drug delivery systems (Bhise et al, 2014).…”
Section: Introductionmentioning
confidence: 99%